Food and Drug Administration, Oak Ridge Institute for Science and Education (ORISE) contractor, Silver Spring, Maryland 20993-0002, USA.
Ophthalmology. 2012 Jul;119(7):e30-5. doi: 10.1016/j.ophtha.2012.04.016. Epub 2012 May 11.
To investigate whether enzymatic detergents used in cleaning ophthalmic surgical instruments can cause toxic anterior segment syndrome (TASS)-like responses in a rabbit model.
Randomized, investigator-masked, controlled experimental animal study.
Thirty-five New Zealand white rabbits.
The rabbit eyes were randomized into 7 treatment groups to receive intracameral injection of 1 of 3 different doses of Medline Dual Detergent or Enzol Detergent, or sterile limulus amoebocyte lysate reagent water as a control. The eyes were evaluated for anterior segment inflammation at baseline and at 1, 3, 6, 24, 48, and 72 hours after treatment by slit-lamp biomicroscopy.
Anterior chamber (AC) inflammation, including cells, flare, fibrin, and iris injection; time course of inflammation; and residual detergent levels in luminated instruments.
Moderate to marked injection of the iris vessels was seen as early as 1 hour after treatment with the enzymatic detergents in 41 of 60 eyes, with the response being more severe in the Enzol Detergent-exposed eyes. Severe iris hemorrhages were accompanied by blood in the AC in 13 eyes, which usually persisted through 72 hours, with an associated increase in AC cell and flare. Corneal haze was present in 52 of 56 eyes 1 hour after treatment, but was mild and resolved within 24 hours in all but the Enzol 4.5%-exposed eyes. Median AC cell and flare peaked at 6 hours and resolved by 48 hours.
Enzymatic detergents caused a severe but unusual response from the iris when injected intracamerally into rabbit eyes. This response has not been reported in humans with TASS. The time course of inflammation was faster (peak at 6 hours) and resolved more quickly (within 48 hours) than TASS. Simulated cleaning and extraction studies indicate that the level of residual detergent to which a patient could be exposed is significantly less than the lowest dose used in this study. Because that low dose caused no significant observations other than injection of the iris vessels, these results do not support residual enzymatic detergents on surgical instruments as a cause for TASS.
研究用于清洗眼科手术器械的酶清洁剂是否会在兔模型中引起类似毒性前节综合征(TASS)的反应。
随机、研究者盲法、对照的实验动物研究。
35 只新西兰白兔。
将兔眼随机分为 7 个治疗组,分别向眼内注射 3 种不同剂量的 Medline 双清洁剂或 Enzol 清洁剂,或无菌鲎阿米巴样细胞溶解物试剂水作为对照。在治疗后 1、3、6、24、48 和 72 小时,通过裂隙灯生物显微镜评估眼前节炎症。
前房(AC)炎症,包括细胞、闪光、纤维蛋白和虹膜注射;炎症的时间过程;以及发光器械中残留的清洁剂水平。
在接受酶清洁剂治疗的 60 只眼中,41 只眼在 1 小时内出现中度至重度虹膜血管注射,暴露于 Enzol 清洁剂的眼中反应更严重。13 只眼出现严重虹膜出血伴房水中出血,通常持续至 72 小时,伴有 AC 细胞和闪光增加。在治疗后 1 小时,52 只眼出现角膜混浊,但除 Enzol 4.5%-暴露的眼外,所有眼均为轻度,24 小时内消退。AC 细胞和闪光的中位数在 6 小时达到峰值,48 小时内消退。
酶清洁剂在兔眼内眼内注射时会引起虹膜严重但异常的反应。这种反应在 TASS 患者中尚未报道。炎症的时间过程更快(6 小时达到峰值),48 小时内更快消退(48 小时内消退)。模拟清洗和提取研究表明,患者可能暴露于残留清洁剂的水平明显低于本研究中使用的最低剂量。由于低剂量除了引起虹膜血管注射外,没有其他明显的观察结果,因此这些结果不支持手术器械上残留的酶清洁剂是 TASS 的原因。