目的前瞻性评估多电极转换系统射频消融技术治疗肾细胞癌的安全性及有效性。材料与方法 2009年11月—2010年12月,共33例病人(年龄44~86岁;平均70.7岁)纳入了此次Ⅱ期研究,包括24例男性病人(年龄44~86岁,平均69.5岁)和9例女性病人(年龄64~83岁,平均74.1岁),所有病人均经病理证实为肾细胞癌。此项研究得到了审查委员会批准,所有病人均签署了知情同意书。所有肿瘤最大径的平均值为(2.9±1.0)cm(1.5~5.0cm),均采用多电极自动转换系统的射频消融技术来治疗。按照不良事件统一命名法的标准(Common Terminology Criteria for Adverse Events)评估主要终点,次要终点包括肾功能改变、技术有效性、局部肿瘤进展以及生存期,肾功能变化通过Mann-WhitneyU检验给予评估。结果所有病人均未发生严重不良事件,但33例病人中有3例(发生率9%)发生二级不良事件。尽管有双侧肾脏的26例病人射频消融术后1年平均肾小球滤过率与基准值相近(P=0.14),但仅有单侧肾脏的6例病人射频消融术后肾小球滤过率却明显降低(P=0.03)。31例病人在行一次射频消融术后肿瘤强化完全消失,另外2例病人在行第二次射频消融术后肿瘤强化完全消失(首次射频技术有效率为94%,二次射频技术有效率为100%)。随访期间没有发现局部肿瘤进展(平均随访时间20个月,范围11.6~27.6个月)。33例病人1年生存率、与肾细胞癌相关的1年生存率分别为97%(95%CI:91%～100%)和100%。结论多电极转换系统的射频消融技术用于肾细胞癌的治疗是安全有效的。尽管如此,仍需要更进一步的研究来决定这项技术是否优越于其他原先的方法。 Objective To prospectively evaluate the safety and efficacy of multi-electrode system radiofrequency ablation in the treatment of renal cell carcinoma. Materials and Methods From November 2009 to December 2010, a total of 33 patients (aged 44-86 years; mean age 70.7 years) were included in this phase II study, including 24 male patients (aged 44-86 years, mean 69.5 years Year) and 9 female patients (aged 64-83 years, mean 74.1 years). All patients were pathologically confirmed as renal cell carcinoma. The study was approved by the review board and all patients signed informed consent. The mean maximum diameters of all tumors were (2.9 ± 1.0) cm (1.5-5.0 cm), all of which were treated with radiofrequency ablation of a multi-electrode automatic transfer system. The primary endpoint was assessed according to the Common Terminology Criteria for Adverse Events. Secondary endpoints included changes in renal function, technical efficacy, local tumor progression, and survival, and changes in renal function were assessed by the Mann-Whitney U test. Results No serious adverse events occurred in all patients, but 3 of 33 (9%) patients had secondary adverse events. Although the average 1-year glomerular filtration rate after radiofrequency ablation in two patients with bilateral kidneys was similar to the baseline (P = 0.14), glomerular filtration was performed in 6 patients with unilateral renal radiofrequency ablation The passing rate was significantly lower (P = 0.03). Thirty-one patients completely disappeared after radiofrequency ablation. The other two patients completely disappeared after the second radiofrequency ablation (the first radiofrequency technique was 94%, the second radiofrequency technique was 100 %). No local tumor progression was observed during the follow-up (mean follow-up of 20 months, range, 11.6-27.6 months). One-year survival rates for 33 patients were 97% (95% CI: 91% -100%) and 100% for 1-year renal cell carcinoma. Conclusion The multi-electrode system RFA is safe and effective for the treatment of renal cell carcinoma. However, more research is still needed to determine whether the technology is superior to other previous methods.