经皮射频消融联合瘤内无水酒精注射与单纯射频消融治疗小肝癌的疗效比较

Randomized clinical trial of percutaneous radiofrequency ablation plus absolute ethanol injection compared with radiofrequency ablation alone for small hepatocellular carcinoma

目的比较经皮射频消融联合瘤内无水酒精注射(RFA-PEI)与单纯射频消融(RFA)治疗单发小肝癌的疗效.方法随机应用RFA-PEI和RFA分别治疗小肝癌45例和41例,并按病灶大小分为A组(最大直径≤3 .0 cm)和B组(最大直径3.1～5.0 cm),以生存率和无局部复发率作为评价指标,比较两种疗法的疗效.结果 RFA-PEI组和RFA组的6,12,18,24个月生存率分别为88.9%、84.0%、80.6%、73.9%和87.6%、78.3%、73.7%、61.4%(P＝0.6181).无局部复发率分别为95.4%、95.4%、87.8%、73.7%和94.9%、72.7%、68.4%、57.0%(P=0.0393),其中A组为95.7%、95.7%、79.1%、79.1%和92.3%、83.2%、81.3%、65.9%(P=0.3679);B组为95.0%、95.0%、95.0%、72.6%和100.0%、58.3%、45.4%、45.4%(P=0.0440).结论 RFA-PEI治疗肝癌安全有效,操作简单易行,可以提高RFA治疗的疗效,特别是对于肿瘤直径为3～5 cm的病灶,可以减少局部复发率,提高远期生存率.

Objective To compare percutaneous radiofrequeney ablation （RFA） alone and RFA combined with percutaneous absolute ethanol injection（ RFA-PEI ） in the treatment of single hepatocellular carcinoma smaller than 5.0 cm in diameter. Methods From Jan. 2002 till Dec. 2003, eighty-six patients were put on a randomized clinical trial. For RFA, the American Radiothelapeuties RF 2000^TM machine and 3.5 cm/LEE VEEN ＋ electroradiofrequency needle was introduced under ultra-beta sound guide. Fur tumor 〈3 cm, the needle was left in center of tumor and for tmnor 〉3 cm, the needle was first left in situ and twisted by 180 as it was withdrawn for every 1cm, till the surface border was reached. Power output was increased from 20W and raised by 10-20W per minute until the impedance became rapidly raised and the pu＇put decreased. Forty-five patients were treated with RFA-PEI and 41 with RFA, with each group divided into group A（diameter≤3.0 cm） and group B（diameter= 3.1-5.0cm） according to tumor size. The overall and local recurrence-free survival was used to evaluate the treatment effeet. Results There was no mortality or serious morbidity in either group. The 6-, 12-. 18-,24-month survival rate of RFA-PEI and RFA was 88.9%,84.0%,80.6%,73.9% and 87.7%,78.3%,73.7%,61.4% （P=0.6181）, respectively; and the local recurrence-free survival rates was 95.4% , 95.4% , 87.8% , 73.7% and 94.9% , 72.7% , 68.4% ,57.1% （P = 0. 0393 ） , respectively. The local recurrence-free survival rate in group A was 95.7% , 95.7% ,79.1% ,79.1% and 92.3% ,83.2% ,81.3% ,65.9% （ P = 0. 3679 ） , respectively; while in group Bwas95.0% ,95.0% ,95.0% ,72.6% and100.0% ,58.3% ,45.4% ,45,4% （ P = 0. 0440）. Conclusion Pereutaneous radiofrequency ablation combined with pereutaneous absolute ethanol injection is safe,and more effective and easily practiced than percutaneous radiofrequeney ablation alone in the treatment of small hepatoeellular carcinoma,especially when the tumor is greater than 3 cm in diameter, for which RFA-PE1 may be able to reduce local reeurrenee and improve long-term survival.