黄药子的安全性评价与风险控制措施探讨

Safety evaluation of Rhizoma Dioscoreae bulbiferae and discussion risk control

本研究从源流品种考证、古今文献毒性记载及近年来相关毒性实验研究等方面对有关黄药子及口服制剂安全性文献进行了系统回顾和分析,初步归纳了与黄药子安全性相关病例临床特点、影响因素及安全性相关最新研究结果,并提出积极开展相关制剂的上市后评价、规范临床使用和进一步加强毒性的物质基础、毒性机制和增效减毒等研究是有效控制药物风险,充分发挥疗效的重要措施。

Safety literatures on Rhizoma Dioscoreae bulbiferae and oral preparation have been reviewed and analyzed systematically,including textual research for origin and varieties,ancient and modern toxic record and toxic empirical study.Characteristics of clinical manifestations,risk factors and latest findings related to Rhizoma Dioscoreae bulbiferae have been concluded initially.The following measures may be effective for risk control and improving efficacy of Rhizoma Dioscoreae bulbiferae： to develope post-marketed evaluation actively;to regulate clinical medication;to strengthen safety-related basic study including the basis of toxic substances,toxic mechanism,efficacy enhancing and toxicity reducing etc.