养心氏片治疗冠心病慢性心力衰竭气虚血瘀证临床研究

Clinical Study of Using Yangxinshi Pill Treating Patients with Qi Deficiency Blood Stagnation Syndrome and Chronic Heart Failure Caused by Coronary Heart Disease

目的:探讨养心氏片治疗冠心病慢性心力衰竭气虚血瘀证中的临床疗效。方法:采用分层随机、多中心、阳性药平行对照的临床研究方法,以北京中医药大学东直门医院、中国中医研究院广安门医院、首都医科大学北京中医医院就诊的77例患者为研究对象,以洛汀新和倍他乐克为阳性对照,通过4周治疗,观察心功能(NYHA分级标准)、中医症状、6min步行试验、超声心动图、地高辛停减率、氢氯噻嗪停减率及不良反应等指标。结果:中医证候疗效、心功能(NYHA分级标准)疗效、6min步行试验、地高辛停减率、氢氯噻嗪停减率等方面,两组组间比较,无统计学意义(P>0.05);但在乏力、自汗、面色晦黯及舌象症状的疗效方面试验组优于对照组(均P<0.05);在对心率、血压的影响方面试验组不及对照组,但也有降低收缩压的作用。两组患者治疗前后对超声心动图各指标的影响方面:LVEF、FS、E峰、E/A有增高的趋势,A峰有降低的趋势,但经统计学分析,差异无显著意义(P>0.05),在不良反应方面,试验组1例出现恶心、腹胀,1例出现口微干,均不影响继续服药,未见严重不良反应。结论:养心氏片能改善冠心病慢性心衰患者的心功能,改善症状,无明显毒副作用及不良反应,是治疗冠心病慢性心力衰竭气虚血瘀证的有效药物。

Objective： To disclose the clinical influnce of Yangxinshi pill on patients with Qi deficiency blood stagnation syndrome and chronic heart failure caused by coronary heart disease. Methodes： We studied this thesis adopting stratified random, multi center, positive medicine parallel contrast clinical research method, adopting 77 patients who visited cardio and vessel section of DongZhiMen hospital which affiliated Beijing TCM university, GuangAnMen hospital which affiliated China TCM Academy and Beijing TCM hospital which affiliated Capital Medicine university, contrasting with Lotinsin and Betaloc as the positive medicine. We observed such indexes as cardiac function, symptomes of TCM, 6-minute- walk trail, echocardiogram, the stopping and decreasing rate of Digoxin, the stopping and decreasing rate of Hydrodiuril, adverse reactions and so on. Result： There is no remarkable difference in following aspects as general curative effect of TCM Syndromes, cardiac function curative effect （NY多HA grading standards）, 6-minute-walk trail curative effect, the stopping and decreasing rate of Digoxin, the stopping and decreasing rate of Hydrodiuril after statistics analysis between the two group（P〉0.05）. The curative effect of the test group is better than that of the contrast group in the following aspects： asthenia, sweating, darkish complexion and picture of tongue （P〈0.05）. The contrast group is better than the test group in decreasing heart rate and blood pressure, however the test group can decrease systolic pressure too. There is no statistical difference by contrast their echocardiogram index （LVEF, FS, E peak, A peak, E/A） before and after therapy （P〉0.05）, although LVEF, FS, E peak and E/A of the two groups manifest increasing trend, A peak of the two groups manifest decreasing trend. In adverse reaction aspect, 1 patient of the test group appears sickness and abdominal distention. 1 patient of the test group appears slight dry mouth, these can＇t affect their continuing taking medicine. We can＇t find severe adverse reactions. Conclusion： Yangxinshi pill can improve the heart function, can improve symptom of the patient with chronic heart failure caused by coronary heart disease. Few adverse reaction, it is an efficient medicine to treat the patient with CHF caused by CHD, TCM syndrome belonging to Qi deficiency blood stagnation.