应用鱼骨图及帕累托图进行2621例药品不良反应分析

Analysis on 2 621 cases of adverse drug reaction reports by Fishbone and Pareto diagram

目的分析厦门大学附属成功医院2013—2016年2 621例药品不良反应(ADR)的规律和特点,探究影响ADR的要素和产生的原因,为合理用药的持续改进提供依据。方法回顾分析2 621例ADR报告,用监测软件提取ADR报告来源、患者的性别及年龄、涉及的药品剂型、给药途径、临床表征、累及器官等信息,用帕累托图法找出引发ADR的主要药品,并用鱼骨图进行ADR要因分析。结果 ADR主要由医师呈报(2 573例,98.17%),药师报道最少(3例,0.11%),年龄>70岁人群所占比例最大(570例,21.74%),由静脉滴注引发的ADR居多(1 680例,64.10%),临床表现以胃肠系统损害为主(717例,24.17%);帕累托图分析显示ADR主要因素(A类)药品为抗感染药物、抗肿瘤药物、中药注射剂、静脉营养药;用鱼骨图分析高龄患者、静脉给药、监测不全面和主要药品引发ADR的具体原因,并针对性地提出解决措施。结论应关注特殊患者的用药监护,减少注射剂使用,重点监控高发药品,开展个体化用药监测,加大临床药师投入,以促进临床合理用药,减少药源性疾病的发生。

Objective To analyze the regularity and characteristics of 2 621 cases of adverse drug reaction（ADR）occurring in our hospital during 2013-2016,and to explore the factors and causes of ADRs,so as to provide evidence for the continuous improvement of rational use of drugs.Methods 2 621 cases of ADR reports were retrospectively analyzed by monitoring software to extract ADR report source,patient age and sex,related pharmaceutical dosage forms,routes of administration,clinical characterization,organ involvement and other information.The Pareto method was used to identify the main drugs that caused ADR and ADR factorial analysis was performed with Fishbone diagram.Results ADR mainly reported by physicians（2 573 cases,98.17%）and pharmacists reported at least（3 cases,0.11%）;population aged70 years accounted for the largest proportion（570 cases,21.74%）;ADR mainly caused by intravenous infusion（1 680 cases,64.10%）.The clinical manifestations were gastrointestinal system lesions（717 cases,24.17%）.Pareto analysis showed that the main drug factors involved anti-infective drugs,anti-neoplastic drugs,Chinese medicine injections and parenteral nutrition drugs.Fishbone analysis showed that elderly patients,intravenous administration,incomplete monitoring and related drugs were the determining factors associated with ARDs.Conclusion The close attention should be paid to monitoring and guidance of special populations,especially the elderly;reducing intravenous forms,monitoring the main factors of medicines,carrying out the individualized medication monitoring,strengthening clinical pharmacy,in order to promote clinical rational use drug and reduce the occurrence of drug-induced diseases.