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目的系统评价肝动脉化疗栓塞(TACE)联合索拉非尼与单一TACE治疗中国人群中晚期肝癌的疗效与安全性。方法检索Pub Med、Embase、Cochrane图书馆、CBM、CNKI、VIP、万方等数据库,查找比较TACE联合索拉非尼与单一TACE治疗中国人群中晚期肝癌的随机对照试验(RCT),检索时限从建库至2014年12月。对纳入的文献进行资料提取和质量评价,采用Rev Man 5.1软件进行meta分析。结果最终纳入6项研究共498例患者。meta分析结果显示,在中国人群中,相比单一TACE治疗,TACE联合索拉非尼治疗能提高中晚期肝癌患者的客观有效率(OR=2.28,95%CI为1.52~3.42,P<0.000 1)及疾病控制率(OR=6.62,95%CI为4.12~10.65,P<0.000 01),差异有统计学意义,能有效提高患者的1年生存率(OR=3.27,95%CI为2.06~5.22,P<0.000 01)及2年生存率(OR=4.55,95%CI为2.28~9.07,P<0.000 1),同时对不良反应具有良好的耐受性及安全性。结论在中国人群中,对于不可手术切除的中晚期肝癌患者,TACE联合索拉非尼治疗,相比单一TACE治疗可以有效提高客观有效率、疾病控制率,提高患者1年及2年生存率,但是由于纳入文献的评价质量不高等因素的限制,应谨慎对待本研究结论。
Objective To evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) in combination with sorafenib and single TACE in the treatment of advanced hepatocellular carcinoma in Chinese population. Methods The databases of Pub Med, Embase, Cochrane Library, CBM, CNKI, VIP and Wanfang were searched and searched for randomized controlled trials (RCTs) comparing TACE with sorafenib and single TACE in the treatment of advanced hepatocellular carcinoma in Chinese population. Construction of the library until December 2014. Data extraction and quality evaluation of the included literature were performed using the Rev Man 5.1 software for meta-analysis. Results The final study included 498 patients in 6 studies. Meta-analysis showed that in the Chinese population, TACE combined with sorafenib increased the objective efficiency of patients with advanced liver cancer (OR = 2.28, 95% CI 1.52 ~ 3.42, P <0.000 1 ) And disease control rate (OR = 6.62, 95% CI 4.12 ~ 10.65, P <0.000 01). The difference was statistically significant and could effectively improve the 1-year survival rate of patients (OR = 3.27, 95% CI 2.06 ~ 5.22, P <0.000 01) and 2-year survival rate (OR = 4.55, 95% CI 2.28-9.07, P <0.0001), with good tolerance and safety to adverse reactions. Conclusion TACE and sorafenib in patients with unresectable advanced hepatocellular carcinoma can effectively improve objective efficiency and disease control rate and improve patients’ 1-year and 2-year survival rate compared with single TACE treatment in Chinese population. However, due to the low quality of the included documents, the conclusion of this study should be treated with caution.