注射用核糖核酸Ⅱ改善晚期胰腺癌化疗患者整体获益可能性的真实世界研究  

A real-world study of the potential for overall benefits:Ribonucleic acid for injectionⅡcombined with chemotherapy for advanced pancreatic cancer

作　　者：孙旭 李恩孝[2] 高毅[3] 李双全 权胜伟 袁野 张大昕[5] 段成洲 陆晓[6] 王海久[7] 庞明泉[7] 季家超 杨永丽 刘怀民[1] SUN Xu;LI Enxiao;GAO Yi;LI Shuangquan;QUAN Shengwei;YUAN Ye;ZHANG Daxin;DUAN Chengzhou;LU Xiao;WANG Haijiu;PANG Mingquan;JI Jiachao;YANG Yongli;LIU Huaimin(Department of Oncology with Integrated Traditional and Western Medicine,Henan Cancer Hospital,Henan Zhengzhou 450008,China;Department of Oncology,First Affiliated Hospital of Xi'an Jiaotong University,Shaanxi Xi'an 710061,China;Liver and Gallbladder Surgery,Zhujiang Hospital of Southern Medical University,Guangdong Guangzhou 510280,China;Liver and Gallbladder Surgery,General Hospital of Heilongjiang Province Land Reclamation Bureau,Heilongjiang Harbin 150088,China;Department of Oncology,First Affiliated Hospital of Harbin Medical University,Heilongjiang Harbin 150001,China;Intervention Section,Anyang Cancer Hospital,Henan Anyang 455000,China;Hepatobiliary and Pancreatic Surgery,Qinghai University Affiliated Cancer Hospital,Qinghai Xining 810000,China;LinkDoc(Beijing)Co,Ltd,Clinical Research Business Unit,Beijing 100080,China)

机构地区：[1]河南省肿瘤医院中西医结合肿瘤内科,河南郑州450008 [2]西安交通大学第一附属医院肿瘤内科,陕西西安710061 [3]南方医科大学附属珠江医院肝胆二科,广东广州510280 [4]黑龙江省农垦总局总医院肝胆(微创)外科,黑龙江哈尔滨150088 [5]哈尔滨医科大学附属第一医院肿瘤内一科,黑龙江哈尔滨150001 [6]安阳市肿瘤医院介入二科,河南安阳455000 [7]青海大学附属肿瘤医院肝胆胰外科,青海西宁810000 [8]零氪科技(北京)有限公司临床研究事业部,北京100080

出　　处：《现代肿瘤医学》2022年第23期4285-4290,共6页Journal of Modern Oncology

摘　　要：目的:评价注射用核糖核酸Ⅱ联合化疗在真实世界中治疗晚期胰腺癌的疗效和安全性。方法:基于LinkDoc数据库纳入2012年至2018年就诊于河南省肿瘤医院等10家研究中心且确诊为局部进展期和晚期胰腺癌的患者923例,试验组采用化疗联合注射用核糖核酸Ⅱ治疗,对照组采用单纯化疗治疗。采用倾向性评分匹配的方法均衡两组的基线信息,比较两组间的总生存期(overall survival,OS)、无进展生存期(progression-free survival,PFS)及不良事件和化疗相关不良反应的发生率。结果:试验组和对照组的中位OS分别为7.5个月和6.7个月,中位PFS分别为3.7个月和3.3个月,差异均无统计学意义(P>0.05)。试验组不良事件发生率略低于对照组(88.7%vs 92.1%),试验组化疗相关不良反应发生率略高于对照组(64.1%vs 57.1%),差异均无统计学意义(P>0.05)。结论:注射用核糖核酸Ⅱ联合化疗治疗晚期胰腺癌具有生存获益趋势,无肝转移患者是潜在的优势人群,该结论尚需前瞻性研究进一步确证。Objective:To evaluate the efficacy and safety of ribonucleic acid for injectionⅡcombined with chemotherapy in the treatment of advanced pancreatic cancer(PC)in the real world.Methods:We included 923 patients with advanced PC from 2012 to 2018 from the LinkDoc database involving 10 research centers such as Henan Cancer Hospital.Patients in the experimental group treated by chemotherapy combined with ribonucleic acid for injectionⅡ,control group adopts only chemotherapy treatment.The baseline information of the two groups was balanced by the method of propensity score matching(PSM).The overall survival(OS),progression-free survival(PFS)and the incidence of adverse events and chemotherapy-related adverse reactions(ADR)were compared between the two groups.Results:The median OS of the treatment group and the control group was 7.5 months and 6.7 months respectively(P>0.05),and the median PFS was 3.7 months and 3.3 months respectively(P>0.05).The incidence of adverse events in the treatment group was slightly lower than the control group(88.7%vs 92.1%,P>0.05),and the incidence of chemotherapy-related adverse reactions in the treatment group was slightly higher than that in the control group(64.1%vs 57.1%,P>0.05).Conclusion:Ribonucleic acid for injectionⅡcombined with chemotherapy in the treatment of advanced pancreatic cancer has a trend of survival benefit,patients without liver metastasis might benefit more,but this conclusion remains to be confirmed by well-designed prospective study.

关 键 词：胰腺癌 化疗 注射用核糖核酸Ⅱ 回顾性研究 

分 类 号：R735.9[医药卫生—肿瘤]