注射用红花黄色素治疗冠心病心绞痛(心血瘀阻证)的临床研究

目的评价注射用红花黄色素治疗冠心病心绞痛(心血瘀阻证)安全性及有效性。方法采用随机、阳性药平行对照、多中心临床试验方法。试验组静滴注射用红花黄色素,对照组静滴香丹注射液,2周为1个疗程。结果注射用红花黄色素组心绞痛、心电图及中医证候疗效均明显优于香丹注射液(P<0.05或P<0.01)。注射用红花黄色素对心绞痛发作次数、持续时间、疼痛程度及其中医证候积分均有明显改善,与治疗前比较,有统计学意义(P<0.05)。而且心绞痛持续时间、疼痛程度及中医证候积分改善均优于香丹注射液组(P<0.05)。257例受试者接受运动试验心电图的检测,结果注射用红花黄色素组的运动当量、诱发心绞痛时间、ST段开始下降的时间、ST段最大下降幅度总和均有明显改善,与治疗前比较,有统计学意义(P<0.05)。结论注射用红花黄色素治疗冠心病心绞痛心血瘀阻证疗效确切,同时安全性良好。

Clinical Study of Safflower Yellow Injection in Treatment of Patient with Coronary Heart Disease and Angina Pectoris

Objective To evaluate the safety and efficacy of Safflower Yellow Injection(SYI)in treating coronary heart disease and angina pectoris(CHD-AP)with heart blood stagnation syndrome(HBSS).Methods A randomized,positive parallel contral and multi-center clinical trial was adopted.The SYI injection group was treated with SYI and Xiangdan injection group with Xiangdan injection by intravenous dripping for 2 weeks.Results The efficacy on angina pectoris,electrocardiogram,and traditional Chinese medicine(TCM)syndrome in SYI injection group was superior to that in Xiangdan injection group,showing significant differences(P < 0.05 or P < 0.01).Compared with pre-treatment,the frequency of paroxysm,duration time,severity of angina and TCM syndrome scoring were all obviously improved after treatment with SYI(P < 0.05).Moreover,the duration and severity of angina and TCM syndrome scoring were improved in SYI injection group as compared with that in Xiangdan injection group(P < 0.05).In ECG of 257 patients subjected to exercise test,quantity of exercise,the time required to elicit angina,the time of ST segment starting to lower,the sum of maximum ST lowering amplitude were improved significantly as compared with that before treatment(P < 0.05).Conclusion SYI injection is effective and safe in treating CHD-AP with HBSS.