中成药治疗失眠症有效性与安全性的网状Meta分析

Network Meta-analysis of efficacy and safety of Chinese patent medicines in treatment of insomnia

运用频率学网状Meta分析评价中成药辅助治疗失眠症的有效性及安全性。计算机检索CNKI、Wanfang、VIP、SinoMed、PubMed、EMbase、Cochrane Library数据库,自建库至2020年10月收录的中成药辅助治疗失眠症的随机对照试验,用Cochrane偏倚风险评估对纳入文献进行质量评价,用RevMan 5.3、Stata/MP 15.1进行分析。最终纳入27个RCTs,11种中成药。网状Meta分析显示:有效率方面,甜梦口服液、枣仁安神胶囊、舒眠胶囊、参松养心胶囊、参芪五味子片、舒肝解郁胶囊、安神补脑液、七叶安神片联合非苯二氮卓类药物(NBZDs)优于单用NBZDs;改善匹兹堡睡眠质量指数(Pittsburg sleeping quality index,PSQI)评分方面,甜梦口服液、舒眠胶囊、参松养心胶囊、百乐眠胶囊、参芪五味子片、舒肝解郁胶囊、养血清脑颗粒、银丹心脑通软胶囊联合NBZDs优于单用NBZDs;安全性方面,舒眠胶囊、参松养心胶囊、参芪五味子片、七叶安神片联合NBZDs优于单用NBZDs;避免头晕头痛发生方面,七叶安神片联合NBZDs优于单用NBZDs。结果表明,有效率方面前3种治疗方案为NBZDs联合舒肝解郁胶囊>联合枣仁安神胶囊>联合参松养心胶囊;改善PSQI评分方面前3种治疗方案为NBZDs联合养血清脑颗粒>联合甜梦口服液液>联合银丹心脑通软胶囊;安全性方面前3种治疗方案为NBZDs联合七叶安神片>联合参松养心胶囊>联合参芪五味子片;避免头晕头痛发生方面前3种治疗方案为NBZDs联合七叶安神片>联合枣仁安神胶囊>联合舒眠胶囊;避免疲乏乏力方面前3种治疗方案为NBZDs联合参松养心胶囊>联合舒眠胶囊>联合七叶安神片。中成药联合NBZDs能有效改善失眠症症状,安全性高,但纳入研究的方法学质量偏低,该研究结论有待高质量的研究加以验证。

To evaluate the efficacy and safety of Chinese patent medicines in the treatment of insomnia by frequency network Metaanalysis.Randomized controlled trials of Chinese patent medicines for insomnia were retrieved from CNKI,Wanfang,VIP,SinoMed,PubMed,EMbase and Cochrane Library databases from the time of database establishment to October 2020.The quality of the included RCTs was evaluated according to the Cochrane bias risk standard,and the data was analyzed by RevMan 5.3 and Stata/MP 15.1.A total of 11 kinds of Chinese patent medicines in 27 RCTs were included.According to Meta-analysis,in term of the effective rate,Tianmeng Liquid,Zaoren Anshen Capsules,Shumian Capsules,Shensong Yangxin Capsules,Shenqi Wuweizi Tablets,Shugan Jieyu Capsules,Anshen Bunao Liquid and Qiye Anshen Tablets combined with nonbenzodiazepine drugs(NBZDs)were superior to NBZDs alone.In term of the improvement of Pittsburg sleeping quality index(PSQI)score,Tianmeng Liquid,Shumian Capsules,Shensong Yangxin Capsules,Bailemian Capsules,Shenqi Wuweizi Tablets,Shugan Jieyu Capsules,Yangxue Qingnao Granules and Yindan Xinnaotong Capsules combined with NBZDs were superior to NBZDs alone.In terms of the safety,Shumian Capsules,Shensong Yangxin Capsules,Shenqi Wuweizi Tablets and Qiye Anshen Tablets combined with NBZDs were superior to NBZDs alone.In terms of the avoidance of dizziness and headache,Qiye Anshen Tablets combined with NBZDs were superior to NBZDs alone.The results of Network Meta-analysis indicated that in term of the effective rate,top three optimal medication regimens were NBZDs combined with Shugan Jieyu Capsules,combined with Zaoren Anshen Capsules and combined with Shensong Yangxin Capsules in the order from high to low.With the respect of improvement of PSQI score,top three optimal medication regimens were NBZDs combined with Yangxue Qingnao Granules,combined with Tianmeng Liquid and combined with Yindan Xinnaotong Capsules in the order from high to low.In terms of the safety,top three optimal medication regimens were NBZDs combined with Qiye Anshen Tablets,combined with Shensong Yangxin Capsules and combined with Shenqi Wuweizi Tablets in the order from high to low.In terms of the avoidance of dizziness and headache,top three optimal medication regimens were NBZDs combined with Qiye Anshen Tablets,combined with Zaoren Anshen Capsules and combined with Shumian Capsules in the order from high to low.In terms of the avoidance of fatigue,top three optimal medication regimens were NBZDs combined with Shensong Yangxin Capsules,combined with Shumian Capsules and combined with Qiye Anshen Tablets in the order from high to low.In conclusion,Chinese patent medicines combined with NBZDs can effectively alleviate the symptoms of insomnia with a high safety.However,the conclusion of this study needs to be verified by more high-quality studies because of the low methodological quality of the included studies.