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