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.

Abstract

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.