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  

A comparative study of human immunoglobulin versus recombinant human tumor necrosis factored receptorⅡ:IgG Fc fusion protein in the treatment of toxic epidermal necrolysis

作　　者：包诗杰[1] 程杨[1] 晏莹[1] 范昉[1] 高婷婷[1] 冯小兰[1] 郑亮[1] 雷卫 黄琴斯[1] 张伟明[1] 周小勇[1] Bao Shijie;Cheng Yang;Yan Ying;Fan Fang;Gao Tingting;Feng Xiaolan;Zheng Liang;Lei Wei;Huang Qinsi;Zhang Weiming;Zhou Xiaoyong(Department of Dermatology,Wuhan No.1 Hospital,Wuhan 430022,China)

机构地区：[1]武汉市第一医院皮肤科,武汉430022

出　　处：《中华皮肤科杂志》2022年第2期153-156,共4页Chinese Journal of Dermatology

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±3.14d),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。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 I

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 

分 类 号：R751[医药卫生—皮肤病学与性病学]