药物性心脏骤停：2004-2024年基于FAERS数据库的药物警戒研究

IF 2.8 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Frontiers in Cardiovascular Medicine Pub Date : 2025-05-01 eCollection Date: 2025-01-01 DOI:10.3389/fcvm.2025.1498700

Gaocan Ren, Pingping Huang, Jinhui Zhang, Jin Liu, Zian Yan, Xiaochang Ma

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引用次数: 0

摘要

目的：利用FDA不良事件报告系统（FAERS）数据库，对心脏骤停（CA）相关药物进行信号检测，优化临床决策，保障用药安全。方法：从FAERS数据库中提取2004年第一季度至2024年第二季度与CA相关的不良事件报告。采用报告优势比（ROR）和比例报告比（PRR）进行信号检测，识别与ca风险增加相关的药物。结果：共分析66,431份报告，其中男性34,508例（51.9%），女性31,923例（48.1%）。大多数病例（71.8%）由卫生保健专业人员报告，以成人（≥18岁）为主要群体。临床结果显示，67.2%的病例导致死亡。在82种有超过100例ca相关报告的药物中，43种显示出阳性信号。经ROR鉴定出的前5位药物分别为：卡异普罗多尔[ROR (95% CI): 34.13(29.62 ~ 39.32)]、糖胺酮[ROR (95% CI): 26.93(22.56 ~ 32.16)]、瑞腺苷松[ROR (95% CI): 20.00(17.69 ~ 22.60)]、阿普唑仑[ROR (95% CI): 12.82(12.19 ~ 13.48)]、异丙酚[ROR (95% CI): 11.93(10.61 ~ 13.41)]。在系统药物信号检测中，肌肉骨骼系统药物排名最高[ROR (95% CI): 30.99(27.74 ~ 34.62)]，其次是消化道和代谢药物[ROR (95% CI): 4.75(4.59 ~ 4.92)]、神经系统药物[ROR (95% CI): 4.51(4.4 ~ 4.61)]、抗感染药物[ROR (95% CI): 4.13(3.74 ~ 4.57)]、心血管药物[ROR (95% CI): 3.89(3.78 ~ 4.01)]、抗肿瘤和免疫调节剂[ROR (95% CI): 2.16(2.13 ~ 2.2)]。结论：根据FAERS数据，本研究确定了40多种可能与CA风险升高相关的药物。医疗保健专业人员在开这些药物时应特别警惕，特别是对有心脏病史的患者，并确保严格监测他们的心脏健康。

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Drug-induced cardiac arrest: a pharmacovigilance study from 2004-2024 based on FAERS database.

Objective: Utilizing the FDA Adverse Event Reporting System (FAERS) database, this study conducts signal detection for drugs associated with cardiac arrest (CA), aiming to optimize clinical decision-making and ensure safer drug usage.

Methods: Adverse event reports related to CA from the first quarter of 2004 to the second quarter of 2024 were extracted from the FAERS database. Signal detection was conducted using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) to identify drugs associated with an increased risk of CA.

Results: A total of 66,431 reports were analyzed, comprising 34,508 males (51.9%) and 31,923 females (48.1%). The majority of cases (71.8%) were reported by healthcare professionals, with adults (≥18 years old) representing the predominant group. Clinical outcomes showed that 67.2% of cases resulted in death. Out of 82 drugs with over 100 CA-related reports, 43 displayed positive signals. The top five drugs identified by ROR were: carisoprodol [ROR (95% CI): 34.13 (29.62-39.32)], sugammadex [ROR (95% CI): 26.93 (22.56-32.16)], regadenoson [ROR (95% CI): 20.00 (17.69-22.60)], alprazolam [ROR (95% CI): 12.82 (12.19-13.48)], and propofol [ROR (95% CI): 11.93 (10.61-13.41)]. In the system drug signal detection, musculo-skeletal system drugs ranked highest [ROR (95% CI): 30.99 (27.74-34.62)], followed by alimentary tract and metabolism drugs [ROR (95% CI): 4.75 (4.59-4.92)], nervous system drugs [ROR (95% CI): 4.51 (4.4-4.61)], anti-infective drugs [ROR (95% CI): 4.13 (3.74-4.57)], cardiovascular drugs [ROR (95% CI): 3.89 (3.78-4.01)], and antineoplastic and immunomodulating agents [ROR (95% CI): 2.16 (2.13-2.2)].

Conclusion: This study identifies over 40 drugs potentially associated with an elevated risk of CA based on FAERS data. Healthcare professionals should be particularly vigilant when prescribing these drugs, especially to patients with a history of heart disease, and ensure rigorous monitoring of their cardiac health.

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来源期刊

Frontiers in Cardiovascular Medicine Medicine-Cardiology and Cardiovascular Medicine

CiteScore

3.80

自引率

11.10%

发文量

3529

审稿时长

14 weeks

期刊介绍： Frontiers? Which frontiers? Where exactly are the frontiers of cardiovascular medicine? And who should be defining these frontiers? At Frontiers in Cardiovascular Medicine we believe it is worth being curious to foresee and explore beyond the current frontiers. In other words, we would like, through the articles published by our community journal Frontiers in Cardiovascular Medicine, to anticipate the future of cardiovascular medicine, and thus better prevent cardiovascular disorders and improve therapeutic options and outcomes of our patients.