西尼地平胶囊治疗原发性高血压双盲双模拟随机对照多中心研究  

Cilnidipine capsule in treatment of essential hypertension:a double-blind,double-dummy,multicenter,randomized,controlled trial

作　　者：陈焕芹[1] 刘向群[1] 高海青[1] 张慧琴[2] 周世文[3] 王安才[4] 秦玉花[5] 邱蕾[1] 

机构地区：[1]山东大学齐鲁医院保健科,山东济南250012 [2]郑州大学医学院第一附院,河南郑州450052 [3]中国人民解放军第三军医大学新桥医院,重庆400037 [4]皖南医学院弋矶山医院,安徽芜湖241001 [5]河南省人民医院,河南郑州450003

出　　处：《中国新药与临床杂志》2007年第4期276-280,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:评价国产西尼地平胶囊治疗轻度至中度高血压的临床疗效及安全性。方法:以国产西尼地平片为对照药,在252例轻度至中度高血压病人中进行多中心、随机、双盲、平行、活性药物对照的临床试验。结果:治疗8wk后,西尼地平胶囊组平均坐位收缩压和舒张压分别下降(18±s 11)mmHg (11．9％)和(12±8)mmHg(12．6％),西尼地平片组平均坐位收缩压和舒张压分别下降(19±13)mmHg (12．5％)和(12±8)mmHg(12．9％),2药的总有效率分别为80．3％和82．9％。西尼地平胶囊和西尼地平片对心率无明显影响,与药物有关的不良反应分别为6例和4例,主要表现为轻到中度的头晕、头痛、面红、心悸等。2药的疗效和不良反应比较无统计学差异(P＞0．05)。结论:国产西尼地平胶囊与国产西尼地平片相似,治疗轻中度原发性高血压具有明确的降压疗效与良好的安全性。[ABSTRACT] AIM： To assess the clinical efficacy and safety of domestic cilnidipine capsule in treatment of mild and moderate essential hypertension. METHODS： In a double-blind, double-dummy, multicenter, randomized, controlled trial, the antihypertensive effects and safety of cilnidipine capsule were compared with cilnidipine tablet in 252 patients with mild to moderate essential hypertension. RESULTS： After 8 wk treatment, mean sitting systolic blood pressure and diastolic blood pressure decreased （18 ± s 11 ） mmHg （11.9 % ） and （12 ± 8） mmHg （12.6 %） in cilnidipine capsule group while （19 ± 13） mmHg （12.5 %） and （12 ± 8） mmHg （ 12.9 % ） in cilnidipine tablet group, respectively. The total effective rate of cilnidipine capsule was 80.3 % and that of cilnidipine tablet was 82.9 %. The change of heart rates was not significant in both groups. There were 6 drug relatively adverse reactions in cilnidipine capsule group and 4 in cilnidipine tablet group. The adverse drug reactions were mild and moderate dizziness, headache, palpitation, and face flushing. There was no significant difference of clinical efficacy and safety between the two groups （P 〉 0.05）. CONCLUSION： Similar with domestic cilnidipine tablet, domestic cilnidipine capsule is effective and safe in treatment of mild to moderate essential hypertension.

关 键 词：高血压 二氢吡啶类 随机对照试验 双盲法 多中心研究 西尼地平 

分 类 号：R972.4[医药卫生—药品] R544.1[医药卫生—药学]