某儿童医院2019—2023年所上报药物不良反应的流行病学特点分析

Analysis of Epidemiological Characteristics of Adverse Drug Reactions Reported by a Children's Hospital from 2019 to 2023

目的:分析医院2019—2023年所上报药物不良反应(adverse drug reactions,ADRs)的流行病学特点,为临床的用药安全提供参考。方法:选取2019年1月—2023年12月福建省福州儿童医院上报至国家药品不良反应监测系统的775份ADRs报告作为研究资料,采集ADRs的报告类型、患儿的年龄和性别,以及ADRs所涉药物的种类和给药途径等信息,分析所上报ADRs的临床特点。结果:2019—2023年,医院上报的ADRs数量逐年增多,其报告类型主要为“一般的”(630例,占81.29%),其次为“严重的”(88例,占9.23%);775例ADRs报告中,男性患儿多于女性患儿(435例vs 340例),年龄上以≤3岁者为主(289例,占37.29%),其次为>3~6岁(174例,占22.45%)和>6~9岁(167例,占21.55%);775例ADRs报告涉及的药物中,前5位的种类依次为抗菌药物(315例,占40.65%)、内分泌系统用药(75例,占9.68%)、神经系统用药(72例,占9.29%)、抗肿瘤药(71例,占9.16%)和呼吸系统用药(64例,占8.26%),而前3位的品种依次为注射用头孢噻肟钠(63例,占8.13%)、奥卡西平片(43例,占5.55%)和注射用头孢唑肟钠(41例,占5.29%);所涉药物的给药途径主要为静脉给药(416例,占53.68%),其次为口服(253例,占32.65%);775例ADRs主要累及的是皮肤及其附件(357例,占46.06%),其次为消化系统(179例,占23.10%)。结论:医院低龄患儿为发生ADRs的主要群体,而所涉药物主要为抗菌药物和静脉给药药物,对此临床应加强对重点群体和重点药物的监护,以保证患儿的用药安全。

Objective:To analyze the epidemiological characteristics of adverse drug reactions(ADRs)reported by the hospital from 2019 to 2023,and provide a reference for clinically safe use of drugs.Methods:A total of 775 cases of ADRs reported to the National Adverse Drug Reaction Monitoring System by Fuzhou Children's Hospital of Fujian Province from January 2019 to December 2023 were used as the research data.The information such as the types of ADRs reported,the age and sex of children,and the types of drugs involved in ADRs and the route of administration was collected to analyze the clinical characteristics of the reported ADRs.Results:The ADRs reported by the hospital increased year by year from 2019 to 2023.The reported types of ADRs were mainly"general"(630 cases,81.29%),followed by"severe"(88 cases,9.23%).Among the 775 cases of ADRs reported,the number of male children was more than that of female children(435 cases vs 340 cases);the age of children was mainly less than and equal to 3 years(289 cases,37.29%),followed by more than 3 years and less than 6 years(174 cases,22.45%),more than 6 years and less than 9 years(167 cases,21.55%).In terms of drugs involved in the 775 cases of ADRs,the top 5 types were antibacterial drugs(315 cases,40.65%),endocrine system drugs(75 cases,9.68%),nervous system drugs(72 cases,9.29%),anti‐neoplastic drugs(71 cases,9.16%)and respiratory system drugs(64 cases,8.26%),and the top three drugs were cefotaxime sodium for injection(63 cases,8.13%),oxcarbazepine tablets(43 cases,5.55%)and ceftizoxime sodium for injection(41 cases,5.29%).The main routes of administration were intravenous administration(416 cases,53.68%),followed by oral administration(253 cases,32.65%).The main organs and systems involved in the 775 cases of ADRs were skin and appendages of skin(357 cases,46.06%),followed by digestive system(179 cases,23.10%).Conclusion:Young children are the main group with ADRs,and the involved drugs are mainly antibacterial drugs and intravenous drugs.Therefore,it is necessary to strengthen the monitoring of key groups and key drugs clinically to ensure the safe medications of children.