从通报含钆磁共振造影剂看我国的药品风险管理

目的通过简要介绍通报含钆磁共振造影剂引起肾源性系统纤维化的背景及内容，分析药品风险管理的模式及药品不良反应监测信息在风险管理中的作用。方法通过系统分析通报含钆磁共振造影剂的依据及其存在的风险，讨论国外药品不良反应监测信息如何影响我国的风险管理。结果含钆磁共振造影剂的风险管理是一个过程，随着病例报告的增多，更多相关研究结果的发表，即使我国尚未发现类似的病例报告，也应及时对安全性信息进行通报以规避风险。结论药品风险管理是动态的管理过程，信息的及时获取及不断积累以及各国信息的及时有效沟通是有效实施药品风险管理的保障。

Safety Information about Gadolinium-containing Contrast Agents and Drug Risk Management in China

Through analysis of warning background and safety information about gadolinium-containing contrast agents and evaluation of scientific evidences about safety and risk of using gadolinium-containing contrast agents in patients, the role of monitoring of adverse drug reaction in risk management was illuminated and influence of adverse drug reaction monitoring on risk management were also discussed. Risk management of gadolinium-containing contrast agents is a safety information based process. Following more case reports received by drug regulatory agencies and more results of safety studies of gadolinium-containing contrast agents came out, many drug regulatory authorities like FDA in United States and MHRA in United Kingdom released several warning information in 2006 and 2007, and changed the labeling of gadolinium-containing contrast agents in 2007. So it is necessary to warn the public about the risk of using gadolinium-containing contrast agents in China even there is no domestic similar reports received by then. Risk management is also a dynamic process. Following new safety information obtained and more effective communication between drug regulatory agencies, different actions will be taken to reduce the risk of drug use.