经导管动脉内化疗栓塞术联合索拉非尼序贯微波消融和经导管动脉内化疗栓塞术联合索拉非尼治疗肿瘤直径>5cm肝细胞癌的前瞻性研究  

A prospective study on transcatheter arterial chemoembolization combined with sorafenib and sequential microwave ablation versus transcatheter arterial chemoembolization combined with sorafenib in the treatment of hepatocellular carcinoma with tumor diameter over 5 cm

作　　者：朱忠杰 王喜功 李雷 李晶 纪立杰 邹声泉[4] Zhu Zhongjie;Wang Xigong;Li Lei;Li Jing;Ji Lijie;Zou Shengquan(Department of General Surgery,Laiyang Central Hospital of Yantai City Affiliated to Weifang Medical College,Laiyang 265200,Shandong Province,China;Tumor Intervention Center,Qingdao Central Hospital Affiliated to Qingdao University,Qingdao 266000,China;Department of Radiology Intervention,Qingdao Central Hospital Affiliated to Qingdao University,Qingdao 266000,China;Department of General Surgery,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)

机构地区：[1]潍坊医学院附属烟台市莱阳中心医院普通外科,山东莱阳265200 [2]青岛大学附属青岛市中心医院肿瘤介入科,266000 [3]青岛大学附属青岛市中心医院放射介入科,266000 [4]华中科技大学同济医学院附属同济医院普通外科,武汉430030

出　　处：《中华消化外科杂志》2020年第2期145-155,共11页Chinese Journal of Digestive Surgery

基　　金：国家高新技术研究发展计划(2002AA214061)。

摘　　要：目的比较经导管动脉内化疗栓塞术(TACE)联合索拉非尼序贯微波消融(MWA)和TACE联合索拉非尼治疗肿瘤直径>5 cm肝细胞癌的疗效和安全性,分析预后影响因素。方法采用前瞻性队列研究方法。选取2012年7月至2013年11月两家医疗中心收治的61例(潍坊医学院附属烟台市莱阳中心医院30例、青岛大学附属青岛市中心医院31例)肿瘤直径>5 cm肝细胞癌患者的临床病理资料。患者采用TACE联合索拉非尼序贯MWA治疗设为观察组;采用TACE联合索拉非尼治疗设为对照组。观察指标:(1)治疗和并发症及药物不良反应情况。(2)近期疗效。(3)随访和生存情况。(4)预后影响因素分析。采用住院、门诊或电话方式进行随访。随访时间为治疗后6个月内每个月随访1次,之后每3个月随访1次,随访内容包括实验室指标、肿瘤标志物、腹部增强X线计算机体层摄影术或磁共振成像检查。了解患者生存与疾病进展情况。随访时间截至2018年11月。正态分布的计量资料以±s表示,组间比较采用t检验;偏态分布的计量资料以M(范围)表示,组间比较采用Wilcoxon秩和检验。计数资料以绝对数和(或)百分比表示,组间比较采用χ2检验或Pearson校正χ2检验。等级资料采用Wilcoxon秩和检验。采用Kaplan-Meier法计算生存率并绘制生存曲线,采用Log-rank检验进行生存分析。多个时间点生存率比较采用Bonferroni法调整检验水准。采用多元COX比例风险模型进行单因素和多因素分析。结果筛选出符合研究条件的肝细胞癌患者61例;男36例,女25例;年龄为(58±8)岁,年龄范围为43~73岁。61例患者中,观察组31例,对照组30例。(1)治疗和并发症及药物不良反应情况:①治疗情况,观察组患者TACE治疗次数、MWA治疗次数、首次TACE治疗至首次索拉非尼服药时间、索拉非尼服药时间分别为1次(1~5次)、2次(1~4次)、5 d(5~9 d)、24个月(6~72个月),对照组患者上述指Objective To investigate the efficacy and safety of transcatheter arterial chemoembolization(TACE)combined with sorafenib and sequential microwave ablation(MWA)versus TACE combined with sorafenib in the treatment of hepatocellular carcinoma(HCC)with tumor diameter over 5 cm,and to analyze risk factors affecting the prognosis of patients.Methods The prospective cohort study was conducted.The clinicopathological data of 61 HCC patients with tumor diameter over 5 cm who were admitted to two medical centers(30 in the Laiyang Central Hospital of Yantai City Affiliated to Weifang Medical College and 31 in the Qingdao Central Hospital Affiliated to Qingdao University)between July 2012 and November 2013 were collected.Patients who were treated with TACE combined with sorafenib and sequential MWA were allocated into observation group,and patients who were treated with TACE combined with sorafenib were allocated into control group.Observation indicators:(1)treatment,complications and adverse drug reactions;(2)short-term efficacies;(3)follow-up and survival situations;(4)analysis of prognostic factors.Follow-up was performed by inpatient,outpatient examinations or telephone interview once a month within the first 6 months after treatment and once every 3 months thereafter up to November 2018.The follow-up included laboratory indicators,tumor markers,abdominal enhanced computed tomography or magnetic resonance imaging examinations.The survival of patients and disease progression were fully documented.Measurement data with normal distribution were expressed as Mean±SD,and comparison between groups was performed by the t test.Measurement data with skewed distribution were described as M(range),and comparison between groups was performed using the Wilcoxon rank sum test.Count data were expressed as absolute numbers or percentages,and comparison between groups was performed using the chi-square test or pearson-corrected chi-square test.Ranked data were analyzed using the Wilcoxon rank sum test.The Kaplan-Meier method was used t

关 键 词：肝肿瘤 放射学 介入性 动脉化疗栓塞 超声 微波消融 索拉非尼 

分 类 号：R735[医药卫生—肿瘤]