Department of Rheumatology and Clinical Immunology, Charité University Medicine, Berlin 10117, Germany.
Ann Rheum Dis. 2013 Feb;72(2):204-10. doi: 10.1136/annrheumdis-2011-201067. Epub 2012 May 5.
To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA).
In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed.
MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%).
Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. CLINICALTRIALS.GOV, NUMBER: NCT00650078.
评估使用新的改良释放（MR）制剂的低剂量泼尼松时间疗法治疗类风湿关节炎（RA）的疗效和安全性。
在这项为期 12 周、双盲、安慰剂对照的研究中，350 例活动性 RA 患者被随机分为 2:1，分别接受 MR 泼尼松 5 毫克或安慰剂，每晚一次，同时接受其现有的 RA 疾病修饰抗风湿药物（DMARD）治疗。主要终点是在第 12 周时达到美国风湿病学会（ACR）标准的 20%改善的患者比例（即 ACR20 反应）。还评估了早晨疼痛、晨僵持续时间、28 关节疾病活动评分和健康相关生活质量的变化。
MR 泼尼松加 DMARD 治疗的 ACR20 反应率（48%对 29%，p<0.001）和 ACR50 反应率（22%对 10%，p<0.006）以及晨僵的中位数相对基线降低率（55%对 35%，p<0.002）均高于安慰剂加 DMARD 治疗。在第 12 周时，MR 泼尼松组与安慰剂组相比，RA 严重程度（疾病活动评分 28）（p<0.001）和疲劳（慢性疾病治疗的功能评估-疲劳评分）（p=0.003）显著减轻，以及身体功能的显著改善（36 项简短健康调查评分）（p<0.001）。MR 泼尼松（43%）和安慰剂（49%）的不良事件发生率相似。
在现有的 DMARD 治疗基础上添加低剂量 MR 泼尼松可迅速改善 RA 的症状和体征。临床试验.gov，编号：NCT00650078。
