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英夫利昔单抗联合植物性饮食作为重度溃疡性结肠炎一线(IPF)治疗的高缓解率:单组试验。

High Remission Rate with Infliximab and Plant-Based Diet as First-Line (IPF) Therapy for Severe Ulcerative Colitis: Single-Group Trial.

机构信息

Gastroenterology Division, Akita City Hospital, Akita, Japan.

Gastroenterology Division, Nakadori General Hospital, Akita, Japan.

出版信息

Perm J. 2020 Nov;24:1-10. doi: 10.7812/TPP/19.166.

Abstract

INTRODUCTION

About one-third of patients with severe ulcerative colitis (UC) do not respond to corticosteroid therapy and receive rescue therapy with infliximab or cyclosporine. Up to 20% of such patients fail to respond to rescue therapy and undergo colectomy.

OBJECTIVE

We investigated the outcomes of infliximab and a plant-based diet (PBD) as first-line therapy for severe UC.

METHODS

Patients with severe UC defined by the Truelove and Witts criteria were admitted and given standard induction therapy with infliximab (5.0 mg/kg-7.5 mg/kg) at 0, 2, and 6 weeks. Additionally, they received a PBD. The primary endpoint was remission or colectomy in the induction phase and 1 year after discharge. Secondary endpoints were changes in inflammatory markers in the induction phase and the PBD score at baseline and follow-up. A higher PBD score indicates greater adherence to a PBD.

RESULTS

Infliximab and PBD as first-line therapy was administered in 17 cases. The remission rate was 76% (13/17), and the colectomy rate was 6% (1/17) in the induction phase. C-reactive protein values and the erythrocyte sedimentation rate significantly decreased at week 6 from 9.42 mg/dL to 0.33 mg/dL and from 59 to 17 mm/h, respectively (p < 0.0001). At 1-year follow-up, the cumulative relapse rate was 25%, and there were no additional colectomy cases. Mean PBD scores of 27.7 at 1 year and 23.8 at 4 years were significantly higher than baseline scores of 8.3 and 9.9, respectively (p < 0.0001 and p = 0.0391).

CONCLUSION

This new first-line therapy for severe UC demonstrated a higher remission rate and lower colectomy rate than with the current modality.

摘要

简介

约三分之一的重度溃疡性结肠炎(UC)患者对皮质类固醇治疗无反应,并接受英夫利昔单抗或环孢素的挽救治疗。多达 20%的此类患者对挽救治疗无反应,需要进行结肠切除术。

目的

我们研究了英夫利昔单抗和植物性饮食(PBD)作为重度 UC 一线治疗的结果。

方法

根据 Truelove 和 Witts 标准,将重度 UC 患者纳入研究并接受标准诱导治疗,即英夫利昔单抗(5.0 mg/kg-7.5 mg/kg),分别在第 0、2 和 6 周给予治疗。此外,患者还接受了 PBD。主要终点是诱导期和出院后 1 年内的缓解或结肠切除术。次要终点是诱导期炎症标志物的变化以及基线和随访时的 PBD 评分。PBD 评分越高表示对 PBD 的依从性越高。

结果

17 例患者接受了英夫利昔单抗和 PBD 作为一线治疗。诱导期的缓解率为 76%(13/17),结肠切除术率为 6%(1/17)。C 反应蛋白值和红细胞沉降率在第 6 周分别从 9.42 mg/dL 降至 0.33 mg/dL 和从 59 降至 17 mm/h,差异均有统计学意义(p < 0.0001)。在 1 年随访时,累积复发率为 25%,无额外的结肠切除术病例。1 年和 4 年时的平均 PBD 评分分别为 27.7 和 23.8,明显高于基线时的 8.3 和 9.9,差异均有统计学意义(p < 0.0001 和 p = 0.0391)。

结论

这种治疗重度 UC 的新一线疗法的缓解率和结肠切除术率高于目前的治疗方法。

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