通心络胶囊对原发性肥厚型心肌病左室功能和心绞痛疗效影响的随机对照研究  

RCT study of Tongxinluo capsules(通心络胶囊) on left ventricular function and angina of patients with primary hypertrophic cardiomyopathy

作　　者：苏晓燕 韩振祥 梁燕敏 高丽华 张奕[2] 

机构地区：[1]河北省沧州市人民医院心内科,河北沧州061000 [2]沧州市中西医结合医院,河北沧州061001

出　　处：《中国中西医结合急救杂志》2008年第5期286-288,共3页Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care

基　　金：河北省沧州市科技局课题资助(08ZD16)

摘　　要：目的观察通心络胶囊对原发性肥厚型心肌病(HCM)左室功能的影响及作用机制。方法采用前瞻性随机对照研究方法,选择2004年1月-2008年7月沧州市人民医院和中西医结合医院住院或门诊收治的178例HCM患者,按随机原则分为对照组(60例)和治疗组(118例)。对照组采用一般常规治疗;治疗组在对照组治疗基础上加用通心络胶囊,每次3粒(饭后服),每日3次,连用5周,治疗前后采用彩色多普勒超声和心电图检查测定左室收缩和舒张功能,并判定心绞痛疗效。结果两组治疗后等容舒张时间(IRT)、二尖瓣前叶斜率(MVS)、快充盈分数(RFF)、慢充盈分数(SFF)及快充盈期平均充盈速率(RFR/EDV)均有明显改善,且与对照组比较差异也有统计学意义(P均<0.05);两组治疗前后左室射血分数(LVEF)、心排血量(CO)、左室短轴收缩率(△FS)、心房充盈分数(AFF)比较差异均无统计学意义(P均>0.05)。两组治疗后心率(HR)均显著减慢(P均<0.05),但治疗组与对照组比较差异无统计学意义(P>0.05)。治疗组对心绞痛的总有效率(89%)明显高于对照组(60%),差异有统计学意义(P<0.05)。结论通心络胶囊可显著改善原发性HCM患者的左室收缩和舒张功能,缓解心绞痛,对治疗原发性HCM具有较好疗效。Objective To observe the mechanism and effects of Tongxinluo capsules （通心络胶囊） on left ventricular function and angina of patients with primary hypertrophic cardiomyopathy （HCM）. Methods A prospective and randomized controlled trial （RCT） was adopted to select 178 patients with primary HCM among the inpatients and outpatients treated in Cangzhou People＇s Hospital and Hospital of Integrative Traditional Chinese and Western Medicine during January 2004 to July 2008. They were randomly divided into a control group （60 cases） and a treated group （118 cases）. The conventional treatment was given to the control group, and in the treated group, beside the conventional treatment as in the control group, 3 Tongxinluo capsules taken orally after a meal, 3 times a day for 5 weeks were added to the patients. Left ventricular systolic function and diastolic function were measured by using color Doppler echocardiography and electrocardiogram （ECG） before and after treatment. Results Left ventricular ejection fraction （LVEF）, cardiac out-put （CO）, left ventricular systolic rate of minor axis （AFS） and atrial filling fraction （AFF） were not changed. After treatment, the patients＇ levels of isovolumic relaxation time （IRT）, mitral valve slope （MVS）, rapid filling fraction （RFF）, slow filling fraction （SFF） and rapid filling rate/end diastolic velocity （RFR/EDV） were changed significantly compared with those before treatment （all P〈 0. 05） in the two groups; the heart rate （HR） was remarkably reduced after treatment （both P〈0. 05）. The total effective rate in improving angina was 89 % in treated group, obviously higher than that in control group （60%, P〈0. 05）. Conclusion Tongxinluo capsules can significantly improve the left ventricular systolic and diastolic functions in patients with HCM, ameliorate angina, and have good therapeutic effects on treatment of primary HCM.

关 键 词：通心络胶囊 心肌病 肥厚型 原发性 左室功能 心绞痛 

分 类 号：R259[医药卫生—中西医结合]