海捷亚和科素亚双盲、随机、对照降压疗效临床研究

Randomized, Double-blind Study to Compare the Antihypertensive Effects of HYZZAR versus COZAAR in Mild to Moderate Hypertension

    摘要
  • 摘要: 目的　本研究旨在对比评价氯沙坦钾 /氢氯噻嗪 (海捷亚组 )和氯沙坦钾 (科素亚 )治疗原发性高血压病的疗效、安全性和耐受性。　方法　 179例原发性高血压门诊患者 (舒张压 95mmHg～ 115mmHg)参加了双盲、随机对照的临床治疗研究。经过 2周安慰剂洗脱期后 ,患者被随机分入海捷亚组 (氯沙坦钾加氢氯噻嗪 ) ,或科素亚组 (氯沙坦钾 5 0mg～ 10 0mg) ,每日服药一次。 16 8例患者完成了 8周治疗研究。疗效判定标准为 4,8周DBP血压下降到正常或下降 10～ 19mmHg以上为有效。　结果　两组血压均较药前显著下降。海捷亚有效率 81.9% (4周 ) ,88.0 % (8周 )较单纯科素亚组的 41.2 %和 5 0 .6 %组高。两组间心率和不良反应为 15 %～ 19% ,两组无明显差异。　结论　氯沙坦钾片和氢氯噻嗪联合使用治疗原发性高血压疗效比单用氯沙坦钾片好。海捷亚的安全性和耐受性同科素亚。

     

    Abstract: Objective\ To compare the safety, tolerability and antihypertensive effects of HYZAAR and COZAAR（Lorsartan） in clinic patients with mild-to-moderate hypertension. Design and Method\ 179 patients with diastolic blood pressure（DBP 95 mmHg～110 mmHg） were randomized into double blind study. Following a 2 week placebo washing out period,patients were randomized into HYZAAR（COZAAR complex） or COZAAR group for 8 weeks.Efficacy was evaluated by determine the change from baseline DBP,SBP, and the percentage of patients with normalized DBP（＜90mmHg）. Results\ Both HYZAAR and COZAAR produced a significant reduction in blood pressure（ P ＜0 01）.The efficacy of HYZAAR was 81.9%（4 weeks）, 88.0%(8 weeks better than 41.2% and 50.6% in COZAAR. Overall,19.1% of patients experienced drug related adverse events with HYZAAR,compared with 15.6% for COZAAR. Conclusion\ HYZAAR and COZAAR are effective and well tolerated in the treatment of patients with mild to moderate hypertension. HYZAAR produces more effect than COZAAR.

     

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