中国中西医结合杂志2017，Vol.37Issue(5)：596-598,3.DOI:10.7661/j.cjim.20170315.049
药品上市后临床安全性再评价医院集中监测方案的实施要点
Kay Points of Enforcing Hospital-based Monitoring Scheme for Clinical Safety Reevaluation after Marketing
摘要
Abstract
Hospital-based monitoring are conducted to identify adverse events/adverse drug reactions (AEs/ADRs) within a particular hospital or a region during a certain period of time (several months or years),or to some extent as well as drug use,thus observing the occurrence laws of AEs/ADRs.Currently,hospital-based ADR monitoring in China,as a newly developed research field,is just in start-up stage.Hospital-based ADR monitoring technologies are not mature.Key points of enforcing a number of hospital-based monitoring schemes were summarized by combining clinical safety reevaluation on patent Chinese herbal injections after marketing hosted and participated at Pharmacy Department,Henan University of Traditional Chinese Medicine.关键词
医院集中监测/上市后再评价/不良事件/不良反应Key words
hospital-based monitoring/post-marketing evaluation/adverse event/adverse drug reaction引用本文复制引用
邢冬梅,李春晓,李彬,张俊华,张伯礼,朱明军..药品上市后临床安全性再评价医院集中监测方案的实施要点[J].中国中西医结合杂志,2017,37(5):596-598,3.基金项目
国家重点基础研究发展计划(973)(No.2015CB554401) （973）
河南省创新型科技团队(No.C20130050) （No.C20130050）
河南省高校科技创新团队支持计划(No.13IRTSTHN012) （No.13IRTSTHN012）
