基于自发呈报系统的喜炎平注射液不良反应风险预警研究  

Research on early warning signals of adverse drug reactions to parenterally administered Xiyanping based on spontaneous reporting system(SRS) data

作　　者：王志飞[1] 向永洋[2] 谢雁鸣[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 [2]中国人民大学,北京100872

出　　处：《中国中药杂志》2013年第18期3008-3012,共5页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030);国家自然科学基金青年基金项目(81202776);中国中医科学院第7批自主选题项目(Z0255);国家中医药管理局中医药行业科研专项课题(200907001-5-6)

摘　　要：该研究基于自发呈报系统喜炎平注射液2005—2012年的数据(共9 633例),针对报告次数500以上的不良反应/事件(包括"皮疹"、"瘙痒"、"过敏样反应"、"寒战")应用报告比例比算法和贝叶斯置信度增殖神经网络算法开展预警研究。研究发现"皮疹"在每年度和季度的不良反应发生率均高于背景药物的平均水平;"瘙痒"在2009年第二季度发生预警;"过敏样反应"在2011年第四季度和2012年第二季度发生预警;"寒战"则没有出现预警信号。结果提示"皮疹"可能为喜炎平注射液常发的不良反应,"寒战"可能不是其常见不良反应,而"瘙痒"和"过敏样反应"发生率高于背景药物时须关注其安全性。This article focused on early warning signals regarding the safety of parenterally administered Xiyanping. The study data was obtained from reports made between 2005--2012 from the national spontaneous reporting system （SRS）. Proportion reporting ratio （PRR） and Bayesian confidence propagation neural network （BCPNN） algorithms were used to analyse： erythra, pruritus, ana- phylactoid reactions and shiver with cold, these 4 adverse drug reactions had a total count of more than 500 events. The article found that Xiyanping＇s incidence rate of erythra was higher than for background-drugs in every year and in every season. Pruritus was an early warning signal in the second season of 2009, and anaphylactoid reaction was an early warning signal in the fourth season of 2011 and in the second season of 2012. There was however no early warning signal indicated by shiver with cold. This data indicates that erythra maybe an adverse drug reactions to parenterally administered Xiyanping, and if the incidence rate of pruritus and anaphylactoid reaction rises attention should be paid to its safety.

关 键 词：自发呈报系统 喜炎平注射剂 不良反应 预警 倾向评分 

分 类 号：R288[医药卫生—中药学]