Patel Dipika V, Horne Anne, Mihov Borislav, Stewart Angela, Reid Ian R, McGhee Charles N J
Department of Ophthalmology, New Zealand National Eye Centre, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand,
Calcif Tissue Int. 2015 Jul;97(1):58-61. doi: 10.1007/s00223-015-0015-4. Epub 2015 May 23.
To determine the incidence of adverse ocular side effects following re-challenge in patients who previously developed ocular symptoms following intravenous zoledronate. Secondary data analysis of a large, prospective, randomized, double-blind, placebo-controlled clinical trial was performed. Participants consisted of postmenopausal females with osteopenia randomized to placebo (N = 1000) or zoledronate 5 mg (N = 1001) intravenous infusion. Recruitment occurred over a 2-year period, with the first infusion being administered at recruitment, and subsequent infusions every 18 months. Eight participants developed acute anterior uveitis (AAU) (diagnosed by an ophthalmologist) following the first infusion of zoledronate. Following appropriate ophthalmic treatment, no patients had visual loss or other ocular sequelae. One further participant reported "sore red eyes" but did not attend for ophthalmology review. Six participants declined further infusions. The remaining three participants were administered two further zoledronate infusions, 18 months apart, and none developed any ocular symptoms following each infusion. As a precaution, two of these participants were examined by an ophthalmologist 3 days after their second infusion and neither had ocular symptoms or signs of AAU and no subsequent ocular side effects. AAU following zoledronate infusion is likely to be part of the acute phase response. If treated promptly under the care of an ophthalmologist, the visual prognosis is excellent. The results of this study suggest that the development of AAU should not be a contraindication to further infusion. However, in such cases, patients should be warned of the symptoms of AAU (ocular pain, redness, photophobia or blurred vision) and should be promptly referred to an ophthalmologist if symptoms develop.
为确定既往静脉注射唑来膦酸后出现眼部症状的患者再次用药后不良眼部副作用的发生率。对一项大型、前瞻性、随机、双盲、安慰剂对照临床试验进行了二次数据分析。参与者包括骨质疏松的绝经后女性,随机分为安慰剂组(N = 1000)或静脉输注5 mg唑来膦酸组(N = 1001)。招募工作历时2年,首次输注在招募时进行,随后每18个月输注一次。8名参与者在首次输注唑来膦酸后出现急性前葡萄膜炎(AAU)(由眼科医生诊断)。经过适当的眼科治疗,没有患者出现视力丧失或其他眼部后遗症。另有一名参与者报告“眼睛红肿疼痛”,但未前往眼科复诊。6名参与者拒绝进一步输注。其余3名参与者又接受了两次间隔18个月的唑来膦酸输注,每次输注后均未出现任何眼部症状。作为预防措施,其中两名参与者在第二次输注后3天接受了眼科医生检查,两人均无眼部症状或AAU体征,且随后未出现眼部副作用。唑来膦酸输注后发生的AAU可能是急性期反应的一部分。如果在眼科医生的护理下及时治疗,视力预后良好。本研究结果表明,AAU的发生不应成为进一步输注的禁忌证。然而,在这种情况下,应告知患者AAU的症状(眼痛、眼红、畏光或视力模糊),如果出现症状应立即转诊至眼科医生处。