冠心静胶囊治疗冠心病心绞痛的临床疗效与经济学评价.docxVIP

冠心静胶囊治疗冠心病心绞痛的临床疗效及经济学评价 王海兵1,2、张天豪1,2、张学斌1,2 1.中国中药协会中药药物经济学专业委员会，北京 100101 2.北京康派特医药科技开发有限公司，北京 100101 [摘要]：目的：评价冠心静胶囊治疗冠心病心绞痛的临床疗效和经济性，为临床治疗提供参考依据。方法：采用前瞻性随机对照、双盲、多中心临床试验。根据冠心静胶囊销售地区和医院分布情况选择国内11家医院420例患者作为研究对象，其中冠心静胶囊组313例、参芍胶囊组107例，治疗4周。以心绞痛症状疗效、中医症候疗效、硝酸甘油减停率、心电图有效率、Duck评分改善和运动持续时间改善为疗效指标，经济性分析方法采用成本效果分析，以药品的价格为变量进行单因素敏感性分析。结果：试验组的心绞痛症状疗效、中医证候疗效优于对照组。硝酸甘油减停率、心电图有效率、Duck评分改善和运动持续时间改善两组疗效相当。成本效果分析结果显示，冠心静胶囊更具有经济性，敏感性分析结果不改变基础分析结果。结论：冠心静胶囊治疗冠心病心绞痛的疗效确切，临床用药安全，其经济性优于参芍胶囊。 关键词：冠心病心绞痛；冠心静胶囊；药物经济学；成本—效果分析 Clinical Efficacy and Economic Evaluation of Guanxinjing Capsule for Angina Pectoris of Coronary Heart Disease [Abstract]: Objective: To evaluate the clinical efficacy and economic of Guanxinjing capsule for angina pectoris of coronary heart disease, and to provide reference for drug payment and clinical treatment. Methods: By prospective, randomized design，420 patients with angina pectoris of coronary heart disease from 11 hospitals were selected as subjects according to the sale distribution of Guanxinjing Capsule in district and hospital, 313 cases of experimental group (Guanxinjing capsule group) and 107 cases of control group (Shenshao capsule group), and the course of treatment in the two groups were 4 weeks. The efficacy of angina pectoris symptom, TCM symptom, nitroglycerin reduction rate, electrocardiogram efficiency, Duck score improvement and exercise duration improvement were taken as the curative index. The economic analysis method was cost-effect analysis, and drug price was the single factor sensitive Analysis. Results: The curative effect of angina pectoris and TCM syndromes were better than that of the control group. Nitroglycerin reduction rate, ECG efficiency, Duck score improved and duration of exercise to improve the efficacy of the two groups. The results of cost-effectiveness analysis showed that Guanxinjing capsule was more economical and the results of sensitivity analysis did not change the basic analysis results. Conclusion: Guanxinjin