【热点追踪】美国爆发罕见脑膜炎,双语版
From VOA Learning English, this is the Health Report in Special English.这里是***慢速英语健康报道。
Health officials in the United States are attempting to contact patients who recently received steroid injections for back pain. That is because the injections may have been carrying a fungus. Thousands of patients may be at risk of developing a rare form of fungal meningitis.
美国卫生官员正试图联系最近因为背部疼痛接受了类固醇注射的患者。这是因为这种注射剂可能携带了一种真菌。数千名患者可能患上一种罕见的真菌性脑膜炎。
Health officials reported Monday that fifteen people had died from fungal meningitis linked to steroid shots. The Centers for Disease Control and Prevention said there were more than two hundred confirmed cases of the disease in fifteen states. The majority of the cases were in three states: Tennessee, Michigan and Virginia.
卫生官员周一报告称,已经有15人死于和类固醇注射有关的真菌性脑膜炎。美国疾病控制和预防中心表示,已经在15个州发现了超过200例确诊病例,其中多数病例位于田纳西州,密歇根州和弗吉尼亚州这三个州。
Meningitis infects membranes that protect the brain and the spinal cord. There are five kinds of meningitis. Fungal meningitis is the rarest form of the disease. Other forms can result from bacteria, a virus or a parasite.
脑膜炎会感染保护大脑和脊髓的膜。当今有5种类型的脑膜炎,真菌性脑膜炎是最罕见的一种。其它类型的脑膜炎可以由细菌、病毒或寄生虫导致。
Last Thursday, officials reported that tests found evidence of the suspect fungus in more than fifty vials of the steroid. They said all those vials were manufactured by the New England Compounding Center in Massachusetts. The company has suspended operations and recalled all of its products for inspection.
上周四有关官员报告,通过测试在超过50瓶这种类固醇中发现了可疑真菌的证据。他们说,所有这些类固醇都是在马萨诸塞州的新英格兰化合制剂中心生产。该公司已经暂停运营,并召回所有产品进行检查。
Compounding or specialty pharmacies often custom-mix medicines at levels, and in forms, that may not be available from other manufacturers. Under Massachusetts law, compounding pharmacies are only permitted to make small amounts of made-to-order prescription drugs.
复合药房或特种药房通常定制各种级别和形式的药物,这些药物无法通过其它厂商获得。根据马萨诸塞州的法律,复合药房只允许生产少量的定制处方药。
The patients who developed meningitis were being treated for back pain. The Centers for Disease Control says others who received the injections in their joints are not thought to be at risk.
患上脑膜炎的患者当时正因背部疼痛在接受治疗。疾控中心表示,其他接受关节注射的患者被认为没有危险。
John Jernigan of the CDC is investigating the meningitis outbreak.
疾控中心的约翰·杰尼根(John Jernigan)正在调查脑膜炎疫情。
"CDC is working with state and local health departments to contact patients who may have received injections at the facilities who received the recalled lots of this medication to inform (them) that they, that they may have been exposed, to find out if they're having symptoms, and to instruct them to seek health care should they be ill."
“疾控中心正与州和地方卫生部门合作,联系在得到这种药物召回通知的机构注射过的患者,提醒他们可能已经暴露(于这种疾病中),以查出他们是否有症状,并指导患病者寻求医疗服务。”
Dr. Jernigan says there are many different signs of fungal meningitis.
杰尼根表示,真菌性脑膜炎有多种不同症状。
"Fever, new or worsening headache, sometimes neck stiffness. We've also seen in a few patients signs and symptoms of stroke, sudden onset of slurred speech, dizziness, difficulty walking, sudden weakness."
“发烧,新发头痛或头痛加剧,有时会颈部僵硬。我们还在一些患者中发现中风,突发口齿不清、头晕、行走困难,突感无力的症状和体征。”
Health experts say they do not know how many people will actually become sick. They say it could take several months for a fungal infection to develop.
健康专家表示,他们不知道实际上有多少人会患病。他们说,真菌感染的发展可能需要数月时间。
非常震惊啊!感控无小事,任何一点细节问题都有可能导致难以挽回的后果。比较奇怪:作为一家知名药厂,这类制剂出厂难道没有经过质控?如果只有形式质控,那么可能还会有更多的问题。美国尚且如此,那么比他要次发达的国家,法律法规监管尚不严谨的发展中国家,那该有多大的漏洞需要感控人士去弥补。
刚才查了美国CDC的网站,死亡人数已经达到了23人。感控界的悲剧呀!这个公司是不是就因此而破产?中国药界的朋友,一定要引以为戒啦!http://t.cn/zln7VWp
本文转发自:胡必杰教授的围脖 CDC Responds to Multistate Outbreak of Fungal Meningitis and Other Infections
On this Page
[*]CDC Responds
[*]About the Outbreak
[*]Related Drug Recalls
http://www.cdc.gov/hai/outbreaks/maps/case-counts-184px-2012-11-01.gif View case count map.
Information on this site is focused on the outbreak of fungal meningitis and other infections linked to the use of injectable steroids from three recalled lots of preservative-free methylprednisolone acetate (MPA) distributed by the New England Compounding Center (NECC).
