一项关于射频消融联合乙醇注射治疗小肝细胞癌的随机对照试验。

A randomized controlled trial of radiofrequency ablation with ethanol injection for small hepatocellular carcinoma.

作者信息

Shiina Shuichiro, Teratani Takuma, Obi Shuntaro, Sato Shinpei, Tateishi Ryosuke, Fujishima Tomonori, Ishikawa Takashi, Koike Yukihiro, Yoshida Haruhiko, Kawabe Takao, Omata Masao

机构信息

Department of Gastroenterology, University of Tokyo, Japan.

出版信息

Gastroenterology. 2005 Jul;129(1):122-30. doi: 10.1053/j.gastro.2005.04.009.

DOI:10.1053/j.gastro.2005.04.009

PMID:16012942

Abstract

BACKGROUND & AIMS: Percutaneous radiofrequency ablation is a recently introduced treatment for hepatocellular carcinoma, whereas ethanol injection is now a standard therapy. We compared their long-term outcomes.

METHODS

Two hundred thirty-two patients with hepatocellular carcinoma who had 3 or fewer lesions, each 3 cm or less in diameter, and liver function of Child-Pugh class A or B were entered onto a randomized controlled trial. The primary end point was survival, and the secondary end points were overall recurrence and local tumor progression.

RESULTS

One hundred eighteen patients were assigned to radiofrequency ablation and 114 to ethanol injection. The number of treatment sessions was smaller (2.1 times vs 6.4 times, respectively, P < .0001) and the length of hospitalization was shorter (10.8 days vs 26.1 days, respectively, P < .0001) in radiofrequency ablation than in ethanol injection. Four-year survival rate was 74% (95% CI: 65%-84%) in radiofrequency ablation and 57% (95% CI: 45%-71%) in ethanol injection. Radiofrequency ablation had a 46% smaller risk of death (adjusted relative risk, 0.54 [95% CI: 0.33-0.89], P = .02), a 43% smaller risk of overall recurrence (adjusted relative risk 0.57 [95% CI: 0.41-0.80], P = .0009), and an 88% smaller risk of local tumor progression (relative risk, 0.12 [95% CI: 0.03-0.55], P = .006) than ethanol injection. The incidence of adverse events was not different between the 2 therapies.

CONCLUSIONS

Judging from higher survival but similar adverse events, radiofrequency ablation is superior to ethanol injection for small hepatocellular carcinoma.

摘要

背景与目的

经皮射频消融术是最近引入的一种肝细胞癌治疗方法，而乙醇注射目前是一种标准疗法。我们比较了它们的长期疗效。

方法

232例肝细胞癌患者，其病灶3个或更少，每个病灶直径3cm或更小，肝功能为Child-Pugh A级或B级，进入一项随机对照试验。主要终点是生存率，次要终点是总体复发率和局部肿瘤进展情况。

结果

118例患者被分配接受射频消融治疗，114例接受乙醇注射治疗。射频消融治疗的疗程数较少（分别为2.1次和6.4次，P <.0001），住院时间较短（分别为10.8天和26.1天，P <.0001）。射频消融治疗的4年生存率为74%（95%可信区间：65%-84%），乙醇注射治疗为57%（95%可信区间：45%-71%）。与乙醇注射相比，射频消融治疗的死亡风险降低46%（调整后相对风险，0.54 [95%可信区间：0.33-0.89]，P =.02），总体复发风险降低43%（调整后相对风险0.57 [95%可信区间：0.41-0.80]，P =.0009），局部肿瘤进展风险降低88%（相对风险，0.12 [95%可信区间：0.03-0.55]，P =.006）。两种治疗方法的不良事件发生率没有差异。