目的 基于频率学派方法进行网状Meta分析，评价口服中成药联合选择性5-羟色胺再摄取抑制剂（selective serotonin reuptake inhibitor，SSRIs）治疗卒中后抑郁的有效性及安全性。方法 计算机检索中文数据库中国知网（CNKI）、万方（Wanfang data）、中国生物医学文献数据库（SinoMed）、维普（VIP）和外文数据库PubMed、EMbase、Cochrane Library建库至2021年2月18日收录的口服中成药联合SSRIs治疗卒中后抑郁的随机对照试验（randomized controlled trials，RCTs），利用Cochrane手册RCT偏倚风险评估工具对纳入研究进行质量评价，通过RevMan 5.4、Stata 15.1进行数据分析。结果 最终共纳入49项RCTs，涉及8种口服中成药舒肝解郁胶囊（Shugan Jieyu Capsule，SGJY）、乌灵胶囊（Wuling Capsule，WL）、养血清脑颗粒（Yangxue Qingnao Granules，YXQN）、逍遥类方（Xiaoyaosan and its analogous prescriptions，XYLF）、解郁丸（Jieyu Pills，JYW）、甜梦系列成药（Tianmeng series patent medicine，TMXL）、安脑丸（Annao Pills，ANW）、解郁安神颗粒（Jieyu Anshen Granules，JYAS）。Meta分析显示，降低汉密尔顿抑郁量表17项（HAMD-17）评分方面，SSRIs分别联合SGJY、WL、YXQN、JYW、JYAS优于单用SSRIs；降低汉密尔顿抑郁量表24项（HAMD-24）评分方面，SSRIs分别联合SGJY、XYLF、JYW、TMXL、ANW优于单用SSRIs；提高5-羟色胺（5-hydroxytryptamine，5-HT）水平方面，SSRIs分别联合YXQN、XYLF、JYW、TMXL、JYAS优于单用SSRIs；降低美国国立卫生研究院卒中量表（National Institutes of Health Stroke Scale，NIHSS）评分方面，SSRIs联合JYW优于单用SSRIs；提高治疗有效率方面，SSRIs分别联合SGJY、WL、YXQN优于单用SSRIs；降低不良反应发生率方面，SSRIs联合TMXL优于单用SSRIs。网状Meta分析结果显示，降低HAMD-17评分最佳的前3种方案为SGJY＋SSRIs>JYW＋SSRIs>TMXL＋SSRIs；降低HAMD-24评分最佳的前3种方案为TMXL＋SSRIs>SGJY＋SSRIs>JYW＋SSRIs；提高5-HT水平最佳的前3种方案为XYLF＋SSRIs>TMXL＋SSRIs>YXQN＋SSRIs；降低NIHSS评分最佳的前3种方案为JYW＋SSRIs>YXQN＋SSRIs>SGJY＋SSRIs；提高治疗有效率最佳的前3种方案为ANW＋SSRIs>WL＋SSRIs>JYW＋SSRIs；降低不良反应发生率最佳的前3种方案为TMXL＋SSRIs>WL＋SSRIs>ANW＋SSRIs。结论 SSRIs联合口服中成药可有效改善卒中后抑郁状态，安全性较平稳，因纳入研究质量水平不均，仍需得到更多高质量研究的验证。

Objective To evaluate the efficacy and safety of Chinese patent drugs combined with selective serotonin reuptake inhibitors (SSRIs) in the treatment of poststroke depression with frequency network Meta-analysis. Methods Randomized controlled trials (RCTs) of Chinese patent drugs for poststroke depression were retrieved from CNKI, Wanfang data, SinoMed, VIP, PubMed, EMbase and Cochrane Library databases from inception to February 18, 2021. The quality of the included RCTs were evaluated according to the Cochrane recommendation standard, and the data were analyzed by RevMan 5.4 and Stata 15.1. Results Eight kinds of Chinese patent drugs and 49 RCTs were included, involving Shugan Jieyu Capsule (SGJY, 舒肝解郁胶囊), Wuling Capsule (WL, 乌灵胶囊), Yangxue Qingnao Granules (YXQN, 养血清脑颗粒), Xiaoyaosan and its analogous prescriptions (XYLF, 逍遥类方), Jieyu Pills (JYW, 解郁丸), Tianmeng series patent medicine (TMXL, 甜梦系列成药), Annao Pills (ANW, 安脑丸), and Jieyu Anshen Granules (JYAS, 解郁安神颗粒). Meta-analysis results showed that in term of improving HAMD-17 score, SGJY, WL, YXQN, JYW and JYAS combined with SSRIs were superior to SSRIs; In reducing HAMD-24 score, SGJY, XYLF, JYW, TMXL and ANW combined with SSRIs were superior to SSRIs; In improving 5-hydroxytryptamine (5-HT) level, YXQN, XYLF, JYW, TMXL, JYAS combined with SSRIs were superior to SSRIs; In improving National Institutes of Health Stroke Scale (NIHSS) score, JYW combined with SSRIs were superior to SSRIs; In terms of treatment effective rate, SGJY, WL, YXQN combined with SSRIs were superior to SSRIs; In terms of safety, TMXL combined with SSRIs were superior to SSRIs. The results of the network Meta-analysis indicated that the top three interwentiong to improve HAMD-17 score were SGJY + SSRIs > JYW + SSRIs > TMXL + SSRIs; The top three interwentiong to reduce HAMD-24 score were TMXL + SSRIs > SGJY + SSRIs > JYW + SSRIs; The top three interwentiong to improve 5-HT level were XYLF + SSRIs > TMXL + SSRIs > YXQN + SSRIs; The top three interwentiong to improve NIHSS score were JYW + SSRIs > YXQN + SSRIs > SGJY + SSRIs; In terms of treatment effective rate, the top three optimal medication regimens were ANW + SSRIs > WL + SSRIs > JYW + SSRIs; The top three interwentiong in terms of safety were TMXL + SSRIs > WL + SSRIs > ANW + SSRIs. Conclusion Chinese patent drugs combined with SSRIs can effectively improve the symptoms of poststroke depression and have a high security, but due to the methodological quality of the included studies is low, the conclusions of this study need to be verified by more high-quality research.

R285.64

中医药传承与创新“百千万”人才工程（岐黄工程）-岐黄学者（国中医药人教函〔2018〕284号）；全国名老中医药专家传承工作室建设项目“王新志全国名老中医药专家传承工作室”[豫中医科教2017（5）号]