针刺对比卡马西平治疗三叉神经痛的系统评价与序贯分析

Acupuncture Versus Carbamazepine for Trigeminal Neuralgia:A Systematic Review and Sequential Analysis

目的基于当前针刺对比卡马西平治疗三叉神经痛的随机对照试验(RCT),应用Meta及序贯分析,为针刺对比卡马西平治疗三叉神经痛提供临床决策。方法对中国生物医学文献数据库、中国期刊全文数据库、万方资源数据库、维普数据库、Embase、Cochrane library、PubMed、Web of Science及相关临床注册平台(WHO ICTRP、ChiCTR、Clinical Trials)中有关针刺对比卡马西平治疗三叉神经痛的RCT文献进行检索,检索时间截止为2020年4月1日。使用Cochrane协作风险偏倚工具评估偏倚风险,STATA软件对主要结局指标(疼痛降低程度)进行Meta分析,TSA 0.9.5.10 Beta对结局指标进行试验序贯分析,GRADE对证据进行分级,同时详细描述不良反应发生情况。结果本研究纳入了16篇随机对照试验研究,涉及了1231名参与者。Meta分析显示,针刺与卡马西平在疼痛降低程度方面具有统计学差异[SMD=1.47;95%CI(0.99;1.95)],但证据质量为极低质量。按文献发表年份进行累积Meta分析,提示针刺对比卡马西平治疗三叉神经痛初次被证明有统计学差异且较为稳定的时间是在2014年[SMD=1.84;95%CI(0.22;3.47)]。同时,针刺的不良事件发生数远低于卡马西平。结论针刺治疗三叉神经痛在镇痛方面优于卡马西平,且较卡马西平更安全。但确切结论仍需要高质量、多中心、大样本的RCT来确认这些发现。

Objective Based on the current randomized controlled trial(RCT)of acupuncture versus carbamazepine in the treatment of trigeminal neuralgia,the meta-analysis and sequential analysis of the research status of acupuncture versus carbamazepine in the treatment of trigeminal neuralgia was provided to provide clinical evidence and make decision.Methods CBM,CNKI,WF,VIP,Embase,Cochrane library,PubMed,Web of Science and related clinical registration.The RCTs on these about acupuncture versus carbamazepine in the treatment of trigeminal neuralgia was searched.The search deadline was April 1,2020.The Cochrane collaborative risk bias tool was used to assess the risk of bias.The STATA software performed a meta-analysis of the primary outcome(reduction of pain).TSA 0.9.5.10 Beta software was used to make trial sequential analysis.GRADE assessed the quality of evidence.Meanwhile,we described the occurrence of adverse reactions in detail.Results This study included 16 randomized controlled trials involving1231 participants.Meta-analysis showed that acupuncture and carbamazepine had statistically significant differences in the reduction of pain[SMD=1.47;95%CI(0.99;1.95)],but the quality of evidence was very low.A cumulative metaanalysis based on the year of publication suggested that acupuncture versus carbamazepine in the treatment of trigeminal neuralgia for the first time proved to be statistically different in 2014[SMD=1.84;95%CI(0.22;3.47)].At the same time,the number of adverse events of acupuncture is much lower than carbamazepine.Conclusion Acupuncture treatment of trigeminal neuralgia is superior to carbamazepine in analgesia and is safer than carbamazepine.But the exact conclusion still needs high-quality,multi-center,large sample RCT to confirm these findings.