国家药品不良反应监测中心发布的《药品不良反应信息通报》简析

目的:对国家药品不良反应(ADR)监测中心发布的《ADR信息通报》(简称《通报》)进行分析,为促进临床合理用药和避免一些严重ADR的重复发生提供参考。方法:以2001年1月-2011年4月发布的《通报》提供的信息为基础,就其发布频度、涉及药品类别及剂型、ADR累及器官或系统、主要临床表现及引发ADR的原因进行简要分析。结果:2001年1月-2011年4月国家ADR监测中心共发布《通报》37期,涉及药品88种,其中化学药75种,中成药13种,分别占85.23%和14.77%;在通报的化学药品中,以抗微生物药占比最大,达40.00%;通报药品中由注射剂引发的ADR与口服制剂引发的大致相当;ADR累及器官或系统以皮肤及其附件受损或过敏反应最多;而引发ADR的原因除药品因素外还与患者个体差异及不合理用药等因素有关。结论:临床应重视ADR的监测工作。

Brief Analysis of Adverse Drug Reaction Information Bulletin Issued by National Center for Adverse Drug Reaction Monitoring

OBJECTIVE： To provide reference for the promotion of rational drug use in the clinic and to avoid the occurrence of some serious adverse drug reactions （ADR） by analyzing the Adverse Drug Reaction Information Bulletin （called Bulletin in short） issued by National Center for Adverse Drug Reaction Monitoring. METHODS ： On the basis of the information in Bulletin is- sued in Jan. 2001--Apr. 2011, the frequency of bulletin issued, the class and dosage forms of involved drugs, the organ or systems involved in ADR, the main clinical manifestations and the reasons of ADRs were analyzed briefly. RESULTS： There were 37 issues of Bulletin issued by National Center for ADR Monitoring from Jan. 2001 to Apr. 2011, in which there were 88 drugs involved including 75 chemical drugs （85.23%） and 13 Chinese patent medicines （14.77%）; and the largest proportion of chemical drugs were antimicrobial drugs, accounting for 40.00%. The adverse drug reactions induced by injections were nearly equal to those induced by oral preparations. The main clinical manifestations were lesion of skin and its appendants or allergic reactions. Individual differences of patients, irrational drug use and other factors are also the reasons for adverse drug reactions besides drug factors. CONCLUSION ： Clinical importance should be attached to ADR monitoring.