氨甲环酸注射液严重用药错误病例分析及防范建议  

Analysis of severe medication errors of tranexamic acid injection and prevention suggestions

作　　者：李思妍 张青霞[1] 合理用药国际网络中国中心组临床安全用药组 Li Siyan;Zhang Qingxia;Analysis of severe medication errors of tranexamic acid injection and prevention suggestions(Department of Pharmacy,Xuanwu Hospital,Capital Medical University,National Clinical Research Center for Geriatric Disease,Beijing 100053,China;不详)

机构地区：[1]首都医科大学宣武医院药学部,国家老年疾病临床医学研究中心,北京100053 [2]不详

出　　处：《药物不良反应杂志》2025年第1期17-24,共8页Adverse Drug Reactions Journal

基　　金：国家卫生健康委员会医院管理研究所研究项目(NIHAYS2326);中国药学会医院药学专业委员会科研专项(CPA-Z05-ZC-2023-002);国家重点研发计划(2020YFC2008305);中国药理学会药源性疾病学专业委员会研究项目(ADR2024MS04)。

摘　　要：目的探讨氨甲环酸注射液(TXAI)严重用药错误(ME)的风险因素,并提出防范建议。方法收集全国临床安全用药监测网(监测网)中TXAI相关ME报告;检索国内外医学文献数据库,收集TXAI相关ME的个案报道;检索中国裁判文书网和北大法宝数据库,收集医方错误的TXAI相关司法案例。所有数据的检索时间均截至2024年5月1日。对监测网中TXAI相关ME报告的ME级别、发生环节、场所和引发人员进行回顾性分析;对收集到的严重ME病例的报告年份、发生国家、临床应用情况、错误内容、发生场所、导致患者伤害的临床特征、患者结局和ME级别进行回顾性分析。结果2012年9月22日至2024年5月1日监测网共收到TXAI相关ME报告138例,报告数量呈逐年上升趋势。138例ME中79例(57.3%)发生在药品调剂与分发环节;58例(42.0%)发生在处方/医嘱开具与传递环节,错误主要涉及易混淆药物和剂量过大,其中1例(1.7%)为严重ME(E级);1例(0.7%)发生在给药环节,误将碘海醇当作TXAI注入患者关节腔。共收集到TXAI严重ME报告29例,其中24例(82.8%)为给药途径错误(与麻醉药混淆22例,注射通路混淆2例,均导致错误鞘内注射),5例(17.2%)为处方错误(剂量过大3例,血栓高危者用药和血栓高危者联合蛇毒血凝酶治疗各1例);23例(79.3%)发生在手术室,6例(20.7%)发生在病房。24例TXAI错误鞘内注射的患者主要表现为剧烈疼痛、神经毒性(癫痫持续状态)和/或心脏毒性(心律失常和心室颤动),其中11例(45.8%)死亡、2例(8.3%)后遗肢体肌肉无力。5例处方错误中4例患者发生严重血栓性疾病,其中2例死亡,2例出现脑血管相关后遗症;另有1例出现心慌、气促、恶心和呕吐。29例严重ME中,E级者2例(6.9%),F级3例(10.3%),G级4例(13.8%),H级7例(24.2%),I级13例(44.8%)。结论TXAI相关ME主要涉及易混淆药物和处方错误,严重ME发生的主要场所为手术室,主要为错误鞘内注射,导致患�Objective To explore the risk factors of severe medication errors(ME)of tranexamic acid injection(TXAI),and put forward prevention suggestions.Methods TXAI-related ME reports in the National Monitoring Network for Clinical Safe Medication(Monitoring Network)and medical literature databases at home and abroad were searched,and case reports of TXAI-related ME were collected;China Judgements Online and PKULAW database were searched,and TXAI-related judicial cases judged to be responsible by the hospital were collected.The retrieval time of all data was up to May 1,2024.The severity grade,occurrence link and place,and the trigger person of TXAI-related ME reported in the Monitoring Network were retrospectively analyzed.The year of report,country of occurrence,clinical application,error content,and occurrence place of the collected severe ME cases,and the clinical characteristics of patient injury,patient outcome and the ME grading were retrospectively analyzed.Results From September 22,2012 to May 1,2024,the Monitoring Network received a total of 138 TXAI-related ME reports,and there was an increasing trend in the number of reports year by year.Among 138 cases of ME,79(57.3%)occurred in the drug dispensing and distribution link;58(42.0%)occurred in the prescription/doctor's order prescribing and delivery link and mainly involved easily mixed drugs and drug overdose,of which 1(1.7%)was a severe ME(grade E);1(0.7%)occurred in the drug administration link,and iodohexol was mistakenly injected as TXAI into the patient's joint cavity.A total of 29 severe ME reports related to TXAI were collected.Of them,24(82.8%)were due to incorrect administration routes(22 were confused with anesthetics and 2 were confused with injection catheters,all resulting in incorrect intrathecal injections)and 5(17.2%)were due to prescription errors(3 were overdosed,1 was used for high-risk thrombosis patient,and 1 was treated with combination use of hemocoagulase for high-risk thrombosis patient);23(79.3%)occurred in the operating rooms,and 6(20

关 键 词：氨甲环酸 用药错误 高警示药品 用药安全 全国临床安全用药监测网 

分 类 号：R986[医药卫生—药品]