2017—2019年广西地区严重药品不良反应/事件帕累托法分析  

Pareto analysis of serious adverse drug reaction/event in Guangxi,2017-2019

作　　者：黄小理 陆海鹏[1] 吕聪[1] 曾尚勇[1] 许江芬 赵小英 Huang Xiaoli;Lu Haipeng;Lv Cong;Zeng Shangyong;Xu Jiangfen;Zhao Xiaoying(Department of Pharmacy,Minzu Hospital of Guangxi Zhuang Autonomous Region,Nanning 530001,China;Guangxi Chongzuo Administration for Market Regulation,Chongzuo 532200,China)

机构地区：[1]广西壮族自治区民族医院药学部,南宁530001 [2]崇左市市场监督管理局,崇左532200

出　　处：《广西医科大学学报》2022年第10期1661-1665,共5页Journal of Guangxi Medical University

基　　金：广西壮族自治区卫生健康委员会科研课题(No.Z20200779)。

摘　　要：目的:分析广西地区严重药品不良反应/事件(ADR/ADE)的发生规律和危险因素,为促进临床药物警戒和安全合理用药提供参考。方法:收集2017年1月至2019年12月广西地区上报至国家药品不良反应监测系统的严重ADR/ADE报告,并对性别、年龄、怀疑药品、严重ADR/ADE名称进行帕累托法分析。结果:2017年1月至2019年12月上报严重ADR/ADE共19922例,涉及男性9473例(47.55%),女性10449例(52.45%),51~70岁患者发生严重ADR/ADE的比例较高(40.37%)。药品种类主要影响因素为抗肿瘤药(14196例,47.40%)、抗感染药物(6899例,23.04%)、中枢神经系统药物(2504例,8.36%)。主要累及系统/器官为血液系统(10495例,32.42%)、全身(6952例,21.52%)、皮肤及附件系统(5206例,16.10%)、呼吸系统(2519例,7.78%)。结论:广西地区51~70岁患者严重ADR/ADE发生率高,应加强老年患者的用药监护,尤其是在使用抗肿瘤药、抗感染药物、中枢神经系统药物时应加强用药前评估、疗效监护和不良反应监护,重点监护患者是否发生血液系统、全身、皮肤及附件系统、呼吸系统等的不良反应,充分发挥临床药师在不良反应管理中的作用,减少严重ADR/ADE发生。Objective:To analyze the occurrence pattern of and risk factors for serious adverse drug reaction/event(ADR/ADE)in Guangxi so as to provide reference for promoting clinical pharmacovigilance as well as safe and rational use of medication.Methods:The reports of serions ADR/ADE in Guangxi submitted to the national adverse drug reaction monitoring system from January 2017 to December 2019 were collected and analyzed by Pareto chart for gender,age,suspected drugs,and names of serious ADR/ADE.Results:A total of 19,922 cases of serious ADR/ADE were reported from January 2017 to December 2019,involving 9,473 male cases(47.55%)and 10,449 female cases(52.45%),with a higher proportion of patients aged 51 to 70 years(40.37%)having serious ADR/ADE.The main influencing factors in terms of drug type were antineoplastic drugs(14,196cases,47.40%),anti-infective drugs(6,899 cases,23.04%),and central nervous system drugs(2,504 cases,8.36%).The main systems/organs involved were the hematological system(10,495 cases,32.42%),the whole body(6,952 cases,21.52%),skin and its appendages(5,206 cases,16.10%),and the respiratory system(2,519cases,7.78%).Conclusion:The incidence of serious ADR/ADE is high in patients aged 51-70 in Guangxi.The medication monitoring of elderly patients should be strengthened,especially in the use of antineoplastic drugs,anti-infective drugs,and central nervous system drugs,at the same time,premedication evaluation,efficacy monitoring and ADR monitoring should be emphasized,focusing on monitoring whether patients have ADR in the hematological system,the whole body,skin and its appendages as well as the respiratory system.The role of clinical pharmacists in the management of ADR should be given full play to reduce the occurrence of serious ADR/ADE.

关 键 词：严重药品不良反应 帕累托法 合理用药 安全用药 

分 类 号：R97[医药卫生—药品]