胆囊癌意向性根治术后肿瘤早期复发影响因素及辅助化疗效果分析的全国多中心临床研究  

Analysis of influencing factors for early tumor recurrence and efficacy of adjuvant chemotherapy in gallbladder carcinoma patients after curative-intent resection:a nationwide,multicenter clinical study

作　　者：张东[1] 李起 郭伟[2] 黄帆[3] 朱沂 林科灿 尹大龙 陈伟[7] 丁睿 岳平[9] 李云峰[10] 陈志宇 耿智敏[1] Zhang Dong;Li Qi;Guo Wei;Huang Fan;Zhu Yi;Lin Kecan;Yin Dalong;Chen Wei;Ding Rui;Yue Ping;Li Yunfeng;Chen Zhiyu;Geng Zhimin(Department of Hepatobiliary Surgery,The First Affiliated Hospital of Xi'an Jiaotong University,Xi′an 710061,China;Department of General Surgery,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Department of General Surgery,The First Affiliated Hospital of Anhui Medical University,Hefei 230022,China;Department of Hepatopancreatic and Biliary Surgery,The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310003,China;Department of Hepatology,Mengchao Hepatobiliary Hospital of Fujian Medical University,Fuzhou 350025,China;Department of Hepatobiliary Surgery,The First Affiliated Hospital of University of Science and Tech-nology of China,Hefei 230002,China;Department of Hepatobiliary and Pancreatic Surgery,The First Affiliated Hospital of Sun Yat-sen University,Guangzhou 510080,China;Department of Hepatobiliary and Pancreatic Surgery,The First Affiliated Hospital of Air Force Military Medical University,Xi′an 710032,China;Department of General Surgery,The First Hospital of Lanzhou University,Lanzhou 730013,China;Department of Hepatobiliary and Pancreatic Surgery,Hunan Provincial People′s Hospital,Changsha 410002,China;Department of Hepatobiliary Surgery,The First Affiliated Hospital of Army Medical University,Chongqing 400038,China)

机构地区：[1]西安交通大学第一附属医院肝胆外科,西安710061 [2]首都医科大学附属北京友谊医院普通外科,北京100050 [3]安徽医科大学第一附属医院普通外科,合肥230022 [4]浙江大学医学院附属第二医院肝胆胰外科,杭州310003 [5]福建医科大学孟超肝胆医院肝病中心,福州350025 [6]中国科学技术大学附属第一医院肝胆外科,合肥230002 [7]中山大学第一附属医院肝胆胰外科,广州510080 [8]空军军医大学第一附属医院肝胆胰外科,西安710032 [9]兰州大学第一医院普通外科,兰州730013 [10]湖南省人民医院肝胆胰外科,长沙410002 [11]陆军军医大学第一附属医院全军肝胆外科研究所,重庆400038

出　　处：《中华消化外科杂志》2024年第1期125-133,共9页Chinese Journal of Digestive Surgery

基　　金：国家自然科学基金(62076194);陕西省重点研发计划(2021?SF-016, 2022-SF-606)。

摘　　要：目的探讨胆囊癌意向性根治术后肿瘤早期复发影响因素及辅助化疗效果。方法采用回顾性病例对照研究方法。回顾性分析2016年1月至2020年12月西安交通大学第一附属医院等11家医学中心收治的506例胆囊癌患者的临床病理资料;男168例,女338例;年龄为(62±11)岁。患者均行意向性胆囊癌根治术;根据患者术后肿瘤复发时间分为早期复发和非早期复发。观察指标:(1)治疗情况。(2)随访及生存情况。(3)胆囊癌意向性根治术后肿瘤早期复发的影响因素。(4)术后辅助化疗效果。正态分布的计量资料以x±s表示,偏态分布的计量资料以M(范围)表示。计数资料以绝对数表示,组间比较采用χ2检验,等级资料比较采用Mann-WhitneyU检验。单因素分析根据资料类型选择对应的统计学方法。多因素分析采用Logistic回归模型前进法。采用Kaplan-Meier法绘制生存曲线和计算生存率,采用Log-Rank检验进行生存分析。结果 (1)治疗情况。506例患者中,112例行术后辅助化疗,394例未行术后辅助化疗;术后辅助化疗周期为5(3~9)个周期。(2)随访及生存情况。506例患者术后均获得随访,随访时间为55(34~93)个月,随访期间肿瘤复发248例(早期复发158例、晚期复发90例),肿瘤未复发258例。506例患者中,生存275例,死亡231例,死亡原因均为肿瘤复发转移致多器官衰竭。506例患者术后无复发生存时间为52(1~93)个月、总生存时间为62(2~93)个月;1、3、5年无病生存率分别为68.8%、53.8%、47.9%,1、3、5年总生存率分别为78.3%、58.7%、51.6%。生存分析结果显示:158例术后早期复发患者中位总生存时间为9(2~73)个月,348例非早期复发患者(晚期复发90例、肿瘤未复发258例)中位总生存时间未达到,两者生存情况比较,差异有统计学意义(χ2=456.15,P<0.05)。(3)胆囊癌意向性根治术后肿瘤早期复发的影响因素。多因素分析结果显示:癌胚抗原>5.0 μg/L、病Objective To investigate the influencing factors for early tumor recurrence and the efficacy of adjuvant chemotherapy in gallbladder carcinoma(GBC)patients after curative-intent resection.Methods The retrospective case-control study was conducted.The clinicopathological data of 506 patients with GBC in 11 medical centers,including The First Affiliated Hospital of Xi'an Jiaotong University et al,from January 2016 to December 2020 were collected.There were 168 males and 338 females,aged(62±11)years.All patients underwent curative-intent resection of GBC,and they were divided into patients with and without early recurrence based on time to postoperative recurrence.Observation indicators:(1)treatment;(2)follow-up and survival of patients;(3)analysis of influencing factors for early tumor recurrence after curative-intent resection of GBC;(4)efficacy of postoperative adjuvant chemotherapy.Measurement data with normal distribution were represented as Mean±SD,and measurement data with skewed distribution were represented as M(range).Count data were described as absolute numbers,and comparison between groups was conducted using the chi-square test.Comparison of ordinal data was conducted using the Mann-Whitney U test.Univariate analysis was conducted using the corresponding statistical methods based on data type.Multivariate analysis was conducted using the Logistic regression model with forward method.The Kaplan-Meier method was used to draw survival curve and calculate survival rate,and Log-Rank test was used for survival analysis.Results(1)Treatment.Of 506 patients,there were 112 cases with postoperative adjuvant chemotherapy,and 394 cases without postopera-tive adjuvant chemotherapy.They underwent 5(range,3-9)cycles of postoperative adjuvant chemo-therapy.(2)Follow-up and survival of patients.All 506 patients underwent postoperative follow-up,with the follow-up time of 55(range,34-93)months.During the follow-up,there were 248 patients with tumor recurrence,including 158 cases of early recurrence and 90 cases of late

关 键 词：胆道肿瘤 意向性根治术 早期复发 辅助化疗 预后 

分 类 号：R735.8[医药卫生—肿瘤]