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克罗恩病生物诱导治疗后的超声缓解及长期内镜缓解:一项前瞻性队列研究

Ultrasound remission after biologic induction and long-term endoscopic remission in Crohn's disease: a prospective cohort study.

作者信息

Allocca Mariangela, Dell'Avalle Cecilia, Zilli Alessandra, Furfaro Federica, D'Amico Ferdinando, Jairath Vipul, Rubin David T, Peyrin-Biroulet Laurent, Fiorino Gionata, Danese Silvio

机构信息

IRCCS Hospital San Raffaele and University Vita-Salute San Raffaele, Gastroenterology and Endoscopy, Milan, Italy.

IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.

出版信息

EClinicalMedicine. 2024 Mar 21;71:102559. doi: 10.1016/j.eclinm.2024.102559. eCollection 2024 May.

Abstract

BACKGROUND

The Bowel Ultrasound Score (BUSS) accurately detects therapy-related changes by using the Simple Endoscopic Score for Crohn's disease (SES-CD) as the reference standard. We aimed to evaluate ultrasound remission as a treatment target and its prediction for long-term endoscopic remission.

METHODS

This single-centre prospective observational study, based at a tertiary referral centre in Milan, Italy, enrolled, between March 1, 2018, and January 31, 2021, adult patients with active CD (SES-CD >2) who were starting biologics. Colonoscopy and IUS was performed at baseline and at 12 months (mean 12.8 ± 4.2). The primary outcome was the predictive value of ultrasound remission at week 12 (BUSS ≤3.52) for long-term endoscopic remission at 12 months. The International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) was also calculated and optimal cut-point to detect endoscopic remission was identified through ROC analysis.

FINDINGS

93 patients with CD were included. Of these, 22 patients (24%) achieved endoscopic remission. Week 12 ultrasound remission predicted endoscopic remission (59% compared with 41% of the patients who were not in ultrasound remission; OR 9.93, 95% CI 3.10-31.80; p < 0.001), while week 12 calprotectin values (<50, <100, <250 μg/g) did not. Week 12 ultrasound activity was associated with failure to achieve long-term endoscopic remission (NPV 87%, PPV 54%). IBUS-SAS cut-off to discriminate endoscopic remission was 22.8 (AUC 0.906). ROC curve comparison showed no-significant difference between BUSS and IBUS-SAS (p = 0.46) for detecting endoscopic remission.

INTERPRETATION

Early ultrasound remission predicts long-term endoscopic remission, making it a valuable early treatment target for clinical practice and in clinical trials. Larger multicentre validation studies are warranted to confirm these findings.

FUNDING

None.

摘要

背景

肠道超声评分(BUSS)以克罗恩病简易内镜评分(SES-CD)作为参考标准,能准确检测出与治疗相关的变化。我们旨在评估超声缓解作为一种治疗目标及其对长期内镜缓解的预测作用。

方法

这项单中心前瞻性观察性研究在意大利米兰的一家三级转诊中心进行,于2018年3月1日至2021年1月31日纳入开始使用生物制剂的活动性克罗恩病成年患者(SES-CD>2)。在基线和12个月时(平均12.8±4.2)进行结肠镜检查和肠道内超声检查。主要结局是第12周时超声缓解(BUSS≤3.52)对12个月时长期内镜缓解的预测价值。还计算了国际肠道超声节段性活动评分(IBUS-SAS),并通过ROC分析确定检测内镜缓解的最佳切点。

结果

纳入了93例克罗恩病患者。其中,22例患者(24%)实现了内镜缓解。第12周的超声缓解可预测内镜缓解(超声缓解患者为59%,未实现超声缓解的患者为41%;OR 9.93,95%CI 3.10 - 31.80;p<0.001),而第12周的钙卫蛋白值(<50、<100、<250μg/g)则不能。第12周的超声活动与未实现长期内镜缓解相关(阴性预测值87%,阳性预测值54%)。区分内镜缓解的IBUS-SAS切点为22.8(AUC 0.9并通过ROC分析确定检测内镜缓解的最佳切点。

结果

纳入了患者。其中,例患者(%)实现了内镜缓解。第周的超声缓解可预测内镜缓解(超声缓解患者为%,未实现超声缓解的患者为%;OR 9.93,95%CI 3.10 - 31.80;p<0.001),而第周的钙卫蛋白值(<50、<100、<250μg/g)则不能。第周的超声活动与未实现长期内镜缓解相关(阴性预测值87%,阳性预测值54%)。区分内镜缓解的IBUS-SAS切点为22.8(AUC)。ROC曲线比较显示,在检测内镜缓解方面,BUSS和IBUS-SAS之间无显著差异(p = 0.46)。

解读

早期超声缓解可预测长期内镜缓解,使其成为临床实践和临床试验中有价值的早期治疗目标。需要开展更大规模的多中心验证研究来证实这些发现。

资金来源

无。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/708d/10972812/caa234ce3b02/gr1.jpg

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