甲氨喋呤治疗强直性脊柱炎的系统评价  

A Systematic Review of Methotrexate for Ankylosing Spondylitis

作　　者：林珺芳[1] 陈君敏[1] 刘超[2] 

机构地区：[1]福建医科大学附属第一医院风湿科,福州350005 [2]河北医科大学附属第一医院,石家庄050031

出　　处：《中国循证医学杂志》2007年第4期260-266,共7页Chinese Journal of Evidence-based Medicine

基　　金：福建医科大学科学研究发展基金项目(JJGXY04030)~~

摘　　要：目的评价甲氨喋呤(MTX)治疗强直性脊柱炎(AS)的疗效和副作用。方法计算机检索CENTRAL(Cochrane图书馆2005年第4期)、MEDLINE (1966～2005．11)、EMbase(1980～2005．11)和CINAHL(1982～2005．11)中的相关文献,语种不限。纳入所有MTX治疗AS的随机对照试验和半随机对照试验,由两名评价员独立纳入试验和提取资料,并对其方法学质量进行评价。对符合纳入标准的研究采用RevMan 4．2软件进行Meta分析。结果共纳入3个随机对照试验(n=116例)。Meta分析结果显示,在改善身体功能、疼痛、脊柱活动度、外周关节/附着点疼痛、肿胀和压痛、脊柱放射学变化、以及患者和医生总体评价等主要结局指标方面,用与不用MTX比较,其差异无统计学意义。唯一的阳性结果是,有1个试验显示MTX组与安慰剂组相比,缓解率提高36%[RR 3．18,95%CI(1．03,9．79)]。该试验中判定缓解的根据是综合晨僵、身体健康状况、Bath强直性脊柱炎活动指数(BASDAI)、Bath强直性脊柱炎功能指数(BASFI)、健康评定问卷(HAQ-S)、患者和医生总体评价等7项指标的变化值,而对所有这些指标的终点值进行分析发现。没有一项显示MTX组与安慰剂组之间有统计学差异。因此,MTX治疗强直性脊柱炎是否有益,值得怀疑。纳入的试验没有报告MTX有严重的副作用。结论目前尚没有足够的证据显示MTX对AS患者有益。还需要开展更多高质量、大样本和更长疗程的随机对照试验,验证MTX治疗强直性脊柱炎的疗效和安全性。中国循证医学杂志,2007,7(4):260～266．Objective To evaluate and toxicity of methotrexate （MTX） in the ankylosing spondylitis （AS）. Methods the efficacy treatment of Randomized controlled trials （RCTs） were identified from CENTRAL （The Cochrane Library Issue 4, 2005）; MEDLINE （1966 to November 2005）; EMBASE （1980 to November 2005）; CINAHL （1982 to November 2005）. The quality of included trials was evaluated. Data were extracted by two reviewers independently using a specially designed extraction form. The Cochrane Collaboration＇s RevMan 4.2 software was used for data analysis. Results Three trials involving I16 patients were included. One 12-month trial compared naproxen plus MTX with naproxen alone. Two 24-week trials compared different doses of MTX with placebo. No statistically significant differences were found for the primary outcome measures of physical function, pain, spinal mobility, peripheral joints/entheses pain, swelling and tenderness, changes in spine radiographs and patient and physician global assessment.The response rate in one trial showed statistically significant benefits of 36% in the MTX group compared with the placebo group （RR 3.18, 95% CI 1.03 to 9.79）. This response rate was a composite index including assessment of morning stiffness, physical well-being, Bath ankylosing spondylitis disease activity index （BASDAI）, Bath ankylosing spondylitis functional index （BASFI）, health assessment questionnaire for spondyloarthropathies （HAQ-S）, and physician and patient global assessment. However, no single outcome showed a statistically significant difference between the MTX and placebo groups when endpoint results were compared. Therefore, this benefit of MTX was questionable. No serious side effects were reported in these studies. Conclusions There is no enough evidence to show any benefit of MTX in the treatment of AS. High quality randomized controlled trials of longer duration and with larger sample size are needed to clarify the effect of MTX on AS.

关 键 词：甲氯喋呤 强直性脊柱炎 系统评价 

分 类 号：R593.23[医药卫生—内科学]