Pigmentary demarcation lines (PDLs) are physiological abrupt transitions between hyperpigmented and lighter skin, a common and sometimes troubling feature of normal skin. They are seen in a majority of dark‐complexioned women and a substantial percentage of light‐complexioned ones too. We review this salient finding and approaches to its management.
3D Printing and Additive Manufacturing, Ahead of Print.
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AbstractBackground.Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors.Materials and Methods.Consecutive patients with advanced cancer, treated with anti‐programmed death‐1 (PD‐1) agents, were evaluated according to the presence of pre‐existing AIDs. The incidence of immune‐related adverse events (irAEs) and clinical outcomes were compared among subgroups.Results.A total of 751 patients were enrolled; median age was 69 years. Primary tumors were as follows: non‐small cell lung cancer, 492 (65.5%); melanoma, 159 (21.2%); kidney cancer, 94 (12.5%); and others, 6 (0.8%). Male/female ratio was 499/252. Eighty‐five patients (11.3%) had pre‐existing AIDs, further differentiated in clinically active (17.6%) and inactive (82.4%). Among patients with pre‐existing AIDs, incidence of irAEs of any grade was significantly higher when compared with patients without AIDs (65.9% vs. 39.9%). At multivariate analysis, both inactive (p = .0005) and active pre‐existing AIDs (p = .0162), female sex (p = .0004), and Eastern Cooperative Oncology Group Performance Status <2 (p = .0030) were significantly related to a higher incidence of irAEs of any grade. No significant differences were observed regarding grade 3/4 irAEs and objective response rate among subgroups. Pre‐existing AIDs were not significantly related with progression‐free survival and overall survival.Conclusion.This study quantifies the increased risk of developing irAEs in patients with pre‐existing AIDs who had to be treated with anti‐PD‐1 immunotherapy. Nevertheless, the incidence of grade 3/4 irAEs is not significantly higher when compared with control population. The finding of a greater incidence of irAEs among female patients ranks among the "hot topics" in gender‐related differences in immuno‐oncology.Implications for Practice.Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors but are frequent in clinical practice. This study quantifies the increased risk of developing immune‐related adverse events (irAEs) in patients with pre‐existing AIDs who had to be treated with anti‐programmed death‐1 immunotherapy. Nevertheless, their toxicities are mild and the incidence of grade 3/4 irAEs is not significantly higher compared with those of controls. These results will help clinicians in everyday practice, improving their ability to offer a proper counselling to patients, in order to offer an immunotherapy treatment even to patients with pre‐existing autoimmune disease.
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AbstractBackground.Up to 30% of patients with cancer continue to suffer from pain despite aggressive supportive care. The present study aimed to determine whether cordotomy can improve cancer pain refractory to interdisciplinary palliative care.Materials and Methods.In this randomized controlled trial, we recruited patients with refractory unilateral somatic pain, defined as a pain intensity (PI) ≥4, after more than three palliative care evaluations. Patients were randomized to percutaneous computed tomography‐guided cordotomy or continued interdisciplinary palliative care. The primary outcome was 33% improvement in PI at 1 week after cordotomy or study enrollment as measured by the Edmonton Symptom Assessment Scale.Results.Sixteen patients were enrolled (nine female, median age 58 years). Six of seven patients (85.7%) randomized to cordotomy experienced >33% reduction in PI (median preprocedure PI = 7, range 6–10; 1 week after cordotomy median PI = 1, range 0–6; p = .022). Zero of nine patients randomized to palliative care achieved a 33% reduction in PI. Seven patients (77.8%) randomized to palliative care elected to undergo cordotomy after 1 week. All of these patients experienced >33% reduction in PI (median preprocedure PI = 8, range 4–10; 1 week after cordotomy median PI = 0, range 0–1; p = .022). No patients were withdrawn from the study because of adverse effects of the intervention.Conclusion.These data support the use of cordotomy for pain refractory to optimal palliative care. The findings of this study justify a large‐scale randomized controlled trial of percutaneous cordotomy.Implications for Practice.This prospective clinical trial was designed to determine the improvement in pain intensity in patients randomized to either undergo cordotomy or comprehensive palliative care for medically refractory cancer pain. This study shows that cordotomy is effective in reducing pain for medically refractory cancer pain, and these results can be used to design a large‐scale comparative randomized controlled trial that could provide the evidence needed to include cordotomy as a treatment modality in the guidelines for cancer pain management.
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AbstractIntroduction.To reduce health care costs and improve care, payers and physician groups are piloting value‐based and episodic or bundled‐care payment models in oncology. Disease progression and associated costs may affect these models, particularly if such programs do not account for disease severity and progression risk across patient populations. This study estimated the incremental cost of disease progression in patients diagnosed with metastatic breast cancer (mBC), colorectal cancer (mCRC) and lung cancer (mLC) and compared costs among patients with and without progression.Methods.This was a retrospective study using U.S. administrative claims data from commercial and Medicare Advantage health care enrollees with evidence of mBC, mCRC, and mLC and systemic antineoplastic agent use from July 1, 2006, to August 31, 2014. Outcome measures included disease progression, 12‐month health care costs, and 3‐year cumulative predictive health care costs.Results.Of 5,709 patients with mBC, 3,707 patients with mCRC, and 5,201 patients with mLC, 56.8% of patients with mBC, 58.1% of those with mCRC, and 80.3% of those with mLC patients had evidence of disease progression over 12 months. Among patients with mBC and mCRC, adjusted and unadjusted health care costs were significantly higher among progressors versus nonprogressors. Per‐patient‐per‐month costs, which accounted for variable follow‐up time, were almost twice as high among progressors versus nonprogressors in patients with mBC, mCRC, and mLC. In each of the three cancer types, delays in progression were associated with lower health care costs.Conclusion.Progression of mLC, mBC, and mCRC was associated with higher health care costs over a 12‐month period. Delayed cancer progression was associated with substantial cost reductions in patients with each of the three cancer types.Implications for Practice.Data on the rates and incremental health care costs of disease progression in patients with solid tumor cancers are lacking. This study estimated the incremental costs of disease progression in patients diagnosed with lung cancer, breast cancer, and colorectal cancer and compared health care costs in patients with and without evidence of disease progression in a real‐world population. The data obtained in our study quantify the economic value of delaying or preventing disease progression and may inform payers and physician groups about value‐based payment programs.
