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美国FDA批准GATTEX用于治疗短肠综合症（SBS）儿童患者

2019-05-18 不详 MedSci原创

GATTEX短肠综合症儿童
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武田制药宣布美国食品和药物管理局（FDA）批准扩展GATTEX（teduglutide）注射液，用于1岁以上需要额外营养或静脉注射（IV）喂养（肠外支持）的短肠综合症（SBS）儿童患者。

武田制药宣布美国食品和药物管理局（FDA）批准扩展GATTEX（teduglutide）注射液，用于1岁以上需要额外营养或静脉注射（IV）喂养（肠外支持）的短肠综合症（SBS）儿童患者。

SBS是一种危及生命的吸收不良症，由手术切除大部分肠道引起。患有SBS的儿童无法从饮食中吸收足够的营养，SBS治疗的目标是恢复剩余的肠道吸收营养素的能力，并减少对肠外支持（PS）的长期依赖性。

GATTEX是第一种也是唯一一种模仿天然存在的胰高血糖素样肽-2（GLP-2）的药物，它可以帮助剩余的肠道吸收更多的营养。在成人的药效学研究中，GATTEX被证明可以改善肠道吸收量。

在一项为期24周的儿科研究中，GATTEX帮助减少了每日所需PS的量和服用PS的时间，部分儿童甚至完全摆脱了PS。

GATTEX在儿科和成人患者中具有相似的安全性。在临床试验中用GATTEX治疗的成年患者中最常见的不良反应（≥10％）是腹痛，恶心，上呼吸道感染，腹胀，注射部位反应，呕吐，体液超负荷和超敏反应。

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    2020-02-24 12498e67m28暂无昵称

    #TTE#

    0

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    2019-09-11 智者为医08

    #FDA批准#

    0

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    2019-11-16 minlingfeng

    #SBS#

    0

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    2019-05-20 10518098zz

    #美国FDA#

    0