中华皮肤科杂志

• 论著 •    下一篇

重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗寻常性银屑病多中心、随机、双盲试验

黄琼1, 杨勤萍1, 方栩1, 韩凌1, 郑志忠1, 傅雯雯1, 孙建方2, 姜祎群2, 顾军3, 高春芳3, 许爱娥4, 陈俊帆4, 苏炳华5, 何清波5   

  1. 1. 复旦大学附属华山医院, 上海200040;
    2. 中国医学科学院皮肤病研究所;
    3. 第二军医大学附属长海医院;
    4. 杭州市第三人民医院;
    5. 上海第二医科大学生物统计教研室
  • 收稿日期:2006-12-13 出版日期:2007-11-15 发布日期:2007-11-15
  • 通讯作者: 杨勤萍,email:dxq93216@medmail.com.cn E-mail:dxq93216@medmail.com.cn

Treatment of psoriasis vulgaris with a recombinant human tumor necrosis factor receptor:Fc fusion protein:a multicentre, randomized, double blind trial

HUANG Qiong1, YANG Qin-ping1, FANG Xu1, HAN Ling1, ZHENG Zhi-zhong1, FU Wen-wen1, SUN Jian-fang2, JIANG Yi-qun2, GU Jun3, GAO Chun-fang3, XU Ai-e4, CHEN Jun-fan4, SU Bing-hua5, HE Qing-bo5   

  1. Department of Dermatology, Huashan Hospital, Fudan University, Shanghai 200040, China
  • Received:2006-12-13 Online:2007-11-15 Published:2007-11-15

PDF (PC)

168

赞

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(rhTNFR:Fc,商品名益赛普)治疗中、重度寻常性银屑病的临床疗效和安全性.方法 采用多中心、随机、双盲双模拟、阳性药物平行对照的临床试验.4个研究中心共144例中、重度寻常性银屑病患者,随机分为试验组和对照组,试验组皮下注射rhTNFR:Fc 50 mg/周,同时口服空白模拟甲氨蝶呤7.5 mg/周;对照组口服甲氨蝶呤7.5 mg/周,同时皮下注射空白模拟rhTNFR:Fc 50 mg/周,疗程12周.结果 124例患者完成了试验,治疗12周后,试验组PAS150、PASI75、PASI90的比例分别为86.11%,76.39%,52.78%,对照组分别为63.89%,44.44%,22.22%,两组间差异有统计学意义(P<0.01).医生对病情的整体评分、皮肤病生活质量指数和患者10 cm视觉模拟评分试验组改善优于对照组(P<0.05);试验组达到痊愈和几乎达到痊愈的比例显著高于对照组(P<0.05).不良反应主要有白细胞或中性粒细胞下降、感染、肝功能异常、注射局部水肿、瘙痒等,发生率试验组为26.39%,对照组为29.17%,两组差异无统计学意义(P>0.05),未见严重不良反应.结论 rhTNFR:Fc比甲氨蝶呤起效快,治愈率高,且毒性反应小.

关键词: 银屑病, 临床对照试验, 甲氨蝶呤, 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白

Abstract: Objective To investigate the efficacy and tolerability of a recombinant human tumor necrosis factor:Fc fusion protein (rhTNFR:Fc,with a trade name of Yisaipu) in the treatment of moderate to severe psoriasis vulgaris.Methods A multicentre,randomized,double blind,and parallel-controlled trial was performed.One hundred and forty-four patients with moderate to severe psoriasis vulgaris from four centres were randomly assigned and treated with either once-weekly subcutaneous injection of rhTNFR:Fc (50 mg) or oral methotrexate (MTX)(7.5 mg) for 12 weeks.Patients were followed up at 2,4,8,12 weeks after the treatment.Results One hundred and twenty-four patients finished the 12-week course of treatment.At 12 weeks after the treatment,a 50%,75%,90% improvement in psoriasis area and severity index (PASI) was achieved by 86.11%,76.39%,52.78% respectively of rhTNFR:Fc-treated patients,and by 63.89%,44.44%,22.22% respectively in MTX-treated patients,and all the three improvement rates were of significant difference between the two groups of patients (all P<0.01).Physician global assessment (PGA), dermatology life quality index (DLQI) and 10-cm visual analog scale (VAS) all reduced more significantly, and more patients were cured or approximately cured in rhTNFR:Fc-treated patients than in MTX-treated patients (all P<0.05).Adverse reactions,mainly including decrease of leucocytes or neutrophils,infection, dysfunction of liver,edema and pruritus at the injection site,etc,occurred in 26.39% of rhTNFR:Fc-treated patients and 29.17% of MTX-treated patients (P>0.05).Conclusion Compared with MTX,rhTNFR:Fc acts more quickly with a higher cure rate and less toxic reactions in the treatment of psoriasis vulgaris.

Key words: Psoriasis, Controlled clinical trials, Methotrexate, rhTNFR:Fc