Fraunfelder Frederick W, Fraunfelder Frederick T, Jensvold Bree
Casey Eye Institute, Oregon Health Sciences University, Portland, Oregon, USA.
Am J Ophthalmol. 2003 Feb;135(2):219-22. doi: 10.1016/s0002-9394(02)01840-8.
To evaluate reported cases of scleritis and other ocular side effects associated with pamidronate disodium, with emphasis on previously unreported cases of scleritis.
Observational case series.
Case reports from the National Registry of Drug-Induced Ocular Side Effects (Casey Eye Institute), the Food and Drug Administration, the World Health Organization, and the literature were reviewed to determine possible adverse ocular side effects associated with pamidronate disodium. The World Health Organization's Causality Assessment Guide was used to categorize an adverse drug reaction.
Seventeen cases of unilateral scleritis and one case of bilateral scleritis occurred, usually within 6 hours to 2 days after intravenous pamidronate disodium. Six patients had positive rechallenge testing with the scleritis occurring after a repeat drug exposure. Other ocular side effects with positive rechallenge data, associated with pamidronate disodium, include blurred vision, nonspecific conjunctivitis, ocular pain, bilateral anterior uveitis, and episcleritis.
This is the first report, with rechallenge data, of any drug causing scleritis. Pamidronate disodium can cause vision-threatening diseases, which may require discontinuing the drug in some uveitis cases and, in this series, all cases of scleritis.
评估已报告的与帕米膦酸二钠相关的巩膜炎及其他眼部副作用病例,重点关注此前未报告的巩膜炎病例。
观察性病例系列。
对来自药物性眼部副作用国家登记处(凯西眼科研究所)、美国食品药品监督管理局、世界卫生组织的病例报告以及相关文献进行回顾,以确定与帕米膦酸二钠相关的可能的不良眼部副作用。使用世界卫生组织的因果关系评估指南对药物不良反应进行分类。
发生了17例单眼巩膜炎和1例双眼巩膜炎,通常在静脉注射帕米膦酸二钠后6小时至2天内出现。6例患者再次用药试验呈阳性,巩膜炎在再次接触药物后发生。其他有再次用药阳性数据的与帕米膦酸二钠相关的眼部副作用包括视力模糊、非特异性结膜炎、眼痛、双侧前葡萄膜炎和表层巩膜炎。
这是第一份有再次用药数据的关于任何药物导致巩膜炎的报告。帕米膦酸二钠可引起威胁视力的疾病,在某些葡萄膜炎病例以及本系列所有巩膜炎病例中可能需要停药。