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目的 :采用Meta分析评价西妥昔单抗联合化疗治疗晚期胃癌的有效性及安全性。方法 :计算机检索Pub Med、Cochrane Library、Embase、Web of Science、中国期刊全文数据库、维普中文科技期刊数据库、中国生物医学文献数据库和万方数据库等,收集国内外公开发表的有关西妥昔单抗联合化疗治疗晚期胃癌的相关研究。对纳入的研究进行方法学质量评价。采用Rev Man 5.3软件进行Meta分析。结果 :本研究共纳入4篇文献,包含1 152例患者。Meta分析结果显示,西妥昔单抗联合化疗组与单纯化疗组相比,完全缓解率[比值比(odds ratio,OR)为1.64,95%可信区间(confi dence interval,CI)为0.47~5.70,P=0.430]、部分缓解率(OR:1.14,95%CI:0.88~1.47,P=0.310)、有效率(OR:1.16,95%CI:0.90~1.50,P=0.240)以及1年生存率(OR:1.14,95%CI:0.41~3.16,P=0.810)的差异均无统计学意义;对种族进行亚组分析,提示在亚洲人群中,西妥昔单抗联合化疗组与单纯化疗组的完全缓解率、部分缓解率和有效率的差异均无统计学意义(P值均>0.05);基于基因型进行亚组分析,结果显示人表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)阳性与阴性以及K-ras基因突变型与野生型的完全缓解率、部分缓解率和有效率的差异均无统计学意义(P值均>0.05)。在3~4级不良反应方面,西妥昔单抗联合化疗组与单纯化疗组血小板减少发生率的差异无统计学意义(P=0.490),但中性粒细胞减少(OR:0.64,95%CI:0.49~0.83,P=0.001)、皮疹(OR:38.96,95%CI:5.30~286.45,P=0.000)、手足综合征(OR:3.25,95%CI:1.58~6.60,P=0.001)和腹泻(OR:1.81,95%CI:1.11~2.97,P=0.020)发生率的差异有统计学意义。结论 :西妥昔单抗联合化疗未能使晚期胃癌患者的生存获益,却增加不良反应的发生率。
OBJECTIVE: To evaluate the efficacy and safety of cetuximab plus chemotherapy in the treatment of advanced gastric cancer using Meta-analysis. METHODS: PubMed, Cochrane Library, Embase, Web of Science, Chinese Journal Full-text Database, VIP Chinese Sci-tech Periodical Database, Chinese Biomedical Literature Database and Wanfang Database were searched by computer. The data of cetuximab Study of combined chemotherapy in the treatment of advanced gastric cancer. Methodological quality evaluation of included studies. Meta-analysis was performed using Rev Man 5.3 software. RESULTS: Four articles were included in this study, including 152 patients. Meta-analysis showed that the complete response rate (odds ratio, OR) was 1.64 in the cetuximab plus chemotherapy group compared with the chemotherapy alone group, and the 95% confidence interval (confi dence interval, CI) was 0.47 ~ (OR: 1.16, 95% CI: 0.90-1.50, P = 0.240) and one year (OR = 1.14, 95% CI: 0.88-1.47, P = There was no significant difference in survival rate (OR: 1.14, 95% CI: 0.41-3.16, P = 0.810). Subgroup analysis of races suggested that among Asian populations, the combination of cetuximab and chemotherapy There was no significant difference in the complete remission rate, partial remission rate and effective rate in the chemotherapy group (all P> 0.05). Based on the genotypes, the subgroup analysis showed that the human epidermal growth factor receptor 2 (human epidermal growth factor There was no significant difference in the complete remission rate, partial remission rate and effective rate between the positive and negative of HER-2 and K-ras gene (P> 0.05). There was no significant difference in the incidence of thrombocytopenia between cetuximab plus chemotherapy group and chemotherapy alone group (P = 0.490), but neutropenia (OR: 0.64, 95% (OR: 3.25, 95% CI: 1.58-6.60, P = 0.001), skin rash (OR: 38.96,95% CI: 5.30-286.45, P = 0.000) And diarrhea (OR: 1.81, 95% CI: 1.11-2.97, P = 0.020), the difference was statistically significant. Conclusions: Cetuximab combined with chemotherapy failed to benefit the survival of patients with advanced gastric cancer, but increased the incidence of adverse reactions.