1143份严重药品不良反应报告回顾性分析  

Analysis of 1143 severe adverse drug reactions

作　　者：马飞 冯亚楠 李科南 MA Fei;FENG Yanan;LI Kenan(Center for ADR Monitoring of Xingtai,Xingtai 054001,China;不详)

机构地区：[1]邢台市药品不良反应和药物滥用监测中心,河北省邢台市054001 [2]河北省药品警戒中心,河北省石家庄市050000

出　　处：《临床合理用药杂志》2022年第21期37-40,44,共5页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的回顾性分析邢台市2021年收集的严重药品不良反应发生情况,以促进临床合理用药。方法对国家药品不良反应监测系统中邢台市2021年收集的严重药品不良反应报告进行统计和分析。结果2021年累计收集1143份严重药品不良反应报告,其中男女比例为1.04∶1,65岁以上424例(占37.10%)。报告涉及的化学药品占86.31%,其中报告数量最多的为肿瘤用药,占33.93%,其次为抗感染药(占22.11%);给药途径以注射给药为主,占70.23%。多数患者对症治疗后好转。结论药品上市许可持有人和医疗机构应当加强风险监测,通过对潜在和非预期的药品风险进行分析,及时掌握药品的风险与获益变化,实现药品风险发现、评估和监管闭环,保障公众用药安全。Objective To investigate the incidence of severe adverse drug reactions(ADR)of Xingtai in 2021,so as to provide reference for the rational drug application in clinic.Methods Severe ADR reports received by the National Adverse Drug Reaction Monitoring System in 2021 were counted and analyzed.Results A total of 1143 severe ADR reports were identified,among which the ratio of males and females was 1.04∶1,424 cases were 65 or elder(37.1%).The most common drugs were chemicals,33.93%were tumor drugs and 22.11%were anti-infectives,of which 70.23%induced by injection.After symptomatic treatment,most patients got better after symptomatic treatment.Conclusion Patient safety challenge requires the joint efforts,MAHs and medical staffs should pay attention to the risk of severe ADRs and provide an evaluation of the risk-benefit balance of a medicinal product,so as to take effective planning and actions to reduce serious and avoidable drug-related injuries.

关 键 词：药品不良反应 药物警戒 风险 合理用药 

分 类 号：R969.3[医药卫生—药理学]