替吉奥联合顺铂与5-氟尿嘧啶联合顺铂治疗晚期胃癌对照研究的Meta分析

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。

Meta-analysis of S-1 plus cisplatin chemotherapy versus 5-fluorouracil plus cisplatin chemotherapy for advanced gastric cancer

OBJECTIVE: To investigate the efficacy and safety of S-1 plus cisplatin(SP) regimen versus 5-fluorouracil plus cisplatin(FP) regimen as a first-line regimen for patients with advanced gastric cancer.METHODS: We searched relevant randomized controlled trials(RCTs) from Pubmed,EMBASE,Cochrane Library,Abstracts presented at ASCO conferences,Chinese Journal Full-text Database,Chinese Biomedical Literature Database,Chinese Scientific Journals Full-text Database,and traced the related references to obtain the information that has not been found.We made quality assessment of qualified RCTs assessed by the exclusion and inclusion criteria and used RevMan 5.0 provided by the Cochrane Collaboration to perform Meta-analysis.RESULTS: Four RCTs involving 1 263 patients were identified.There were no statistical differences between SP and FP regimens in the response rate(OR=1.58,95%CI:0.76-3.29,P=0.22),while compared with FP regimen,SP regimen could decrease the the risk of the incidence of adverse reactions,especially the grade 3-4 thrombocytopenia(OR=0.58,95%CI:0.40-0.85,P=0.004) and nausea,vomiting(OR=0.70,95%CI:0.52-0.95,P=0.02).Three RCTs(Chinese populations) involving 234 patients were identified.Compared with FP regimen,SP regimen had a statistically significant benefit in increasing the response rate(OR=2.39,95%CI:1.30-4.38,P=0.005),while it could not decrease the risk of the incidence of adverse reactions.CONCLUSIONS: As the current evidence shows,SP regimen has similar efficacy to FP regimen for advanced gastric cancer patients,but it has fewer side effects of thrombocytopenia and nausea,vomiting.Compared with FP regimen,SP regimen(Chinese populations) can significantly improve the response rate and but the side effects were similar;due to less number of cases,the conclusion remains to be further evaluated.