A multistate outbreak of Serratia marcescens bloodstream infection associated with contaminated intravenous magnesium sulfate from a compounding pharmacy. Clin Infect Dis. 2007 Sep 1;45(5):527-33. Epub 2007 Jul 24.
PMID: 17682984 [PubMed - indexed for MEDLINE]
Sunenshine RH, Tan ET, Terashita DM, Jensen BJ, Kacica MA, Sickbert-Bennett EE, Noble-Wang JA, Palmieri MJ, Bopp DJ, Jernigan DB, Kazakova S, Bresnitz EA, Tan CG, McDonald LC.
Centers for Disease Control and Prevention, Arizona Dept. of Health Services, 150 N. 18th Ave., Ste. 150, Phoenix, AZ 85007, USA. Sunensr@azdhs.gov
BACKGROUND: In contrast to pharmaceutical manufacturers, compounding pharmacies adhere to different quality-control standards, which may increase the likelihood of undetected outbreaks. In 2005, the Centers for Disease Control and Prevention received reports of cases of Serratia marcescens bloodstream infection occurring in patients who underwent cardiac surgical procedures in Los Angeles, California, and in New Jersey. An investigation was initiated to determine whether there was a common underlying cause. METHODS: A matched case-control study was conducted in Los Angeles. Case record review and environmental testing were conducted in New Jersey. The Centers for Disease Control and Prevention performed a multistate case-finding investigation; isolates were compared using pulsed-field gel electrophoresis analysis. RESULTS: Nationally distributed magnesium sulfate solution (MgSO(4)) from compounding pharmacy X was the only significant risk factor for S. marcescens bloodstream infection (odds ratio, 6.4; 95% confidence interval, 1.1-38.3) among 6 Los Angeles case patients and 18 control subjects. Five New Jersey case patients received MgSO(4) from a single lot produced by compounding pharmacy X; culture of samples from open and unopened 50-mL bags in this lot yielded S. marcescens. Seven additional case patients from 3 different states were identified. Isolates from all 18 case patients and from samples of MgSO(4) demonstrated indistinguishable pulsed-field gel electrophoresis patterns. Compounding pharmacy X voluntarily recalled the product. Neither the pharmacy nor the US Food and Drug Administration could identify a source of contamination in their investigations of compounding pharmacy X. CONCLUSIONS: A multistate outbreak of S. marcescens bloodstream infection was linked to contaminated MgSO(4) distributed nationally by a compounding pharmacy. Health care personnel should take into account the different quality standards and regulation of compounded parenteral medications distributed in large quantities during investigations of outbreaks of bloodstream infection.
PMID: 17682984 [PubMed - indexed for MEDLINE]
编译：
题目：一起因制剂厂静脉注射用硫酸镁污染引起的粘质沙雷氏菌血液感染爆发
与制药厂相比，制剂厂执行不同的质量控制标准，增加了感染爆发的可能性。在2005年，美国疾病预防控制中心接到多例发生在洛杉矶、加州和新泽西州的因接受心脏外科手术而引起粘质沙雷氏菌血液感染病例报告。一个调查随后展开以确定发生感染事件是否有一个共同的原因。在洛杉矶开展配对病例对照研究。疾控中心对病例进行个案调查，微生物鉴定采用脉冲场凝胶电泳分析。在对6例病人和18名对照者研究中发现从X制剂厂生产的全国使用的硫酸镁溶液是粘质沙雷氏菌血液感染唯一的危险因素（比值比为6.4，95%可信区间为1.1-38.3）。5例新泽西州的病人注射用的硫酸镁溶液也来自X制剂厂，从生产量大的打开和未打开的50ml袋装的硫酸镁中培养出粘质沙雷氏菌。随后来自这3个州的7例病人也得到确诊。脉冲场凝胶电泳图谱证实从18例病人和硫酸镁样本中细菌基因型相似。X制剂厂召回了这些硫酸镁产品。X.制剂厂和美国食品药品管理局在他们的调查中都找不到污染的来源。这起多重血液感染沙雷氏菌与某制剂厂生产的污染的硫酸镁溶液有关。医务人员在调查血液感染爆发时应关注那些用量较大的、不同质量标准和规格的胃肠道外用药的配制制剂。 |
发表于 2007-9-15 19:41
发表于 2007-9-16 10:17
发表于 2010-1-13 15:31
发表于 2010-1-14 17:22