Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2).
Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2).
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DOI：
10.1136/annrheumdis-2011-201067
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发表时间：
2013-02
影响因子：
27.4
通讯作者：
Saag KG
中科院分区：
文献类型：
--
作者：
Buttgereit F;Mehta D;Kirwan J;Szechinski J;Boers M;Alten RE;Supronik J;Szombati I;Romer U;Witte S;Saag KG
评估低剂量泼尼松时辰疗法使用新型缓释（MR）制剂治疗类风湿关节炎（RA）的疗效和安全性。在这项为期12周的双盲、安慰剂对照研究中，活动性RA患者（n=350）以2：1的比例随机接受MR泼尼松5 mg或安慰剂，每日一次，在其现有的RA疾病缓解抗风湿药（DMARD）治疗基础上加用。主要终点为第12周时根据美国风湿病学会标准（即ACR 20应答），RA体征和症状改善20%的患者百分比。还评估了晨痛、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。与安慰剂+DMARD治疗相比，MR泼尼松+DMARD治疗产生了更高的ACR 20应答率（48% vs 29%，p <0.001）和ACR 50应答率（22% vs 10%，p<0.006），第12周时晨僵较基线的中位相对降低（55% vs 35%，p<0.002）更大。在第12周，与安慰剂相比，MR泼尼松组RA（疾病活动评分28）（p<0.001）和疲劳（慢性疾病治疗-疲劳评分的功能评估）（p=0.003）的严重程度显著降低，身体功能（36项简明健康调查评分）（p<0.001）的改善也更大。MR泼尼松组（43%）和安慰剂组（49%）的不良事件发生率相似。在现有DMARD治疗基础上加用低剂量MR泼尼松可迅速改善RA体征和症状。NCT00650078
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. NCT00650078
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DOI：
10.1111/j.1749-6632.2009.05367.x
发表时间：
2010-01-01
期刊：
NEUROENDOCRINE IMMUNOLOGY IN RHEUMATIC DISEASES
影响因子：
--
作者：
Todoerti, Monica;Scire, Carlo Alberto;Caporali, Roberto
通讯作者：
Caporali, Roberto
影响因子：
--
作者：
Straub, RH;Paimela, L;Leirisalo-Repo, M
通讯作者：
Leirisalo-Repo, M
影响因子：
3.9
作者：
Alten, Rieke;Doering, Gisela;Buttgereit, Frank
通讯作者：
Buttgereit, Frank
影响因子：
27.4
作者：
Buttgereit, Frank;Doering, Gisela;Alten, Rieke
通讯作者：
Alten, Rieke
影响因子：
--
作者：
Meyer-Hermann, Michael;Figge, Marc Thilo;Straub, Rainer H.
通讯作者：
Straub, Rainer H.