[目的]分析中国人民解放军陆军第七十三集团军医院(后称我院)严重药品不良反应(severe adverse drug reaction,SADR)发生的规律和特点,为临床合理用药提供参考.[方法]采用回顾性分析方法,对我院2013年1月至2022年1月收集上报的SADR报告进行统计分析.[结果]1 315例SADR报告中,60岁以上患者最多,占39.85％;静脉滴注给药途径出现最多,占75.51％;注射剂引起的占89.05％;用药后出现SADR的时间在1 h至1 d的占26.31％;SADR累及的系统或器官损害以消化系统为主,占38.53％;抗肿瘤药物引起的占67.98％.[结论]应加强SADR监测和上报工作,尤其是抗肿瘤药物和抗感染药物,以降低用药风险,保障患者用药安全.
Retrospective analysis on 1 315 cases of severe adverse drug reaction reports
[Objective]In clinical medication,the incidence of serious adverse drug reaction(SADR)is relatively low,but it poses great risks to the health and safety of patients and warrants serious attention from medical workers.This study analyzes the patterns and characteristics of SADR at the Army 73rd Group Military Hospital of People's Liberation Army of China,providing reference for the rational clinical use of drugs.Medical workers can reduce the occurrence of SADR by increasing their ability to identify high-risk factors and implementing necessary medication monitoring.[Methods]A retrospective analysis method was conducted on 1 315 SADR reports collected in our hospital from January 2013 to January 2022.We performed statistical analysis on the gender,age,distribution of drug administration routes causing SADR,pharmaceutical dosage forms,time distribution of SADR occurrence after medication,system-organ damages,clinical manifestations involved in SADR,SADR outcome statistics,and drug categories involved in SADR in the SADR reports.[Results]In the 1 315 cases of SADR reports,the male to female ratio was 1.16∶1.with slightly more males affected.The number of cases with SADR increased with age,with patients over 60 years old representing the highest proportion of SADR,accounting for 39.85％of cases.Among the 9 different administration routes,the top 3 causes of SADR were intravenous infusion(75.51％),oral administration(10.04％),and pump injection(5.32％).However,the cases of SADR caused by arterial administration,nasal feeding,and topical administration were rare,accounting for less than 1.00％of cases.Among the 8 different dosage forms,injection causes the most SADR,accounting for 89.05％.Solution,emulsion,suspension,patch,and powders accumulatedly account for 1.00％.SADR occurred mostly between 1 h to 2 weeks(with the highest incidence within 1 h to 1 d),while rapid reactions and reactions occurring several months later were relatively rare.The 1 315 cases of SADR affected 13 system-organ damages,with a total of 1 783 clinical manifestations.The main system-organ damages affected by SADR was the gastrointestinal system,accounting for 38.53％of cases.Vomiting and nausea were the primary clinical manifestations of the gastrointestinal system.Next was the blood system,accounting for 32.81％,with bone marrow suppression being the main clinical manifestation.Systemic damage occurred in 7.46％of cases,mainly manifesting as pain and allergic shock.The proportion of SADR caused by anti-tumor drugs was the highest in the category of drugs,accounting for 67.98％.The anti-tumor drugs that cause SADR were mainly platinum and plant-based anti-tumor drugs and their derivatives.The highest number of SADR cases by single variety were caused by cisplatin(112 cases),and docetaxel(102 cases).Among the 1 315 cases of SADR,133 cases were caused by anti-infective drugs,of which 127 cases were caused by antibiotics,accounting for 95.49％.The antibiotics that cause SADR were mainly compound preparations of β-lactams and β-lactamase inhibitors(22.05％)and quinolones(20.47％).[Conclusions]In summary,the occurrence of SADR is influenced by various factors such as the patient's age,administration route,drug dosage form,and drug type.The resultant caused by SADR is very harmful,and medical workers should closely monitor patient's medication situation during the medication process to ensure safety.Emphasis should be placed on pharmacovigilance,especially in monitoring high-risk special populations such as the elderly patients,and on high-risk drugs like anti-tumor drugs and antibiotics.In addition,we should also enhance the awareness of clinical medical personnel to report SADR actively and accurately to ensure the safety of patient medication.
serious adverse drug reactionmonitoringrational drug use
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