| 摘要: |
| 目的 挖掘与分析鱼精蛋白的不良事件（adverse?event，AE）信号。 方法 借助OpenVigil 2.1-MedDRA数据平台，收集美国 FDA 不良事件报告系统 (FDA?Adverse?Event?Reporting?System，FAERS)数据库中2004年第1季度至2024年第4季度以鱼精蛋白为首要怀疑药物的相关AE报告，采用比例失衡法中的比例报告比值（proportional?reporting?ratio，PRR）法和报告比值比（reporting?ratio?ratio，ROR）法进行数据挖掘，应用《国际医学用语词典》26.1版中药物不良反应术语集的首选术语（preferred ?terminology，PT）和首选系统器官分类（system?organ classification，SOC）对挖掘到的风险信号进行分类和总结。结果 研究共收集到273例使用鱼精蛋白的药物不良事件（adverse drug?event，ADE）报告，涉及227个PT。上报数最多的国家是美国，报告中药品的主要适应证为肝素中和疗法；通过PRR法和ROR法计算及筛选后共获得34个ADE阳性信号，其中ADE信号频数位于前3位的PT分别为低血压、速发严重过敏反应、心脏停搏，ADE信号强度（PRR法）位于前3位的PT分别为操作性低血压、肺动脉压升高、右心室功能障碍。与鱼精蛋白说明书对比，有21个ADE信号尚未被说明书收录，如心脏停搏、循环性虚脱、支气管痉挛等；涉及2个新的SOC，分别为全身性疾病及给药部位各种反应、皮肤及皮下组织类疾病。结论 基于FAERS数据库AE信号的挖掘显示，临床使用鱼精蛋白时，存在多项未被说明书收录的严重不良反应，提示需进一步密切关注和评估鱼精蛋白的安全性，以优化临床用药安全性，保障临床用药安全。 |
| 关键词: 鱼精蛋白 药品不良事件 风险信号 |
| DOI： |
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| 基金项目:宁波市医疗卫生高端团队重大攻坚项目 |
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| Mining and Analysis of Protamine Risk Signals Based on the FAERS Database |
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lishanshan1,2,3, miaocaiyun1,2,3, maopeizhi1,2,3, shenlonghui1,2,3
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1.Women and Children'2.'3.s Hospital Affiliated to Ningbo University
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| Abstract: |
| OBJECTIVE To mine and analyze the adverse event (AE) signals of protamine. METHODS AE reports related to protamine as the primary suspected drug collected from the FAERS database from Q1 2004 to Q4 2024 using the OpenVigil 2.1-MedDRA data platform. The proportional reporting ratio (PRR) method and the reporting ratio ratio (ROR) method were used for data mining. The?mined?risk?signals were?classified?and?described?using?the?preferred?terminology(PT)?and?preferred?system?organ?classification(SOC)?of?the?"Adverse Drug?Reaction?Terminology?Set"?in?the?International Dictionary of Medical Terminology(version?26.1)s. RESULTS A total of 273 adverse drug event (ADE) reports of protamine use were collected, involving 227 PTs. The country with the largest number of reports was the United States, and the main indication of the drug in the reports was heparin neutralisation therapy. After calculation and screening by the PRR method and the ROR method, a total of 34 ADE positive signals were obtained. Among them, the top three PTs in terms of the frequency of ADE signals were hypotension, anaphylactic reaction, cardiac arrest, and the top three PTs in terms of the intensity of ADE signals (by the PRR method) were procedural hypotension, pulmonary arterial pressure increased, and right ventricular dysfunction. Compared with the instructions for protamine, 21 ADE signals had not been included in the instructions, such as cardiac arrest, circulatory collapse, bronchospasm. Two new SOCs were involvedGeneral disorders and administration site conditionsand Skin and subcutaneous tissue disorders. CONCLUSION The mining of AE signals based on the FAERS database shows that when protamine is used clinically, especially for the severe adverse reactions not included in the instructions, it is necessary to pay closer attention to and evaluate the safety of protamine to optimize the safety of clinical medication and ensure the safety of clinical medication. |
| Key words: Protamine adverse drug events risk signals |