复方利血平片治疗原发性高血压的有效性和安全性系统评价

Efficacy and Safety of Compound Reserpine Tablets for Essential Hypertension:Systematic Review

目的:评价复方利血平片治疗原发性高血压的疗效和安全性。方法:计算机检索Cochrane Library、PubMed、Embase、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普中文科技期刊全文数据库(VIP),制定严格的纳入和排除标准,纳入复方利血平片对比常规降压药治疗原发性高血压的随机对照试验,对纳入的随机对照试验进行方法学质量评价和Meta分析。由2名研究员对原始研究独立进行质量评价和资料提取,采用RevMan5.0软件进行Meta分析,根据各原始研究间异质性大小选择随机/固定效应模型,并进行敏感性分析和亚组分析。结果:共纳入11个随机对照试验,其中4篇为中等质量,其余7篇均为低质量。Meta分析结果显示,复方利血平片组与常规降压药组间降压效果的总有效率差异有统计学意义[RR=0.80,95%CI(0.74,0.85),P<0.00001];2组不良反应均较少见且轻微,未观察到严重不良反应事件。结论:根据目前研究证据,复方利血平片的降压有效率不及其他常规降压药,但2组降压药均安全、有效。由于观察例数和时间有限,上述结论仍需更多设计严谨、大样本、多中心的随机对照试验进行证实和补充。

OBJECTIVE： To evaluate the efficacy and safety of Compound reserpine tablets in the treatment of essential hyper- tension. METHODS： We searched the Cochrane library, PubMed database, Embase database, CBMDisc, CNKI and VIP, and de- veloped strict inclusion and exclusion criteria. Randomized controlled trials （RCT） of Compound reserpine tablets vs. conventional an- tihypertensive drugs for primary hypertension were included for methodological quality assessment and Meta-analysis. Two indepen- dent researchers conducted the original study, data extraction and quality assessment. Meta-analysis was performed by using RevMan 5.0 software. Random or fixed effect models were used according to degree of heterogeneity. Sensitivity analysis and subgroup analy- sis were performed too. RESULTS： 11 RCTs were included, including four as the medium-quality studies, and the remaining seven were of low quality. Meta-analysis showed that effectiveness： there was significant difference in total effective rate of antihypertensive effects between Compound reserpine tablets group and conventional antihypertensive drug group [RR=0.80, 95%CI （0.74, 0.85）, P〈0.000 01]; security： unusual and mild adverse drug reactions were found in both 2 groups, and no serious adverse events were observed. CONCLUSION： Based on current research evidence, Compound reserpine tablets are less effective than other conventional antihypertensive drugs. But antihypertensive drugs of the two groups are safe and effective. Because of the number of observed cases and the limit of time, the above conclusions still need more rigorously designed, large-scale, multi-center randomized controlled tri- als to confirm and add.