肝细胞癌根治性治疗后辅助干扰素随机对照试验的Meta分析  

Adjuvant interferon therapy for hepatocellular carcinoma after curative treatment: A meta-analysis of randomized controlled trials

作　　者：李长仔[1] 刘剑勇[1] 张志明[1] 

机构地区：[1]广西医科大学附属肿瘤医院肝胆外科,广西南宁530021

出　　处：《中华肿瘤防治杂志》2013年第13期1030-1035,共6页Chinese Journal of Cancer Prevention and Treatment

基　　金：广西科学研究与技术开发计划(桂科攻0719006-2-5);广西医疗卫生重点科研(重200611);广西科学基金(桂科自0728196)

摘　　要：目的:系统评价乙肝或丙肝相关性肝细胞癌(HCC)患者根治性治疗后辅助干扰素治疗对复发和生存期的疗效。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的相关文献,所有检索均截止至2012-04。由2名评价员筛选和提取资料,并用GRADE进行证据质量评估。对符合纳入标准的研究采用RevMan 5.1软件进行统计分析。收集公开发表的关于HCC根治性治疗后辅助干扰素组与单纯根治治疗组(对照组)比较的随机对照试验,主要结局指标是比较早期复发(2年复发)和1、3、5年总生存率,次要结局指标是不良反应事件。结果:共纳入8个随机对照试验,患者总数818例。Meta分析结果显示,丙肝相关性HCC根治性治疗后辅助干扰素组与对照组早期复发比较,差异有统计学意义,风险比(RR)为0.78,95%CI:0.62～0.99,P=0.04;然而乙肝相关性HCC组与对照组比较,差异无统计学意义,RR=0.83,95%CI:0.64～1.07,P=0.15。丙肝相关性HCC根治性治疗后辅助干扰素组与对照组1年总生存率比较,差异无统计学意义,RR=1.01,95%CI:0.95～1.07,P=0.86;3年总生存率比较,差异无统计学意义,RR=1.04,95%CI:0.92～1.16,P=0.57;5年总生存率比较,差异有统计学意义,RR=1.30,95%CI:1.01～1.67,P=0.04。乙肝相关性HCC根治性治疗后辅助干扰素组与对照组1年总生存率比较,差异无统计学意义,RR=1.09,95%CI:0.96～1.24,P=0.17;3年总生存率比较差异无统计学意义,RR=为1.16,95%CI:0.90～1.49,P=0.24;5年总生存率比较差异无统计学意义,RR=1.22,95%CI:0.99～1.49,P=0.06。结论:HCC根治性治疗后辅助干扰素治疗可以有效减少丙肝相关性HCC早期复发和提高5年总生存率,然而其对乙肝相关性HCC的作用目前尚缺乏有效证据。OBJECTIVE： To assess the effect of the IFN on recurrence and survival after curative treatment of the patients with chronic hepatitis C virus （HCV） or hepatitis B virus （HBV） related hepatocellular carcinoma （HCC）. METHODS： Medline,Embase, the Cochrane Library and CBM were systematically searched until April 2012. Two investi- gators screened and extracted data. GRADE was used for evaluation the quality of evidence and RevMan 5.1 for statistic analysis. Randomized controlled trials （RCTs） were searched comparing adjuvant IFN versus without IFN after curative treatment among HCC. Primary outcomes were early recurrence and 1-, 3-, 5-year overall survival （OS）, and second prima- ry outcome was adverse effects. RESULTS： A total of 818 patients from eight RCTs were included in this meta-analysis. Results showed that early recurrence had statistical significance in HCV related HCC after curative treatment between two groups, the risk ratio（RR） was 0.78 （95 % CI ： 0.62- 0.99, P = 0.04）, while there was no statistical significance in HBV related HCC （RR=0.83,95%CI：0.64--1.07,P=0.15）. The RR of 1-year OS in HCV related HCC after curative treat- ment between adjuvant IFN group and control group was 1.01 （95% CI： 0. 95 - 1.07, P = 0. 86） % 3-year （RR= 1.04, 95%CI：0.92--1.16,P=0.57） 5-year （RR=I. 30,95%CI： 1.01-1.67,P=0.04）, whereas 1-, 3-, 5-year OS showedwithout statistical significance in HBV related HCC between IFN group and control group （RR= 1.09,95%CI..0.96- 1.24,P=0.17;RR = 1.16,95%CI：0.90-1.49,P=0.24;RR= 1.22,95%CI：0.99--1.49,P=0.06 ;respectively）. CON- CLUSION： Adjuvant IFN therapy after curative treatment can reduce the early recurrence and improve the 5-year OS in HCV related HCC. However,there is no sufficient evidence in HBV related HCC.

关 键 词：癌 肝细胞 肝肿瘤 乙肝 丙肝 干扰素 随机对照试验 META分析 

分 类 号：R735.7[医药卫生—肿瘤]