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AbstractBackground.Helicobacter pylori (HP) can induce epithelial cells and intestinal metaplasia with genetic damage that makes them highly susceptible to the development of gastric cancer (GC).Materials and Methods.Between 2005 and 2010, 356 patients with gastric cancer who received curative surgery were enrolled. Analysis of HP, Epstein‐Barr virus (EBV) infection, PIK3CA amplification, and mutation analysis of 68 mutations in eight genes using a mass spectrometric single‐nucleotide polymorphism genotyping technology was conducted. The clinicopathological characteristics of patients with or without HP infection were compared.Results.Among the 356 patients, 185 (52.0%) had HP infection. For intestinal‐type GC, patients with HP infection were more likely to be younger and had fewer PI3K/AKT pathway genetic mutations than those without HP infection. For diffuse‐type GC, patients with HP infection were characterized by less male predominance, less lymphoid stroma, fewer microsatellite instability‐high tumors, and fewer PI3K/AKT pathway genetic mutations than those without HP infection. Patients with HP infection had less tumor recurrence and a better 5‐year overall survival (87.7% vs. 73.9%, p = .012) and disease‐free survival (64.1% vs. 51.3%, p = .013) than those without HP infection, especially for intestinal‐type GC. For EBV‐negative GC, patients with HP infection had fewer PI3K/AKT pathway mutations and a better 5‐year overall survival and disease‐free survival than those without HP infection. Multivariate analysis demonstrated that HP infection was an independent prognostic factor regarding overall survival and disease‐free survival.Conclusion.Patients with GC with HP infection were associated with fewer PI3K/AKT pathway genetic mutations and better survival than those without HP infection, especially for EBV‐negative and intestinal‐type GC.Implications for Practice.Patients with gastric cancer with Helicobacter pylori (HP) infection had fewer PI3K/AKT pathway genetic mutations, less tumor recurrence, and better survival than those without HP infection, especially for Epstein‐Barr virus (EBV)‐negative and intestinal‐type gastric cancer. HP infection is an independent prognostic factor regarding overall survival and disease‐free survival. Future in vivo and in vitro studies of the correlation among HP infection, PI3K/AKT pathway, and EBV infection in gastric cancer are required.
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AbstractLessons Learned. Induction chemotherapy with Genexol‐PM and cisplatin demonstrated modest tumor response in locally advanced head and neck squamous cell carcinoma.Considering favorable toxicity profiles and promising survival data, further studies on this regimen are warranted in patients with head and neck squamous cell carcinoma.Background.Genexol‐PM is a polymeric micellar formulation of paclitaxel without Cremophor EL. We investigated the efficacy and safety of Genexol‐PM plus cisplatin as induction chemotherapy (IC) in patients with locally advanced head and neck squamous cell carcinoma (LA‐HNSCC).Methods.Patients received Genexol‐PM (230 mg/m2) and cisplatin (60 mg/m2) every 3 weeks as IC. After three cycles of IC, definitive treatment of either concurrent chemoradiotherapy (CCRT) with weekly cisplatin (30 mg/m2) or surgery was performed. The primary endpoint was overall response rate (ORR) after IC.Results.Of 52 patients enrolled, 47 completed three cycles of IC, and the ORR was 55.8% (95% confidence interval, 42.3–69.3). Although there was one treatment‐related death, toxicity profiles to Genexol‐PM and cisplatin were generally favorable, and the most common grade 3 or 4 toxicities were neutropenia (15.4%), anorexia (7.7%), and general weakness (7.7%). Fifty‐one patients received definitive treatment (CCRT [n = 44] or radical surgery [n = 7]). The rate of complete response following CCRT was 81.8% (36/44). After a median follow‐up of 39 months, estimates of progression‐free survival (PFS) and overall survival (OS) at 3 years were 54.3% and 71.3%, respectively.Conclusion.IC with Genexol‐PM and cisplatin demonstrated modest tumor response with well‐tolerated toxicity profiles for patients with LA‐HNSCC.
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AbstractBackground.Immune checkpoint blockade has systemic efficacy in patients with metastatic melanoma, including those with brain metastases (MBMs). However, immunotherapy‐induced intracranial tumoral inflammation can lead to neurologic compromise, requiring steroids, which abrogate the systemic efficacy of this approach. We investigated whether upfront neurosurgical resection of MBM is associated with a therapeutic advantage when performed prior to initiation of immunotherapy.Material and Methods.An institutional review board‐approved, retrospective study identified 142 patients with MBM treated with immune checkpoint blockade between 2010 and 2016 at Massachusetts General Hospital, of whom 79 received surgery. Patients were classified based on the temporal relationship between immunotherapy, surgery, and development of central nervous system metastases. Overall survival (OS) was calculated from the date of diagnosis of MBM until death from any cause. Multivariate model building included a prognostic Cox model of OS, the effect of immunotherapy and surgical sequencing on OS, and the effect of immunotherapy and radiation sequencing on OS.Results.The 2‐year overall survival for patients treated with cytotoxic T‐lymphocyte antigen 4, programmed death 1, or combinatorial blockade was 19%, 54%, and 57%, respectively. Among immunotherapy‐naïve melanoma brain metastases, surgery followed by immunotherapy had a median survival of 22.7 months (95% confidence interval [CI], 12.6–39.2) compared with 10.8 months for patients treated with immunotherapy alone (95% CI, 7.8–16.3) and 9.4 months for patients treated with immunotherapy followed by surgery (95% CI, 4.1 to ∞; p = .12). On multivariate analysis, immunotherapy‐naïve brain metastases treated with immunotherapy alone were associated with increased risk of death (hazard ratio, 1.72; 95% CI, 1.00–2.99) compared with immunotherapy‐naïve brain metastases treated with surgery followed by immunotherapy.Conclusion.In treatment‐naïve patients, early surgical resection for local control should be considered prior to commencing immunotherapy. A prospective, randomized trial comparing the sequence of surgery and immunotherapy for treatment‐naïve melanoma brain metastases is warranted.Implications for Practice.In this retrospective study of 142 patients with melanoma brain metastases treated with immune checkpoint blockade, the development of melanoma brain metastases following immunotherapy was associated with decreased survival compared with diagnosis of immunotherapy‐naïve brain metastases. The benefit of surgical intervention was seen in immunotherapy‐naïve brain metastases in contrast to brain metastases that developed on immunotherapy. These results suggest that upfront local control with surgery for immunotherapy‐naïve melanoma brain metastasis may provide a bridge toward immunotherapy‐mediated systemic control.
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J reconstr Microsurg
DOI: 10.1055/s-0039-1679882
Background Preclinical training in perforator flap harvesting is typically conducted on living animal models; however, repeated training is not possible with these models because of ethical and/or economical constraints. We describe an anterolateral thigh flap (ALT flap) training model using chicken thigh that seems to be an appropriate training model prior, for example, to raise a perforator flap in a living rat or swine model. Methods A total of 10 chicken legs were used in this study. Six chicken legs were anatomically dissected to confirm the presence of the perforator and to identify the main vascular tree. In four chicken legs, a skin flap was planned based on the perforator and intramuscular dissection was performed under magnification. Results The perforator was identified in all dissections and was consistently found 3 cm above the line extending from the patella to the head of the femur in its third proximal. Proximally, the mean diameter of the artery and vein was 0.56 (σ = 0.04) and 0.84 (σ = 0.06) mm, respectively. The mean dissection time to raise the flap was 88 (σ = 7) min. Conclusion This is the first description of a nonliving biological simulation model for training in perforator flap dissection that mimics an ALT flap. As an ex vivo chicken model, it is a cost effective and readily accessible model suitable for repeated practice.
