伊贝沙坦与缬沙坦治疗高血压病的疗效和安全性的临床研究

Clinical Study of Irbesartan and Valsartan for Essential Hypertension

目的对比观察伊贝沙坦和缬沙坦治疗轻、中度高血压病病人的临床疗效与安全性。方法采用随机、开放、平行、单盲对照方法,伊贝沙坦(n=68)组每日150mg或加用双氢克尿噻12.5mg,缬沙坦(n=66)组每日80mg或加用双氢克尿噻12.5mg,观察治疗6周、8周和12周后的有效率和副反应发生率。结果两组治疗第2周开始收缩压(SBP)、舒张压(DBP)较治疗前均明显降低(P<0.01);在整个治疗期间血压持续平稳下降,而服药8周伊贝沙坦组降压效果稍优于缬沙坦组,总有效率伊贝沙坦组为69.1%和缬沙坦组为63.6%;治疗12周后加用双氢克尿噻总有效率为89.5%和84.8%;动态血压监测(ABPM)显示伊贝沙坦的谷峰比值和降低清晨血压骤升与缬沙坦相似(P>0.05)。副反应两组均很轻微。结论伊贝沙坦和缬沙坦均是有效、安全的血管紧张素Ⅱ受体拮抗剂的长效降压药,而伊贝沙坦各方面表现与缬沙坦相似。

Objective To evaluate of clinic efficacy and safety of Irbesartan and Valsartan for essential hypertension. Methods One hundred and thirty - four patients were divided into two group randomly： Irbesartan group （ n = 68）, treated with Irbesartan 150 mg daily, or combined with Hydrochlorothiazide 12.5 mg daily; Valsrtan group （ n = 66）, treated with Valsartan 80mg daily, or combined with hydrochlorothiazide 12.5 mg daily. The clinic efficacy and the side effect were evaluated following 6 and 8 and 12 week. Results The average systolic blood pressure （SBP）, average diastolic blood pressure （DBP） decreased significantly in both groups following 2 week therapy （ P 〈 0.01）. The blood pressure decreased continuously and smoothly during the entire therapy. The total efficacy rate was 69.1% for Irbesartan group and 63.6% for Valsartan group following the 8 week therapy （P 〉0.05）. The total efficacy rate is 85 % for Irbesrtan with hydrochlorothiazide and 84.8 % for Valsartan with hydrochlorothiazide after 12 weeks＇ treatment （P 〉 0.05）. The side effective was rare during therapy in both groups. Conclusion Irbesartan and Valsartan are the effective, safe anti- hypertension agents.