抗感染药物致严重药品不良反应/事件5490例帕累托图分析  

Analysis of 5490 cases serious adverse drug reactions/events of anti-infective agents by Pareto diagram

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;不详)

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

出　　处：《临床合理用药杂志》2023年第8期30-35,共6页Chinese Journal of Clinical Rational Drug Use

基　　金：广西壮族自治区卫生健康委员会科研课题(Z20200779)。

摘　　要：目的分析抗感染药物致严重药品不良反应/事件(ADR/ADE)的发生特点和主要影响因素。方法收集2017年1月—2019年12月广西地区上报至国家药品不良反应监测系统的抗感染药物致严重ADR/ADE报告5490例,采用帕累托图分析患者性别、年龄、怀疑药品的药物分类及累及系统/器官。结果5490例患者中,男3174例,女2316例;61~70岁严重ADR/ADE发生率最高(18.32%),其次是51~60岁(16.23%),≤10岁发生率为12.90%,51~70岁和≤10岁累计构成比为47.45%。怀疑药品种类主要为抗生素(3464例次,50.35%)和抗结核药(2140例次,31.10%),其中β-内酰胺酶抑制剂及复方制剂(1300例次,31.56%)、头孢菌素类(1206例次,29.28%)、喹诺酮类(571例次,13.86%)为主要抗感染药物。累及系统/器官主要为全身症状(2414例次,22.25%)、皮肤及其附属器(2290例次,21.10%)、肝胆系统(1385例次,12.76%)、内分泌系统(1105例次,10.18%)、血液系统(820例次,7.56%)。结论广西地区使用抗感染药物时,应重点关注中老年和儿童的不良反应,尤其是使用抗菌药物和抗结核药物时应更加密切监护,重点监护患者是否发生过敏症状、发热、肝损伤、血尿酸升高、血小板减少和白细胞减少等不良反应。Objective To analyze the regularity and risk factors of occurrence of serious adverse drug reactions/events(ADR/ADE)induced by anti-infective agents.Methods 5490 cases of serious ADR/ADE induced by anti-infective agents reported to the National Adverse Drug Reaction Monitoring System in Guangxi from January 2017 to December 2019 were collected,the gender,age,drug classification of suspected drugs and cumulative system/organ of patients were analyzed by Pareto diagram.Results Among 5490 patients,3174 were male and 2316 were female;The incidence of severe ADR/ADE in patients aged 61 to 70 years was the highest(18.32%),followed by aged 51 to 60 years(16.23%),the incidence of≤10 years was 12.90%,and the cumulative constituent ratio in patients aged 51 to 70 years and≤10 years was 47.45%.Suspected drugs mainly include antibiotics(3464 cases,50.35%)and anti-infective agents(2140 cases,31.10%),among whichβ-lactamase inhibitors and compound preparations(1300 cases,31.56%),cephalosporins(1206 cases,29.28%)and quinolones(571 cases,13.86%)were the main anti-infective agents.The main systems/organs involved were systemic symptoms(2414 cases,22.25%),skin and basal appendages(2290 cases,21.10%),hepatobiliary system(1385 cases,12.76%),endocrine system(1105 cases,10.18%),and blood system(820 cases,7.56%).Conclusion When anti-infective agents are used in Guangxi,attention should be paid to the adverse reactions of middle-aged,elderly and pediatric patients,especially in the use of antibacterial drugs and anti-tuberculosis drugs,adverse reactions such as allergic symptoms,fever,liver injury,elevated serum uric acid,thrombocytopenia and leukopenia should be monitored more closely.

关 键 词：抗感染药物 药品不良反应 帕累托图 合理用药 安全用药 

分 类 号：R969.3[医药卫生—药理学]