柴胡加龙骨牡蛎汤加减治疗失眠的Meta分析

Meta-Analysis of Modified Chaihu Longgu Muli Decoction in the Treatment of Insomnia

目的:系统评价柴胡加龙骨牡蛎汤加减治疗失眠的临床疗效和安全性。方法:由两位研究者进行文献筛选和文献质量评价,运用Rev Man 5.3软件对纳入随机对照试验(RCT)进行Meta分析。结果:最终纳入15项RCT,共计1521例患者。Meta分析结果显示,相对于西药组,柴胡加龙骨牡蛎汤加减组明显降低患者PSQI评分(MD=-2.28,95%CI[-3.25,-2.40],P<0.00001),提高总有效率(RR=1.21,95%CI[1.13,1.30],P<0.00001),明显降低一周复发率(RR=0.24,95%CI[0.10,0.56],P=0.0009);不良反应发生率明显低于西药组(RR=0.16,95%CI[0.09,0.29],P<0.00001)。结论:柴胡加龙骨牡蛎汤加减治疗失眠具有较好的临床疗效和安全性,但由于样本量小,仍需高质量、大样本、设计规范、多中心的临床研究进一步验证。

Objective:To systematically evaluate the clinical efficacy and safety of modified Chaihu Longgu Muli Decoction in the treatment of insomnia. Methods:Literature screening and literature quality evaluation were conducted by two researchers. Meta-analysis of randomized controlled trials(RCTs) was performed using Rev Man 5.3. Results:Fifteen RCTs were included with 1521 patients. Meta-analysis showed that compared with the chemical drugs,Chaihu Longgu Muli Decoction can significantly reduced the Pittsburgh Sleep Quality Index(PSQI) score(MD=-2.28,95%CI[-3.25,-2.40],P< 0.00001),increased the total effective rate(RR=1.21,95%CI[1.13,1.30],P< 0.00001),significantly reduced the recurrence rate(RR= 0.24,95%CI[0.10,0.56],P= 0.0009) and the incidence of adverse reactions(RR= 0.16,95%CI [0.09,0.29],P< 0.00001). Conclusion:Modified Chaihu Longgu Muli Decoction has good clinical efficacy and safety in the treatment of insomnia.However,the sample size is small. In the future,RCTs of high quality,large sample size,better protocol and multi-center are needed to further verify this conclusion.