CRGGC研究2024年阶段性报告：2010—2017年中国胆囊癌诊治流程与预后分析（附 7874例报告）

摘要： 目的    回顾总结并探讨2010—2017年间中国人群胆囊癌的诊断、治疗流程与预后情况。方法    收集并整理2010年1月至2017年12月间全国49家医院共计7874例胆囊癌病人的临床诊疗资料。观察指标包括确诊年份、首诊年龄、确诊医院行政区划、确诊医院等级划分、确诊医院年均胆囊癌诊断例数、性别、B超检查情况、CT检查情况、MRI检查情况、肿瘤标记物［癌胚抗原（CEA）、CA19-9、CA125］检查情况、确诊方式、诊断时机、是否接受手术治疗、接受手术是否达根治标准、TNM分期及是否接受辅助治疗等，结局指标包括死亡日期，根本死因，失访日期，失访原因。计量资料通过Kolmogorov-Smirnov test进行正态性检验，符合正态分布的资料以均值±标准差来描述，组间比较采用t检验；不符合正态分布的资料以中位数（第一四分位数，第三四分位数）来描述，组间比较采用U检验。计数资料以频数（占总体百分比）来描述，组间比较采用卡方检验。单因素分析采用Logistics回归分析，多因素分析采用多因素逐步后退Logistics回归分析。总体生存情况采用寿命表法进行计算，生存数据以中位生存期（95%CI）来描述，固定时间点处组间生存率比较采用Z检验，并采用Kaplan-Meier法绘制生存曲线，采用Log-rank检验进行生存分析。结果    胆囊癌确诊病例数随年份持续增长，确诊病人女性多于男性，中位确诊年龄为64（56，71）岁。随时间推移，增强CT、增强MRI、肿瘤标记物CEA、CA19-9、CA125检查比例不断上升，增强CT、增强MRI、磁共振胰胆管造影（MRCP）检出率也在不断提升。首诊年龄、性别、确诊医院行政区划、确诊医院等级划分、确诊医院年均胆囊癌诊断例数、B超检查、平扫及增强CT检查、增强MRI检查、MRCP检查、肿瘤标记物CEA、CA19-9、CA125检查对于胆囊癌早期诊断有着显著作用，其中确诊医院行政区划、确诊医院等级划分、确诊医院年均胆囊癌诊断例数、性别、增强CT检查、肿瘤标记物CA125检查是胆囊癌早期诊断的独立影响因素。研究中病人的中位生存期为334 d，6个月总体生存率为66.0%，1年总体生存率为48.0%，2年总体生存率为31.3%，3年总体生存率为22.2%，5年总体生存率为11.2%，各生存指标随肿瘤TNM分期升高快速下降，其中可切除胆囊癌病人在接受根治性手术治疗后中位生存期为699 d，6个月总体生存率为88.0%，1年总体生存率为71.6%，2年总体生存率为48.6%，3年总体生存率为33.8%，5年总体生存率为17.6%。研究还发现确诊年份、首诊年龄、确诊医院行政区划、确诊医院等级划分、确诊医院年均胆囊癌诊断例数、术前血清肿瘤标记物CEA、CA19-9、CA125水平、是否接受手术治疗、接受手术是否达根治标准、TNM分期对胆囊癌病人的总生存期有显著影响。结论    胆囊癌的诊治流程规范化程度与诊疗水平随时间推移均有一定程度提高，胆囊癌的综合治疗方式和总体生存情况仍有较大进步空间，需要投入更多的关注和努力到胆囊癌的综合治疗中。

