雷米普利治疗轻、中度原发性高血压的疗效和安全性

The Efficacy and Safety of Ramipril in Chinese Patients with Mild to Moderate Essential Hypertension

评价雷米普利治疗轻、中度原发性高血压的临床疗效和安全性。选取轻、中度原发性高血压（坐位舒张压95－115mmHg）患者128例，一组采用随机、双盲平行对照的方法进行4周诊室血压研究，另一组采用开放活，分别进行4周的24h动态血压研究和24周的诊室血压研究。经1周药物冲洗期，2周安慰剂期后服双盲药，雷米普利2．5mg·d－1或对照药依那普利10mg·d－1。2周后坐位舒张压＞90mmmHg者剂量增加至雷米普利5mg·d-1或依那普利20mg·d-1。继续服用2周。于安慰剂期末及治疗1，2,3，4周末测血压、心率并记录症状、体征；于安慰剂期末及治疗4周末各行一次24h动态血压监测。4周末雷米普利组（n＝61）有效率66％，依那普利组（n=59）有效率51％。组间比差异无显著性（P＞0．05）。雷米普利组坐位收缩压／舒张压下降11．8±11．7／9．4±7．3mmHg，依那普利组坐位收缩压／舒张压下降14．9±12．9／9．7±5．9mmHg。动态血压监测组服药4周后，各时点血压均较治疗前下降，舒张压降压谷／峰达64％。24周开放组（n＝24）自4周末血压维持平稳。双盲和开放组结果显示雷米普利降压的同时不引起心率增快。两组药物不良反应均较轻，雷米普利咳嗽发生率6．7％。

To evaluate the efficacy and safety of ramipril in Chinese patients with mild tomoderate essential hypertension, patients with mild to moderate essential hypeftension(sitting diastolic blood pressure in the range of 95~ 114mmHg) were recruited. Group onewas a double-blind, randomized, parallel study. The second group was an open-label study.Ambulatory blood pressure monitoring (ABPM) was performed during a 4-week periodand clinical blood pressure was measured during a 24-week period. After a l-week washoutand 2-week placebo run-in period, the patients were administered ramipril 2.5mg or enalaprillomg for 2 weeks, followed by dose titration to ramipril 5mg or enalapril 20mg for another2 weeks in those patients with blood pressure > 90mmHg. At the end of the placebo run-inand 1,2,3,4weeks,the results of clinical blood pressure, heart rate, symptom and physicalcxaminations were recorded. At the end of 4 weeks, no statistical difference was foundbetween the efficacy rates of ramipril (n=61) and enalapril (n=59) (66% vs. 51%, P>0.05).SISBP/DBP was decreased by 11.8±11.7/9.4±7.3 mmHg by ramipril and 14.9±12.9 /9.7 ±5.9 mmHg by Enalapril, respectively. Analysis of the ABPM profiles showed thatthe ramipril exerted its antihypertensive effect throughout the 24-h dose-interval withoutaffecting the natural variations. Placebo-corrected trough: peak ratio was 64%. Theantihypertensive effect was maintained from 4 weeks to 24 weeks. Heed rate was unaffectedin any treatment group. The adverse effects in both groups were very mild. The incidenceof cough in the ramipriI group was 6.7%. Ramipril 2.5~5mg once-daily is effective andwell tolerated by Chinese patients with mild to moderate essential hypertension.