某院414例严重药品不良反应报告分析  

Analysis of 414 Cases of Severe Adverse Drug Reaction Reports in a Hospital

作　　者：赵云 颜成 于锦 成美 ZHAO Yun;YAN Cheng;YU Jin;CHENG Mei(Yancheng First People′s Hospital,Yancheng,Jiangsu,China 224001;Fangqiang Compulsory Drug Rehabilitation Hospital,Yancheng,Jiangsu,China 224165)

机构地区：[1]江苏省盐城市第一人民医院,江苏盐城224001 [2]江苏省方强强制隔离戒毒所医院,江苏盐城224165

出　　处：《中国药业》2025年第5期124-128,I0001,共6页China Pharmaceuticals

基　　金：江苏省研究型医院学会精益化用药-石药专项科研基金项目[JY202205]。

摘　　要：目的 分析严重药品不良反应(SADR)的上报情况及其发生规律,为临床防治SADR提供参考。方法 收集某院2019年至2023年上报的SADR报告414份,涉及患者414例,对SADR上报情况,报告人职业分布,患者的性别、年龄、给药途径,SADR的发生时间、缓解时间、涉及药物种类、累及系统/器官及临床表现、关联性评价及转归等指标进行分析与评价。结果 SADR上报数量和上报率均整体呈增长趋势,2023年的上报率高达15.22%。2022年和2023年的药师上报率显著增加,分别为96.73%和82.51%。414例SADR患者中,男女比例为1︰1,平均年龄为(59.81±14.65)岁。SADR发生的中位时间为用药后第8天,95.17%的SADR发生在用药后30 d内。231例(55.80%)SADR在1周内缓解,131例(31.64%)SADR的缓解时间不明确。导致SADR的药物中,抗肿瘤药物的占比最高(85.85%),其次为抗感染药物(3.58%)、内分泌系统药物(2.11%)、中药制剂(1.63%)等。主要累及系统/器官分别为血液系统(45.06%)、胃肠系统(11.27%)、全身性反应(9.88%)、皮肤及其附件(9.57%)等。转归情况主要为好转(88.65%)。结论 临床应重视SADR监测工作,临床药师应深入临床进行全程药学监护,及时与医师、护士、患者沟通,提高对SADR的鉴别和处理能力,确保患者用药安全。Objective To analyze the reporting situation and occurrence pattern of severe adverse drug reactions(SADR),and to provide a reference for clinical prevention and treatment of SADR.Methods A total of 414 SADR cases(involving 414 patients)reported from a hospital from 2019 to 2023 were collected.The SADR reporting situation,the occupational distribution of the reporter,the gender,age,route of administration of patients,the onset time of SADR,remission time,types of drugs involved,systems/organs involved,clinical manifestations,correlation evaluation and outcome were analyzed and evaluated.Results The overall number and reporting rate of SADR have shown an increasing trend,with a reporting rate of 15.22%in 2023.The pharmacist reporting rates have significantly increased in 2022 and 2023,accounting for 96.73% and 82.51%respectively.Among 414 SADR patients,the male-to-female ratio was 1∶1,and the average age was(59.81±14.65)years old.The median time of SADR occurrence after medication was 8 d,and 95.17%of SADR occurred within 30 d after medication.A total of 231 cases(55.80%)achieved SADR remission within one week,and 131 cases(31.64%)of SADR had unclear remission time.Among the drugs that caused SADR,anti-tumor drugs accounted for the highest proportion(85.85%),followed by anti-infection drugs(3.58%),endocrine system drugs(2.11%),and traditional Chinese medicine preparations(1.63%).The main involved systems/organs were the blood system(45.06%),gastrointestinal system(11.27%),systemic reactions(9.88%),skin and its appendages(9.57%),etc.The main outcome was improvement(88.65%).Conclusion Clinical pharmacists should pay attention to the monitoring of SADR,go deep into clinical practice,perform full pharmaceutical care,and communicate with physicians,nurses,and patients in time,so as to improve the ability to identify and deal with SADR,and ultimately ensure the patients′medication safety.

关 键 词：严重药品不良反应 药物警戒 临床药师 抗肿瘤药物 药学监护 

分 类 号：R95[医药卫生—药学]