Department of Ophthalmology, New Zealand National Eye Centre, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
Ophthalmology. 2013 Apr;120(4):773-6. doi: 10.1016/j.ophtha.2012.10.028. Epub 2013 Jan 3.
To investigate the incidence of significant adverse ocular side effects after intravenous zoledronate infusion for osteopenia.
Data analysis of a large, prospective, randomized, double-blind, placebo-controlled clinical trial.
Postmenopausal women (n = 2001) with osteopenia randomized to placebo or zoledronate infusion.
Intravenous infusion of zoledronate 5 mg or placebo.
Adverse ocular events.
Eight participants (mean age, 70.4 ± 5.3 years) with uniocular or bilateral painful red eye were diagnosed with acute anterior uveitis (AAU) after examination by an ophthalmologist. All cases of AAU were from the zoledronate arm of the study, where the incidence was 0.8%. The mean time from infusion to onset of symptoms was 3 ± 2 days (range, 1-7 days). The AAU affected 3 right eyes and 4 left eyes and was bilateral in 1 patient (12.5%). Six of the participants exhibited mild to moderate AAU and 2 had severe AAU. Posterior synechiae occurred in 3 cases. The mean best-corrected visual acuity was reduced slightly at 20/30 (range, 20/20-20/60) at presentation, but improved to 20/25 (range, 20/20-20/30) upon resolution of AAU. All cases were treated with intensive, potent, topical corticosteroids: prednisolone acetate 1% eye drops with or without dexamethasone 0.1% eye ointment, with a tapering regimen based on the response to treatment. All eyes also were treated with topical cyclopentolate 1% to break or minimize the development of posterior synechiae. The mean duration of topical corticosteroid treatment was 45 ± 28 days (median, 47 days; range, 12-94 days). No long-term sequelae were reported (range, 8-23 months after infusion).
This is the largest reported cohort of cases of ophthalmologist-confirmed AAU occurring after intravenous infusion of zoledronate (5 mg). Eight of 1001 subjects receiving zoledronate (0.8%) exhibited mild to severe AAU within 7 days of treatment. The severity of ocular inflammation identified ranged from mild to severe AAU and thus required several weeks of treatment. Physicians and patients should be aware of the risk of ocular inflammatory side effects of bisphosphonate infusions and the need for referral to an ophthalmologist if symptoms develop.
研究骨质疏松症患者静脉注射唑来膦酸后出现显著眼部不良反应的发生率。
对一项大型、前瞻性、随机、双盲、安慰剂对照临床试验的数据进行分析。
2001 名患有骨质疏松症的绝经后妇女，随机分为安慰剂或唑来膦酸组。
静脉输注唑来膦酸 5mg 或安慰剂。
眼部不良事件。
8 名患者（平均年龄 70.4±5.3 岁）经眼科医生检查诊断为单侧或双侧疼痛性红眼的急性前葡萄膜炎（AAU）。所有 AAU 病例均来自唑来膦酸组，发生率为 0.8%。从输注到症状出现的平均时间为 3±2 天（范围，1-7 天）。AAU 影响了 3 只右眼和 4 只左眼，1 例患者为双侧（12.5%）。6 名参与者表现为轻度至中度 AAU，2 名参与者表现为重度 AAU。3 例出现后粘连。就诊时平均最佳矫正视力略有下降至 20/30（范围，20/20-20/60），但在 AAU 缓解后改善至 20/25（范围，20/20-20/30）。所有病例均采用强效皮质类固醇进行治疗：醋酸泼尼松龙 1%滴眼液联合或不联合地塞米松 0.1%眼膏，根据治疗反应采用逐渐减量方案。所有眼睛均采用环戊醇 1%进行治疗以打破或最小化后粘连的发生。皮质类固醇局部治疗的平均持续时间为 45±28 天（中位数 47 天；范围 12-94 天）。未报告长期后遗症（输注后 8-23 个月）。
这是迄今为止报告的最大宗眼科医生确诊的 AAU 病例队列，发生在静脉注射唑来膦酸（5mg）后。在接受唑来膦酸治疗的 1001 名受试者中，有 8 名（0.8%）在治疗后 7 天内出现轻度至重度 AAU。眼部炎症的严重程度从轻度至重度 AAU 不等，因此需要数周的治疗。医生和患者应意识到双膦酸盐输注引起眼部炎症副作用的风险，如果出现症状，应转介至眼科医生。
