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Buckwheat is a rare causative food for food protein–induced enterocolitis syndrome (FPIES). To date, it is unknown what laboratory data patients with FPIES caused by buckwheat show. We report a 4-year-old female with FPIES caused by buckwheat and the laboratory results. Skin prick, specific IgE antibody, and basophil activation tests were negative; however, the lymphocyte stimulation test (LST) revealed a 10.2-fold increase in activation compared with the negative control. In an open-label oral food challenge (OFC) of 80 g boiled buckwheat noodles, 3 hours after ingestion, vomiting occurred four times in a 2-hour duration. Therefore, we diagnosed the patient with FPIES caused by buckwheat. Her neutrophil count, C-reactive protein, and thymus and activation-regulated chemokine were elevated after the OFC. Moreover, the patient had a positive reaction to the LST, which may theoretically be useful in diagnosing non-immunoglobulin E-mediated gastrointestinal food allergies. FPIES caused by buckwheat is rare; however, we found that the same laboratory results were observed in a comparison of FPIES cases caused by other foods.

The mechanism of antioxidant defense system is still controversial. As islet ß-cell is weak in oxidative condition, that causes diabetes mellitus, therefore, antioxidant defense system of human pancreatic islet derived 1.1B4 cell was analyzed. Cells were exposed to H2O2 and comprehensive gene expression was analyzed by Agilent human microarray. HMOX1 and NR4A3, member of orphan receptor, were up-regulated. Therefore, NR4A3 was knocked down with siRNA, then analyzed gene expression by microarray, and found that the knocked down cells were weak in oxidative stress. HMOX1 expression was strongly inhibited by siRNA of NR4A3, and NR4A3 responsible sequence of aaggtca was found near the HMOX1 gene, suggesting NR4A3 is oxidative stress responsible transcription factor through HMOX1 expression. The expression of CCNE1 and CDK2 was also inhibited by knocked down of NR4A3, it is suggested NR4A3 is also important transcription factor for cell growth regulation.Graphical abstractHydrogen peroxide induces NR4A3 and binds to aaggtca sequence of HMOX1, and increased transcription of HMOX1. Resulting heme oxygenase produces biliverdin, antioxidants, from heme. NR4A3 also bind to aaggtca sequence of CDK2 and CCNE1, resulting CDK2 and Cyclin E. CDK2 bind to cyclin E and cell goes from G1 to S phase.

In Japan, different regulatory tracks prior to marketing have been applied to medical devices dependent on whether they have predefined certification or approval standards in addition to the risk category. A regulatory track for some high-risk medical devices (class III or IV in Japan) using certification standards newly became effective in 2014. This study aimed to explore potential candidate devices for the certification track.We analyzed approval, recall, and classification information databases for medical devices in Japan. High-risk medical devices approved between 2010 and 2014 were examined (N = 3222). The medical devices were categorized into 3 groups based on availability of certification or approval standards. Recall rates were calculated for each group and for each device category within the groups. Recall reasons were classified into two main categories: design problems and other problems.The overall recall rates were 12.1% in the group with certification standards (recalled n = 17, approved n = 141), 4.1% in the group with approval standards (recalled n = 49, approved n = 1187), and 5.6% in the group without either standard (recalled n = 106, approved n = 1894). The design recall rates were 9.2%, 1.4%, and 1.6%, respectively. The recall rate for bio-phenomena-monitoring devices was high (recalled n = 13, approved n = 31; 41.9%), which contributed to the high recall rate of the group with certification standards.The overall recall rates and the recall rates due to design problems varied considerably across and within the 3 groups. As possible good candidates for the transition into the new certification track, high-risk medical devices with low recall rates in frequently approved device categories should be given priority.

