麝香心痛宁片治疗冠心病心绞痛(气滞血瘀证)的临床研究

目的:评价麝香心痛宁片治疗冠心病心绞痛(气滞血瘀证)的临床疗效和安全性。方法:206例受试者采用随机、双盲双模拟、阳性药平行对照、多中心临床研究方法(麝香心痛宁组服用麝香心痛宁片,对照组服用心可舒片),其中麝香心痛宁组103例、对照组103例。结果:麝香心痛宁组心绞痛显效率为48.54%,总有效率为90.29%;对中医症状的总有效率91.26%,优于心可舒组(P<0.01);麝香心痛宁组试验后心绞痛平均发作次数、中医症状平均积分均有明显减少(P<0.01),低于心可舒组(P<0.05);麝香心痛宁组胸痛、胸闷、气短、心悸症状与心可舒组比较有显著减少(P<0.05);麝香心痛宁组试验后血液流变学主要指标均有明显改善(P<0.05)。结论:麝香心痛宁片治疗冠心病心绞痛(气滞血瘀证)疗效确切,临床试验期间无不良反应发生。

Clinical efficacy and safety of shexiang xintongning tablets in treatment of patients with coronary heart disease and angina pectoris

AIM: To evaluate the clinical efficacy and safety of the shexiang xintongning tablets in treatment of patients with coronary heart disease and angina pectoris. METHODS: 206 subjects were involved in a multi-center, randomized, double-blinded, double-simulation and positive drug parallel-controlled clinical trail, and the trial group was treated with the shengxiang xintongning tablets, the control group was treated with the xinkeshu tablets. Among them, 103 patients were enrolled in experimental group, while 103 cases enrolled in the control group. RESULTS: The total therapeutic effective rate of the experimental group has reached 90.29%, and was significantly better than that in the control group which has reached 75.91% (P< 0.01). There was a significant decrease on the score of symptoms of the traditional Chinese medicine in trial group in comparison with those in control group (P< 0.01). CONCLUSION: The shengxiang xintongning tablet is an effective drug against coronary heart disease and angina pectoris and no side-effect was found.