{"title":"一项关于以胃肠道疾病为主的儿科患者院内口服硒制剂的管理状况和安全性的多机构、回顾性、观察性研究。","authors":"Jumpei Saito, Eiji Suzuki, Keiko Kobayashi, Keisuke Doi, Yosuke Miwa, Setsuko Ihara, Kei Nakai, Miki Akabane","doi":"10.3390/nu16183142","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>Selenium deficiency in patients with gastrointestinal diseases treated with long-term central venous nutrition is a clinical problem. Only injectable selenium is approved in Japan, and oral selenium preparations are prepared in hospitals from reagents, but their efficacy and safety are unknown.</p><p><strong>Methods: </strong>We conducted a retrospective study investigating the relationship between selenium administration and oral selenium formulations and adverse events.</p><p><strong>Results: </strong>In this study, 239 selenium-treated cases and 220 selenium-untreated cases adjusted for patient background were selected as a reference group. The median (interquartile range, IQR) age was 1.3 (0.4-4.4) and 1.3 (0.3-4.5) years, respectively; gastrointestinal diseases were most common in 110 (46.0%) and 104 (47.3%) cases. The median (IQR) duration of treatment or observation with oral selenium was 446 (128-1157) and 414 (141-1064) days, respectively. The median (IQR) dose per body weight at the maintenance dose was 2.6 (1.7-3.9) μg/kg, and the median (IQR) serum selenium concentration at the maintenance dose was 8.5 (7.0-10.6) μg/mL within the upper tolerated dose limit and approximately the reference range. There was no difference in selenium dose, serum selenium concentration, or serum-selenium-concentration-to-dose ratio (C/D ratio) for adverse events. The incidence of adverse events was compared with that of patients not treated with selenium.</p><p><strong>Conclusions: </strong>An oral selenium preparation administered below the upper tolerated dose limit can be used effectively and safely in pediatric patients.</p>","PeriodicalId":19486,"journal":{"name":"Nutrients","volume":null,"pages":null},"PeriodicalIF":4.8000,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11435100/pdf/","citationCount":"0","resultStr":"{\"title\":\"A Multi-Institutional, Retrospective, Observational Study on Administration Status and Safety of In-Hospital Oral Selenium Preparation in Pediatric Patients Predominantly Suffering from Gastrointestinal Disease.\",\"authors\":\"Jumpei Saito, Eiji Suzuki, Keiko Kobayashi, Keisuke Doi, Yosuke Miwa, Setsuko Ihara, Kei Nakai, Miki Akabane\",\"doi\":\"10.3390/nu16183142\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>Selenium deficiency in patients with gastrointestinal diseases treated with long-term central venous nutrition is a clinical problem. Only injectable selenium is approved in Japan, and oral selenium preparations are prepared in hospitals from reagents, but their efficacy and safety are unknown.</p><p><strong>Methods: </strong>We conducted a retrospective study investigating the relationship between selenium administration and oral selenium formulations and adverse events.</p><p><strong>Results: </strong>In this study, 239 selenium-treated cases and 220 selenium-untreated cases adjusted for patient background were selected as a reference group. The median (interquartile range, IQR) age was 1.3 (0.4-4.4) and 1.3 (0.3-4.5) years, respectively; gastrointestinal diseases were most common in 110 (46.0%) and 104 (47.3%) cases. The median (IQR) duration of treatment or observation with oral selenium was 446 (128-1157) and 414 (141-1064) days, respectively. The median (IQR) dose per body weight at the maintenance dose was 2.6 (1.7-3.9) μg/kg, and the median (IQR) serum selenium concentration at the maintenance dose was 8.5 (7.0-10.6) μg/mL within the upper tolerated dose limit and approximately the reference range. There was no difference in selenium dose, serum selenium concentration, or serum-selenium-concentration-to-dose ratio (C/D ratio) for adverse events. The incidence of adverse events was compared with that of patients not treated with selenium.</p><p><strong>Conclusions: </strong>An oral selenium preparation administered below the upper tolerated dose limit can be used effectively and safely in pediatric patients.</p>\",\"PeriodicalId\":19486,\"journal\":{\"name\":\"Nutrients\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.8000,\"publicationDate\":\"2024-09-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11435100/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nutrients\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3390/nu16183142\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"NUTRITION & DIETETICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nutrients","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/nu16183142","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NUTRITION & DIETETICS","Score":null,"Total":0}
A Multi-Institutional, Retrospective, Observational Study on Administration Status and Safety of In-Hospital Oral Selenium Preparation in Pediatric Patients Predominantly Suffering from Gastrointestinal Disease.
Objectives: Selenium deficiency in patients with gastrointestinal diseases treated with long-term central venous nutrition is a clinical problem. Only injectable selenium is approved in Japan, and oral selenium preparations are prepared in hospitals from reagents, but their efficacy and safety are unknown.
Methods: We conducted a retrospective study investigating the relationship between selenium administration and oral selenium formulations and adverse events.
Results: In this study, 239 selenium-treated cases and 220 selenium-untreated cases adjusted for patient background were selected as a reference group. The median (interquartile range, IQR) age was 1.3 (0.4-4.4) and 1.3 (0.3-4.5) years, respectively; gastrointestinal diseases were most common in 110 (46.0%) and 104 (47.3%) cases. The median (IQR) duration of treatment or observation with oral selenium was 446 (128-1157) and 414 (141-1064) days, respectively. The median (IQR) dose per body weight at the maintenance dose was 2.6 (1.7-3.9) μg/kg, and the median (IQR) serum selenium concentration at the maintenance dose was 8.5 (7.0-10.6) μg/mL within the upper tolerated dose limit and approximately the reference range. There was no difference in selenium dose, serum selenium concentration, or serum-selenium-concentration-to-dose ratio (C/D ratio) for adverse events. The incidence of adverse events was compared with that of patients not treated with selenium.
Conclusions: An oral selenium preparation administered below the upper tolerated dose limit can be used effectively and safely in pediatric patients.
期刊介绍:
Nutrients (ISSN 2072-6643) is an international, peer-reviewed open access advanced forum for studies related to Human Nutrition. It publishes reviews, regular research papers and short communications. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.