Introduction: Component-resolved diagnostics is used to diagnose food allergies. However, few reports have evaluated the severity of peach fruit allergy using peach allergen components, including Pru p 7. Objective: This study aimed to predict peach fruit allergy severity based on the presence of specific IgE (sIgE) antibodies (Abs) to peach allergenic components. Methods: Twenty-seven patients with peach fruit allergy were enrolled and classified into two groups: the local reaction (LR) group, including 12 patients with only oral or throat mucosal symptoms, and the systemic reaction (SR) group, including 15 patients, 10 of whom experienced anaphylaxis. Serum sIgE Abs against crude peach extract – Pru p 1, 2, 3, 4, and 7 – and tree pollen were measured. Results: sIgE Ab titers of Pru p 1 and 4 and alder pollen in the LR group were significantly higher than those in the SR group. sIgE against Pru p 7 was significantly higher in the SR group than in the LR group. The frequencies of sIgE Abs against Pru p 1, 4, and 7 in the LR group were 91.7, 66.7, and 16.7%, respectively, while in the SR group these were 80, 20, and 60%. Sensitization to Pru p 2 and 3 was detected but limited in all patients. Conclusions: These findings suggest that sensitization to Pru p 1 and Pru p 4 is associated with local symptoms, and sensitization to Pru p 7 is associated with SR and anaphylaxis. To predict the severity of peach fruit allergy, it is useful to assess sIgE Ab reactions combining Pru p 1, 4, and 7.

This paper describes a case of anaphylaxis due to latex exposure during surgery. Allergic reactions to latex during surgery have been described in spinal bifida patients. The case presented in our manuscript is a 15-year old girl who experienced an anaphylactic reaction during her 12th surgery of giant hairy nevus on the thigh. She had a history of oral pruritus after ingestion of chestnut suggesting latex-fruit syndrome. Specific IgE was positive to latex and the allergen components Hev b 1, 3, 5 and 6.02. The diagnosis was latex-allergy due to sensitization obtained after multiple surgeries, possibly due to the contact of latex-containing gloves. Anaphylactic shock during surgery due to NRL allergy is being reported continuously. To prevent allergic reactions during surgery in patients who undergo multiple surgeries, not only in Spina Bifida (SB) patients, frequent analyses of specific IgE to NRL are essential as well as the documentation of the clinical history after ingestion of latex-fruit syndrome related foods. Measurement of specific IgE to allergen components from NRL might be useful in the diagnosis of NRL allergy and in the investigation of the route of NRL sensitization.

Background: Medical devices are continuously being improved in routine clinical practice. As necessary, new or additional clinical data for an investigational medical device is collected through clinical research and/or registered clinical investigations. We conducted a questionnaire survey to determine the current environment for clinical research with medical devices, particularly focusing on infrastructure and human resources in hospitals. Methods: The questionnaire for this study included 6 main topics: experience of clinical research, in-hospital manuals, issues on clinical research, related regulations, and effectiveness of a guidance published by the Medical Engineering Technology Industrial Strategy Consortium. The questionnaire was mailed to all 10 core clinical research centers and 30 major clinical trial institutions at the time of survey in Japan. Results: Eighteen hospitals (45%) provided responses. Relatively few clinical research activities with medical devices had been conducted in each hospital, and two-thirds of respondents thought low number of clinical research activities was problematic. A shortage of experts in medical devices was also raised as an important challenge. Most of the hospitals had established in-hospital manuals for clinical research with medical devices; however, specific features required for the evaluation of medical devices might not be included in the manuals. Many hospitals had too few clinical research coordinators (CRCs) for support of clinical research with medical devices, but half of the hospitals could not afford to increase the number of CRCs. Conclusion: Our study revealed that the current environment for clinical research with medical devices in hospitals has been partly organized, but it was suggested that a shortage of experts, the complexity of the regulatory system, and a need for financial support are remaining issues.

Residual organophosphorus pesticides (OPP) in rice decrease when rice is cooked, but the extent of the decrease varies largely with the kind of pesticide used, ranging from 20% for Dimethoate to 93.5% for Ronnel. To determine the mechanism of this decrease, 14 kinds of pesticides were tested in a model experiment designed to determine their thermal decomposition and steam distillation behavior. From the results of the experiment, the test pesticides can be classified into three groups: 1) compounds resistant to both thermal decomposition and steam distillation (e. g., Dimethoate), 2) compounds thermally stable but susceptible to steam distillation (e. g., Fenitrothion=MEP), and 3) compounds thermally unstable and susceptible to steam distillation (e. g., Diazinon). The experimental results accounted well for the behavior of residual. OPPs in rice during the cooking process, and the residual amounts of OPPs after cooking can be estimated from the results.