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一项评估贝西沙星、阿昔洛韦和环丙沙星的前房毒性的研究。

An anterior chamber toxicity study evaluating Besivance, AzaSite, and Ciprofloxacin.

机构信息

Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT 84132, USA.

出版信息

Am J Ophthalmol. 2010 Oct;150(4):498-504.e1. doi: 10.1016/j.ajo.2010.05.006. Epub 2010 Aug 3.

DOI:10.1016/j.ajo.2010.05.006
PMID:20678751
Abstract

PURPOSE

We determined whether Besivance (Bausch & Lomb), AzaSite (Inspire Pharmaceuticals, Inc; both with DuraSite bioadhesive [InSite Vision, Inc]) and ciprofloxacin are toxic inside the anterior chamber.

DESIGN

Randomized, masked, placebo-controlled animal study.

METHODS

Twenty New Zealand white rabbits (40 eyes) were randomized to 1 of 4 study groups: Besivance, AzaSite, ciprofloxacin, and balanced salt solution. Each eye was injected with 0.1 mL of the study medication. Clinical slit-lamp examinations were conducted at 24 and 48 hours after injection. All rabbits then were killed and all eyes were enucleated. We randomized eyes to either corneal vital staining or histopathologic examination. The main outcome measures were clinical and pathologic signs of toxicity.

RESULTS

The 2 DuraSite-based study groups (Besivance and AzaSite) showed clinically and pathologically significant differences when compared with the ciprofloxacin and balanced salt solution groups. Besivance and AzaSite eyes exhibited significantly similar and severe clinical damage, including severe corneal edema. Ciprofloxacin and balanced salt solution eyes appeared very similar and had only mild conjunctival injection and limbal vascularity. Vital staining and histopathologic evaluation revealed glaucomatous and toxic damage in eyes given DuraSite-based medications, whereas non-DuraSite groups showed minimal changes.

CONCLUSIONS

DuraSite blocks the trabecular meshwork and may be additionally toxic when introduced as a large bolus. Until the safety of these medications is established with further studies using smaller injected volumes, we recommend placement of a suture over a clear corneal wound if DuraSite-based medications are used.

摘要

目的

我们旨在确定贝西氟沙星(博士伦)、阿昔洛韦(Inspire 制药公司;均与 DuraSite 生物黏附剂[Insite 视觉公司])和环丙沙星在眼前房内是否有毒性。

设计

随机、双盲、安慰剂对照动物研究。

方法

20 只新西兰白兔(40 只眼)被随机分为 4 个研究组之一:贝西氟沙星组、阿昔洛韦组、环丙沙星组和平衡盐溶液组。每组眼内注射 0.1ml 研究药物。注射后 24 小时和 48 小时进行临床裂隙灯检查。所有兔子随后被处死,所有眼睛均被摘除。我们随机将眼睛分配进行角膜活细胞染色或组织病理学检查。主要观察指标为毒性的临床和病理表现。

结果

2 个 DuraSite 基础研究组(贝西氟沙星组和阿昔洛韦组)与环丙沙星组和平衡盐溶液组相比,在临床和病理上表现出显著差异。贝西氟沙星组和阿昔洛韦组眼睛表现出明显相似且严重的临床损害,包括严重的角膜水肿。环丙沙星组和平衡盐溶液组眼睛表现出相似且仅轻度结膜充血和角膜缘血管化。活细胞染色和组织病理学评估显示,给予 DuraSite 药物的眼睛出现青光眼和毒性损害,而非 DuraSite 组显示最小变化。

结论

DuraSite 阻止小梁网,并在大剂量注射时可能具有额外的毒性。在使用较小注射体积的进一步研究确定这些药物的安全性之前,我们建议在使用 DuraSite 药物时,如果眼内有透明角膜伤口,应缝合缝线。

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