奥沙利铂超说明书适应证联合卡培他滨治疗食管癌的Meta分析

田照; 袁丽君; 王文晟; 尹聪; 李占鹰; 刘强; 余远鹏; 涂星

doi:10.12019/j.issn.1671-5144.2019.04.010

奥沙利铂超说明书适应证联合卡培他滨治疗食管癌的Meta分析

Meta-Analysis of Oxaliplatin Out of Instructive Indication Combined with Capecitabine in Treatment of Esophageal Cancer

摘要

摘要: 目的探讨奥沙利铂联合卡培他滨治疗食管癌的临床疗效及安全性,为奥沙利铂超说明书适应证用于食管癌提供临床用药参考。方法通过计算机检索PubMed、Cochrane 图书馆、中国期刊全文数据库、中国科技期刊全文数据库和万方数字化期刊全文库自建库到2018年5月公开发表的关于奥沙利铂与卡培他滨联合用药治疗食管癌的研究,应用RevMan 5.3软件进行数据分析。研究人群为食管癌或胃食管交界处癌患者。干预措施: 治疗组以奥沙利铂、卡培他滨结合放疗,不含其他药物;对照组为其他药物、卡培他滨;可结合放疗等基础疗法,且两组一致;临床疗效结局指标为客观有效率、疾病控制率;安全性结局指标为白细胞减少率、血小板减少率及恶心呕吐发生率,并分别以优势比及其95%可信区间作为效应量对结局指标进行比较。结果共检索到符合纳入标准的文献11篇（n=999）进行Meta分析,纳入的文献偏倚风险较小。Meta分析结果显示: ①奥沙利铂联合卡培他滨结合放疗治疗食管癌的客观有效率（优势比=2.31,95%可信区间1.75~3.05,P<0.000 01）、疾病控制率（优势比=1.61,95%可信区间1.16~2.23,P=0.004）及生存率（优势比=2.64,95%可信区间1.86~3.75,P<0.000 01）明显优于与其他药物或卡培他滨结合放疗;②奥沙利铂联用卡培他滨结合放疗治疗食管癌的白细胞减少率（优势比=1.55,95%可信区间1.13~2.13,P<0.006）高于其他药物或卡培他滨结合放疗;血小板减少率与对照组相比无显著性差异;恶心呕吐发生率（优势比=2.07,95%可信区间1.47~2.90,P<0.000 1）高于其他药物或卡培他滨结合放疗。结论奥沙利铂联合卡培他滨结合放疗治疗食管癌的客观有效率、疾病控制率及生存率优于其他药物或卡培他滨结合放疗,临床可以优先考虑奥沙利铂联合卡培他滨结合放疗以提高疗效。

Abstract: Objective To perform a meta-analysis in the clinical efficacy and safety of the therapy protocols and provide a large data demonstration for esophageal cancer（EC）by Oxaliplatin out of instructions combined with Capecitabine. Methods Researching PubMed, the Cochrane library, CNKI, VIP and Wangfang data et al, domestic and overseas published documents about Oxaliplatin combined with Capecitabine in treatment of EC collected by us from building date library to May 2018 and RevMan 5.3 was applied to data analysis. The patients were who got EC or gastro-oesophageal junction cancer. Using Oxaliplatin and Capecitabine is experiment group without other medicines, other medicine or Capecitabine are contral group. The clinical efficacy index are disease control rate （DCR）, overall response rate （ORR） and survival rate. The safety index are occurrence of leukocytopenia, thrombocytopenia, nausea and vomiting. The OR and the 95% confidence interval （CI） was calculated to estimate outcome index from each group. Results Eleven literatures were analyzed in the meta-analysis and showed lower bias risk. ①DCR, ORR and survival rate in treatment of EC by Oxaliplatin combined with Capecitabine showed better than the control group（ORR: OR=2.31,95%CI 1.75~3.05,P<0.000 01; DCR: OR=1.61,95%CI 1.16~2.23,P=0.004; Survival rate: OR=2.64,95%CI 1.86~3.75,P<0.000 01）. ②The leukocytopenia in treatment of EC by Oxaliplatin combined with Capecitabine is higher than the control group（OR=1.55,95%CI 1.13~2.13,P<0.006）. The thrombocytopenia in treatment of EC by Oxaliplatin combined with Capecitabine showed no significant statistical differences. Occurrence of nausea and vomiting in treatment of EC by Oxaliplatin combined with Capecitabine showed clearly higher than the control group with other medicine or Capecitabine（OR=2.07,95%CI 1.47~2.90,P<0.000 1）. Conclusions DCR, ORR and survival rate in treatment of EC by Oxaliplatin combined with Capecitabine showed better than the control group with other medicine or Capecitabine. This programme could be consided as the priority in order to improve clinical efficacy.

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