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Drugs. 2013 Jun;73(9):935-47. doi: 10.1007/s40265-013-0070-y.
The recombinant analogue of human glucagon-like peptide-2 (GLP-2) teduglutide (Gattex(®), Revestive(®)) is a novel therapy for short bowel syndrome (SBS). GLP-2 is a naturally occurring hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract. Subcutaneous teduglutide is the first long-term medical therapy approved for the treatment of adult patients with SBS who are dependent on parenteral support (parenteral nutrition and/or intravenous fluids). In a pivotal, double-blind, multicentre, phase III study in adult patients with SBS who were dependent on parenteral support, a significantly higher proportion of teduglutide 0.05 mg/kg/day recipients than placebo recipients achieved at least a 20% reduction from baseline in weekly parenteral support volume at week 20 and maintained at week 24 (primary endpoint). The overall mean reduction in weekly parenteral support volume from baseline was greater in patients who received teduglutide compared with those who received placebo. Additionally, more teduglutide-treated patients achieved at least a one-day reduction in parenteral support than those receiving placebo. Subcutaneous teduglutide had an acceptable tolerability profile; the most frequently reported adverse events were of gastrointestinal origin, consistent with the underlying disease condition and the known mechanism of action of teduglutide.
人胰高血糖素样肽-2(GLP-2)重组类似物特迪格鲁肽(Gattex(®),Revestive(®))是治疗短肠综合征(SBS)的新型疗法。GLP-2 是一种天然存在的激素,可调节胃肠道细胞的生长、增殖和维持。特迪格鲁肽皮下注射是第一种被批准用于治疗依赖肠外支持(肠外营养和/或静脉补液)的成年 SBS 患者的长期医疗疗法。在一项依赖肠外支持的成年 SBS 患者的关键性、双盲、多中心、III 期研究中,与安慰剂组相比,接受特迪格鲁肽 0.05mg/kg/天治疗的患者中有更高比例的患者在第 20 周时实现了每周肠外支持量较基线至少减少 20%,并在第 24 周时维持(主要终点)。与接受安慰剂的患者相比,接受特迪格鲁肽治疗的患者每周肠外支持量的总体平均基线降低幅度更大。此外,与接受安慰剂的患者相比,更多接受特迪格鲁肽治疗的患者实现了至少一天的肠外支持减少。特迪格鲁肽具有可接受的耐受性特征;最常报告的不良事件是胃肠道来源的,与潜在疾病状况和特迪格鲁肽的已知作用机制一致。