盐酸贝尼地平治疗稳定型心绞痛的多中心临床研究

Multicenter Clinical Trial on Benidipine in the Treatment of Stable Angina Pectoris

目的评价盐酸贝尼地平对中国稳定性心绞痛患者的临床疗效和安全性。方法多中心随机单盲平行对照试验,贝尼地平(试验组)126例,硝苯地平缓释片(对照组)111例。结果治疗4周后,活动平板试验心电图ST段下压达1mm的时间在试验组和对照组均延长,增加量分别为(64.2±108.0)及(62.8±110.6)s,P>0.05;两组治疗后运动试验心电图最大运动时间、最大运动当量均增加,P>0.05;心绞痛发作次数及硝酸甘油用量在两组中较服药前均减少,P>0.05;总有效率在试验组和对照组分别为55%及44.8%,P>0.05;两组不良事件发生率分别为10.1%及13.9%,均无严重不良事件。结论盐酸贝尼地平治疗稳定型心绞痛安全、有效。

OBJECTIVE To evaluate the efficacy and safety of benidipine hydrochloride in Chinese patients with stable angina pectoris.METHODS The multicenter,single-blind,random sample,active-controlled study was processed in stable angina pectoris patients.126 patients in benidipine group （trial） and 111 patients in nifedipine group （control） completed the study.RESULTS After 4 weeks of treatment,in the exercise tolerance test,the time to 1 mm ST segment depression were prolonged in both trial and control groups,the increment were （64.2±108.0） and （62.8±110.6） s,respectively （P〉0.05）;the maximal exercise time and the maximal metabolic equivalent were improved,showed no significant difference （P〉0.05） between groups.Although the angina frequency and nitroglycerin consumption in the two groups were reduced,but not significantly different between two groups.The total efficacy rates of two groups were 55% and 44.8%,respectively.The incidence of adverse events were 10.1% and 13.9%,respectively,and there were no serious adverse events.CONCLUSION Benidipine treatment of stable angina pectoris is safe and effective.