重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗中、重度寻常性银屑病81例临床观察

Clinical Observation of Recombinant Human Tumor Necrosis Factor Receptor Type Ⅱ-Fc Fusion Protein in the Treatment of 81 Patients with Moderate to Severe Psoriasis Vulgaris

目的评价皮下注射用重组人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、重度寻常性银屑病的临床疗效。方法采用多中心、开放临床试验,对81例中、重度寻常性银屑病患者给予益赛普25mg皮下注射,2次/周,共治疗12周。结果 81例患者治疗12周后银屑病皮损面积和严重程度指数(PASI)、医生对病情的整体评分(PGA)、皮肤病生活质量指数(DLQI)和患者10cm视觉模拟评分(VAS)与基线相比均有显著改善(P<0.001)。结论益赛普是治疗中、重度寻常性银屑病的一种安全、有效的方法。

Objective To investigate the efficacy and tolerability of subcutaneous injection of a recombinant human tumor necrosis factor receptor type Ⅱ -Fc fusion protein （ rhTNFR：Fc, with a trade name of Yisaipu ） in the treatment of moderate to severe psoriasis vulgaris. Methods A muhicenter, open-label clinical trial was performed. Eighty-one patients with moderate to severe psoriasis vulgaris were treated with subcutaneous injection of rhTNFR：Fc （25mg） twice-weekly for 12 weeks. Results Eighty-one patients had completed the 12-week clinical trial. After 12-week treatment, psoriasis area and severity index （PASI） ,physician global assessment （PGA）, dermatology life quality index （DLQI） and 10cm visual analog scale （VAS） were significantly improved in comparison to the baseline （P 〈 0. 001 ）. Conclusion rhTNFR： Fc is safe and effective in the treatment of moderate to severe psoriasis vulgaris.