宽胸气雾剂缓解冠心病心绞痛的多中心随机对照临床研究  

Effect of Kuanxiong Aerosol on Coronary Heart Disease Angina Patients:a Multicenter Randomized Controlled Clinical Study

作　　者：李立志[1] 董国菊[1] 葛长江[2] 周京敏[3] 黄力[4] 何燕[5] 王峻[6] 任爱华[7] 黄兆铨[8] 祝光礼[9] 陆曙[10] 熊尚全[11] 冼绍祥[12] 朱志军[13] 史大卓[1] 吕树铮[2] 陈可冀[1] 

机构地区：[1]中国中医科学院西苑医院心血管中心北京100091 [2]首都医科大学附属北京安贞医院心内科北京100029 [3]复旦大学附属中山医院心内科上海200032 [4]卫生部中国友好医院中医科北京100029 [5]上海中医药大学附属龙华医院心内科上海200126 [6]浙江省中西医结合医院心内科杭州310003 [7]浙江医院心内科杭州310013 [8]浙江中医药大学附属第一医院心内科杭州310006 [9]浙江中医药大学附属广兴医院心内科杭州310007 [10]南京中医药大学附属无锡市中医院心内科江苏无锡214071 [11]福建中医药大学附属人民医院心内科福州350004 [12]广东中医药大学附属第一医院心内科广州510405 [13]解放军第117医院心内科杭州310007

出　　处：《中国中西医结合杂志》2014年第4期396-401,共6页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的评价宽胸气雾剂缓解冠心病心绞痛疗效及安全性。方法选择2011年11月—2012年12月,13个临床中心诊断为冠心病心绞痛患者780例,按区组随机序号随机分为宽胸气雾剂组(试验组)376例和硝酸甘油片组(对照组)374例。心绞痛发作时,治疗组宽胸气雾剂舌下连续3喷,每喷0.6mL;对照组舌下含服硝酸甘油0.5 mg/片。观察心绞痛缓解有效率、心电图疗效、不良反应发生率。结果治疗组患者心绞痛3min缓解率为53.72%(202/376),5min缓解率为94.41%(355/376);对照组患者心绞痛3min缓解率为47.86%(179/374),5min缓解率为90.64%(339/374)。3min、5min心绞痛缓解率组间差值95%可信区间分别为[-1.84%,12.32%]和[-1.33%,6.85%],组间比较差异均无统计学意义(P>0.05)。治疗组治疗后心电图改善总有效率74.07%(140/189),对照组心电图改善总有效率73.13%(147/201),组间比较差异无统计学意义(P>0.05)。治疗组和对照组不良反应发生率分别为9.31%(35/376)和22.46%(84/374),两组比较差异有统计学意义(P<0.01)。结论宽胸气雾剂缓解心绞痛和改善心电图缺血改变方面不劣于硝酸甘油片,不良反应发生率明显少于硝酸甘油片。Objective To evaluate the anginal attack-relieving efficacy and safety of Kuanxiong Aerosol （KA） in patients with coronary heart disease （CHD）. Methods A total of 780 patients confirmatively diagnosed as CHD angina from November 2011 to December 2012 in 13 medical centers in the mainland area were assigned to 2 groups by blocked randomization, the treatment group （376 cases） and the control group （374 cases）. When the angina attacked, patients in the treatment group received sublingual spray three times, 0.6 mL each time, while those in the control group sublingually dissolved Nitroglycerin Tablet （ NT）, 0.5 mg each tablet. The effective rate of angina relief, efficacy of electrocardiogram （ECG）, and the incidence of adverse reactions were observed. Results The 3 min and 5 min remission rates of angina attack were 53.72% （2021376） and 94.41% （3551376） in the treatment group, and 47.86% （179/374） and 90.64% （339/374） in the control group. The 95% confidence interval （CI） of the difference between the 2 groups of 3 rain and 5 min remission rates of angina attacks were （[ （ -1.84%, 12.32% ） and （ - 1.33%, 6, 85% ） respectively, P 〉0.05 （, The total improvement rates of ST-T changes in the treatment group and the control group after treatment were 74.07% and 73.13% respectively （P 〉0.05）. The adverse reaction rate was 9.31 （35/376 cases） in the treatment group and 22.46% （84/374 cases） in the control group （P 〈0.01 ）. Conclusion KA was not inferior to NT in relieving anginal attacks and improving ischemic ECG changes, and had obviously less adverse reaction.

关 键 词：冠心病心绞痛 宽胸气雾剂 中药 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]