Florholmen Jon R, Johnsen Kay-Martin, Meyer Renate, Olsen Trine, Moe Øystein K, Tandberg Petter, Gundersen Mona D, Kvamme Jan-Magnus, Johnsen Knut, Løitegård Terje, Raschpichler Gabriele, Vold Cecilia, Sørbye Sveinung W, Goll Rasmus
Research Group of Gastroenterology and Nutrition, Department of Clinical Medicine, University of Tromsø, Tromsø, Norway.
Department of Gastroenterology, Division of Internal Medicine, University Hospital of North Norway, Tromsø, Norway.
BMC Gastroenterol. 2020 Oct 2;20(1):321. doi: 10.1186/s12876-020-01447-0.
There are no accurate markers that can predict clinical outcome in ulcerative colitis at time of diagnosis. The aim of this study was to explore a comprehensive data set to identify and validate predictors of clinical outcome in the first year following diagnosis.
Treatment naive-patients with ulcerative colitis were included at time of initial diagnosis from 2004 to 2014, followed by a validation study from 2014 to 2018. Patients were treated according to clinical guidelines following a standard step-up regime. Patients were categorized according to the treatment level necessary to achieve clinical remission: mild, moderate and severe. The biopsies were assessed by Robarts histopathology index (RHI) and TNF gene transcripts.
We included 66 patients in the calibration cohort and 89 patients in the validation. Mucosal TNF transcripts showed high test reliability for predicting severe outcome in UC. When combined with histological activity (RHI) scores the test improved its diagnostic reliability. Based on the cut-off values of mucosal TNF and RHI scores from the calibration cohort, the combined test had still high reliability in the validation cohort (specificity 0.99, sensitivity 0.44, PPV 0.89, NPV 0.87) and a diagnostic odds-ratio (DOR) of 54.
The combined test using TNF transcript and histological score at debut of UC can predict severe outcome and the need for anti-TNF therapy with a high level of precision. These validated data may be of great clinical utility and contribute to a personalized medical approach with the possibility of top-down treatment for selected patients.
在溃疡性结肠炎诊断时，尚无准确的标志物能够预测临床结局。本研究的目的是探索一个综合数据集，以识别和验证诊断后第一年临床结局的预测因素。
纳入2004年至2014年初次诊断时未接受过治疗的溃疡性结肠炎患者，随后在2014年至2018年进行验证研究。患者按照标准的逐步升级方案根据临床指南进行治疗。根据实现临床缓解所需的治疗水平将患者分为轻度、中度和重度。活检通过罗伯茨组织病理学指数（RHI）和肿瘤坏死因子基因转录本进行评估。
我们在校准队列中纳入了66例患者，在验证队列中纳入了89例患者。黏膜肿瘤坏死因子转录本在预测溃疡性结肠炎的严重结局方面显示出较高的检测可靠性。当与组织学活性（RHI）评分相结合时，该检测提高了其诊断可靠性。根据校准队列中黏膜肿瘤坏死因子和RHI评分的临界值，联合检测在验证队列中仍具有较高的可靠性（特异性0.99，敏感性0.44，阳性预测值0.89，阴性预测值0.87），诊断比值比（DOR）为54。
在溃疡性结肠炎初发时使用肿瘤坏死因子转录本和组织学评分的联合检测能够高精度地预测严重结局以及抗肿瘤坏死因子治疗的必要性。这些经过验证的数据可能具有很大的临床实用性，并有助于采用个性化医疗方法，为选定患者提供自上而下治疗的可能性。
