Kirwan J R
N Engl J Med. 1995 Jul 20;333(3):142-6. doi: 10.1056/NEJM199507203330302.
Oral glucocorticoids are widely used to treat patients with rheumatoid arthritis, but their effect on joint destruction, as assessed radiologically, is uncertain.
We conducted a randomized, double-blind trial comparing oral prednisolone (7.5 mg daily for two years) with placebo in 128 adults with active rheumatoid arthritis of less than two years' duration. Except for systemic corticosteroids, other treatments could be prescribed. The primary outcome variables were the progression of damage as seen on radiographs of the hand after one and two years, as measured by the Larsen index, and the appearance of erosions in hands that had no erosions at base line. The radiographs were viewed jointly by a radiologist and a rheumatologist who were unaware of the treatment assignment and the time point at which the films were obtained.
The statistical analysis of radiologically detected changes was based on 106 patients for whom there were films obtained at base line and two years later. After two years, the Larsen scores increased by a mean of 0.72 unit in the prednisolone group, indicating very little change, and by 5.37 units in the placebo group, indicating substantial joint destruction (P = 0.004). Of the 212 hands of these patients, 147 (69.3 percent) had no erosions at the start of the study. At two years, 15 of the 68 such hands in the prednisolone group (22.1 percent) and 36 of the 79 such hands in the placebo group (45.6 percent) had acquired erosions (difference, 23.5 percentage points; 95 percent confidence interval, 5.9 to 40.7; P = 0.007). The patients in the prednisolone group had greater reductions than the patients in the placebo group in scores on an articular index and for pain and disability at 3 months; for pain at 6 months; and for disability at 6, 12, and 15 months (all P < 0.05). There was no difference between groups in standardized scores for the acute-phase response. The adverse events were typical of those encountered with antirheumatoid drugs.
In patients with early, active rheumatoid arthritis, prednisolone (7.5 mg daily) given for two years in addition to other treatments substantially reduced the rate of radiologically detected progression of disease.
口服糖皮质激素广泛用于治疗类风湿关节炎患者，但其对关节破坏的影响（通过放射学评估）尚不确定。
我们进行了一项随机双盲试验，将128例病程少于两年的活动性类风湿关节炎成年患者随机分为两组，一组服用口服泼尼松龙（每日7.5毫克，共两年），另一组服用安慰剂。除全身用糖皮质激素外，可开具其他治疗药物。主要结局变量为一年和两年后手X线片上显示的损伤进展情况（通过Larsen指数测量），以及基线时无侵蚀的手部出现侵蚀的情况。放射科医生和风湿病学家共同阅片，他们不知道治疗分配情况以及获取片子的时间点。
对放射学检测到的变化进行的统计分析基于106例患者，这些患者在基线和两年后均有片子。两年后，泼尼松龙组的Larsen评分平均增加0.72个单位，表明变化很小，而安慰剂组增加5.37个单位，表明关节有实质性破坏（P = 0.004）。在这些患者的212只手中，147只（69.3%）在研究开始时无侵蚀。两年时，泼尼松龙组68只此类手中有15只（22.1%）出现侵蚀，安慰剂组79只此类手中有36只（45.6%）出现侵蚀（差异为23.5个百分点；95%置信区间为5.9至40.7；P = 0.007）。泼尼松龙组患者在3个月时关节指数、疼痛和残疾评分的降低幅度大于安慰剂组患者；在6个月时疼痛评分降低幅度大于安慰剂组患者；在6、12和15个月时残疾评分降低幅度大于安慰剂组患者（均P < 0.05）。两组在急性期反应的标准化评分方面无差异。不良事件是抗类风湿药物常见的那些。
在早期活动性类风湿关节炎患者中，除其他治疗外，给予泼尼松龙（每日7.5毫克）两年可显著降低放射学检测到的疾病进展速度。
