阿帕替尼联合替吉奥治疗进展期胃癌有效性和安全性的系统评价  

Systematic evaluation of the efficacy and safety of apatinib combined with tegafur for advanced gastric cancer

作　　者：王凯[1,2] 张学琴[1,2] 刘秀菊 王好雨[1] 杨珍珍 王淑梅 WANG Kai;ZHANG Xue-qin;LIU Xiu-ju;WANG Hao-yu;YANG Zhen-zhen;WANG Shu-mei(Department of Pharmacy,The Second Hospital of Hebei Medical University,Shijiazhuang 050000;Hebei Medical University,Shijiazhuang 050000)

机构地区：[1]河北医科大学第二医院药学部,石家庄050000 [2]河北医科大学,石家庄050000

出　　处：《中南药学》2021年第9期1969-1975,共7页Central South Pharmacy

基　　金：2019年度河北省医学科学研究课题计划(No.20190499)。

摘　　要：目的系统评价阿帕替尼联合替吉奥对比替吉奥单药治疗二线及二线以上进展期胃癌的有效性和安全性,以期为临床合理用药提供依据。方法系统检索Embase、Cochrane Library、PubMed/Medline、中国知网、万方数据库、维普中文科技期刊全文数据库,收集阿帕替尼联合替吉奥(试验组)和替吉奥(对照组)治疗晚期胃癌的随机对照试验(RCT),筛选文献、提取数据并采用Cochrane系统评价员手册5.1.0提供的偏倚风险评估工具对纳入研究的质量进行评价,采用RevMan 5.3软件进行meta分析。结果共纳入15项RCT,合计1121例患者。Meta分析结果显示,与对照组比较,试验组总体缓解率和疾病控制率显著高于对照组,差异有统计学意义[OR=0.33,95%CI(0.25,0.44),P<0.00001;OR=0.37,95%CI(0.28,0.50),P<0.00001]。安全性方面,试验组手足综合征、高血压和蛋白尿的发生率显著高于对照组[OR=2.11,95%CI(1.09,4.08),P=0.03;OR=0.13,95%CI(0.06,0.28),P<0.00001;OR=0.26,95%CI(0.13,0.51),P<0.00001],两组恶心呕吐、腹泻、乏力和血小板减少等其他不良反应发生率的差异均无统计学意义(P>0.05)。结论替吉奥联合阿帕替尼提高了晚期胃癌患者的总体缓解率和疾病控制率,但要警惕手足综合征、高血压和蛋白尿等不良反应的发生。Objective To systematically evaluate the efficacy and safety of apatinib combined with tegafur(S-1)for advanced gastric cancer in the second line and beyond to provide evidence for the rational use of drugs in clinical practice.Methods Embase,the Cochrane Library,PubMed/Medline,China National Knowledge Infrastructure(CNKI),Wanfang Database and VIP Database were searched.Randomized controlled trias(RCT)on apatinib combined with S-1(the experimental group)and S-1(the control group)for advanced gastric cancer were collected.The data and the quality of the included RCTs were evaluated with the bias risk assessment tool provided by the Cochrane system evaluator manual 5.1.0.The meta analysis was carried out with RevMan 5.3 software.Results Totally 1121 patients were included in 15 RCTs.Meta-analysis showed that the objective remission rate and disease control rate in the experimental group were significantly higher than those in the control group[OR=0.33,95%CI(0.25,0.44),P<0.00001;OR=0.37,95%CI(0.28,0.50),P<0.00001].In terms of safety,hand-foot syndrome the incidence of hypertension and albuminuria in the experimental group were significantly higher than those in the control group[OR=2.11,95%CI(1.09,4.08),P=0.03;OR=0.13,95%CI(0.06,0.28),P<0.00001;OR=0.26,95%CI(0.13,0.51),P<0.00001].There was no significant difference in the incidence of other adverse reactions such as nausea and vomiting,diarrhea,fatigue and thrombocytopenia between the two groups.Conclusion Apatinib combined with S-1 can improve the objective remission rate and effective control rate of patients with advanced gastric cancer,but precaution is needed against the occurrence of adverse reactions such as hand-foot syndrome,hypertension and albuminuria,and other adverse reactions.

关 键 词：胃癌 阿帕替尼 替吉奥(S-1) 疗效 安全性 系统评价 

分 类 号：R735.2[医药卫生—肿瘤]