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保留肝实质肝切除术治疗巴塞罗那A期肝细胞癌的临床疗效及预后因素分析

Clinical efficacy of parenchymal-sparing hepatectomy for Barcelona clinic liver cancer stage A hepatocellular carcinoma and prognostic factors analysis

摘要:

目的 比较解剖性肝切除术(AR)与保留肝实质肝切除术(PSH)治疗巴塞罗那临床肝癌(BCLC)分期A期肝细胞癌(以下简称肝癌)的临床疗效,并分析影响患者预后的因素.方法 采用倾向评分匹配及回顾性队列研究方法.收集2009年1月至2017年12月南京医科大学第一附属医院收治的269例BCLC A期肝癌患者的临床病理资料;男226例,女43例;中位年龄为56岁,年龄范围为23~ 84岁.269例患者均行根治性肝切除术,术后病理学检查证实为肝细胞癌,其中146例行解剖性肝切除术,设为AR组;123例行保留肝实质肝切除术,设为PSH组.观察指标:(1)倾向评分匹配情况及匹配后两组患者一般资料比较.(2)术中和术后情况.(3)随访和生存情况.(4)术后预后因素分析.采用门诊或电话方式进行随访,患者术后1年内每3个月复查1次,术后2~5年每6个月复查1次,5年后每年复查1次,了解其生存情况.随访时间截至2018年10月.总体生存时间定义为自手术日期到患者死亡日期或末次随访日期.无瘤生存时间定义为自手术日期到患者复查发现肿瘤复发日期,若无肿瘤复发则定义为从手术日期至末次随访日期.倾向评分匹配按1∶1最近邻匹配法匹配.计数资料以绝对数表示,组间比较采用x2检验;经倾向评分匹配后组间比较采用McNemar检验.偏态分布的计量资料以M(范围)表示,组间比较采用Mann-WhitneyU检验;经倾向评分匹配后组间比较采用Wilcoxon符号秩检验.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.采用COX比例风险模型进行单因素和多因素分析.结果 (1)倾向评分匹配情况及匹配后两组患者一般资料比较:269例患者中,180例(AR组和PSH组各90例)配对成功.AR组和PSH组倾向评分匹配前患者肿瘤最大直径,脉管癌栓,TNM分期(Ⅰ期、Ⅱ期)分别为5.0 cm(0.8~17.0 cm)和3.0 cm(1.0~ 17.0 cm),42例和16例,97、49例和99、24例,两组比较,差异均有统计学意义(Z=-4.277,x2=9.803,6.664,P<0.05);经倾向评分匹配后两组上述指标分别为4.0 cm(0.8~ 16.0 cm)和3.5cm(1.0~17.0cm),15例和16例,70、20例和68、22例,两组比较,差异均无统计学意义(Z=-0.241,x2=0.039,0.124,P>0.05);消除了患者肿瘤最大直径、脉管癌栓、TNM分期因素混杂偏倚.(2)术中和术后情况:倾向评分匹配后AR组患者手术时间,术中出血量,术中输血例数,手术切缘(《1 cm、≥1 cm),术后严重并发症,住院时间,术后肿瘤复发,术后肿瘤2年内复发,术后肿瘤复发行手术治疗,术后肿瘤复发行TACE分别为180 min(60~ 448 min),130 mL(30~6 000 mL),9例,2、88例,8例,18 d(8~77 d),41例,32例,15例,23例;PSH组上述指标分别为150 rmin(55 ~ 400 min),100 mL(50~3 000 mL),6例,2、88例,6例,18 d(9~37 d),37例,29例,10例,24例,两组比较,差异均无统计学意义(Z=-1.987,-0.439,x2=0.655,0.000,0.310,Z=-0.805,x2=0.362,0.223,0.816,0.624,P>0.05).