活心丸(浓缩丸)治疗冠心病稳定性心绞痛气虚血瘀证——一项多中心、随机、双盲、安慰剂对照临床研究

A multicenter, Randomized, Double-Blind, Placebo-Controlled clinical study of Huo Xin Wan (concentrated pill) for the treatment of stable angina pectoris with the syndrome of qi deficiency and blood stasis

目的观察活心丸(浓缩丸)治疗冠心病稳定性心绞痛的有效性及安全性。方法采用多中心、随机、双盲、安慰剂对照的临床研究,对131例冠心病稳定性心绞痛(气虚血瘀证)患者随机分组,分别采用活心丸(浓缩丸)或安慰剂进行治疗8周,其中48例进行心电图平板运动试验,观察治疗前后心绞痛症状、硝酸甘油停减率、心电图平板运动试验(总运动时间、运动诱发ST段下降0.1 m V或出现心绞痛的时间、诱发心电图ST段最大下移程度、运动诱发心电图ST段下移超过0.1 m V的导联数、运动代谢当量)、西雅图心绞痛调查量表总评分、中医证候变化情况、炎性因子以及血脂。结果治疗后,试验组心绞痛症状总积分明显低于对照组(P<0.01),试验组硝酸甘油停减率明显高于对照组(P<0.01),试验组西雅图心绞痛量表总分明显高于对照组(P<0.01),试验组中医证候疗效明显高于对照组(P<0.01)。心电图平板运动试验,试验组的ST段下降≥0.1 m V导联数较治疗前的减少数量明显高于对照组(P<0.01)。试验组V4、V5、V6导联ST段最大下移幅度较对照组明显降低(P<0.05)。炎性因子与血脂指标组间均没有明显统计学差异(P>0.05)。试验组不良事件发生率与对照组相当。结论活心丸(浓缩丸)治疗冠心病稳定性心绞痛的效果显著优于对照组,且具有良好的安全性和耐受性。

Objective To evaluate the efficacy and safety of Huo Xin Wan（concentrated pill） for the treatment of stable angina pectoris. Methods A multicenter, randomized, double-blind, placebo-controlled clinical trial was carried out in 131 patients with the syndrome of qi deficiency and blood stasis. Patients were randomly divided into two groups： test group received Huoxin wan（concentrated pill）, and the control group received placebo. After 8-weeks＇ treatment, 48 patients of them received electrocardiogram treadmill exercise test（total exercise time, time of ST segment decreased 0.1m V or occurrence of angina pectoris, maximum extent of ST segment reduction, number of leads of ST-segment depressed than 0.1m V, Metabolic equivalents）, and the efficacy and safety of Huo Xin Wan（concentrated pill） were evaluated, including symptom score of angina pectoris, the reduce amount of nitroglycerin, SAQ score, change of TCM syndrome, inflammatory factors and blood fat. Results After 8-weeks treatment, Symptom score of angina pectoris in test group was significantly lower than control group（P〈0.01）. Seattle Angina Questionnaire（SAQ） and the reduce amount of Nitroglycerin in test group was significantly lower than control group（P〈0.01）, Curative efficacy of TCM in test group was better than control group（P〈0.01）. The number of leads of ST-segment depressed than 0.1m V of test group was reduced significantly than that of control group（P〈0.01）. Maximum extents of ST segment reduction in leads V4, V5 and V6 were lower than control group（P〈0.05）. There was no significant difference between the two groups as to inflammatory factors, blood fat and the incidence of adverse events（P〉0.05）. Conclusion Huo Xin Wan（concentrated pill） is effective and safe for the treatment of stable angina pectoris in patients with the syndrome of qi deficiency and blood stasis.