【摘要】：目的采用Meta分析法系統(tǒng)評價含西地尼布方案治療晚期實體瘤的療效及安全性。方法檢索Pub Med、Cochrane Library、EMBase、ASCO Abstract、萬方、知網(wǎng)、維普等數(shù)據(jù)庫,收集有關(guān)含西地尼布方案治療晚期實體瘤的隨機對照試驗(RCT),按納入、排除標(biāo)準(zhǔn)進(jìn)行篩選、資料提取及方法學(xué)質(zhì)量評價,采用Revman 5.3軟件進(jìn)行Meta分析,結(jié)局指標(biāo)為無進(jìn)展生存期(PFS)、總生存期(OS)、客觀緩解率(ORR)及≥3級不良反應(yīng)。結(jié)果共納入9項RCT,包括6種實體瘤和2 345例患者。Meta分析結(jié)果顯示,與不含西地尼布方案組相比,含西地尼布方案組在PFS(HR=0.78,95%CI:0.71~0.85,P0.000 01)方面差異有顯著意義,效果更優(yōu);但在OS(HR=0.91,95%CI:0.81~1.02,P=0.12)及ORR(RR=1.21,95%CI:0.97~1.51,P=0.09)方面,兩組無顯著差異。在≥3級不良反應(yīng)方面,含西地尼布方案組增加了腹瀉(RR=4.06,95%CI:2.97~5.54,P0.000 01)、疲乏(RR=1.91,95%CI:1.49~2.54,P0.000 01)、高血壓(RR=3.55,95%CI:2.54~4.96,P0.00 001)、食欲不振(RR=4.05,95%CI:2.31~7.07,P0.000 01)、中性粒細(xì)胞減少(RR=1.31,95%CI:1.14~1.50,P=0.000 2)、白細(xì)胞減少(RR=1.63,95%CI:1.09~2.43,P=0.02)和血小板減少(RR=1.68,95%CI:1.31~2.14,P0.000 1)事件的發(fā)生率。外周感覺神經(jīng)障礙(RR=1.42,95%CI:0.91~2.23,P=0.12)、貧血(RR=1.13,95%CI:0.51~2.47,P=0.77)和惡心(RR=1.46,95%CI:0.56~3.77,P=0.44)事件的發(fā)生率無顯著差異。結(jié)論含西地尼布方案能夠延長晚期實體瘤患者的PFS,但對OS及ORR并無明顯改善,同時含西地尼布方案增加了不良反應(yīng)的發(fā)生。
[Abstract]:Objective to evaluate the efficacy and safety of cidenib regimen in the treatment of advanced solid tumors by Meta analysis. Methods the databases of Pub Med,Cochrane Library,EMBase,ASCO Abstract, Wanfang, Zhiwang and Wiper were searched, and (RCT), of randomized controlled trials containing cidenib regimen for the treatment of advanced solid tumors were collected and screened according to the inclusive and exclusion criteria. Data extraction and methodological quality evaluation were performed with Revman 5.3 software for Meta analysis. The outcome indexes were (OS), objective remission rate (ORR) and 鈮，

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