Pironi Loris, Sasdelli Anna Simona, Venerito Francesca Maria, Musio Alessandra, Pazzeschi Caterina, Guidetti Mariacristina
Centre for Chronic Intestinal Failure - Clinical Nutrition and Metabolism Unit - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; University of Bologna, Department of Medical and Surgical Sciences, Bologna, Italy.
Centre for Chronic Intestinal Failure - Clinical Nutrition and Metabolism Unit - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Clin Nutr. 2021 Jun;40(6):4065-4074. doi: 10.1016/j.clnu.2021.02.011. Epub 2021 Feb 13.
The glucagon-like peptide-2 (GLP-2) analogue, teduglutide, allows to reduce the intravenous supplementation (IVS) dependency of patients with short bowel syndrome and intestinal failure (SBS-IF). The rate of candidacy of SBS-IF patients for the treatment is unknown. The candidacy for teduglutide treatment of our patient cohort was investigated by a systematic analysis.
The indications, contraindications, special warnings and precautions for use of teduglutide, listed in the drug monographs and in the phase-III trial protocol were adopted to categorize the patients as non-candidates (NC), potential candidates (PC) or straight candidates (SC) for the treatment. All the SBS-IF adult patients who were cured at our centre were assessed according to their clinical status on January 1st, 2020.
Seventy-nine patients were evaluated: 34.2% were NC due to risk of digestive malignancy, recent history of any other cancer, or listing for intestinal transplantation; 30.4% were PC, because of other premalignant conditions, risk of intestinal obstruction, entero-cutaneous fistulas, or severe co-morbidities; 35.4% were SC. The SC group showed the lowest requirement of IVS: the lowest number of days of infusion per week (p = 0.0054), the lowest amount of energy (p = 0.0110) and volume (p = 0.0136).
This systematic analysis allowed a pragmatic categorization of the candidacy of patients with SBS-IF for GLP-2 analogue treatment. The SC group appeared to have the highest probability of a successful response to the treatment. A systematic analysis of SBS-IF patient candidate for GLP-2 analogue therapy would allow a homogeneous patient selection and facilitate the worldwide comparison of the results of clinical practice and research.
胰高血糖素样肽-2(GLP-2)类似物替度鲁肽可降低短肠综合征和肠衰竭(SBS-IF)患者对静脉补充营养(IVS)的依赖。SBS-IF患者的治疗候选率尚不清楚。我们通过系统分析对患者队列中替度鲁肽治疗的候选情况进行了研究。
采用药品专论和III期试验方案中列出的替度鲁肽的适应证、禁忌证、特殊警告和使用注意事项,将患者分类为治疗的非候选者(NC)、潜在候选者(PC)或直接候选者(SC)。对2020年1月1日在我们中心治愈的所有成年SBS-IF患者,根据其临床状况进行评估。
共评估了79例患者:34.2%为NC,原因是存在消化系恶性肿瘤风险、有任何其他癌症的近期病史或列入肠移植名单;30.4%为PC,原因是存在其他癌前病变、肠梗阻风险、肠皮肤瘘或严重合并症;35.4%为SC。SC组对IVS的需求最低:每周输液天数最少(p = 0.0054),能量需求最低(p = 0.0110),液体量需求最低(p = 0.0136)。
该系统分析对SBS-IF患者接受GLP-2类似物治疗的候选情况进行了务实分类。SC组似乎对治疗成功反应的可能性最高。对GLP-2类似物治疗的SBS-IF候选患者进行系统分析,将有助于进行同质化的患者选择,并促进全球范围内临床实践和研究结果的比较。