目的 觀察冠心靜膠囊治療穩(wěn)定型勞力性心絞痛的臨床療效。方法 采用隨機(jī)、雙盲單模擬、陽(yáng)性藥平行對(duì)照的研究方法，將448例患者隨機(jī)分為對(duì)照組（112例）和治療組（336例），對(duì)照組口服參芍膠囊，4粒/次，2次/d，早、晚服用；口服參芍膠囊模擬劑，4粒/次，1次/d，中午服用；治療組口服冠心靜膠囊，4粒/次，3次/d。兩組均連續(xù)治療4周。比較兩組患者的心絞痛癥狀療效、心電圖療效、Duke風(fēng)險(xiǎn)評(píng)價(jià)和硝酸甘油停減率，并對(duì)其安全性進(jìn)行評(píng)價(jià)。結(jié)果 治療后，對(duì)照組和治療組心絞痛癥狀療效的總有效率分別為82.14%、89.88%，心電圖療效的總有效率分別為74.11%、80.65%，兩組比較差異均有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療組的Duke風(fēng)險(xiǎn)率（85.12%）明顯低于對(duì)照組（98.21%），兩組比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）；對(duì)照組和治療組的硝酸甘油停減率分別為87.80%、98.36%，兩組比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。兩組均未發(fā)生不良事件，一般體檢指標(biāo)均未發(fā)現(xiàn)異常。結(jié)論 冠心靜膠囊對(duì)冠心病心絞痛具有良好的療效，且臨床應(yīng)用安全性良好，具有一定的臨床推廣應(yīng)用價(jià)值。

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.