同步放化疗联合尼妥珠单抗治疗食管癌疗效及安全性的Meta分析

目的:系统评价同步放化疗联合尼妥珠单抗治疗食管癌的疗效及安全性。方法:计算机检索PubMed、Cochrane Clinical Trial、Web of Science、重庆维普数据库、中国学术期刊全文数据库、中国生物医学文献数据库、万方数据库收录的相关研究，搜索年限从建库到2020年02月21日。研究对象为食管癌患者，实验组采用同步放化疗联合尼妥珠单抗，对照组采用同步放化疗。比较两组的疗效及安全性。使用Cochrane手册5.1.0版的质量评价标准对纳入研究进行质量评价,使用 RevMan5.3.0版软件进行数据分析。结果:最终纳入14项研究，共900例患者。Meta分析结果表明，与对照组比较,实验组有效率、疾病控制率、1年生存率、2年生存率及3年生存率均提高［OR=2.96,95%CI(2.07，4.22)］、［OR=3.06,95%CI(1.75,5.35)］、［OR=2.06,95%CI（1.35，3.14）］、［OR=1.81,95%CI（1.08，3.03）］、［OR=1.78,95%CI（1.00，3.17）］（P＜0.05），但两组的2年局控率无明显差别［OR=1.48,95%CI（0.74，2.96）］（P=0.27）。实验组与对照组在放射性食管炎发生率［OR=1.13,95%CI（0.79，1.60）］、放射性肺炎发生率［OR=1.15，95%CI（0.66，1.99）］、白细胞减少发生率［OR=1.04,95%CI（0.59，1.84）］、血小板减少发生率［OR=0.84,95%CI（0.43，1.65）］、消化道反应发生率［OR=0.82,95%CI（0.47，1.44）］等方面差异无统计学意义（P＞0.05）。结论:与同步放化疗相比，同步放化疗联合尼妥珠单抗治疗食管癌可提高疗效，且不增加不良反应。受纳入研究质量限制和可能存在的发表偏倚影响，上述结果尚需更高质量的随机对照研究来验证。

Effectiveness and safety of concurrent chemoradiotherapy combined with nimotuzumab for esophageal cancer:A Meta-analysis

Objective:To evaluate the effectiveness and safety of concurrent chemoradiotherapy combined with nimotuzumab for esophageal cancer.Methods:Electronic databases including the PubMed,Cochrane Clinical Trial,Web of Science,VIP,China National Knowledge Internet,Chinese Biomedical Literature Database and WanFang Database System were searched.Search term was from building to February 21,2020.The inclusion criteria included efficacy and safety studies of controlled clinical studies,in which concurrent chemoradiotherapy combined with nimotuzumab (experimental group) was compared with concurrent chemoradiotherapy (control group) for patients with esophageal cancer.Cochrane handbook 5.1.0 was applied in evaluating the quality of included trials and RevMan5.3.0 software was used for data analysis.Results:Fourteen studies including 900 cases of esophageal cancer were included.The Meta-analysis results showed that compared with control group,experimental group could increase response rate,disease control rate,1-year survival rate,2-year survival rate,3-year survival rate［OR=2.96,95%CI(2.07，4.22)］,［OR=3.06,95%CI(1.75,5.35)］,［OR=2.06,95%CI(1.35，3.14)］,［OR=1.81,95%CI(1.08，3.03)］,［OR=1.78,95%CI(1.00，3.17)］(P＜0.05)，but not the 2-year local control rate［OR=1.48,95%CI(0.74，2.96)］(P=0.27).There were no significant differences in rate of radiation esophagitis［OR=1.13,95%CI(0.79，1.60)］,rate of radiation pneumonitis［OR=1.15，95%CI(0.66，1.99)］,rate of leucopenia［OR=1.04,95%CI(0.59，1.84)］,rate of thrombocytopenia［OR=0.84,95%CI(0.43，1.65)］,rate of gastrointestinal reaction［OR=0.82,95%CI(0.47，1.44)］between experimental group and control group (P＞0.05).Conclusion:Compared with concurrent chemoradiotherapy,concurrent chemoradiotherapy combined with nimotuzumab may be more effective for esophageal cancer,whereas adverse reactions are similar.For the quality restriction and possible publication bias of the included studies,more high quality randomized controlled trials are required to further verify this conclusion.