391例新出现和严重药品不良反应回顾性分析

Retrospective analysis of 391 cases of new and severe adverse drug reactions reported in our hospital

目的:分析阜阳市人民医院新出现和严重的药品不良反应(ADR),为临床安全、合理、有效地使用药品提供参考。方法:采用回顾性分析方法,收集阜阳市人民医院2020年1月至2022年12月上报的新的和严重的ADR,共391例,统计分析患者的年龄、性别、药物剂型、给药途径、药物种类、不良反应累及系统(器官)及临床表现、转归情况、关联性和上报人员职业等。结果:在391例报告中,女210例,男181例,女性占比略高于男性(1.16:1);年龄段分布以60~69岁患者居多[24.80%(97/391)],其次为50~59岁患者[24.55%(96/391)];涉及的药品剂型以粉针剂[42.97%(168/391)]、注射液[30.69%(120/391)]和片剂[16.11%(63/391)]为主;涉及的给药途径以静脉滴注[67.01%(262/391)]和口服[24.3%(95/391)]为主;涉及的药品主要为抗肿瘤药[31.97%(124/391)]、抗感染药[14.83%(58/391)]、心血管系统用药[13.04%(51/391)]、中成药及其他[10.23%(40/391)]。不良反应分布及临床表现主要为血液系统、消化系统。其中,90%以上好转或痊愈,关联性评价主要为可能[31.46%(123/391)]、很可能[61.63%(241/391)]。由药师上报的ADR最多[49.87%(195/391)],其次为医生[46.04%(180/391)]。结论:该研究将ADR中新的和严重的部分抽取出来进行统计分析,各项数据占比虽略有出入,但整体差别不多。抗肿瘤药、抗感染药、心血管系统用药、中成药制剂仍是药品不良反应的监测重点品种;老年患者是用药监护重点对象,警惕注射剂不良反应。

Objective:To analyze the new and serious adverse drug reactions(ADR)in Fuyang People’s Hospital,and to provide reference for the safe,rational and effective use of drugs in clinic.Methods:Retrospective analysis was used to collect 391 cases of new and serious ADRs reported in Fuyang People’s Hospital from January 2020 to December 2022.The patients’age,gender,drug dosage form,route of administration,drug type,system/organ involved in adverse reactions,clinical manifestations,outcome,correlation and occupation of reporting staff were statistically analyzed.Results:Among the 391 cases reported,210 were female and 181 were male.The proportion of females was slightly higher than that of males(1.16:1).Patients aged 60-69 years were the majority(24.80%(97/391)),followed by patients aged 50-59 years(24.55%(96/391)).The drug dosage forms involved were mainly powder injection(42.97%(168/391)),injection(30.69%(120/391))and tablet(16.11%(63/391)).The main routes of administration involved were intravenous drip(67.01%(262/391))and oral administration(24.3%(95/391)).The drugs involved were mainly anti-tumor agents(31.97%(124/391)),anti-infective agents(14.83%(58/391)),cardiovascular system drugs(13.04%(51/391)),proprietary Chinese medicines and others(10.23%(40/391)).The distribution and clinical manifestations of adverse reactions were mainly in the blood system and digestive system.Among them,more than 90%were improved or cured,and the correlation evaluation was mainly possible(31.46%(123/391))and very likely(61.63%(241/391)).The most ADRs were reported by pharmacists(49.87%(195/391)),followed by doctors(46.04%(180/391)).Conclusion:In this study,the new and serious ADRs were selected for statistical analysis.Although the proportion of each data was slightly different,the overall difference was not much.Anti-tumor drugs,anti-infective drugs,cardiovascular drugs,proprietary Chinese medicine preparations are still the key varieties of ADR monitoring.Elderly patients are the key objects of drug monitoring and should be alert to adverse reactions of injections.