碳青霉烯类常用药物致中枢神经系统不良反应的主动监测研究  

Active monitoring study of central nervous system adverse drug reactions due to commonly used carbapenems

作　　者：肖静 李海艳 郭代红[1] 朱曼[1] 高奥 李鹏[1] 崔利强 XIAO Jing;LI Hai-yan;GUO Dai-hong;ZHU Man;GAO Ao;LI Peng;CUI Li-qiang(Department of Pharmacy,Medical Supplies Center,Chinese People’s Liberation Army General Hospital,Beijing 100853,China;College of Pharmacy,Chongqing Medical University,Chongqing 400016,China)

机构地区：[1]解放军总医院医疗保障中心药剂科,北京100853 [2]重庆医科大学药学院,重庆400016

出　　处：《中国临床药理学杂志》2024年第17期2562-2566,共5页The Chinese Journal of Clinical Pharmacology

基　　金：中国研究型医院学会专项基金资助项目(Y2023FH-YWPJ03)。

摘　　要：目的获取3种碳青霉烯类药物相关中枢神经系统药物不良反应(CNS-ADR)的发生率和临床特征,为临床安全用药提供参考。方法基于临床药物不良事件(ADE)主动监测与智能评估警示系统-Ⅱ(ADE-ASAS-Ⅱ),回顾性自动监测某三甲医院2022年1月至2022年12月用亚胺培南西司他丁钠、美罗培南和比阿培南住院患者,计算相关CNS-ADR发生率,并对阳性病例的基本情况、疾病情况、药物应用情况、ADR发生时间及临床表现进行描述性统计分析。结果本研究共纳入2482例用药患者,用药2709例次,发生CNS-ADR的阳性病例共93例次,3种药物总发生率3.43%,其中亚胺培南西司他丁钠3.98%、美罗培南3.51%、比阿培南2.78%。93例次发生CNS-ADR的阳性病例的适应证主要为肺部感染(59.13%)、腹腔感染(25.80%);发生时间多在用药后7 d内;临床表现多样,焦虑/烦躁不安最常见,严重病例中,癫痫出现最多。联用质子泵抑制药、头孢类药物的阳性病例占比较大,50.54%的阳性病例具有手术史,69.89%的阳性病例合并电解质紊乱。结论临床使用碳青霉烯类药物应根据患者实际情况制定个体化用药方案,用药期间尤应密切关注合并肾疾病、电解质紊乱,以及既往有手术史、神经系统疾病史的患者,以降低CNS-ADR的发生风险。Objective To obtain the occurrence and clinical characteristics of central nervous system adverse drug reactions(CNS-ADR)associated with three kinds of carbapenems,and to provide reference for clinical drug safety.Methods Based on adverse drug event active surveillance and assessment system-Ⅱ(ADE-ASAS-Ⅱ),retrospective automated monitoring of inpatients using imipenem,meropenem,and biapenem in a tertiary hospital from January 2022 to December 2022 was conducted.The incidence of carbapenem related CNS-ADR was calculated,and the basic conditions,disease conditions,drug use,occurrence time of ADR and symptoms of patients with CNS-ADR were analyzed by descriptive statistics.Results A total of 2482 patients with 2709 times of medication were included in this study,and a total of 93 positive cases of CNS-ADR occurred,with an overall incidence of 3.43%for all three medications,3.98%for imipenem,3.51%for meropenem,and 2.78%for biapenem.The ind ica tions for the 93 positive cases of CNS-ADR were mainly pulmonary infections(59.13%)and abdominal infections(25.80%);they occurred mostly within 7 days of the administration of the medication;with a variety of clinical manifestations,with anxiety/irritability being the most common,and epilepsy appearing most frequently in severe cases.Co-administration of proton pump inhibitors and cephalosporins accounted for a greater proportion of positive cases,50.54%of positive cases had a history of surgery,and 69.89%of positive cases were associated with electrolyte disturbances.Conclusion Clinical use of carbapenems should be based on the actual situation of the patient to develop an individualised drug regimen,and special attention should be paid to patients with comorbidities of renal disease,electrolyte disorders,and a history of previous surgery and neurological disorders,in order to reduce the risk of the occurrence of CNS-ADR.

关 键 词：碳青霉烯类药物 中枢神经系统 药物不良反应 自动监测 发生率 

分 类 号：R978.1[医药卫生—药品]