目的 系统评价健胃消食口服液联合多潘立酮治疗儿童功能性消化不良的临床疗效及安全性。方法 计算机检索中国学术期刊全文数据库（CNKI）、万方数据知识服务平台（Wanfang Data）、维普中文科技期刊数据库（VIP）、中国生物医学文献服务系统（SinoMed）、The Cochrane Library、PubMed和Web of Science等数据库，收集自建库起至2022年1月22日健胃消食口服液联合多潘立酮治疗儿童功能性消化不良的临床随机对照试验（RCT），使用RevMan 5.4软件进行Meta分析。结果 共纳入12项RCTs、包括1 417例患儿，Meta分析结果显示：健胃消食口服液联合多潘立酮组较单独使用多潘立酮（对照）组能缩短患儿食欲恢复时间［MD＝-2.06，95% CI（-2.32，-1.81）］、恶心呕吐消失时间［MD＝-2.07，95% CI（-2.34，-1.70）］、提高总有效率［RR＝1.26，95% CI（1.20，1.33）］，两组比较差异均有统计学意义（P<0.000 01）；不良反应率［RR＝0.71，95% CI（0.44，1.14），P＝0.16］，两组比较差异无统计学意义。结论 健胃消食口服液联合多潘立酮治疗儿童功能性消化不良的疗效优于单用多潘立酮，且安全性没有明显差别。

Objective To systematically evaluate the clinical efficacy and safety of Jianweixiaoshi Oral Liquid combined with domperidone in the treatment of functional dyspepsia in children. Methods Data were electronically searched from the CNKI, Wanfang Data, VIP, SinoMed, The Cochrane Library, PubMed, and Web of Science, in order to collect the randomized controlled trials (RCTs) on Jianweixiaoshi Oral Liquid combined with domperidone in the treatment of functional dyspepsia in children. The search time was from the establishment of the database to 22, January 2022. The Meta-analysis was carried out by RevMan 5.4 software. Results A total of 12 RCTs were selected, including 1 417 children with functional dyspepsia. The Meta-analysis results that compared with domperidone alone (control) group, Jianweixiaoshi Oral Liquid combined with domperidone group could reduce the appetite recovery time[MD=-2.06, 95%CI (-2.32, -1.81)], reduce the disappearance time of nausea and vomiting[MD=-2.07, 95%CI (-2.34, -1.70)], increase total effective rate[RR=4.61, 95%CI (3.23, 6.57)], the differences are statistically significant (P<0.000 01). There was no statistically significant in adverse reaction rate between two groups[RR=0.71, 95%CI (0.44, 1.14), P=0.16]. Conclusion Jianweixiaoshi Oral Liquid combined with domperidone is more effective than Domperidone alone in the treatment of children with functional dyspepsia, and there is no significant difference in safety.

国家自然科学基金青年基金资助项目（82004422）