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Background: Although giant cell arteritis (GCA) is a well-known cause of transient and permanent vision loss, diplopia as a presenting symptom of this condition is uncommon. We compared symptoms and signs of patients presenting with diplopia from GCA to those from other causes. Methods: This was a multicenter, retrospective study comparing the clinical characteristics of patients presenting with diplopia from GCA with age-matched controls. Demographic information, review of symptoms, ophthalmic examination, and laboratory data of biopsy-proven patients with GCA were compared with those of age-matched controls presenting with diplopia. Results: A total of 27 patients presented with diplopia from GCA, 19 with constant diplopia, and 8 with transient diplopia. All patients with constant diplopia from GCA were matched with 67 control subjects who had diplopia from other etiologies. Patients with GCA were more likely to describe other accompanying visual symptoms (58% vs 25%, P = 0.008), a greater number of systemic GCA symptoms (3.5, GCA vs 0.6, controls, P
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Background: While often idiopathic, anterior ischemic optic neuropathy occasionally may occur from an identifiable cause. Methods: Observational case report. Results: A 19-year-old woman with unremarkable medical and ophthalmic histories developed visual loss from nonarteritic anterior ischemic optic neuropathy in her right eye after otherwise uneventful dental extraction of the inferior third molars. Conclusions: Anterior ischemic optic neuropathy may rarely occur after dental extraction. Potential pathophysiologic mechanisms of this rare occurrence are discussed.
Background: Myoclonic epilepsy with ragged-red fibers (MERRF, OMIM, #545000) is a rare neurological condition mostly caused by the m.8344A>G mitochondrial DNA pathogenic variant, which can variably affect multiple tissues, including the retina and optic nerve. We report detection of visually asymptomatic neuroretinal loss in 3 patients with genetically confirmed MERRF, using spectral domain optical coherence tomography (SD-OCT). Methods: All patients underwent a complete ophthalmic examination including assessments of visual acuity, color vision, pupillary reactions, extraocular movements, applanation tonometry, slit-lamp, and dilated fundus examinations. Standard automated perimetry or Goldmann kinetic perimetry was performed, as well as fundus photographs and SD-OCT of the optic nerve head and macula. Results: Despite the absence of visual symptoms in all patients, and normal visual acuity and visual fields in 1 patient, the 3 genetically confirmed patients (point mutations m.8344A>G; age range: 18–62 years) with MERRF-related neurological manifestations, displayed thinning of the retinal nerve fiber layer and variable alterations of the macular ganglion cell complex. Conclusions: Visually asymptomatic patients with genetically confirmed MERRF can display features of structural neuroretinal loss, quantifiable with SD-OCT. Further investigations are needed to establish whether OCT can assess early neurodegeneration in MERRF.
Background: Optic disc drusen (ODD) are acellular deposits in the optic nerve head. ODD can be diagnosed using different imaging modalities, including enhanced depth imaging optical coherence tomography (EDI-OCT) and autofluorescence (AF). It is unknown which factors determine the sensitivity of AF. The aim of this study was to investigate the effect of volume and anatomic location of ODD on the sensitivity of AF. Methods: Cross-sectional study. Results: A total of 38 patients (75 eyes) with ODD were included. In 12 of 75 eyes (16%) and in 11 of 38 patients (29%), EDI-OCT detected ODD that were not detected by AF. In 24 distinctly solitary ODD, both increase in ODD volume (P = 0.0388) and a more superficial ODD location (P
Abstract: A 60-year-old woman experienced sudden onset of vision loss in her right eye. Neuroimaging studies initially were interpreted as tumorous compression of the right optic nerve. On referral to our institution, examination findings were that of a right central retinal artery occlusion (CRAO). Review of the previous imaging studies was consistent with an aneurysm of the intraorbital ophthalmic artery at the origin of the central retinal artery, which was believed to be the cause of the CRAO.
Background: To compare macular and optic nerve head optical coherence tomography (OCT) measurements in mild to moderate papilledema and pseudopapilledema. Methods: One hundred nineteen eyes of 61 patients with mild to moderate papilledema, 84 eyes of 48 patients with pseudopapilledema, and 60 eyes of 60 healthy normal individuals were enrolled in this cross-sectional study. Using Spectralis SD-OCT, macular scans with macular ganglion cell–inner plexiform layer (GCIPL) and macular retinal nerve fiber layer (RNFL) segmentation were performed and divided into 2 regions (inner and outer, with a diameter of 3 and 6 mm, respectively); in addition, Bruch membrane opening (BMO) area and peripapillary RNFL thickness were obtained. Results: BMO area was similar in papilledema (1.83 ± 0.34 mm2), pseudopapilledema (1.85 ± 0.37 mm2), and controls (1.85 ± 0.32 mm2). Average inner region macular GCIPL thickness in the papilledema, pseudopapilledema, and control groups was 87.2 ± 14.4 μm, 90.8 ± 6.1 μm, and 91.2 ± 9.8 μm, respectively (P > 0.05). Outer temporal region macular GCIPL was significantly thinner in the papilledema group compared with control group (P = 0.01). By contrast, outer inferior and outer nasal macular RNFL sectors were significantly thicker in the papilledema group compared with control groups (P = 0.01 and P
Background: Optic nerve sheath tortuosity is a previously reported, but incompletely characterized, finding in idiopathic intracranial hypertension (IIH). We hypothesized that optic nerve angle (ONA), as a quantitative measure of tortuosity, would change dynamically with cerebrospinal fluid (CSF) pressure status of patients with IIH immediately before and after lumbar puncture (LP). Methods: Consecutive patients with suspected IIH referred for MRI and diagnostic LP were prospectively enrolled in this single institution, institutional review board–approved study. Each patient underwent a pre-LP MRI, diagnostic LP with opening pressure (OP) and closing pressure (CP), and then post-LP MRI all within 1 session. Sagittal and axial ONAs were measured on multiplanar T2 SPACE images by 2 neuroradiologists on pre- and post-LP MRI. Effects of measured pressure and CSF volume removal on changes in ONA were analyzed as was interrater reliability for ONA measurement. Results: Ten patients with IIH were included {all female, median age 29 (interquartile range [IQR] 25–32)}. All patients had elevated OP (median 37, IQR 34–41 cm H2O), and significantly reduced CP (median 18, IQR 16–19 cm H2O, P
Background: To describe an unusual case of traumatic globe luxation with optic chiasmal avulsion and review the existing literature on this rare condition for further discussion of mechanisms, diagnosis, and management. Methods: Case report and review of existing case reports and case series identified through literature search. Results: A 28-year-old woman, with no previous medical history, had left globe luxation and optic chiasm avulsion after being stabbed directly into the left orbit with the use of the stiletto high heel of a shoe. Automated visual field testing detected a temporal hemianopia in the unaffected eye despite normal central visual acuity. Chiasmal avulsion was demonstrated by MRI. Conclusions: This case suggests that perimetry and MRI should always be considered in traumatic globe luxation to localize the site of injury. Temporal hemianopia in the fellow eye indicates a concomitant chiasmal injury.
