某院196例严重药品不良反应分析

Analysis of 196 cases of serious adverse drug reactions in a hospital

目的分析某院上报的严重药品不良反应(ADR)的类型和特点,为临床合理、安全用药提供依据。方法通过国家药品不良反应监测系统筛选出某院2017~2020年上报的1066例药品不良反应报告,选取“严重”、“新的严重”报告196例进行统计分析,肯定11例(5.61%),很可能134例(68.37%),可能51例(26.02%)。对患者基本情况、药品种类、用药途径、系统-器官及临床表现、转归情况进行统计分析。结果196例药品不良反应患者中,男113例,女83例,男︰女为1.36︰1;年龄最小6个月,最大92岁,平均年龄52.68岁。196例药品不良反应患者共涉及306种药品,其中化学药品295种(96.41%)、中成药11种(3.59%)。306种药品的给药途径中排名第一的为口服(58.82%),第二为静脉滴注(31.05%)。累及系统-器官构成比由高到低依次为肝胆系统(26.82%)、皮肤及其附件(13.41%)、呼吸系统(11.73%)、胃肠系统(11.17%)、神经系统(10.06%)、血液系统(9.50%)、全身性(4.47%)、心血管系统(4.19%)、代谢和营养障碍(3.63%)、肌肉骨骼(3.35%)、泌尿系统(1.68%)。临床表现主要有肝酶升高(66例)、皮疹伴瘙痒(39例)、肝功能异常(30例)。196例患者中,17例痊愈,171例好转,5例不详,3例未见好转。结论抗感染药物和抗肿瘤药物所致严重药品不良反应最多,应加强肝功能监测,特别是长期联合用药的>50岁的中老年患者,确保患者用药安全。

Objective To analyze the types and characteristics of serious adverse drug reactions(ADRs)reported by a hospital,so as to provide a basis for rational and safe clinical use of drugs.Methods Through the national adverse drug reaction monitoring system,1066 cases of adverse drug reaction reports reported by a hospital from 2017 to 2020 were screened,and 196 cases of"serious"and"new serious"reports were selected for statistical analysis,among which,11 cases(5.61%)were definitely,134 cases(68.37%)were likely,and 51 cases(26.02%)were possible.Statistical analysis was performed on the basic conditions of patients,types of drugs,route of administration,system-organ and clinical manifestations,and outcomes.Results Among the 196 patients with adverse drug reactions,113 cases were male and 83 cases were female,with a male:female ratio of 1.36︰1;the minimum age was 6 months,the maximum age was 92 years,and the average age was 52.68 years.A total of 306 drugs were involved in 196 patients with adverse drug reactions,including 295 kinds(96.41%)of chemicals and 11 kinds(3.59%)of Chinese patent medicines.The first ranked route of administration of 306 drugs was oral(58.82%)and the second was intravenous(31.05%).The system-organ composition ratios involved were,in descending order,hepatobiliary system(26.82%),skin and its adnexa(13.41%),respiratory system(11.73%),gastrointestinal system(11.17%),nervous system(10.06%),hematological system(9.50%),systemic(4.47%),cardiovascular system(4.19%),metabolic and nutritional disorders(3.63%),musculoskeletal(3.35%),and urinary system(1.68%).The main clinical manifestations were elevated liver enzymes(66 cases),skin rash with pruritus(39 cases),and abnormal liver function(30 cases).Of the 196 patients,17 cases were cured,171 cases were improved,5 case were unknown,and 3 did not show improvement.Conclusion The most serious adverse drug reactions are caused by anti-infective drugs and anti-tumor drugs;liver function monitoring should be strengthened in patients,especially middle-aged and elderly patients>50 years old who take long-term combined medication,to ensure the medication safety of patients.