OBJECTIVE:To systematically evaluate therapeutic efficacy of thalidomide in the treatment of ankylosing spondylitis,and to provide evidence-based reference for clinic.METHODS:Retrieved from Chinese Journal Full-text Database,China Science and Technology Journal Database,China Biology Medicine disc,Wanfang database,Medline,PubMed,Elsevier database and Cochrane library,the references of the included literatures were also reviewed,randomized controlled trials (RCTs) about thalidomide alone or combined with other routine drug (trial group) versus routine treatment or other drug (control group) in the treatment of ankylosing spondylitis were collected.After data extraction,quality evaluation of included studies by modified Jadad scale,Meta-analysis of response rate,bath ankylosing spondylitis disease activity index (BASDAI) score,erythrocyte sedimentation rate (ESR),C-reaction protein (CRP) level,thoracic mobility,pillow wall distance,Schober trial result,morning stiffness time and the number of peripheral joints with swelling and pain were conducted by using Rev Man 5.1 statistical software.RESULTS:A total of 10 RCTs were included,involving 636 patients.Results of Meta-analysis showed that response rate [OR=2.50,95％CI(1.36,4.62),P=0.003],thoracic mobility [MD=0.22,95％ CI (0.01,0.42),P=0.04],occipital wall distance [MD=-0.82,95％ CI (-1.32,-0.32),P=0.001],Schober trial result [MD=0.64,95％CI(0.28,0.99),P=0.000 4] and morning stiffness time [MD=-2.33,95 ％ CI (-3.92,-0.73),P=0.004] of trial group were significantly better than those control group,with statistical significance.There were no statistical significance in BASDAI score [MD=-4.40,95％CI(-8.96,0.16),P=0.06],ESR [MD=-3.51,95％CI(-7.76,0.74),P=0.11],CRP level [MD=-1.60,95％CI(-3.22,0.03),P=0.05] or the number of peripheral joints with swelling and pain [MD=-0.06,95％CI(-0.29,0.17),P=0.60] between 2 groups.CONCLUSIONS:Thalidomide shows significant improve effect on ankylosing spondylitis.Thalidomide is more effective than conventional drugs in the improvement of peripheral joint function and the control of inflammatory indicators.%目的:系统评价沙利度胺治疗强直性脊柱炎的疗效,为临床提供循证参考.方法:计算机检索中国期刊全文数据库(CJFD)、中文科技期刊全文数据库、中国生物医学文献数据库(CBMdisc)、万方数据库、Medline、PubMed、Elsevier数据库和TheCochrane Library,并查阅纳入文献的参考文献,收集单用沙利度胺或者沙利度胺联合其他常规药物(试验组)对比常规治疗或者其他药物(对照组)治疗强直性脊柱炎疗效的随机对照试验(RCT),提取资料并根据改良Jadad评分量表评价纳入研究质量后,采用Rev Man 5.1统计软件对有效率、强直性脊柱炎活动指数(BASDAI评分)、红细胞沉降率(ESR)、C反应蛋白(CRP)水平、胸廓活动度、枕臂距、Schober试验结果、晨僵时间及外周关节肿痛数进行Meta分析.结果:最终纳入10项RCT,共636例患者.Meta分析结果显示,试验组患者有效率[OR=2.50,95％CI(1.36,4.62),P=0.003]、胸廓活动度[MD=0.22,95％CI(0.01,0.42),P=0.04]、枕臂距[MD=-0.82,95％CI(-1.32,-0.32),P=0.001]、Schober试验结果[MD=0.64,95％CI(0.28,0.99),P=0.000 4]、晨僵时间[MD=-2.33,95％ CI(-3.92,-0.73),P=0.004]均显著优于对照组,差异均有统计学意义;两组患者BASDAI评分[MD=-4.40,95％ CI(-8.96,0.16),P=0.06]、ESR[MD=-3.51,95％ CI(-7.76,0.74),P=0.11]、CRP水平[MD=-1.60,95％ CI(-3.22,0.03),P=0.05]、外周关节肿痛数[MD=-0.06,95％CI(-0.29,0.17),P=0.60]比较,差异均无统计学意义.结论:沙利度胺对患者中轴关节症状的改善有更明显的效果;而在外周关节功能的改善及炎性指标的控制方面,沙利度胺与常规用药的疗效相当.
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