伊贝沙坦与氯沙坦随机对照治疗原发性高血压多中心临床试验  

A Randomized Controlled Multi-center Clinical Trial on Irbesartan Versus Losartan in the Treatment of Essensial Hypertension

作　　者：张雪华[1] 单江[1] 蔡思宇[1] 吕兴广[1] 阮邹荣[1] 陈君柱[2] 胡晓晟[2] 戚文航[3] 邱慧丽[3] 范明昌[3] 欧阳淑其[4] 郭令军[4] 周芝兰[4] 苏海[5] 刘东 

机构地区：[1]浙江大学医学院附属第二医院,杭州310009 [2]浙江大学医学院附属第一医院,杭州310006 [3]上海第二医科大学附属瑞金医院,上海200025 [4]湖南医科大学附属湘雅医院,长沙410078 [5]江西医学院附属第二医院,南昌330008

出　　处：《中国临床药理学杂志》2001年第5期333-336,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目 的：观察伊贝沙坦治疗轻中度原发性高血压的疗效和安全性。方法：采用随机对照、双盲双模拟、多中心的研究方法，以氯沙坦为对照药。伊贝沙坦组１３４例，氯沙坦组１３５例，起始剂量分别为７５ｍｇ．ｄ－１和５０ｍｇ．ｄ－１；治疗第４周疗效未达到有效标准则加大剂量，疗程为８周；３１例患者完成了治疗前后两次ＡＢＰＭ检查。结果：二组服药８周后坐位ＤＢＰ．分别降低了１３．８±５．７ｍｍＨｇ和１３．９±５．３ｍｍＨｇ，坐位ＳＢＰ分别降低了２０．４±１０．８ ｍｍＨｇ和２０．６±１０．５ ｍｍＨｇ，治疗前后相比均有显著性差异；伊贝沙坦组总有效率为８７．０２％，氯沙坦组总有效率７９．７０％，两组比较无显著性差异；伊贝沙坦组ＳＢＰ和ＤＢＰ下降谷／峰比值分别为８０．６％和６９．６％；两药的药物不良反应发生率分别为１２．０３％和１３．５３％，均较轻，可耐受。结论：国产伊贝沙坦片对轻中度原发性高血压的治疗作用和安全性与氯沙坦片基本相同。OBJECTIVE: To assess the efficacy and safety of irbesartan in Chinese patients with mild-to-moderate essensial hypertension. METHODS: The multi- center,randomized,double-blind, placebo-controlled trial was conducted in 5 hospitals. After a placebo lead-in period of 14 days,269 patients who had a mean seated diastolic blood pressure 95 to 114mmHg were randomized to irbesartan 75-150mg.d-1) or losartan(50-100 mg.d-1) treatment for 8 weeks. Blood pressure was measured at 0,2,4 and 8 weeks of treatment. 24h ambulatory blood pressure monitoring (ABPM )was performed before and after the treatment. RESULTS: Both treatments lowered blood pressure with no significant difference in efficacy. Total effective rate is 87.02% in irbesartan group and 79.70% in losartan group at the end of 8 weeks. Systolic and diastolic blood pressure reductions in irbesartan group were 20.4±10.8 mmHg and 13.8±5.7mmHg,and in losartan group 20.6±10.5 mmHg and 13.9±5.3mmHg. T/P ratio of diastolic blood pressure reduction calculated from ABPM was 69.6% in irbesartan group. The common adverse effects in the two groups were dizziness and headache. No patients developed severe adverse effects. CONCLUSIONS: 75-150mg irbesartan once daily is effective and well tolerated in treating mild-to-moderate essensial hypertension in Chinese.

关 键 词：高血压 伊贝沙坦 氯沙坦 药物治疗 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]