DG de Salut Pública i Participació, Illes Balears, Palma, Spain.
Enferm Infecc Microbiol Clin. 2011 Aug-Sep;29(7):510-4. doi: 10.1016/j.eimc.2011.03.006. Epub 2011 Jun 17.
In February 2009 an outbreak of subcutaneous abscesses due to Mycobacterium abscessus was detected in Spain which affected healthy women who had undergone mesotherapy procedures in an aesthetic clinic.
Epidemiological research, health inspection and microbiological studies were conducted. The patients were given antibiotic treatment (according to susceptibility testing) with clarithromycin, and in some cases, combined with amikacin.
Seventeen out of 77 patients treated in the clinic were affected. The products used for the injections were homeopathic drugs in multi-dose vials. The environmental samples were negative. The sterile injection equipment and the clinical procedures were evaluated as correct. The storage conditions for the drugs were also correct, and all the samples tested negative for Mycobacteria. However Paenibacillus provencensis was isolated from samples of unused multi-dose vials and the withdrawal of the product from distribution was ordered. Deficiencies were detected in the sterile products process of at the homeopathic drug factory, so the production line was suspended.
The results of environmental investigation suggest the most likely cause of the outbreak could have been the contamination of the products in the factory, although there was no laboratory confirmation. The widespread use of homeopathic products in invasive procedures requires extreme control during the manufacturing, handling and packaging process. It is important to consider mesotherapy and parenteral use of homeopathic medicines as potential sources of infection and therefore the same precautions in the procedures and quality assurance of products should be applied as with any other drug or medical activity.
2009 年 2 月,西班牙发现一起因脓肿分枝杆菌引起的皮下脓肿暴发疫情,受影响者均为在一家美容诊所接受过中胚层疗法的健康女性。
开展了流行病学调查、卫生学检查和微生物学研究。对患者采用了克拉霉素(根据药敏试验结果),部分患者联合阿米卡星进行了抗生素治疗。
在该诊所接受治疗的 77 名患者中,有 17 人受到影响。所用注射产品为多剂量小瓶的顺势疗法药物。环境样本为阴性。无菌注射设备和临床操作被评估为正确。药物储存条件也正确,所有样本的分枝杆菌检测均为阴性。然而,从未使用的多剂量小瓶样本中分离出了 provencensis 类芽孢杆菌,并下令停止该产品的分销。在顺势药物工厂的无菌产品处理过程中发现了缺陷,因此生产线被暂停。
环境调查结果表明,此次暴发最有可能的原因是工厂产品污染,尽管没有实验室确认。顺势疗法产品在侵入性操作中的广泛使用要求在制造、处理和包装过程中进行严格控制。应将中胚层疗法和顺势疗法药物的注射使用视为潜在感染源,因此应与任何其他药物或医疗活动一样,对这些程序和产品质量保证采取同样的预防措施。