摘要
目的 系统评价阿帕替尼联合SOX方案(替吉奥+奥沙利铂)治疗晚期胃癌的有效性和安全性.方法 检索PubMed、Embase、Cochranelibrary、ClinicalTrials.gov、万方、中国知网,查找研究阿帕替尼联合SOX方案治疗晚期胃癌患者的有效性与安全性的随机对照试验.对纳入的文献进行数据提取,主要结局指标为客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR);次要结局指标为部分缓解率(partial response rate,PRR)、安全性相关指标(高血压、蛋白尿、手足综合征、腹泻、口腔黏膜炎、疲劳、白细胞减少症、血小板减少症等不良反应的发生人数).应用R 4.0.3进行统计分析,应用RevMan 5.3进行质量评价图的制作.结果 共检索到1 699篇文献,最终纳入28项研究,包含2 110例患者.相较于SOX方案,阿帕替尼联合SOX方案能够提高患者DCR(OR=3.90,95%CI:3.15～4.83,P<0.001)、ORR(OR=2.73,95%CI:2.26～3.31,P<0.001)、PRR(OR=2.33,95%CI:1.94～2.81,P<0.001),差异有统计学意义.该治疗方案的药品不良反应:高血压(OR=2.47,95%CI:1.26～4.83,P=0.008)、蛋白尿(OR=2.16,95%CI:1.46～3.21,P<0.001)、手足综合征(OR=2.19,95%CI:1.44～3.32,P<0.001)的发生率增加,差异有统计学意义.结论 本荟萃分析结果表明,阿帕替尼联合SOX方案治疗晚期胃癌有效性显著,不良反应相对轻微,有望在临床上得到应用.
Abstract
Objective:A Meta-analysis was conducted to systematically analyze the efficacy and safety of apatinib combined with SOX regime(oxaliplatin+tegafur)in patients with advanced gastric cancer.Methods:PubMed,Embase,Cochrane Library,ClinicalTrials.gov,WANFANG DATA and CNKI were searched for randomized controlled trials studying the efficacy and safety of apatinib combined with SOX in the treatment of advanced gastric cancer patients.Data were extracted from the included literature,and the main outcome indicators were as follows:objective response rate(ORR),disease control rate(DCR);secondary outcome indicators:partial response rate(PRR)and safety related indicators,including hypertension,proteinuria,hand-foot syndrome,diarrhea,oral mucositis,fatigue,leukopenia,thrombocytopenia.All statistical analyses were performed using meta package for R version 4.0.3.Results:1699 articles were retrieved and 28 articles with a total of 2110 subjects were ultimately included.Compared with SOX regimen,apatinib combined with SOX regimen improved DCR(OR=3.90,95%CI:3.15-4.83,P<0.001)and ORR(OR=2.73,95%CI:2.26-3.31,P<0.001),PRR(OR=2.33,95%CI:1.94-2.81,P<0.001),but increased hypertension(OR=2.47,95%CI:1.26-4.83,P=0.008),proteinuria(OR=2.16,95%CI:1.46-3.21,P<0.001),hand-foot syndrome(OR=2.19,95%CI:1.44-3.32,P<0.001).The difference was statistically significant.Conclusion:The results of this meta-analysis showed that apatinib combined with SOX regime was effective in the treatment of advanced gastric cancer with relatively mild adverse events,which is expected to be applied in clinical practice.
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