国产西尼地平治疗原发性轻中度高血压的疗效和安全性

目的:评价西尼地平治疗原发性轻中度高血压的疗效和安全性.方法:采用随机、双盲、前瞻性平行对照试验,64例原发性轻中度高血压患者分为试验组和对照组各32例,两组分别口服西尼地平和氨氯地平5mg·d -1 ,4周时如血压未达到有效标准则两组都增加剂量至10mg·d -1 至8周结束.检测两组治疗前后的血压、心率、心电图和血、尿实验室检查的变化.结果:63例完成全部试验,治疗8周末,经ITT分析,试验组平均坐位收缩压和舒张压降低程度与对照组比较差异无显著性收缩压降低(17.63±12.06)mmHg vs(21.18±13.67)mmHg,P=0.1695;舒张压降低(13.06±6.73)mmHg vs(15.67±6.80)mmHg,P=0.1564];对照组降压的总有效率为90.63%,试验组为90.63%,两组差异无显著性(P=0.427);两组患者不良事件发生率也差异无显著性.结论:国产西尼地平治疗轻中度高血压安全有效.

Efficacy and Safety of cilnidipine for mild and moderate primary hypertension

Objective: To evaluate the efficacy and safety of cilnidipine domestically manufactured in the treatment of patients with mild to moderate primary hypertension. Methods: A randomized, double-blind, double-mimic controlled trial enrolled sixty-four patients with mild to moderate primary hypertension,who were randomized to administer either cilnidipine (5mg) or amlodipine (5mg) once daily for four weeks. After 4-week therapy, the patients who had not responded the therapy dose were doubled for additional 4 weeks. The blood pressure, heart rate, ECG, blood and urinary lab tests were comparable for the two treatment groups. Results: There was no significant difference in the reduction of both sitting systolic and diastolic pressure between the two treatment groups. Conclusion: Cilnidipine is safe and effective in the treatment of mild to moderate hypertension.