原研和仿制氨氯地平治疗高血压有效性和安全性的Meta分析

Efficacy and Safety of Generic and Patented Amlodipine for Hypertension:A Meta-Analysis

目的:运用Meta分析的方法系统评价原研与仿制氨氯地平治疗高血压的有效性和安全性。方法:在维普数据库(VIP)、万方数据库(WANFANG)和中国期刊网全文数据库(CNKI)中检索2014年12月25日之前发表的相关文献。在进行文献质量评估基础上提取文献数据,采用Rev Man 5.3软件进行Meta分析。结果:经过检索并剔除重复文献后共获得62篇文献,最终纳入综述文献4篇。Meta分析结果显示,仿制氨氯地平与原研氨氯地平治疗高血压的有效率RR=0.99(95%CI:0.65,1.52,P=0.97);根据用药剂量、病例纳入标准进行亚组分析;临床研究报道了显效率,合并效应量RR=0.99(95%CI:0.83,1.19,P=0.95);不良反应发生率RR=1.01(95%CI:0.51,1.99,P=0.98)。研究结果显示均无统计学上的显著性差异。结论:仿制氨氯地平有效性和安全性与原研氨氯地平相当,因此仿制氨氯地平在治疗高血压时是安全有效的。

Objective： To systematically estimate the efficacy and safety of generic and patented amlodipine for hypertension. Methods：VIP,WANFANG and CNKI were searched for relevant literatures published before December 25,2014. Based on quality of literature evaluation,we extract the literature data,using Rev Man 5. 3 software. Results： After retrieving and eliminating duplicate documents,we received 62 papers with 4 RCTs being reviewed eventually. Meta-analysis results show that the generic amlodipine and original amlodipine are efficient for the treatment of hypertension with RR = 0. 99（ 95% CI： 0. 65,1. 52,P = 0. 97）. According to the dosage and patients inclusion criteria,we conduct subgroup analysis; Clinical studies reported a significant efficiency with the combined effect of RR = 0. 99（ 95% CI： 0. 83,1. 19,P = 0. 95）. The incidence rate of adverse drug reactions is RR = 1. 01（ 95% CI： 0. 51,1. 99,P = 0. 98）. The results show that there is no statistically significant difference. Conclusion： The efficacy and safety of generic and patented amlodipine is equal. As a result,generic amlodipine is safe and effective in hypertension treatment.