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含保湿因子的润明护理液温度不稳定性:解释2004 - 2006年全球镰刀菌角膜炎流行的新理论

Temperature instability of ReNu With MoistureLoc: a new theory to explain the worldwide Fusarium keratitis epidemic of 2004-2006.

作者信息

Bullock John D, Warwar Ronald E, Elder B Laurel, Northern William I

机构信息

Department of Ophthalmology, Wright State University Boonshoft School of Medicine, Dayton, OH 45420-4006, USA.

出版信息

Arch Ophthalmol. 2008 Nov;126(11):1493-8. doi: 10.1001/archopht.126.11.1493.

DOI:10.1001/archopht.126.11.1493
PMID:19001215
Abstract

OBJECTIVE

To investigate the effect of storage temperature on the ability of contact lens solutions to inhibit growth of Fusarium species. A 2006 Food and Drug Administration inspection of Bausch & Lomb's Greenville, South Carolina, manufacturing site indicated that Bausch & Lomb failed to regulate storage and transport temperatures of their products.

METHODS

Six contact lens solutions were studied: ReNu with MoistureLoc, ReNu MultiPlus, COMPLETE Moistureplus, AQuify, Clear Care, and OPTI-FREE RepleniSH. Two bottles of each solution were separately stored at room temperature and 60 degrees C for 4 weeks, serially diluted, and then tested for their ability to inhibit growth of 11 Fusarium isolates (7 of which were associated with the keratitis epidemic).

RESULTS

ReNu with MoistureLoc demonstrated the greatest decline in efficacy after 60 degrees C storage. Clear Care and ReNu MultiPlus performed the best. Regarding the keratitis epidemic isolates only, the ReNu with MoistureLoc bottle stored at room temperature allowed growth in 27 of 84 combinations vs 67 of 84 combinations with the 60 degrees C-stored bottle.

CONCLUSIONS

When exposed to prolonged temperature elevation, ReNu with MoistureLoc loses its in vitro fungistatic activity to a much greater extent than other products. Improper temperature control of ReNu with MoistureLoc may have contributed to the Fusarium keratitis epidemic of 2004-2006.

摘要

目的

研究储存温度对隐形眼镜护理液抑制镰刀菌属生长能力的影响。美国食品药品监督管理局2006年对博士伦位于南卡罗来纳州格林维尔的生产基地进行检查时发现,博士伦未能对其产品的储存和运输温度进行有效管控。

方法

对六种隐形眼镜护理液进行研究:爱尔康水润护理液、博士伦多功能护理液、全视康水润护理液、傲滴恒润护理液、清境护理液和乐敦莹护理液。每种护理液各两瓶,分别在室温及60摄氏度下储存4周,进行系列稀释,然后测试其对11株镰刀菌分离株(其中7株与角膜炎疫情相关)生长的抑制能力。

结果

爱尔康水润护理液在60摄氏度储存后,其功效下降最为明显。清境护理液和博士伦多功能护理液表现最佳。仅就与角膜炎疫情相关的分离株而言,室温储存的爱尔康水润护理液在84种组合中有27种出现生长情况,而60摄氏度储存的护理液在84种组合中有67种出现生长情况。

结论

长时间暴露于温度升高环境时,爱尔康水润护理液在体外的抑菌活性比其他产品丧失程度更大。爱尔康水润护理液温度控制不当可能是导致2004 - 2006年镰刀菌性角膜炎疫情的原因之一。

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