纳武利尤单抗相关垂体炎文献病例分析  

Literature case analysis of hypophysitis due to nivolumab

作　　者：戴珩珩 孔炜伟 Dai Hengheng;Kong Weiwei(Department of Pharmacy,Yancheng Second People′s Hospital,Jiangsu Province,Yancheng 224003,China;Department of Oncology,Yancheng Second People′s Hospital,Jiangsu Province,Yancheng 224003,China)

机构地区：[1]江苏省盐城市第二人民医院药剂科,盐城224003 [2]江苏省盐城市第二人民医院肿瘤内科,盐城224003

出　　处：《药物不良反应杂志》2025年第2期99-106,共8页Adverse Drug Reactions Journal

摘　　要：目的:了解纳武利尤单抗致垂体炎的临床特点,为临床安全使用该药提供参考。方法:检索国内外有关数据库(截至2024年5月31日),收集纳武利尤单抗致垂体炎的病例报告类文献。提取患者性别、年龄、原发疾病、纳武利尤单抗单药和联合用药情况、垂体炎发生情况、关联性评价、干预措施及转归,进行描述性统计分析。结果:纳入分析的病例报告共56篇,英文文献53篇,中文文献3篇。涉及59例患者,男性40例,女性19例;年龄26~84岁,平均61岁;原发疾病为恶性黑色素瘤者20例,肾细胞癌19例,肺癌11例,舌咽癌4例,食管癌2例,胃癌、结肠癌和胸膜间皮瘤各1例。59例患者中使用纳武利尤单抗单药治疗者33例,与伊匹木单抗联用24例,与安罗替尼和铂类药物联用各1例。纳武利尤单抗单药致垂体炎的平均时间为用药后25.6周,联合用药发生垂体炎的平均时间为用药后9.9周。纳武利尤单抗致垂体炎的主要临床表现为疲劳、厌食、头痛和恶心等。56例患者停止使用纳武利尤单抗并接受糖皮质激素治疗,其中20例临床症状改善后恢复纳武利尤单抗治疗;3例停药情况及治疗方案不详。59例患者中,4例痊愈,46例症状缓解,2例垂体功能未恢复,4例死亡,1例继发自身免疫性血管炎,1例继发免疫性肝炎,1例转归情况不详。结论:纳武利尤单抗单药所致垂体炎发生的平均时间长于联合用药,其主要临床表现为疲劳、厌食、头痛等,及时停药并接受糖皮质类激素治疗后大部分患者预后良好,但严重者可致死亡。Objective To understand the clinical characteristics of hypophysitis due to nivolumab and provide reference for the safe use of nivolumab in clinic.Methods Relevant databases at home and abroad(up to May 31,2024)were searched and case reports of hypophysitis caused by nivolumab were collected.Relevant information of patients(gender,age,primary disease),single and combined use of nivo-lumab,occurrence of hypophysitis,causality evaluation,intervention measures and outcomes were extracted and analyzed descriptively and statistically.Results A total of 56 case reports,53 in English and 3 in Chinese,were enrolled in the analysis,involving 59 patients,with 40 males and 19 females.Their ages ranged from 26 to 84 years,with an average age of 61 years.The primary diseases were malignant melanoma in 20 cases,renal cell carcinoma in 19 cases,lung cancer in 11 cases,glossopharyngeal cancer in 4 cases,esophageal cancer in 2 cases,and gastric cancer,colon cancer and pleural mesothelioma in 1 case each.Among the 59 patients,33 were treated with nivolumab monotherapy,24 with nivolumab and ipilimumab,1 with nivolumab and anlotinib and 1 with nivolumab and platinum.The average time of hypophysitis caused by nivolumab alone was 25.6 weeks after treatment,and that caused by the combination therapy was 9.9 weeks after treatment.The main clinical manifestations of hypophysitis caused by nivolumab were fatigue,anorexia,headache,and nausea.Among the 59 patients,56 patients discontinued nivolumab and received glucocorticoid,20 of whom resumed nivolumab treatment after improvement of clinical symptoms;3 patients′situation was not described clearly.The outcomes of the 59 patients were as follows.Four were recovered,46 were relieved,2 patients′pituitary function was not recovered,4 died,1 developed secondary autoimmune vasculitis,1 developed secondary autoimmune hepatitis,and it was unknown in one patient.Conclusions The average occurrence time of hypophysitis caused by nivolumab monotherapy is longer than that caused by combination the

关 键 词：抗肿瘤药 免疫检查点抑制剂 免疫相关不良事件 垂体炎 纳武利尤单抗 

分 类 号：R979.1[医药卫生—药品]