7938 University of Toronto, Faculty of Medicine, Toronto, Ontario.
8166 Department of Dermatology and Skin Science, University of British Columbia; Division of Dermatology, St. Paul's Hospital, Vancouver, British Columbia.
J Cutan Med Surg. 2021 Nov-Dec;25(6):598-615. doi: 10.1177/1203475421993779. Epub 2021 Feb 25.
Biologic drugs have the potential to halt the progression of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) by decreasing concentrations of tumor necrosis factor-α, a cytokine implicated in epithelial cell death. The objective of this systematic review is to investigate the efficacy and safety of biologic monotherapy and combination therapy for SJS/TEN.
MEDLINE and EMBASE in OVID were searched on October 28, 2020. Inclusion criteria were original studies containing human participants diagnosed with SJS/TEN and treated with biologics. Studies were excluded if they were literature reviews, systematic reviews, letters to the editor, or conference abstracts.
The 38 articles reviewed included 27 (71.1%) case reports, 6 (15.8%) case series, 3 (7.9%) retrospective reviews, and 2 (5.3%) RCTs. The age range of the included studies was 2 to 85 years, the mean age was 46.4 years. The mean body surface (BSA) across the 38 included articles was 31.0%. The average actual mortality reported within the 38 included articles was 9.2%. Both biologic monotherapy and combination therapy were associated with improved outcomes in SJS/TEN. Furthermore, anti TNF-alpha therapy, specifically etanercept, showed improved outcomes as monotherapy.
Overall, reviewed studies presented a strong case for biologic treatment, both monotherapy and combination use, in SJS/TEN treatment. Based on the number of fatal adverse events observed, biologic monotherapy may be safer compared to combination therapy. Further research with a larger sample size and a randomized control trial design is required.
生物制剂通过降低细胞因子肿瘤坏死因子-α的浓度，有可能阻止史蒂文斯-约翰逊综合征（SJS）和中毒性表皮坏死松解症（TEN）的进展，这种细胞因子与上皮细胞死亡有关。本系统评价的目的是研究生物单药治疗和联合治疗 SJS/TEN 的疗效和安全性。
于 2020 年 10 月 28 日在 OVID 的 MEDLINE 和 EMBASE 中进行检索。纳入标准为包含人类 SJS/TEN 患者并接受生物制剂治疗的原始研究。如果研究为文献综述、系统评价、给编辑的信或会议摘要，则将其排除在外。
综述的 38 篇文章包括 27 篇（71.1%）病例报告、6 篇（15.8%）病例系列、3 篇（7.9%）回顾性研究和 2 篇（5.3%）RCT。纳入研究的年龄范围为 2 至 85 岁，平均年龄为 46.4 岁。纳入的 38 篇文章中平均体表面积（BSA）为 31.0%。纳入的 38 篇文章中报告的平均实际死亡率为 9.2%。生物单药治疗和联合治疗均与 SJS/TEN 结局的改善相关。此外，抗 TNF-α 治疗，特别是依那西普，作为单药治疗显示出更好的结局。
总体而言，回顾性研究强烈支持生物治疗，包括单药和联合使用，用于 SJS/TEN 的治疗。基于观察到的致死性不良事件数量，生物单药治疗可能比联合治疗更安全。需要进一步开展具有更大样本量和随机对照试验设计的研究。
