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在静脉注射期间对生物化学应答不足的炎症性肠病患者进行皮下注射英夫利昔单抗转换治疗的效果。

Effectiveness of switching to subcutaneous infliximab in inflammatory bowel disease patients with inadequate biochemical response during intravenous administration.

机构信息

Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.

出版信息

Sci Rep. 2024 Oct 17;14(1):24347. doi: 10.1038/s41598-024-75693-7.

Abstract

Infliximab (IFX) has transformed the management of inflammatory bowel diseases (IBD). While intravenous (IV) IFX has been effective, a subcutaneous (SC) formulation offers advantages in convenience and cost. However, there is lack of evidence regarding the transition from IV to SC-IFX, especially for patients with inadequate responses. This study investigates the effectiveness of switching from IV to SC-IFX in patients with inadequate responses during IV maintenance therapy. A retrospective study enrolled IBD patients who transitioned to SC-IFX after demonstrating inadequate responses during IV maintenance therapy. The study collected data of demographics of patients and dose and therapies administered prior to the IV-IFX. Primary outcomes included improvements in C-reactive protein (CRP) or fecal calprotectin (FC) levels. This study evaluated the trough levels and its differences between pre- and post-switching. Among 44 patients included, 10 exhibited CRP elevation before the switch, with 6 showing normalization post-switch. Similarly, 42 patients had elevated FC levels pre-switch, with 26 experiencing reductions post-switch. Trough levels increased after the switch. However, there were no significant differences between responders and non-responders. This study is the first study to investigate the transition therapy of IV to SC-IFX in patients with inadequate response. This suggests that SC-IFX could be a viable alternative in the management of IBD. However, further research is necessary to evaluate its efficacy in a larger population of patients who exhibit inadequate responses during IV-IFX maintenance therapy.

摘要

英夫利昔单抗(IFX)改变了炎症性肠病(IBD)的治疗方式。静脉内(IV)IFX 已经有效,而皮下(SC)制剂在便利性和成本方面具有优势。然而,对于应答不足的患者,从 IV 到 SC-IFX 的转换缺乏证据。本研究调查了在 IV 维持治疗中应答不足的患者从 IV 转换为 SC-IFX 的有效性。一项回顾性研究纳入了在 IV 维持治疗中显示应答不足后转为 SC-IFX 的 IBD 患者。该研究收集了患者的人口统计学数据以及在开始 IV-IFX 之前使用的剂量和治疗方案。主要结局包括 C 反应蛋白(CRP)或粪便钙卫蛋白(FC)水平的改善。本研究评估了转换前后的谷浓度及其差异。在纳入的 44 名患者中,10 名患者在转换前 CRP 升高,其中 6 名患者在转换后恢复正常。同样,42 名患者在转换前 FC 水平升高,其中 26 名患者在转换后水平降低。转换后谷浓度升高。然而,应答者和无应答者之间没有显著差异。本研究是第一项研究 IV 到 SC-IFX 转换治疗在应答不足患者中的研究。这表明 SC-IFX 可能是 IBD 管理的一种可行替代方案。然而,需要进一步研究来评估其在更大的 IV-IFX 维持治疗中应答不足的患者群体中的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a0a/11487171/7c6a7e295726/41598_2024_75693_Fig1_HTML.jpg

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