Division of Gastroenterology & Farncombe Family Digestive Health Research Institute, HSC-3V3, McMaster University, 1280 Main Street West, Hamilton, ON L8S 4K1, Canada.
Norwich Medical School, University of East Anglia, 2.12 Bob Champion Research & Education Bldg, Norwich, England, UK.
Clin Nutr. 2020 Jun;39(6):1774-1777. doi: 10.1016/j.clnu.2019.08.020. Epub 2019 Aug 23.
BACKGROUND & AIMS: Teduglutide promotes intestinal growth and is approved for the treatment of short bowel syndrome and intestinal failure (SBS-IF). Based on the pharmacologic activity and preclinical findings, teduglutide can potentially induce proliferative colonic mucosal changes. The aim of this study is to report the occurrence of colorectal polyps in adult patients with SBS-IF who received teduglutide in clinical studies conducted to date.
A post hoc analysis of the completed Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent Short Bowel Syndrome Subjects (STEPS) clinical study series (NCT00798967, EudraCT 2008-006193-15; NCT00930644, EudraCT 2009-011679-65; NCT01560403) evaluated electronic case report form data for baseline colonoscopies (performed before treatment) and for surveillance or end-of-study (performed after treatment with teduglutide 0.05 mg/kg/day for 24 and 36 months) post-exposure procedures.
In the STEPS studies, 73 patients treated with teduglutide had a baseline colonoscopy. No post-exposure colonoscopy was scheduled in STEPS. In STEPS-2/3, 50 of 65 patients with remnant colon (77%) underwent a protocol-mandated post-exposure colonoscopy. Colon polyps were reported at baseline in 12% (9/73) of patients and post-exposure in 18% (9/50) of patients. Two had polyps both at baseline and post-exposure. On histology, available for 7 patients, 5 had adenomas (1 serrated, 4 tubular) and none had malignancy or high-grade dysplasia.
These data support recommendations for colonoscopic screening before teduglutide therapy and subsequent on-therapy colonoscopic surveillance for patients with SBS-IF. Further studies are required to assess the risk of polyp formation in patients with SBS-IF and the most appropriate colon polyp surveillance strategies.
特杜古肽可促进肠生长，被批准用于治疗短肠综合征和肠衰竭（SBS-IF）。基于其药理学活性和临床前研究结果，特杜古肽可能会引起结肠黏膜增生性改变。本研究旨在报告迄今为止在接受特杜古肽治疗的 SBS-IF 成年患者中发生的结直肠息肉。
对已完成的特杜古肽治疗肠外营养依赖型短肠综合征患者的有效性研究（STEPS）临床研究系列（NCT00798967，EudraCT 2008-006193-15；NCT00930644，EudraCT 2009-011679-65；NCT01560403）的电子病例报告表数据进行了事后分析，这些数据包括基线结肠镜检查（治疗前进行）和暴露后程序（特杜古肽 0.05mg/kg/天治疗 24 个月和 36 个月后进行）的监测或研究结束时的结肠镜检查。
在 STEPS 研究中，73 例接受特杜古肽治疗的患者进行了基线结肠镜检查。STEPS 未计划暴露后进行结肠镜检查。在 STEPS-2/3 中，50 例有残余结肠的患者（77%）进行了方案规定的暴露后结肠镜检查。基线时报告有结肠息肉的患者占 12%（9/73），暴露后报告有息肉的患者占 18%（9/50）。其中 2 例患者在基线和暴露后均有息肉。组织学检查结果可用于 7 例患者，其中 5 例为腺瘤（1 例锯齿状，4 例管状），均无恶性肿瘤或高级别异型增生。
这些数据支持在特杜古肽治疗前进行结肠镜筛查和 SBS-IF 患者随后进行治疗期间结肠镜监测的建议。需要进一步研究以评估 SBS-IF 患者形成息肉的风险和最适当的结肠息肉监测策略。
