Yao Wen-Qiang, Zhao Yu-Hao, Zheng Ya-Wei, Zhang Qing, Han Xu
Affiliated Hospital of Nanjing University of Chinese Medicine Nanjing 210029, China Nanjing University of Chinese Medicine Nanjing 210023, China.
Nanjing University of Chinese Medicine Nanjing 210023, China.
Zhongguo Zhong Yao Za Zhi. 2021 Sep;46(17):4541-4554. doi: 10.19540/j.cnki.cjcmm.20210114.501.
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 4 196 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.
采用网状Meta分析系统评价酸枣仁口服中成药治疗原发性失眠的疗效。系统全面地检索9个数据库(中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Web of Science、Medline和Cochrane图书馆),以查找从各数据库建库至2020年8月发表的文献。根据纳入标准和排除标准,筛选出酸枣仁口服中成药单独或联合常规镇静催眠药治疗原发性失眠的随机对照试验(RCT)。由2名研究人员独立进行文献筛选、数据提取及对纳入研究的偏倚风险评估。然后使用Stata 15.0和R软件进行传统Meta分析和贝叶斯网状Meta分析。最终共纳入42项RCT,涉及9种酸枣仁口服中成药和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,联合用药的疗效显著优于镇静催眠药或大多数单独使用的中成药,百乐眠胶囊联合镇静催眠药效果最佳;参芪五味子片和复方枣仁安神胶囊单独使用的疗效均显著优于常规镇静催眠药治疗,参芪五味子片效果最佳。(2)在安全性方面,中成药单独使用或联合使用与常规镇静催眠药治疗相比有一定改善。由于临床异质性大,研究无法进行定量合并,且纳入研究的所有患者均未发生严重不良反应。结果表明,酸枣仁中成药联合常规镇静催眠药可显著改善原发性失眠患者的短期睡眠质量。在单药比较中,参芪五味子片效果最佳的可能性最大。然而,临床应用前应考虑缺乏国际推广证据、不同类型镇静催眠药治疗及干预时间对疗效的影响以及患者对联合治疗的不同接受程度。受纳入研究数量和质量的限制,上述结论需要更多大样本、高质量研究进一步验证。