No abstract available
Objective: Neurofibromatosis type 2 (NF2) is an uncommon but well-recognized disorder characterized by multiple schwannomas and meningiomas. Adults typically present with hearing loss and balance disturbance, and children with ocular, dermatological, and neurological signs. Clinical diagnosis is confirmed by neuroimaging and genetic testing. Although ophthalmic features are present in patients with NF2, there are no reports correlating genetic severity subtypes with ophthalmic involvement. Methods: We retrospectively reviewed longitudinal ophthalmological data of 83 patients with NF2, with known genetic severity subtype, to determine visual function over time. We created a scoring system (Oxford NF2 Ophthalmic Score [ONOS]) to quantify visually debilitating pathology. Results: The prevalence of optic atrophy, combined hamartomas, cataract, and epiretinal membranes significantly increased with genetic severity. Median age of survival to visual acuity worse than 1.0 logarithm of minimum angle of resolution in one eye significantly decreased with genetic severity and was 38 years in the genetically severe group, 49 years in moderate classics, 64 years in mild classics, and 84 years in the tissue mosaics. In the genetically severe, the visually damaging pathologies were largely untreatable. The ONOS correlated with genetic severity longitudinally and cross-sectionally. Conclusions: Mutations associated with severe systemic disease result in greater visual morbidity at an earlier age. Those with tissue mosaicism are unlikely to have visually debilitating pathology secondary to NF2. Potentially treatable sources of damage to vision, however, affect all groups and must be identified early and treated effectively to retain useful vision throughout life.Chlordecone (CLD), also named Kepone, is a synthetic organochlorine pesticide. As one of the common persistent organic pollutants (POPs) in nature, CLD has a profound impact on the environment and human health. The study aims to investigate the reproductive toxicity effects of CLD on male Caenorhabditis elegans and on progeny. L1-stage male nematodes were exposed to the control group (M9 solution) and four dose groups (0.02, 0.2, 2, and 20 μg/L). After exposure for 48 h, the male nematodes were picked to mating experiment and progeny experiment that the number of progeny and the time of observation in male parent and in F1 generation were counted; the number of germ cells and the number of sperm in the meiotic division of male nematodes were counted by staining with dimercaptophenyl hydrazine (DAPI), and the nematode gland area was observed under the bright field of the microscope. In male nematodes, the results showed that a number of progeny were 351.20 ± 31.40, 321.60 ± 24.70, 307.30 ± 19.30, 240.10 ± 27.60, and 227.90 ± 22.70 (P < 0.05); the generation times were 55.80 ± 1.95 h, 56.40 ± 1.60 h, 56.70 ± 0.92 h, 60.80 ± 0.95 h, and 69.60 ± 1.97 h (P < 0.05); relative areas of gonad were (99.80 ± 6.27)%, (93.00 ± 1.70)%, (85.00 ± 1.70)%, (70.70 ± 9.81)%, and (60.00 ± 5.23)% (P < 0.05); DAPI staining results showed the number of germ cells in meiosis area were 191.00 ± 10.97, 181.10 ± 15.56, 177.00 ± 9.20, 147.50 ± 10.56, and 139.30 ± 23.79 (P < 0.05); the sperm numbers were 335.60 ± 21.31, 308.60 ± 19.60, 306.00 ± 11.23, 260.10 ± 27.41, and 255.00 ± 3.72 (P < 0.05). In the F1 generation, the progeny numbers were 328.10 ± 22.28, 167.50 ± 15.30, 150.00 ± 13.65, 131.30 ± 18.40, and 130.20 ± 16.17 (P < 0.05); the generation times were 55.50 ± 2.36, 71.10 ± 0.97, 70.90 ± 0.52, 74.10 ± 2.07, and 73.90 ± 1.35 h (P < 0.05). The groups are grouped in order as M9 solution, 0.02, 0.2, 2, and 20 μg/L. The results revealed that CLD caused decrease in progeny number, relative area of gonad, number of germ cells, and sperm number and prolonged the generation time in the male nematode. In offspring grown up without CLD, the effect of CLD on generation time and sperm number can still be observed on offspring. In conclusion, CLD induces male nematode reproductive toxicity and causes defects in offspring.
Employment of biosurfactants and biodegradable chelants could further promote sustainability of soil and groundwater remediation tasks. Biosurfactant (soapnut saponin) and biodegrading chelants (ethylenediamine-N,N′-disuccinic acid (EDDS)) were employed to enhance the phytoextraction by native Taiwanese chenopod (Chenopodium formosanum Koidz.), Napier grass (Pennisetum purpureum) cultivar Taishi No. 4, and soapwort (Saponaria officinalis). Ethylene diamine tetraacetic acid (EDTA) was also employed as the control. Contaminated soils as silty clay loam texture was collected from a defunct rice paddy, containing chromium (Cr), cadium (Cd), and copper (Cu). Addition of both soapnut saponin and EDDS proportionally increased bioaccumulation factors (BCFs) of aboveground biomass for all three plants. Taiwanese chenopod demonstrated the best BCF values among three plants, with BCF increased from 0.76 to 2.6 and 1.3 for Cu under the presence of the highest dosages of EDDS and saponin. Plant aboveground biomass did exhibit negative correlation toward biomass metal concentrations. Presence of saponin did exhibit the least negative slopes among the correlations of all three additives for three plants. Taiwanese chenopod did exhibit the least negative slopes among the correlations of all three additives for three plants. Above observations suggested that saponin may have some protection for plants, especially for Napier grass. Taiwanese chenopod could possess more tolerance toward heavy metals than Napier grass does.
Globalization persists the tendency to alter numerous aspects of today's world including religion, transport, language, living styles, and international relations; however, its potential to influence quality of environment is the prime concern for trade and environmental policies guidelines (Audi and Ali 2018). In response to the growing interest for identifying the dynamic relationship between globalization and environmental performance, the present study seeks to investigate the critical link between globalization and ecological footprints in top 15 globalized countries between 1970 and 2016. Applying the novel methods of quantile-on-quantile regression (QQ) and Granger causality in quantiles, the findings examine the manners in which quantiles of globalization affect the quantiles of ecological footprints and vice versa. The empirical results suggest that globalization has a long-term positive effect on ecological footprint and vice versa in case of Belgium, the Netherlands, Sweden, Switzerland, Denmark, Norway, Canada, and Portugal. On the other hand, the estimated results indicate a negative effect between globalization and ecological footprint in the case of France, Germany, the UK, and Hungary. These results extend the recent findings on the globalization–environment nexus implying that the magnitude of relationship among both variables varies with countries demanding individual focus and cautions for postulating environmental and trade policies.
