|
|
|
本文已被:浏览 3278次 下载 1829次 |
码上扫一扫! |
|
真实世界中50例免疫检查点抑制剂相关严重不良反应分析 |
艾罗燕1,2, 余一祎1,2, 林瑾仪3, 刘红春4, 胡洁5, 高地6, 吴薇7, 金航8, 赵琳9, 孙颖10, 王妍1,2, 李倩1,2, 崔越宏1,2, 徐蓓1,2, 刘天舒1,2
|
1.复旦大学附属中山医院肿瘤内科, 上海 200032;2.复旦大学附属中山医院肿瘤防治中心, 上海 200032;3.复旦大学附属中山医院心内科, 上海 200032;4.复旦大学附属中山医院消化内科, 上海 200032;5.复旦大学附属中山医院呼吸内科, 上海 200032;6.复旦大学附属中山医院皮肤科, 上海 200032;7.复旦大学附属中山医院药剂科, 上海 200032;8.复旦大学附属中山医院放射科, 上海 200032;9.复旦大学附属中山医院内分泌科, 上海 200032;10.复旦大学附属中山医院风湿科, 上海 200032
|
|
摘要: |
目的:探讨真实世界中免疫检查点抑制剂(immune checkpoint inhibitors,ICIs)导致的严重免疫相关不良事件(immune-related adverse events,irAEs)的发生情况。方法:选取2018年6月至2020年6月复旦大学附属中山医院收治的50例重型irAEs住院患者,收集并分析基本资料、用药情况、中位发病时间、实验室检查、治疗及预后等。结果:50例重型irAEs包括心肌炎、肝炎、肠炎、肺炎、肾上腺皮质功能减退、糖尿病及神经系统炎症。中位发病年龄为61岁,其中男性33例(66%),总体irAEs中位发病时间为6周,全身静脉应用糖皮质激素45例(90%)。好转39例(78%),死亡11例(22%),死亡患者主要发生心肌炎和肝炎。相比于好转患者,死亡患者激素应用剂量更大[(267.27±190.22)mg vs(105.38±145.49)mg,P=0.021],联合应用其他免疫抑制剂比例更高(10.0%vs 6.0%,P=0.009)。心肌炎患者19例,与其他系统单个器官累及不同,心肌炎患者易合并肌炎、肝炎和甲状腺炎。心肌炎死亡患者较好转患者的氨基末端脑钠肽前体(NT-proBNP)和心肌肌钙蛋白T(cTnT)明显升高(12 844 vs 479.7 pg/mL,P=0.000 6;0.928 vs 0.233 ng/mL,P=0.006 4),左室射血分数无明显变化(62.75%vs 65.11%,P=0.348 2)。结论:重型irAEs可累及心、肝、肺、肠等多种关键器官,即使大剂量糖皮质激素干预,预后仍较差。 |
关键词: 免疫检查点抑制剂 严重免疫相关不良事件 真实世界 心肌炎 |
DOI:10.12025/j.issn.1008-6358.2020.20201356 |
分类号:R979.5 |
基金项目:上海市科学技术委员会基金(19DZ1910102),2020复旦大学附属中山医院智慧医疗专项基金(2020ZHZS02). |
|
Analysis of 50 cases of severe adverse reactions associated with immune checkpoint inhibitors in the real world |
AI Luo-yan1,2, YU Yi-yi1,2, LIN Jin-yi3, LIU Chun-hong4, HU Jie5, GAO Di6, WU Wei7, JIN Hang8, ZHAO Lin9, SUN Ying10, WANG Yan1,2, LI Qian1,2, CUI Yue-hong1,2, XU Bei1,2, LIU Tian-shu1,2
|
1.Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai 200032, China;2.Department of Cancer Center, Zhongshan Hospital, Fudan University, Shanghai 200032, China;3.Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China;4.Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai 200032, China;5.Department of Respiratory, Zhongshan Hospital, Fudan University, Shanghai 200032, China;6.Department of Dermatology, Zhongshan Hospital, Fudan University, Shanghai 200032, China;7.Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai 200032, China;8.Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China;9.Department of Endocrinology, Zhongshan Hospital, Fudan University, Shanghai 200032, China;10.Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai 200032, China
|
Abstract: |
Objective: To explore the general situation of severe immune-related adverse events (irSAEs) in the real world. Methods: A total of 50 patients who were diagnosed with serious irSAEs in Zhongshan Hospital, Fudan University between June 2018 and June 2020 were included. Clinical data including the basic data, drug use, median onset time, laboratory examination, treatment, and prognosis were recorded and analyzed.Results: The spectrum of severe irSAEs included myocarditis, hepatitis, colitis, pneumonitis, primary adrenal insufficiency, diabetes, and nervous system adverse events. The median age of patients was 61 years, 66% of patients were male, and the median time of onset was 6 weeks after starting immune checkpoint inhibitors (ICIs). Steroids were administered in 45 patients (90%). After intensive treatments, 39 patients (77.5%) recovered, and 11 patients (22.5%) had the outcome of death. Main causes of death were myocarditis and hepatitis. Compared with those recovered, patients who died received higher doses of glucocorticoids ([267.27±190.22]mg vs[105.38±145.49] mg, P=0.021), and more patients were additionally given another immunosuppressant (10.0% vs 6.0%, P=0.009). In this study, 19 patients were diagnosed with myocarditis. Different from other irAEs usually affecting one organ, myocarditis was more prone to be concurrent with other system irAEs such as hepatitis, myositis, and thyroiditis. Patients who died from myocarditis had higher NT-proBNP (12 844 vs 479.7 pg/mL, P=0.000 6) and cTnT levels (0.928 vs 0.233 ng/mL, P=0.006 4) than those recovered from myocarditis. But no statistical significance existed between the two groups for left ventricular ejection fraction (62.75% vs 65.11%, P=0.348 2).Conclusions: Severe irSAEs affect key organs including heart, liver, lung, and intestine. The prognosis of irSAEs is poor even if high-dose glucocorticoids were administrated. |
Key words: immune checkpoint inhibitors severe immune-related adverse events real-world myocarditis |
|
|
|
|