苯磺酸氨氯地平治疗国人轻中度原发性高血压疗效和安全性的系统评价  

Efficacy and Safety of Amlodipine Besylate Tablet for Mild to Moderate Essential Hypertension in China: A Systematic Review

作　　者：胡鸿保[1] 杨拯[2] 张晓[2] 陈兵[3] 

机构地区：[1]成都医学院临床医学院,成都610081 [2]成都医学院实验技术教研室,成都610081 [3]成都医学院基础医学院,成都610081

出　　处：《循证医学》2011年第2期107-111,共5页The Journal of Evidence-Based Medicine

摘　　要：目的评价苯磺酸氨氯地平治疗国人轻中度原发性高血压的临床疗效和安全性。方法按纳入标准,检索PubMed(1999年至2010年8月),西文生物医学期刊文献服务系统(1999年至2010年8月),中国期刊全文数据库(1999年至2010年8月),维普数据库(1999年至2010年8月),中国生物医学文献数据库(1999年至2010年8月)。全面搜集有关苯磺酸氨氯地平治疗原发性高血压的随机对照试验,并对文献进行筛选,提取资料并进行质量评价,采用RevMan4.2.8软件进行数据分析。结果共检索到文献81篇,经排查后,符合纳入标准并进入系统评价的文献共5篇,均为低质量随机对照试验。Meta分析结果显示苯磺酸氨氯地平与硝苯地平比较,平均收缩压变化结果:加权均数差为-3.99,95%可信区间为-6.67～-1.31,两组差异有统计学意义(P=0.004);平均舒张压变化结果:加权均数差为-3.94,95%可信区间为-5.72～-2.17,两组差异有统计学意义(P<0.0001);总有效率结果:加权均数差为1.77,95%可信区间为0.79～3.97,两组差异无统计学意义(P=0.16);不良反应发生率结果:加权均数差为0.37,95%可信区间为0.19～0.73,两组差异有统计学意义(P=0.004)。结论苯磺酸氨氯地平能有效降低收缩压和舒张压,不良反应较少。但由于纳入研究存在语言偏倚、选择性偏倚和测量偏倚,势必影响结果的论证强度,期待更多高质量的随机双盲试验提供更有效的证据。Objective To assess the efficacy and safety of Amlodipine Besylate tablet for essential hypertension. Methods We searched MEDLINE （1999 to 2010.8）, EMCC（1999 to 2010.8）, CNKI（1999 to 2010.8）, VIP（1999 to 2010.8） and CBM（1999 to 2010.8）. Randomized controlled trials（RCT） about Amlodipine Besylate tablet for essential hypertension will be included. The quality of each trial was assessed according to the Cochrane reviewers handbook 4.2.8 statistical software（RevMan 4.2.8） provided by the Cochrane colaboration was applied. Results 81 related articles were identified, but only 5 with patients who were eligible and were included in the systematic review. All articles were of low quality. Meta-analyses showed that Amlodipine Besylate tablet compared with Nifedipine for average SBP, WMD= -3.99, 95%CI -6.67～-1.31, P=0.004; for average DBP, WMD=-3.94, 95%CI -5.72～-2.17, P0.000 1; for total effective rate, WMD=1.77, 95%CI 0.79～3.97, P=0.16; for total adverse events, WMD=0.37, 95%CI 0.19～0.73, P=0.004. Conclusion Amlodipine Besylate tablet may decrease systolic and diastolic blood pressure. Moreover, EAmlodipine Besylate tablet has fewer adverse effects and less economy load. Due to a high risk of language bias, selection bias and detection bias in the included studies, the evidence is insufficient to determine the effect of Amlodipine Besylate tablet. Further largescale trials are required to define the role of Amlodipine Besylate tablet in the treatment of essential hypertension.

关 键 词：苯磺酸氨氯地平 原发性高血压 硝苯地平 疗效 系统评价 

分 类 号：R544.105[医药卫生—心血管疾病]