目的 分析信迪利單抗引起的皮膚藥物不良反應(yīng)（CADR）的發(fā)生特點與治療轉(zhuǎn)歸，為臨床合理使用信迪利單抗提供參考。方法 檢索中國知網(wǎng)（CNKI）、萬方、維普（VIP）、PubMed等數(shù)據(jù)庫收載的信迪利單抗致CADR的文獻報道并進行數(shù)據(jù)分析。結(jié)果 收集信迪利單抗導致CADR的個案報道15篇，涉及患者15例，其中男性9例（60.00%），女性6例（40.00%），年齡分布以50歲以上居多（11例，73.33%），發(fā)生時間主要集中在用藥84 d以內(nèi)（14例，93.33%），CADR類型以中毒性表皮壞死松解癥和大皰性類天皰瘡最常見，分別有6例（40.00%）和2例（13.33%）。13例患者經(jīng)停藥和/或?qū)ΠY處理后均好轉(zhuǎn)，1例患者因Stevens-Johnson綜合征死亡，1例患者因中毒性表皮壞死松解癥死亡。結(jié)論 信迪利單抗可誘發(fā)CADR，應(yīng)注意紅斑、黏膜損傷、皮疹、水皰等可能為CADR發(fā)生的信號，除了全身性糖皮質(zhì)激素治療以外，靜脈注射用人免疫球蛋白和腫瘤壞死因子-α（TNF-α）抑制劑也可作為CADR的補充治療。

Objective To analyze the occurrence characteristics and treatment outcome of cutaneous adverse drug reactions (CADRs) caused by sintilimab and provide reference for clinical drug use. Methods The literature reports of CADR induced by sintilimab were collected from the databases of CNKI, Wanfang, VIP, and PubMed databases and data analyzed. Results A total of 15 cases were reported in 15 articles, including 9 males (60.00%) and 6 females (40.00%), most of them were over 50 years old (11 cases, 73.33%), the occurrence time was mainly within 84 days (14 cases, 93.33%). Toxic epidermal necrolysis and bullous pemphigoid were the most common types of CADR, with 6 cases (40.00%) and 2 cases (13.33%) respectively. All 13 patients improved after drug withdrawal and/or symptomatic treatment. One patient died of Stevens-Johnson syndrome and one patient died of toxic epidermal necrolysis.Conclusion Sintilimab can induce CADR, it should be noted that erythema, mucosal damage, rash and blister may be the signals of CADR, in addition to systemic glucocorticoid therapy, intravenous administration of human immunoglobulin and tumor necrosis factor (TNF)- α inhibitors can also be used as a complementary treatment for CADR.

R986

十堰市科學技術(shù)研究與開發(fā)項目（18Y84，21Y77，21Y78）；湖北醫(yī)藥學院附屬國藥東風總醫(yī)院青年人才項目（2021Q10，2022Q27）