索拉菲尼联用肝动脉化疗栓塞治疗原发性肝癌的Meta分析  

Sorafinib Combined with Thanscatheter Artierial Chemoembolzation in the Treatment of Primary Hepatocellular Carcinoma：A Meta- analysis

作　　者：杨晟[1] 张海平[1] 林军[1] 

机构地区：[1]武汉大学中南医院消化内科,湖北武汉430071

出　　处：《医学新知》2016年第1期19-26,共8页New Medicine

摘　　要：目的评价肝动脉化疗栓塞（TACE）联合索拉非尼治疗原发性肝癌的疗效和安全性。方法计算机检索Cochrane图书馆、PubMed、EMBASE、中国生物医学文献数据库（CBM）、万方数据库、中文科技期刊全文数据库（CNKI）和中国期刊全文数据库（VIP）中创建以来至2015年3月关于TACE联合索拉非尼治疗原发性肝癌的文献资料，对纳入的文献进行资料提取和质量评价，采用Revman5．2软件进行统计分析。结果纳入14个研究，共1372例患者。Meta分析结果显示：索拉菲尼联合TACE为试验组与TACE做单一治疗的对照组比较，其客观有效率、临床受益率及6个月、12个月的生存率均有所提高，差异均有统计学意义（ORORR=2．47，95％CI1．72～3．54，P〈0．00001；ORCBR=3．07，95％CI2．18—4．31，P〈0．00001；OR6个月=4．38，95％CI1．83—10．48，P=0．0009；OR12全月3．34，95％CI2．22～5．03，P〈0．00001），用药前VEGF变化率无统计学意义（SMD：0．00，95％CI=0．37—0．37，P=1．00），用药后VEGF变化率及AFP变化率有统计学意义（SMD=1．23，95％CI-1．64～0．82，P〈0．00001；ORAFP=4．02，95％CI1．89～8．54，P=0．0003）。在不良反应方面，试验组与对照组相比，手足皮肤反应、腹泻、高血压、皮疹、疲劳的发生率差异有统计学意义（ORHFSR=57．33，95％CI33．30～98．69；OR腹泻=9．03，95％CI5．62～14．49；OR高血压=5．39，95％CI3．44～9．08；OR皮疹：5．58，95％CI3．58—8．70，P〈0．00001；OR疲劳=1．77，95％CI1．01～3．12，P=0．05）。结论索拉菲尼联合肝动脉化疗栓塞术治疗与单独肝动脉化疗栓塞术治疗比较，能显著提高肝癌患者的客观有效率、临床受益率及6个月、12个月的生存率。降低VEGF、AFP水平，但不良反应（手足皮肤反应、腹泻、高血压、皮疹、疲劳）的发生率较高。Objective To evaluate the effectiveness and safety of sorafinib combined with thanscatheter artierial chemoembolzation（TACE） in the treatment of primary hepatocellular carcinoma（PHC）. Methods Cochrane library, PubMed, EMBASE, CBM, Wanfang, CNKI and VIP were searched from establishment to Mar. 2015 to find literature about TACE combined with sorafenib in the treatment of primary hepatocellular carcinoma. Data were extracted and quality of included studies was assessed. RevMan5.2 software was used for statistic analysis. Results Fourteen studies were included with 1 372 PHC patients. The results showed that the objective response rate（ ORR）, clinical benefit rate（CBR）, 6 months and 12 months survival rate in experimental group were much better than those of TACE alone （ ORORR = 2.47, 95 % CI 1.72 - 3.54, P 〈 0. 00001 ; ORess = 3.07,95% CI 2.18 - 4.31, P 〈 0. 00001 ; OR6个月 = 4.38,95% CI 1.83 - 10.48,P = 0. 0009 ; OR12个月 = 3.34, 95 % CI 2.22 - 5.03, P 〈 0. 00001 ）. There was no significant difference in the rate of VEGF changes before treatment （ SMD = 0.00, 95% CI - 0.37 - 0.37, P = 1.00 ）. There was significant difference in the rate of VEGF and AFP changes after treatment（ SMD = - 1.23,95% CI - 1.64 - 0.82,P 〈 0.00091 ; ORArP = 4.02, 95% CI 1.89 - 8.54,P = 0. 0003 ）. There were significant differences on adverse reactions such as hand -foot skin reaction, diarrhea, hypertension, rash and fatigue between experimental group andcontrol group（ ORHFsR = 57.33, 95% CI 33.30 - 98.69 ; OR腹泻 = 9.03, 95% CI 5.62 - 14.49 ; OR高血压 = 5.39, 95%CI 3.44 -9.08; OR皮疹 =5.58,95%CI 3.58 -8.70,P 〈0.00001; OR疲劳 = 1.77, 95% CI 1.01 -3.12,P = 0.05 ）. Conclusion Sorafenib combined with TACE group has higher objective response rate, clinical benefit rate, 6 months and 12 months survival rate compared with TACE group. VEGF and AFP levels are lower with higher incidence of adverse reactions（ hand- foot skin reaction, diarrhea, hypertension, rash and fatigue） in sorafenib c

关 键 词：索拉菲尼 肝动脉化疗栓塞 原发性肝癌 META分析 

分 类 号：R735.7[医药卫生—肿瘤]