Lichens are useful biomonitors for atmospheric polycyclic aromatic hydrocarbons (PAHs). Different sample preparation techniques were explored in this regard, including ultrasound-assisted solvent extraction, microwave-assisted extraction, Soxhlet, and the quick, easy, cheap, effective, rugged, and safe (QuEChERS) technique. It was found that a QuEChERS technique using hexane:acetone (1:1, v/v), never reported before for application to lichens, provided the best recoveries of internal standards, the highest total peak area for all PAHs of interest, and %RSDs comparable with the other preparation techniques tested. The optimized sample preparation technique was found to be a comparatively fast method (45 min), with good recoveries (96%), using less solvents and minimal energy consumption. Strong matrix effects were found: both strong enhancement (for the lighter PAHs) and strong suppression (for the heavier PAHs). The use of matrix-matched standards is thus imperative for the accurate determination of PAH concentrations in the lichen samples.
Graphical abstract
The aim of this work is to convert agroforestry residue to a novel adsorbent (M-1CTA-SDS-BT) used for adsorptive benzene sequestration from aqueous solution. In this study, the anionic surfactant-coated-cationized banana trunk was synthesized and characterized for batch adsorption of benzene from aqueous solution. The surface morphology, surface chemistry, surface area, and pore properties of the synthesized adsorbents were examined. It was proven that surface cationization successfully increased the benzene adsorption capacity of sodium dodecyl sulfate-coated adsorbents. The Langmuir isotherm model satisfactorily described the equilibrium adsorption data. The maximum benzene adsorption capacity (qmax) of 468.19 μmol/g was attained. The kinetic data followed the pseudo-second-order kinetic model in which the rate-limiting step was proven to be the film diffusion. The batch-adsorbent regeneration results indicated that the M-1CTA-SDS-BT could withstand at least five adsorption/desorption cycles without drastic adsorption capacity reduction. The findings demonstrated the adsorptive potential of agroforestry-based adsorbent as a natural and cheap material for benzene removal from contaminated water.
In the current literature, cone beam computed tomography (CBCT) seems to be more accurate in detecting apical lesions (AL) than two-dimensional radiographs. Cortical bone thickness might have an influence on AL visibility. Therefore, the purpose of the study was to directly compare the diagnostic accuracy of panoramic radiography (PANO) and CBCT in detecting AL in the upper jaw and determine the influence of cortical bone thickness on AL visibility.
Anonymised digital images of 351 patients who received a CBCT image and a panoramic radiograph within 90 days were examined for AL in the upper jaw. The analysis was conducted by a trained examiner and reviewed by an expert in dental radiology. Further, the dimensions of AL and cortical bone thickness in the region affected by AL were measured to determine their influence on visibility. Statistical analysis was carried out by means of statistical software (IBM SPSS 25; Armonk, NY, USA).
The mean age of the patients was 58.9 years with an almost equal gender distribution. A total of 2223 teeth in the upper jaw were included in the final analysis. CBCT detected AL on 144 teeth (6.5%), of which only 23 were also visible on a PANO. The difference between both methods was significant (p < 0.001). The dimensions of AL measured within a PANO were approximately twice as high as those measured by CBCT. However, the difference was not significant (p ≥ 0.005). Cortical bone thickness had no influence on AL visibility.
Panoramic radiographs are unsuitable for a reliable diagnosis of AL in the upper jaw, while CBCT leads to a better visualisation of AL. Bone thickness has no significant influence on AL visibility with either imaging method.
Publication date: Available online 22 February 2019
Source: Autoimmunity Reviews
Author(s): Giada Mondanelli, Alberta Iacono, Agostinho Carvalho, Ciriana Orabona, Claudia Volpi, Maria T. Pallotta, Davide Matino, Susanna Esposito, Ursula Grohmann
In mammals, amino acid metabolism has evolved to control immune responses. Autoimmune diseases are heterogeneous conditions that involve the breakdown of tolerogenic circuitries and consequent activation of autoreactive immune cells. Therefore, critical enzymes along amino acid degradative pathways may be hijacked to keep in check autoimmunity. We examined here current knowledge of indoleamine 2,3-dioxygenase 1 (IDO1) and arginase 1 (ARG1), the main enzymes catabolizing tryptophan and arginine, respectively, in organ-specific and systemic autoimmune diseases as well as in the development of autoantibodies to therapeutic proteins. At variance with neoplastic contexts, in which it is known to act as a pure immunosuppressive molecule, ARG1 exhibited a protective or pathogenetic profile, depending on the disease. In contrast, in several autoimmune conditions, the bulk of data indicated that drugs capable of potentiating IDO1 expression and activity may represent valuable therapeutic tools and that IDO1-based immunotherapeutic protocols could be more effective if tailored to the genetic profile of individual patients.
The increasing incidence of actinic keratosis (AK) is causing a large burden on health care systems. The current management of AK patients seems to vary within and between primary and secondary care; however, an in‐depth understanding of healthcare providers' management of AK is currently lacking.
To gain insight into the management of AK by exploring underlying motives of current practices among general practitioners (GPs) and dermatologists in The Netherlands.
A qualitative study was conducted consisting of semi‐structured individual interviews with 22 GPs and 18 dermatologists focusing on the underlying motives regarding AK management. A predefined topic list was used. All interviews were audiotaped, transcribed verbatim, and inductively analysed by two researchers drawing on elements of grounded theory.
GPs reported conducting limited proactive clinical assessments of cutaneous photodamage due to a perceived lack of value, varying in their method of diagnosing AK, mainly applying cryotherapy or referral to secondary care due to lack of experience, varying in their applications and providing mostly patient‐driven follow‐up care; they also reported a high need for guidelines due to a lack of knowledge of AK management. Dermatologists indicated to pursue proactive clinical assessments of cutaneous photodamage and the goal of providing guideline‐driven AK care. Patient preferences, though, still largely influence both treatment choices and follow‐up regimens. Furthermore, dermatologists reported the need for improving AK and skin cancer management in primary care.
For AK care to become more standardized and uniform in Dutch primary care, the implementation of guidelines and (continuing) education are needed to address the commonly reported barriers of lack of value, experience and knowledge among GPs. For efficient use of care among dermatologists, shared decision‐making tools along with adequate (framing of) patient information may be useful.
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As an adjuvant therapeutic strategy in advanced gastric cancer, both adjuvant chemotherapy (CTx) and postoperative radiochemotherapy (RCTx) can be considered. Both approaches have been shown to improve overall survival compared to resection alone. Several prospective randomized trials have compared the two postoperative concepts.
We performed a literature search to identify prospective randomized trials which compared adjuvant chemotherapy to adjuvant radiochemotherapy in patients with advanced gastric cancer. As effect sizes, we extracted hazard ratios (HR) as well as event rates from the included trials for the endpoints overall survival, disease-free survival and locoregional control.
