与 PARP 抑制剂相关的造血不良事件：FAERS 数据库研究。

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2024-12-24 DOI:10.1080/14740338.2024.2443781

Qindai Shuai, Xuefei Bai, Gen Li, Li Wang, Jia Chen, Li Chen

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引用次数: 0

摘要

目的：利用美国食品和药物管理局不良事件报告系统（FAERS）数据库的数据，识别和分析与奥拉帕尼、尼拉帕尼、鲁卡帕尼和塔拉唑帕尼-聚（adp -核糖）聚合酶（PARP）抑制剂相关的造血药物不良反应（ADR）信号，为临床合理使用提供指导。方法：从FAERS数据库中提取2019年第一季度至2024年第二季度目标药物相关ASCII数据。MedDRA不良反应词汇表中的标准化MedDRA查询（SMQ）和首选术语（PT）用于国际术语标准化和本地化。采用报告优势比（ROR）、比例报告比（PRR）和综合MHRA方法筛选ADR信号。比较4种药物的SMQ数据组成比。结果：研究发现，4种PARP抑制剂的造血不良反应在治疗后30天内集中出现，并有一定的潜伏期，提示需要对造血细胞进行短期和长期监测。最常见的造血系统不良事件包括细胞减少和白细胞减少。尼拉帕尼的不良事件数量最多，信号强度最强。奥拉帕尼和塔拉唑帕尼都表现出强烈的血液毒性信号，需要仔细考虑它们的安全性。结论：4种PARP抑制剂在不良反应发生次数、发生率、持续时间等方面存在显著差异。临床医生应根据患者的具体情况制定治疗方案，以提高PARP抑制剂使用的合理性和安全性。

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Hematopoietic adverse events associated with PARP inhibitors: A FAERS database study.

Objectives: Analyze hematopoietic ADR signals of PARP inhibitors (Olaparib, Niraparib, Rucaparib, Talazoparib) using FAERS data to inform clinical practice.

Methods: Extracted ASCII data for these drugs from Q1 2019 to Q2 2024. Employed SMQ and PT for standardization. Screened ADR signals via ROR, PRR, and MHRA method, comparing SMQ ratios.

Results: Hematopoietic ADRs peaked within 30 days post-treatment, with cytopenia and leukopenia most prevalent. Niraparib showed the highest adverse event count and signal intensity. Olaparib and Talazoparib also indicated strong hematotoxicity.

Conclusion: PARP inhibitors vary in ADR incidence and duration, necessitating personalized treatment plans for optimized safety and rational use.

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来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.