Liu Chengzhi, Wang Xinyu, Cao Xusheng
Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Lab, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Front Pharmacol. 2024 Dec 11;15:1502047. doi: 10.3389/fphar.2024.1502047. eCollection 2024.
Corticosteroids are extensively used in ophthalmology, particularly for treating various inflammatory conditions. Despite their effectiveness, prolonged or high-dose corticosteroid use is associated with significant adverse drug reactions (ADRs), such as increased intraocular pressure, cataract formation, and secondary infections. However, there is currently no systematic study comparing the side effects of ophthalmic corticosteroids. This study aims to investigate the safety profiles of ophthalmic corticosteroids through pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) database.
We conducted a retrospective analysis of ADR reports related to commonly used ophthalmic corticosteroids from the FAERS database, covering the period from Q1 2004 to Q4 2023. Clinical features such as gender, age, administration route, and dosage form were also analyzed. Signal detection methods, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and the Multi-Item Gamma Poisson Shrinker (MGPS), were used to identify potential safety signals.
A total of 9,854 ADRs related to ophthalmic corticosteroids were retrieved, with the most frequently reported drugs being Ozurdex (1,784 cases), Lotemax (3,239 cases), and Durezol (2,789 cases). Women accounted for a higher proportion of ADRs across most corticosteroids. ADR induction time analysis results showed that ADRs tend to occur in the early stages of drug use. The most common ophthalmic ADRs identified included eye inflammation, cataract, visual impairment, uveitis, eye pain, blurred vision, and retinal detachment. Additionally, Maxidex has been linked to endocrine disorders, while Ozurdex, Iluvien, and Triesence exhibited significant signals for product issues, likely related to their intraocular injection procedures. Notably, cataract was the most common PT among these drugs.
Our study reveals significant safety concerns related to using ophthalmic corticosteroids, particularly regarding adverse reactions that can impact visual function. These findings highlight the need for careful monitoring and individualized treatment plans to minimize the risk of ADRs in patients receiving corticosteroid therapy. Future studies combining FAERS data with large-scale clinical research are needed to explore these safety concerns further.
皮质类固醇在眼科中广泛应用，尤其用于治疗各种炎症性疾病。尽管其疗效显著，但长期或高剂量使用皮质类固醇会引发严重的药物不良反应（ADR），如眼压升高、白内障形成和继发感染。然而，目前尚无比较眼科皮质类固醇副作用的系统性研究。本研究旨在通过使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库进行药物警戒分析，来调查眼科皮质类固醇的安全性概况。
我们对FAERS数据库中2004年第一季度至2023年第四季度期间与常用眼科皮质类固醇相关的ADR报告进行了回顾性分析。还分析了性别、年龄、给药途径和剂型等临床特征。使用信号检测方法，包括报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS），来识别潜在的安全信号。
共检索到9854例与眼科皮质类固醇相关的ADR，报告最多的药物是Ozurdex（1784例）、Lotemax（3239例）和Durezol（2789例）。在大多数皮质类固醇药物的ADR中，女性占比更高。ADR诱导时间分析结果表明，ADR往往在用药早期出现。确定的最常见眼科ADR包括眼部炎症、白内障、视力损害、葡萄膜炎、眼痛、视力模糊和视网膜脱离。此外，Maxidex与内分泌紊乱有关，而Ozurdex、Iluvien和Triesence在产品问题方面显示出显著信号，可能与其眼内注射程序有关。值得注意的是，白内障是这些药物中最常见的不良反应首选术语。
我们的研究揭示了使用眼科皮质类固醇存在的重大安全问题，特别是那些可能影响视觉功能的不良反应。这些发现凸显了仔细监测和制定个性化治疗方案的必要性，以尽量降低接受皮质类固醇治疗患者发生ADR的风险。未来需要将FAERS数据与大规模临床研究相结合的研究，以进一步探讨这些安全问题。
