【摘要】 目的 基于文献报告分析斯鲁利单抗致不良反应的发生特点及处置转归，为该药的安全使用提供借鉴。方法 检索国内外数据库中斯鲁利单抗致药品不良反应的个案报告，并采用文献回顾的方法对纳入的病例进行分析总结。结果 共纳入15篇研究文献，计15例患者，其中男性13例、女性2例，患者平均年龄（58.47±6.44）岁。纳入患者以肺癌治疗病例最多，所有患者均存在联合用药，多数患者在使用斯鲁利单抗前并无不良反应相关病史。斯鲁利单抗使用符合说明书规定，不良反应发生时间范围为5～476 d，以100 d内（73.33%）常见。斯鲁利单抗不良反应可累及多个系统或器官，且以内分泌系统、心血管系统最多，其次为皮肤及其附件、消化系统。不良反应关联评价提示9例为很可能；经积极治疗后，13例患者好转，2例患者死亡。结论 斯鲁利单抗相关不良反应好发于50岁以上的中老年男性，以用药100 d内最为常见，多累及内分泌系统、心血管系统、皮肤及其附件和消化系统。除胃肠道假性梗阻这一新的不良反应外，其余不良反应在斯鲁利单抗说明书中均有述及。临床应用斯鲁利单抗时，应做好患者用药教育及用药安全性监测，加强药物不良反应防范，以保证用药安全。更多还原

【Abstract】 Objective To analyze the clinical characteristics, management and outcomes of adverse drug reactions induced by serplulimab based on literature reports, so as to provide evidence for the safe clinical application of this drug. Methods Case reports on adverse drug reactions induced by serplulimab were retrieved from domestic and foreign databases. A literature review method was adopted to analyze and summarize the enrolled cases. Results A total of 15 literatures involving 15 patients were included, including 13 males and 2 females, with an average age of(58.47±6.44) years old. Most patients received serplulimab for lung cancer, and all patients were given combined medication. The majority of patients had no previous medical history related to adverse reactions before serplulimab administration. The medication of serplulimab in all cases complied with the specifications. The onset time of adverse reactions ranged from 5 to 476 days, among which 73.33% occurred within 100 days. Serplulimab-related adverse reactions involved multiple systems and organs, predominantly the endocrine system and cardiovascular system, followed by the skin and its appendages as well as the digestive system. Adverse reaction causality assessment showed that 9 cases were assessed as probable. After active intervention and treatment, 13 patients improved and 2 cases died. Conclusion Serplulimab-related adverse reactions predominantly occur in middle-aged and elderly males aged over 50 years, mostly within 100 days after medication, and mainly involve the endocrine system, cardiovascular system, skin and its appendages, and digestive system. Except for gastrointestinal pseudo-obstruction identified as a new adverse reaction, other adverse reactions have been documented in the instruction manual of serplulimab. In clinical practice, standardized medication education and safety monitoring should be implemented for patients receiving serplulimab. It is necessary to strengthen the prevention and management of adverse drug reactions to ensure clinical medication safety.更多还原