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人免疫球蛋白(Gamunex 10%)与眼用灌洗液(BSS 和 BSS Plus)的生物相容性:一种用于治疗感染性眼内炎的潜在抗毒素治疗方法的体外评估。

Biocompatibility of pooled human immunoglobulin (Gamunex 10%™) with ocular infusion solutions (BSS™ and BSS Plus™): an in vitro evaluation of a potential antitoxin treatment for infectious endophthalmitis.

机构信息

Department of Ophthalmology, Medical College of Wisconsin, Milwaukee, WI 53226, USA.

出版信息

J Ocul Pharmacol Ther. 2011 Aug;27(4):343-6. doi: 10.1089/jop.2011.0009. Epub 2011 Jun 1.

DOI:10.1089/jop.2011.0009
PMID:21631364
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3146742/
Abstract

PURPOSE

Gamunex 10% (Talecris Biotherapeutics, Research Triangle Park, NC), a commercially available preparation of pooled human immunoglobulin G, has been proposed as an antitoxin therapy against bacterial toxins released in infectious endophthalmitis. Its biocompatibility with two commonly used intraocular infusion fluids was evaluated to determine feasibility of its clinical application in endophthalmitis treatment.

METHODS

Gamunex 10% was mixed with BSS or BSS Plus (Alcon Laboratories, Fort Worth, TX) such that it constituted a range of 1.25%-50% by volume. Osmolality, pH, optical density, and ionic strength were measured across this range of concentrations.

RESULTS

The amount of pH reduction with increasing concentrations of Gamunex 10% was similar for both BSS and BSS Plus. In BSS Plus, solutions containing up to 20% by volume of Gamunex 10% remained at near-physiologic pH (∼7.0 or above). No physiologically significant changes in osmolality or optical density measurements that would be anticipated to have profound physiological effects were observed at any of the measured concentrations, nor was there visual evidence of tubidity/precipitation. A gradual increase in ionic strength was observed with increasing concentrations of Gamunex 10%.

CONCLUSIONS

Potentially therapeutic mixtures of Gamunex 10% in 2 commonly used intraocular infusion fluids, BSS and BSS Plus, showed no evidence of bioincompatibility when the solutions were evaluated for changes in osmolality, pH, ionic strength, aggregation, or precipitation.

摘要

目的

Gamunex 10%(Talecris Biotherapeutics,Research Triangle Park,NC)是一种市售的人免疫球蛋白 G 混合制剂,已被提议作为一种抗毒素疗法,用于对抗感染性眼内炎中释放的细菌毒素。评估其与两种常用的眼内灌注液的生物相容性,以确定其在眼内炎治疗中的临床应用的可行性。

方法

将 Gamunex 10%与 BSS 或 BSS Plus(Alcon Laboratories,Fort Worth,TX)混合,使其体积比为 1.25%-50%。测量该浓度范围内的渗透压、pH 值、光密度和离子强度。

结果

随着 Gamunex 10%浓度的增加,BSS 和 BSS Plus 的 pH 值降低量相似。在 BSS Plus 中,含有高达 20%体积比的 Gamunex 10%的溶液仍保持接近生理 pH 值(≥7.0)。在任何测量浓度下,都没有观察到预期会产生深远生理效应的渗透压或光密度测量值的生理显著变化,也没有可见的浑浊/沉淀迹象。随着 Gamunex 10%浓度的增加,离子强度逐渐增加。

结论

在两种常用的眼内灌注液 BSS 和 BSS Plus 中,潜在治疗性的 Gamunex 10%混合液在评估渗透压、pH 值、离子强度、聚集或沉淀变化时,没有显示出生物不相容性的证据。

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