Post-stroke insomnia is one of the most common post-stroke complications, which seriously damages the quality of life and delays the process of rehabilitation. Clinical studies have shown that Western medicine alone, Chinese patent medicine alone and the combination of both are effective in the treatment of post-stroke insomnia. However, at present, there is still no network Meta-analysis to compare the efficacy of the three treatments.

To evaluate the efficacy of Western medicine alone, Chinese patent medicine alone and their combination in treating post-stroke insomnia by network Meta-analysis.

Chinese databases such as CNKI, CBM, Wanfang Data, VIP and English databases such as PubMed, Embase and Cochrane Library were researched by computer for randomized controlled trials involving Western medicine alone, Chinese patent medicine alone and the combination of both from inception to December 2022. Two researchers independently performed the evaluation of the risk of bias and quality assessment for the included studies. RevMan5.4、StataMP 14 and R 4.2.3 were used for statistical analysis.

A total of 41 papers (41 two-arm RCT studies) with 3 916 patients were enrolled, including 1 959 cases in the treatment group and 1 957 cases in the control group. Network Meta-analysis results showed that in terms of improving efficiency, combination treatment was superior to Chinese patent medicine alone and Western medicine alone (P<0.05) ; in short-term treatment (duration≤4 weeks), the effective rate of combined treatment and Chinese patent medicine alone was better than that of Western medicine alone (P<0.05) ; in long-term treatment (duration ≥8 weeks), the effective rate of combined treatment was better than that of Western medicine or proprietary Chinese medicine alone (P<0.05). In terms of improving PSQI score, combination treatment was superior to Chinese patent medicine alone and Western medicine alone (P<0.05) ; in terms of safety, the use of Chinese patent medicine can reduce the occurrence of adverse events. The ranking of efficiency improvement was (with rank probability values in parentheses) : combination treatment (0.999) >Chinese patent medicine alone (0.889) >Western medicine alone (0.890). The ranking of short-term treatment efficiency was combination treatment (0.535) >Chinese patent medicine alone (0.526) >Western medicine alone (0.991). The ranking of long-term treatment efficiency was combination treatment (0.989) >Chinese patent medicine alone (0.529) >Western medicine alone (0.537). The ranking of PSQI score improvement was combination treatment (0.982) >Chinese patent medicine alone (0.975) >Western medicine alone (0.992) .

All three treatments for post-stroke insomnia have shown good efficacy and safety in terms of improving clinical efficiency and PSQI scores, and the most significant effect was shown in the combination treatment. However, high-quality, large sample studies are needed to verify the results.

卒中后失眠是卒中后常见的并发症之一，其严重损害患者生活质量、延缓康复进程。临床研究表明单纯西药、单纯中成药及两者联合治疗卒中后失眠均有明确的疗效。目前尚无采用网状Meta分析方法比较三者治疗效果的研究。

采用网状Meta分析方法，评价单纯西药、中成药及其联合治疗卒中后失眠的有效性。

计算机检索中国知网（CNKI）、万方数据知识服务平台（Wanfang Data）、维普网（VIP）、中国生物医学文献数据库（CBM）、PubMed、Embase、Cochrane Library中英文数据库收录的涉及单纯西药、单纯中成药及两者联合治疗卒中后失眠的随机对照试验，检索时限为建库至2022年12月。由2位研究人员对纳入文献独立进行偏倚风险评估及质量评价，采用RevMan5.4、StataMP 14、R 4.2.3进行数据分析。

最终纳入41篇文献（41项双臂RCT研究），包含3 916例患者，其中治疗组1 959例，对照组1 957例。网状Meta分析结果显示：在提高有效率方面，联合治疗优于单纯中成药治疗、单纯西药治疗（P<0.05）；短期治疗（疗程≤4周）时，联合治疗与单纯中成药治疗的有效率均优于单纯西药治疗（P<0.05）；长期治疗（疗程≥8周）时，联合治疗有效率优于单纯西药治疗或单纯中成药治疗（P<0.05）。在改善PSQI评分方面，联合治疗优于单纯中成药治疗、单纯西药治疗（P<0.05）；在安全性方面，中成药的使用能够降低不良反应事件的发生率。提高有效率排序结果为（括号内为等级概率值）：联合治疗（0.999）>单纯中成药治疗（0.889）>单纯西药治疗（0.890）；短期治疗有效率排序结果为：联合治疗（0.535）>单纯中成药治疗（0.526）>单纯西药治疗（0.991）；长期治疗有效率排序结果为：联合治疗（0.989）>单纯中成药治疗（0.529）>单纯西药治疗（0.537）；改善PSQI评分排序结果为：联合治疗（0.982）>单纯中成药治疗（0.975）>单纯西药治疗（0.992）。

3种干预措施治疗卒中后失眠在提高临床有效率、改善PSQI评分方面均有较好的疗效和安全性，其中联合治疗的效果最显著，但结论仍需要高质量、大样本研究予以验证。