(3)随访和生存情况:倾向评分匹配后180例患者均获得术后随访,随访时间为4~114个月,中位随访时间为43个月.180例患者随访期间,死亡40例(AR组21例、PSH组19例),肿瘤复发78例(AR组41例、PSH组37例).AR组和PSH组患者1、3、5年总体生存率分别为92.0%、76.3%、71.8%和92.3%、80.6%、62.0%,1、3、5年无瘤生存率分别为70.8%、53.0%、47.4%和72.3%、56.4%、46.1%,两组患者总体生存情况和无瘤生存情况比较,差异均无统计学意义(x2=0.034,0.000,P>0.05).分层分析:术前白蛋白-胆红素分级为Ⅰ级,肿瘤最大直径≤5 cm,肝硬化,肿瘤分化为中低分化AR组患者的1、3、5年总体生存率分别为95.3%、82.0%、82.0%,100.0%、86.8%、86.8%,91.3%、75.0%、69.7%,89.9%、73.2%、66.6%;中位无瘤生存率分别为54.6%,61.5%,43.1%,54.6%.PSH组患者上述分层分析中1、3、5年总体生存率分别为90.9%、74.9%、63.0%,98.2%、85.8%、61.7%,98.0%、88.7%、70.0%,90.7%、79.2%、59.0%;中位无瘤生存率分别为43.4%,46.0%,43.4%,43.4%.两组患者上述指标总体生存情况比较,差异均无统计学意义(x2=1.892,1.320,0.732,0.002,P>0.05);无瘤生存情况比较,差异均无统计学意义(x2=0.337,0.051,0.551,0.061,P>0.05).(4)术后预后因素分析.单因素分析结果表明:术前白蛋白-胆红素分级、术前甲胎蛋白水平、肿瘤最大直径、肿瘤数目、卫星病灶、脉管癌栓、TNM分期、术中出血量、术后严重并发症是影响患者肝癌根治性肝切除术后总体生存情况的因素(风险比=1.762,1.001,1.139,1.955,2.561,2.495,2.766,1.000,2.599,95%可信区间为1.048 ~ 2.962,1.000~1.001,1.080~ 1.201,1.063 ~ 3.596,1.254~5.227,1.446~4.304,1.655~4.624,1.000~1.001,1.317~5.128,P<0.05).术前天冬氨酸氨基转移酶水平、术前乙型肝炎病毒表面抗原阳性、术前甲胎蛋白水平、肿瘤最大直径、脉管癌栓、TNM分期、术后严重并发症是影响患者肝癌根治性肝切除术后无瘤生存情况的因素(风险比=1.004,1.594,1.000,1.065,2.203,2.132,1.775,95%可信区间为1.001 ~ 1.007,1.020 ~2.490,1.000~ 1.001,1.019~ 1.113,1.474~3.293,1.462~3.109,1.034~3.047,P<0.05).多因素分析结果表明:术前甲胎蛋白水平、肿瘤最大直径、卫星病灶、术后严重并发症是影响患者肝癌根治性肝切除术后总体生存情况的独立因素(风险比=1.001,1.114,2.241,2.251,95%可信区间为1.000~1.001,1.033~1.202,1.003 ~ 5.008,1.100~4.607,P<0.05).术前乙型肝炎病毒表面抗原阳性是影响患者肝癌根治性肝切除术后无瘤生存情况的独立因素(风险比=1.576,95%可信区间为0.987~2.516,P<0.05).结论 PSH治疗BCLC A期肝癌的远期临床疗效与AR相当.术前甲胎蛋白水平、肿瘤最大直径、卫星病灶、术后严重并发症是影响BCLC A期肝癌根治性肝切除术后患者总体生存情况的独立因素.