关键词: 胆囊恶性肿瘤, 术前诊断, 外科治疗, 综合治疗, 流行病学, 预后

Abstract: To review, summarize, and discuss the diagnosis, treatment, and prognosis of gallbladder cancer in China between 2010 and 2017. Methods    Electronic health records of 7874 patients diagnosed with gallbladder cancer from 49 hospitals were collected and structured from January 2010 to December 2017. Observational indicators included the year of diagnosis, age at first diagnosis, the administrative district of the diagnosing hospital, the rank of the diagnosing hospital, the annual number of gallbladder cancer diagnosed at the diagnosing hospital, sex, ultrasound results, CT results, MRI results, CEA levels, CA19-9 levels, CA125 levels, diagnostic criteria, the timing of diagnosis, whether surgical treatment was received, whether the surgery met the radical treatment standard, TNM staging, and whether adjuvant treatment was received. Quantitative data were tested for normal distribution using the Kolmogorov-Smirnov test, described by mean ± standard deviation if normally distributed, and compared using the t-test; non-normally distributed data were described by median (first and third quartiles) and compared using the U-test. Categorical data were described by frequency (percentage of total) and compared using the Chi-squared test. Univariate analysis was performed using logistic regression, and multivariate analysis was conducted using stepwise logistic regression. Overall survival rates were calculated using the life table, survival data were described by median survival time (95% confidence interval), comparisons of overall survival rates between groups at certain time points were conducted using the z-test, and survival curves were plotted using the Kaplan-Meier method, with survival analysis performed using the Log-rank test. Results    The number of gallbladder cancer cases has continuously increased over time, with more females than males, and the median diagnosis age is 64 years old. The proportion of patients undergoing enhanced CT, enhanced MRI, tumor marker CEA, CA19-9, and CA125 exams has steadily increased, as has the detection rate of enhanced CT, enhanced MRI, and MRCP. Factors such as age at first diagnosis, sex, the administrative district of the diagnosing hospital, the rank of the diagnosing hospital, the annual number of gallbladder cancer diagnosed at the diagnosing hospital, ultrasound, plain and enhanced CT scans, enhanced MRI scans, MRCP scans, and tumor markers CEA, CA19-9, and CA125 have played a significant role in the early diagnosis of gallbladder cancer. Independent influencing factors for early gallbladder cancer diagnosis include the administrative district of the diagnosing hospital, the rank of the diagnosing hospital, the annual number of gallbladder cancer diagnosed at the diagnosing hospital, sex, enhanced CT scans, and CA125 levels. The median survival time of patients in the study was 334 days, with overall survival rates at six months of 66.0%, one year of 48.0%, two years of 31.3%, three years of 22.2%, and five years of 11.2%, and the survival rates rapidly decreased as tumor TNM stages increased. For patients with resectable gallbladder cancer who underwent radical surgical treatment, the median survival time was 699 days, with overall survival rates at six months of 88.0%, one year of 71.6%, two years of 48.6%, three years of 33.8%, and five years of 17.6%. It’s also found that the year of diagnosis, age at first diagnosis, the administrative district of the diagnosing hospital, the rank of the diagnosing hospital, the annual number of gallbladder cancer diagnosed at the diagnosing hospital, preoperative serum tumor markers CEA, CA19-9, CA125 levels, whether surgical treatment was received, whether the surgery met radical treatment standards, and TNM staging had a significant impact on the overall survival time of patients with gallbladder cancer. Conclusion    The standardization of diagnosis and treatment for gallbladder cancer in China has greatly improved over time, but the epidemiological characteristics and corresponding causes still require further research. For gallbladder cancer, there is substantial room for improvement in the comprehensive treatment methods and overall survival outcomes, and more attention and effort need to be devoted to the comprehensive treatment.

Key words: gallbladder cancer, preoperative diagnosis, surgical treatment, comprehensive treatment, epidemiology, prognosis

本文来源：中国实用外科杂志 ›› 2024, Vol. 44 ›› Issue (09): 1038-1054.

引用本文：王一钧, 孙旭恒, 冯佳毅, 任 泰, 贾子衡, 李 霖, 李雪川, 刘 珂, 刘立果, 刘照南, 蒲 鹏, 等. 2010—2017年中国胆囊癌诊治流程与预后分析（附 7874例报告）[J]. 中国实用外科杂志, 2024, 44(09): 1038-1054.

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https://www.zgsyz.com/zgsywk/CN/10.19538/j.cjps.issn1005-2208.2024.09.14

https://www.zgsyz.com/zgsywk/CN/Y2024/V44/I09/1038