Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Medical Department, Division of Hepatology and Gastroenterology, Campus Virchow-Klinikum and Campus Charité Mitte, 10117 Berlin, Germany.
Berlin Institute of Health (BIH), 10178 Berlin, Germany.
Nutrients. 2023 Apr 18;15(8):1949. doi: 10.3390/nu15081949.
Quality of life (QoL) data of chronic intestinal failure (cIF) patients treated with the GLP-2 analogue teduglutide are scarce. This study aims to analyze QoL changes over time in teduglutide-treated patients and compare the results to a matched non-treated cIF control group in a real-world setting.
QoL data (SF-36 and SBS-QoL) were obtained from adult cIF patients being treated with teduglutide and compared to previously collected QoL data from a PNLiver trial (DRKS00010993), during which patients had been therapy naive. The dataset was then extended by a pairwise matched control group (non-teduglutide-treated PNLiver trial patients) and follow-up data from this group were collected accordingly.
Median teduglutide treatment duration and the follow-up period of controls were both 4.3 years. SBS-QoL subscales and the SBS-QoL sum score showed significant improvements over time in teduglutide-treated patients, as well as for the SF-36 physical and mental component summary scores (all < 0.02), while non-treated patients showed no significant changes in any of the mentioned scores. Significant differences of QoL changes between treated and non-treated patients were seen for both SF-36 summary scores ( = 0.031 and 0.012).
We herein demonstrate for the first time that QoL significantly improved during teduglutide treatment in SBS-cIF patients in a real-world setting compared to individually matched non-treated SBS-cIF patients, indicating relevant clinical benefits.
接受 GLP-2 类似物特迪格鲁肽治疗的慢性肠衰竭（cIF）患者的生活质量（QoL）数据稀缺。本研究旨在分析特迪格鲁肽治疗患者的 QoL 随时间的变化，并将结果与真实环境中匹配的未经治疗的 cIF 对照组进行比较。
从接受特迪格鲁肽治疗的成年 cIF 患者中获取 QoL 数据（SF-36 和 SBS-QoL），并将其与先前在 PNLiver 试验（DRKS00010993）中收集的未经治疗的患者的 QoL 数据进行比较。然后，通过配对匹配的对照组（未经特迪格鲁肽治疗的 PNLiver 试验患者）扩展数据集，并相应地收集该组的随访数据。
特迪格鲁肽治疗的中位时间和对照组的随访时间均为 4.3 年。SBS-QoL 子量表和 SBS-QoL 总分在特迪格鲁肽治疗患者中随时间显著改善，SF-36 身体和心理成分综合评分也显著改善（均 < 0.02），而未经治疗的患者在任何评分中均无显著变化。在 SF-36 综合评分方面，治疗和未治疗患者的 QoL 变化存在显著差异（ = 0.031 和 0.012）。
我们首次证明，与个体匹配的未经治疗的 SBS-cIF 患者相比，特迪格鲁肽治疗可显著改善 SBS-cIF 患者的 QoL，表明具有相关的临床获益。
