电针治疗卒中后失眠Meta分析与试验序贯分析

Meta-Analysis and Trial Sequential Analysis of Electroacupuncture Treatment for Post-Stroke Insomnia

目的:系统评价电针治疗卒中后失眠的临床疗效。方法:检索中国知网(CNKI)、万方数据知识服务平台(万方数据)、中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM)、PubMed、Web of Science、Embase、Cochrane Library等数据库中以电针为主要治疗措施治疗卒中后失眠的随机对照试验(RCTs)文献,检索时限为建库至2023年10月31日。对纳入文献进行数据提取,采用Cochrane RoB 2.0风险偏倚评价工具对纳入研究进行评价,Review Manager 5.4.1软件进行Meta分析,TSA 0.9.5.10 Beta软件进行试验序贯分析。结果:共纳入8项研究,涉及516例患者。Meta分析结果显示,在总有效率方面,电针联合传统针刺优于传统针刺[RR=1.14, 95%CI (1.03, 1.27), Z=2.41, P=0.02],电针与药物比较差异无统计学意义[RR=1.11,95%CI (0.92,1.33),Z=1.10,P=0.27],电针联合药物优于药物[RR=1.21,95%CI (1.02,1.43),Z=2.21,P=0.03]。在降低匹兹堡睡眠质量指数(PSQI)总分方面,电针联合传统针刺优于传统针刺[MD=-1.61,95%CI (-2.21,-1.01),Z=5.22,P<0.001],电针与药物比较差异无统计学意义[MD=-3.01,95%CI (-6.61,0.59),Z=1.64,P=0.10],电针联合药物优于药物[MD=-1.65,95%CI (-2.02,-1.28),Z=8.85,P<0.001]。在改善神经功能缺损方面,电针联合传统针刺优于传统针刺[MD=-1.65,95%CI (-2.18,-1.12),Z=6.10,P<0.001]。在改善抑郁程度方面,电针联合传统针刺优于传统针刺[MD=-1.42,95%CI (-2.23,-0.61),Z=3.44,P<0.001]。经敏感性分析验证,本研究关于总有效率的Meta分析结果稳定。试验序贯分析结果显示,在总有效率方面,电针联合传统针刺优于传统针刺的分析结果较为稳健,结论可排除假阳性;电针与药物比较无明显差异的分析结果需要纳入更多试验来验证;电针联合药物优于药物的分析结果需要纳入更多试验以排除假阳性结论。结论:在治疗卒中后失眠疗效方面,电针联合传统针刺优于传统针刺,电针联合药物优于药物。结论有待更多高质量的RCTs支持。

Objective:To systematically evaluate the clinical effect of electroacupuncture in the treatment of post-stroke insomnia.Methods:The literature on randomized controlled trials(RCTs)using electroacupuncture as the main treatment for post-stroke insomnia was searched in databases such as the China National Knowledge Infrastructure(CNKI),Wangfang Data Knowledge Service Platform(Wanfang Data),Chinese Science and Technology Journal Database(VIP),China Biology Medicine(CBM),PubMed,Web of Science,Embase,and Cochrane Library,with a search deadline of October 31,2023.Data were extracted from the included literature and the included studies were evaluated by the Cochrane RoB 2.0 risk bias assessment tool;Meta-analysis was performed by Review Manager 5.4.1 software,and trial sequential analysis was performed by TSA 0.9.5.10 Beta software.Results:A total of eight studies were included,involving 516 patients.The Meta-analysis results showed that in terms of total effective rate,electroacupuncture combined with traditional acupuncture was superior to traditional acupuncture[RR=1.14,95%CI(1.03,1.27),Z=2.41,P=0.02],and there was no significant difference between electroacupuncture and medication[RR=1.11,95%CI(0.92,1.33),Z=1.10,P=0.27],electroacupuncture combined with medication was superior to medication[RR=1.21,95%CI(1.02,1.43),Z=2.21,P=0.03].In terms of reducing the total score of Pittsburgh Sleep Quality Index(PSQI),electroacupuncture combined with traditional acupuncture was superior to traditional acupuncture[MD=-1.61,95%CI(-2.21,-1.01),Z=5.22,P<0.001],and there was no significant difference between electroacupuncture and medication[MD=-3.01,95%CI(-6.61,0.59),Z=1.64,P=0.10],electroacupuncture combined with medication was superior to medication[MD=-1.65,95%CI(-2.02,-1.28),Z=8.85,P<0.001].As for improving neurological deficits,electroacupuncture combined with traditional acupuncture was superior to traditional acupuncture[MD=-1.65,95%CI(-2.18,-1.12),Z=6.10,P<0.001].In terms of improving depression,electroacupuncture combined with traditional acupuncture was superior to traditional acupuncture[MD=-1.42,95%CI(-2.23,-0.61),Z=3.44,P<0.001].After sensitivity analysis verification,the Metaanalysis results of the total effective rate in this study were stable.The trial sequential analysis results showed that in terms of total effective rate,the analysis results of electroacupuncture combined with traditional acupuncture superior to traditional acupuncture were robust,and the conclusion could exclude false positives.The analysis results of no significant difference between electroacupuncture and medication need to be included in more trials to verify.The analysis results of electroacupuncture combined with medication superior to medication need to be included in more trials to exclude false positives.Conclusion:In terms of the curative effect on post-stroke insomnia,the combination of electroacupuncture and traditional acupuncture is superior to traditional acupuncture,and electroacupuncture combined with medication is superior to medication.The conclusion requires more high-quality RCTs to support.