注射用红花黄色素冻干粉针治疗冠心病稳定型心绞痛心血瘀阻证的多中心随机对照临床研究

目的 评价注射用红花黄色素冻干粉针剂治疗冠心病心绞痛心血瘀阻证的有效性及安全性.方法 采用多中心、随机、单盲、阳性药平行对照研究.受试者共220例,试验组110例,对照组110例.试验组用注射用红花黄色素冻干粉针剂250 mg,加入生理盐水100 mL内,静脉点滴,每日1次;对照组用红花注射液5 mL×3瓶,加入5％葡萄糖注射液250 mL内,静脉点滴,每日1次.治疗14 d后,观察并评价其临床疗效和安全性.结果 两组中医证候学积分较治疗前均明显降低,差异有统计学意义(P＜0.05),两组中医证候疗效总有效率差异无统计学意义(P＞0.05);两组疾病总有效率比较无明显差异(P＞0.05);两组心绞痛症状积分较治疗前均明显降低,差异有统计学意义(P＜0.05),两组硝酸甘油停减疗效、心电图疗效差异无统计学意义(P＞0.05).不良事件发生率分别为2.8％和3.7％,两组比较无显著差异(P＞0.05).结论 注射用红花黄色素冻干粉针剂治疗冠心病稳定型心绞痛心血瘀阻证患者安全有效,可以进一步研究.

Multi-center randomized controlled clinical study of Saffron Yellow Sterile Powder for Injection for the treatment of stable angina pectoris with heart-blood stagnation syndrome in patients

AIM To evaluate the efficacy and safety of Saffron Yellow Sterile Powder for Injection(SYSPI) for the treatment of stable angina pectoris with heart-blood stagnation syndrome in patients.METHODS A multi-center,randomized,single-blind,parallel to the positive drug control clinical trial was carried out in 220 patients.Patients were randomly divided into two groups: test group received SYSPI(250 mg) in 0.9% NaCl 100 mL(n=110),and the control group received Honghua Injection 15 mL in 5% glucose injection 250 mL(n=110).After 14-day treatment,the efficacy and safety of SYSPI were evaluated.RESULTS The points of heart-blood stagnation syndrome of two groups were significantly lower than those before treatment(P<0.05).There was no significant difference between the two groups in total effective rate based on traditional Chinese medicine syndrome(P>0.05).There was no significant difference between the two groups in total effective rate based on angina pectoris analyzed(P>0.05).The points of angina pectoris of the two groups were significantly lower than those before treatment(P<0.05).There was no significant difference between the two groups in effective rate of reduction or stop of nitroglycerin and ECG(P>0.05).The incidence of adverse events in the two groups was 2.8% and 3.7%,respectively,and there was no significant difference between the two groups(P>0.05).CONCLUSION SYSPI is effective and safe for the treatment of stable angina pectoris with heart-blood stagnation syndrome in patients with coronary heart disease.