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验证克罗恩病活动指数用于评估术后复发。

Validating Crohn's disease activity indices for use in assessing postoperative recurrence.

机构信息

Department of Health Policy, Management and Evaluation, Toronto, Ontario, Canada.

出版信息

Inflamm Bowel Dis. 2011 Jul;17(7):1547-56. doi: 10.1002/ibd.21524. Epub 2010 Nov 15.

Abstract

BACKGROUND

The Crohn's Disease Activity Index (CDAI) has been used in medical trials with scores <150 indicative of remission. Its value in assessing postoperative recurrence is unknown. The objective of this study was to explore the utility of the CDAI in determining the presence or absence of symptomatic disease recurrence in patients having previously undergone ileocolic resection for Crohn's disease.

METHODS

Ninety-three patients underwent clinical and colonoscopic evaluation within 12 months of ileocolic resection. Endoscopic appearance was assessed using the Rutgeerts score (i0-i4). Symptomatic disease recurrence was defined by the composite of symptom severity warranting therapy and an endoscopic score ≥ i2. CDAI scores were calculated. Comparisons were made using the receiver operator curve (ROC).

RESULTS

Thirty-nine (42%) patients had recurrent disease (22% symptomatic, 20% endoscopic only) at 12 months. Median CDAI for symptomatic recurrence was 198 (interquartile range [IQR]: 106-293), 80 for asymptomatic subjects (IQR 35-115). The area under the ROC curve for symptomatic disease and CDAI was 0.78 (95% confidence interval [CI] 0.64-0.91). Recurrence was best predicted by a CDAI of ≥ 148 (sensitivity 70%, specificity 81%). A strong linear relationship existed between the CDAI and Inflammatory Bowel Disease Questionnaire (r = 0.82).

CONCLUSIONS

The CDAI performs reasonably well in the postoperative setting and 150 appears the best cutpoint for indicating symptomatic disease. However, it is likely not suitable for use as the primary outcome measure. These data suggest that a combination of symptom assessment plus endoscopic evidence of recurrence should remain the gold standard definition for assessing outcomes in postoperative CD trials.

摘要

背景

克罗恩病活动指数(CDAI)已在临床试验中使用,得分<150 表明缓解。其在评估术后复发中的价值尚不清楚。本研究旨在探讨 CDAI 在评估先前接受过回肠结肠切除术治疗的克罗恩病患者是否存在症状性疾病复发方面的作用。

方法

93 例患者在回肠结肠切除术后 12 个月内接受临床和结肠镜评估。内镜表现采用 Rutgeerts 评分(i0-i4)进行评估。症状性疾病复发定义为需要治疗的症状严重程度和内镜评分≥i2 的复合表现。计算 CDAI 评分。使用接收器工作特征曲线(ROC)进行比较。

结果

39 例(42%)患者在 12 个月时出现疾病复发(22%为症状性,20%为仅内镜)。症状性复发的中位 CDAI 为 198(四分位距[IQR]:106-293),无症状患者为 80(IQR 35-115)。症状性疾病和 CDAI 的 ROC 曲线下面积为 0.78(95%置信区间[CI]:0.64-0.91)。CDAI≥148 预测复发的效果最佳(敏感性 70%,特异性 81%)。CDAI 与炎症性肠病问卷(IBDQ)之间存在很强的线性关系(r = 0.82)。

结论

CDAI 在术后环境中表现良好,150 似乎是指示症状性疾病的最佳切点。然而,它可能不适合作为主要的疗效指标。这些数据表明,症状评估加内镜复发证据的组合应仍然是评估术后 CD 试验结局的金标准定义。

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