The Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, China ; Department of Medical Administration, 363 Hospital, Chengdu, China.
National Chengdu Center for Safety Evaluation of Drugs, West China Hospital, Chengdu, China.
PLoS One. 2014 Jan 3;9(1):e84484. doi: 10.1371/journal.pone.0084484. eCollection 2014.
To evaluate the efficacy and safety of radiofrequency ablation (RFA) versus hepatic resection (HR) for early hepatocellular carcinoma (HCC) meeting the Milan criteria.
A meta-analysis was conducted, and PubMed, Web of Science, the Cochrane Library, CBM, CNKI and VIP databases were systematically searched through November 2012 for randomized and nonrandomized controlled trials (RCTs and NRCTs). The Cochrane Collaboration's tool and modified MINORS score were applied to assess the quality of RCTs and NRCTs, respectively. The GRADE approach was employed to evaluate the strength of evidence.
Three RCTs and twenty-five NRCTs were included. Among 11,873 patients involved, 6,094 patients were treated with RFA, and 5,779 with HR. The pooled results of RCTs demonstrated no significant difference between groups for 1- and 3-year overall survival (OS), recurrence-free survival (RFS) and disease-free survival (DFS) (p>0.05). The 5-year OS (Relative Risk, RR 0.72, 95% CI 0.60 to 0.88) and RFS (RR 0.56, 95% CI 0.40 to 0.78) were lower with RFA than with HR. The 3- and 5-year recurrences with RFA were higher than with HR (RR 1.48, 95% CI 1.14 to 1.94, and RR 1.52, 95% CI 1.18 to 1.97, respectively), but 1-year recurrence and in-hospital mortality showed no significant differences between groups (p>0.05). The complication rate (RR 0.18, 95% CI 0.06 to 0.53) was lower and hospital stays (Mean difference -8.77, 95% CI -10.36 to -7.18) were shorter with RFA than with HR. The pooled results of NRCTs showed that the RFA group had lower 1-, 3- and 5-year OS, RFS and DFS, and higher recurrence than the HR group (p<0.05). But for patients with very early stage HCC, RFA was comparable to HR for OS and recurrence.
The effectiveness of RFA is comparable to HR, with fewer complications but higher recurrence, especially for very early HCC patients.
评估符合米兰标准的早期肝细胞癌（HCC）患者接受射频消融（RFA）与肝切除术（HR）的疗效和安全性。
进行了一项荟萃分析，系统检索了 2012 年 11 月前发表的 PubMed、Web of Science、Cochrane 图书馆、CBM、CNKI 和 VIP 数据库中的随机和非随机对照试验（RCT 和 NRCT）。分别采用 Cochrane 协作工具和改良的 MINORS 评分评估 RCT 和 NRCT 的质量。采用 GRADE 方法评估证据强度。
纳入了 3 项 RCT 和 25 项 NRCT，涉及 11873 例患者，其中 6094 例接受 RFA 治疗，5779 例接受 HR 治疗。RCT 汇总结果显示，两组 1 年和 3 年总生存率（OS）、无复发生存率（RFS）和无病生存率（DFS）无显著差异（p>0.05）。RFA 组 5 年 OS（相对危险度，RR 0.72，95%置信区间 0.60 至 0.88）和 RFS（RR 0.56，95%置信区间 0.40 至 0.78）均低于 HR 组。RFA 组 3 年和 5 年复发率均高于 HR 组（RR 1.48，95%置信区间 1.14 至 1.94，RR 1.52，95%置信区间 1.18 至 1.97），但两组 1 年复发率和住院死亡率无显著差异（p>0.05）。RFA 组并发症发生率（RR 0.18，95%置信区间 0.06 至 0.53）较低，住院时间（平均差-8.77，95%置信区间-10.36 至-7.18）较短。NRCT 汇总结果显示，RFA 组 1 年、3 年和 5 年 OS、RFS 和 DFS 均低于 HR 组，复发率高于 HR 组（p<0.05）。但对于极早期 HCC 患者，RFA 与 HR 的 OS 和复发率相当。
RFA 的疗效与 HR 相当，并发症较少，但复发率较高，尤其是对于极早期 HCC 患者。
