氨氯地平单用及其与ACEI联用治疗成人原发性高血压有效性与安全性的Meta分析

Amlodipine and Angiotensin-Converting Enzyme Inhibitor Combination versus Amlodipine Monotherapy in Adult Primary Hypertension:A Meta-Analysis of Randomized Controlled Trials

目的评价氨氯地平单用及其与ACEI联用治疗成人原发性高血压的有效性与安全性。方法电子检索Cochrane对照试验注册数据库(2009年第2期)、PubMed、EMbase、CBM、CNKI(从建库至2009年8月)。由两名评价者按纳入与排除标准和Cochrane协作网推荐的简单评价法选择文献、评价质量,而后对同质研究采用Stata10.0软件进行Meta分析。结果共纳入17个RCT,包括3291例病人。Meta分析结果显示:与单用氨氯地平相比,氨氯地平与ACEI联用能进一步降低收缩压[WMD=5.72,95%CI(4.10,7.33),P=0.016]和舒张压[WMD=3.62,95%CI(4.85,2.39),P=0.000],总不良反应率下降[RR0.86,95%CI(0.75,0.99),P=0.034],其差异有统计学意义。结论现有证据表明,氨氯地平与ACEI联用能进一步降低成人原发性高血压患者血压和不良反应发生率,其有效性和安全性均优于氨氯地平单用。而氨氯地平与ACEI联用能否降低远期联合心血管事件风险,且组织型ACEI是否更有优势,则尚需大样本、高质量的随机对照试验来进一步研究。

Objective To estimate the efficacy and tolerability of combination of Amlodipine and different angiotensin-converting enzyme inhibitors （ACEIs） in comparison with Amlodipine monotherapy in the treatment of hypertension. Methods We searched the Cochrane Central Register of Controlled Trials （Issue 2, 2009）, PubMed, MEDLINE, EMbase, CBM, and CNKI （from their inception to August 2009） for relevant studies. Two reviewers independently retrieved randomized controlled trials （RCTs） according to the inclusion and exclusion criteria, assessed the methodological quality of included trials, and extracted data. Meta-analysis was performed by Stata 10.0 soft. Results Seventeen RCTs involving 3 291 patients were ultimately identified. The results of meta-analyses showed combination had a greater systolic blood pressure reduction （WMD=5.72, 95%CI 4.10 to 7.33, P=0.016） and diastolic blood pressure reduction （WMD=3.62, 95%CI 4.85 to 2.39, P=0.000） than monotherapy. Combination had fewer overall adverse events （RR=0.86, 95% CI 0.75 to 0.99） than that of monotherapy. Conclusion The results of meta-analyses indicate that combination provides a superior blood pressure control to that of monotherapy and has fewer adverse events and better tolerability in hypertensive patients.