【摘要】：目的:化療與表皮生長因子受體酪氨酸激酶抑制劑(epidermal growth factor receptor-tyrosine kinase inhibitors,EGFR-TKIs)聯(lián)合療法一直是許多研究的焦點,其中間插聯(lián)合療法受到了更多研究者的關(guān)注。本研究旨在系統(tǒng)評價化療與EGFR-TKIs間插聯(lián)合療法對比單獨化療一線治療晚期非小細(xì)胞肺癌(non-small cell lung cancer,NSCLC)的有效性及安全性。方法:檢索The Cochrane Library、Pub Med、EMBASE、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(CBM)、知網(wǎng)和萬方等數(shù)據(jù)庫關(guān)于化療間插聯(lián)合EGFR-TKIs療法對比單獨化療一線治療晚期NSCLC的隨機(jī)對照試驗(randomized controlled trial,RCT),分析如下結(jié)局指標(biāo):無進(jìn)展生存期(progression free survival,PFS)、總體生存期(overall survival,OS)、客觀緩解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)以及不良反應(yīng)發(fā)生率。由兩名研究者根據(jù)Cochrane系統(tǒng)評價手冊篩選文獻(xiàn)、進(jìn)行質(zhì)量評價以及提取并交叉核對數(shù)據(jù)。應(yīng)用Stata12.0軟件進(jìn)行meta分析。結(jié)果:本研究共納入6個RCT,共計933例晚期NSCLC患者。Meta分析結(jié)果表明,在晚期NSCLC患者一線治療中,與單獨化療相比,間插聯(lián)合療法雖然延長了患者的PFS(HR=0.72,95%CI=0.53-0.98,P=0.037),但并不能提高其OS(HR=0.85,95%CI=0.72-1.01,P=0.060)、ORR(OR=1.59,95%CI=0.86-2.95,P=0.142)和DCR(OR=1.09,95%CI=0.95-1.25,P=0.226)。進(jìn)一步的亞組分析發(fā)現(xiàn),間插聯(lián)合療法顯著提高了女性、腺癌、從不吸煙和EGFR突變等患者的PFS,差異具有統(tǒng)計學(xué)意義。在安全性方面,間插聯(lián)合療法的主要不良反應(yīng)為皮疹(OR=7.81,95%CI=3.74-16.34,P=0.000)和腹瀉(OR=2.73,95%CI=1.92-3.89,P=0.000)。結(jié)論:一線接受化療間插聯(lián)合EGFR-TKIs治療的NSCLC患者的PFS明顯高于接受單獨化療者,其主要不良事件是皮疹和腹瀉。因此,間插聯(lián)合治療具有一定優(yōu)勢,但仍需要更多大樣本、高質(zhì)量的RCT進(jìn)一步驗證。
[Abstract]:Objective: chemotherapy combined with epidermal growth factor receptor tyrosine kinase inhibitor (epidermal growth factor receptor-tyrosine kinase inhibitors,EGFR-TKIs) has been the focus of many studies. The purpose of this study was to evaluate the efficacy and safety of chemotherapy and EGFR-TKIs interventional therapy in the treatment of advanced non-small cell lung cancer (non-small cell lung cancer,NSCLC). Methods: a randomized controlled trial (randomized controlled trial,RCT) of The Cochrane Library,Pub Med,EMBASE, Chinese biomedical literature database, (CBM), Zhiwang and Wanfang, on the comparison of chemotherapeutic interventional therapy with EGFR-TKIs therapy in late stage NSCLC was conducted. The results were analyzed as follows. Outcome measures: progression-free survival (progression free survival,PFS), total survival (overall survival,OS), objective remission rate (objective response rate,ORR), disease control rate (disease control rate,DCR) and adverse reactions. According to the Cochrane system evaluation manual, two researchers sifted the literature, evaluated the quality, extracted and cross-checked the data. Meta analysis was carried out with Stata12.0 software. Results: in this study, 933 patients with advanced NSCLC were included in 6 RCT, patients. The results of Meta analysis showed that in the first-line treatment of advanced NSCLC patients, the intercalation combined therapy could not improve the OS (HR=0.85,95%CI=0.72-1.01,P=0.060), ORR (OR=1.59,95%CI=0.86-2.95,P=0.142) and DCR (OR=1.09,95%CI=0.95-1.25,P=0.226), although it prolonged the PFS (HR=0.72,95%CI=0.53-0.98,P=0.037) of the patients compared with chemotherapy alone. Further subgroup analysis showed that interventional therapy significantly increased PFS, in women, adenocarcinoma, non-smoking and EGFR mutation. In terms of safety, the main adverse effects of interventional therapy were skin rash (OR=7.81,95%CI=3.74-16.34,P=0.000) and diarrhea (OR=2.73,95%CI=1.92-3.89,P=0.000). Conclusion: the PFS of NSCLC patients treated with interventional chemotherapy plus EGFR-TKIs was significantly higher than that of patients treated with chemotherapy alone. The main adverse events were rash and diarrhea. Therefore, interventional therapy has some advantages, but still needs more large samples, high quality RCT further verification.
【學(xué)位授予單位】：重慶醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R734.2

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