目的 系统评价逍遥类方联合帕罗西汀治疗抑郁症的临床疗效与安全性。方法 计算机检索PubMed、Embase、Web of Science、the Cochrane Library、中国学术期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、维普中文期刊全文数据库（VIP）、万方数据库等国内外数据库，搜索逍遥类方联合帕罗西汀治疗抑郁症的临床随机对照试验（RCT），检索时间为数据库建立至2021年1月1日。并采用Cochrane协作网研发的偏倚风险评估工具进行文献质量评价，最后采用Review Manager 5.3软件进行Meta分析。结果 共纳入21项RCTs，总计1 894例患者，其中试验组947例、对照组947例。Meta分析结果显示：逍遥类方联合帕罗西汀抗抑郁疗效优于单用帕罗西汀，显著提高有效率［OR=3.61，95% CI（2.72，4.80），P<0.01］。在降低汉密尔顿抑郁量表（HAMD）评分［MD=-2.43，95% CI（-3.10，-1.75）］、汉密尔顿焦虑量表（HAMA）评分［MD=- 3.53，95% CI（- 3.84，- 3.22）］、不良反应量表（TESS）评分［OR=0.31，95% CI（0.21，0.45）］等方面，逍遥类方联合帕罗西汀疗效显著优于帕罗西汀单用，差异均有统计学意义（P<0.01）。且逍遥类方与帕罗西汀联用显著减少了嗜睡、便秘、恶心呕吐、头痛等事件的发生。结论 逍遥类方与帕罗西汀联用治疗抑郁症较单一帕罗西汀有显著优势，具增效减毒之效。但受纳入文献数目和质量的影响，该研究结论仅供临床医生作为治疗决策参考，还需更多严格设计的高质量RCTs来支持。

Objective To systematically evaluate the clinical efficacy and the safety of the combination of Xiaoyao prescriptions (XYPs) in combination and paroxetine on depression. Methods Literature search was conducted across PubMed, Embase, Web of Science, the Cochrane Library, CNKI, CBM, Wanfang, and VIP, to search for randomized controlled trial (RCT) of XYPs and paroxetine in the treatment of depression. The retrieval time was set from the establishment of the database to January 1, 2021. Data extraction and quality assessment were performed according to the Cochrane standards, and Meta-analysis was conducted by Review Manager 5.3 software. Results A total of 1 894 patients were included in 21 RCTs, including 947 in the experimental group and 947 in the control group. Meta-analysis showed that XYPs combined with paroxetine exhibited significantly greater effects on depression than paroxetine alone[OR=3.61, 95%CI (2.72, 4.80), P < 0.01]. In terms of reducing the Hamilton Depression Scale (HAMD) score[MD=-2.43, 95%CI (-3.10, -1.75)], Hamilton Anxiety Scale (HAMA) score[MD=-3.53, 95%CI (-3.84, -3.22)], and the Treatment Emergent Symptom Scale (TESS) score[OR=0.31, 95%CI (0.21, 0.45)], the combination of XYPs and paroxetine were significantly better than the group of paroxetine alone, which were statistically significant (P < 0.01). Moreover, the combination of XYPs and paroxetine significantly reduced the occurrences of drowsiness, constipation, nausea and vomiting, headaches, and so forth. Conclusion The combination of XYPs and paroxetine in the treatment of depression has significant advantages over paroxetine alone, with increasing efficacy and reducing toxicity. However, due to the number and the quality of the literatures included, the above conclusions could be referred by clinicians for treatment decisions, and more rigorously designed high-quality clinical randomized controlled trials (RCTs) are needed to support.

R287.5

国家自然科学基金青年基金资助项目（81803962）；山西省留学回国人员科研活动资助项目（20200013）；地产中药功效物质研究与利用山西省重点实验室（202105D121009）