摘要
目的:评价注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(商品名:益赛普)治疗中、重度寻常性银屑病患者的疗效。方法:采用多中心、随机、双盲、双模拟、阳性平行对照临床试验方法,对144例中、重度寻常性银屑病患者进行银屑病皮损面积和严重度指数(PASI)评分,其中益赛普组72例,甲氨蝶呤(MTX)组72例。结果:144例患者中124例完成了12周的治疗。治疗12周后,益赛普组PASI50、PASI75、PASI90的比例(PP人群)高于MTX组,差异具有统计学意义(P<0.01)。益赛普组从第4周起PASI评分的改善优于MTX组,且对躯干、四肢的疗效好于MTX组。结论:与MTX比较,益赛普具有起效快、治疗效果明显、PASI评分改善明显的特点。
Objective: To evaluate the effect of recombinant human tumor necrosis factor receptor(rhTNFR:Fc) in the treatment of moderate to severe plaque psoriasis on psoriasis area and severity index (PASI). Methods: Using randomized, doubleblind and double-simulated, parallel-controlled with positive drug, multicenter, clinical trial was employed to investigate 144 cases of patients with moderate to severe plaque psoriasis, of which there were 72 cases in both trial group and the control group respectively, to evaluate the effect on PASI. Results: 124 cases of patients had accomplished the 12-week clinical trial. After 12 weeks the rate of PASIS0, PASI75. PASI90 were significantly higher than those of the control group(P〈 0.01). The therapeutic effects on trunk and limbs of the trial group were also much better. Conclusion: The effect of rbTNFR:Fc is more quick and significant, especially assessed by PASI sore.
出处
《临床皮肤科杂志》
CAS
CSCD
北大核心
2007年第11期730-732,共3页
Journal of Clinical Dermatology