可切除大肝癌术前行与不行肝动脉插管化疗疗效的临床随机对照研究

目的:采用随机对照研究评价可切除大肝癌术前肝动脉插管化疗(TACE)对术后肝功能恢复及患者生存率的价值。方法:采用随机对照实验的方法,将2001年7月至2003年12月符合纳入标准的108例可切除大肝癌(直径≥5 cm)患者随机分为一期手术组(OP组,n=56)和TACE+手术组(TACE+OP组,n=52)。比较两组患者术中情况,肿瘤切除率,手术前后肝功能变化,术后1、3、5年无瘤生存率及总生存率的差异。结果:术前两组患者基线情况一致。TACE+OP组插管化疗后γ-球蛋白水平明显高于OP组(P=0.046),手术切除后第7天前白蛋白水平明显低于OP组(P=0.031)。OP组平均手术时间明显短于TACE+OP组(P=0.042),肿瘤切除率明显高于TACE+OP组(P=0.017),肿瘤转移患者明显少于TACE+OP组(2vs9,P=0.018)。两组患者术中肝血流阻断时间及出血量以及术后1、3、5年无瘤生存率及总生存率均无统计学差异。结论:可切除大肝癌术前TACE并不能延长术后无瘤生存期及总生存期,且可能促进肿瘤转移,损害肝功能。

Effect of preoperative transcatheter arterial chemoembolization for treatment of resectable large hepatocellular carcinoma:a clinical randomized controlled trial

Objective:To evaluate the effect of preoperative transcatheter arterial chemoembolization(TACE)on liver function and survival of patients after resection of large hepatocellular carcinoma(HCC)by a randomized controlled approach.Methods:From July 2001 to December 2003,a total of 108 patients with resectable large HCC(≥5 cm),who met the inclusion criteria,were prospectively randomized into surgical resection group(OP group,n=56)or preoperative TACE group(TACE+OP group,n=52).Operative outcomes,resection rate,1-,3-,and 5-year tumor-free survival rates and overall survival rate were compared between the two groups.Results:The preoperative baseline conditions were equivalent between the two groups.The γ-globulin level in TACE+OP group was significantly higher than that in the OP group(P=0.046)after chemoembolization.The prealbumin level was significantly lower than that of the OP group seven days after operation(P=0.031).Compared with TACE+OP group,OP group had a significantly higher resection rate(100%vs 89.4%,P=0.017),a less average operative time(P=0.042),and less metastases(2 vs 9,P=0.018).There were no significant differences between the two groups in intraoperative blood loss,warm isehemic time,1-,3-,and 5-year tumor-free survival rates,or overall survival rate.Conclusion:The preoperative TACE can not improve post-operative tumor-free and overall survivalrates,and it may result in tumor metastasis or hepatic function damages.