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心肌灌注研究中使用的受污染放射性药物导致的丙型肝炎病毒感染。

Hepatitis C virus infections from a contaminated radiopharmaceutical used in myocardial perfusion studies.

作者信息

Patel Priti R, Larson A Kirsten, Castel Amanda D, Ganova-Raeva Lilia M, Myers Robert A, Roup Brenda J, Farrell Katherine P, Edwards Leslie, Nainan Omana, Krick John P, Blythe David, Fiore Anthony E, Roche Jeffrey C

机构信息

Office of Workforce and Career Development, Centers for Disease Control and Prevention, Atlanta, Ga 30333, USA.

出版信息

JAMA. 2006 Oct 25;296(16):2005-11. doi: 10.1001/jama.296.16.2005.

Abstract

CONTEXT

Nuclear pharmacies prepare radiopharmaceutical products for use in common diagnostic procedures, including myocardial perfusion studies. Hepatitis C virus (HCV) transmission has not been reported previously in the setting of nuclear imaging studies.

OBJECTIVE

To investigate an outbreak of acute HCV infection identified among patients who underwent myocardial perfusion studies on October 15, 2004, using an injected radiopharmaceutical.

DESIGN, SETTING, AND PATIENTS: Outbreak investigation including molecular epidemiology and pharmacy site investigation at outpatient cardiology clinics and a nuclear pharmacy in Maryland. Ninety patients who received injections drawn from select radiopharmaceutical vials prepared on October 14-15, 2004, at a single nuclear pharmacy were offered testing for bloodborne pathogens. Pharmacy procedures were reviewed and HCV quasi species analysis was performed.

MAIN OUTCOME MEASURES

Hepatitis C virus infection and quasispecies sequence similarity.

RESULTS

Sixteen patients with acute HCV infection were identified from 3 separate clinics. All patients received radiopharmaceutical injections drawn from a single pharmacy vial (vial 1). None of the 59 tested patients who received doses from 6 other vials had acute HCV infection. Blood from a potential source patient with HCV and human immunodeficiency virus (HIV) infection was processed for a radiolabeled white blood cell study in the pharmacy 12 hours before vial 1 was prepared. The HCV quasispecies sequences from this potential source patient were nearly identical to those from cases (97.8%-98.5% similarity). No acute HIV infections were identified. Pharmacy practices that could have led to blood cross-contamination included reuse of needles and syringes during dilutions and use of common flow hoods for some steps in the preparation of sterile and blood-derived products.

CONCLUSIONS

Sixteen persons acquired HCV infection from a blood-contaminated radiopharmaceutical. The source and practices that could have facilitated breaks in aseptic technique were identified at the pharmacy. Nuclear pharmacies that handle biological products should follow appropriate aseptic technique to prevent contamination of sterile radiopharmaceuticals.

摘要

背景

核药房制备用于常见诊断程序(包括心肌灌注研究)的放射性药物产品。此前尚未有在核医学成像研究中发生丙型肝炎病毒(HCV)传播的报道。

目的

调查2004年10月15日接受心肌灌注研究的患者中出现的急性HCV感染暴发情况,这些患者使用了注射用放射性药物。

设计、地点和患者:暴发调查,包括在马里兰州的门诊心脏病诊所和一家核药房进行分子流行病学及药房现场调查。对90名接受了从2004年10月14 - 15日在一家核药房制备的特定放射性药物小瓶中抽取的注射剂的患者进行了血源性病原体检测。审查了药房操作流程并进行了HCV准种分析。

主要观察指标

丙型肝炎病毒感染及准种序列相似性。

结果

从3个不同诊所中识别出16例急性HCV感染患者。所有患者均接受了从单个药房小瓶(小瓶1)中抽取的放射性药物注射。接受来自其他6个小瓶剂量的59名检测患者中无一例发生急性HCV感染。在制备小瓶1前12小时,药房对一名潜在的HCV和人类免疫缺陷病毒(HIV)感染源患者的血液进行了放射性标记白细胞研究。该潜在感染源患者的HCV准种序列与病例的序列几乎相同(相似性为97.8% - 98.5%)。未识别出急性HIV感染。可能导致血液交叉污染的药房操作包括在稀释过程中重复使用针头和注射器,以及在无菌和血液制品制备的某些步骤中使用共用的通风橱。

结论

16人因受血液污染的放射性药物而感染HCV。在药房确定了可能促成无菌技术违规的源头及操作。处理生物制品的核药房应遵循适当的无菌技术,以防止无菌放射性药物受到污染。

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