重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗红皮病性银屑病的疗效观察  

Recombinant human tumor necrosis factor receptor Ⅱ： IgG Fc fusion protein for the treatment of erythrodermic psoriasis： a clinical observation

作　　者：英丽 苏玉华[1] 施辛[1] 路丹丹[1] 丁兰[1] 陈小建[3] 谢立夏[1] 经晶[1] 杨晓雯[1] 徐倩倩[1] 张云[1] 陈晶晶[1] 陈玲玲[3] 

机构地区：[1]苏州大学附属第二医院皮肤科,215004 [2]苏州市相城区第二人民医院皮肤科,215143 [3]苏州市立医院本部皮肤科

出　　处：《中华皮肤科杂志》2016年第9期645-648,共4页Chinese Journal of Dermatology

摘　　要：目的 评价重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（rhTNFR：Fc）治疗红皮病性银屑病的疗效。方法 红皮病性银屑病患者23例，给予rhTNFR：Fc 25 mg皮下注射，每周2次，首剂加倍，疗程12周，之后随访至2年。以治疗中不同时间的银屑病面积与严重度指数（PASI）评分达PASI50、PASI75和PASI90的患者比例、肿瘤坏死因子α（TNF-α）值及不良反应等情况为观察指标。用SPSS 19.0版统计软件进行非参数Friedman检验和重复测量方差分析。结果 23例红皮病性银屑病患者PASI评分从治疗前57.35 ± 3.45降至12周时5.57 ± 3.60（P＜0.01），PASI50、PASI75、PASI90改善例数至12周时分别为23例（100%）、22例（95.65%）和14例（60.87%）（均P＜0.01），TNF-α值从治疗前（62.87 ± 15.23） ng/L降至12周时（4.57 ± 2.99） ng/L（P＜0.01）。未发现不良反应。第24个月随访时，PASI评分与12周时比较差异无统计学意义；PASI50改善例数为23例，PASI75为20例，PASI90为15例；TNF-α值［（3.37 ± 1.62） ng/L］低于12周时（P 〈 0.05）。结论 rhTNFR：Fc是控制红皮病性银屑病急性期炎症的一个有效的药物。Objective To evaluate the efficacy of recombinant human tumor necrosis factor receptor Ⅱ： IgG Fc fusion protein （rhTNFR∶Fc） for the treatment of erythrodermic psoriasis. Methods A total of 23 patients with erythrodermic psoriasis were subcutaneously injected with rhTNFR∶Fc 25 mg （starting dose, 50 mg） twice a week for 12 weeks. Thereafter, they were followed up for 2 years. Outcome measures included the proportion of patients achieving 50%, 75% and 90% reduction in psoriasis area and severity index （PASI50, PASI75 and PASI90）, the serum level of tumor necrosis factor-α （TNF-α）, and incidence of adverse reactions. Statistical analysis was carried out by using nonparametric Friedman test and repeated measures ANOVA with the software SPSS 19.0. Results After 12-week treatment, the PASI score significantly decreased from 57.35 ± 3.45 at the baseline to 5.57 ± 3.60 in the patients with erythrodermic psoriasis （P 〈 0.01）, with the proportion of patients achieving PASI50, PASI75 and PASI90 being 100% （23 cases）, 95.65% （22 cases）, and 60.87% （14 cases） respectively. The serum level of TNF-α showed a significant decrease from 62.87 ± 15.23 ng/L before the treatment to 4.57 ± 2.99 ng/L （P 〈 0.01） after 12-week treatment. No adverse reactions were observed during the treatment. After 24-month follow-up, PASI scores experienced no significant changes in these patients compared with those at the end of 12-week treatment, and the number of patients achieving PASI50, PASI75 and PASI90 was 23, 20 and 15 respectively. The serum level of TNF-α was significantly lower at the end of 24-month follow-up than at that of 12-week treatment （3.37 ± 1.62 vs. 4.57 ± 2.99 ng/L, P 〈 0.05 ）. Conclusion rhTNFR∶Fc is effective for the control of acute inflammation in erythrodermic psoriasis.

关 键 词：银屑病 肿瘤坏死因子Α Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 TNF-α拮抗剂 

分 类 号：R758.63[医药卫生—皮肤病学与性病学]