中药注射剂上市后安全性集中监测研究医院相关问题的思考

摘要

The implementation process management plays a important role for the quality of centralized safety monitoring study of post-marketing Chinese medical injections.One of the critical link is hospital.Currently,there is no principle or specification for hospital choosing,number of monitoring points,data collection responsible part and forms of data collection as well.These issues caused uneven quality,huge differences in results and questioned conclusion.Based on the previous research experience,this paper focused on discussing the link of hospital where research data may be influenced,and proposed some suggestions.%中药注射剂上市后安全性集中监测研究实施过程管理对研究质量至关重要,而医院是其中的关键环节.目前相关研究的开展,对选择监测医院的原则、监测点的数量、数据采集的主体、数据采集形式等方面尚无规范,导致研究质量参差不齐,研究结果差异巨大,研究结论受到质疑.本文在前期研究经验基础上,着重探讨医院环节对研究数据的影响,并提出建议.