目的系统评价阿达木单抗治疗斑块型银屑病的疗效与安全性。方法计算机检索MEDLINE(1966~2009.12)、Cochrane图书馆(2009年第12期)、EMbase(1980~2009.12)、CBM(1978~2009.12)和CNKI(1979~2009.12),语种限于英、中文,收集所有关于阿达木单抗与其它治疗方法比较的随机对照试验。根据纳入与排除标准筛选文献、评价质量、提取资料,采用RevMan4.2软件进行Meta分析。结果共纳入3个随机对照试验,包括1630例中重度斑块型银屑病患者。Meta分析结果显示:①阿达木单抗隔周皮下注射治疗4周、8周、12周、16周时获银屑病皮损面积和严重性指数积分下降75%的患者例数(PASI75)显著多于安慰剂组及甲氨蝶呤口服组;但治疗24周、60周时与安慰剂组比较并无显著差异。②阿达木单抗每周皮下注射组治疗12周时获PASI75者显著多于安慰剂组及阿达木单抗隔周组;但至24和60周时,与后两组比较并无显著性差异。③阿达木单抗隔周皮下注射组治疗12~16周时,除注射部位疼痛、上呼吸道病毒感染的发生率显著高于安慰剂组外,其它不良反应发生率与安慰剂比较并无显著性差异。阿达木单抗每周皮下注射组治疗12~60周时各种严重不良反应发生率均高于阿达木单抗隔周组及安慰剂继以阿达木单抗隔周组,而其它不良反应发生率比较则无显著性差异。结论现有证据表明,阿达木单抗隔周皮下注射治疗12~16周对于中重度斑块型银屑病患者安全、有效,但延长治疗时间至24周以上并不能进一步增强疗效;阿达木单抗每周皮下注射方案较隔周皮下注射方案并无明显优势。受本系统评价纳入研究数量和质量限制,上述结论尚需要更多高质量的随机对照试验验证。
Objective To assess the efficacy and safety of adalimumab on plaque psoriasis.Methods We searched the MEDLINE (1966 to December 2009),Cochrane Central Register of Controlled Trials (The Cochrane Library,Issue 12,2009),EMbase (1980 to December 2009),CBM (1978 to December 2009),and CNKI (1979 to December 2009) to collect randomized controlled trials (RCTs) of adalimumab for plaque psoriasis.The language was confined to English and Chinese.We screened the retrieved studies according to the predefined inclusion and exclusion criteria,evaluated the quality of included studies,and performed meta-analyses by using the Cochrane Collaboration's RevMan 4.2 software.Results Three RCTs involving 1 630 patients with chronic moderate or severe plaque psoriasis were included and assessed.At the end of 4th,8th,12th and 16th week,the PASI 75s of subcutaneous injection every other week in adalimumab (EOW) group were obviously higher than that of placebo group and methotrexate group.While at the end of 24th week and 60th week,the PASI 75s showed no difference between adalimumab EOW and placebo group.Twelve weeks after subcutaneous injection each week with adalimumab (QW),PASI 75 was obviously higher than those of placebo and EOW groups.However,at the end of 24th week and 60th week,there was no significant difference between adalimumab QW and placebo followed by adalimumab EOW.At end of week 12-16,there was no difference between adalimumab EOW group and placebo group in the incidence of adverse effects,with the exception of pain on injection site and upper respiration viral infection.At week 12-60,there was no difference between adalimumab QW and EOW groups in the incidence of adverse effects,with the exception of all serious adverse effects.Conclusion The limited evidence indicates that subcutaneous injection of adalimumab every other week for 12-16 weeks is safe and efficient for patients with moderate or severe plaque psoriasis.The efficacy can't be enhanced when the treatment is prolonged to 2