Page 107 - 《中国药房》2023年14期

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

＊
#
高石曼 ，刘 畅，闫美兴（青岛大学附属妇女儿童医院/青岛市妇女儿童医院临床药学科，山东 青岛 266034）
中图分类号 R978.7 文献标志码 A 文章编号 1001-0408（2023）14-1761-07
DOI 10.6039/j.issn.1001-0408.2023.14.19

摘 要 目的 系统分析儿童轮状病毒感染治疗药物的相关临床研究，为提升临床试验实施过程的科学性和规范性提供参考。
方法 系统检索PubMed、the Cochrane Library和Embase数据库，纳入2000－2022年发表的儿童轮状病毒感染治疗药物随机对照
试验（RCT）的英文文献。筛选文献、提取资料后，采用 Cochrane 系统评价员手册推荐的偏倚评价量表对纳入文献进行质量评
价，对其研究目的、试验设计、受试者的选择与退出、干预措施、疗程、随访、有效性与安全性评价、试验结果等进行描述性分析。
结果与结论 共纳入17项RCT，共计1 345例儿童受试者。研究目的包括缓解轮状病毒感染引起的腹泻发作，促进粪便中轮状病
毒脱落，改善脱水、发热、呕吐等临床症状，缩短住院时间等；所有研究均采用随机方法，均为单中心研究，多采用双盲设计（13项）
和安慰剂对照（16项），且64.71%的研究有样本量估算；受试者的纳入与排除标准涉及腹泻发作情况、病毒检测情况、临床症状、病
种、试验用药物等；干预措施包括益生菌（8项）、生物制剂（3项）、抗感染药（3项）等，疗程以1～5 d为主（13项）；58.82%的研究设
计了随访；有效性评价主要针对腹泻发作情况，微生物学试验和粪便培养结果，脱水、发热及呕吐等临床症状，住院时间或症状持
续时间等，指标评价标准包括Vesikari量表、WHO推荐标准及研究者相关记录等；有10项研究对不良事件/不良反应进行了观察；
仅有1项研究列出了伦理批件号。纳入研究的文献信息涵盖了儿童轮状病毒感染治疗药物RCT设计的基本要素，但均为单中心
研究，部分研究缺乏样本量估算依据及基础治疗之外的合并用药情况，质量有待提升。今后应进一步开展高质量的多中心临床试
验，以客观测量指标为主要有效性结果，并重视伦理审查和药物安全性评价。
关键词 轮状病毒感染；儿童；随机对照试验；设计要素

Systematic review on the design of randomized controlled trials about therapeutic drugs for rotavirus
infection in children
GAO Shiman，LIU Chang，YAN Meixing（Dept. of Clinical Pharmacy， Women and Children’s Hospital，
Qingdao University/Qingdao Women and Children’s Hospital， Shandong Qingdao 266034， China）

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
＊第一作者 主管药师，博士。研究方向：中药及其复方药效物质
review and safety evaluation should be emphasized.
基础、临床药学。E-mail：gaoshiman151@163.com
# 通信作者 主任药师，硕士。研究方向：医院药学管理、临床药 KEYWORDS rotavirus infection； children； randomized
学。E-mail：meixing@163.com controlled trials； design elements

中国药房 2023年第34卷第14期 China Pharmacy 2023 Vol. 34 No. 14 · 1761 ·