中华皮肤科杂志 ›› 2022, Vol. 55 ›› Issue (2): 153-156.doi: 10.35541/cjd.20200823

• 研究报道 • 上一篇    下一篇

人免疫球蛋白和重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗中毒性表皮坏死松解症的对比研究

包诗杰    程杨    晏莹    范昉    高婷婷    冯小兰    郑亮    雷卫    黄琴斯    张伟明    周小勇   

  1. 武汉市第一医院皮肤科，武汉  430022
  • 收稿日期:2020-08-17 修回日期:2021-07-25 发布日期:2022-01-27
  • 通讯作者: 周小勇 E-mail:13018097526@126.com

A comparative study of human immunoglobulin versus recombinant human tumor necrosis factor-α receptor Ⅱ:IgG Fc fusion protein in the treatment of toxic epidermal necrolysis

Bao Shijie, Cheng Yang, Yan Ying, Fan Fang, Gao Tingting, Feng Xiaolan, Zheng Liang, Lei Wei, Huang Qinsi, Zhang Weiming, Zhou Xiaoyong   

  1. Department of Dermatology, Wuhan No.1 Hospital, Wuhan 430022, China
  • Received:2020-08-17 Revised:2021-07-25 Published:2022-01-27
  • Contact: Zhou Xiaoyong E-mail:13018097526@126.com

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摘要： 【摘要】 目的 评价静脉注射人免疫球蛋白（IVIG）及重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（rhTNFR：Fc）治疗中毒性表皮坏死松解症（TEN）的疗效。方法 收集2013—2019年武汉市第一医院使用IVIG及rhTNFR：Fc治疗的TEN患者资料。IVIG组11例，男3例，女8例，年龄25 ~ 72岁，中位TEN疾病严重程度评分（SCORTEN）3分；rhTNFR：Fc组10例，男女各5例，年龄32 ~ 84岁，中位SCORTEN评分2分。采用相当于0.6 ~ 1.0 mg·kg-1·d-1醋酸泼尼松龙治疗5 d皮损无改善时，加用IVIG 400 mg·kg-1·d-1连续5 d，或隔日皮下注射25 mg rhTNFR：Fc 4 ~ 6次。记录两组患者的皮损变化及不良事件。采用Mann-Whitney U检验进行统计分析。结果 IVIG组皮损渗液开始减少时间（1.73 ± 1.19 d）、皮损区疼痛开始减轻时间（1.64 ± 1.28 d）、皮损基底颜色变淡时间（2.45 ± 1.12 d）、新生表皮开始出现时间（3.09 ± 1.13 d）、间擦部位皮损开始干燥时间（4.82 ± 2.22 d），均少于rhTNFR：Fc组（分别为3.00 ± 1.56、3.70 ± 1.63、3.90 ± 1.59、5.20 ± 1.22、7.90 ± 3.14 d），差异均有统计学意义（均P < 0.05）。IVIG组住院时间（17.70 ± 8.33 d）与rhTNFR：Fc组（16.70 ± 4.71 d）差异无统计学意义（P > 0.05）。治疗过程中未见不良反应，21例患者随访6个月未见复发及并发症。结论 IVIG和rhTNFR：Fc治疗TEN均有效，但前者在减轻皮损疼痛、渗出，促进新生表皮生长速度上优于后者。

关键词: 表皮坏死松解症, 中毒性, 治疗, 生物制剂, 免疫球蛋白疗法, 肿瘤坏死因子α拮抗剂

Abstract: 【Abstract】 Objective To evaluate and compare efficacy of intravenous immunoglobulin （IVIG） versus recombinant human tumor necrosis factor-α receptor Ⅱ:IgG Fc fusion protein （rhTNFR:Fc） in the treatment of toxic epidermal necrolysis （TEN）. Methods Clinical data were collected from patients with TEN treated with IVIG or rhTNFR:Fc in Wuhan No.1 Hospital from 2013 to 2019. There were 11 patients in the IVIG group, including 3 males and 8 females, aged 25 - 72 years, and the median TEN-specific severity-of-illness score （SCORTEN） was 3 points; there were 10 patients in the rhTNFR:Fc group, including 5 males and 5 females, aged 32 - 84 years, and the median SCORTEN was 2 points. These patients all showed no response to the 5-day treatment with prednisolone acetate at a dose of 0.6 - 1.0 mg·kg-1·d-1, and then received IVIG at a dose of 400 mg·kg-1·d-1 for 5 consecutive days, or subcutaneous injection of rhTNFR:Fc at a dose of 25 mg every other day for 4 - 6 sessions. Changes in skin lesions and adverse events were recorded in the 2 groups. Statistical analysis was carried out by using Mann-Whitney U test. Results Compared with the rhTNFR:Fc group, the IVIG group showed a significant decrease in the time to onset of reduction of skin lesion exudate （1.73 ± 1.19 days vs. 3.00 ± 1.56 days, P < 0.05）, time to onset of pain relief in the lesion area （1.64 ± 1.28 days vs. 3.70 ± 1.63 days, P < 0.05）, time to lightening of color of the lesion base （2.45 ± 1.12 days vs. 3.90 ± 1.59 days, P < 0.05）, time to onset of new epidermis growth （3.09 ± 1.13 days vs. 5.20 ± 1.22 days, P < 0.05）, and in the time to onset of lesion drying at the intertriginous sites （4.82 ± 2.22 days vs. 7.90 ± 3.14 days, P < 0.05）. However, there was no significant difference in the length of hospital stay between the IVIG group （17.70 ± 8.33 days） and rhTNFR:Fc group （16.70 ± 4.71 days, P > 0.05）. No adverse reactions were observed during the treatment, and no recurrence or complications were found in the 21 patients during the follow-up of 6 months. Conclusion IVIG and rhTNFR:Fc are both effective in the treatment of TEN, but IVIG is superior to rhTNFR:Fc in terms of the time to onset of pain relief, skin lesion exudate reduction and epidermal growth.

Key words: Epidermal necrolysis, toxic, Therapy, Biological agents, Immunoglobulin therapy, Tumor necrosis factor-α antagonists