脉络通治疗冠心病心绞痛(心血瘀阻证)多中心临床研究

Multi-Center clinical study of Mailuotong treating coronary disease and angina(stagnation of the heard blood)

[目的]评价脉络通治疗冠心病心绞痛(心血瘀阻证)的有效性和安全性,以复方丹参片为对照药作多中心临床分析。[方法]符合冠心病稳定型劳力性心绞痛西医诊断标准,每周发作心绞痛2次以上的轻度、中度及较重度心绞痛患者,进行分层区组随机、阳性药平行对照、多中心临床研究。试验药脉络通,口服,4片/次,3次/d。疗程4:周;对照药复方丹参片,口服,3片/次3,次/d。疗程:4周。评价治疗冠心病心绞痛(心血瘀阻证)的有效性和安全性。[结果]脉络通组心绞痛疗效、中医证候疗效、心电图疗效及硝酸甘油停减率均与复方丹参片组无统计学差异,疗效较好。且均无不良事件发生。[结论]脉络通治疗冠心病心绞痛心血瘀阻证具有较好疗效,在改善心绞痛方面优于对照药复方丹参片,且临床使用安全。

[Objective] The study is to evaluate the effectiveness and security of mailuotong that treat coronary disease and angina rstagnation of the heard-blood）.111e medicine compare with fufangdansen as a control medicine.[Methods] According to west-medicine diagnoses standard of stable and effort angina.Pa tients who suffering from angina twice a week choosed in this study.The reseach uses lam blocking ran domization,positive parallel controlled design and multi—Center clinical study.Taking Luomaitong is 4pills,three times a day orally for 4 weeks;fufangdansen is 4 pills,three times a day orally for 4 weeks.The study is to evaluat the effectiveness and security of mailuotong that treating coronary disease and angina（stagnation of the heard-blood）.[Result] Curative effect of angina,syndrome,EKG and rate of glonoincease of luomaitong group have no statistics difference with fufangdancen group.Either there is noharmful events occured.[Conclusion] To treat coronary disease and angina（stagnation of the heard-blood）ailuotong is better than fufangdansen especially in treating angina,also it is more safe.