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[皮肤科已获批的全身治疗方法]

[Approved systemic therapies in dermatology].

作者信息

Kleinhans Monika, Funke-Lorenz Carolin, Dissemond Joachim

机构信息

Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Essen, Hufelandstr. 55, 45147, Essen, Deutschland.

出版信息

Hautarzt. 2021 Sep;72(9):785-796. doi: 10.1007/s00105-021-04816-2. Epub 2021 Apr 21.

DOI:10.1007/s00105-021-04816-2
PMID:33884435
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8417003/
Abstract

BACKGROUND

In recent years, an increasing spectrum of systemic therapies has become available in the field of dermatology. Some of these drugs are used off-label, which for example can lead to problems with reimbursement. This article is therefore intended to provide an overview of the currently approved systemic therapies in dermatology and to point out further alternatives such as Compassionate Use and Early Access Programs.

MATERIALS AND METHODS

The search for approved drugs in Germany was conducted online in the database for drugs of the Federal Institute for Drugs and Medical Devices. In addition, a comparison was made with the information provided from the Rote Liste.

RESULTS

For a total of 50 dermatologically relevant diseases, the respective approved system therapies are presented in tabular form.

CONCLUSIONS

It can be stated that the enormous developments over the last few years and the increasingly good evidence offer in many cases very promising systemic treatment concepts despite the frequent lack of clinical studies in the field of dermatology. However, the often necessary off-label use can cause difficulties in everyday clinical practice. The attending physician should therefore always be informed if a planned therapy involves off-label use. Previously approved alternatives should be considered and patients should be adequately informed.

摘要

背景

近年来,皮肤科领域有越来越多的全身治疗方法可供使用。其中一些药物存在超说明书用药的情况,例如这可能会导致报销问题。因此,本文旨在概述目前皮肤科已获批的全身治疗方法,并指出其他替代方案,如同情用药和早期获取计划。

材料与方法

在德国联邦药品和医疗器械研究所的药品数据库中在线搜索已获批的药物。此外,还与《德国药品报销目录》提供的信息进行了比较。

结果

以表格形式列出了总共50种与皮肤科相关疾病各自获批的全身治疗方法。

结论

可以说,尽管皮肤科领域经常缺乏临床研究,但过去几年的巨大进展以及越来越多的有力证据在许多情况下提供了非常有前景的全身治疗概念。然而,超说明书用药在日常临床实践中常常会带来困难。因此,如果计划的治疗涉及超说明书用药,主治医师应始终了解情况。应考虑先前获批的替代方案,并应充分告知患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1345/8417003/66e0c2b3a23f/105_2021_4816_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1345/8417003/66e0c2b3a23f/105_2021_4816_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1345/8417003/66e0c2b3a23f/105_2021_4816_Fig1_HTML.jpg

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Hautarzt. 2021 Sep;72(9):785-796. doi: 10.1007/s00105-021-04816-2. Epub 2021 Apr 21.
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["With all suitable means". Off-label-use and public statutory employers' liability insurance].["采取一切适当手段"。药品未按说明书使用与公共法定雇主责任保险]
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Comparative study of adalimumab versus conventional therapy in sight-threatening refractory Behçet's uveitis with vasculitis.阿达木单抗与常规治疗对视神经威胁性难治性伴有血管炎的 Behçet 葡萄膜炎的对比研究。
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[Off-label use and G-BA. Legal framework for off-label use].[超说明书用药与德国联邦联合委员会。超说明书用药的法律框架]
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[Off-label use in dermatological practice. The conflict between professional duty and legal requirements].[皮肤科实践中的超说明书用药。专业职责与法律要求之间的冲突]
Hautarzt. 2004 Aug;55(8):727-34. doi: 10.1007/s00105-004-0764-x.