起搏器治疗血管迷走神经性晕厥荟萃分析和试验序贯分析

The efficacy of pacemaker in treatment of vasovagal syncope:a meta-analysis and trial sequential analysis

目的通过荟萃分析及试验序贯分析（TSA）系统评价起搏器对血管迷走神经性晕厥（VVS）的治疗效果。方法检索PubMed、Medline、Cochrane、Cochrane临床对照试验注册数据库（CENTRAL）、万方、中国知网数据库,收集2015年1月前有关起搏器与VVS治疗的随机对照研究。利用RavMan5.3软件对起搏器治疗VVS后晕厥复发率进行荟萃分析,利用TSA0.9软件进行TSA。结果共纳入15篇文献,424例患者。结果显示,与药物及一般治疗比较,起搏器能够降低晕厥的复发率（4.8%比46.5%,RR=0.15,95%CI 0.08-0.30,P〈0.01）。TSA分析显示,其累计Z值同时穿过传统界值和TSA界值,该结论较为可靠。而起搏治疗组与假手术组（指安装了心脏永久起搏器,但仅启用起搏器的感知功能而未启用起搏功能）相比,晕厥事件的复发率差异无统计学意义（RR=0.63,95%CI0.25-1.56,P=0.32）。DDD起搏器组较非DDD起搏器组的晕厥发生率减少（RR=0.17,95%CI0.06-0.48,P〈0.01）。但上述两项比较的TSA曲线既没有穿过传统界值也没有跨过TSA界值,提示该结论尚需更多随机对照试验来验证。具有闭环刺激功能的起搏器与无闭环刺激功能的起搏器相比,晕厥发生率下降（RR=0.08,95%CI0.08-0.42,P〈0.01）。结论起搏器治疗相对于药物治疗或一般治疗,能够降低晕厥复发率,但仍不能排除手术的安慰剂效应,DDD起搏器优于非DDD型起搏器的结果只存在于成人中,具有闭环刺激功能的起搏器优于无闭环刺激功能的起搏器。然而以上结论仍需要更多的随机对照试验来证实。

Objective To evaluate the efficacy of pacemaker in the treatment of vasovagal syncope （ VVS）. Methods Published articles concerning randomized controlled trials （RCTs） about the efficacy of pacemaker on treatment of VVS before January 2015 were retrieved from PubMed, Medline, Cochrane, the Cochrane central register of controlled trials（CENTRAL）, CNKI and Wanfang Data. The recurrence of VVS was analyzed with RevMan 5.3 software. A trial sequential analysis （TSA） was performed using TSA 0. 9 software. Results Fifteen trials with 424 patients met the criteria. Compared with drug therapy or conventional standard therapy, pacemaker significantly decreased the recurrence of syncope during follow-up [4.8% vs 46.5%, risk ratio （RR）=0.15, 95% CI 0. 08-0. 30 , P〈0.01]. In TSA, the curve crossed the traditional boundary （ P= 0. 051 and interim monitoring boundaries. When compared with non-active pacemaker, active pacemaker did not show a significant lower recurrence rate （RR=0.63, 95% CI 0. 25-1.56, P=0.32）. DDD pacemaker had a lower recurrence rate than non- DDD pacemaker （RR=0.17, 95 % CI 0. 06-0.48, P〈0.01）. The accumulated Z scores of the last two comparation did not cross the traditional boundary or the interim monitoring boundaries, which might suggest further randomized controlled trail is needed. Pacemaker with closed-loop stimulation （CLS） function was superior to those without in reducing the recurrence of syncope （RR=0.08, 95% CI 0. 08-0.42, P〈0.01 ）. Conclusion Compared with drug therapy or conventional standard therapy, pacemaker significantly decreased the recurrence of syncope during follow-up, however the placebo effect could not be ruled out by this meta analysis. Only in adult pa tients, DDD pacemaker was superior over non-DDD pacemaker and pacemaker with CLS function was superior overthose without. More RCTs are needed to draw a definitive conclusion.