目的 对生化汤加味促进剖宫产后子宫复旧的有效性与安全性进行系统评价，为其在临床应用提供循证医学证据。方法 检索中国生物医学文献数据库（CBM）、中国知网（CNKI）、万方资源数据库（WanFang）、维普期刊数据库（VIP）、Cochrane Library、PubMed、Web of Science等，检索时限为建库至2020年7月，选择生化汤加味促进剖宫产后子宫复旧的随机对照试验（RCT），采用Cochrane系统评价员手册提供的偏倚风险评估工具进行文献质量评价，应用RevMan5.3软件进行Meta分析。结果 共纳入12篇RCT文献，共计1804例剖宫产产妇；Meta分析结果显示，生化汤加味联合缩宫素组在产后第1、3、5天子宫底高度［MD = -0.75，95%CI（-1.35， -0.15），P < 0.00001；MD = -1.92，95%CI（-3.13， -0.72），P < 0.00001；MD = -1.92，95%CI（-3.79， -0.06），P < 0.00001］低于单用缩宫素组，联合用药组血性恶露时间［MD = -1.52，95%CI（-2.71，-0.34），P < 0.00001］和产后恶露持续时间［MD = -4.47，95%CI（-6.20，-2.75），P < 0.00001］均短于单用缩宫素组。结论 生化汤加味联合缩宫素与单用缩宫素比较，更能促进产后子宫复旧；不良反应少，报道的仅有4例出现轻微腹泻，安全性较高；但由于纳入文献质量较低，上述结论尚需更多的随机对照临床研究加以证实。

Objective To systematically evaluate the efficacy and safety of modified Shenghua Decoction in promoting uterine involution after cesarean section, so as to provide evidence-based medical evidence for its clinical application.Methods We searched the Biomedical Literature Database (CBM), Chinese academic journal full-text database(CNKI), Wanfang Database (Wanfang), Chinese scientific journal full-text database (VIP), Cochrane Library, PubMed, Web of Science, etc. from the establishment of the database to May 2020. Randomized controlled trials (RCTs) of modified Shenghua Decoction to promote uterine involution after cesarean section were selected. The bias risk assessment tool provided by Cochrane system evaluator handbook was used to evaluate the literature quality and Revman5.3 software was used for Meta analysis.Results A total of 12 RCT literatures were included, including 1804 cases of cesarean section. The results of Meta-analysis showed that the height of uterine fundus [MD = -0.75, 95% CI (-1.35, -0.15), P < 0.00001; MD = -1.92, 95% CI (-3.13, -0.72), P < 0.00001; MD = -1.92, (-3.79, -0.06), P < 0.00001] were lower in the modified Shenghua Decoction combined with oxytocin group than those in oxytocin group on the first, third and fifth day after delivery [MD = -1.52, 95%CI (-2.71,-0.34), P < 0.00001]. The duration of lochia postpartum [MD = -4.47, 95% CI (-6.20, -2.75), P < 0.00001] was shorter than oxytocin group.Conclusion Compared with oxytocin alone, modified Shenghua Decoction combined with oxytocin can promote postpartum uterine involution with less adverse reactions and high safety, and only 4 cases of mild diarrhea reported. However, due to the low quality and small number of included literatures, more randomized controlled clinical studies are needed to confirm the above conclusions.

国家中医药管理局全国名老中医药专家传承工作室建设项目(粤中医办函(2017)209号)：广东省2017年名老中医药专家传承工作室建设项目，负责人：罗仁；南方医科大学大学生创新创业训练计划项目（201912121395）：基于循证医学探讨中医体质类型与常见慢性疾病的相关性，负责人：廖嘉新