冠心静胶囊治疗稳定型劳力性心绞痛的疗效观察

目的观察冠心静胶囊治疗稳定型劳力性心绞痛的临床疗效。方法采用随机、双盲单模拟、阳性药平行对照的研究方法,将448例患者随机分为对照组(112例)和治疗组(336例),对照组口服参芍胶囊,4粒/次,2次/d,早、晚服用;口服参芍胶囊模拟剂,4粒/次,1次/d,中午服用;治疗组口服冠心静胶囊,4粒/次,3次/d。两组均连续治疗4周。比较两组患者的心绞痛症状疗效、心电图疗效、Duke风险评价和硝酸甘油停减率,并对其安全性进行评价。结果治疗后,对照组和治疗组心绞痛症状疗效的总有效率分别为82.14%、89.88%,心电图疗效的总有效率分别为74.11%、80.65%,两组比较差异均有统计学意义(P0.05)。治疗组的Duke风险率(85.12%)明显低于对照组(98.21%),两组比较差异具有统计学意义(P0.05);对照组和治疗组的硝酸甘油停减率分别为87.80%、98.36%,两组比较差异具有统计学意义(P0.05)。两组均未发生不良事件,一般体检指标均未发现异常。结论冠心静胶囊对冠心病心绞痛具有良好的疗效,且临床应用安全性良好,具有一定的临床推广应用价值。

Clinical observation of Guanxinjing Capsules in treatment of stable exertional angina pectoris

Abstract:Objective To observe the clinical efficacy of Guanxinjing Capsules in treatment of stable exertional angina pectoris. Methods The stratified random, double blind, single dummy, and parallel control of positive drugs method were applied to this study. Patients (448 cases) were randomly divided into control group (112 cases) and treatment group (336 cases). Patients in the control group were po administered with Shenshao Capsules, 4 grains/time, twice daily, in the morning and evening. And they were po administered with simulation of Shenshao Capsules, 4 grains/time, once daily, at noon. Patients in the treatment group were po administered with Guanxinjing Capsules, 4 grains/time, three times daily. The patients in two groups were treated for 4 weeks. Clinical efficacy of pectoris symptoms, ECG efficacy, Duke risk assessment, and stopping and decreasing rate of nitroglycerin were observed. And the medication security was evaluated. Results The curative rates of treatment and control groups in pectoris symptoms were 82.14% and 89.88%, and the clinical curative rates of both groups in ECG efficacy were 74.11% and 80.65%. And there were differences between two groups (P<0.05). The Duke risk rate in the treatment group (85.12%) was lower than that in the control group (98.21%) with significant difference (P<0.05). The stopping and decreasing rate of nitroglycerin of treatment and control groups were 87.80% and 98.36%, respectively, and there were differences between two groups (P<0.05). There was no adverse event in two groups, and general physical examination indicators were normal. Conclusion Guanxinjing Capsules has a good clinical efficacy in the treatment of stable exertional angina pectoris with good safety, which has a certain clinical application value.