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为验证血管紧张素转换酶抑制剂雷米普利的疗效和安全性,以及将其临床试验的结果用于广泛的治疗实践,我们开展了该药上市后的调查。共有11 100位由临床初级诊疗医师诊治的轻中度高血压患者被选入这项为期8周的开放研究。雷米普利起始剂量从2.5mg每天1次开始调整直至达到目标血压。从8 261例血压记录完整(即诊疗开始时就有血压记录)的患者中评价此药的疗效;从全部用药者中评价安全性。收缩压和舒张压均增高的患者中,86％的患者治疗后终末舒张压≤90mmHg或比治疗前水平下降超过10mmHg。治疗反应最佳的是老年患者(87.2％),最差的是黑人患者(81.2％)。单纯收缩期高血压患者中,70.4％患者治疗后最终达到收缩压≤140mmHg或比治疗前水平下降20mmHg以上,女性为70.6％,男性为70.3％,老年患者为69.1％;治疗反应最佳者为白人(71.8％),反应最差者为黑人(64.6％),不良反应大都轻微,最常见的为咳嗽(3.0％)。因此,在这个为期8周的大样本试验中,来自不同人群的、由初级诊疗医师诊治的轻中度高血压患者用雷米普利每天1次治疗既是有效的,又是安全的。
To validate the efficacy and safety of the angiotensin converting enzyme inhibitor ramipril and to use the results of its clinical trials for a wide range of treatment practice, we conducted a postmarketing survey of the drug. A total of 11 100 patients with mild-to-moderate hypertension diagnosed by clinical primary physicians were enrolled in this 8-week open-label study. The initial dose of ramipril was adjusted from 2.5 mg once daily until the target blood pressure was reached. The efficacy of this drug was evaluated from 8,261 patients whose blood pressure was recorded intact (ie, blood pressure was recorded at the start of treatment); safety was evaluated from all patients. In patients with systolic and diastolic blood pressure, 86% of patients had a terminal diastolic blood pressure of ≤90 mm Hg or a decrease of more than 10 mm Hg compared to pretreatment levels. The best treatment response was in elderly patients (87.2%) and the worst in blacks (81.2%). Among patients with isolated systolic hypertension, 70.4% of patients eventually achieved systolic blood pressure ≤140mmHg or more than 20mmHg before treatment, 70.6% in women, 70.3% in males and 69.1% in elderly patients. The best treatment response was White (71.8%), the worst response was black (64.6%), most of the minor adverse reactions, the most common cough (3.0%). Therefore, in this 8-week large sample trial, once-daily treatment with ramipril was effective and safe for patients with mild-to-moderate hypertension diagnosed by primary care physicians from different populations.