目的 系统评价中医药治疗复发性流产及调节外周血辅助性T 细胞（T helper cell 17，Th17）和调节性T 细胞（regulatory T cells，Treg）水平的疗效。方法 计算机检索中国知网（CNKI）、万方数据库（Wanfang）、维普 数据库（VIP）、中国生物医学文献数据库（SinoMed）、外文医学信息资源检索平台（FMRS）、PubMed、Cochrane Library、Embase、Web of science 等数据库，筛选自建库至2023 年6 月公开发表的与中医药调控Th17、Treg 细胞治疗复发性流产相关的随机对照试验（RCT）。由2 名评价者按照Cochrane 手册评价文献质量，应用 RevMan 5.4 软件进行Meta 分析。结果 纳入10 项研究，共计1 052 例患者。Meta 分析结果显示，相较于对 照组，试验组患者孕后应用中药治疗可显著提高有效率[RR=1.20，95%CI（1.11，1.30），P＜0.000 01]和活产率 [RR=1.32，95%CI（1.16，1.50），P＜0.000 01]，减少药物不良反应[RR=0.34，95%CI（0.14，0.83），P=0.02]。中 药治疗后，Th17 细胞表达降低[MD=-0.71，95%CI（-1.01，-0.41），P＜0.000 01]，Treg 细胞表达升高[SMD= 1.21，95%CI（0.80，1.62），P＜0.000 01]，Th17/Treg 细胞比值下降[SMD=-2.62，95%CI（-4.09，-1.14），P = 0.000 5]。结论 中医药孕后或孕前、孕后同时治疗可明显改善复发性流产患者的临床症状，提高活产率，且 安全性较高。同时，中医药可降低Th17 细胞表达，上调Treg 细胞表达，调节Th17/Treg 细胞免疫平衡，有利 于妊娠后胚胎发育。

Abstract： Objective To systematically evaluate the efficacy of traditional Chinese medicine （TCM） in the treatment of recurrent spontaneous abortion and their regulatory effects of levels of peripheral blood Th17 cells and Treg cells. Methods Computer retrieval of CNKI，WanFang，VIP，SinoMed，FMRS，PubMed，Cochrane Library， Embase，Web of science and other databases were carried out. RCTS related to the regulation of Th17 and Treg cells by TCM in the treatment of recurrent spontaneous abortion，published from the establishment of the database to June 2023 were screened. Two reviewers evaluated the quality of the literature according to the Cochrane handbook. RevMan5.4 software was used for Meta-Analysis. Results A total of 10 studies that involved 1 052 patients were included. The Meta-Analysis results showed that compared to the control group，the effective rate [RR=1.20，95%CI （1.11，1.30），P＜0.000 01]，live birth rate [RR=1.32，95%CI （1.16，1.50），P＜0.000 01] and the reduction of adverse drug reactions [RR=0.34，95%CI （0.14，0.83），P=0.02] were significantly improved by the intervention of TCM. After treatment with TCM，the expression of Th17 cells was decreased [MD=-0.71，95%CI（-1.01，-0.41）， P＜0.000 01]，and the expression of Treg cells was increased [SMD=1.21，95%CI （0.80，1.62），P＜0.000 01]. The ratio of Th17/Treg cells was decreased [SMD=-2.62，95%CI（-4.09，-1.14），P = 0.000 5]. Conclusion TCM used for post-pregnancy or before and after pregnancy can significantly improve the clinical symptoms and live birth rate of patients with recurrent spontaneous abortion， wihch showed high safety. Moreover， TCM can reduce the expression of Th17 cells， up-regulate the expression of Treg cells and regulate the immune balance of Th17/Treg cells，which is conducive to embryonic development after pregnancy.

R285.6

国家自然科学基金面上项目（82274574）；中国中医科学院科技创新工程重大攻关项目（CI2021A02407）；中国中医科学院广安门医院 所级科研基金课题（2022S472）。