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abstracts:

Objective To compare the clinical efficacy of anatomical hepatectomy (AR) and parenchymal-sparing hepatectomy (PSH) for Barcelona clinic liver cancer (BCLC) stage A hepatocellular carcinoma(HCC),and investigate its prognostic factors.Methods The propensity score matching and retrospective cohort study was conducted.The clinicopathological data of 269 patients with BCLC stage A HCC who were admitted to the First Affiliated Hospital of Nanjing Medical University from January 2009 to December 2017 were collected.There were 226 males and 43 females,aged from 23 to 84 years,with a median age of 56 years.All the 269 patients underwent radical resection and were confirmed as HCC using postoperative pathological examination.Of the 226 patients,146 undergoing AR and 123 undergoing PSH were allocated into the AR group and PSH group,respectively.Observation indicators:(1) the propensity score matching conditions and comparison of general data between groups after the propensity score matching;(2) intraoperative and postoperative situations;(3) follow-up and survival situations;(4) prognostic factors analysis.Patients were followed up by outpatient examination and telephone interview to detect survival once every 3 months within 1 year postoperatively,once every 6 months within 2-5 years postoperatively and once a year after 5 years postoperatively up to October 2018.The overall survival time was from surgery data to death or end of follow-up.The tumor-free survival time was from surgery date to time of tumor recurrence detected or end of follow-up without tumor recurrence.The propensity score matching was used to perform 1∶1 matching by nearest neighbor method.Count data were represented as absolute number,comparison between groups was analyzed using the chi-square test and McNemar test after propensity score matching.Measurement data with skewed distribution were represented as M (range),and comparison between groups was done using the Mann-Whitney U test and Wilcoxon signed rank sum test after propensity score matching.The survival rate and curve were respectively calculated and drawn by the Kaplan-Meier method,and Log-rank test was used for survival analysis.The COX proportional risk model was used for univariate and multivariate analysis.Results (1) The propensity score matching conditions and comparison of general data between groups after the propensity score matching:180 of 269 patients had successful matching,including 90 in each group.The maximum tumor diameter,cases with vascular embolism,cases of stage Ⅰ and Ⅱ (TNM staging) before matching were 5.0 cm (range,0.8-17.0 cm),42,97,99 in the AR group and 3.0 cm (range,1.0-17.0 cm),16,49,24 in the PSH group,respectively,with statistically significant differences between the two groups (Z =-4.277,x2 =9.803,6.664,P< 0.05).The above indices after matching were 4.0 cm (range,0.8-16.0 cm),15,70,68 in the AR group and 3.5 cm (range,1.0-17.0 cm),16,20,22 in the PSH group,with no statistically significant difference between the two groups (Z =-0.241,x2=0.039,0.124,P>0.05).The confounding bias of maximum tumor diameter,vascular embolism and TNM staging were eliminated.(2) Intraoperative and postoperative situations:the operation time,volume of intraoperative blood loss,cases with intraoperative blood transfusion,cases with surgical margin < 1 cm and ≥ 1 cm,cases with postoperative severe complications,duration of hospital stay,cases with postoperative tumor recurrence,cases with tumor recurrence within 2 years postoperatively,cases undergoing surgical treatment due to postoperative tumor recurrence,cases undergoing transcatheter arterial chemoemblization due to postoperative tumor recurrence after matching were 180 minutes (range,60-448 minutes),130 mL (range,30-6 000 mL),9,2,88,8,18 days (range,8-77 days),41,32,15,23 in the AR group,and 150 minutes (range,55-400 minutes),100 mL (range,50-3 000 mL),6,2,88,6,18 days (range,9-37 days),37,29,10,24 in the PSH group,respectively,showing no statistically significant difference between the two groups (Z =-1.987,-0.439,x2 =0.655,0.000,0.310,Z=-0.805,x2=0.362,0.223,0.816,0.624,P>0.05).