Botulism in 4 adults following cosmetic injections with an unlicensed, highly concentrated botulinum preparation
Botulism in 4 adults following cosmetic injections with an unlicensed, highly concentrated botulinum preparation
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DOI：
10.1001/jama.296.20.2476
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发表时间：
2006-11-22
影响因子：
120.7
通讯作者：
Braden, Christopher R.
中科院分区：
文献类型：
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作者：
Chertow, Daniel S.;Tan, Esther T.;Braden, Christopher R.
背景肉毒中毒是一种潜在的致命性瘫痪疾病，主要由厌氧、芽胞形成细菌肉毒梭菌的毒素引起。虽然A型肉毒杆菌毒素可通过处方用于美容和治疗，但以前没有可检测到血清毒素的肉毒杆菌中毒病例被归因于美容或治疗性肉毒毒素注射。2004年11月27日，向美国疾病预防控制中心报告了4例疑似肉毒中毒病例。目的调查4例医源性肉毒中毒疑似病例的临床、流行病学和实验室特征。设计、设置4例肉毒中毒患者的病例系列。主要观察指标4例患者的临床特征、流行病学特征、小鼠生物中和试验结果。结果4例患者的临床特征与自然发生的肉毒中毒一致。所有病例患者都注射了一种高度浓缩的未经许可的A型肉毒毒素制剂，注射剂量可能是估计的人类致死剂量的2857倍。4例患者中有3例患者的治疗前血清毒素水平相当于估计的人类致死量的21-43倍；第四例流行病学相关病例患者的治疗前血清不可用。一瓶100亩的毒素与给患者注射的毒素从同一制造商的批次中提取，如果均匀传播，患者注射的毒素足以杀死大约14 286名成年人。结论这些实验室确认的肉毒杆菌中毒病例表明，临床使用未经许可的肉毒杆菌毒素A可导致严重的危及生命的疾病。需要进一步的教育和监管，以防止未经许可的肉毒杆菌毒素产品的不当营销、销售和临床使用。
Context Botulism is a potentially lethal paralytic disease caused primarily by toxins of the anaerobic, spore-forming bacterium Clostridium botulinum. Although botulinum toxin A is available by prescription for cosmetic and therapeutic use, no cases of botulism with detectable serum toxin have previously been attributed to cosmetic or therapeutic botulinum toxin injections. On November 27, 2004, 4 suspected botulism case-patients with a link to cosmetic botulinum toxin injections were reported to the Centers for Disease Control and Prevention.Objective To investigate the clinical, epidemiological, and laboratory aspects of 4 suspected cases of iatrogenic botulism.Design, Setting, and Patients Case series on 4 botulism case-patients.Main Outcome Measures Clinical characteristics of the 4 case-patients, epidemiological associations, and mouse bioassay neutralization test results from case-patient specimens and a toxin sample.Results Clinical characteristics of the 4 case-patients were consistent with those of naturally occurring botulism. All case-patients had been injected with a highly concentrated, unlicensed preparation of botulinum toxin A and may have received doses 2857 times the estimated human lethal dose by injection. Pretreatment serum toxin levels in 3 of the 4 case-patients were equivalent to 21 to 43 times the estimated human lethal dose; pretreatment serum from the fourth epidemiologically linked case-patient was not available. A 100-mu g vial of toxin taken from the same manufacturer's lot as toxin administered to the case-patients contained a toxin amount sufficient to kill approximately 14 286 adults by injection if disseminated evenly.Conclusions These laboratory-confirmed cases of botulism demonstrate that clinical use of unlicensed botulinum toxin A can result in severe, life-threatening illness. Further education and regulation are needed to prevent the inappropriate marketing, sale, and clinical use of unlicensed botulinum toxin products.