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目的本研究旨在系统评价射频消融术(RFA)联合无水乙醇注射(PEI)治疗肝癌的疗效及安全性,为临床实践与研究提供参考。方法计算机检索Cochrane Library、Pub Med、EMBase、Web of Science、CBM、CNKI、VIP及Wanfang八大数据库,同时辅以其他检索,收集所有相关的临床对照试验(CCT)。由2位评价员按照研究计划书进行文献筛选和资料提取,并对纳入文献的质量进行评价后,使用Rev Man 5.3软件进行Meta分析。结果共纳入15个CCT(1 374例患者)。Meta分析结果显示:RFA+PEI组的1、2、3年生存率及肿瘤完全坏死率高于RFA组,局部复发率低于RFA组,差异均有统计学意义(P<0.05);除发热外,RFA+PEI组不增加其他并发症和不良反应的发生率。RFA+PEI组1年生存率、肿瘤完全坏死率高于PEI组,局部复发率低于PEI组,差异均有统计学意义(P<0.05)。结论与单纯RFA或单纯PEI治疗相比,RFA联合PEI治疗肝癌能明显提高患者生存率和肿瘤完全坏死率、降低局部复发率,并具有较好的临床安全性。但其长期疗效和安全性评价尚需更多大样本高质量的临床研究进一步验证。
Objective This study was designed to systematically evaluate the efficacy and safety of radiofrequency ablation (RFA) combined with absolute ethanol injection (PEI) in the treatment of liver cancer and provide references for clinical practice and research. Methods Eight databases of Cochrane Library, PubMed, EMBase, Web of Science, CBM, CNKI, VIP and Wanfang were searched by computer, and other related clinical controlled trials (CCTs) were collected. Two reviewers screened the literature and extracted the data according to the research plan. After evaluating the quality of the included documents, Meta-analysis was performed using RevMan 5.3 software. Results A total of 15 CCTs were included (1 374 patients). Meta-analysis showed that the 1, 2, 3-year survival rates and complete tumor necrosis rates of RFA + PEI group were higher than those of RFA group, but the local recurrence rate was lower than RFA group (P <0.05) In addition, RFA + PEI did not increase the incidence of other complications and adverse reactions. The 1-year survival rate, complete tumor necrosis rate and the local recurrence rate were higher in RFA + PEI group than in PEI group (P <0.05). Conclusion Compared with simple RFA or simple PEI treatment, RFA combined with PEI can significantly improve the survival rate of patients with liver cancer and complete tumor necrosis and reduce the local recurrence rate, and has good clinical safety. However, its long-term efficacy and safety evaluation still need more large samples of high-quality clinical studies to further verify.