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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 systematically evaluate the efficacy of adjuvant interferon therapy in relapse and survival of patients with hepatitis B or C-associated hepatocellular carcinoma (HCC) after radical treatment. METHODS: The relevant literature in Medline, Embase, Cochrane Library and China Biomedical Literature Database was searched by computer. All searches were completed by 2012-04. Data was screened and extracted by two reviewers and evidence of quality was evaluated using GRADE. RevMan 5.1 software was used for statistical analysis of eligible studies. Collected published randomized controlled trials comparing post-HCC adjuvant therapy with those in the radical-only treatment group (control group). The primary outcome measures were early recurrence (2-year relapse) and 1, 3, 5-year overall survival Rates, secondary outcome measures are adverse events. Results: A total of 8 randomized controlled trials were included, with a total of 818 patients. The results of Meta analysis showed that there was significant difference in the early relapse between the adjuvant interferon group and the control group after radical treatment of HCC, the risk ratio (RR) was 0.78, 95% CI 0.62-0.99, P = 0.04; However, there was no significant difference between hepatitis B-related HCC group and control group (RR = 0.83, 95% CI: 0.64-1.07, P = 0.15). There was no significant difference in the 1-year overall survival rate between the adjuvant interferon group and the control group (RR = 1.01, 95% CI: 0.95-1.07, P = 0.86); 3-year overall survival rate , The difference was not statistically significant, RR = 1.04, 95% CI: 0.92-1.16, P = 0.57; 5-year overall survival rate, the difference was statistically significant, RR = 1.30,95% CI: 1.01-1.67, P = 0.04. There was no significant difference in the 1-year overall survival rate between the adjuvant interferon group and the control group after radical treatment of hepatitis B-related HCC (RR = 1.09, 95% CI: 0.96-1.24, P = 0.17); 3-year overall survival rate There was no significant difference between the two groups (RR = 1.16, 95% CI: 0.90-1.49, P = 0.24). There was no significant difference in 5-year overall survival rate (RR = 1.22, 95% CI: 0.99-1.49, P = 0.06) . Conclusions: Adjuvant interferon therapy after HCC can effectively reduce the early relapse and increase the 5-year overall survival rate of hepatitis C-related HCC. However, there is no valid evidence for its effect on hepatitis B-related HCC.