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目的系统评价尼妥珠单抗治疗食管癌的有效性和安全性。方法检索Medline、EMbase、Cochrane Library、Clinical Trials、中国生物医学文献数据库、中国期刊全文数据库、维普和万方数据库,收集尼妥珠单抗治疗食管癌的临床试验,试验组予以尼妥珠单抗联合常规放化疗/化疗方案治疗,对照组予以常规放化疗/化疗方案治疗。用Rev Man 5.3对有效率、控制率、生存率和药物不良反应发生率等主要指标进行Meta分析。结果共纳入10项研究,共计535例患者。试验组和对照组的有效率分别为79.84%和65.96%;1年生存率分别为83.76%和67.13%;3年生存率分别为30.00%和14.29%;1年无进展生存率分别为85.26%和69.47%,差异均有统计学意义(均P<0.05)。试验组和对照组的控制率分别为90.71%和79.88%;血液学毒性发生率分别为52.17%和50.95%;胃肠道反应发生率分别为31.90%和38.79%;放射性食管炎发生率分别为41.15%和36.17%;放射性肺炎发生率分别为15.82%和19.02%,差异均无统计学意义(均P>0.05)。结论尼妥珠单抗对提高食管癌患者有效率并延长生存期有优势,且未增加药物不良反应的发生,可推荐联合放化疗/放疗用于食管癌患者治疗。
Objective To evaluate the efficacy and safety of nimotuzumab in the treatment of esophageal cancer. Methods The clinical trials of nimotuzumab in the treatment of esophageal cancer were collected from Medline, EMbase, Cochrane Library, Clinical Trials, China Biomedical Literature Database, Chinese Journal Full-text Database, VIP and Wanfang Database. The patients in the trial group received nimotuzumab Combined conventional radiotherapy and chemotherapy / chemotherapy regimen, the control group to conventional radiotherapy / chemotherapy regimen. Rev Man 5.3 was used to conduct meta-analysis of the main indicators such as the efficiency, control rate, survival rate and adverse drug reaction rate. Results A total of 10 studies were included for a total of 535 patients. The effective rates of the experimental group and the control group were 79.84% and 65.96% respectively; the 1-year survival rates were 83.76% and 67.13% respectively; the 3-year survival rates were 30.00% and 14.29% respectively; the 1-year progression-free survival rates were 85.26% And 69.47%, respectively (all P <0.05). The control rates of the experimental group and the control group were 90.71% and 79.88% respectively; the hematological toxicities were 52.17% and 50.95% respectively; the incidence of gastrointestinal reactions were 31.90% and 38.79% respectively; the incidences of esophagitis were 41.15% and 36.17% respectively. The incidence of radiation pneumonitis was 15.82% and 19.02% respectively, with no significant difference (all P> 0.05). Conclusion Nimotuzumab has the advantage of improving the efficiency and prolonging the survival of patients with esophageal cancer, and does not increase the incidence of adverse drug reactions. Chemotherapy / radiotherapy may be recommended for esophageal cancer patients.