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目的:比较替吉奥联合顺铂方案(SP方案)和5-氟尿嘧啶联合顺铂方案(FP方案)一线治疗晚期胃癌的疗效及安全性。方法:计算机检索Pubmed、EMBASE、Cochrane Library、ASCO会议摘要、中国期刊全文数据库、中国生物医学文献数据库、中文科技期刊全文数据库等,同时追查纳入文献的参考文献,纳入SP方案对比FP方案治疗晚期胃癌的随机对照试验(RCT)。根据Cochrane Handbook 5.0的质量评价标准,用RevMan 5.0软件进行统计学分析。结果:纳入4项RCT,1 263例患者,Meta分析结果显示,采用SP方案与FP方案治疗后疗效相当(OR=1.58,95%CI:0.76～3.29,P=0.22),但可以降低3/4级血小板减少(OR=0.58,95%CI:0.40～0.85,P=0.004)及恶心呕吐(OR=0.70,95%CI:0.52～0.95,P=0.02)发生率;亚组分析(中国人群),纳入3项RCT,234例患者,Meta分析结果显示,与FP方案相比,SP方案可提高患者有效率(OR=2.39,95%CI:1.30～4.38,P=0.005),但不能降低不良反应发生率,差异均无统计学意义。结论:SP方案与FP方案在有效率方面疗效相当,但可以增加安全性,不良反应发生率与FP方案类似,但由于研究例数较少,该结论尚待进一步扩大样本量进行评估。
Objective: To compare the efficacy and safety of first-line treatment of advanced gastric cancer with combination of cisplatin (SP) and 5-fluorouracil combined with cisplatin (FP). METHODS: Pubmed, EMBASE, Cochrane Library, Abstract of ASCO Conference, Chinese Journal Full-text Database, Chinese Biomedical Literature Database, Chinese Science and Technology Journal Full-text Database were searched. References included in the literature were also included in this study. SP regimen was compared with FP regimen in the treatment of advanced gastric cancer Randomized controlled trial (RCT). Statistical analysis was performed using RevMan 5.0 software according to the Cochrane Handbook 5.0 quality evaluation criteria. Results: A total of 1 263 RCTs were enrolled in 4 RCTs. The results of Meta analysis showed that the efficacy of SP and FP regimens was comparable (OR = 1.58, 95% CI: 0.76 to 3.29, P = 0.22) Grade 4 thrombocytopenia (OR = 0.58, 95% CI: 0.40-0.85, P = 0.004) and nausea and vomiting (OR = 0.70,95% CI: 0.52-0.95, P = 0.02) ) Were enrolled in 3 RCTs and 234 patients. Meta-analysis showed that the SP regimen improved the patient response rate (OR = 2.39, 95% CI: 1.30-4.38, P = 0.005) The incidence of adverse reactions, the difference was not statistically significant. Conclusion: The efficacy of SP regimen and FP regimen is comparable to that of FP regimen, but it can increase the safety. The incidence of adverse reactions is similar to that of FP regimen. However, due to the small number of cases, this conclusion needs to be further expanded.