The Centers for Disease Control and Prevention (CDC), in collaboration with state and local health departments and the Food and Drug Administration (FDA)http://www.cdc.gov/TemplatePackage/images/icon_out.png, is investigating a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free MPA steroid injections from NECC. Several patients suffered strokes that are believed to have resulted from their infections. The investigation also includes other infections from injections in a peripheral joint, such as a knee, shoulder, or ankle. Patients who received injections in peripheral joints only are not believed to be at risk for meningitis, but they could be at risk for joint and other infections.
CDC has recently become aware of reports of spinal epidural abscess and arachnoiditis among a number of patients undergoing treatment for fungal meningitis associated with the outbreak. Both conditions are rare but serious disorders in the general population that require prompt medical attention.Most of these early reports have been about patients in Michigan and Tennessee, but other states have reported patients with these conditions as well.Additional information is found in the Clinician FAQ’s. CDC is working with clinicians and public health officials to obtain more information and refine its clinical guidance as needed.
CDC and public health officials are referring any patients who have symptoms that suggest possible infections to their physicians, who can evaluate them further.
About the Outbreak
FDA Updates
[*]FDA continues to provide updates for New England Compounding Center (NECC) customers, healthcare professionals and patients on its Fungal Meningitis Outbreak website.http://www.cdc.gov/TemplatePackage/images/icon_out.png
[*]FDA announced the voluntary recall of all Ameridose products on October 31, 2012.http://www.cdc.gov/TemplatePackage/images/icon_out.png
[*]As of November 2, 2012, the predominant fungus identified in patients continues to be Exserohilum rostratum, with 75 CDC laboratory-confirmed cases. One patient, the index case, had a laboratory-confirmed Aspergillus fumigatus infection. These fungi are common in the environment; fungal infections are not transmitted from person to person.
[*]CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free MPA from two of the three implicated lots (Lot #06292012@26, BUD12/26/2012 and Lot #08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid injections from these lots from NECC to the outbreak. Testing on the third implicated lot continues.
[*]CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the three implicated lots of methylprednisolone, and nearly 97% have now been contacted for further follow-up.
[*]Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop. In this outbreak, symptoms typically have appeared 1 to 4 weeks following injection, but it’s important to know that longer and shorter periods between injection and onset of symptoms have been reported. Therefore, patients and physicians need to closely watch for symptoms for at least several months following the injection. See updated Patient Guidance for more information, and contact your physician if you are concerned you may have become ill from your injection.
[*]Information about the investigation and guidance for clinicians, including interim treatment guidelines, is available at www.cdc.gov/hai/outbreaks/meningitis.html. CDC recommendations are subject to change as more information becomes available.
Top of PageRelated Drug RecallsRecalls of medications beyond the three lots of preservative-free MPA are ongoing.
[*]On October 6, 2012 NECC voluntarily recalled all productshttp://www.cdc.gov/TemplatePackage/images/icon_out.png compounded at and distributed from its facility in Framingham, Massachusetts. The product list http://www.cdc.gov/TemplatePackage/images/icon_pdf.gif http://www.cdc.gov/TemplatePackage/images/icon_out.png, posted on FDA’s website, was the focus of an October 15 MedWatch Alerthttp://www.cdc.gov/TemplatePackage/images/icon_out.png. FDA advised clinicians out of an abundance of caution to follow up with patients who were administered NECC injectable products, including an ophthalmic drug that is injectable or used in conjunction with eye surgery and a cardioplegic solution. Investigation and laboratory testing of products is ongoing by CDC and FDA.
[*]CDC Information About Additional Medical Products (non-MPA) From New England Compounding Center.
[*]FDA Information on the NECC recallhttp://www.cdc.gov/TemplatePackage/images/icon_out.png and product list http://www.cdc.gov/TemplatePackage/images/icon_pdf.gif http://www.cdc.gov/TemplatePackage/images/icon_out.pngbeyond the preservative-free MPA: Archive of Updates and http://www.cdc.gov/TemplatePackage/images/icon_out.png.
[*]On October 31, 2012 The U.S. Food and Drug Administration announced that Ameridose, LLC, based in Westborough, Mass., voluntarily recalled all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logohttp://www.cdc.gov/TemplatePackage/images/icon_out.png. A complete list of all products subject to this recall can be accessed at www.ameridose.comhttp://www.cdc.gov/TemplatePackage/images/icon_out.png. Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigationhttp://www.cdc.gov/TemplatePackage/images/icon_out.png. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Mass., the firm associated with compounded drugs linked to the ongoing outbreak.
[*]CDC Information About Voluntary Recall of All Ameridose Medical Products
[*]FDA Information on the recall of all Ameridose products. http://www.cdc.gov/TemplatePackage/images/icon_out.png
[*]November 1, 2012 Health Alert Network (HAN): Contamination Identified in Additional Medical Products from New England Compounding Center
[*]November 1, 2012 Health Alert Network (HAN): Voluntary Recall of All Ameridose Medical Products
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