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特迪格鲁肽:短肠综合征治疗药物的综述。

Teduglutide: A Review in Short Bowel Syndrome.

机构信息

Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand.

出版信息

Drugs. 2017 Mar;77(3):345-352. doi: 10.1007/s40265-017-0703-7.

Abstract

Subcutaneous teduglutide (Revestive), a glucagon-like peptide-2 analogue that increases intestinal absorption, is approved in the EU for the treatment of short bowel syndrome (SBS) in patients aged ≥1 year who are stable following a period of postsurgical intestinal adaptation. In a phase III trial in adults with SBS intestinal failure (IF) dependent on parenteral support (PS), a significantly greater proportion of teduglutide 0.05 mg/kg/day than placebo recipients achieved a ≥20% reduction in weekly PS volume from baseline to week 20 and maintained it to week 24. The proportion of patients who had a reduction in one or more days on PS was also significant with teduglutide compared with placebo. Improved intestinal absorption and reduced PS requirements were generally maintained in the longer term. Results from a phase III trial in paediatric patients with SBS-IF dependent on PS were consistent with those in adults. Adverse events were mostly of mild to moderate severity and generally consistent with the underlying condition or known mechanism of the drug (e.g. central line-related issues, gastrointestinal events). Teduglutide is therefore a useful treatment option in children (aged ≥1 year), adolescents and adults with SBS.

摘要

皮下注射型特度鲁肽(Revestive)是一种胰高血糖素样肽-2 类似物,可增加肠道吸收,在欧盟获批用于治疗年龄≥1 岁、经术后肠道适应期后稳定的短肠综合征(SBS)患者。在一项依赖肠外支持(PS)的成人 SBS 肠衰竭(IF)的 III 期试验中,与安慰剂组相比,特度鲁肽 0.05mg/kg/天组有更大比例的患者在从基线到第 20 周时实现每周 PS 量减少≥20%,并在第 24 周时维持该水平。与安慰剂相比,特度鲁肽组患者中有更多的患者减少了 PS 使用天数。在更长的时间内,肠道吸收的改善和 PS 需求的减少通常得以维持。在依赖 PS 的 SBS-IF 儿科患者中进行的 III 期试验结果与成人结果一致。不良事件大多为轻至中度严重程度,且通常与基础疾病或药物的已知作用机制一致(例如中心静脉相关问题、胃肠道事件)。因此,特度鲁肽是儿童(≥1 岁)、青少年和成人 SBS 的一种有效治疗选择。

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