Hasik P N, Thomas Christy, Hazarika Munlima, Undela Krishna
Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research (NIPER) Guwahati, Kamrup, India.
Department of Medical Oncology, Dr. Bhubaneswar Borooah Cancer Institute, Guwahati, India.
Expert Opin Drug Saf. 2024 Aug 19:1-14. doi: 10.1080/14740338.2024.2392860.
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.
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.
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; χ = 4527.1; lower bound (LB) ROR = 140.7; IC = 5.1] and orbital hemorrhage [PRR = 120.0; χ = 300.5; LB ROR = 35.1; IC = 1.3] were the strong signals identified for carboplatin. Optic disc hyperemia [PRR = 208.2; χ = 742.5; LB ROR = 74.1; IC = 2.2] and blindness cortical [PRR = 23.7; χ = 382.5; LB ROR = 14.8; IC = 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.
The study revealed a potential risk of OAEs when using platinum-based chemotherapy drugs as an anticancer medication.
抗癌药物，尤其是铂类化疗药物，在接受化疗的患者中一直表现出眼部不良事件（OAE），这令人担忧，因为它可能会影响患者的生活质量以及继续进行有效癌症治疗的能力。
使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库中关于铂类药物引起的OAE的自发报告进行回顾性病例/非病例研究。通过计算比例报告比（PRR）、报告比值比（ROR）和信息成分（IC）进行不成比例分析，以确定铂类化疗药物的OAE信号。同时，通过在PubMed和谷歌学术上进行系统的文献检索，对铂类药物引起的OAE的病例报告进行综述。
通过不成比例分析，确定了69个铂类化疗药物与OAE的信号（卡铂：42个，奥沙利铂：16个，顺铂：11个）。脉络膜梗死[PRR = 215.1；χ = 4527.1；下限（LB）ROR = 140.7；IC = 5.1]和眼眶出血[PRR = 120.0；χ = 300.5；LB ROR = 35.1；IC = 1.3]是卡铂确定的强信号。视盘充血[PRR = 208.2；χ = 742.5；LB ROR = 74.1；IC = 2.2]和皮质盲[PRR = 23.7；χ = 382.5；LB ROR = 14.8；IC = 3.1]分别是奥沙利铂和顺铂确定的信号。通过在PubMed和谷歌学术上的系统检索，共确定了32例铂类化疗药物引起的OAE病例报告，加强了这种关联。
该研究揭示了使用铂类化疗药物作为抗癌药物时存在OAE的潜在风险。
