目的 了解我国关于麦考酚类药品生殖毒性的认知和风险控制能力,为临床正确认识及合理防治提供参考.方法 对世界卫生组织药品不良反应监测数据库以及我国药品不良反应监测数据库中关于麦考酚类药品的生殖毒性报告、国内文献数据库、国内外的风险控制措施等相关资料进行整理与分析.结果 目前关于麦考酚类药品的生殖毒性风险已经得到确认,但在我国,无论是从文献的数量,还是药品不良反应报告的资料,均显示出对麦考酚类药品的生殖毒性的监测能力尚存不足.结论 麦考酚类药品的生殖毒性风险在我国持续存在,但我国药品不良反应监测系统对该类风险的监测能力与国外相比仍存在一定差距.为更好提升我国麦考酚类药品生殖毒性风险的监测及控制能力,需要包括药品生产企业、临床医生及药师以及监管部门在内的多个部门不断努力和沟通协调.%Objective To investigate the perception ability and management ability of reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid in China, and to provide support to treat and prevent reproduction toxicity risk reasonably. Methods The literatures in domestic bibliographic databases, the individual adverse drug reaction cases in Vigibase, China adverse drug reaction database, and the risk management measures in domestic and overseas were analyzed. Results The reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid has been identified. But in our country, the monitoring and perception of the reproduction toxicity risk is insufficient. Conclusion The reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid will be existing for a long time, while the monitoring ability in our country legs behind other countries. In order to improve the monitoring and risk management ability on the reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid, several departments, such as manufacturers, health professionals and regulators need do more efforts and communication.
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