信迪利单抗致垂体炎的回顾性系列病例分析  

Retrospective case series analysis of hypophysitis induced by sintilimab

作　　者：单彬[1] 翟柏航 吕雨科 郭静汝 陈梦如 梁平[1] 侯娟[1] SHAN Bin;ZHAI Bai-hang;LÜYu-ke;GUO Jing-ru;CHEN Meng-ru;LIANG Ping;HOU Juan(Department of Pharmacy,the Fourth Hospital of Hebei Medical University,Shijiazhuang HEBEI 050011,China;Department of Pharmacy,North China Petroleum Administration General Hospital,Renqiu HEBEI 050011,China;College of Pharmacy,Hebei Medical University,Shijiazhuang HEBEI 050011,China)

机构地区：[1]河北医科大学第四医院药学部,河北石家庄050011 [2]华北石油管理局总医院药学部,河北任丘050011 [3]河北医科大学药学院,河北石家庄050011

出　　处：《中国新药与临床杂志》2025年第1期72-77,共6页Chinese Journal of New Drugs and Clinical Remedies

基　　金：河北省医学科学研究课题计划(20240159);河北省河北医科大学临床药学青年学者托举项目——星火计划(XHJH202304);河北医科大学2023年大学生创新性实验计划项目(USIP2023373)。

摘　　要：本研究探讨信迪利单抗导致免疫治疗相关垂体炎(IH)的系列病例,分析信迪利单抗导致IH的病例特点、发病机制及处置方法。选择河北医科大学第四医院2019年1月1日至2023年5月31日应用信迪利单抗所致IH的病例,并在数据库中检索信迪利单抗导致IH的文献报道。分析信迪利单抗导致IH的患者临床表现,促肾上腺皮质激素(ACTH)、皮质醇、血钠等生化指标的变化,IH的处理措施、临床转归等,总结病例特点。18个月观察期内,本院信迪利单抗导致的IH有3例,在数据库中检索到3例个案报道。6例IH患者均为老年男性,应用首剂信迪利单抗后平均7.7个月出现IH。停药后,经糖皮质激素治疗,6例患者的临床症状均好转,2例患者有复发,6例患者的ACTH均偏低。信迪利单抗导致的IH患者垂体MRI一般无异常,严重者可出现精神症状。糖皮质激素替代治疗后,ACTH很可能不会恢复正常,需要长期的糖皮质激素规律治疗。IH属于信迪利单抗偶见的药物不良反应;患者接受信迪利单抗治疗期间应定期监测垂体相关内分泌激素水平,警惕免疫相关不良反应的发生。This study investigates the case series of immunotherapy induced hypophysitis(IH)by sintilimab,and analyzes the characteristics of the cases and the pathogenesis of IH induced by sintilimab.Cases of IH due to application of sintilimab from 1st January 2019 to 31st May 2023 in the Fourth Hospital of Hebei Medical University were collected.And case reports of IH due to sintilimab were retrived in the databases.The characteristics of the clinical manifestations of patients with IH induced by sintilimab,the changes in the values of adrenocorticotropic hormone(ACTH),cortisol,serum level of sodium ions and other biochemical indexes,the management measures of IH,and the clinical prognosis of IH were analysed,and finally the characteristics of the cases were summarized.During the 18-month observation period,there were three cases of IH induced by sintilimab in this hospital,and three case reports were retrieved from the databases.Six patients with IH,all of whom were elderly males,developed IH after a mean of 7.7 months since the first dosage of sintilimab.After treatment of glucocorticoids therapy following withdrawal of sintilimab,six patients showed improvement in clinical symptoms,two patients had relapses,and all six patients had low level of ACTH.MRI of pituitary was generally normal in patients with IH induced by sintilimab,and in severe cases,psychiatric symptoms may occur.ACTH was likely not to return to normal after glucocorticoid replacement therapy,and long-term glucocorticoid treatment was required.IH is an uncommon adverse drug reaction of sintilimab.Therefore,pituitary-related hormone levels should be regularly monitored to avoid the occurrence of immune-related adverse drug reactions during the treatment.

关 键 词：信迪利单抗 免疫疗法 程序性死亡受体1 垂体炎 药物不良反应 

分 类 号：R979.1[医药卫生—药品]