一项大样本长期随访医院集中监测研究实施方案的解析——碟脉灵苦碟子注射液为例  

Protocol of intensive hospital monitoring with long follow up and large sample: Diemailing Kudiezi injection as example

作　　者：廖星[1] 谢雁鸣[1] 王桂倩[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2016年第24期4494-4499,共6页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金青年基金项目(81202776);中央级公益性科研院所基本业务费项目(Z0406);国家"重大新药创制"科技重大专项(2009ZX09502-030);第七批博士后特别项目(2014T70202)

摘　　要：基于前期系列研究结果,开展一项针对碟脉灵苦碟子注射液的大样本长期随访医院集中监测研究。旨在明确碟脉灵苦碟子注射液不良反应发生率,包括已知不良反应发生率、新的不良反应发生率、各不良反应症状的发生率和各亚人群的不良反应发生率等;明确碟脉灵苦碟子注射液不良反应临床特征;探讨碟脉灵苦碟子注射液不良反应发生影响因素;掌握碟脉灵苦碟子注射液临床用药情况。由于类似的上市后中药医院集中监测国内尚无现存经验可借鉴,该研究借鉴国内相关政策法规以及观察性研究设计要点,并广泛征求行业内专家意见,制定了该监测研究的实施方案,现予以介绍,以供参考和借鉴。This is a protocol of intensive hospital monitoring with long follow up and large sample of Diemailing Kudiezi injection, which aims to identify adverse drug reactions（ADRs） of Diemailing Kudiezi injection, including known incidence of adverse reactions, the incidence of new adverse reactions, the incidence of various ADR symptoms and the incidence of ADR among the sub populations ; clarify the clinical features of ADRs of Diemailing Kudiezi injection; explore risk factors for ADRs; and analyze their usage in real world. After all, no existing experience about active surveillance on safety issues for postmarkeing traditional Chinese medicine injec- tions could be used for us to learn. On the basis of references to related domestic policies and regulations as well as the design points for observational studies, we extensively solicited opinions from experts in the industry to develop this implementation protocol on moni- toring research.

关 键 词：医院集中监测 中药上市再评价 方案 安全性 主动监测 

分 类 号：R286[医药卫生—中药学]