School of Clinical Sciences, University of Bristol, Bristol, UK.
Inflamm Bowel Dis. 2012 Nov;18(11):2056-62. doi: 10.1002/ibd.22879. Epub 2012 Jan 23.
There is no gold standard index in the measurement of ulcerative colitis (UC) disease activity in clinical trials. Mucosal healing has been described as an important clinical endpoint requiring endoscopic assessment, which is unpleasant for the patient and may hamper recruitment to trials. The aim of this study was to determine whether endoscopy is necessary in the assessment of UC disease activity and whether a noninvasive disease activity index (partial Mayo score) could be used to predict the Mayo score.
In all, 149 subjects with moderate to severe UC enrolled in a clinical trial were assessed using total and partial Mayo scores. Histologic assessment of biopsies was performed. A regression model was constructed to predict total Mayo score from the partial Mayo score and histology score from the Mayo score. A Bland-Altman test of agreement was performed.
The partial Mayo score correlated closely with the total Mayo score at week 4 (rho = 0.97) and week 8 (rho = 0.98). The model to predict total from partial Mayo score showed excellent correlation (rho = 0.97) and good agreement with the total Mayo score at week 4 and the week 8 validation set (rho = 0.97) and accurately classified disease severity (kappa = 0.82). The model to predict histology score from the Mayo score correlated only moderately with the actual histology score at week 4 (rho = 0.59) and week 8 (rho = 0.36).
The Mayo score can be accurately predicted from the partial Mayo score. A noninvasive index can replace the Mayo score in future clinical trials.
在临床试验中，溃疡性结肠炎（UC）疾病活动度的测量尚无金标准指标。黏膜愈合已被描述为需要内镜评估的重要临床终点，这对患者来说是不愉快的，可能会阻碍试验的招募。本研究旨在确定内镜评估在 UC 疾病活动度评估中的必要性，以及非侵入性疾病活动指数（部分 Mayo 评分）是否可用于预测 Mayo 评分。
共有 149 名中度至重度 UC 患者入组临床试验，使用总 Mayo 评分和部分 Mayo 评分进行评估。对活检进行组织学评估。构建了一个回归模型，以预测总 Mayo 评分来自部分 Mayo 评分，预测 Mayo 评分中的组织学评分来自部分 Mayo 评分。进行了 Bland-Altman 一致性检验。
第 4 周（rho=0.97）和第 8 周（rho=0.98）时，部分 Mayo 评分与总 Mayo 评分密切相关。预测总 Mayo 评分来自部分 Mayo 评分的模型显示出极好的相关性（rho=0.97），并与第 4 周和第 8 周验证集的总 Mayo 评分有良好的一致性（rho=0.97），并准确地分类了疾病严重程度（kappa=0.82）。预测 Mayo 评分中组织学评分的模型仅与第 4 周（rho=0.59）和第 8 周（rho=0.36）的实际组织学评分中度相关。
可以从部分 Mayo 评分准确预测 Mayo 评分。未来的临床试验中，可以用非侵入性指数替代 Mayo 评分。
