盐酸贝尼地平治疗原发性高血压的多中心临床研究

Multicenter clinical trial on benidipine in the treatment of hypertension

目的评价盐酸贝尼地平治疗原发性高血压病患者的疗效和安全性。方法用多中心随机单盲平行对照试验方法。贝尼地平(试验组)112例,氨氯地平(对照组)105例。结果治疗8周后,2组血压均有明显下降,与用药前比较差异均有统计学意义(P<0.001)。总有效率为贝尼地平77.68%,氨氯地平83.81%,2组间比较差异无统计学意义(P>0.05)。药物不良反应发生率为贝尼地平42.86%,氨氯地平41.60%,2组比较差异无统计学意义(P>0.05)。结论盐酸贝尼地平治疗原发性高血压安全、有效。

Objective To evaluate the antihypertensive effects and safety of benidipine hydrochloride. Methods The multicenter,single-blind,random sample,active-controlled study had been processed in hypertensive patients. One hundred twelve patients of benidipine group(trial) and 105 patients of amlodipine group(control) completed the study. Results At the end of the treatment,blood presure of two groups all declined(P<0.001). The total efficacy rates of two groups were 77.68% and 83.81%,respectively.There was no remarkable difference between the efficacy rates of two groups.The adverse events in benidipine group were 42.86% and in amlodipine group were 41.60%.No severe side effect occurred.Conclusion Benidipine once daily can remarkable reduce blood pressure and no severe adverse reaction occurred.