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 rhTN FR:Fc是控制红皮病性银屑病急性期炎症的一个有效的药物.

abstractsObjective 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.