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目的系统评价术中植入缓释氟尿嘧啶治疗原发性肝癌的疗效及安全性。方法计算机检索CENTRAL、MEDLINE、EMbase、WanFang Data、CBM、CNKI和VIP,收集国内外公开发表的关于术中植入缓释氟尿嘧啶与单纯手术治疗肝癌的随机对照试验(RCT),检索时限均为从建库至2012年10月。由2位评价者按照纳入与排除标准独立筛选文献、提取资料和评价质量后,采用RevMan 5.0软件进行统计分析。结果最终纳入6个研究,共951例患者。Meta分析结果显示:术中植入缓释氟尿嘧啶的1年和3年总复发率明显低于单纯手术治疗[1年:RR=0.48,95%CI(0.36,0.65),P<0.000 01;3年:RR=0.69,95%CI(0.50,0.96),P=0.03],但在降低术后血清甲胎蛋白(AFP)水平方面,两者无明显差异。此外,术中植入缓释氟尿嘧啶常见不良反应为腹痛、胆瘘等症状。结论对于原发性肝癌患者,尤其是早期肝细胞性肝癌患者,术中植入缓释氟尿嘧啶优于单纯手术治疗,可明显降低1年和3年总复发率。受纳入研究质量和数量限制,对上述结论的解释应保持谨慎,尚需更多设计严格、随访时间足够长的大样本RCT加以验证。
Objective To evaluate the efficacy and safety of intraoperative implantation of sustained-release fluorouracil in the treatment of primary liver cancer. Methods The randomized controlled trials (RCTs) published at home and abroad about intraoperative implantation of sustained-release fluorouracil and surgical treatment of hepatocellular carcinoma were collected from CENTRAL, MEDLINE, EMbase, WanFang Data, CBM, CNKI and VIP. The retrieval time was from Construction of the library until October 2012. Two reviewers independently screened the literature according to inclusion and exclusion criteria, extracted data and evaluated the quality, and then used RevMan 5.0 software for statistical analysis. The results eventually included 6 studies, a total of 951 patients. The results of Meta analysis showed that the total recurrence rates of intraoperative implantation of sustained-release fluorouracil at 1-year and 3-year were significantly lower than those treated by simple operation [1 year: RR = 0.48,95% CI (0.36,0.65), P <0.0001; 3 Year: RR = 0.69, 95% CI (0.50, 0.96), P = 0.03]. However, there was no significant difference between the two groups in reducing postoperative serum AFP levels. In addition, intraoperative implantation of sustained-release fluorouracil common adverse reactions of abdominal pain, biliary fistula and other symptoms. Conclusion In patients with primary liver cancer, especially in patients with early-stage hepatocellular carcinoma, intraoperative implantation of sustained-release fluorouracil is superior to surgery alone in reducing the overall recurrence rates of 1 year and 3 years. Due to the quality and quantity limitations of the study, care should be taken to interpret the above conclusion and more RCTs need to be validated for a more well-designed, long-term follow-up.