中华皮肤科杂志 ›› 2016, Vol. 49 ›› Issue (9): 645-648.

• 研究报道 • 上一篇    下一篇

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

英丽1,苏玉华2,施辛3,路丹丹3,丁兰2,陈小建3,谢立夏2,4,经晶3,杨晓雯3,徐倩倩3,5,张云3,6,陈晶晶3,陈玲玲7   

  1. 1. 苏州市相城区第二人民医院
    2. 苏州大学附属第二医院皮肤科
    3. 苏州大学附属第二医院
    4. 成都市第二人民医院
    5. 湖北医药学院附属随州医院皮肤科
    6. 扬州市第一人民医院
    7. 南京医科大学附属苏州医院
  • 收稿日期:2015-12-31 修回日期:2016-02-23 出版日期:2016-09-15 发布日期:2016-08-30
  • 通讯作者: 施辛 E-mail:shx9@163.com

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

  • Received:2015-12-31 Revised:2016-02-23 Online:2016-09-15 Published:2016-08-30

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。

关键词: TNF-&alpha, 拮抗剂

Abstract:

Ying Li, Su Yuhua, Shi Xin, Lu Dandan, Ding Lan, Chen Xiaojian, Xie Lixia, Jing Jing, Yang Xiaowen, Xu Qianqian, Zhang Yun, Chen Jingjing, Chen Lingling Department of Dermatology, The Second Affiliated Hospital of Soochow University, Suzhou 215004, Jiangsu, China (Ying L [current affiliation: Department of Dermatology, The Second People′s Hospital of Xiangcheng, Suzhou 215143, China], Su YH, Shi X, Lu DD, Ding L, Xie LX, Jing J, Yang XW, Xu QQ, Zhang Y, Chen JJ); Department of Dermatology, Suzhou Municipal Hospital, Suzhou 215006, Jiangsu, China (Chen XJ, Chen LL) Corresponding authors: Shi Xin, Email: shx9@163.com; Chen Lingling, Email: chenlingling031@126.com 【Abstract】 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.