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【medical-news】眼力健召回全能水润隐形眼镜多功
眼力健召回全能水润隐形眼镜多功能护理液
Yael Waknine
May 30, 2007 (updated May 31, 2007) — Consumers who wear soft contact lenses have been advised to stop using Complete MoisturePlus multipurpose solution (Advanced Medical Optics), the US Food and Drug Administration (FDA) warned yesterday.
昨天，美国食品药物管理局警告带隐形眼睛的消费者不要再使用眼力健公司的全能水润隐形眼镜多功能护理液。
The product was voluntarily recalled after a Centers for Disease Control and Prevention (CDC) multistate investigation linked its use to a 7-fold increased risk for Ancathamoeba keratitis (AK), according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.
在一项由疾病控制和预防中心开展的，在许多州进行的调查发现，使用眼力健公司的全能水润隐形眼镜多功能护理液后，发生Ancathamoeba角膜炎的几率增加了7倍。随后公司自动招回了这一产品。美国食品药物管理局通过其安全信息和有害事件报告机构（MedWatch）对这一事件向公众发出警报。
The multistate investigation revealed 46 confirmed cases of AK since January 2005; 39 occurred in soft contact lens wearers, 21 of whom reported using Complete MoisturePlus solution. According to the CDC, the background annual incidence rate of the corneal infection is approximately 0.0002%.
多中心的调查显示从2005年1月份以来，有46例Ancathamoeba角膜炎确诊；其中有39例患者是隐形眼睛使用者，而这中间有21例使用了全能水润隐形眼镜多功能护理液。而依据疾病控制和预防中心的标准，角膜感染的年基础发病率应该只有大约0.0002%。
Although early symptoms of AK resemble that of more common infections, AK can last several weeks to months and eventually cause severe pain and vision loss. Left untreated, the condition may require corneal transplant in some patients. Additional information regarding AK is available from the CDC at 1-800-CDC-INFO (1-800-232-4636) or online at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.
虽然Ancathamoeba角膜炎的早期症状和一般感染无异，但是其持续时间可达几周甚至数月，并最终导致剧痛和视力减退。一些患者如果不治疗，其结果是可能需要进行角膜移植。其他有关Ancathamoeba角膜炎的资料请致电疾病控制和预防中心(1-800-232-4636)索取,或者登陆网站http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.
Consumers are advised to stop using the solution, discard all partially used or unopened bottles, and replace their lenses and storage container. Healthcare providers should be contacted for advice on appropriate alternative cleaning/disinfecting products. Because early treatment for AK is essential, immediate medical evaluation should be sought for symptoms such as eye pain/redness, blurred vision, light sensitivity, sensation of something in the eye, or excessive tearing.
美国食品药物管理局建议隐形眼镜使用者停止使用这种护理液，丢弃所有未用完以及未使用的产品，并更换隐形眼镜和存放盒。找医疗保健机构寻求恰当的清洗和消毒产品。Ancathamoeba角膜炎的早期治疗是很重要的，如果有眼痛、红眼、实力模糊，畏光、异物感以及多泪等症状，请立即就诊。
The company notes in a news release that it is currently contacting retailers, customers, and distributors regarding return and replacement instructions, and providing reply cards and mailing slips for product return. Consumers who may be in possession of the recalled product may contact the company 1-888-899-9183 for more information.
眼力健公司已发布新闻，表示已经就招回和替换此产品一事与经销商、零售商和客户联系。拥有这一产品的用户可以通过电话1-888-899-9183与公司联系。
To assist in the ongoing CDC/FDA investigation, healthcare professionals should consider obtaining clinical specimens (eg, corneal scrapings) for culture by state laboratories prior to initiating treatment for AK. Cases should be reported to state and local health authorities or directly to the CDC by phone at 1-770-488-7775.
医疗保健机构在对Ancathamoeba角膜炎患者进行治疗前，必须提供临床标本(角膜涂片)以供政府实验室培养。病例必须报告给各州以及本地权威机构，或者直接通过电话（1-770-488-7775）报告疾病控制和预防中心。
Adverse reactions related to use of the multipurpose contact lens solution should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at
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作者:admin@医学,生命科学 2011-04-16 05:11
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