药源性低纤维蛋白原血症自发报告分析及数据挖掘  

Analysis and data mining of spontaneous reports of drug-induced hypofibrinogenemia

作　　者：高奥 蔡乐[1] 朱曼[1] 伏安 文笑 GAO Ao;CAI Le;ZHU Man;FU An;WEN Xiao(Department of pharmacy,Medical Supplies Center of Chinese PLA General Hospital,Beijing 100853,China;Adverse Drug Reaction Monitoring Center of Chinese PLA,Beijing 100853,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]解放军药品不良反应监测中心,北京100853

出　　处：《临床药物治疗杂志》2024年第12期22-27,共6页Clinical Medication Journal

基　　金：首都卫生发展科研专项(首发2024-2-5012);临床重点药品的使用监测和评价研究专项(Y2023FH-YWPJ03-101)。

摘　　要：目的分析自发报告中药源性低纤维蛋白原血症(HFIB)的发生规律及分布特点,挖掘药品风险信号,为药源性HFIB的防治提供依据。方法回顾性研究药品不良反应(ADR)监测中心数据库2014年1月至2023年12月ADR报告中药源性HFIB的相关报告,分析报告的基本情况、发生时间及持续时间、涉及药品分布、治疗与转归等,结合报告比值比法、比例报告比法、英国药品和保健产品管理局综合标准法、贝叶斯置信度递进神经网络法4种数据挖掘技术挖掘药品风险信号。结果获得的258495例报告中涉及药源性HFIB相关报告259例,新的ADR和严重的ADR报告145例(55.98%);男159例,女100例,中位年龄为55(35,71)岁,≥60岁患者44.02%。40.54%(105/259)的药源性HFIB发生在首次使用怀疑药品后1~3 d,持续1~3 d的比例为41.70%(108/259),87.26%(226/259)的患者好转或痊愈。怀疑药品ADR报告例数排名前5位的为替加环素(55例)、巴曲酶(54例)、门冬酰胺酶(22例)、培门冬酶(21例)和白眉蛇毒血凝酶(17例);通过4种数据挖掘方法发现11种药品具有风险信号。结论药源性HFIB中新的ADR和严重的ADR占比较高,涉及多种药品,相关研究有限,有必要加强对药源性HFIB风险信号药品的监测和研究。Objective To analyze the occurrence regularity and distribution characteristics of drug-induced hypofibrinogenemia(HFIB)in spontaneous reports and identify key risk signal drugs,so as to provide data support for the prevention and treatment of drug-induced HFIB.Methods The related reports of drug-induced HFIB in the adverse drug reaction(ADR)monitoring center database from January 2014 to December 2023 were retrospectively studied,and the basic situation,occurrence and duration of ADR reports,drug distribution,treatment and outcome of ADR reports were analyzed.Four data mining techniques,reporting odds ratio(ROR)method,proportional reporting ratio(PRR)method,UK Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive standard method and Bayesian confidence propagation neural network(BCPNN)method,were combined to mine the risk signals of key drugs.Results 259 reports of drug-induced HFIB were reported in 258495 reports.New ADR reports and serious ADR reports accounted for 145 cases(55.98%).Male reports were 159 and female reports were 100.The median age was 55.00(35.00,71.00)years old,and 44.01%of the patients were over 60 years old.40.54%(105/259)of the drug-induced HFIB occurred within 1 to 3 days after the first dose,and 41.70%(108259)of the duration concentrated within 1 to 3 days.87.26%(226/259)of the patients were improved or cured.The top 5 frequently reported drugs were tigecycline(55 cases),batroxobin(54 cases),asparaginase(22 cases),pegaspargase(21 cases),and hemocoagulase(17 cases).11 drugs were found to have risk signals through 4 kinds of data mining methods.Conclusion Drug-induced HFIB involves a relatively high proportion of new ADR and serious ADR reports,involving a variety of drugs,and related studies are limited.It is necessary to strengthen the monitoring and research of key risk signal drugs for drug-induced HFIB.

关 键 词：药源性低纤维蛋白原血症 自发报告 药品不良反应 数据挖掘 

分 类 号：R973[医药卫生—药品] R595.3[医药卫生—药学]