BackgroundChronic hepatic complications are common in patients with short bowel syndrome–associated intestinal failure (SBS‐IF). Teduglutide, a glucagon‐like peptide‐2 analogue, demonstrated efficacy in reducing parenteral nutrition and/or intravenous fluid dependence among patients with SBS‐IF in phase 3 clinical studies.MethodsThis was a post hoc analysis of pooled data from two separate randomized, double‐blind, placebo‐controlled, multinational phase 3 clinical studies. Adult patients with SBS‐IF with parenteral nutrition and/or intravenous fluid dependence without liver disease at baseline were randomized to treatment with the glucagon‐like peptide‐2 analogue teduglutide (0.05 or 0.10 mg/kg/day) or placebo subcutaneously once daily for 24 weeks. Mixed‐effects models assessed the baseline predictors of change in liver chemistries.ResultsBetween baseline and week 24, teduglutide treatment (n = 109) was associated with least squares mean reductions in aspartate aminotransferase (–7.51 IU/L; P = 0.014), alanine aminotransferase (–12.15 IU/L; P = 0.002), and bilirubin (–5.03 µmol/L [–0.057 mg/dl]; P < 0.001) compared with that of the placebo (n = 59). These values were independent of reductions in parenteral nutrition and/or intravenous fluid dependence.ConclusionTeduglutide treatment was associated with reductions in liver chemistries by week 24, which is beneficial for patients with SBS‐IF beyond improvements in parenteral nutrition and/or intravenous fluid dependence. Future studies should examine how long‐term teduglutide might mitigate the risk of liver disease in patients with SBS‐IF.

中文翻译：

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替度鲁肽改善短肠综合征相关肠衰竭中的肝脏化学成分：事后分析

背景慢性肝脏并发症在短肠综合征相关肠衰竭（SBS-IF）患者中很常见。 Teduglutide 是一种胰高血糖素样肽-2 类似物，在 3 期临床研究中证明可以有效减少 SBS-IF 患者的肠外营养和/或静脉液体依赖。方法这是对来自两个独立的随机、双倍的汇总数据进行的事后分析‐盲法、安慰剂对照、多国 3 期临床研究。基线时患有肠外营养和/或静脉液体依赖且无肝病的 SBS-IF 成年患者被随机分配接受胰高血糖素样肽 2 类似物替度鲁肽（0.05 或 0.10 mg/kg/天）或安慰剂治疗，每日一次皮下注射，持续时间24 周。混合效应模型评估了肝脏化学变化的基线预测因子。结果在基线和第 24 周之间，替度鲁肽治疗（n= 109）与天冬氨酸转氨酶的最小二乘平均降低相关（–7.51 IU/L；磷= 0.014)，丙氨酸转氨酶 (–12.15 IU/L；磷= 0.002) 和胆红素 (–5.03 µmol/L [–0.057 mg/dl]；磷< 0.001) 与安慰剂相比 (n= 59）。这些值与肠外营养和/或静脉液体依赖的减少无关。 结论 Teduglutide 治疗与第 24 周时肝脏化学成分的减少相关，这对于 SBS-IF 患者除了改善肠外营养和/或静脉液体依赖之外还有益处。未来的研究应该探讨长期服用替度鲁肽如何降低 SBS-IF 患者患肝病的风险。