与普拉廷斯相关的眼部不良事件:药物警戒数据的比例失调分析和病例报告的广泛系统回顾。

IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-08-19 DOI:10.1080/14740338.2024.2392860
P N Hasik, Christy Thomas, Munlima Hazarika, Krishna Undela
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引用次数: 0

摘要

背景:抗癌药物,尤其是铂类化疗药物,在接受化疗的患者中出现了眼部不良事件(OAEs),这令人担忧,因为这可能会影响患者的生活质量和继续进行有效癌症治疗的能力:利用美国食品药物管理局不良事件报告系统(FAERS)数据库中关于普拉提类药物 OAEs 的自发报告,进行了一项回顾性病例/非病例研究。通过计算比例报告比(PRR)、报告几率比(ROR)和信息成分(IC)进行了比例失调分析,以确定铂类化疗药物的 OAE 信号。同时,通过在 PubMed 和谷歌学术网上进行系统的文献检索,对铂类药物引起的 OAE 病例报告进行了综述:结果:通过比例失调分析,共发现 69 个铂类化疗药物和 OAEs 信号(卡铂:42 个;奥沙利铂:16 个;顺铂:11 个)。脉络膜梗塞[PRR = 215.1;χ2 = 4527.1;下限(LB)ROR = 140.7;IC025 = 5.1]和眼眶出血[PRR = 120.0;χ2 = 300.5;LB ROR = 35.1;IC025 = 1.3]是卡铂的强信号。视盘充血[PRR = 208.2; χ2 = 742.5; LB ROR = 74.1; IC025 = 2.2]和皮质失明[PRR = 23.7; χ2 = 382.5; LB ROR = 14.8; IC025 = 3.1]分别是奥沙利铂和顺铂的信号。通过在PubMed和谷歌学术上进行系统搜索,共发现了32例铂类化疗药物引起的OAEs病例报告,从而加强了这一关联:该研究揭示了使用铂类化疗药物作为抗癌药物时出现 OAEs 的潜在风险。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Ocular adverse events associated with platins: a disproportionality analysis of pharmacovigilance data and extensive systematic review of case reports.

Background: Anti-cancer drugs, particularly platinum-based chemotherapy drugs, have been showing ocular adverse events (OAEs) in patients undergoing chemotherapy, which is concerning due to the potential impact on patient's quality of life and the ability to continue effective cancer treatment.

Research design and methods: A retrospective case/non-case study was conducted using spontaneous reports on OAEs by platins from the FDA Adverse Event Reporting System (FAERS) database. A disproportionality analysis was performed by calculating the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and the Information Component (IC) to identify OAE signals for platinum-based chemotherapy drugs. In parallel, a review of case reports for OAEs from platins was conducted by a systematic literature search in PubMed and Google Scholar.

Results: Using disproportionality analysis, 69 signals were identified for platinum-based chemotherapy drugs and OAEs (carboplatin: 42, oxaliplatin: 16, cisplatin: 11). Choroidal infarction [PRR = 215.1; χ2 = 4527.1; lower bound (LB) ROR = 140.7; IC025 = 5.1] and orbital hemorrhage [PRR = 120.0; χ2 = 300.5; LB ROR = 35.1; IC025 = 1.3] were the strong signals identified for carboplatin. Optic disc hyperemia [PRR = 208.2; χ2 = 742.5; LB ROR = 74.1; IC025 = 2.2] and blindness cortical [PRR = 23.7; χ2 = 382.5; LB ROR = 14.8; IC025 = 3.1] were the signals identified for oxaliplatin and cisplatin, respectively. A total of 32 case reports of OAEs from platinum-based chemotherapy drugs were identified through a systematic search in PubMed and Google Scholar, strengthening the association.

Conclusion: The study revealed a potential risk of OAEs when using platinum-based chemotherapy drugs as an anticancer medication.

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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
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.
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