目的 评价逍遥散加减治疗慢性乙型肝炎（chronic hepatitis B，CHB）的临床疗效和安全性。方法 电子检索中国知网（CNKI）、维普数据库（VIP）、万方数据库（Wanfang）、中国生物医学文献数据库（CBM）、中华医学期刊网、Web of Science、PubMed等数据库中逍遥散加减方治疗CHB的中英文文献，时间从建库至2022年5月26日。由2名研究者独立筛选文献、提取数据和评价纳入研究偏倚风险后，对资料进行系统性评价和Meta分析。结果 共纳入30项研究，研究对象2705例。逍遥散加减方治疗CHB在改善总有效率[RR＝0.78，95%CI（0.76，0.83），P＜0.00001]、乙肝病毒（hepatitis B virus，HBV）-DNA转阴率[RR＝0.85，95%CI（0.80，0.91），P＜0.00001]、乙型肝炎e抗原（hepatitis Be antigen，HBeAg）转阴率[RR＝0.65，95%CI（0.56，0.76），P＜0.00001]、总胆红素（total bilirubin，TBIL）[SMD＝-0.97，95%CI（-1.34，-0.60），P＜0.00001]、天冬氨酸氨基转移酶（aspartate transaminase，AST）[SMD＝-0.73，95%CI（-1.08，-0.50），P＜0.00001]和丙氨酸氨基转移酶（alanineaminotransferase，ALT）[SMD＝-1.03，95%CI（-1.42，-0.64），P＜0.00001]等方面效果显著优于对照组。结论 目前临床证据表明，逍遥散加减方单用或联合临床常规药物，治疗CHB安全有效，但该研究结论仍需更多高质量的临床试验予以验证。

Objective To systematically evaluate the efficacy and safety of modified Xiaoyao Powder (逍遥散) in the treatment of chronic hepatitis B (CHB). Methods Chinese and English literature on the treatment of CHB by Xiaoyao Powder in CNKI, VIP, Wanfang, CBM, Chinese Medical Journey, Web of Science, and PubMed were searched electronically. The retrieval time was from database establishment to May 26, 2022. Two researchers independently screened extracted data and evaluated the risk of bias, and then conducted a systematic review and Meta-analysis. Results A total of 30 studies involving 2705 patients were included. In the treatment of CHB, Xiaoyao Powder was significantly better than the control group in the improvement of the overall effective rate [RR = 0.78, 95%CI (0.76, 0.83), P<0.00001], hepatitis B virus (HBV)-DNA negative conversion rate [RR = 0.85, 95%CI (0.80, 0.91), P<0.00001], hepatitis Be antigen (HBeAg) negative conversion rate [RR = 0.65, 95%CI (0.56, 0.76), P<0.00001], total bilirubin (TBIL) [SMD = -0.97, 95%CI (-1.34, -0.60), P<0.00001], aspartate transaminase (AST) [SMD = -0.73, 95%CI (-1.08, -0.50), P<0.00001], alanine aminotransferase (ALT) [SMD = -1.03, 95%CI (-1.42, -0.64), P<0.00001]. Conclusion Current evidence shows that modified Xiaoyao Powder used alone or combined with conventional clinical drugs have a certain efficacy and safety in the treatment of CHB, and more high-quality clinical trials need to be carried out to verify the conclusion.

R285.64

湖南中医药大学中西医结合一流学科重点项目(2021ZXYJH01);湖北省医学青年拔尖人才项目(EWT2019-48)