Liu Huan, Xie Yanming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2848-50.
The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.
上市后中药的临床文献评价是基于文献证据，对药物综合获益、药物分析、药物疗效、安全性、经济性进行全面分析的综合评价，是循证医学评价的组成部分。上市后中药临床评价中的文献评价处于基础和关键地位。通过文献评价，能够全面掌握信息，把握上市中药品种二次开发方向，明确进一步的临床适应证，完善药品等。本文探讨了临床文献评价的主要步骤和重点。强调安全性文献评价应重视全面收集药物安全性信息。安全性评价应注意中药在改善证候、提高患者生活质量方面的有效性评价具有独特优势。经济性文献评价应注重结论的可靠性、敏感性和实用性。
