炙甘草汤加减联合PD-1治疗晚期NSCLC(气阴两虚型)的疗效  

Efficacy of Fried Licorice Decoction Plus-minus combined with PD-1 for advanced non-small cell lung cancer with Qi-Yin deficiency

作　　者：丁欢[1] 陈卓[2] 于洪鹏 冯卓 仕丽[1] Huan Ding;Zhuo Chen;Hongpeng Yu;Zhuo Feng;Li Shi(Lung Disease,Tumor and Hematology Center-Department of Lung Disease,Affiliated Hospital of Changchun University of Chinese Medicine,Changchun 130000,China;Department of Integrated Traditional Chinese and Western Medicine,Jilin Provincial Cancer Hospital,Changchun 130000,China;College of Traditional Chinese Medicine,Changchun University of Chinese Medicine,Changchun 130000,China)

机构地区：[1]长春中医药大学附属医院肺病肿瘤血液中心·肺病科,长春市130000 [2]吉林省肿瘤医院中西医结合科 [3]长春中医药大学中医学院

出　　处：《中国肿瘤临床》2024年第9期461-466,共6页Chinese Journal of Clinical Oncology

基　　金：吉林省自然科学基金(编号:YDZJ202301ZYTS116)资助。

摘　　要：目的:分析炙甘草汤加减联合程序性死亡受体1(programmed cell death protein-1,PD-1)治疗晚期非小细胞肺癌(nonsmall cell lung cancer,NSCLC)(气阴两虚型)的临床疗效。方法:回顾性分析2020年12月至2022年12月就诊于吉林省肿瘤医院、长春中医药大学附属医院的晚期NSCLC(气阴两虚型)患者72例,随机分为两组各36例,对照组(PD-1单抗)、治疗组(PD-1单抗联合炙甘草汤加减)。主要观察指标为免疫功能(CD3^(+)、CD3^(+)/CD4^(+)、CD3^(+)/CD8^(+))和生存质量评分(KPS),次要观察指标为客观缓解率(objective response rate,ORR)、中医症候积分、血清肿瘤标志物癌胚抗原(CEA)、神经元特异性烯醇化酶(NSE)、细胞角蛋白片段(CYFRA211)、免疫相关不良反应(胃肠毒性、肺毒性、肝毒性、甲状腺毒性)发生率。结果:治疗组在调节免疫功能CD3^(+)、CD3^(+)/CD4^(+)、CD3^(+)/CD8^(+),提高患者生存质量在T3时间点、T4时间点、降低肿瘤标志物CEA、CY211、改善中医证候咳嗽、乏力、心悸、腹泻的症状和减少免疫相关性肺炎、腹泻方面,均优于对照组(P<0.05)。两组患者客观缓解率分别为治疗组36.1%,对照组25.0%,无显著性差异(P>0.05)。结论:炙甘草汤加减联合PD-1治疗晚期NSCLC的患者,可以显著增强免疫功能,提高临床疗效,减少免疫相关不良反应且安全性较好。Objective:To evaluate the clinical efficacy of Fried Licorice Decoction Plus-minus in combination with PD-1 therapy for patients with advanced non-small cell lung cancer(NSCLC)with Qi-Yin deficiency.Methods:From December 2020 to December 2022,72 patients diagnosed with advanced NSCLC with Qi-Yin deficiency were enrolled in this study.The patients were recruited from Jilin Provincial Cancer Hospital and the Affiliated Hospital of Changchun University of Chinese Medicine.The patients were randomly assigned into two groups,with 36 patients in each group.The control group received PD-1 treatment alone,and the treatment group received PD-1 combined with Fried Licorice Decoction Plus-minus.The measures of primary outcomes included immune function(CD3^(+),CD3^(+)/CD4^(+),and CD3^(+)/CD8^(+))and quality of life score(Kamofsky,KPS).The measures of secondary outcomes included the objective response rate(ORR);traditional Chinese medicine(TCM)symptom score;serum tumor marker carcinoembryonic antigen(CEA);neuron-specific enolase(NSE);cytokeratin fragment(CYFRA211);and incidence of immune-related adverse events such as gastrointestinal toxicity,pulmonary toxicity,hepatotoxicity,and thyroid toxicity.Results:Regarding immune function regulation,a significant improvement was observed in CD3^(+),CD3^(+)/CD4^(+),and CD3^(+)/CD8^(+).Furthermore,at T3 and T4 time points,an improvement was observed in patient quality of life indicators such as the tumor markers CEA and CY211.In addition,symptoms related to TCM syndrome,including coughing,fatigue,palpitations,and diarrhea were significantly reduced compared to the baseline levels.Moreover,the treatment group exhibited superior outcomes compared to those of the control group in terms of reducing immune-associated pneumonia and diarrhea(P<0.05).The ORR for both groups was similar;36%for those receiving combination therapy vs.25%for those receiving PD-1 monotherapy.Therefore,no significant differences between these two groups were observed(P>0.05).Conclusions:The combination of Fried Lico

关 键 词：晚期NSCLC 气阴两虚型 炙甘草汤 PD-1 

分 类 号：R273[医药卫生—中西医结合]