PD-1抑制剂联合靶向药物治疗晚期原发性肝癌的安全性及临床疗效观察  

Safety and clinical efficacy of PD-1 inhibitor combined with targeted drugs in the treatment of advanced primary liver cancer

作　　者：闫向勇 李俊[1] 牛小娟 蔺彩娟[1] 宋书征 党政 YAN Xiangyong;LI Jun;NIU Xiaojuan;LIN Caijuan;SONG Shuzheng;DANG Zheng(Department of Integrative Medicine,the 940th Hospital of PLA Joint Logistics Support Force,Gansu Lanzhou 730050,China;Department of Hepatobiliary Surgery,the 940th Hospital of PLA Joint Logistics Support Force,Gansu Lanzhou 730050,China.)

机构地区：[1]中国人民解放军联勤保障部队第940医院中医康复科,甘肃兰州730050 [2]中国人民解放军联勤保障部队第940医院肝胆外科,甘肃兰州730050

出　　处：《现代肿瘤医学》2023年第5期875-880,共6页Journal of Modern Oncology

基　　金：国家自然科学基金面上项目(编号:82173738);甘肃省自然科学基金(编号:20JR10RA001);甘肃省兰州市科技计划项目(编号:2018-3-60)。

摘　　要：目的:探讨PD-1抑制剂联合靶向药物治疗晚期原发性肝癌的安全性及有效性。方法:选取2020至2021年本院收治的70例晚期原发性肝癌患者作为研究对象,分为两组,分别予以单药PD-1抑制剂治疗(单药治疗组)、PD-1抑制剂联合靶向药物治疗(联合用药组),并对两组患者的相关病历资料及获取的有效性及安全性数据行回顾性分析。结果:安全性比较可知,单药治疗组发生不良事件的比率分别为皮肤及皮下组织类疾病占17.14%,肝功能异常占25.71%,血液学毒性占31.42%,全身性症状占8.57%,胃肠道占17.14%,呼吸系统、胸及纵隔疾病占11.43%,代谢及营养类疾病占20.00%,肾脏及泌尿系统疾病占5.71%,内分泌系统疾病占5.71%;联合用药组发生不良事件的比率分别为皮肤及皮下组织类疾病占22.85%,肝功能异常占28.57%,血液学毒性占25.71%,全身性症状占11.43%,胃肠道占20.00%,呼吸系统、胸及纵隔疾病占14.29%,代谢及营养类疾病占17.14%,肾脏及泌尿系统疾病占8.57%,内分泌系统疾病占2.86%,两组比较差异均无统计学意义(P> 0.05),联合用药并不会增加不良事件发生。有效性比较可知,单药治疗组患者的完全缓解率为8.57%、部分缓解率为31.43%、疾病稳定率为48.57%、疾病进展率为11.43%;联合治疗组患者的完全缓解率为14.29%、部分缓解率为54.29%、疾病稳定率为25.71%、疾病进展率为5.71%,差异具有统计学意义(P<0.05)。联合用药组对疾病更为有效。T淋巴细胞水平高于单药组(P<0.05)。结论:对晚期原发性肝癌患者行PD-1抑制剂联合靶向药物治疗比单药PD-1抑制剂提升T淋巴细胞水平,治疗能取得更好的临床效果,保证患者足够的安全性。Objective:To explore the safety and efficacy of PD-1 inhibitor combined with targeted drugs in the treatment of advanced primary liver cancer.Methods:A total of 70 patients with advanced primary liver cancer admitted to our hospital from 2019 to 2020 were selected as the research subjects and divided into two groups, which were treated with single drug PD-1 inhibitor(single drug treatment group) and pD-1 inhibitor combined with targeted drug therapy(combined drug treatment group).The relevant medical records and efficacy and safety data of the two groups were retrospectively analyzed.Results:Safety comparison showed that the probability of AE events in the monotherapy group was skin and subcutaneous tissue diseases(17.14%),abnormal liver function(25.71%),hematological toxicity(31.42%),systemic symptoms(8.57%),gastrointestinal tract(17.14%),respiratory system, chest and mediastinal diseases(11.43%).Metabolic and nutritional diseases accounted for 20.00%,kidney and urinary system diseases for 5.71%,endocrine system diseases for 5.71%.The incidence of AE events in the combination group was 22.85% for skin and subcutaneous tissue diseases, 28.57% for abnormal liver function, 25.71% for hematological toxicity, 11.43% for systemic symptoms, 20.00% for gastrointestinal tract, 14.29% for respiratory system, chest and mediastinal diseases, and 17.14% for metabolic and nutritional diseases.Kidney and urinary system diseases accounted for 8.57%,endocrine system diseases accounted for 2.86%(P>0.05).Efficacy comparison showed that the complete response rate, partial response rate, disease stability rate and disease progression rate in monotherapy group were 8.57%,31.43%,48.57% and 11.43% respectively.In the combined treatment group, the complete response rate was 14.29%,partial response rate was 54.29%,disease stability rate was 25.71%,and disease progression rate was 5.71%,indicating significant differences and comparability(P<0.05).The combination group was more effective against the disease.The level of lymohocyte was high

关 键 词：晚期原发性肝癌 PD-1抑制剂 靶向药物 安全 有效性 

分 类 号：R735.7[医药卫生—肿瘤]