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

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. [