盐酸马尼地平片治疗轻、中度高血压的有效性和安全性研究  

Efficacy and safety of manidipine hydrochloride in treatment of mild to moderate hypertension

作　　者：钱岳晟[1] 王谷亮[1] 张伟忠[1] 朱鼎良[1] 

机构地区：[1]上海交通大学医学院附属瑞金医院上海市高血压研究所,上海200025

出　　处：《中国新药杂志》2013年第15期1793-1796,共4页Chinese Journal of New Drugs

摘　　要：目的:评估盐酸马尼地平片治疗轻、中度高血压的有效性、安全性。方法:研究采用5个中心、随机、双盲、双模拟、以苯磺酸氨氯地平(简称氨氯地平)作对照药物观察。结果:205例高血压患者(盐酸马尼地平片组103例,氨氯地平组102例),治疗8周后血压下降幅度(收缩压/舒张压)盐酸马尼地平组为(14.47±11.38)/(12.35±6.392)mmHg,氨氯地平组为(17.05±12.77)/(13.02±6.59)mmHg,治疗后疗效无差别(P>0.05);降压的总有效率盐酸马尼地平组为80.58%,氨氯地平组为85.29%,组间无明显差别(P=0.351 5);两组的不良反应主要为头痛、头晕、面红,可能与药物有关的不良反应的分别为11.6%和12.7%,两组无显著差异(P>0.05);盐酸马尼地平组收缩压(SBP)谷/峰比值(0.85±0.38),舒张压(DBP)的T/P比(0.87±0.60)。结论:两种药物都显示出良好的降压疗效,表明国产的盐酸马尼地平是一种长效和有效的抗高血压药物、临床应用是安全的。Objective： To evaluate the efficacy and safety of manidipine hydrochloride in treatment of mild to moderate hypertension. Methods： This was a randomized, double-blinded, double-dummy, and amlodipine be- sylate controlled study performed in 5 centers. Results： Two hundred and five hypertensive patients were enrolled, among whom 103 received manidipine and 102 received amlodipine. After 8 weeks treatment, the blood pressure decreases were （ 14.47 ± 11.38）/（ 12.35 ± 6. 392） mmHg in manidipine group and （ 17.05± 12.77 ）/（ 13.02 ± 6.59） mmHg in amlodipine group. There was no significant difference between the two groups （P 〉 0.05）. The effective rates of manidipine （80.58%） and amlodipine （85.29%） were statistically equivalent （P = 0. 351 5 ）. The adverse reactions mainly included headache, dizziness and flush. The incidences of adverse reactions in mani- dipine （ 11.6% ） and amlodipine （ 12.7% ） groups were not significantly different （ P 〉 0.05 ）. In manidipine group, the trough to peak ratios （T/P） of systolic and diastolic blood pressure were （0.85 ±0.38） and （0.87± 0.60） , respectively. Conclusion： The two drugs both displayed good efficacy in hypertension treatment, which in- dicated that generic manidipine was a long-acting, effective and safe antihypertensive drug.

关 键 词：原发性高血压 盐酸马尼地平 苯磺酸氨氯地平 

分 类 号：R972.4[医药卫生—药品]