柴胡加龙骨牡蛎汤治疗失眠的Meta分析

Efficacy and Safety of Radix Bupleuri Plus Longgu Oyster Decoction in the Treatment of Insomnia:a Meta-analysis

目的系统评价柴胡加龙骨牡蛎汤治疗失眠的疗效与安全性,以期为临床应用提供参考。方法以“柴胡加龙骨牡蛎汤”“失眠”“不寐”“随机”等为关键词,检索时间从建库至2018年5月,中文数据库包括中国期刊全文数据库(CNKI)、维普数据库(VIP)、中国生物医学文献数据库(CBM)、万方数据库,英文数据库包括PubMed、EMbase、Cochrane Library数据库,纳入柴胡加龙骨牡蛎汤治疗失眠的随机对照试验,采用Cochrane手册临床试验质量评价标准对纳入文献进行方法学质量评价,采用RevMan 5.3软件进行统计分析。结果本研究共纳入26篇文献,1919例病人。Meta分析结果显示:观察组治疗失眠临床总有效率优于对照组[OR=3.56,95%CI(2.73,4.64),P<0.00001],对照组反弹性失眠发生率高于观察组[OR=0.30,95%CI(0.15,0.62),P=0.001],对照组匹兹堡睡眠质量指数量表(PSQI)积分高于观察组[MD=-3.04,95%CI(-3.21,-2.86),P<0.00001],对照组不良反应发生率高于观察组[OR=0.16,95%CI(0.10,0.26),P<0.00001]。结论现有证据表明,柴胡加龙骨牡蛎汤加减或联合抗失眠药治疗失眠优于单独使用抗失眠药,并能有效降低失眠病人反弹性失眠发生率和PSQI积分,且安全性更高。

Objective To systematically evaluate the efficacy and safety of Radix Bupleuri plus Longgu Oyster decoction in the treatment of insomnia.Methods The keywords of"Radix Bupleuri plus Longgu Oyster decoction""insomnia"and"randomness"were used to search Chinese databases before May 2018,including China Journal Full-Text Database(CNKI),VIP Database(VIP),China Biomedical Literature Database(CBM)and Wanfang database.Foreign language databases included PubMed,EMbase,and Cochrane.Randomized controlled trials(RCTs)for the treatment of insomnia with Radix Bupleuri plus Longgu Oyster decoction were used.The methodological quality evaluation of the included literature was conducted using the Cochrane Manual clinical Trial Quality Evaluation Criteria.The study results of the included literatures were analyzed by RevMan 5.3.Results Twenty-six literatures were included,including 1919 patients.The resultsof Meta-analysis showed that the clinical efficacy in the observation group was better than that in the control group[OR=3.56,95%CI(2.73,4.64),P<0.00001],the incidence of rebound insomnia was higher in the control group than that in the observation group[OR=0.30,95%CI(0.15,0.62),P=0.001],the scores of Pittsburgh Sleep Quality Index(PSQI)in the control group were higher than those in the observation group[MD=-3.04,95%CI(-3.21,-2.86),P<0.00001],the rate of adverse reaction in the control group was significantly higher than that in the observation group[OR=0.16,95%CI(0.10,0.26),P<0.00001].Conclusion Current evidence showed that Radix Bupleuri plus Longgu Oyster decoction alone or combined with anti-insomnia drugs was superior to anti-insomnia drugs alone in the treatment of insomnia,and could effectively improve the incidence of rebound insomnia in insomnia patients,reduce PSQI scores,and it was safety.