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目的系统评价经皮无水酒精(PEI)治疗直径≤3cm肝癌的疗效和安全性。方法计算机检索Cochrane图书馆临床对照试验数据库(2008年第2期)、PubMed(1978～2008)、EMbase(1966～2008)、Ovid(2000～2008)、中国生物医学文献数据库(1978～2008)和中国期刊全文数据库(1979～2008),手工检索中、英文已发表和未发表的资料以及查阅文后参考文献,文献检索无语种限制。按Cochrane系统评价方法筛选试验、评价纳入研究的方法学质量、提取资料,并用RevMan4.2.10版软件进行Meta分析。结果本系统评价纳共入7个随机对照试验,包括891例患者。按测量指标和干预措施进行亚组分析。结果显示,直径≤3cm肝癌治疗后1、3年生存率与局部复发率,PEI与经皮射频消融(RFA)治疗比较差异均有统计学意义[RR=0.95,95%CI(0.91,1.00);RR=0.80,95%CI(0.71,0.91);RR=2.18,95%CI(1.11,4.30);RR=2.59,95%CI(1.55,4.32)];PEI与经RFA治疗比较,直径2～3cm的肝癌治疗后3年无瘤生存率差异有统计学意义[RR=0.47,95%CI(0.24,0.93)];两种治疗方式在其余指标方面的差异均无统计学意义。结论现有有限证据表明,对于直径≤3cm的肝癌,PEI与经皮醋酸注射(PAI)治疗、手术切除的疗效相当;PEI注射+RFA与RFA治疗的疗效无差异;治疗直径≤2cm肝癌,PEI的疗效与RFA无差别,但RFA治疗直径2～3cm肝癌的疗效优于PEI。由于本系统评价纳入RCT数量及样本量较少,质量偏低,一些主要测量指标报道过少,缺乏足够信息进行分析,尚需开展更多更高质量RCT进一步验证其疗效和安全性。
Objective To evaluate the efficacy and safety of percutaneous ethanol (PEI) in the treatment of liver cancer ≤3 cm in diameter. Methods The Cochrane Central Register of Controlled Trials Database (No. 2, 2008), PubMed (1978-2008), EMbase (1966-2008), Ovid (2000-2008), Chinese Biomedical Literature Database The Chinese Journal Full-text Database (1979-2008), manual search of published and unpublished data in Chinese and English, as well as access to literature references, literature search without language restrictions. Screening tests were performed according to the Cochrane review method, the methodology quality of the included studies was evaluated, data were extracted and Meta-analysis was performed using RevMan version 4.2.10 software. Results The systematic review included 7 randomized controlled trials, including 891 patients. Sub-group analysis by measurement indicators and interventions. The results showed that there was significant difference in 1-year and 3-year survival rates between the 1-year-3-year and 3-year-old liver cancer patients with diameter less than 3 cm (RR = 0.95,95% CI 0.91, 1.00) ; RR = 0.80,95% CI (0.71,0.91); RR = 2.18,95% CI (1.11,4.30); RR = 2.59,95% CI The 3-year disease-free survival rates of 3 ~ 3cm hepatocellular carcinoma after treatment were statistically significant [RR = 0.47,95% CI (0.24,0.93)]. There was no significant difference between the two treatment methods in other indicators. CONCLUSIONS There is limited evidence available to show that resection of PEI is similar to percutaneous acetic acid injection (PAI) for liver cancer ≤3 cm in diameter and that PEI + RFA and RFA are of no difference in efficacy; for PEI ≤2 cm in diameter, The efficacy and RFA no difference, but the RFA treatment of diameter 2 ~ 3cm liver cancer better than PEI. Due to the small number of RCTs included in this review and the low quality of the RCTs, some of the major measurement indicators were reported too little and lacked sufficient information for analysis, more and better RCTs need to be developed to further verify their efficacy and safety.