对中医药领域开展循证医学研究的几点看法

近年来，随着循证医学在世界范围内的迅速发展，国内外学者对中医药学是否需要用循证医学的标准来评价，以及如何发展循证的中医药学进行了广泛而热烈地讨论。我们的观点是：中医药学需要循证医学；循证医学认可的证据并不仅仅是大样本的随机双盲对照试验和系统评价；中医药学的理论体系与临床诊疗有许多不同于现代医学的特点，需要针对这些特点进行方法学的创新性研究。本文根据作者近年来在中医药领域进行方法学培训与临床研究的经验，从完善临床试验流程、规范临床研究报告、系统评价当前的中医药临床研究、开展方法学研究、以及证据管理和资源优化整合等五个方面对如何在中医药领域进一步开展循证医学研究进行了讨论。

Key Methodological and Institutional Issues on How to Promote the Evidence Based Traditional Chinese Medicine

Intensive discussions and debates concerning whether we should and how to apply evidence-based medicine (EBM) research in traditional Chinese medicine (TCM) have arisen worldwide. We always hold the opinion: TCM needs EBM; the evidence from EBM is not limited to randomized controlled trials and systematic reviews; innovative methodological studies are urged based on the characteristics of TCM theoretically and clinically. Based on the methodological training and studies in this area, the authors discussed how to promote the evidence based TCM from five aspects including completing clinical trial procedure, reporting clinical trials according to international standards, reviewing the current clinical studies on TCM systematically, promoting the methodological research and academic exchange and better evidence (knowledge) management.