治疗中的盲点:通过全国性分析揭开药物性闭角型青光眼的神秘面纱。

IF 2.8 Q1 OPHTHALMOLOGY
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引用次数: 0

摘要

目的通过美国食品和药物管理局联邦不良事件报告系统(FAERS)识别并量化导致闭角型青光眼的药物:对象、参与者和/或对照组:2004-2022年第三季度FDA联邦不良事件报告系统(FAERS)数据库中的不良事件报告总数为11,737,133份,其中包括1,629份闭角型青光眼报告:在 FAERS 中确定了与闭角型青光眼报告相关的药物。为了确定这些报告是否产生了具有统计学意义的信号,我们使用了比例报告率 (PRR)、报告几率比例 (ROR)、经验贝叶斯几何平均数 (EBGM) 和信息成分 (IC) 作为比例失调分析的一部分。当四项比例失调分析指标均为正值时,我们认为检测到了信号:在 20 年间(2004-2023Q3),我们共发现了 1,629 份与 611 种可疑药物相关的不良事件报告。经常报告的药物包括托吡酯(520 份报告)和西酞普兰(69 份报告)等。有 18 种药物出现了阳性信号,其中包括奥氮平、芬特明和雷尼珠单抗等鲜为人知的药物。托吡卡胺具有最显著的统计学意义(n=18;PRR:164.263;ROR (95%CI):167.95 (104.994-268.655);EBGM (EBGM05):162.421 (109.994-268.655)):162.421 (109.5);IC (IC05):7.344(4.591)),而乙酰唑胺是第二强的(n=51;PRR:113.088;ROR 95% CI:114.782(86.665-152.021);EBGM(EBGM05):109.506 (86.501);IC (IC05):6.775(5.115)):药物诱发的青光眼既包括托吡酯等知名药物,也包括奥氮平、芬特明和雷尼珠单抗等鲜为人知的药物。临床医生对这些发现的认识非常重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Blind Spots in Therapy

Objective

To identify and quantify medications causing angle-closure glaucoma through the FDA Adverse Event Reporting System (FAERS).

Design

National retrospective database analysis.

Subjects

There were 11 737 133 total adverse event reports from the FDA Federal Adverse Event Reporting System (FAERS) database 2004 to third quarter of 2023 (2023Q3), which included 1629 reports of angle-closure glaucoma.

Methods

Drugs associated with reports of angle-closure glaucoma were identified in FAERS through disproportionality analysis

Main Outcome Measures

To ascertain if these reports yielded statistically significant signals, we used the proportional reporting ratio (PRR), reporting odds ratio (ROR), empirical Bayes geometric mean (EBGM), and information component (IC). We considered a signal to be detected when all 4 disproportionality analysis metrics were positive.

Results

We identified a total of 1629 adverse event reports linked to 611 suspected drugs over the course of 20 years (2004–2023Q3). Frequently reported drugs included topiramate (520 reports) and citalopram (69 reports), amongst many others. Eighteen medications yielded a positive signal, including lesser-known medications like olanzapine, phentermine, and ranibizumab. Tropicamide exhibited the most robust statistical significance (n = 18; PRR: 164.263; ROR [95% confidence interval {CI}]: 167.95 [104.994–268.655]; EBGM [EBGM05]: 162.421 [109.5]; IC [IC05]: 7.344 [4.591]), while acetazolamide was the second strongest (n = 51; PRR: 113.088; ROR 95% CI: 114.782 [86.665–152.021]; EBGM [EBGM05]: 109.506 [86.501]; IC [IC05]: 6.775 [5.115]).

Conclusions

Drug-induced glaucoma included both well-known medications such as topiramate as well as lesser-known medications such as olanzapine, phentermine, and ranibizumab. Clinician awareness of these findings is important.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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来源期刊
Ophthalmology. Glaucoma
Ophthalmology. Glaucoma OPHTHALMOLOGY-
CiteScore
4.80
自引率
6.90%
发文量
140
审稿时长
46 days
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