Systematic review on the design of randomized controlled trials about therapeutic drugs for rotavirus infection in children
- VernacularTitle:儿童轮状病毒感染治疗药物随机对照试验设计的系统评价
- Author:
Shiman GAO
1
;
Chang LIU
1
;
Meixing YAN
1
Author Information
1. Dept. of Clinical Pharmacy，Women and Children’s Hospital，Qingdao University/Qingdao Women and Children’s Hospital，Shandong Qingdao 266034，China
- Publication Type:Journal Article
- Keywords:
rotavirus infection;
children;
randomized
- From:
China Pharmacy
2023;34(14):1761-1767
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To systematically analyze the related clinical research of therapeutic drugs for rotavirus infection in children， and to provide reference for the improvement of scientific and normative implementation in clinical trials. METHODS PubMed， the Cochrane Library and Embase databases were systematically searched， and English literature on randomized controlled trials （RCTs） about therapeutic drugs for pediatric rotavirus infection published between 2000 and 2022 was included. After literature screening and data extraction， the quality of the included literature was evaluated using the bias risk assessment scale recommended by Cochrane Handbook for Systematic Reviews. The research objectives， overall design， subject inclusion and exclusion criteria， interventions， course of treatment， follow-up visits， efficacy and safety evaluations， and results were analyzed descriptively. RESULTS & CONCLUSIONS A total of 17 RCTs were included， involving 1 345 subjects. The purpose included relieving rotavirus infection-induced diarrhea， promoting rotaviral shedding， improving clinical symptoms such as dehydration， fever， vomiting， and shortening hospital stays， etc. All trials were randomized and single-center studies， mostly double-blind （13 trials） and placebo-controlled （16 trials）， and 64.71% had sample size estimation. The inclusion and exclusion criteria included diarrhea attack， virus detection， clinical symptoms， disease types and drugs， etc. The interventions included probiotics （8 trials）， biological agents （3 trials）， anti-infective agents （3 trials）， etc. Most of treatment course was 1-5 days （13 trials）. A total of 58.82% were designed for follow-up. In the validity evaluation， diarrhea attack， microbiology test and fecal culture， clinical symptoms such as dehydration， fever and vomiting， length of hospital stays or duration of symptoms were included. Vesikari scale， WHO criteria and researcher evaluation were the evaluation criteria. In the safety evaluation， 10 trials were designed for adverse events/adverse reaction observation； only one trial listed ethical approval numbers. The information of literature included in the study covers the basic elements for the design of RCTs of drugs for rotavirus infection in children. Nevertheless， all are single- center studies. Partial studies lack the basis for sample size estimation and related contents of drug combination， and the quality needs to be improved. In the future， the high-quality multi-center clinical trials should be further conducted， with objective measurement indexes as the validity results， and the ethical review and safety evaluation should be emphasized.
