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目的 评价中药复方治疗功能性消化不良(FD)的有效性与安全性.方法 计算机检索PubMed,Embase,Cochrane Library,Web of Science,CBM,Wanfang Data,CNKI和VIP数据库,搜集有关中药复方治疗FD的随机、双盲、安慰剂对照试验,检索时限均为建库至2021年3月2日.由2名研究者独立筛选文献,提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.4软件进行Meta分析.结果 共纳入23项临床试验,包括2898例患者.Meta分析结果显示:中药复方治疗FD总体缓解率明显高于安慰剂(73.8％vs 46.2％)[RR=1.50,95％CI(1.29,1.76),P<0.00001].各单项症状中,中药复方对上腹痛[MD=?0.99,95％CI(?1.37,?0.61),P<0.00001],上腹烧灼感[MD=?0.32,95％CI(?0.59,?0.05),P=0.02],餐后饱胀不适[MD=?1.59,95％CI(?1.96,?1.21),P<0.00001],早饱症状[MD=?0.93,95％CI(?1.32,?0.54),P<0.00001]的改善均优于安慰剂.与安慰剂相比,中药复方治疗可明显改善FD患者中医证候[MD=?5.58,95％CI(?7.55,?3.61),P<0.00001],胃排空率[MD=12.22,95％CI(8.90,15.55),P<0.00001],有助于提高患者生活质量[MD=11.27,95％CI(0.10,22.43),P=0.05].中药复方治疗与安慰剂均未见严重不良事件报道,两组不良反应发生情况无显著差异[RR=1.34,95％CI(0.91,1.96),P=0.14].结论 当前证据表明,中药复方治疗能显著缓解FD症状,有效改善FD患者胃排空,有助于提高患者生活质量,临床应用未见严重不良反应.受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证.“,”Objective To evaluate the efficacy andsafety of traditional Chinese medicine (TCM) compounds for the treatment offunc-tional dyspepsia (FD). Methods The PubMed, Embase, Cochrane Library, Web of Sci-ence, Chinese Biomedical Database (CBM), Wanfang Data, China National Knowledge Infrastructure (CNKI), and China Science and Technology Journal Database (VIP) were searched to collect randomized, double-blind, and placebo-controlled trials of FD treated with TCM compounds. The search duration was from the establishment of the database to March 2, 2021. After two re-searchers independently screened the literature, extracted the data, and evaluated the bias risk included in the study, they used RevMan 5.4 software for meta-analysis. Results A total of 23 clinical trials were included, including 2898 patients. Meta-analysis showed that the overall remission rate of FD treated with TCM compounds was significantly higher than that of placebo (73.8％ vs. 46.2％) [RR = 1.50, 95％ CI (1.29, 1.76), P <0.00001]. Among the single symptoms, TCMcompounds were superior to the placebo in improving epigastric pain [MD = ﹣0.99, 95％ CI (﹣1.37,﹣0.61), P < 0.00001], epigastric burning sensa-tion [MD = ﹣0.32, 95％ CI (﹣0.59,﹣0.05), P = 0.02], postprandi-al fullness discomfort [MD =﹣1.59, 95％ CI (﹣1.96, ﹣1.21), P < 0.00001], and early satiety symptoms [MD = ﹣0.93, 95％ CI (﹣1.32, ﹣0.54), P < 0.00001]. Compared with the placebo, TCM compounds treatment can obviously improve TCM syndrome in patients with FD [MD = ﹣5.58, 95％ CI (﹣7.55,﹣3.61), P < 0.00001], gastric emptying rate [MD = 12. 22, 95％ CI (8.90, 15.55), P <0.00001], and helped to improve patients\' quality of life [MD = 11.27, 95％ CI (0.10, 22.43), P = 0.05]. No severe adverse events were reported between the two groups [RR = 1.34, 95％ CI (0.91, 1.96), P =0.14]. Conclusion Our results showed that TCM compounds treatment could significantly alleviate FD symptoms, improve gastric emptying in FD patients, and help to improve their quality of life. No severe adverse reactions have been reported in clinical ap-plications. Due to the limitation of the quantity and quality of the included studies, the above conclusions need to be verified by more high-quality studies.