中成药上市后临床文献评价的流程与要点

中成药上市后临床文献评价是通过全面获取、分析药物的相关研究文献,对药物的有效性、安全性、经济性等进行基于文献证据的综合评估,是循证药物评价的一部分.文献评价在中药上市后临床再评价中处于基础和关键的地位.通过文献评价,可以全面掌握上市药物的文献信息、把握中药品种二次开发的朝向、进一步明确临床适应症、完善药品说明书等.该文论述了中药上市后临床文献评价的主要步骤与重点.强调安全性文献评价应重视全面收集药品的安全性信息;有效性评价应注重中药在改善证候、提高患者生存质量方面的特色优势;经济学文献评价应注意研究方法和结论的可靠性、灵敏度与外推性.

Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine

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