奥美沙坦酯/氢氯噻嗪复方片剂用于奥美沙坦酯单药治疗血压未达标的原发性轻中度高血压患者的临床研究
Clinical study of olmesartan/hydrochlorothiazide compound tablet in mild to moderate essential hypertensive patients who did not reach goal with olmesartan
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摘要: 目的评价奥美沙坦酯20mg/氢氯噻嗪12.5mg用于奥美沙坦酯20mg单药治疗血压未达标的原发性轻中度高血压患者的疗效和安全性。方法采用多中心、随机、双盲双模拟、活性药物对照设计。438例轻中度高血压患者入选,经过2周安慰剂导入期,380例进入4周奥美沙坦酯20mg/d单药治疗期,最后304例血压未达标者(平均坐位舒张压≥90mmHg)随机进入8周双盲治疗期,分别接受奥美沙坦酯40mg/d(单药组)或者奥美沙坦酯20mg/氢氯噻嗪12.5mg/d(复方片剂组)治疗。结果双盲治疗8周后,复方片剂组平均坐位收缩压/平均坐位舒张压较基线降低14.8/11.9mmHg,下降幅度大于单药组(9.0/9.0mmHg,P<0.01)。复方片剂组的血压治疗有效率达84.1%,显著高于单药组的64.4%(P<0.01)。两组间与试验药物有关的不良事件发生率无差异(P>0.05)。结论对于奥美沙坦酯单药治疗控制不良的高血压患者,使用奥美沙坦酯/氢氯噻嗪复方片剂,较之递增奥美沙坦酯单药剂量的用法,显示出更强的降压作用和更优的降压有效率。复方片剂具有良好的安全性。Abstract: Objective To evaluate the efficacy and safety of olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg in mild to moderate essential hypertensive patients who did not reach goal with olmesartan medoxomil 20 mg monotherapy.Methods This was a multi-center,randomized,double-blind and double dummy,active-controlled design study.The trial enrolled 438 participants with mild to moderate hypertension.After 2 weeks of placebo run-in period,380 participants were treated with olmesartan medoxomil 20 mg/d for 4 weeks.At the end of this period,304 patients who did not respond to monotherapy mean sitting diastolic blood pressure（MSDBP）≥90 mm Hg) were randomized to 8 weeks’ double-blind treatment with olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg（compound tablet）daily or olmesartan medoxomil 40 mg（monotherapy）daily.Results Compared with baseline,the decrease of mean sitting systolic blood pressure（MSSBP）and MSDBP of olmesartan/hydrochlorothiazide group（14.8/11.9 mm Hg）were significantly more than monotherapy group（9.0/9.0 mm Hg）at 8 weeks（P ＜0.01）.The total efficacy rate of olmesartan/hydrochlorothiazide group（84.1%）were significantly higher than olmesartan
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