We identified seven studies that enrolled 1807 patients overall. Combined radiochemotherapy showed no significant improvement of overall survival in comparison to chemotherapy alone (HR = 0.93; 95%CI: 0.82–1.06; p = 0.28). For disease-free survival (HR = 0.86; 95%CI: 0.76–0.98; p = 0.023) and locoregional control (odds ratio [OR] = 0.56; 95%CI: 0.42–0.75; p = <0.001) we detected significant advantages from the addition of radiation to chemotherapy. A subgroup analysis demonstrated an improvement in survival when the radiochemotherapy protocol was not de-intensified.
Adjuvant chemotherapy or radiochemotherapy demonstrate similar oncologic efficacy and therapy-associated toxicity. Individual patient characteristics should therefore determine the therapeutic approach in a multidisciplinary discussion. Irradiation added to standard-dose chemotherapy possibly results in a survival benefit.
Partial breast irradiation using intraoperative radiotherapy (IORT) after breast-conserving surgery could be sufficient for a selected group of breast cancer patients. We report the results of a cohort of patients from a single center treated as part of the randomized phase-3 TARGIT-A trial.
Patients (≥50 years) with cT1 cN0 cM0 and invasive ductal histology on biopsy were randomized between IORT with 20 Gy (arm-A) or postoperative whole-breast RT (WBRT) up to 56 Gy in 2 Gy fractions (arm-B). Postoperatively, patients in arm-A with multifocality, lymphovascular invasion, nodal invasion, extensive intraductal component, invasive lobular carcinoma, or resection margins <1 cm received additional postoperative WBRT.
Between 2002 and 2012, 184 patients were randomized, of whom 90 in arm-A and 90 in arm-B were evaluated. Median follow-up was 8.5 years. The 5‑year overall survival was 94.4% in arm-A and 93.3% in arm-B (p = 0.73). Two local recurrences were observed: one at 70.3 months in an arm-A patient who received IORT + WBRT and another at 4.5 months in an arm-B patient who refused all forms of adjuvant treatment, thus resulting in a 5-year local recurrence of 0% in arm-A and 1.1% in arm-B. The 5‑year in-breast recurrence (outside of the index quadrant) was 0% in arm-A and 1.2% in arm-B. Salvage mastectomy was performed successfully in all patients with relapse.
Long-term follow-up of this single-center cohort consolidates the earlier reports of low local recurrence rates after single-dose IORT. Our results are in line with non-inferiority of risk-adapted IORT for selected patients with early breast cancer.
The primary end-point was to evaluate the cure fraction. Secondary end-points were to investigate the time to cure, the excess of death risk, the probability of cure and the factors related to these parameters.
Retrospective study of an ENETS database regarding patients affected by Si-NENs. For each patients, clinical, pathological and follow-up data were collected. The survival analysis was made using a novel approach: the cure model approach.
The cure fraction was 92.1%. The death risk, time to cure and the probability of cure were 6/1000 person-years, 3.6 years and 98.2%, respectively. The independent factors influencing these parameters were the grading and the R status (P = 0.041 and P = 0.017, respectively). Patients affected by Si-NENs G2 increased the death risk and time to cure respect to Si-NENs G1 (51 versus 6 per 1000 person-years and 5.1 versus 3.6 years, respectively) as well as patients not operated respect to those radically resected (R0/1) (66 versus 1 per 1000 person-years and 4.8 versus 0.4 years, respectively). The probability of cure decreased (88.1 versus 97.8% and 80.4 versus 99.7%, respectively). R2 resection shows better results than no resection.
A large portion of patients affected by Si-NENs can be cured. The highest probability of cure regards patients with Si-NENs G1 who underwent to R0/R1 resection; the lower, those with Si-NENs G2 and no resection. R2 resection seems to be preferred respect to no resection.
The primary end-point was to evaluate the cure fraction. Secondary end-points were to investigate the time to cure, the excess of death risk, the probability of cure and the factors related to these parameters.
Retrospective study of an ENETS database regarding patients affected by Si-NENs. For each patients, clinical, pathological and follow-up data were collected. The survival analysis was made using a novel approach: the cure model approach.
The cure fraction was 92.1%. The death risk, time to cure and the probability of cure were 6/1000 person-years, 3.6 years and 98.2%, respectively. The independent factors influencing these parameters were the grading and the R status (P = 0.041 and P = 0.017, respectively). Patients affected by Si-NENs G2 increased the death risk and time to cure respect to Si-NENs G1 (51 versus 6 per 1000 person-years and 5.1 versus 3.6 years, respectively) as well as patients not operated respect to those radically resected (R0/1) (66 versus 1 per 1000 person-years and 4.8 versus 0.4 years, respectively). The probability of cure decreased (88.1 versus 97.8% and 80.4 versus 99.7%, respectively). R2 resection shows better results than no resection.
A large portion of patients affected by Si-NENs can be cured. The highest probability of cure regards patients with Si-NENs G1 who underwent to R0/R1 resection; the lower, those with Si-NENs G2 and no resection. R2 resection seems to be preferred respect to no resection.
The serum calcium/phosphorus (Ca/P) ratio is an accurate tool to differentiate patients with primary hyperparathyroidism (PHPT) from healthy subjects. However, other disorders of the Ca–P metabolism might impair the Ca/P ratio, such as hypophosphatemia (HypoP) not PHPT related. The aim of this study is to examine the diagnostic value of Ca/P ratio in the diagnosis of PHPT and HypoP not PHPT related.
Single-center, retrospective, case–control study, including 150 patients with PHPT and 306 patients with HypoP, compared with 150 controls. HypoP patients were enrolled among HIV-infected patients by selecting those with Fanconi-like syndrome due to antiretroviral treatment. Parameters which were measured were serum Ca, P, parathyroid hormone (PTH), 25-OH vitamin D, albumin and creatinine).
The Ca/P ratio was significantly higher in PHPT and HypoP patients, compared to controls (p < 0.0001). At receiver operator characteristic (ROC) curve analysis, the cut-off of 3.56 (2.75 SI) for Ca/P ratio was able to identify patients with PHPT and HypoP (sensitivity 95%; specificity 93%). Among patients with Ca/P ratio above 3.56, the thresholds of 10.3 mg/dL (2.6 mmol/L) for serum Ca (sensitivity 93%; specificity 98%) and 80.5 pg/mL for PTH (sensitivity 91%; specificity 91%) were defined for the specific diagnosis of PHPT.
The Ca/P ratio above 3.56 (2.75 SI) is a highly accurate tool to identify PHPT and HypoP not PHPT-related patients. Thanks to its simplicity, this index can be proposed as a screening and first-line examination in the diagnostic work-up when a disorder of Ca–P metabolism is suspected or should be ruled out.
