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严重污染的药品和医疗器械引起的真菌病,以及使用纳米诊断工具的快速真菌检测:批判性评价。

Fungal Diseases Caused by Serious Contamination of Pharmaceuticals and Medical Devices, and Rapid Fungal Detection Using Nano-Diagnostic Tools: A Critical Review.

机构信息

Department of Microbiology and Immunology, Faculty of Pharmaceutical Science and Drug Manufacturing, Misr University for Science and Technology, Cairo, 6th of October City, Egypt.

Microbiology Department, Egyptian Drug Authority, Previously National Organization for Drug Control and Research, Giza, Egypt.

出版信息

Curr Microbiol. 2023 Nov 17;81(1):10. doi: 10.1007/s00284-023-03506-7.

Abstract

Fungal-contaminated compounded pharmaceuticals and medical devices pose a public health problem. This review aimed to provide an organized overview of the literature on that critical issue. Firstly, it was found that compounding pharmacies can produce drugs that are contaminated with fungi, leading to outbreaks of severe fungal diseases. Secondly, inadequate sterile compounding techniques or storage conditions, or exceeding the limit of a fungal count, can result in fungal contamination. Lastly, nanotools can be used to rapidly detect fungi, thus improving fungal diagnostic procedures. To achieve this goal, we have reviewed the published data on PubMed, the CDC, and FDA Web sites, and a literature search was undertaken to identify severe fungal infections associated with compounding pharmacies outside of hospitals, limited by the dates 2003 to 2021. The "Preferred Reporting Items for Critical Reviews" were followed in searching, including, and excluding papers. Fungal outbreaks have been documented due to contaminated pharmaceuticals and medical devices. In 2013, 55 people died from fungal meningitis caused by contaminated steroid injections containing methylprednisolone acetate. Additionally, in 2021, Aspergillus penicillioides contamination was reported in ChloraPrep drugs, which was attributed to the storage conditions that were conducive to the growth of this fungus. These incidents have resulted in severe infectious diseases, such as invasive mycoses, cornea infections, Endophthalmitis, and intestinal and gastric mycosis. By implementing preventive measures and policies, it is possible to avoid these outbreaks. Creating Nano-diagnostics presents a major challenge, where promptly diagnosing fungal infections is required to determine the proper corrective and preventive measures.

摘要

真菌污染的复方药物和医疗器械构成了公共卫生问题。本综述旨在提供该关键问题文献的系统概述。首先,发现复方药剂师可以生产出被真菌污染的药物,导致严重真菌感染的爆发。其次,无菌复方技术或储存条件不当,或真菌计数超标,都可能导致真菌污染。最后,可以使用纳米工具快速检测真菌,从而改进真菌诊断程序。为实现这一目标,我们查阅了 PubMed、CDC 和 FDA 网站上发表的数据,并进行了文献检索,以确定医院外复方药房与真菌感染相关的文献,检索时间限制在 2003 年至 2021 年。在检索时,我们遵循了“关键评论报告的首选项目”,包括和排除了论文。由于药物和医疗器械受到污染,真菌爆发已经被记录在案。2013 年,有 55 人因含有醋酸甲基强的松龙的受污染类固醇注射剂引起的真菌性脑膜炎而死亡。此外,2021 年,ChloraPrep 药物中报告了青霉 penicillioides 的污染,这归因于有利于这种真菌生长的储存条件。这些事件导致了严重的传染病,如侵袭性真菌感染、角膜感染、眼内炎和肠道和胃真菌感染。通过实施预防措施和政策,可以避免这些爆发。创建纳米诊断学提出了一个重大挑战,需要及时诊断真菌感染,以确定适当的纠正和预防措施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dbc1/10656328/bfe149820461/284_2023_3506_Fig1_HTML.jpg

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