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磁共振肠造影和小肠超声对新发和复发克罗恩病(METRIC)的程度和活动的诊断准确性:一项多中心试验。

Diagnostic accuracy of magnetic resonance enterography and small bowel ultrasound for the extent and activity of newly diagnosed and relapsed Crohn's disease (METRIC): a multicentre trial.

机构信息

Centre for Medical Imaging, University College London (UCL), London, UK.

Institute of Applied Health Research, National Institute of Health and Research Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.

出版信息

Lancet Gastroenterol Hepatol. 2018 Aug;3(8):548-558. doi: 10.1016/S2468-1253(18)30161-4. Epub 2018 Jun 18.

Abstract

BACKGROUND

Magnetic resonance enterography (MRE) and ultrasound are used to image Crohn's disease, but their comparative accuracy for assessing disease extent and activity is not known with certainty. Therefore, we did a multicentre trial to address this issue.

METHODS

We recruited patients from eight UK hospitals. Eligible patients were 16 years or older, with newly diagnosed Crohn's disease or with established disease and suspected relapse. Consecutive patients had MRE and ultrasound in addition to standard investigations. Discrepancy between MRE and ultrasound for the presence of small bowel disease triggered an additional investigation, if not already available. The primary outcome was difference in per-patient sensitivity for small bowel disease extent (correct identification and segmental localisation) against a construct reference standard (panel diagnosis). This trial is registered with the International Standard Randomised Controlled Trial, number ISRCTN03982913, and has been completed.

FINDINGS

284 patients completed the trial (133 in the newly diagnosed group, 151 in the relapse group). Based on the reference standard, 233 (82%) patients had small bowel Crohn's disease. The sensitivity of MRE for small bowel disease extent (80% [95% CI 72-86]) and presence (97% [91-99]) were significantly greater than that of ultrasound (70% [62-78] for disease extent, 92% [84-96] for disease presence); a 10% (95% CI 1-18; p=0·027) difference for extent, and 5% (1-9; p=0·025) difference for presence. The specificity of MRE for small bowel disease extent (95% [85-98]) was significantly greater than that of ultrasound (81% [64-91]); a difference of 14% (1-27; p=0·039). The specificity for small bowel disease presence was 96% (95% CI 86-99) with MRE and 84% (65-94) with ultrasound (difference 12% [0-25]; p=0·054). There were no serious adverse events.

INTERPRETATION

Both MRE and ultrasound have high sensitivity for detecting small bowel disease presence and both are valid first-line investigations, and viable alternatives to ileocolonoscopy. However, in a national health service setting, MRE is generally the preferred radiological investigation when available because its sensitivity and specificity exceed ultrasound significantly.

FUNDING

National Institute of Health and Research Health Technology Assessment.

摘要

背景

磁共振肠造影术(MRE)和超声检查用于诊断克罗恩病,但它们在评估疾病程度和活动方面的准确性尚不确定。因此,我们进行了一项多中心试验来解决这个问题。

方法

我们从英国的八家医院招募了患者。符合条件的患者年龄在 16 岁及以上,患有新诊断的克罗恩病或已确诊的疾病且怀疑复发。连续的患者除了标准检查外,还进行了 MRE 和超声检查。如果尚未进行 MRE 和超声检查以确定小肠疾病的存在,则触发进一步检查。主要结局是小肠疾病程度(正确识别和节段定位)的每位患者的敏感度差异,以构建参考标准(小组诊断)为基准。该试验在国际标准随机对照试验(ISRCTN)注册,编号为 ISRCTN03982913,现已完成。

结果

284 名患者完成了试验(新诊断组 133 名,复发组 151 名)。根据参考标准,233 名(82%)患者患有小肠克罗恩病。MRE 对小肠疾病程度(80%[72-86%])和存在(97%[91-99%])的敏感性显著大于超声(疾病程度 70%[62-78%],疾病存在 92%[84-96%]);程度上差异 10%(95%CI 1-18;p=0.027),存在上差异 5%(1-9;p=0.025)。MRE 对小肠疾病程度的特异性(95%[85-98%])显著大于超声(81%[64-91%]);差异 14%(1-27;p=0.039)。MRE 对小肠疾病存在的特异性为 96%(95%CI 86-99%),而超声为 84%(65-94%)(差异 12%[0-25];p=0.054)。无严重不良事件。

解释

MRE 和超声检查对小肠疾病的存在均具有较高的敏感性,且均为有效的一线检查方法,是回结肠镜检查的可行替代方法。然而,在国家卫生服务机构中,只要有 MRE,通常首选 MRE 作为放射学检查,因为其敏感性和特异性显著优于超声。

资金来源

英国国民保健署健康技术评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/328a/6278907/91d9c88956bc/gr1.jpg

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