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目的:评价国产复方赖诺普利片治疗轻、中度原发性高血压(EH)的疗效和安全性。方法:本研究为随机、双盲、安慰剂对照临床试验,从98例EH患者中筛选出经赖诺普利(10 mg/d)单药治疗4周、血压不能满意控制者(≥140/90 mmHg,1 mmHg=0.133 kPa)49例,随机分为对照组(n=25)和试验组(n=24),继续治疗8周,分别服用赖诺普利2片(每片10 mg)或者复方赖诺普利(每片含赖诺普利10 mg、氢氯噻嗪12.5 mg)1片,每日1次。结果:复方赖诺普利与赖诺普利(2片/d)的降压效果相似,有效率分别为88%和84%。两组的不良反应均较轻,主要为咳嗽,分别为17%和20%,无统计差异。结论:国产复方赖诺普利片治疗轻中度EH安全、有效。
Objective: To evaluate the efficacy and safety of the domestic compound lisinopril tablet in the treatment of mild to moderate essential hypertension (EH). METHODS: This randomized, double-blind, placebo-controlled clinical trial randomized 98 patients with EH to lisinopril (10 mg / d) monotherapy for 4 weeks and subjects with unsatisfactory BP control (≥140 / (N = 25) and the experimental group (n = 24). The patients were treated for another 8 weeks and treated with lisinopril 2 tablets (10 mg per tablet) Or compound lisinopril (each containing lisinopril 10 mg, hydrochlorothiazide 12.5 mg) 1 tablet daily. Results: The effects of compound lisinopril and lisinopril (2 tablets / d) were similar. The effective rates were 88% and 84% respectively. Adverse reactions were mild in both groups, mainly cough, respectively, 17% and 20%, no statistical difference. Conclusion: The domestic compound lisinopril tablet is safe and effective in the treatment of mild to moderate EH.