McKeage Kate
Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand,
Clin Drug Investig. 2015 May;35(5):335-40. doi: 10.1007/s40261-015-0286-6.
Teduglutide (Gattex(®)) is a recombinant analogue of human glucagon-like peptide-2 and is indicated for the treatment of adults with short bowel syndrome (SBS) dependent on parenteral support (PS). In a pivotal, 24-week clinical trial in SBS patients, subcutaneous teduglutide 0.05 mg/kg once daily increased absorption from the remnant intestine as evidenced by significant reductions in PS volume requirements versus placebo. Improvements attained in absorption in the first 6 months of therapy were maintained during the extension trial (total teduglutide treatment periods of up to 30 months), with evidence indicating that benefits accrue over time. Among patients who received teduglutide treatment for up to 30 months, 11 of 30 were able to achieve at least one additional day off PS and another ten achieved complete independence from PS. Subcutaneous teduglutide was generally well tolerated in clinical trials, including over the long term, with most adverse events that led to study discontinuation being gastrointestinal in origin.
替度鲁肽（商品名：Gattex(®)）是一种重组人胰高血糖素样肽-2类似物，适用于治疗依赖肠外支持（PS）的短肠综合征（SBS）成人患者。在一项针对SBS患者的关键24周临床试验中，皮下注射替度鲁肽0.05 mg/kg每日一次可增加残余小肠的吸收，与安慰剂相比，PS量需求显著减少即证明了这一点。在延长期试验（替度鲁肽总治疗期长达30个月）中，治疗前6个月吸收方面取得的改善得以维持，有证据表明益处会随着时间累积。在接受替度鲁肽治疗长达30个月的患者中，30人中有11人能够实现至少多一天无需PS，另有10人实现了完全不依赖PS。皮下注射替度鲁肽在临床试验中总体耐受性良好，包括长期试验，导致研究中止的大多数不良事件源于胃肠道。
