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验证和更新 Lémann 指数以衡量克罗恩病的累积结构性肠道损伤。

Validation and Update of the Lémann Index to Measure Cumulative Structural Bowel Damage in Crohn's Disease.

机构信息

Hepato-Gastroenterology Department, Claude Huriez Hospital, University of Lille, Lille, France.

Division of Gastroenterology, Surgical Department, Hospital Beatriz Ângelo, Loures, Portugal.

出版信息

Gastroenterology. 2021 Sep;161(3):853-864.e13. doi: 10.1053/j.gastro.2021.05.049. Epub 2021 May 28.

Abstract

BACKGROUND & AIMS: The Lémann Index is a tool measuring cumulative structural bowel damage in Crohn's disease (CD). We reported on its validation and updating.

METHODS

This was an international, multicenter, prospective, cross-sectional observational study. At each center, 10 inclusions, stratified by CD duration and location, were planned. For each patient, the digestive tract was divided into 4 organs, upper tract, small bowel, colon/rectum, anus, and subsequently into segments, explored systematically by magnetic resonance imaging and by endoscopies in relation to disease location. For each segment, investigators retrieved information on previous surgical procedures, identified predefined strictures and penetrating lesions of maximal severity (grades 1-3) at each organ investigational method (gastroenterologist and radiologist for magnetic resonance imaging), provided segmental damage evaluation ranging from 0.0 to 10.0 (complete resection). Organ resection-free cumulative damage evaluation was then calculated from the sum of segmental damages. Then investigators provided a 0-10 global damage evaluation from the 4-organ standardized cumulative damage evaluations. Simple linear regressions of investigator damage evaluations on their corresponding Lémann Index were studied, as well as calibration plots. Finally, updated Lémann Index was derived through multiple linear mixed models applied to combined development and validation samples.

RESULTS

In 15 centers, 134 patients were included. Correlation coefficients between investigator damage evaluations and Lémann Indexes were >0.80. When analyzing data in 272 patients from both samples and 27 centers, the unbiased correlation estimates were 0.89, 0,97, 0,94, 0.81, and 0.91 for the 4 organs and globally, and stable when applied to one sample or the other.

CONCLUSIONS

The updated Lémann Index is a well-established index to assess cumulative bowel damage in CD that can be used in epidemiological studies and disease modification trials.

摘要

背景与目的

Lémann 指数是一种衡量克罗恩病(CD)累积结构肠道损伤的工具。我们报告了其验证和更新。

方法

这是一项国际多中心前瞻性横断面观察研究。在每个中心,计划分层纳入 10 例患者,按 CD 病程和部位分层。对于每位患者,消化道分为 4 个器官,上消化道、小肠、结肠/直肠、肛门,然后分为节段,通过磁共振成像和内镜检查系统地探查与疾病部位有关的节段。对于每个节段,研究人员检索了之前手术的信息,确定了每个器官检查方法(胃肠病学家和放射科医生用于磁共振成像)中最大严重程度的预定狭窄和穿透性病变(1-3 级),提供了从 0.0 到 10.0(完全切除)的节段损伤评估。然后,根据节段损伤的总和计算无器官切除的累积损伤评估。然后,研究人员从 4 个器官标准化累积损伤评估中提供 0-10 的整体损伤评估。研究了研究人员损伤评估与 Lémann 指数之间的简单线性回归以及校准图。最后,通过应用于联合开发和验证样本的多元线性混合模型得出更新的 Lémann 指数。

结果

在 15 个中心,共纳入 134 例患者。研究人员损伤评估与 Lémann 指数之间的相关系数>0.80。当分析来自两个样本和 27 个中心的 272 例患者的数据时,4 个器官和整体的无偏相关估计值分别为 0.89、0.97、0.94、0.81 和 0.91,当应用于一个样本或另一个样本时,该值稳定。

结论

更新后的 Lémann 指数是一种评估 CD 累积肠道损伤的成熟指数,可用于流行病学研究和疾病修饰试验。

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