国产缬沙坦治疗原发性高血压病的疗效和安全性评价  

Evaluation of the efficacy and safety of domestic valsartan in treatment of primary hypertension

作　　者：张云[1] 李一石[1] 郭冀珍[2] 江时森[3] 徐军[3] 蒋文[1] 王莉[2] 龚培[1] 成小如[1] 华潞[1] 

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暨阜外心血管病医院临床药理研究室,北京100037 [2]上海第二医学院瑞金医院高血压科,上海200025 [3]南京军区南京总医院,南京210002

出　　处：《中国新药杂志》2001年第5期363-365,共3页Chinese Journal of New Drugs

摘　　要：目的 :评价国产缬沙坦治疗原发性高血压病的临床疗效和安全性。方法 :12 4例原发性高血压患者坐位舒张压 (SeDBP) 12 .6 3～ 15 .2 9kPa,坐位收缩压 (SeSBP) <2 3.94kPa,进行随机、盲法的 8周平行对照观察。经 1周药物洗脱期及 2周安慰剂期后 ,随机双盲口服缬沙坦 (n =6 4) 80mg·d-1或对照药赖诺普利 (n =6 0 ) 10mg·d-1,4周末测诊室血压SeDBP >11.97kPa者剂量分别增加至 16 0mg·d-1和 2 0mg·d-1,继续服用 4周。结果 :8周末缬沙坦组总有效率 6 9% ,SeDBP/SeSBP下降 (1.73± 0 .6 7) / (2 .13± 1.6 0 )kPa ;赖诺普利组总有效率 72 % ,SeDBP/SeSBP下降 (1.86± 0 .6 7) / (2 .39± 1.33)kPa ,组间比较无显著性差异 (P >0 .0 5 )。 2 ,4,6 ,8周末血压下降值组间比较无显著性差异 (P >0 .0 5 )。 8周末缬沙坦 2 4h动态血压监测结果 (n =2 9)显示DBP及SBP的降压T/P比值分别为5 0 .2 %和 6 7%。缬沙坦组咳嗽发生率为 0 ,赖诺普利组为 17.2 % ,有显著性差异 (P <0 .0 1)。结论 :国产缬沙坦80～ 16 0mg/d治疗国人原发性高血压疗效确切 。Objective:To evaluate the efficacy and tolerability of domestic valsartan in treatment of primary hypertension.Methods:After 1 week washing out and 2 weeks of placebo run in period,124 patients with a seated diastolic BP (SeDBP) of 12.63～15.29 kPa were randomly divided to receive once daily 80 mg valsartan or once daily 10 mg lisinopril both for 8 weeks.Doses were doubled at weeks 4 for patients with SeDBP≥11.97 kPa.Results:At the end of 8 weeks,the total effective rate and decrease in SeSBP/SeDBP ratio for valsartan were 69% and (1.73±0.67)/(2.13±1.60) kPa respectively,for lisinopril were 72% and (1.86±0.67)/(2.39±1.33) kPa respectively.No significant difference between groups was observed(P>0.05).At the end of 8 weeks,ABPM of valsartan showed that T/P of DBP and SBP was 50.2% and 67% respectively.No cough occurred to valsartan group and 17.2% to lisinopril group.Conclusion:Domestic valsartan is very effective in treatment of primary hypertension in daily dose of 80～160 mg with good tolerability. [

关 键 词：缬沙坦 赖诺普利 原发性高血压 临床治疗 安全性 降压 

分 类 号：R972.4[医药卫生—药品] R969.4[医药卫生—药学]