摘要
收集2017年1月1日~2019年12月31日全院所发生的抗菌药物引起的不良反应,并进行统计分析,进一步了解ADR(Adverse drug reaction)的发生状况,以便为患者临床安全用药提供参考。采用回顾性研究的方法,分别对全院395份抗菌药物ADR报告中患者年龄及性别、ADR发生时间、给药途径、引起ADR的抗菌药物种类、ADR累及器官/系统及临床表现、ADR分布类型及转归、严重ADR及引起的抗菌药物、上报来源评价等因素进行统计分析。全院1185例怀疑药品ADR中,抗菌药物引起的共395例,占所有ADR报告的33.33%。其中男性219例(55.44%),女性176例(44.56%)。ADR多发生于用药第1 d,最长可达用药11 d后发生。在395例报告中涉及的给药途径为4种,分别为静脉滴注381例(96.45%)、静脉注射3例(0.76%)、口服给药6例(1.52%)和外用3例(1.27%)。引发ADR的抗菌药物种类涉及10个大类,分别为青霉素类(31.64%)、头孢菌素类(39.49%)、喹诺酮类(14.94%)、大环内酯类(2.53%)、氨基糖苷类(2.03%)、林可霉素类(1.52%)、糖肽类(1.27%)、碳青霉烯类(1.01%)、抗真菌药类(2.03%)、其它(3.54%)。ADR报告中主要累及器官或系统为皮肤及其附件(71.56%)、消化系统(8.63%)。严重的不良反应有24例,其中8例为新的严重的ADR。从转归来看,在停药及对症治疗后,痊愈的有380例(96.20%),好转的有15例(3.80%)。根据ADR因果关系标准进行判断,"肯定"11例,"很可能"351例,"可能"30例;"可能无关"3例。ADR上报来源护理人员178例(占45.06%),临床医生上报121例(占30.63%),临床药师上报96例(占24.31%)。临床医师在治疗患者过程中应严格遵循2015版《抗菌药物临床应用指导原则》要求,严格掌握抗菌药物的使用指征。明确有感染时,应严格按照诊疗规范及指南,合理选用抗菌药物,控制抗菌药物的使用剂量(如老年患者、肾功能不全者等)、疗程(如哌拉西林他唑巴坦、头孢唑肟钠等),避免超适应症和超剂量用药、不必要的联合用药等,同时应充分重视ADR的发生,临床医师、护士与临床药师紧密合作保证患者应用抗菌药物安全、有效。
To collect and analyze the adverse drug reactions caused by antibacterial drugs in the whole hospital from January 1,2017 to December 31,2019,and to conduct statistical analysis to further understand the occurrence of ADR,so as to provide reference for clinical safe drug use.Using the method of retrospective study,395 ADR reports of antimicrobial agents in the author’s hospital were analyzed,including the age and gender of patients,the time of occurrence of ADR,the route of administration,the types of antibiotics causing ADR,the organs/systems involved in ADR,clinical manifestations,distribution types and outcomes,serious ADR and antibiotics,and the evaluation of reported sources.In 1185 cases,395 cases were caused by antibiotics,accounting for 33.33%of all ADR reports.Among 395 ADR cases,219 cases(55.44%)were male and 176 cases(44.56%)were female.ADR usually occurred within 1 day after treatment,and the longest one occurred after 11 days.In 395 cases,there were 4 routes of administration,381 cases(96.45%)were intravenous drip,3 cases(0.76%)were intravenous injection,6 cases(1.52%)were oral administration and 3 cases(1.27%)were external use.There were 10 kinds of antibiotics causing ADR,including penicillins(31.64%),cephalosporins(39.49%),quinolones(14.94%),macrolides(2.53%),aminoglycosides(2.03%),lincomycin(1.52%),glycopeptides(1.27%),carbapenems(1.01%),antifungal drugs(2.03%)and others(3.54%).The main organs or systems involved in ADR were skin and its appendages(71.56%),digestive system(8.63%).There were 24 cases of severe adverse reactions,including 8 cases of new severe ADR.From the point of return,380 cases(96.20%)were cured and 15 cases(3.80%)were improved after drug withdrawal and symptomatic treatment.According to the standard of ADR causality,11 cases were positive,351 cases were likely,30 cases were possible,3 cases were not related,178 cases(45.06%)were reported by nursing staff,121 cases(30.63%)were reported by clinicians and 96 cases(24.31%)were reported by clinical pharmacists.Clinicians should strictly follow the 2015 edition of"guiding principles for clinical application of antibiotics"in the treatment of patients,and strictly grasp the indications for the use of antibiotics.In case of infection,doctors should strictly follow the diagnosis and treatment norms and guidelines,reasonably choose antibiotics,control the dosage of antibiotics(such as elderly patients,renal insufficiency,etc.),course of treatment(such as piperacillin tazobactam,ceftizoxime sodium,etc.),avoid over indication and over dose medication,unnecessary combination medication,etc,and pay full attention to the occurrence of ADR nurses and clinical pharmacists work closely to ensure the safe and effective use of antibiotics.
作者
陈伟
李贤文
任俊
CHEN Wei;LI Xian-wen;REN Jun(Dept.of Pharmacy,Subei Peopled Hospital of Jiangsu Province,Yangzhou 225001,China)
出处
《药物生物技术》
2021年第3期266-271,共6页
Pharmaceutical Biotechnology
基金
江苏省药学会临床药学科研项目(No.A201617)。
关键词
药物不良反应
抗菌药物
临床合理用药
临床药师
哌拉西林他唑巴坦
五水头孢唑林
Adverse drug reaction
Antibacterial drugs
Clinically reasonable drugs
Clinical pharmacist
Piperacillin/sulbactam
Cefazolin sodium pentahydrate
作者简介
陈伟(1981-),男,江苏扬州人,副主任中药师,研究方向:合理用药,Tel:18051060217,E-mail:12429694@qq.com;通信作者:任俊(1982-),女,江苏扬州人,主管药师,带教临床药师,研究方向:抗感染药物,Tel:18051060216,E-mail:renjuncpu@sina.com。
