某院新的和严重的药物不良反应报告的流行病学特征分析

Analysis of Epidemiological Characteristics of New and Serious Adverse Drug Reaction Reports in a Hospital

目的:分析医院临床患者所发生的新的和严重的药物不良反应(adverse drug reactions,ADRs)的流行病学特点,为今后患者的安全、合理用药提供参考。方法:选取2021年1月—2022年7月常熟市第一人民医院上报国家药品不良反应监测中心的696例ADRs报告,采集患者的性别、年龄、所患疾病等,以及ADRs的累及器官(或系统)、临床表现和所涉药品的种类、给药方式等信息,分析新的和严重的ADRs的流行病学特点。结果:上报的696例ADRs报告中,新的和严重的ADRs共308例,其中报告类型为新的一般的有214例,新的严重的有23例,严重的有71例;308例新的和严重的ADRs报告中,前3位的上报部门分别为重症医学科(19例,占6.17%)、神经内科(17例,占5.52%)和骨科(17例,占5.52%),所涉患者的年龄主要集中在60~<80岁(157例,占50.97%)和40~<60岁(78例,占25.32%),而其所患疾病前3位的分别为胃恶性肿瘤(21例,占6.82%)、肺部感染(19例,占6.17%)和骨折(18例,占5.84%);308例新的和严重的ADRs报告主要涉及抗感染药物(70例,占22.73%)、血液系统药物(35例,占11.36%)和心血管系统药物(26例,占8.44%),所涉品种主要为氨甲环酸(14例,占4.55%)和左氧氟沙星(12例,占3.90%),主要累及的器官(或系统)为皮肤及其附件(114例次)、胃肠与肝胆系统(90例次)、全身性反应(74例次),出现较多的临床表现有皮疹性瘙痒(47例次)、皮疹(38例次)、恶心(23例次)、胸闷(20例次)、头晕(19例次);308例新的和严重的ADRs患者经过处置,治愈的有220例(占71.43%),好转的有85例(占27.60%)。结论:医院患者在用药过程中难免发生ADRs,而其中有较大的可能发生新的或严重的ADRs,这其中又以中老年人群发生最多,医院应督促临床安全用药长抓不懈,以确保患者的用药安全。

Objective:To analyze the epidemiological characteristics of new and serious adverse drug reactions(ADRs)in clinical patients in the hospital,so as to provide reference foRpatients'safe and rational drug use in the future.Methods:696 ADRreports of Changshu No.1 People's Hospital reported to National CenteRfoRADRMonitoring,China from January 2021 to July 2022 were selected,and information such as patient gender,age,diseases,and organs(oRsystems)involved in ADRs,clinical manifestations,type of drugs involved,method of administration was collected to analyze the epidemiological characteristics of new and serious ADRs.Results:Among 696 ADRreports,there were 308 new and serious ADRs,of which 214 were new and general,23 were new and serious,and 71 were serious;among 308 new and serious ADRreports,the top three reporting departments were Department of Critical Care Medicine(19 cases,6.17%),Department of Neurology(17 cases,5.52%),and Department of Orthopedics(17 cases,5.52%).The patients involved were mainly 60 to less than 80 years old(157 cases,50.97%)and 40 to less than 60 years old(78 cases,25.32%),and the top three diseases they suffered from were gastric malignant tumors(21 cases,6.82%),lung infections(19 cases,6.17%)and bone fractures(18 cases,5.84%);308 new and serious ADRreports mainly involved anti-infective drugs(70 cases,22.73%),blood system drugs(35 cases,11.36%)and cardiovasculaRsystem drugs(26 cases,8.44%).The varieties of drugs involved were mainly tranexamic acid(14 cases,4.55%)and levofloxacin(12 cases,3.90%);the main organs(oRsystems)involved were skin and its appendages(114 cases),gastrointestinal and hepatobiliary system(90 cases),and systemic reaction(74 cases).Clinical manifestations that occurred more frequently included rash itching(47 cases),rash(38 cases),nausea(23 cases),chest tightness(20 cases),dizziness(19 cases).308 patients with new and severe ADRs were treated,220 cases(71.43%)were cured and 85 cases(27.60%)were improved.Conclusion:ADRs will inevitably occuRin patients in the hospital during the medication process,and new oRserious ADRs are more likely to occur.Among them,middle-aged and elderly people are most likely to have ADRs.Hospitals should supervise the clinical safety of medication and make unremitting efforts to ensure safe medication foRpatients.