用于治疗慢性伤口的冷常压等离子体：药物还是医疗器械？
Cold atmospheric pressure plasma for treatment of chronic wounds: drug or medical device?
作者信息
Kramer A, Conway B R, Meissner K, Scholz F, Rauch B H, Moroder A, Ehlers A, Meixner A J, Heidecke C-D, Partecke L I, Kietzmann M, Assadian O
机构信息
Consultant Clinical Microbiology and Infection Control, Institute of Hygiene and Environmental Medicine, University Medicine Greifswald, Germany.
Department of Pharmacy, School of Applied Sciences, University of Huddersfield, United Kingdom; Institute of Skin Integrity and Infection Prevention, School for Human and Health Sciences, University of Huddersfield.
出版信息
J Wound Care. 2017 Aug 2;26(8):470-475. doi: 10.12968/jowc.2017.26.8.470.
OBJECTIVE
The use of cold atmospheric pressure plasma (CAPP) as a new therapeutic option to aid the healing of chronic wounds appears promising. Currently, uncertainty exists regarding their classification as medical device or medical drug. Because the classification of CAPP has medical, legal, and economic consequences as well as implications for the level of preclinical and clinical testing, the correct classification is not an academic exercise, but an ethical need.
METHOD
A multidisciplinary team of physicians, surgeons, pharmacists, physicists and lawyers has analysed the physical and technical characteristics as well as legal conditions of the biological action of CAPP.
RESULTS
It was concluded that the mode of action of the locally generated CAPP, with its main active components being different radicals, is pharmacological and not physical in nature.
CONCLUSION
Depending on the intended use, CAPP should be classified as a drug, which is generated by use of a medical device directly at the point of therapeutic application.
目的
使用冷常压等离子体（CAPP）作为辅助慢性伤口愈合的一种新治疗选择似乎很有前景。目前，关于将其归类为医疗器械还是药品存在不确定性。由于CAPP的分类具有医学、法律和经济后果，以及对临床前和临床试验水平的影响，正确分类并非学术行为，而是一项伦理需求。
方法
由医生、外科医生、药剂师、物理学家和律师组成的多学科团队分析了CAPP的物理和技术特性以及其生物作用的法律条件。
结果
得出的结论是，局部产生的CAPP的作用方式，其主要活性成分是不同的自由基，本质上是药理学的而非物理的。
结论
根据预期用途，CAPP应归类为一种药物，它是通过在治疗应用点直接使用医疗器械产生的。
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