(3) Follow-up and survival situations:180 patients were followed up for 4-114 months,with a median time of 43 months.Forty of 180 patients died (21 in the AR group and 19 in the PSH group) and 78 had tumor recurrence (41 in the AR group and 37 in the PSH group).The 1-,3-,5-year overall survival rates and tumor-free survival rates were 92.0%,76.3%,71.8% and 70.8%,53.0%,47.4% in the AR group,92.3%,80.6%,62.0% and 72.3%,56.4%,46.1% in the PSH group,respectively,showing no statistically significant difference between the two groups (x2 =0.034,0.000,P>0.05).Stratified analysis:of the AR group,the 1-,3-,5-year overall survival rates and median tumor-free survival rate were 95.3%,82.0%,82.0% and 54.6% in the patients with grade Ⅰ of preoperative albumin-bilirubin,100.0%,86.8%,86.8% and 61.5% in the patients with maximum tumor diameter ≤≤5 cm,91.3%,75.0%,69.7% and 43.1% in the patients with liver cirrhosis,89.9%,73.2%,66.6% and 54.6% in the patients with moderate-low differentiated tumor.Of the PSH group,the 1-,3-,5-year overall survival rates and median tumor-free survival rate were 90.9%,74.9%,63.0% and 43.4% in the patients with grade Ⅰ of preoperative albumin-bilirubin,98.2%,85.8%,61.7% and 46.0% in the patients with maximum tumor diameter ≤≤ 5 cm,98.0%,88.7%,70.0% and 43.4% in the patients with liver cirrhosis,90.7%,79.2%,59.0% and 43.4% in the patients with moderate-low differentiated tumor.There were no statistically significant difference in the 1-,3-,5-year overall survival rates between the two groups (x2 =1.892,1.320,0.732,0.002,P>0.05) and a statistically significant difference in the tumor-free survival rate between the two groups (x2 =0.337,0.051,0.551,0.061,P > 0.05).(4) Prognostic factors analysis.Results of univariate analysis showed that preoperative albumin-bilirubin grade,preoperative alpha fetoprotein (AFP),maximum tumor diameter,number of tumors,satellite lesion,vascular embolism,TNM staging,volume of intraoperative blood loss,postoperative severe complications were related factors affecting overall survival after radical resection for HCC (hazard ratio=1.762,1.001,1.139,1.955,2.561,2.495,2.766,1.000,2.599,95% confidence interval:1.048-2.962,1.000-1.001,1.080-1.201,1.063-3.596,1.254-5.227,1.446-4.304,1.655-4.624,1.000-1.001,1.317-5.128,P<0.05).Preoperative AST,positive HBsAg,preoperative AFP,maximum tumor diameter,vascular embolism,TNM staging,postoperative severe complications were related factors affecting tumor-free survival after radical resection for HCC (hazard ratio=1.004,1.594,1.000,1.065,2.203,2.132,1.775,95% confidence interval:1.001-1.007,1.020-2.490,1.000-1.001,1.019-1.113,1.474-3.293,1.462-3.109,1.034-3.047,P<0.05).Results of multivariate analysis showed that preoperative AFP,maximum tumor diameter,satellite lesion,postoperative severe complications were independent factors affecting overall survival after radical resection for HCC (hazard ratio =1.001,1.114,2.241,2.251,95% confidence interval:1.000-1.001,1.033-1.202,1.003-5.008,1.100-4.607,P<0.05).Positive HBsAg was an independent factor affecting tumor-free survival after radical resection for HCC (hazard =1.576,95% confidence interval:0.987-2.516,P< 0.05).Conclusions There was no significant difference in long-term efficacy between AR and PSH in patients with BCLC stage A HCC.Preoperative AFP,maximum tumor diameter,number of tumors,satellite lesion,postoperative severe complications are independent factors affecting long-term survival of BCLC stage A patients after HCC radical resection.

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作者: 王宏伟 [1] 季顾惟 [1] 张慧 [1] 李高超 [1] 李相成 [1] 王科 [1] 吴晓峰 [1] 李长贤 [1]
期刊: 《中华消化外科杂志》2019年18卷4期 358-367页 ISTICPKUCSCD
栏目名称: 论著
DOI: 10.3760/cma.j.issn.1673-9752.2019.04.011
发布时间: 2019-05-28
基金项目:
国家自然科学基金 江苏省重点病种规范化诊疗研究 国家科技重大专项(2017ZX10203207-004-004)National Natural Science Foundation of China Standardized Diagnosis and Treatment Research of Key Diseases in Jiangsu Province National Major Special Project
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