国产复方赖诺普利治疗原发性高血压的疗效和安全性评价

Evaluation of the efficacy and safety of domestic compound lisinopril in treatment of primary hypertension

目的:采用随机对照双盲方法观察复方赖诺普利治疗原发性高血压的临床疗效和安全性。方法:自2004年5月～7月在4个研究中心筛选出符合入选标准的轻中度原发性高血压患者232名,首先应用安慰剂洗脱2周,然后每日给予赖诺普利10 mg进行4周单药治疗,疗效不佳者进行随机分组,分别给予复方赖诺普利或赖诺普利治疗,初始剂量1片/日,早饭后服用。4周后如血压控制不理想,则将剂量加至2片/日,继续用药4周。观察治疗前后患者血压变化及不良反应情况。结果:106例患者经复方赖诺普利治疗8周后总有效率达81.132%。结论:国产复方赖诺普利是治疗轻中度原发性高血压疗效确切,不良反应少,耐受性好,适合每日1次给药的一线降压药物之一。

Objective： To evaluate the efficacy and safety of compound lisinopril in treatment of primary hypertension in randomized controlled clinical trial. Methods：After 2-week washout period, lisinopril was given for 4 weeks.The failures were randomized to one of two treatment groups： compound lisinopril or lisinopril. The patients started oral administration of compound lisinopril （10 mg/12.5 mg）/day or lisinopril 10 mg/day from 7：00 to 9：00 every day.4 weeks later, if blood pressure of patient was still unsatisfactory, the dose was increased twice for additional 4 weeks. The patients were monitored on blood pressure and incidence of adverse events before and after the therapy. Results ：The total efficacy of 106 patients treated by compound lisinopril for 8 weeks was 81.132%. Conclusion： Domestic compound lisinopril is one of the most effective drug for patients with mild to moderate primary hypertension.