索拉非尼治疗晚期肝细胞癌的系统评价

Sorafenib for Advanced Hepatocellular Carcinoma:A Systematic Review

目的系统评价索拉非尼治疗晚期肝细胞癌的疗效与安全性。方法计算机检索PubMed（1966~2009年）、Cochrane Library（2009年第4期）、Embase（1990~2009年）、中国期刊全文数据库（1994~2009年）、中国生物医学文献数据库（1978~2009年）、中文科技期刊数据库（1989~2009年）、中华医学会数字化期刊库（1997~2009年）,同时手检相关期刊和会议论文集,纳入有关索拉非尼治疗晚期肝细胞癌的随机对照试验,按Cochrane系统评价方法提取资料、评价文献质量并进行统计学分析,数据采用RevMan 5.0软件进行分析。结果最终纳入2个随机对照试验,共828例患者。与安慰剂相比,索拉非尼可显著延长患者总生存期、影像学至疾病进展时间,并提高疾病控制率。索拉非尼的不良反应以1~2级的全身性、胃肠道及皮肤病变为主,各级不良反应的发生率均高于安慰剂组,以腹泻、手足皮肤反应最为常见。结论索拉非尼治疗晚期肝细胞癌有效而安全。

Objective To evaluate the effectiveness and toxicity of sorafenib for advanced hepatocellular carcinoma.Methods According to the Cochrane handbook for systematic review,two reviewers independently completed the whole process of literature search,study selection,data collection,and quality assessment.Seven electric databases（PubMed,Cochrane Library,Embase,Chinese Journal Full-text Database,Chinese Biomedical Literature Database,Chinese Scientific and Technical Journal Database,Chinese Medical Association Digital Periodicals Database） were searched and randomized controlled trials（RCT） of sorafenib in the treatment of advanced hepatocellular carcinoma were collected and analyzed.Results Two RCT involving 828 patients were finally included.Compared with placebo,sorafenib significantly extended the overall survival and time to radiologic progression and improved the disease control rate.The main adverse effects were systemic,gastrointestinal,and dermatologic symptoms（grade 1 or 2 in severity）,although the incidences were significantly higher in sorafenib groups than in control groups.Conclusion Sorafenib is effective and safe for the treatment of advanced hepatocellular carcinoma.