肝动脉化疗栓塞联合经皮无水乙醇注射治疗不能切除肝癌疗效的荟萃分析

Meta-analysis of the efficacy of transcatheter arterial chemoembolization combined with percutaneous ethanol injection in treating unresectable primary liver cancer

目的评价肝动脉化疗栓塞联合经皮无水乙醇注射治疗不能手术切除肝癌的疗效和安全性。方法计算机检索MEDLINE、EMBASE、Cochrane图书馆和中国生物医学文献数据库、中国期刊全文数据库和万方数据库中的相关文献，语种不限，所有检索均截止至2008年06月10日。检索所有有关肝动脉化疗栓塞联合经皮无水乙醇注射治疗不能切除肝癌的随机对照试验，由2名评价员筛选和提取资料，并用Jadad量表进行质量评估，对符合纳入标准的研究采用RevMan4．2软件进行分析。结果共纳入14个随机对照试验，12篇中文，2篇英文，总共857例肝癌患者。荟萃分析结果显示：与单用肝动脉化疗栓塞治疗不能手术切除肝癌组相比，肝动脉化疗栓塞联合经皮无水乙醇注射治疗可以明显提高总生存率、AFP转阴率和下降率，还可以明显提高瘤灶显效率：1、2、3年总生存率的相对危险度RR值（95％CI）分别为1．37（1．21～1．56）、1．74（1．49～2．04）、2．26（1．70～3．02）；AFP转阴率、AFP下降率、瘤灶显效率的RR（95％CI）分别为1．69（1．38～2．07）、1．39（1．24～1．56）、1．56（1．38～1．77）。有11篇研究报道了与治疗相关的不良反应，主要为轻中度发热、肝功能损害，消化道反应和暂时性肝区疼痛，没有与治疗相关严重并发症或死亡的报道。结论现有证据显示相对于单用肝动脉化疗栓塞治疗不能切除肝癌，肝动脉化疗栓塞联合经皮无水乙醇注射治疗可以明显提高总生存率、AFP转阴率及下降率，还可以提高瘤灶坏死率和缩小率，且安全性较好。但由于纳入的研究多数方法学质量偏低，需更多高质量的临床随机对照试验进一步评估其疗效和安全性。

Objective To evaluate the efficacy and safety of transcatheter arterial chemoembolization combined with percutaneous ethanol injection in treating unresectable primary liver cancer. Methods MEDLINE （1966 -June 2008）, EMBASE （ 1974 -June 2008）, the Cochrane Library （ Issue 2, 2008 ）, CBMdisc （ 1978 - June 2008）, CNKI （ 1979 - June 2008）, and Wanfang Database were searched without language limitation. All randomized controlled trials comparing transcatheter arterial chemoembolization alone with transcatheter arterial chemoembolization combined with percutaneous ethanol injection for treating unresectable primary liver cancer were identified and screened by two reviewers, and the methodological quality of the included randomized controlled trials were evaluated by Jadad scale. The Cochrane Collaboration＇ s RevMand. 2 software was used for the analysis of the data extracted from the included randomized controlled trials. Results Fourteen randomized controlled trials involving 857 patients were included with 12 trials published in Chinese and 2 in English. Meta-analysis of the data extracted from the included randomized controlled trials showed that transeatheter arterial chemoembolization combined with percutaneous ethanol injection could significantly improve the overall survival rates compared with transcatheter arterial chemoembolization alone , with the corresponding relative risk （RR） values （95% CI） for the 1, 2, and3-year survival of 1. 37 （1.21-1.56）, 1.74 （1.49-2.04）, and 2. 26 （1.70-3.02） respectively; and the RR alpha-feto-protein （AFP） negative conversion rate, AFP lowering rate, and tumor focus efficacy rate were 1.39 （ 1.24 - 1.56） , 1.69 （ 1.38 - 2. 07） , and 1.56 （ 1.38 - 1.77） respectively. Side effects or adverse events related with transcatheter arterial chemoembolization were reported in 11 randomized controlled trials, mainly liver function impairment, fever , gastrointestinal symptom, and transient pain, and no major treatment-related complication or death was reported. Conclusion Compared with transcatheter arterial chemoembolization alone, transcatheter arterial chemoembolization combined with percutaneous ethanol injection significantly is a better approach in treating unresectable primary liver cancer, increasing the overall survival rate, AFP negative and lowering rates, and tumor response rate. However, the methodological quality of most reported randomized controlled trials is low.