Paulus Harold E, Oh MyungShin, Sharp John T, Gold Richard H, Wong Weng Kee, Park Grace S, Bulpitt Ken J
University of California at Los Angeles, School of Medicine, 90095, USA.
Arthritis Rheum. 2004 Apr;50(4):1083-96. doi: 10.1002/art.20270.
To categorize radiographic joint damage as progressive or nonprogressive in individuals with rheumatoid arthritis (RA) participating in clinical studies.
Using the total Sharp radiographic damage score, erosion score, and joint space narrowing (JSN) score for 751 serial films of the hand/wrist and forefoot obtained from 190 patients with early RA during 6-60 months of followup (mean 31 months), various threshold values for progression of joint damage were evaluated singly and in various combinations. For each patient, the progression rate was estimated from the linear regression line for all available radiographic time points. After preliminary screening, 23 candidate definitions were tested to select a definition that discriminated well between radiographic progression and radiographic nonprogression.
The definition selected describes radiographic nonprogression in individual patients as an increase of < or =0.1 in the standardized response mean of the trimmed population (the central 95% of patients) for > or =5 of 6 change measures (erosion scores and JSN scores for the fingers, wrists, and feet). Using this definition, 59% of the 190 patients with early RA were defined as having nonprogressive radiographic damage. Moreover, 95% of 95 patients with progression of the total Sharp score at or below the median and 24% of 95 patients with progression of the total Sharp score above the median were defined as having nonprogressive joint damage (chi(2) = 98, P < 0.0001), as were 97% of patients in the lowest quintile of total Sharp score progression rates and none of the patients in the highest progression quintile. Patients defined as nonprogressors had significantly lower baseline levels of C-reactive protein and lower erythrocyte sedimentation rates compared with patients defined as progressors, and those patients in the nonprogressive joint damage group more frequently had American College of Rheumatology 20% and 50% improvement criteria responses, "good" improvements (decrease of > or =1.2) in the Disease Activity Score, and > or =50% decreases in the swollen joint counts during the first 2 years of followup.
RA joint damage in an observational cohort can be classified as progressive or nonprogressive with the use of a composite definition. Validation and/or refinement of this definition is needed by utilizing the data from controlled clinical trials that compare placebo with active treatment.
对参与临床研究的类风湿关节炎（RA）患者的影像学关节损伤进行分类，判断其为进展性或非进展性。
利用从190例早期RA患者在6 - 60个月随访期（平均31个月）内获得的751张手/腕和前足的系列X线片的总Sharp影像学损伤评分、侵蚀评分和关节间隙变窄（JSN）评分，对关节损伤进展的各种阈值进行单独及多种组合评估。对于每位患者，根据所有可用影像学时间点的线性回归线估计进展率。经过初步筛选，对23个候选定义进行测试，以选择一个能很好地区分影像学进展和非进展的定义。
所选定义将个体患者的影像学非进展描述为：在6项变化指标（手指、手腕和足部的侵蚀评分和JSN评分）中的≥5项，经修剪后总体人群（中间95%的患者）的标准化反应均值增加≤0.1。使用该定义，190例早期RA患者中有59%被定义为具有非进展性影像学损伤。此外，总Sharp评分进展处于或低于中位数的95例患者中有95%以及总Sharp评分进展高于中位数的95例患者中有24%被定义为具有非进展性关节损伤（χ² = 98，P < 0.0001），总Sharp评分进展率处于最低五分位数的患者中有97%以及进展率处于最高五分位数的患者中无一例被定义为进展性损伤。与被定义为进展性损伤的患者相比，被定义为非进展性损伤的患者的C反应蛋白基线水平显著更低，红细胞沉降率也更低，并且非进展性关节损伤组的患者在随访的前2年中更频繁地达到美国风湿病学会20%和50%改善标准反应、疾病活动评分“良好”改善（降低≥1.2）以及肿胀关节计数降低≥50%。
使用复合定义可将观察队列中的RA关节损伤分类为进展性或非进展性。需要利用比较安慰剂与活性治疗的对照临床试验数据对该定义进行验证和/或完善。
