摘要
目的分析住院患者药源性低纤维蛋白原血症(HFIB)的临床特征及规律,为药源性HFIB防治提供参考。方法通过临床药物不良事件主动监测与智能评估警示系统-Ⅱ(ADE-ASAS-Ⅱ),回顾性调取2022—2023年某三甲医院第一医学中心住院患者信息,对系统报警病例进行人工关联性评价,分析药源性HFIB药品分布以及患者人口学信息、HFIB发生时间、严重程度等特征。结果共监测住院患者202783例次,系统报警病例2777例次,经判定阳性病例1533例次(0.76%,1533/202783)。患者男女性别比为1.36∶1;60岁及以上占比57.66%;81.93%(1256/1533)病例为轻、中度HFIB。涉及药物11类164种,以抗感染药物和血液系统药物为主,HFIB怀疑药品排名前5位分别为巴曲酶(363例,23.68%)、替加环素(260例,16.96%)、甲泼尼龙(81例,5.28%)、矛头蝮蛇血凝酶(67例,4.37%)、头孢哌酮钠舒巴坦钠(66例,4.31%)。巴曲酶与蛇毒类血凝酶HFIB中位发生时间为2 d,替加环素HFIB中位发生时间为7 d;巴曲酶致重度及以上HFIB占比54.82%(199/363),高于替加环素(8.08%,21/260)及蛇毒类血凝酶(10.61%,19/179),差异有统计学意义(P<0.01)。结论药源性HFIB相关药物品种较多,以巴曲酶、替加环素、蛇毒类血凝酶为主,不同药物HFIB发生时间和严重程度等存在差异,应根据HFIB高风险药品的发生特点对高危人群加强监测和预警防范。
Objective To analyze the clinical characteristics and patterns of drug-induced hypofibrinogenemia(HFIB)in hospitalized patients,providing references for prevention and management of HFIB.Methods Using the Adverse drug event active surveillance and assessment system-Ⅱ(ADE-ASAS-Ⅱ),data from hospitalized patients at the first medical center of a tertiary hospital between 2022 and 2023 were extracted retrospectively.System-alerted cases underwent manual causality assessment per WHO-UMC criteria.We evaluated drug profiles,demographics,time-to-onset,severity(per CTCAE v5.0),and clinical outcomes.Results Among 202783 monitored hospitalizations,2777 cases triggered system alerts,with 1533 confirmed HFIB cases(0.76%,1533/202783).The male-to-female ratio was 1.36:1,and 57.66% of patients were aged≥60 years.Mild to moderate HFIB cases accounted for 81.93%(1256/1533).HFIB involved 164 drugs across 11 classes,predominantly anti-infectives and hematologic agents.The top five suspected drugs causing hFIB were bothrops atrox(363 cases,23.68%),tigecycline(260 cases,16.96%),methylprednisolone(81 cases,5.28%),hemocoagulase bothrops atrox(67 cases,4.37%),and cefoperazone-sulbactam(66 cases,4.31%).The median time-to-onset of HFIB was 2 days for batroxobin and snake venom-derived hemocoagulases,compared to 7 days for tigecycline.Severe or life-threatening HFIB occurred in 54.82%(199/363)of batroxobin cases,significantly higher than tigecycline(8.08%,21/260)and snake venom hemocoagulases(10.61%,19/179),with a statistically significant difference(P<0.01).Conclusion Drug-induced HFIB is associated with a wide range of medications,primarily including batroxobin,tigecycline,and snake venom hemocoagulases.Significant variations exist in time-to-onset and severity across drugs.Enhanced monitoring and early warning measures should be implemented for high-risk populations based on the characteristics of HFIB-inducing drugs.
作者
蔡乐
张慕雪
文笑
高奥
郭代红
朱曼
CAI Le;ZHANG Muxue;WEN Xiao;GAO Ao;GUO Daihong;ZHU Man(Department of Pharmacy,Medical Supplies Center of Chinese PLA General Hospital,Beijing 100853,China;School of Pharmacy,Tianjin Medical University,Tianjin 300070,China)
出处
《临床药物治疗杂志》
2025年第9期64-70,共7页
Clinical Medication Journal
基金
首都卫生发展科研专项(首发2024-2-5012)
中国研究型医院学会药物评价专委会临床重点药品的使用监测和评价研究专项(Y2023FH-YWPJ03-101)。
