安徽省某市2020年药品不良反应报告分析

Adverse Drug Reaction Reports in a City of Anhui Province in 2020

目的促进临床合理用药。方法提取2020年安徽省某市行政区域内医疗机构、药品经营企业上报至国家药品不良反应监测中心的药品不良反应(ADR)报告12611份,参照《国家药品不良反应监测年度报告(2020)》进行年龄分层汇总,结合《中华人民共和国药典临床用药须知(2015年版)》进行药品分类,《WHO-ART中文更新版5(2015)》和《药品不良反应术语使用指南》进行ADR名称定义,并分析其特点与转归。结果12611例ADR报告中,医疗机构报告9781例(77.56%),报告人以医师和药师为主(82.76%);男女比例基本持平(1∶0.95),主要集中于45岁及以上人群(71.21%);怀疑药品共使用13169例次,报告例次排名前3的类别为抗感染药(32.09%)、中成药(22.02%)、心血管系统用药(9.20%);给药途径以口服给药(49.43%)和静脉滴注(42.27%)为主;ADR累及系统/器官多见于胃肠系统(37.62%)、皮肤及其附件(19.74%)及全身性(14.75%);97.87%的ADR痊愈或好转。结论该市ADR监测工作需进一步拓宽范围,均衡报告来源,提高报告质量;重视ADR高危因素,提升ADR信号识别能力,降低或避免ADR导致的损害。

Objective To promote rational drug use in the clinic.Methods A total of 12611 adverse drug reaction(ADR)reports reported to the National Adverse Drug Reaction Monitoring Center by medical institutions and drug trading enterprises in an administrative region of Anhui Province in 2020 were extracted,the age stratification was summarized according to the Annual Report for National Adverse Drug Reaction Monitoring(2020),the drug classification was carried out according to the Guidelines for Clinical Use in the China Pharmacopoeia(2015),the ADR names were defined according to the WHO-ART Chinese Update 5(2015)and Guidelines for the Use of Adverse Drug Reaction Terms,and their characteristics and outcomes were analyzed.Results Among 12611 ADR reports,9781 cases(77.56%)were reported by medical institutions,and they were mainly reported by doctors and pharmacists(82.76%).The ratio of male to female patients with ADR was similar(1∶0.95),mainly concentrated in patients with≥45 years old(71.21%).There were 13169 cases of suspected drugs,among which the top three categories of reported cases were anti-infective drugs(32.09%),Chinese patent medicine(22.02%),and cardiovascular system drugs(9.20%).The main routes of administration were oral administration(49.43%)and intravenous drip(42.27%).Systems/organs involved in ADR were mainly gastrointestinal system(37.62%),skin and its accessories(19.74%)and systemic damage(14.75%).Precisely 97.87%of patients with ADRs were cured or improved.Conclusion ADR monitoring in the city needs to further broaden the scope,balance the sources of reports and improve the quality of reports.It is necessary to pay attention to high-risk factors of ADR,and improve the ability to identify ADR signals,so as to reduce or avoid damage caused by ADR.