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中药临床安全性再评价是临床再评价的首要任务,由于面临更为复杂、更为庞大的用药人群,更多的混杂因素,尤其是缺乏客观评价中药上市后临床安全性的核心指导理论和关键应用技术,使中药上市后临床再评价开展与实施受到制约。中药上市后临床安全性再评价应从明确治疗适应证候入手,通过分析中药复方药物组成及功能主治特点,以医院集中监测的主动性安全评价方法为主,围绕证候设计安全性再评价登记表,重点观察真实世界用药条件下,由合理及不合理用药引起的的不良反应,并结合常规性及特异性理化指标检测,早期发现并规避中药安全性风险及隐患,最终达到规范中药说明书安全性标识信息,指导中药临床安全合理使用的目的。
The re-evaluation of clinical safety of traditional Chinese medicine (TCM) is the primary task of clinical re-evaluation. Due to the more complex and larger drug users, more confounding factors, especially the lack of objective guidance and key to objectively evaluate the clinical safety of TCM Application of technology, the clinical re-evaluation of Chinese medicine to carry out and implement are subject to control. After the listing of traditional Chinese medicine clinical re-evaluation of safety should start with a clear treatment of indications for adaptation, by analyzing the composition of traditional Chinese medicine and the main characteristics of functional indications to focus on the initiative of the hospital monitoring of safety evaluation method based around the re-evaluation of the safety of the registration form , Focusing on real-world drug use conditions, the adverse reactions caused by rational and unreasonable use of drugs, combined with conventional and specific physical and chemical indicators detection, early detection and avoid safety risks and risks of traditional Chinese medicine, and ultimately to regulate the safety of traditional Chinese medicine specification Logo information, guiding the rational use of traditional Chinese medicine clinical safety purposes.