阿帕替尼联合TACE治疗原发性肝癌有效性和安全性meta分析  

Apatinib combined with TACE for primary liver cancer:a meta-analysis of its effectiveness and safety

作　　者：陈成 沈艳峰[1] 董云[1] 侯峰岩 段小婷 CHEN Cheng;SHEN Yanfeng;DONG Yun;HOU Fengyan;DUAN Xiaoting(Department of Oncology,Affiliated Hospital of Hebei University of Engineering,Handan,Hebei Province 056002,China)

机构地区：[1]河北工程大学附属医院肿瘤科,河北邯郸056002 [2]河北工程大学附属医院肾内科,河北邯郸056002 [3]山东盛迪医药有限公司

出　　处：《介入放射学杂志》2020年第3期251-259,共9页Journal of Interventional Radiology

摘　　要：目的评价阿帕替尼联合经导管动脉化疗栓塞术(TACE)治疗原发性肝癌(PLC)的有效性和安全性。方法计算机检索2015年1月1日至2019年5月1日PubMed、Cochrane library、NCKI、万方、维普(VIP)数据库中阿帕替尼联合TACE(实验组)和单纯TACE(对照组)治疗PLC的随机对照研究文献,并分别按照Cochrane系统评价手册中随机对照试验质量评价标准筛选文献,提取相关资料,采用RevMan 5.3软件对有效数据进行meta分析。结果共纳入11篇文献,均为实验组与对照组对比研究,其中随机对照文献6篇、回顾性分析文献3篇,未描述文献2篇;累积720例患者,实验组、对照组分别为363例、357例。与对照组相比,实验组客观缓解率(ORR)(OR=3.26,95%CI=2.22~4.79,P<0.001)和疾病控制率(DCR)(OR=3.72,95%CI:2.51~5.52,P<0.001)显著提高,尤其是3个月后;患者6个月(OR=2.89,95%CI=1.36~6.15,P=0.006)、12个月(OR=3.06,95%CI=1.69~5.53,P=0.002)生存率显著提高;血清中基质金属蛋白酶(MMP)(OR=-2.56,95%CI=-3.05^-2.06,P<0.001)、血管内皮细胞生长因子(VEGF)(OR=-3.59,95%CI=-6.0~1.14,P=0.004)及甲胎蛋白(AFP)(OR=-0.69,95%CI=-0.99^-0.40,P<0.001)表达水平降低。但在3个月内,两组间ORR(OR=1.37,95%CI:0.63~3.02,P=0.43)和DCR(OR=1.52,95%CI:0.49~4.68,P=0.47)差异均无统计学意义。与对照组相比,实验组栓塞后综合征(肝区疼痛、食欲下降、发热、恶心呕吐)无明显增加(P>0.05),但药物不良反应(手足综合征、高血压、蛋白尿、腹泻、皮疹)显著增加(P<0.05),无乏力、口腔黏膜炎、血细胞减少不良反应(P>0.05)。结论阿帕替尼联合TACE治疗PLC比单纯TACE更能提高远期临床疗效、延长生存时间,且未增加栓塞后综合征。但也应注意手足综合征、高血压、蛋白尿、皮疹等药物不良反应发生。Objective To systematically evaluate the effectiveness and safety of apatinib combined with transcatheter arterial chemoembolization(TACE)in the treatment of primary liver cancer(PLC).Methods Computer retrieval of PubMed,Cochrane Library,NCKI,Wanfang and VIP data bases between January 1 st,2015 and May 1 st 2019 was conducted to collect the randomized controlled trials(RCTs)concerning apatinib plus TACE(study group)versus simple TACE(control group)for the treatment of PLC The academic papers were respectively screened according to the Cochrane Manual Bias Assessment Form and the revised Jadad Score Scale.The related data were extracted and RevMan 5.3 software was used to make meta-analysis of the valid data.Results A total of 11 articles were included in this study.All of them are the literature of comparative study between the experimental group and the control group,including RCT(n=6),retrospective analytical literature(n=3),and non-descriptive article(n=2).A total of 720 patients were enrolled,including 363 patients in the study group and 357 patients in the control group.Compared with the control group,in the study group the objective remission rate(ORR)(OR=3.26,95%CI:2.22-4.79,P<0.001)and the disease control rate(DCR)(OR=3.72,95%CI:2.51-5.52,P<0.001)were significantly increased,especially at 3 months after treatment;the 6-month survival rate(OR=2.89,95%CI:1.36-6.15,P=0.006,P=0.006)and 12-month survival rate(OR=3.06,95%CI:1.69-5.53,P=0.002)were also remarkably improved.Meanwhile,the serum matrix metalloproteinase(MMP)(OR=-2.56,95%CI:-3.05 to 2.06,P<0.001),vascular endothelial cell growth factor(VEGF)(OR=-3.59,95%CI:-6.05 to-1.14,P=0.004)and AFP(OR=-0.69,95%CI:-0.99 to-0.40,P<0.001)were decreased.No statistically significant differences in ORR(OR=1.37,95%CI:0.63-3.02,P=0.43)and DCR(OR=1.52,95%CI:0.49-4.68,P=0.47)existed between the two groups within 3 months after treatment.Compared with the control group,in the study group the incidence of postembolization syndrome(pain at liver region,loss of appetite,fever,

关 键 词：阿帕替尼 原发性肝癌 经导管动脉化疗栓塞术 META分析 

分 类 号：R735.7[医药卫生—肿瘤]