与污染的甲基泼尼松龙注射剂相关的真菌感染。
Fungal infections associated with contaminated methylprednisolone injections.
机构信息
From the Epidemic Intelligence Service, Scientific Education and Professional Development Program Office (R.M.S., S.G., A.P.), Division of Foodborne, Waterborne, and Environmental Diseases (R.M.S., A.P., A.A.C., K.B., J.R.H., M.E.B., B.J.P.), Division of Healthcare Quality Promotion (M.K.S., M.W., J.J., J.T.W.), and Division of High-Consequence Pathogens and Pathology (D.B.), Centers for Disease Control and Prevention, Atlanta; the Tennessee Department of Health, Nashville (M.A.K., A.D.W.); the Michigan Department of Community Health, Bureau of Epidemiology, Lansing (J. Finks, J. Fiedler); the Indiana State Department of Health, Indianapolis (J.D., C.F.); the Virginia Department of Health, Richmond (E.F., L.G.); the Maryland Department of Health and Mental Hygiene, Baltimore (A.C.); the New Jersey Department of Health, Trenton (B.C.); the Florida Department of Health, Tallahassee (A.R.); and the North Carolina Division of Public Health, Raleigh (S.G.).
出版信息
N Engl J Med. 2013 Oct 24;369(17):1598-609. doi: 10.1056/NEJMoa1213978. Epub 2012 Dec 19.
BACKGROUND
Fungal infections are rare complications of injections for treatment of chronic pain. In September 2012, we initiated an investigation into fungal infections associated with injections of preservative-free methylprednisolone acetate that was purchased from a single compounding pharmacy.
METHODS
Three lots of methylprednisolone acetate were recalled by the pharmacy; examination of unopened vials later revealed fungus. Notification of all persons potentially exposed to implicated methylprednisolone acetate was conducted by federal, state, and local public health officials and by staff at clinical facilities that administered the drug. We collected clinical data on standardized case-report forms, and we tested for the presence of fungi in isolates and specimens by examining cultures and performing polymerase-chain-reaction assays and histopathological and immunohistochemical testing.
RESULTS
By October 19, 2012, more than 99% of 13,534 potentially exposed persons had been contacted. As of July 1, 2013, there were 749 reported cases of infection in 20 states, with 61 deaths (8%). Laboratory evidence of Exserohilum rostratum was present in specimens from 153 case patients (20%). Additional data were available for 728 case patients (97%); 229 of these patients (31%) had meningitis with no other documented infection. Case patients had received a median of 1 injection (range, 1 to 6) of implicated methylprednisolone acetate. The median age of the patients was 64 years (range, 15 to 97), and the median incubation period (the number of days from the last injection to the date of the first diagnosis) was 47 days (range, 0 to 249); 40 patients (5%) had a stroke.
CONCLUSIONS
Analysis of data from a large, multistate outbreak of fungal infections showed substantial morbidity and mortality. The infections were associated with injection of a contaminated glucocorticoid medication from a single compounding pharmacy. Rapid public health actions included prompt recall of the implicated product, notification of exposed persons, and early outreach to clinicians.
背景
真菌感染是慢性疼痛治疗中注射治疗的罕见并发症。2012 年 9 月，我们开始调查与从一家单一的药剂配制药房购买的无防腐剂的醋酸甲泼尼龙注射相关的真菌感染。
方法
该药房召回了三批醋酸甲泼尼龙；对未开封小瓶的检查后来发现了真菌。联邦、州和地方公共卫生官员以及使用该药物的临床机构的工作人员对所有可能接触到受影响的醋酸甲泼尼龙的人进行了通知。我们通过标准病例报告表收集了临床数据，并通过检查培养物以及进行聚合酶链反应检测和组织病理学及免疫组织化学检测，检测分离物和标本中真菌的存在。
结果
截至 2012 年 10 月 19 日，已联系到 13534 名潜在接触者中的 99%以上。截至 2013 年 7 月 1 日，在 20 个州报告了 749 例感染病例，其中 61 人死亡（8%）。从 153 例病例患者的标本中发现了 Exserohilum rostratum 的实验室证据（20%）。还可获得 728 例病例患者的其他数据（97%）；其中 229 例（31%）患者患有脑膜炎，没有其他记录的感染。病例患者接受了受影响的醋酸甲泼尼龙中位数为 1 次注射（范围 1 至 6 次）。患者的中位年龄为 64 岁（范围 15 至 97 岁），中位潜伏期（末次注射至首次诊断的天数）为 47 天（范围 0 至 249 天）；40 例患者（5%）发生中风。
结论
对大规模多州真菌感染暴发的数据分析显示发病率和死亡率很高。感染与从单一药剂配制药房注射污染的糖皮质激素药物有关。快速的公共卫生行动包括迅速召回受影响的产品、通知受影响的人，并尽早与临床医生联系。
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