国产厄贝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 irbesartan in treatment of primary hypertension

目的 :评价国产厄贝沙坦 (irbesartan ,Irb)治疗原发性高血压病的临床疗效和安全性。方法 :原发性高血压患者 (坐位舒张压SeDBP 12 .6 7～ 15 .33kPa,坐位收缩压SeSBP <2 4.0 0kPa)进行 4周随机、双盲的平行对照观察和 2 4周开放研究。短期研究经 1周药物洗脱期及 2周安慰剂期后 ,2 36例患者随机分为Irb组 (n =119)和贝那普利组 (benazepril,Ben) (n =117) ,分别口服Irb 15 0mg·d-1或Ben 10mg·d-1,于 4周末结束试验。共 49例患者入选 2 4周开放的临床研究。经 1周药物洗脱期及 2周安慰剂期后 ,开始服用Irb 15 0mg·d-1,4周末测诊室血压 ,SeDBP≥ 12 .0 0kPa者剂量增加至 30 0mg·d-1,SeDBP <12 .0 0kPa者继续服用Irb 15 0mg·d-1,共治疗 2 4周。于安慰剂期末及治疗 4,8,12 ,16 ,2 0和 2 4周末测诊室血压、心率并纪录症状、体征 ,服药前和服药后 4,12和 2 4周进行血、尿常规及血生化检查。结果 :双盲对照观察 4周末Irb组有效率 79.0 % ,Ben组 77.8% ,组间比较无显著差异(P >0 .0 5 )。49例Irb开放性临床观察 2 4周末SeDBP下降 (2 .0 0± 1.0 7)kPa ,与用药前比较P <0 .0 5。Irb组总不良反应发生率 14.3% ,咳嗽发生率 1.8%。结论 :国产Irb 15 0～ 30 0mg·d-1治疗原发性高血压疗效确切 ,耐受性好。

Objective:To evaluate the clinical efficacy and safety of domestic irbesartan (Irb) in treatment of primary hypertension.Methods:236 patients with SeDBP (seated diastolic blood pressure) of 12.67～15.33 kPa were randomly divided to once daily 150 mg of Irb(n=119) or once daily 10 mg of benazepril(Ben,n=117) for 4 weeks,after 1-week wash out and 2-week placebo run-in period.49 patients took part in an open clinical trial of 24 weeks.They were treated initially with once daily 150 mg of Irb,after 4 weeks the Irb dose was incresed to 300 mg·d -1 for patients with SeDBP≥12.00 kPa until to the end of the trial.The BP,heart rate,tolerability were measured and recored at weeks 4,8,12,16,20 and 24.Results:The effective rate for Irb and Ben were 79.0% and 77.8%(P>0.05) respectively after 4 weeks treatment,SeDBP was significantly decreased by (2.00±1.07)kPa at the end of 24 weeks' open clinical trial(P<0.05),the incidence of ADRs and cough for Irb in 24 weeks trial were 14.3% and 1.8%.Conclusion:The domestic Irb in doses of 150～300 mg·d -1 are a safe,effective and torlerable agent for treatment of primary hypertension.