Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
Chin J Integr Med. 2010 Feb;16(1):75-8. doi: 10.1007/s11655-010-0075-2. Epub 2010 Feb 4.
The existing efficacy evaluation for coronary heart disease (CHD) angina pectoris does not demonstrate the characteristics and advantages of Chinese medicine (CM), so a new system of efficacy evaluation which can scientifically and systematically reflect the specific features of CM needs to be urgently set up. Based on wide references of efficacy evaluations of CHD angina pectoris from our country and abroad, and considering the general acceptance by academic circles and demonstration of the characteristics of CM, this paper tries to set up a new index system of efficacy evaluation, combining both disease and syndrome differentiation for CHD angina pectoris. This paper also offers some explorations based on the results of clinical trials. The system is composed of six aspects, including efficacy evaluation of "disease", syndrome factors and main endpoints (the incidence of important clinical events), as well as patient reported outcomes, safety evaluation and medical economics.
现有的冠心病心绞痛疗效评价方法不能体现中医药特色优势,因此亟待建立能够科学、系统地体现中医药特点的疗效评价体系。本研究在广泛参考国内外冠心病心绞痛疗效评价方法的基础上,综合考虑学术界的认可度和中医药特点的体现,尝试建立冠心病心绞痛病证结合的疗效评价新体系,并结合临床试验结果进行了有益探索。该体系包括“病”的疗效评价、证候要素及主要终点(重要临床事件的发生率)、患者报告结局、安全性评价和药物经济学评价 6 个方面。