阿折地平用于治疗原发性轻中度高血压的临床试验

摘要：目的评价阿折地平用于治疗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（全国范围内6个研究中心）、随机、双盲双模拟、活性药物对照设计，入选2010年3月--2011年6月在全国6个研究中心f解放军总医院、广西医科大学第一附属医院、河北省人民医院、航天中心医院、南京市第一医院、解放军第二炮兵总医院）就诊的231例轻中度高血压患者，经过2周安慰剂导人期，随机进入苯磺酸氨氯地平组（115例）5—10mg／d或阿折地平组（116例）8，16mg／d，共治疗8周，观察坐位、立位血压变化。结果治疗8周后两组病人坐位舒张压较基线均有下降，下降值为（12．94±5．50）mmHg昭（13．56±6．22）mmHg（1mmHg=0．133kPa），两组非劣效界值为3mmHg，双侧95％可信下限为-0．94，P=0．0000〈0．025。阿折地平组非劣效于苯磺酸氨氯地平组。两组间与药物相关的不良事件发生率无统计学差异（P〉0．05）。阿折地平组治疗8周后心率较治疗前无显著升高。结论阿折地平8—16mg／d服用8周能够显著降低原发性轻中度高血压患者血压，安全性良好，且不劣于苯磺酸氨氯地平5—10mg／d。

Azelnidipine in treatment of mild-moderate essential hypertension:A clinical trial

Objective To assess the therapeutic effect of azelnidipine on mild-moderate essential hypertension and its safety. Methods Two hundred and thirty-one patients with mild-moderate hypertension admitted to our hospital from March 2010 to June 2011 were included in this study. After treated with placebos for 2 weeks, they were randomly divided into amlodipine treatment group （n= 115） and azelnidipine treatment group （n = 116）. Patients in amlodipine treatment group were given 5 - 10 mg amlodipine daily and those in azelnidipine treatment group were given 8 - 16 mg azelnidipine daily for 8 weeks during which their blood pressures at sitting and standing position were measured. Results The diastolic blood pressure of the patients at sitting position was lower than their baseline blood pressure after 8 weeks of treatment （12.94 ＋ 5.50 mmHg vs 13.56 ~ 6.22 mmHg） （1 mmHg = 0.133 kPa）. The non- inferiority marigin was 3 mmHg in the two groups and their double side 95% lower confidence limit was -0.94 （P = 0.000 0 〈 0.025）. No significant difference was observed in the drug-related advertise events between the two groups and in the heart rate of azelnidipine treatment group after 8 weeks of treatment （P 〉 0.05）. Conclusion Azelnidipine（8 - 16 mg/d） for 8 weeks can significantly reduce the blood pressure of patients with mild -moderate essential hypertension with a good safety and its effect is similar to that of amlodipine （5 - 10 mg/d）.