参附注射液对比M胆碱受体阻滞药治疗病态窦房结综合征疗效的系统评价

Shenfu Injection versus M Cholinoceptor Blockers for Sick Sinus Syndrome:A Systematic Review

目的:系统评价参附注射液对比M胆碱受体阻滞药治疗病态窦房结综合征(SSS)的临床疗效,以为临床治疗提供循证参考。方法:计算机检索中国期刊全文数据库、中国生物医学文献数据库、万方数据库、中文科技期刊全文数据库、Cochrane图书馆、Pub Med、PMC、Medline、EMBase,全面收集参附注射液(试验组)对比M胆碱受体阻滞药(对照组)治疗SSS的随机对照试验(RCT),采用Rev Man 5.2.3统计软件进行Meta分析。结果:共纳入6项RCT,包括344例患者。Meta分析结果显示,试验组患者临床治疗总有效率[RR=1.44,95%CI(1.26,1.66),P<0.000]和心率[MD=3.65,95%CI(1.05,6.24),P=0.006]均显著优于对照组,两组比较差异均有统计学意义;试验组患者窦房结恢复时间(SNRT)低于对照组,但两组比较差异无统计学意义[MD=-200.35,95%CI(-399.23,-1.47),P=0.05]。结论:参附注射液短期治疗SSS在临床总有效率、心率方面均优于M胆碱受体阻滞药。由于纳入的研究质量欠佳、存在发表偏倚等问题,该结论需要在此系统评价基础上设计样本量合理的、纳入标准遵循中医药理论的双盲RCT进一步研究验证。

OBJECTIVE：To evaluate the clinical efficacy of Shenfu injection vs. M cholinoceptor blocker for sick sinus syndrome（SSS） systematically,and to provide evidence-based reference for clinical treatment. METHODS：Retrieved from CNKI,CBM,Wanfang database,VIP,Cochrane library,Pub Med,PMC,Medline and EMBase,RCTs about Shenfu injection（trial group）vs. M cholinoceptor blocker（control group）for SSS were collected. Meta-analysis was performed using Rev Man 5.2.3 software. RESULTS：6 RCT were included,involving 344 patients. Results of Meta-analysis showed that total effective rate [RR=1.44,95%CI（1.26,1.66）,P〈0.000] and HR [MD=3.65,95%CI（1.05,6.24）,P=0.006] of trial group were better than those of control group;there was statistical significance;SNRT of patients in trial group were lower than in control group. There was no significant difference between 2 groups [MD=-200.35,95%CI（-399.23,-1.47）,P=0.05]. CONCLUSIONS：Shenfu injection is better than M cholinoceptor blocker for short term therapy of SSS in total effective rate and the improvement of HR. Due to poor quality and publication of bias,it is necessary on the basis of this systematic review to perform the randomized double-blind controlled study with reasonable sample size and adhering to TCM theory.