单硝酸异山梨酯缓释片与缓释胶囊治疗心绞痛的多中心临床试验比较  

Comparison with slow released isosorbide mononitrate tablets and capsules in treatment of angina pectoris:a multicenter clinical trial

作　　者：赵美华[1] 荣烨之[1] 王彬尧[2] 过鑫昌[3] 郑明芳[4] 郑柏生[5] 任建英 蔡乃绳[7] 秦永文[8] 吴宗贵[9] 

机构地区：[1]上海第二医科大学附属新华医院,上海200092 [2]上海第二医科大学附属仁济医院,上海200001 [3]上海第二医科大学附属瑞金医院,上海200025 [4]上海市第一人民医院,上海200085 [5]华东医院,上海200040 [6]徐汇区中心医院,上海200031 [7]上海医科大学附属中山医院,上海200032 [8]中国人民解放军第二军医大学附属长海医院,上海200433 [9]中国人民解放军第二军医大学附属长征医院,上海200003

出　　处：《中国新药与临床杂志》2000年第3期161-164,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :观察 2个不同药厂生产的单硝酸异山梨酯 (IS 5 MN)的缓释剂型治疗冠心病心绞痛的疗效比较。方法 :冠心病心绞痛 174例分为 2组。缓释片剂组 130例 (男性 80例 ,女性 50例 ,年龄 6 6a±s10a) ;缓释胶囊组 4 4例 (男性 2 4例 ,女性 2 0例 ,年龄 6 7a± 10a) ;2组均给IS 5 MN 50mg ,po ,qd× 2 0d。结果 :2组对心绞痛、胸闷症状的改善 ,硝酸甘油消耗量的减少 ,对心电图 (倒置T波与S T段压低的总和 )的改善 ,治疗后差别均有显著或非常显著意义 (P <0 .0 5或P <0 .0 1) ;缓释片剂组总有效率 90 .0 % ,胶囊组为 86 % ,2组组间比较 ,差别均无显著意义 (P >0 .0 5)。结论 :2个不同药厂生产的IS 5AIM: To observe the efficacy and to compare these two kinds of different dosage forms(tablets and capsules) of slow released isosorbide mononitrate (IS 5 MN) in the treatment of angina pectoris. METHODS: One hundred and seventy four patients with coronary heart disease with angina pectoris were divided into two groups: tablets group 130 patients (M 80,F 50;age 66 a± s 10 a) received IS 5 MN 50 mg, po ,qd×20 d; capsules group 44 patients (M 24, F 20; age 67 a±10 a) received IS 5 MN 50 mg, po , qd×20 d. RESULTS: There had an extremely significant differences in the symptoms of angina and tightness in the chest and the consumption of nitroglycerin ( P <0.01) after treatment in both groups; there also had an obvious differences in the segment ΣST and the number of lead T wave inverting ( P<0.05, P<0.01 ) after treatment in the two groups; the total effect rate of the tablets group was 90.0%, while that of capsules group was 86%, there was no obvious differences between the two groups ( P <0.05). CONCLUSION: The slow released IS 5 MN drug of the two dosage forms (tablets and capsules) produced by two different factories is safe and effective.

关 键 词：心绞痛 药物疗法 单硝酯异山梨酯 迟效制剂 

分 类 号：R972[医药卫生—药品] R541.405[医药卫生—药学]