50例免疫相关不良反应肿瘤患者中医辨证分型特点的真实世界研究  

Real-world Study on Characteristics of Traditional Chinese Medicine Syndromes of 50 Patients with Immune-related Adverse Events

作　　者：鲁星妤 郑佳彬 薛崇祥 张旭[1] 杨萌[2] 程志强[2] 李利亚[2] 娄彦妮[2] 王超 崔慧娟[2] LU Xingyu;ZHENG Jiabin;XUE Chongxiang;ZHANG Xu;YANG Meng;CHENG Zhiqiang;LI Liya;LOU Yanni;WANG Chao;CUI Huijuan(Beijing University of Chinese Medicine,Beijing,100029;China-Japan Friendship Hospital)

机构地区：[1]北京中医药大学,北京市100029 [2]中日友好医院

出　　处：《中医杂志》2022年第21期2052-2059,共8页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81873396);首都卫生发展科研专项(2018-2-4065,2022-2-4065)。

摘　　要：目的 通过分析真实世界中肿瘤患者发生免疫相关不良反应(irAEs)的临床特征与中医分型,为中医药在irAEs中的临床应用提供参考。方法 采取回顾性队列研究,收集采用免疫检查点抑制剂(ICIs)治疗并发生irAEs的肿瘤患者一般资料、ICIs应用类型、irAEs发生频次、严重程度分级情况、系统毒性等临床特征,并参考《恶性肿瘤中医诊疗指南》中医证型进行统一辨证。比较发生频次≥15%的主要中医证型各系统毒性构成比与总体证型构成比的差异,并对各激素使用方法、不同后续ICIs治疗情况之间的证型分布进行比较。结果 共纳入50例患者,发生73次irAEs。证型组合发生频次从高到低依次为热毒证+痰湿证(34.3%)、气虚证+阴虚证(19.2%)、气虚证+痰湿证(15.1%)。皮肤毒性的辨证分型主要为热毒证+痰湿证(P=0.004),甲状腺功能减退的辨证分型以气虚证+阴虚证、气虚证+痰湿证为主(P=0.001),心脏毒性以气虚证+痰湿证为主(P=0.049),与整体证型分布比较,差异均有统计学意义。使用激素替代治疗的证型与非替代治疗的证型相比差异具有统计学意义,替代治疗以气虚证+阴虚证、气虚证+痰湿证为主(P=0.008)。不同后续ICIs治疗情况的辨证分型差异均无统计学意义(P>0.05)。结论 irAEs中医证型以热毒证+痰湿证表现的湿热相兼为主,同时存在气阴两虚证、气虚痰湿证等情况,可为中医药介入免疫治疗充分发挥辨证论治和个体化治疗优势提供依据与思路。Objective To analyze the clinical characteristics and differentiated traditional Chinese medicine(TCM)syndromes of the real-world tumor patients who have had immune-related adverse reactions(irAEs),thereby providing ideas for TCM in dealing with irAEs in clinical practice.Methods The general data,immune checkpoints inhibitors(ICIs)types,irAEs frequency,severity,systematic toxicity and other clinical characteristics of patients who have been treated by ICIs and have had irAEs were collected in a retrospective cohort design. The TCM syndromes were differentiated by referring to the Malignant Tumor Diagnosis and Treatment Guideline with Chinese Medicine. The ratio of each systemic toxicity component and the proportion of overall syndrome types were compared among TCM syndromes with frequency ≥15%. The syndrome type distribution between different hormone use methods and different subsequent ICIs treatment were compared.Results A total of 50 patients were included,with 73 irAEs.Heat-toxin syndrome plus phlegm-damp syndrome had highest frequency(34. 3%),followed by qi deficiency syndrome plus yin deficiency syndrome(19. 2%),and qi deficiency syndrome plus phlegm-damp syndrome(15. 1%).The main type of skin toxicity was heat toxin syndrome plus phlegm-damp syndrome(P = 0. 004),while that of hypothyroidism and cardiotoxicity were qi deficiency syndrome plus yin deficiency syndrome and deficiency syndrome plus phlegm-damp syndrome(P = 0. 001),and qi deficiency syndrome plus phlegm-damp syndrome(P = 0. 049),respectively. These results showed statistical differences when compared to overall syndromes distribution. The syndrome types of hormone replacement therapy was statistically different from those of non-replacement therapy,and qi deficiency syndrome plus yin deficiency syndrome,qi deficiency syndrome plus phlegm-damp syndrome were the main combinations of replacement therapy(P = 0. 008). There was no statistical difference in syndromes in terms of different follow-up ICIs treatment(P>0. 05).Conclusion TCM syndrome of

关 键 词：肿瘤 免疫相关不良反应 中医辨证 免疫检查点抑制剂 程序性细胞死亡蛋白-1 程序性细胞死亡蛋白配体-1 

分 类 号：R273[医药卫生—中西医结合]