红花黄色素注射液治疗冠心病心绞痛(心血瘀阻证)的Ⅲ期临床研究  

A phase Ⅲ trial of safflor yellow injection for the treatment of angina pectoris with heart-blood stagnation syndrome in patients with coronary heart disease

作　　者：苗阳[1] 李立志[1] 徐风琴[1] 陈可远[1] 汪晓芳[1] 张东[1] 周国栋[1] 高铸烨[1] 赵福海[1] 罗良涛[1] 

机构地区：[1]中国中医科学院西苑医院心血管科,北京100091

出　　处：《中国新药杂志》2010年第7期584-589,共6页Chinese Journal of New Drugs

摘　　要：目的:评价红花黄色素注射液治疗冠心病心绞痛(心血瘀阻证)的安全性及有效性。方法:随机、仿盲、阳性平行对照、多中心研究方法进行红花黄色素注射液的III期临床试验。受试者共439例:试验组330例,对照组109例,其中试验药应用红花黄色素注射液5mL(250mg)+0.9%氯化钠溶液250mL静滴,qd,对照组应用红花注射液20mL+0.9%氯化钠溶液250mL静滴,qd,治疗14d后,观察并评价其临床疗效和安全性。结果:心绞痛症状疗效(PP分析):A组(试验组)和B组(对照组)的总有效率分别为91.6%(n=310),69.2%(n=104),两组比较,A组优于B组(P=0.000)。中医症状疗效分析(PP分析):A组和B组的总有效率分别为91.0%(n=310),70.2%(n=104),两组比较,A组优于B组(P=0.000)。心电图疗效分析(PP分析):A组和B组的总有效率分别为67.3%(n=306),61.2%(n=103),两组比较无统计学意义(P>0.05)。ITT分析与PP分析结果相同。不良事件和不良反应分析:A组有5例发生不良事件,不良事件发生率为1.5%,其中2例判断为不良反应,不良反应发生率为0.6%;B组无不良事件。不良事件发生率和不良反应发生率两组比较无统计学意义(P>0.05)。结论:红花黄色素注射液5mL(250mg)治疗冠心病心绞痛(心血瘀阻证)患者安全有效。Objective：To evaluate the efficacy and safety of safflor yellow injection for the treatment of angina pectoris with heart-blood stagnation syndrome in patients with coronary heart disease （CHD）.Methods：A randomized imitative-blind,controlled,and multi-center clinical trial was carried out in 439 patients.Patients were divided into two groups：test group received safflor yellow injection 5 mL （250 mg） in 0.9% NaCl 250 mL （n=330）,and the control group received Honghua injection 20 mL in 0.9% NaCl 250 mL （n=109）.After 14-day treatment,the efficacy and safety of salvianolate were evaluated.Results：The total effective rate on angina pectoris analyzed by PP was 91.6% （n=310） in test group,and 69.2% （n=104） in control group （P〈0.05）.The total effective rate on TCM syndrome analyzed by PP was 91.0% in test group,and 70.2% in control group （P〈0.05）.The total effective rate on ECG analyzed by PP was 67.3% in test group,and 61.2% in control group （P〉0.05）.The results of ITT were the same as those of PP analysis.Adverse events occurred in 5 patients （1.5%） in test group,among which adverse reactions were confirmed in 2 patients （0.6%）,but no adverse event was found in control group.No statistically significant change was found between two groups.Conclusion：Safflor yellow injection at a dose of 5 mL is effective and safe for the treatment of angina pectoris with heart-blood stagnation syndrome in patients with CHD.

关 键 词：红花黄色素注射液 冠心病 心绞痛 心血瘀阻证 Ⅲ期临床试验 

分 类 号：R256.22[医药卫生—中医内科学]