皮肤移植物应用风险与管理

中国药物警戒 ›› 2010, Vol. 7 ›› Issue (4): 213-216.

皮肤移植物应用风险与管理

许伟

国家食品药品监督管理局医疗器械技术审评中心,北京 100044

收稿日期:2016-02-19 修回日期:2016-02-19 出版日期:2010-04-08 发布日期:2016-02-19
作者简介:许伟,女,副主任医师,医疗器械技术审评。

The Risks and Regulation of Skin Graft Substitute

XU Wei

Center for Medical Devices Evaluation, SFDA, Beijing 100044, China

Received:2016-02-19 Revised:2016-02-19 Online:2010-04-08 Published:2016-02-19

摘要/Abstract

摘要： 目前同种异体皮肤、异种皮肤及组织工程皮肤已广泛应用于临床,但存在疾病传播和免疫排斥的风险,应加强管理以保证其应用的安全性与有效性。通过分析同种皮肤、异种皮肤及组织工程皮肤在应用过程中可能存在的安全风险,阐述我国皮肤移植物安全管理现状,并提出加强安全管理的建议。

关键词: 皮肤移植物, 风险, 管理

Abstract: Alloskin, heteroskin and tissue engineered skin have been extensively used in clinical. The regulation should be emphasized on the safety and effectiveness since the potential risks of virus transmission and immunological rejection. It analyzed the potential risks associated with the application of Alloskin, heteroskin and tissue engineered skin. The present situation on the regulation of these products also summarized and gives some new suggestions and comments on the regulation enhancement.

Key words: skin graft substitute, risks, regulation

中图分类号:

R617

许伟. 皮肤移植物应用风险与管理[J]. 中国药物警戒, 2010, 7(4): 213-216.

XU Wei. The Risks and Regulation of Skin Graft Substitute[J]. Chinese Journal of Pharmacovigilance, 2010, 7(4): 213-216.

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