Due to serious nitrogen pollution in the Huai River, Eastern China, nitrogenous concentrations and dual stable isotopes (δ15N and δ18O) were measured to ascertain the sources and transformation of nitrogen in the Shaying River, the largest and most polluted tributary of the Huai River during the summer and winter seasons. Total nitrogen (TN), NO3−, and NH4+ were significantly higher in winter, with values of 7.84 ± 3.44 mg L−1, 2.31 ± 0.81 mg L−1, and 3.00 ± 2.24 mg L−1, respectively, while the highest nitrogen compounds occurred in the Jialu River, one of the tributaries of the Shaying River, in both summer and winter. Isotope characteristics of nitrate reveal that manure and sewage were the principal nitrate sources in both summer (62.44 ± 19.66%) and winter (67.33 ± 15.45%), followed by soil organic nitrogen, with 24.94 ± 15.52% in summer and 26.33 ± 9.45% in winter. Values of δ15N-suspended particulate nitrogen (SPN) ranged from 0.78 to 13.51%, revealing that point source from industrial and domestic sewage accounted for the largest input to SPN at most sites, whereas soil organic nitrogen and agricultural fertilizers were found in the Jialu River in both sampling periods. Point sources from septic/manure and household waste were the main contributors to ammonium in most river water samples in both summer and winter; most wastewater discharged into the river was untreated, which was one of the main reasons for the high level of ammonium in winter. Nitrogen pollution and the dams had an effect on N transformation in the river. Significant assimilation of NH4+ and aerobic denitrification competed for NH4+, resulting in the weakness of nitrification in the summer. Denitrification was also an important process of nitrate removal during the summer, whereas nitrification was a key N transformation process in the river in the winter time. To reduce nitrogen pollution and improve water quality, greater effort should be focused on the management of sources from urban input as well as on the improvement in sewage treatment.
Risk type: Environment The plastic contains short-chain chlorinated paraffins (SCCPs) (measured value up to 0.32%). SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Environment The hose contains short-chain chlorinated paraffins (SCCPs) (measured value up to 4.66%). SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Chemical, Environment The plastic in the mat contains short-chain chlorinated paraffins (SCCPs) (measured value: 2.2%). SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. SCCPs are suspected human carcinogens. Prolonged exposure to them through the skin may cause cancer. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation). Measures ordered by public authorities (to: Other): Withdrawal of the product from the market |
Risk type: Environment The plastic contains short-chain chlorinated paraffins (SCCPs) (measured value up to 1.12%). SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Chemical The plastic ball contains di-2-ethylhexyl phthalate (DEHP) (measured value up to 0.13% by weight). This phthalate may harm the health of children, causing possible damage to their reproductive system. The product does not comply with the REACH Regulation. Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Chemical The smaller round medallion contains cadmium (measured value: 94 % by weight). Cadmium is harmful to human health because it accumulates in the body, can damage organs and may cause cancer. The product does not comply with the REACH Regulation. Measures ordered by public authorities (to: Importer): Import rejected at border |
Risk type: Environment The solder in the product contains lead above limit values (measured value up to 46% by weight). Lead poses a risk to the environment. The product does not comply with the requirements of the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Environment The solder contains lead (measured value up to 71% by weight) in concentrations above limit values. Lead poses a risk to the environment. The product does not comply with the requirements of the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Environment The solders contain cadmium (measured value up to 0.39% by weight) and lead (measured value up to 48% by weight) in concentrations above limit values. Cadmium and lead pose a risk to the environment. The product does not comply with the requirements of the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Environment The solder contains lead (measured value up to 50% by weight) in concentrations above limit values. Lead poses a risk to the environment. The product does not comply with the requirements of the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Burns, Electric shock The insulation is inadequate. Moreover, the power cord can easily detach or become damaged, giving access to live parts. The user can touch live or hot parts and receive an electric shock or suffer burns. The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60598-1. Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market |
Category: Motor vehicles Product: Passenger car Brand: Porsche Name: Cayenne - conventional and hybrid(PHEV), Macan Type / number of model: Cayenne: Type-approval numbers: e13*2007/46*1085* (92A M1G) e13*2007/46*1106* (92A N1G) e13*2007/46*1107* (92AH N1G) e13*2007/46*1108* (92AH M1G) Types: 92A, 92AN, 92AH, 92AHN, Macan: Type-approval numbers: e13*2007/46*1165 (M1) e13*2007/46*1164 (N1) Types: 95B, 95BN Batch number / Barcode: The vehicles in question were manufactured between January 2017 and February 2018. Risk type: Injuries The retaining straps on the vehicle's ski bag may be defective. The ski bag may not stay in position when subjected to a high load. Measures taken by economic operators: Recall of the product from end users (By: Manufacturer) |
Risk type: Chemical The valve of the inflatable armband contains di(2-etylhexyl) phthalate-DEHP (measured value 21 % by weight) and di-'isononyl' phthalate (DINP) (measured value: 0.3 % by weight). These phthalates may harm the health of children, causing possible damage to the reproductive system and the liver. The product does not comply with the REACH Regulation and the Personal Protective Equipment regulation. Measures ordered by public authorities (to: Retailer): Withdrawal of the product from the market |
Risk type: Environment The plastic contains short-chain chlorinated paraffins (SCCPs) (measured value up to 0.38%). SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Environment The solders contain lead (measured value up to 81%) above limit values and the plastic contains short-chain chlorinated paraffins (SCCPs) (measured value up to 0.931%). SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. Lead poses a risk to the environment. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation) and with the requirements of the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Injuries The frame of the product is not strong enough and has no locking mechanism. It could break or spontaneously fold while still carrying a baby, causing the baby to fall. The product does not comply with the relevant European Standard EN 13209-1. Measures taken by economic operators: Recall of the product from end users (By: Manufacturer) |
Risk type: Chemical The plastic of the swim-ring and the valve contain bis (2-ethylhexyl) phthalate (DEHP) (measured value: 5% and 0.9% by weight, respectively). This phthalate may harm the health of children, causing possible damage to their reproductive system. The product does not comply with the REACH Regulation. Measures ordered by public authorities (to: Retailer): Withdrawal of the product from the market |
Risk type: Chemical, Environment, Injuries The microphone can easily break, causing the button batteries to become accessible. A child may put them in the mouth, causing damage to the gastrointestinal tract. Additionally, the solder in three different places inside the toy contains too much lead (measured value up to: 70% by weight). Lead poses a risk to the environment. The product does not comply with the requirements of the Toy Directive, the relevant European standard EN 62115 and the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). Measures ordered by public authorities (to: Importer): Recall of the product from end users |
Risk type: Chemical, Choking The battery compartment can easily be opened without the use of any tools, leaving button cell batteries accessible. A child may put these in the mouth, which could cause damage to the child's gastrointestinal tract. They may also cause choking if swallowed by a small child. The product does not comply with the requirements of the Toy Safety Directive and with the relevant European standard EN 71-1 and EN 62115. Measures ordered by public authorities (to: Retailer): Withdrawal of the product from the market |
Risk type: Chemical, Injuries The pushchair is not sufficiently resistant to load and can easily collapse, causing injuries. In addition, the doll contains di-(2-ethylhexyl) phthalate (DEHP) (measured value up to 4.8% by weight). This phthalate may harm the health of children, causing possible damage to their reproductive system. Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market |
