国产与进口氨氯地平治疗原发性高血压病的系统评价

摘要

目的：系统评价国产与进口氨氯地平对原发性高血压病的治疗效果和经济性。方法：利用计算机检索中国知网（ CNKI）、万方医学数据库，查找国产与进口氨氯地平治疗原发性高血压病的随机对照试验文献，进行质量评价后，采用RevMan 5．1软件对纳入文献进行荟萃分析（ Meta分析），比较其有效性和安全性，并进一步进行成本－效果分析。结果：共纳入21篇文献、22组数据， Meta分析结果显示，国产和进口氨氯地平总有效率、收缩压及舒张压下降幅度、不良反应发生率方面的差异均无统计学意义（ P＞0．05，I2＜50％）；成本－效果分析结果的差异有统计学意义（ P＜0．05）。结论：对原发性高血压病的治疗，国产与进口氨氯地平的疗效相似，国产氨氯地平更具价格优势。因此，国产氨氯地平替代进口氨氯地平治疗原发性高血压值得临床推广。%OBJECTIVE:To evaluate the therapeutic efficacy and pharmacoeconomics of domestic vs.imported amlodipine for essential hypertension. METHODS: We searched CNKI and Wanfang database for randomized controlled trials ( RCTs) on the domestic vs.imported amlodipine in the treatment of essential hypertension.The RCTs were given quality evaluation and meta-analysis on efficacy and safety using Revman 5.1 software, meanwhile, the cost-effectiveness analysis was performed.RESULTS: 21 RCTs were included, including 22 sets of data.Meta-analysis showed no statistical significance between the domestic and the imported amlodipine with regard to total effective rate, decrease degree in both systolic blood pressure and diastolic blood pressure and the incidence of adverse drug reaction ( P>0.05 , I2 <50%); the differences in cost-effectiveness were statistically significant ( P<0.05 ) . CONCLUSIONS:In treatment of primary hypertension, domestic amlodipine is as effective as but more cost-effective than the imported amlodipine.Therefore, the use of domestic amlodipine rather than the imported amlodipine in treatment of essential hypertension is worthy of promotion.