多机构、回顾性、观察性研究:住院口服硒制剂在主要患有胃肠道疾病的儿科患者中的使用状况和安全性。
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.
机构信息
Department of Pharmacy, National Center for Child Health and Development, 2-10-1, Okura, Setagayaku 157-8535, Tokyo, Japan.
Department of Pharmacy, Nagano Children's Hospital, 3100, Toyoshina, Azumino 399-8288, Nagano, Japan.
出版信息
Nutrients. 2024 Sep 17;16(18):3142. doi: 10.3390/nu16183142.
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.
目的
长期接受中心静脉营养治疗的胃肠道疾病患者存在硒缺乏,这是一个临床问题。日本仅批准了注射用硒,而口服硒制剂则由医院从试剂中制备,但它们的疗效和安全性尚不清楚。
方法
我们进行了一项回顾性研究,调查了硒给药与口服硒制剂和不良事件之间的关系。
结果
在这项研究中,选择了 239 例接受硒治疗的病例和 220 例未接受硒治疗的病例作为参考组,调整了患者背景。中位数(四分位距,IQR)年龄分别为 1.3(0.4-4.4)和 1.3(0.3-4.5)岁;胃肠道疾病最常见,分别为 110(46.0%)和 104(47.3%)例。口服硒维持剂量的中位(IQR)治疗或观察时间分别为 446(128-1157)和 414(141-1064)天。维持剂量时的中位数(IQR)按体质量计剂量为 2.6(1.7-3.9)μg/kg,维持剂量时的中位数(IQR)血清硒浓度为 8.5(7.0-10.6)μg/mL,在可耐受上限和参考范围左右。不良事件的硒剂量、血清硒浓度或血清硒浓度与剂量比(C/D 比)没有差异。比较了不良事件患者与未接受硒治疗的患者的发生率。
结论
在儿童患者中,低于可耐受上限剂量的口服硒制剂可以有效且安全地使用。