目的 系統(tǒng)評(píng)價(jià)逍遙類方聯(lián)合帕羅西汀治療抑郁癥的臨床療效與安全性。方法 計(jì)算機(jī)檢索PubMed、Embase、Web of Science、the Cochrane Library、中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫（CBM）、維普中文期刊全文數(shù)據(jù)庫（VIP）、萬方數(shù)據(jù)庫等國內(nèi)外數(shù)據(jù)庫，搜索逍遙類方聯(lián)合帕羅西汀治療抑郁癥的臨床隨機(jī)對(duì)照試驗(yàn)（RCT），檢索時(shí)間為數(shù)據(jù)庫建立至2021年1月1日。并采用Cochrane協(xié)作網(wǎng)研發(fā)的偏倚風(fēng)險(xiǎn)評(píng)估工具進(jìn)行文獻(xiàn)質(zhì)量評(píng)價(jià)，最后采用Review Manager 5.3軟件進(jìn)行Meta分析。結(jié)果 共納入21項(xiàng)RCTs，總計(jì)1 894例患者，其中試驗(yàn)組947例、對(duì)照組947例。Meta分析結(jié)果顯示：逍遙類方聯(lián)合帕羅西汀抗抑郁療效優(yōu)于單用帕羅西汀，顯著提高有效率［OR=3.61，95% CI（2.72，4.80），P<0.01］。在降低漢密爾頓抑郁量表（HAMD）評(píng)分［MD=-2.43，95% CI（-3.10，-1.75）］、漢密爾頓焦慮量表（HAMA）評(píng)分［MD=- 3.53，95% CI（- 3.84，- 3.22）］、不良反應(yīng)量表（TESS）評(píng)分［OR=0.31，95% CI（0.21，0.45）］等方面，逍遙類方聯(lián)合帕羅西汀療效顯著優(yōu)于帕羅西汀單用，差異均有統(tǒng)計(jì)學(xué)意義（P<0.01）。且逍遙類方與帕羅西汀聯(lián)用顯著減少了嗜睡、便秘、惡心嘔吐、頭痛等事件的發(fā)生。結(jié)論 逍遙類方與帕羅西汀聯(lián)用治療抑郁癥較單一帕羅西汀有顯著優(yōu)勢，具增效減毒之效。但受納入文獻(xiàn)數(shù)目和質(zhì)量的影響，該研究結(jié)論僅供臨床醫(yī)生作為治療決策參考，還需更多嚴(yán)格設(shè)計(jì)的高質(zhì)量RCTs來支持。

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

國家自然科學(xué)基金青年基金資助項(xiàng)目（81803962）；山西省留學(xué)回國人員科研活動(dòng)資助項(xiàng)目（20200013）；地產(chǎn)中藥功效物質(zhì)研究與利用山西省重點(diǎn)實(shí)驗(yàn)室（202105D121009）