Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin Hospital, , Berlin, Germany.
Ann Rheum Dis. 2014 Jan;73(1):243-6. doi: 10.1136/annrheumdis-2012-203055. Epub 2013 Apr 26.
The efficacy of oral prednisolone in patients with active ankylosing spondylitis (AS) has not been studied to date.
In this double-blind, randomised, placebo-controlled trial, patients with AS with active disease despite taking non-steroidal antirheumatic drugs were randomised to three groups in which they were either treated with 20 mg (n=13) or 50 mg (n=12) of prednisolone, or placebo (n=14), administered orally every day for a total of 2 weeks. The primary endpoint was defined as a 50% improvement of the Bath AS Disease Activity Index (BASDAI) at week 2.
The primary endpoint was reached in 33% and 27% of the patients treated with 50 and 20 mg of prednisolone, respectively, versus only 8% on placebo (p=0.16 and p=0.30). However, the mean improvement of BASDAI score was significantly higher in the 50 mg prednisolone compared to the placebo group (2.39±0.5 vs 0.66±0.49, p=0.03), while there was only a small change in the 20 mg group (1.19±0.53; p=0.41). The results for other outcome parameters were similar.
Oral prednisolone 50 mg per day, but not low dose prednisolone, showed a short-term response that was significantly higher than placebo. The clinical significance and the duration of this effect warrant further study.
目前尚未研究口服泼尼松龙治疗活动期强直性脊柱炎（AS）患者的疗效。
在这项双盲、随机、安慰剂对照试验中，接受非甾体类抗风湿药治疗但疾病仍处于活动期的 AS 患者被随机分为三组，分别接受 20mg（n=13）、50mg（n=12）泼尼松龙或安慰剂（n=14），每天口服一次，共 2 周。主要终点定义为第 2 周时 Bath AS 疾病活动指数（BASDAI）改善 50%。
分别有 33%和 27%的 50mg 和 20mg 泼尼松龙治疗患者达到了主要终点，而安慰剂组仅为 8%（p=0.16 和 p=0.30）。然而，与安慰剂组相比，50mg 泼尼松龙组 BASDAI 评分的平均改善明显更高（2.39±0.5 与 0.66±0.49，p=0.03），而 20mg 组的变化较小（1.19±0.53；p=0.41）。其他结局参数的结果相似。
每天口服 50mg 泼尼松龙而非低剂量泼尼松龙可在短期内产生显著高于安慰剂的反应。这种效果的临床意义和持续时间需要进一步研究。
