【摘要】：目的 :評(píng)價(jià)氟維司群與芳香化酶抑制劑(aromatase inhibitor,AI)治療激素受體陽(yáng)性晚期乳腺癌的療效和安全性。方法:計(jì)算機(jī)檢索Pub Med、Cochrane Library、相關(guān)期刊論文和萬(wàn)方數(shù)據(jù)庫(kù),檢索時(shí)間從建庫(kù)起至2016年12月,收集氟維司群與AI治療激素受體陽(yáng)性晚期乳腺癌的臨床隨機(jī)對(duì)照試驗(yàn)。由2名研究人員各自按文獻(xiàn)選擇標(biāo)準(zhǔn)篩選文獻(xiàn),并提取數(shù)據(jù)。應(yīng)用Rev Man 5.3軟件進(jìn)行Meta分析。結(jié)果:共納入8項(xiàng)隨機(jī)對(duì)照試驗(yàn),共計(jì)3 776例患者。Meta分析結(jié)果顯示,氟維司群與AI治療激素受體陽(yáng)性晚期乳腺癌的疾病進(jìn)展時(shí)間(time to progression,TTP)(風(fēng)險(xiǎn)比為0.94,95%可信區(qū)間:0.87~1.00;P=0.07)、治療失敗時(shí)間(time to treatment failure,TTF)(風(fēng)險(xiǎn)比為0.97,95%可信區(qū)間:0.88~1.06;P=0.46)和客觀緩解率(objective response rate,ORR)(比值比為1.11,95%可信區(qū)間:0.92~1.34;P=0.28)以及因不良反應(yīng)而中斷治療(比值比為1.10,95%可信區(qū)間:0.70~1.73;P=0.68)、無(wú)力(比值比為0.83,95%可信區(qū)間:0.66~1.06;P=0.13)和惡心(比值比為1.11,95%可信區(qū)間:0.89~1.38;P=0.35)等不良反應(yīng)的差異均無(wú)統(tǒng)計(jì)學(xué)意義,但是氟維司群能夠提高臨床獲益(比值比為1.17,95%可信區(qū)間:1.02~1.33;P=0.02)。亞組分析中,氟維司群一線治療的TTP(風(fēng)險(xiǎn)比為0.75,95%可信區(qū)間:0.62~0.91;P=0.003)以及500 mg氟維司群高劑量治療的TTP(風(fēng)險(xiǎn)比為0.89,95%可信區(qū)間:0.80~0.99;P=0.03)均可使患者獲益。結(jié)論:氟維司群與AI治療激素受體陽(yáng)性晚期乳腺癌的TTP、TTF、ORR以及因不良反應(yīng)而中斷治療的發(fā)生率相似;但是氟維司群能夠顯著提高患者的臨床獲益。此外,氟維司群一線治療以及500 mg氟維司群高劑量治療均可使患者的預(yù)后得到改善。
[Abstract]:Objective: to evaluate the efficacy and safety of fluoride group and aromase inhibitor (aromatase inhibitor,AI) in the treatment of hormone receptor positive advanced breast cancer. Methods: the full-text database and Wanfang database of Pub Med,Cochrane Library, Chinese journals were searched by computer. From the establishment of the database to December 2016, the clinical randomized controlled trials of fluvidone group and AI in the treatment of advanced breast cancer with positive hormone receptor were collected. The literature was screened by two researchers according to the criteria of literature selection, and the data were extracted. Meta analysis was carried out with Rev Man 5.3 software. Results: a total of 3 776 patients were enrolled in 8 randomized controlled trials. Meta-analysis showed that the disease progression time of flunulide group and AI in the treatment of hormone receptor positive advanced breast cancer was (time to progression,. The risk ratio of TTP) (was 0.94, 95% confidence interval: 0.87 鈮，

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