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特杜古肽治疗儿科肠衰竭:意大利儿科胃肠病学、肝病学和营养学学会(SIGENP)立场声明。

Teduglutide in pediatric intestinal failure: A position statement of the Italian society of pediatric gastroenterology, hepatology and nutrition (SIGENP).

机构信息

Gastroenterology and Nutritional Rehabilitation Unit, Bambino Gesù Children's Hospital, Piazza Sant'Onofrio 4, Rome, Italy.

Dietetics and Clinical Nutrition Unit, Children's Hospital Regina Margherita, Città della Salute e della Scienza Torino, Piazza Polonia 94, Turin, Italy.

出版信息

Dig Liver Dis. 2022 Oct;54(10):1320-1327. doi: 10.1016/j.dld.2022.04.028. Epub 2022 May 31.

Abstract

In recent years, the spectrum of possible treatments for Intestinal Failure (IF)-Short Bowel Syndrome (SBS) has been enriched by the implementation of GLP-2 analogues. In Italy, teduglutide (Ted), an analogue of GLP-2, was approved in January 2021 by the Italian Regulatory Agency for Drugs (AIFA) for IF-SBS patients ≥1 year old. According to the Agency indications, Ted can now be prescribed by regional reference centers, with costs fully charged to the National Health Service. Following pediatric-use approval in our country and in light of scarce evidence in childhood, the pediatric network for IF of the Italian Society for Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP) planned to share management methods of Ted in pediatric IF. The main purpose was to identify the best candidates from a cost-effective perspective. Thus, focusing on available literature and on expert opinions, the present position statement provides consensus-based recommendations on the use of Ted for pediatric gastroenterologists and nutritionists treating children with SBS.

摘要

近年来,GLP-2 类似物的应用丰富了肠衰竭(IF)-短肠综合征(SBS)的可能治疗方法。在意大利,GLP-2 类似物特迪珠单抗(Ted)于 2021 年 1 月被意大利药品监管局(AIFA)批准用于年龄≥1 岁的 IF-SBS 患者。根据该机构的指示,Ted 现在可以由地区参考中心开具处方,费用由国家卫生服务机构全额承担。在我国获得儿科使用批准后,鉴于儿童期证据有限,意大利儿科胃肠病学、肝病学和营养学学会(SIGENP)的 IF 儿科网络计划分享 Ted 在儿科 IF 中的管理方法。主要目的是从成本效益的角度确定最佳人选。因此,本立场声明重点关注现有文献和专家意见,为治疗 SBS 儿童的儿科胃肠病学家和营养师提供关于 Ted 使用的基于共识的建议。

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