信迪利单抗联合瑞戈非尼治疗晚期结直肠癌的疗效与安全性分析  

Efficacy and safety analysis of sintilimab combined with regofenib in the treatment of advanced colorectal cancer

作　　者：梁文龙[1] 曹杰[1] 黄庆 林泳[2] 黄红丽[2] 杨平[1] 李冠炜 胡鹤 Wenlong Liang;Jie Cao;Qing Huang;Yong Lin;Hongli Huang;Ping Yang;Guanwei Li;He Hu(Department of Colorectal and Anal Surgery,Guangzhou First People′s Hospital,Guangzhou 510180,China;Department of Gastroenterology,Guangzhou First People′s Hospital,Guangzhou 510180,China)

机构地区：[1]广州市第一人民医院结直肠肛门外科,510180 [2]广州市第一人民医院消化内科,510180

出　　处：《中华消化病与影像杂志（电子版）》2023年第6期409-413,共5页Chinese Journal of Digestion and Medical Imageology(Electronic Edition)

基　　金：国家自然科学基金面上项目(82173236)。

摘　　要：目的探究免疫检查点抑制剂信迪利单抗联合瑞戈非尼治疗晚期结直肠癌(CRC)患者疗效与安全性的影响。方法前瞻性选取2020年1月至2022年1月在广州市第一人民医院接受治疗的晚期CRC患者90例,按照随机数字表法分为观察组和对照组各45例。对照组口服瑞戈非尼,观察组在对照组基础上加用信迪利单抗注射液。比较两组临床疗效、肿瘤标志物及免疫功能水平、生存时间及不良反应发生情况。结果治疗后,观察组CRC患者的客观缓解率为53.33%、疾病控制率为80.00%,对照组分别为20.00%、60.00%(P<0.05);两组糖类抗原(CA199)、细胞角蛋白19片段抗原21-1(CYFRA21-1)、癌胚抗原(CEA)均下降,且观察组比对照组更低(P<0.05);两组细胞毒性T细胞(CD8^(+))占比均下降,两组辅助性T细胞(CD4^(+))占比、CD4^(+)/CD8^(+)比值均上升,而且观察组CD4^(+)占比、CD4^(+)/CD8^(+)比值比对照组更高(P<0.05),CD8^(+)占比比对照组更低(P>0.05)。观察组总生存期(P=0.040)和无进展生存期(P=0.046)均比对照组长;观察组比对照组出现不良反应概率更低(64.44%比62.22%,P>0.05)。结论免疫检查点抑制剂信迪利单抗联合瑞戈非尼在晚期CRC的治疗中有较好的应用效果和安全性,延长了生存时间,减轻肿瘤给患者带来的痛苦。Objective To explore the efficacy and safety of immune checkpoint inhibitor sintilimab combined with regofenib in the treatment of advanced colorectal cancer(CRC).Methods A total of 90 advanced CRC patients who were treated in Guangzhou First People′s Hospital from January 2020 to January 2022 were prospective selected,and were divided into observation group and control group according to the random number table,with 45 patients in each group.The control group received oral regofini,and the observation group received sintilimab injection on the basis of the control group.The clinical efficacy,tumor markers,immune function,survival time and adverse reaction were compared between the two groups.Results After treatment,objective response rate and disease control rate of the observation group were 53.33%and 80.00%,those of the control group were 20.00%and 60.00%(P<0.05).After treatment,carbohydrate antigen 199(CA199),cytokeratin 19 fragment antigen 21-1(CYFRA21-1),carcinoembryonic antigen(CEA)decreased in both groups,and the indicators of the observed group were lower than those of the control group(P<0.05).The proportion of cytotoxic T cells(CD8^(+))decreased in both groups,while the proportion of helper T cells(CD4^(+))and CD4^(+)/CD8^(+)ratio increased in both groups.Moreover,the proportion of CD4^(+)and CD4^(+)/CD8^(+)in the observed group were higher than those in the control group(P<0.05),while the proportion of CD8^(+)was lower than that in the control group(P>0.05).The overall survival(P=0.040)and progression-free survival(P=0.046)of the observation group were longer than those of the control group.The incidence of adverse reactions in the observation group was lower than that in the control group(64.44%vs.62.22%,P>0.05).Conclusion Immune checkpoint inhibitors sintilimab combined with regofenib has good efficacy and safety in the treatment of the patients with advanced CRC,prolonging survival time and alleviating the pain caused by cancer.

关 键 词：结直肠癌 免疫检查点抑制剂 临床疗效 生存分析 安全性 

分 类 号：R735.34[医药卫生—肿瘤]