Risk type: Chemical The migration of boron from the toy slime is too high (measured value: 879 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-3. Measures ordered by public authorities (to: Distributor): Withdrawal of the product from the market |
Risk type: Chemical The migration of boron from the toy slime is too high (measured value: 981 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-3. Measures ordered by public authorities (to: Distributor): Withdrawal of the product from the market |
Risk type: Burns The fancy-dress costume is easily flammable and the flame propagation is too high. If it catches fire, the child could suffer burns. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-2. Measures taken by economic operators: Withdrawal of the product from the market (By: Retailer) |
Risk type: Chemical The migration of boron from the toy slime is too high (measured value: up to 546 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-3. Measures ordered by public authorities (to: Distributor): Withdrawal of the product from the market |
Risk type: Chemical The plastic material of the doll's head contains 2-ethylhexyl phthalate (DEHP) (measured value: 31 % by weight). This phthalate may harm the health of children, causing possible damage to the reproductive system. The product does not comply with the REACH Regulation. Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market |
Risk type: Choking The eyes and nose of the toy can easily detach. In addition, the fibrous stuffing material of the toy is easily accessible due to the weakness of the plastic zipper. A small child may put the small parts in the mouth and choke. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-1. Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market |
Risk type: Choking The product contains a small wooden ball that can easily fall out between the bars of the rattle. A small child could put it in the mouth and choke on it. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-1. Measures taken by economic operators: Recall of the product from end users (By: Distributor) |
Risk type: Chemical The migration of boron from the toy slime is too high (measured value: 533 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-3. Measures ordered by public authorities (to: Distributor): Withdrawal of the product from the market |
Risk type: Chemical The migration of boron from the toy slime is too high (measured value: 506 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-3. Measures ordered by public authorities (to: Distributor): Withdrawal of the product from the market |
Risk type: Chemical The migration of boron from the toy slimes is too high (measured value: up to 874 mg/kg for red). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-3. Measures ordered by public authorities (to: Distributor): Withdrawal of the product from the market |
Risk type: Chemical Due to the container's characteristic form, appearance and size, this product may be mistaken for a foodstuff. This may lead consumers, and specially children, to put them in the mouth and ingest its content. The migration of boron from the toy slime is too high (measured value: up to 1461 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system. The product does not comply with the requirements of the Food Imitating Products Directive, the Toy Safety Directive and the relevant European standard EN 71-3. Measures ordered by public authorities (to: Distributor): Withdrawal of the product from the market |
Risk type: Choking Some pieces of velcro on the tent can become detached, generating a small part. A small child may put them in the mouth and choke. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-1. Measures ordered by public authorities (to: Importer): Import rejected at border |
Risk type: Chemical The migration of boron from the toy slime is too high (measured value up to 2165 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-3. Measures taken by economic operators: Voluntary withdrawal (By: Manufacturer) |
Risk type: Chemical The dress contains azo-dyes releasing the aromatic amine 4-methyl-m-phenylenediamine (2,4-toluenediamine) (measured concentration: 342 mg/kg). When in direct and prolonged contact with the skin, the aromatic amines may be absorbed by the skin. Aromatic amines can cause cancer, cell mutations and affect reproduction. The product does not comply with the REACH Regulation. Measures ordered by public authorities (to: Other): Withdrawal of the product from the market |
Risk type: Strangulation The drawstrings may become trapped during various activities of the child, leading to strangulation. The product does not comply with European standard EN 14682. Measures ordered by public authorities (to: Distributor): Withdrawal of the product from the market |
Risk type: Environment The holder contains short-chain chlorinated paraffins (SCCPs) (measured value up to 2.75%). The placing on the market and use of articles containing SCCPs is banned. SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation). Measures taken by economic operators: Withdrawal of the product from the market, Withdrawal of the product from the market (By: Distributor, Importer) |
Risk type: Environment The plastic contains short-chain chlorinated paraffins (SCCPs) (measured value up to 1.89%). SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Environment The solder contains lead (measured value up to 83% by weight) in concentrations above limit values. Lead poses a risk to the environment. The product does not comply with the requirements of the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Environment The plastic contains short-chain chlorinated paraffins (SCCPs) (measured value up to 0.32%). SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Environment The solder contains lead (measured value up to 54% by weight) in concentrations above limit values. Lead poses a risk to the environment. The product does not comply with the requirements of the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). Measures taken by economic operators: Withdrawal of the product from the market (By: Importer) |
Risk type: Chemical The body lotion contains isobutylparaben which has a potential endocrine disrupting activity. At the same time, the product contains limonene, linalool, coumarin, citronellol, alpha-isomethyl ionone (measured values: more than 0.001% by weight). These substances can induce allergic reactions and sensitisation. Consumers are not aware of their presence because they are not indicated in the list of ingredients. The product does not comply with the Cosmetic Products Regulation. Measures taken by economic operators: Recall of the product from end users (By: Retailer) |
Risk type: Environment The plastic contains short-chain chlorinated paraffins (SCCPs) (measured value up to 1.65 % by weight). The placing on the market and use of articles containing SCCPs is banned. SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bioaccumulate in wildlife and humans, posing a risk to human health and the environment. The product does not comply with the Regulation on persistent organic pollutants (POP Regulation). Measures taken by economic operators: Withdrawal of the product from the market (By: Manufacturer) |
Risk type: Electric shock Single-pole or partial insertion of a plug into the product's socket is possible. When using the inverter, live pins of the inserted plug could remain accessible, which could result in the user receiving an electric shock. The product does not comply with the requirements of the Low Voltage Directive and the relevant standards EN 60950 and IEC 60884. Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market |
Risk type: Electric shock The dimensions of the socket outlet on the mains lead of the shaver are not suitable. The user could consequently touch live parts while connecting the mains lead to the shaver, leading to electric shock. The insulation between live parts and the accessible metal housing is insufficient. Consequently accessible parts could become live, this could cause the user to receive an electric shock when holding the shaver. The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60335. Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market |
Risk type: Electric shock The product does not have shutters on live parts, nor a fuse. A user could touch live parts of the socket and receive an electric shock. The product does not comply with the relevant National standards BS 1363-3 and BS 8546. Measures ordered by public authorities (to: Importer): Withdrawal of the product from the market |
Risk type: Choking The stuffing material is easily accessible. Young children may put it in the mouth, ingest it and choke on it. The toy does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-1. Measures taken by economic operators: This product listing was removed by Amazon., Withdrawal of the product from the market (By: Other) |
