伊贝沙坦治疗原发性高血压的疗效和安全性评价  

Efficacy and Safety of Irbesartan in Patients with Mild to Moderate Essential Hypertension

作　　者：黄洁[1] 李一石[1] 戚文航[2] 唐树德[2] 邱慧丽[2] 孙兴昌[1] 张朝阳[1] 高润霖[3] 

机构地区：[1]中国医学科学院中国协和医科大学心血管病研究所阜外心血管病医院临床药理研究室,北京市100037 [2]上海瑞金医院心内科 [3]中国医学科学院中国协和医科大学心血管病研究所阜外心血管病医院冠心病研究室,北京市100037

出　　处：《中国循环杂志》2001年第2期94-96,共3页Chinese Circulation Journal

摘　　要：目的：评价伊贝沙坦（ｉｒｂｅｓａｒｔａｎ）治疗轻、中度原发性高血压的疗效和安全性。 方法：选取 １３７例坐位舒张压（ＳｅＤＢＰ）９５～１１５ ｍｍＨｇ（ｌｍｍＨｇ= ０． １３３ ｋＰａ）［根据 １９９３年《新药（西药）临床研究指导原则》：治疗前舒张压水平分成轻（９５～１０４ ｍｍＨｇ）、中（１０５～１１４ ｍｍＨｇ）和重（＞１１５ ｍｍＨｇ）三类］的轻、中度原发性高血压患者，随机分为伊贝沙坦组（１５０ ｍｇ每日 １次）和贝那普利（ｂｅｎａｚｅｐｒｉｌ）组（１０ ｍｇ每日１次）。于４周末ＳｅＤＢＰ≥９０ ｍｍＨｇ者剂量分别加倍，继续服用４周。于安慰剂期末及治疗２、４、６、８周测诊室血压、心率并记录症状、体征；试验前后行实验室检查。 结果：有效率伊区沙坦组８１．２％，贝那普利组７０．５％，两组比较无显著性差异（Ｐ＞０．０５）。８周伊贝沙坦组及贝那普利组ＳｅＳＢＰ／ＳｅＤＢＰ均下降，其中２、４、６、８周伊贝沙坦组ＳｅＤＢＰ的下降幅度大于贝那普利组，两组有显著性差异（４周Ｐ＜０。·０５，２、６、８周Ｐ均＜０．０１）。贝那普利组咳嗽５例，发生率８％。 结论；伊贝沙坦 １５０～３００ ｍｇ／ｄ治疗轻。Objective: To evaluate the antihypertensive effect and safety between the angiotensin Ⅱ receptor antagonist irbesartan(IRB) and the angiotensin converting enzyme inhibitor benazepril (BEN) in patients with mild or moderate essential hypertension. Methods: After l-week wash-out and 2-week placebo run-in period,the patients (n= 137)with seated diastolic blood pressure (SeDBP)95-115 mmHg were randomizedly given either irbesartan 150 mg or benazepril 10 mg once a day for 4 weeks,followed by doses doubled for those patients with SeDBP≥90 mmHg for another 4 weeks. Blood pressure,heart rate,clinical safety,specific symptoms were examined at baseline and at weeks 2, 4, 6 and 8. Laboratory examination was performed at baseline and at weeks 8. Results: At the end of & weeks, no statistical difference was found in response rates (SeDBPs < 90 mmHg, or decreased at least 10 mmHg) between IRB (81. 2 % )and BEN (70. 5% ). SeSBP/SeDBP was decreased by IRB and by BEN. The decrease in SeDBP was more significant at the end of weeks 2 , 4, 6, 8(p<0.05). BEN administration induced dry coughing (8% ) whereas IRB did not. Conclusion:IRB 150-300 mg daily is as effective as and much more tolerated than BEN 10-20 mg daily in Chinese patients with essential hypertension.

关 键 词：伊贝沙坦 贝那普利 原发性高血压 药物疗法 疗效 安全性 

分 类 号：R544.1[医药卫生—心血管疾病] R972.4[医药卫生—内科学]