Takken T, Van der Net J, Helders P J
Department of Pediatric Physical Therapy, University Medical Center Utrecht, Room Kb 02.056.0, POBox 85090, Utrecht, Netherlands, 3508 AB.
Cochrane Database Syst Rev. 2001;2001(3):CD003129. doi: 10.1002/14651858.CD003129.
In both adult rheumatoid arthritis (RA) and juvenile arthritis, the focus has shifted from 'inflammation parameters' to more patient centered disability outcomes. In RA this resulted in the development of the Outcome Measures in Arthritis Clinical Trials (OMERACT), and in juvenile arthritis the Pediatric Rheumatology International Trials Organization (PRINTO) core set. This PRINTO-core set was established using a combination of statistical and consensus formation techniques. This core set contains a number of patient centered disability measures. This review systematically searched the available literature and reports the available evidence of efficacy of MTX, with special focus on patient centered disability measures in Juvenile Idiopathic Arthritis (JIA).
To perform a systematic review on the effects of MTX on functional ability, range of motion, quality of life, overall well-being and pain for patients with JIA.
The Cochrane Controlled Trials Register (CCTR) and MEDLINE were searched up to March 2001, using the search strategy sensitive for randomised controlled trials, used by the Cochrane Collaboration.
Randomized controlled trials and controlled clinical trials comparing MTX against placebo or standard care in patients with Juvenile Idiopathic Arthritis (JIA) were selected.
Two reviewers (TT, JN) determined the studies to be included in this review and extracted the data of patient centered disability measures. The data were pooled using standardized mean differences (SMD) for limited joint range score, number of joints with swelling, and number of joints with pain on motion. Physicians global assessment and parents global assessment were evaluated with pooled odds ratios (OR).
Only two studies with a total 165 JIA patients under 18 years of age were included in this review. For JIA patients, MTX therapy had small to moderate effects on patients centered disability. The effect on joint range of motion, number of joints with pain and swelling and parent's assessment of disease activity showed a relative percentage improvement from 3 to 18% greater with MTX than with placebo.
REVIEWER'S CONCLUSIONS: Current evidence suggests that MTX does not have clinically significant effects (>20%) on patient centered disability measures in JIA patients.
在成人类风湿性关节炎(RA)和青少年关节炎中,关注重点已从“炎症参数”转向更以患者为中心的残疾结局。在类风湿性关节炎中,这促成了关节炎临床试验结局测量(OMERACT)的发展;在青少年关节炎中,则形成了儿科风湿病国际试验组织(PRINTO)核心指标集。该PRINTO核心指标集是通过统计技术和共识形成技术相结合而确立的。此核心指标集包含多项以患者为中心的残疾测量指标。本综述系统检索了现有文献,并报告了甲氨蝶呤(MTX)疗效的现有证据,特别关注青少年特发性关节炎(JIA)中以患者为中心的残疾测量指标。
对MTX对JIA患者的功能能力、关节活动范围、生活质量、总体幸福感和疼痛的影响进行系统综述。
截至2001年3月,检索了Cochrane对照试验注册库(CCTR)和MEDLINE,采用Cochrane协作网使用的对随机对照试验敏感的检索策略。
选取了比较MTX与安慰剂或标准治疗的青少年特发性关节炎(JIA)患者的随机对照试验和对照临床试验。
两名综述作者(TT、JN)确定纳入本综述的研究,并提取以患者为中心的残疾测量指标的数据。对于有限关节活动范围评分、肿胀关节数和运动时疼痛关节数,使用标准化均数差(SMD)合并数据。医师整体评估和家长整体评估采用合并比值比(OR)进行评估。
本综述仅纳入了两项研究,共165名18岁以下的JIA患者。对于JIA患者,MTX治疗对以患者为中心的残疾有小到中度的影响。MTX对关节活动范围、疼痛和肿胀关节数以及家长对疾病活动的评估的改善相对百分比比安慰剂高3%至18%。
目前的证据表明,MTX对JIA患者以患者为中心的残疾测量指标没有临床上显著的影响(>20%)。