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依那西普治疗强直性脊柱炎的随机、双盲、平行对照临床研究
引用本文:邓小虎,黄烽,张亚美,杨春花,郭军华,梁东风,李胜光,王莉莎,张江林.依那西普治疗强直性脊柱炎的随机、双盲、平行对照临床研究[J].军医进修学院学报,2009,30(1):21-23.
作者姓名:邓小虎  黄烽  张亚美  杨春花  郭军华  梁东风  李胜光  王莉莎  张江林
作者单位:解放军总医院风湿科,北京,100853
摘    要:目的:评价依那西普治疗活动性强直性脊柱炎(AS)的临床疗效和安全性。方法:前6周为随机、双盲、安慰剂对照临床试验,后6周为开放研究。52位活动性AS患者随机接受6周的每周2次依那西普(25mg)或安慰剂皮下注射,主要疗效指标为达到ASAS20的患者比例,次要疗效指标达到ASASS0、ASAS70受试者比例,BAS—DAI改善达到50%的受试者比例。结果:6周时80%患者达到治疗反应,而安慰剂组仅31%(P〈0.001);其他各项疗效指标治疗组也有明显的改善。常见不良反应为注射部位皮肤反应。结论:依那西普的安全性和耐受性好,能迅速减轻AS的症状和体征,控制AS患者的病情活动。

关 键 词:脊柱炎  强直性  肿瘤坏死因子d  依那西普  临床试验

Treatment of ankylosing spondylitis with recombinant human tumor necrosis factor-Fc fusion protein (etanercept): a multicenter,randomized,double-blind,placebo-controlled trial
DENG Xiao-hu,HUANG Feng,ZHANG Ya-mei,YANG Chun-hua,GUO Jun-hua,LIANG Dong-feng,LI Sheng-guang,WANG Li-sha,ZHANG Jiang-lin.Treatment of ankylosing spondylitis with recombinant human tumor necrosis factor-Fc fusion protein (etanercept): a multicenter,randomized,double-blind,placebo-controlled trial[J].Academic Journal of Pla Postgraduate Medical School,2009,30(1):21-23.
Authors:DENG Xiao-hu  HUANG Feng  ZHANG Ya-mei  YANG Chun-hua  GUO Jun-hua  LIANG Dong-feng  LI Sheng-guang  WANG Li-sha  ZHANG Jiang-lin
Institution:Department of Rheumatology;Chinese PLA General Hospital;Beijing 100853;China
Abstract:Objective: To evaluate the efficacy and safety of recombinant human tumor necrosis factor receptor,Fc fusion protein,in treating ankylosing spondylitis(AS).Methods: This was a randomized,double-blind,placebo-controlled trial in the first 6 weeks and an open labeled trial in the next 6 weeks.52 patients of active AS were randomly assigned to receive twice weekly subcutaneous injections of etanercept(25mg) or placebo for 6 weeks.The primary endpoint was proportion of ASAS20 responders at week 6.The secondary ...
Keywords:spondylitis  ankylosing  tumor necrosis factor-alpha  etanercept  clinical trial  
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