23种常用中成药治疗失眠的临床研究证据图分析

Evidence mapping of clinical studies on 23 commonly used Chinese patent medicines for treating insomnia

运用证据图系统检索和梳理中成药治疗失眠的临床研究证据,了解该领域证据分布特点,发现中成药治疗失眠相关研究存在的问题。检索3个国家药物目录中明确提及治疗失眠的中成药,检索建库至2023年8月的中、英文文献。采用图、表展示结果。最终纳入中成药23种,相关文献299篇,包括随机对照试验(RCTs)236篇,非随机对照试验(non-RCTs)35篇,回顾性研究7篇,系统评价/Meta分析17篇,指南和专家建议或共识4篇。文献占比较大的是百乐眠胶囊、乌灵胶囊、养血清脑颗粒;结局指标包括睡眠评定量表、临床有效率、安全性指标、焦虑抑郁评分等。结果表明,中成药治疗失眠研究整体呈增长趋势,但研究证据相对较少,研究以单中心、小样本和短周期为主;临床定位宽泛,中医优势不足;结局指标对生活质量、随访及复发率方面关注度不够;RCT整体偏倚风险偏高,系统评价/Meta分析整体质量较低,回顾性研究总体评分不高,non-RCT均未提及随访时间、失访率及样本量估算,结果可信度降低。建议以中医药临床研究规范来设计治疗失眠的中成药研究方案,将中医证候积分评价作为重要结局指标,多关注患者生活质量、随访及复发情况,提高有效治疗失眠中成药的可及性和经济性,加强医保政策与中成药政策的衔接,合理提升具有明确疗效和安全证据支持的中成药在医保甲类目录中的占比。

Evidence mapping was performed to systematically search and review the clinical studies about the treatment of insomnia with Chinese patent medicines. The evidence distribution in this field was analyzed and the problems of the studies were summarized. Chinese-and English-language articles of the studies involving the Chinese patent medicines specified in three national drug catalogs for the treatment of insomnia were searched against the databases with the time interval from inception to August 2023. Figures and tables were established to present the results. Finally, 23 Chinese patent medicines were screened out, which were mentioned in 299 articles involving 236 randomized controlled trials(RCTs), 35 non-randomized controlled trials(non-RCTs), 7 retrospective studies, 17 systematic reviews/Meta-analysis, and 4 guidelines/expert recommendations or consensus. Bailemian Capsules, Wuling Capsules, and Yangxue Qingnao Granules were mentioned in a large proportion of articles. The outcome indicators included sleep rating scale, clinical response rate, safety indicators, and anxiety and depression scores. The results showed that the studies about the treatment of insomnia with Chinese patent medicines were growing. However, there was a scarcity of research evidence, and the available studies were single-center with small sample sizes and short periods. These studies spanned broad clinical scopes with inadequately emphasized advantages of TCM and insufficient outcome indicators about quality of life, follow-up, and recurrence rate. RCT exhibited a high risk of bias, and the systematic reviews/Meta-analysis demonstrated low overall quality. The retrospective studies received suboptimal scores, and the non-RCT failed to mention follow-up time, loss rate to follow-up, and sample size estimations, which compromised result reliability. It is recommended that the research protocol for Chinese patent medicines in treating insomnia should adhere to the clinical research standards of TCM. The TCM syndrome score can serves as a crucial outcome measure, and emphasis should be placed on patients′ quality of life, follow-up, and recurrence prevention. Measures should be taken to enhance the accessibility and affordability of Chinese patent medicines and strengthen the connection between medical insurance policies and the policies pertaining to Chinese patent medicines. Furthermore, it is advisable to reasonably increase the inclusion of Chinese patent medicines with well-established efficacy and safety evidence in the category A list of medical insurance.