参附注射液治疗缓慢性心律失常的有效性和安全性研究:随机对照试验的系统评价和Meta分析

Efficacy and safety of Shenfu injection treating bradycardia: a systematic review with meta-analysis of randomized controlled trials

目的评价参附注射液治疗缓慢性心律失常的有效性及安全性。方法计算机检索中国期刊全文数据库、万方数据库、中文科技期刊数据库、中国生物医学数据库、Medline、EMbase、ClinicalTrials.gov,筛选出参附注射液治疗缓慢性心律失常的随机对照试验;用Cochrane协作网评价偏倚风险工具对纳入研究进行质量评价,Rev Man5.3软件进行Meta分析。结果共收集参附注射液治疗缓慢性心律失常文献99篇,经过初筛和严格评价,纳入13个研究,共978例,纳入文献质量普遍偏低,除一项研究为C级外,其他文献质量级别均为B级。总体疗效(临床症状或心率改善)方面,参附注射液优于阿托品(RR=1.27,95%CI 1.09~1.48,P=0.002),参附注射液联合阿托品较阿托品单用无统计学差异(RR=0.84,95%CI 0.73~0.97,P=0.30),参附注射液与极化液对比,可以更好改善临床症状(RR=0.52,95%CI 0.40~0.67,P=0.01);在心率改善方面无明显差异(RR=0.57,95%CI 0.32~1.20,P=0.06)。有4个研究报道了不良反应的发生,主要表现为口干舌燥等。结论鉴于目前的研究质量较低,尚不能肯定参附注射液在治疗缓慢性心律失常中的疗效,今后需更多高质量的研究以证实其疗效。

Objective To evaluate the efficacy and safety of Shenfu injection in the treatment of brady- cardia. Methods Randomized controlled trials （RCT） on S^rrf~ injection treating hradycardiawas re- trieved from CNKI database, IVanfang Database, VIP Database, CBM, PubMed, EMbase, and Clinical Trials. gov. Cochrane Handbook was used to assess methodological quality, and data were analyzed using RevManS. 3 Software. Results 13 trials involving 978 patients were included into the analysis. The over- all methodological quality was low as most studies were evaluated as B level and one study was C level. Meta - analysis showed that Shenfu injection was better than atropine（ RR = 1.27, 95% CI 1.09-1.48, P = 0.002）in terms of the overall effect （relief of symptoms and improvement of heart rate）, but there were no statistic difference between using atropine alone andusing Shenfu injection and atropine together （RR =0.84, 95% CI 0.73 -0.97, P = 0.30）. Compared with Shenfu injection in polarized solution, Shenfu injection can improve the clinical symptoms better（ RR = 0.52, 95% CI 0.40 -0.67, P = 0.01 ）, but there was no difference in the heart rate increase （RR =0.57,95% CI 0.32 - 1.20,P =0.06）. Safety：Adverse reactions were reported in four studies, with dry mouth being the most common one. Conclusion In view of the quality of the current research, the efficacy of treating bradycardia with Shen- fu injection cannot be ensured. In the future, high quality studies are needed to confirm the efficacy of Shenfu injection.