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[用于治疗的转基因生物的卫生安全性]

[Sanitary safety of GMOs used in therapeutics].

作者信息

Trouvin Jean-Hugues

机构信息

Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), 143 Bd A. France, 93285 Saint-Denis.

出版信息

Bull Acad Natl Med. 2002;186(8):1401-9.

Abstract

The recent progress in human therapeutics has been made possible thanks to molecular biology and its use in producing proteins having the same sequence and structure as that of human proteins. The use of GMOs allows production of proteins with high added value in therapeutics, which are of satisfactory quality. GMOs may also be directly administered to patients as gene therapy vectors. However, the use of GMOs in therapeutics must take into consideration some risks, particularly those of microbiological contamination, of neo-antigenicity as well as environmental risks with regard to the way of use of the GMO. Nevertheless, those risks are taken in due consideration in the development of those new medicinal products; solutions have been found to allow their use in therapeutics with a very positive benefit/risk ratio. Medicinal products from biotechnology have permitted considerable therapeutic progress without compromising health security.

摘要

得益于分子生物学及其在生产与人类蛋白质具有相同序列和结构的蛋白质方面的应用,人类治疗学取得了近期的进展。转基因生物的使用使得在治疗学中生产具有高附加值且质量令人满意的蛋白质成为可能。转基因生物也可作为基因治疗载体直接施用于患者。然而,在治疗学中使用转基因生物必须考虑一些风险,特别是微生物污染风险、新抗原性风险以及与转基因生物使用方式相关的环境风险。尽管如此,在这些新药品的研发过程中已充分考虑了这些风险;已找到解决方案,使其能够以非常有利的效益/风险比用于治疗学。生物技术药物在不损害健康安全的情况下实现了显著的治疗进展。

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