[儿科胃肠病学和营养学会(GPGE)关于已批准用于成人的生物制剂和信号抑制剂在患有IBD的儿童和青少年中的超说明书使用的立场文件]。

IF 1.4 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY
Zeitschrift fur Gastroenterologie Pub Date : 2025-03-01 Epub Date: 2025-02-17 DOI:10.1055/a-2474-3104
Jan Däbritz, Martin Classen, Kathrin Krohn, Andreas Krahl, Stephan Buderus, Elke Lainka, Jan de Laffolie, Carsten Posovszky
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引用次数: 0

摘要

儿童和青少年慢性炎症性肠病(IBD)的治疗基本上与成人患者没有什么不同。然而,随着用于成人的生物制剂和信号抑制剂数量的稳步增加,目前只有两种TNFα抗体在德国被批准用于治疗6岁以上的IBD。这意味着批准用于成人IBD的大部分药物无法用于患有中度至重度疾病的儿童和青少年。批准的药物数量较少也使得难以实现诊断后IBD持续缓解的预后重要目标,其特征是患者无症状,也是黏膜愈合的客观目标。本立场文件旨在介绍目前对年龄限制之外患有IBD的儿童和青少年进行药物治疗的研究情况,并作为医疗服务部门评估个案申请以及治疗医生、费用承付者、卫生政策和社会法院决策者的信息和决策基础。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Position paper of the Society for Paediatric Gastroenterology and Nutrition (GPGE) on the off-label use of biologics and signal inhibitors in children and adolescents with IBD that have already been approved for adults].

Therapy for children and adolescents with chronic inflammatory bowel disease (IBD) is basically no different from that for adult patients. However, of the steadily increasing number of biologics and signalling inhibitors for adults, only two TNFα antibodies are currently approved in Germany for the treatment of IBD from the age of 6. This means that a large proportion of the drugs authorised for adults with IBD are not available for children and adolescents with moderate to severe disease. The small number of approved drugs also makes it difficult to achieve the prognostically important goal of achieving a sustained remission of IBD soon after diagnosis, which is characterised by the patient being free of symptoms and also the objectifiable goal of mucosa healing. This position paper is intended to present the current study situation on the drug treatment of children and adolescents with IBD outside the age limit and to serve as a basis for information and decision-making for the Medical Service in the assessment of individual case applications as well as for the treating physicians, the cost bearers, health policy and social court decision-makers.

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来源期刊
Zeitschrift fur Gastroenterologie
Zeitschrift fur Gastroenterologie 医学-胃肠肝病学
CiteScore
1.40
自引率
15.40%
发文量
562
审稿时长
6-12 weeks
期刊介绍: Die Zeitschrift für Gastroenterologie ist seit über 50 Jahren die führende deutsche Fachzeitschrift auf dem Gebiet der Gastroenterologie. Sie richtet sich an Gastroenterologen und alle anderen gastroenterologisch interessierten Ärzte. Als offizielles Organ der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten sowie der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie informiert sie zuverlässig und aktuell über die wichtigen Neuerungen und Entwicklungen in der Gastroenterologie.
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