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非布司他心脏不良反应信号的数据挖掘和分析
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| 篇名： | 非布司他心脏不良反应信号的数据挖掘和分析 |
| TITLE： | Data mining and analysis of febuxostat-induced cardiac ADR signals |
| 摘要： | 目的 挖掘和分析非布司他上市后心脏不良反应信号，为临床合理用药提供参考。方法采用报告比值比法检测2009年第1季度至2020年第4季度美国食品和药物管理局不良事件报告系统中非布司他的不良反应信号，统计并分析心脏病症信号的相关信息。结果从8282份以非布司他为首要怀疑药品的不良事件报告中共检测出不良反应信号209个，其中心脏病症信号27个，涉及不良事件报告754份。症状类信号上报数（262份）最多，包括头晕、外周水肿、胸痛、心悸、重力性水肿等；随后依次为冠状动脉粥样硬化性心脏病信号、心力衰竭信号、心律失常信号、心脏性猝死信号（报告数分别为233、157、90、12份）。其中一半以上的信号在药品说明书中有所提及，而未被提及的信号主要为各种心力衰竭、心律失常、期前收缩等。应用非布司他发生心脏不良事件的患者中，男性多于女性，年龄集中在60岁及以上，用药剂量多为药品说明书推荐剂量（即40mg/d或80mg/d），相关不良事件多发生在用药1个月内。结论临床需在使用非布司他的过程中常规关注其心脏安全性，且后期仍需进一步评价和验证该药的心脏不良反应信号。 |
| ABSTRACT： | OBJE CTIVE To mine and analyze t he cardiac adverse drug reaction （ADR）signals induced by febuxostat in post-marketing experience ，and to provide reference for rational drug use in clinic. METHODS Reporting odds ratio （ROR） method was used to mine the ADR signals induced by febuxostat from the FDA Adverse Event Reporting System during the first quarter of 2009 to the fourth quarter of 2020；the information of cardiac disease signals was counted and analyzed. RESULTS A total of 209 ADR signals were detected in 8 282 adverse drug event （ADE）reports with febuxostat as the primary suspected drug ， involving 27 cardiac signals and 754 ADE reports. The most reported signals were symptoms （262 reports），including dizziness ， oedema peripheral，chest pain ，palpitations and gravitational oedema and so on ，followed by coronary atherosclerotic heart disease signal，heart failure signal ，arrhythmia signal ，sudden cardiac death signal （233，157，90，12 reports，respectively）. More than half of the signals were mentioned in the drug instructions ，while the unmentioned signals were mainly kinds of cardiac failure ， arrhythmia and extrasystoles ，etc. The patients with cardiac ADEs who received febuxostat were more male than female ，and the age was 60 and over ；the drug dosage was mostly 40 mg/d or 80 mg/d as recommended in the drug instructions ，and cardiac ADEs mostly occurred within 1 month of medication. CONCLUSIONS Routine attention should be paid to the cardiac safety of febuxostat during medication ，further evaluation and validation of febuxostat-induced cardiac ADR signals are still needed. |
| 期刊： | 2022年第33卷第02期 |
| 作者： | 钟燕，姜怡雯，蒋娅莉，刘文艺，郭睿 |
| AUTHORS： | ZHONG Yan，JIANG Yiwen，JIANG Yali，LIU Wen yi，GUO Rui |
| 关键字： | 非布司他；心脏不良事件；不良反应信号；数据挖掘 |
| KEYWORDS： | febuxostat；cardiac adverse event；ADR signal ；data mining |
| 阅读数： | 368 次 |
| 本月下载数： | 17 次 |
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