Svensson Björn, Boonen Annelies, Albertsson Kristina, van der Heijde Désirée, Keller Catharina, Hafström Ingiäld
University of Lund, Lund, Sweden.
Arthritis Rheum. 2005 Nov;52(11):3360-70. doi: 10.1002/art.21298.
To assess the efficacy of low-dose prednisolone on joint damage and disease activity in patients with early rheumatoid arthritis (RA).
At the start of their initial treatment with a disease-modifying antirheumatic drug (DMARD), patients with early (duration < or =1 year) active RA were randomly assigned to receive either 7.5 mg/day prednisolone or no prednisolone for 2 years. Radiographs of the hands and feet were obtained at baseline and after 1 and 2 years and scored according to the Sharp score as modified by van der Heijde. Remission was defined as a Disease Activity Score in 28 joints of <2.6. Bone mineral density was measured by dual x-ray absorptiometry at baseline and after 2 years.
Of the 250 patients included, 242 completed the study and 225 had radiographs available both at baseline and at 2 years. At 2 years, the median and interquartile range (IQR) change in total Sharp score was lower in the prednisolone group than in the no-prednisolone group (1.8 [IQR 0.5-6.0] versus 3.5 [IQR 0.5-10]; P = 0.019). In the prednisolone group, there were fewer newly eroded joints per patient after 2 years (median 0.5 [IQR 0-2] versus 1.25 [IQR 0-3.25]; P = 0.007). In the prednisolone group, 25.9% of patients had radiographic progression beyond the smallest detectable difference compared with 39.3% of patients in the no-prednisolone group (P = 0.033). At 2 years, 55.5% of patients in the prednisolone group had achieved disease remission, compared with 32.8% of patients in the no-prednisolone group (P = 0.0005). There were few adverse events that led to withdrawal. Bone loss during the 2-year study was similar in the 2 treatment groups.
Prednisolone at 7.5 mg/day added to the initial DMARD retarded the progression of radiographic damage after 2 years in patients with early RA, provided a high remission rate, and was well tolerated. Therefore, the data support the use of low-dose prednisolone as an adjunct to DMARDs in early active RA.
评估低剂量泼尼松龙对早期类风湿关节炎（RA）患者关节损伤和疾病活动度的疗效。
在开始使用改善病情抗风湿药（DMARD）进行初始治疗时，将早期（病程≤1年）活动性RA患者随机分为两组，一组接受7.5毫克/天的泼尼松龙治疗，另一组不接受泼尼松龙治疗，为期2年。在基线、1年和2年后拍摄双手和双足的X线片，并根据范德海伊德改良的夏普评分进行评分。缓解定义为28个关节的疾病活动评分<2.6。在基线和2年后通过双能X线吸收法测量骨密度。
纳入的250例患者中，242例完成了研究，225例在基线和2年时均有X线片可供分析。2年后，泼尼松龙组的总夏普评分中位数和四分位间距（IQR）变化低于未使用泼尼松龙组（1.8 [IQR 0.5 - 6.0] 对比 3.5 [IQR 0.5 - 10]；P = 0.019）。在泼尼松龙组，2年后每位患者新出现的侵蚀性关节更少（中位数0.5 [IQR 0 - 2] 对比1.25 [IQR 0 - 3.25]；P = 0.007）。在泼尼松龙组，25.9%的患者出现了超过最小可检测差异的影像学进展，而未使用泼尼松龙组为39.3%（P = 0.033）。2年后，泼尼松龙组55.5%的患者实现了疾病缓解，未使用泼尼松龙组为32.8%（P = 0.0005）。导致停药的不良事件很少。在2年的研究期间，两个治疗组的骨质流失情况相似。
在初始DMARD治疗基础上加用7.5毫克/天的泼尼松龙可延缓早期RA患者2年后影像学损伤的进展，缓解率高，且耐受性良好。因此，这些数据支持在早期活动性RA中使用低剂量泼尼松龙作为DMARDs的辅助治疗。
