术中植入缓释氟尿嘧啶治疗原发性肝癌疗效及安全性的系统评价

Effectiveness and Safety of Implanting Sustained-Release 5-Fluorouracil during Hepatectomy for Primary Liver Cancer:A Systematic Review

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 systematically review the effectiveness and safety of implanting sustained-release 5-fluorouracil during hepatectomy in patients with primary liver cancer（PLC）.Methods We electronically searched the following databases including CENTRAL,MEDLINE,EMbase,WanFang Data,CBM,CNKI and VIP to collect randomized controlled trials（RCTs） on the effectiveness and safety of implanting sustained-release 5-fluorouracil during hepatectomy vs.hepatectomy alone for PLC from inception to October,2012.Two reviewers independently screened literature according to the inclusion and exclusion criteria,extracted data and assessed the quality of the included studies.Then,meta-analysis was performed using RevMan 5.0 software.Results A total of 6 RCTs involving 951 patients were included.The results of meta-analysis showed that,implanting sustained-release 5-fluorouracil during hepatectomy significantly decreased the total recurrence rates of 1-year and 3-year（1 year：RR=0.48,95%CI 0.36 to 0.65,P0.000 01;3 years：RR=0.69,95%CI 0.50 to 0.96,P=0.03）.However,the two groups were alike in decreasing the surem levels of AFP.Besides,the commonly-seen adverse reaction of implanting sustained-release 5-fluorouracil during hepatectomy included abdominal pain and bile leakage.Conclusion Implanting sustained-release 5-fluorouracil during hepatectomy can decrease the 1-year and 3-year recurrence rates of PLC patients,especially for HCC at the early stage.But this conclusion should be interpreted with caution and needs more strictly-designed RCTs with large sample size and enough long follow-up to verify.