中医药综合方案提高根治术后小肝癌患者生存率回顾性队列研究

Traditional Chinese Medicine in Improving Overall Survival Rates for Small Hepatocellular Carcinoma After Resection:A Retrospective Cohort Study

目的:本研究评价中医药综合方案治疗根治术后小肝癌的疗效。方法:对2005年1月—2008年12月在广西医科大学第一附属医院行根治术的小肝癌患者161例纳入回顾性队列分析,其中53例接受中医药综合方案治疗(TCM组),80例接受介入疗法(TACE组),20例接受中医药和介入疗法(TCM-IT组),8例单纯手术治疗(SO),以无病生存期(DFS)和总生存期(OS)为观察指标,Kaplan-Meier方法统计分析各组总生存率和无病生存率。结果:共纳入161例小肝癌患者,12例失访,失访率7.45%,其中TCM组第1年、2年、3年总生存率分别为91.5%、84.8%、84.8%;介入组1年、2年,3年总生存率分别为91%、85.5%、60.5%,有明显统计学差异(P=0.008);TCM与介入联合组和单纯手术组中位生存期分别是30.667个月和29.267个月。TCM组1年、2年的无病生存率分别为84.5%、81.7%,介入组1年、2年的无病生存率为83.9%、76.5%,无统计学差异(P=0.461)。结论:中医药综合治疗方案与TACE介入治疗术相比,在提高根治术后小肝癌患者的生存率方面具有优势,其结果有待于进一步前瞻性随机对照研究验证。

Objective ： To investigate the therapeutic effects of a comprehensive individualized treatment program using TCM for small hepatocellular carcinoma after resection. Methods： In this trial, a total of 161 patients who stayed in First Affiliated Hospital of Guangxi Medical University were enrolled from January 2005 to December 2008. 53 patients were treated with a TCM-only （ TCM ） group. 80 patients were treated with an transarterial ehemoembolization-only （ TACE ） group. 20 patients were treated with a TCM combined with interventional therapy （ TCM-IT ） group. 8 patients were treated with patients were treated with a simple operation （ SO ） group. Disease free survival （ DFS ） and overall survival （ OS ） were the observation indexes. Prognostic factors were correlated with OS rates and （ DFS ） rates, which calculated with the Kaplan-Meier method. Results ： The overall loss to follow-up rate was 14.0% （ 12/161 ）. The Overall survival （OS）rates at 1,2, and 3 years of TCM patients were 91.5%,84.8% and 84.8%. The Overall survival （ OS ）rates at 1,2 and 3 years of TACE group patients were 91%, 85.5%, 60.5%. There was significant difference in survival time between the two groups （ P=0.008 ）. The overall median survival time in TCM combined with interventional therapy （ TCM-IT ）was 30.667 months and simple operation （ SO ） group was 29.267 months. The Disease free survival （ DFS ）rates at 1,2 years of TCMO patients were 84.5% and 81.7%. The DFS rates at 1,2 years of ITO patients were 83.9% and 76.5%. There was no significantdifference in survival time between the two groups （ P=0.461 ）. Conclusions ： In comparison with TACE therapy, the comprehensive individualized treatment program using TCM for small hepatocellular carcinoma after resection may improve overall survival for small- HCC after resection. However, these findings need to be confirmed in a prospective, randomized controlled trial.