酸枣仁类中成药治疗原发性失眠症的网状Meta分析

Network Meta-analysis of Chinese patent medicines of Ziziphi Spinosae Semen in treatment of primary insomnia

运用网状Meta分析方法系统评价口服酸枣仁类中成药治疗原发性失眠症的疗效。计算机检索CNKI、Wanfang、VIP、CBM、PubMed、EMbase、Web of Science、Medline、Cochrane Library数据库,检索时间为建库至2020年8月,按照预先设定的纳入、排除标准,筛选口服酸枣仁类中成药单用或联合常规镇静催眠药治疗原发性失眠症的随机对照试验。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用Stata 15.0和R软件进行传统Meta和贝叶斯网状Meta分析。最终纳入42个RCTs,涉及9种口服中成药,4196例患者。Meta分析结果显示,(1)在改善匹兹堡睡眠质量指数量表评分方面,联合用药显著优于西药或多数中成药单独使用,其中百乐眠胶囊联合西药效果最优;参芪五味子片、复方枣仁安神胶囊单独使用均显著优于常规西药治疗,参芪五味子片疗效最佳;(2)在安全性方面,单用或联合中成药均较常规西药治疗有一定改善,因临床异质性较大无法定量合并,所有纳入研究未发生严重不良反应。结果表明,酸枣仁类中成药联合常规镇静催眠药治疗原发性失眠症能明显改善患者近期睡眠质量,单药比较中参芪五味子片疗效最佳的可能性大。临床运用应当考虑国际推广证据不足,不同西药种类和干预时长对疗效的影响,以及患者对联合治疗的接受程度。受纳入研究数量和质量等限制,上述结论有待更多大样本、高质量研究进一步验证。

To systematically evaluate the efficacy of oral Chinese patent medicines of Ziziphi Spinosae Semen in the treatment of primary insomnia by using network Meta-analysis.Nine databases(CNKI,Wanfang,VIP,CBM,PubMed,EMbase,Web of Science,Medline and Cochrane Library)were systematically and comprehensively undertaken to identify the literatures published from the establishment of each database to August,2020.Randomized controlled trials(RCTs)on oral Chinese patent medicine of Ziziphi Spinosae Semen in the treatment of primary insomnia,either alone or in combination with conventional sedative hypnotics,were screened out according to inclusion criteria and exclusion criteria.Literature screening,data extraction and the evaluation of the risk of bias for the included studies were conducted independently by 2 researchers.Traditional Meta-analysis and Bayesian network Meta-analysis were then conducted with use of Stata 15.0 and R software.Finally,a total of 42 RCTs were included,involving 9 kinds of oral Chinese patent medicines and 4196 patients.The results of Meta-analysis showed that(1)in terms of improving Pittsburgh sleep quality index scale score,the efficacy of the combination of drugs was significantly superior to that of sedative-hypnotics or most of Chinese patent medicines used alone,and Bailemian Capsules combined with sedative-hypnotics had the best effect;both the efficacy of Shenqi Wuweizi Tablets and Compound Zaoren Anshen Capsules alone were significantly superior to that of conventional sedative-hypnotics treatment,and Shenqi Wuweizi Tablets had the best effect.(2)In terms of safety,single use or combined use of Chinese patent medicine had a certain improvement as compared with conventional sedative-hypnotics treatment.Due to the large clinical heterogeneity,the studies could not be combined quantitatively,and no serious adverse reactions occurred in all patients enrolled in the study.The results showed that Chinese patent medicine of Ziziphi Spinosae Semen combined with conventional sedative-hypnotics could significantly improve the short-term sleep quality of patients with primary insomnia.In the comparison among single use of drugs,Shenqi Wuweizi Tablets had the largest possibility for best effect.However,the lack of evidences for international promotion,the influence of different types of sedative-hypnotics treatment and intervention time on the curative effect,and the patients′different acceptance of combined treatment should be considered before clinical application.Limited by the number and quality of the included studies,the above conclusions need to be further verified by more large sample-size and high-quality studies.