摘要
目的:评价托瑞米芬(TOR)与他莫昔芬(TAM)治疗进展期乳腺癌的有效性和安全性.方法:计算机检索PubMed,CBMdisc,Cochrane Library,中国生物医学文献数据库,中国期刊全文数据库,中文科技期刊全文数据库等,并辅以手工检索和其他检索.按纳入标准全面搜集有关TOR对比TAM治疗进展期乳腺癌的随机对照试验,检索截至2008-06.按照Cochrane系统评价手册4.2.6质量评价标准,由2位研究者独立对纳入研究进行方法学质量评价,并进行资料提取,采用RevMan4.2.10软件进行Meta分析,计数资料采用相对危险度(RR)为疗效分析统计量;计量资料采用加权均数差(WMD).结果:纳入10个随机对照试验(3680例患者).Meta分析结果显示:TOR组与TAM组相比,1,3a总生存率差异无统计学意义,5a总生存率差异有统计学意义,其RR和95%可信区间(CI)分别为1.00(0.97,1.03),1.04(0.98,1.09),1.06(1.01,1.12);1,3a无病生存率差异无统计学意义,5a无病生存率差异有统计学意义,其RR(95%CI)分别为1.00(0.98,1.02),1.05(1.00,1.10),1.08(1.02,1.15);完全缓解率、部分缓解率及客观缓解率差异均无统计学意义,其RR(95%CI)分别为1.41(0.90,2.22),0.91(0.71,1.17),0.97(0.82,1.14).TOR组不良事件发生率低于TAM组,生存质量与TAM组相似.结论:TOR在提高进展期乳腺癌患者的远期生存率和安全性方面均优于TAM.
AIM: To evaluate the clinical effectiveness and safety of toremifene ( TOR ) versus tamoxifen ( TAM ) for patients with advanced breast cancer. METHODS: This study retrieved relevant randomized controlled trials in PubMed, EMBASE, Cochrane Library, Chinese Biomedical Literature Database, Chinese Scientific Journal Full-text Database, and Chinese Journal Full-text Database up to June 2008. According to the handbook 4.2.6 of Cochrane collaborate, two reviewers assessed the quality of included trials and extracted data independently. The RevMan 4.2.10 software was used for Meta-analysis, relative risk (RR) was used as statistical index for numeration data and weighted mean difference (WMD) was used for measurement data. RESULTS : Ten studies were included(3680 patients). Meta-analysis showed no statistical difference between the 2 groups in 1 and 3-year overall survival rate, but statistical difference was observed in 5-year overall survival rate. The pooled RR and 95% CI were respectively 1.00 (0.97, 1.03), 1.04(0.98, 1.09) and 1.06(1.01, 1.12). No statistical difference was found between the 2 groups in 1 and 3-year disease-free survival rate but statistical difference was observed in 5-year disease-free survival rate. The pooled RR and 95% CI were respectively 1.00(0.98, 1.02), 1.05( 1.00, 1.10), and 1.08 ( 1.02, 1.15). No statistical difference was found between the 2 groups in complete response, partial response and objective response. The pooled RR and 95% CI were respectively 1.41 (0.90, 2.22), 0.91(0.71, 1.17) and 0.97(0.82, 1.14). Adverse reactions in TOR group were lower than those in TAM group, and the quality of life was similar in the 2 groups. CONCLUSION: The results suggest that TOR has better effectiveness and safety than TAM in improving the long-term survival rate for patients with advanced breast cancer.
出处
《第四军医大学学报》
北大核心
2009年第11期1026-1029,共4页
Journal of the Fourth Military Medical University