【摘要】：背景靶向藥物—索拉非尼聯(lián)合經(jīng)導(dǎo)管肝動脈化療栓塞術(shù)(transcatheter arterial chemoembolization,TACE)治療晚期或不可手術(shù)切除的肝細(xì)胞肝癌,臨床多中心雖已對此治療進(jìn)行多項試驗研究,但就這一治療方案的安全性和遠(yuǎn)期療效尚存有爭議,且目前尚無統(tǒng)一的循證醫(yī)學(xué)依據(jù)。目的評價索拉非尼聯(lián)合經(jīng)導(dǎo)管肝動脈化療栓塞術(shù)治療晚期肝細(xì)胞肝癌的臨床有效性和安全性,為臨床研究和實踐提供直接而可靠的參考依據(jù)。方法電腦檢索并收集索拉非尼聯(lián)合經(jīng)導(dǎo)管肝動脈化療栓塞術(shù)治療晚期HCC的臨床研究文獻(xiàn)。文獻(xiàn)檢索來源:EMbase、中國生物醫(yī)學(xué)文獻(xiàn)、PubMed、中國期刊全文、Cochrane Library、維普、萬方等數(shù)據(jù)庫。檢索時間截止到2015年12月。運用meta分析方法研究評價指標(biāo)包括客觀反應(yīng)率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、疾病進(jìn)展時間(time to progression,TTP)以及總生存期(overall survival,OS)等。采用RevMan5.0和Stata12.0軟件通過固定效應(yīng)或隨機(jī)效應(yīng)模型對相對危險比(riskratio,rr)、風(fēng)險比(hazardratio,hr)及其95%置信區(qū)間(confidenceinterval,ci)等數(shù)據(jù)進(jìn)行統(tǒng)計學(xué)分析,并探討研究該其異質(zhì)和敏感性及發(fā)表偏倚。結(jié)果本研究所納入的9篇研究文獻(xiàn),累計晚期hcc患者1122例,其中505例接受索拉非尼聯(lián)合tace,單純tace617例。經(jīng)meta分析研究其結(jié)果顯示,索拉非尼聯(lián)合tace治療顯著改善和提高了晚期肝細(xì)胞肝癌orr(其固定效應(yīng)模型:hr=1.55,95%ci:1.12-2.15,p定效應(yīng)模型:hr=0.59,95%ci:0.46-0.73,p0.001)和ttp,降低疾病進(jìn)展風(fēng)險(固定效應(yīng)模型:hr=0.56,95%ci:0.47-0.65,p0.001)。本研究顯示:索拉非尼聯(lián)合經(jīng)導(dǎo)管動脈化療栓塞術(shù)較單純經(jīng)導(dǎo)管肝動脈化療栓塞術(shù)治療組,其部分毒性反應(yīng)發(fā)生率明顯增高,統(tǒng)計學(xué)差異顯著。(手足皮膚反應(yīng),rr=11.32,95%ci:7.85-16.32;高血壓rr=4.36,95%ci:2.86-6.66;脫發(fā),rr=3.15,95%ci:2.24-4.45;皮疹,rr=3.96,95%ci:2.72-5.78;腹瀉,rr=5.78,95%ci:3.96-8.44;肝功能異常,rr=2.47,95%ci:1.69-3.62;疲勞,rr=2.6,95%ci:1.74-3.87)。結(jié)論索拉非尼聯(lián)合經(jīng)導(dǎo)管肝動脈化療栓塞術(shù)治療晚期肝細(xì)胞肝癌,患者客觀反應(yīng)率和疾病控制率以及總生存期、疾病進(jìn)展時間得到有效提高和延長,進(jìn)展風(fēng)險顯著降低。較常見不良反應(yīng),高血壓和腹瀉及手足皮膚綜合征,患者耐受性較好且易控制。
[Abstract]:Background targeted drug Solafenib combined with transcatheter hepatic arterial chemoembolization (transcatheter arterial chemoembolization,TACE) is used to treat advanced or unresectable hepatocellular carcinoma. However, the safety and long-term efficacy of this treatment are still controversial, and there is no unified evidence-based medicine basis. Objective to evaluate the efficacy and safety of salafenil combined with transcatheter hepatic arterial chemoembolization (TACE) in the treatment of advanced hepatocellular carcinoma (HCC). Methods the clinical literatures of salafenil combined with transcatheter hepatic arterial chemoembolization (TACE) in the treatment of advanced HCC were searched and collected by computer. Literature Retrieval sources: EMbase, Chinese Biomedical Literature, PubMed, Chinese Journal full text, Cochrane Library, Weip, Wanfang and other databases. The search time is up to December 2015. The objective response rate (objective response rate,ORR), disease control rate (disease control rate,DCR), disease progression time (time to progression,TTP) and total survival time (overall survival,OS) were studied by meta analysis. The data of relative risk ratio (riskratio,rr), risk ratio (hazardratio,hr) and 95% confidence interval (confidenceinterval,ci) were statistically analyzed by RevMan5.0 and Stata12.0 software through fixed or random effect models. The heterogeneity, sensitivity and publication bias were studied. Results 1122 patients with advanced hcc were included in 9 studies, of which 505 received Solafenib combined with tace, with simple tace617. The results of meta analysis showed that Solafenil combined with tace significantly improved and improved orr of advanced hepatocellular carcinoma (hr=1.55,95%ci:1.12-2.15,). P definite effect model: hr=0.59,95%ci:0.46-0.73,p0.001) and ttp, reduce disease progression risk (fixed effect model: hr=0.56,95%ci:0.47-0.65,p0.001). The results showed that the incidence of partial toxicity was significantly higher in Solafenil combined with transcatheter arterial chemoembolization than that in simple transcatheter hepatic artery chemoembolization group (P < 0.05). (skin reaction of hand and foot, rr=11.32,95%ci:7.85-16.32; hypertension, rr=4.36,95%ci:2.86-6.66; alopecia, rr=3.15,95%ci:2.24-4.45; rash, rr=3.96,95%ci:2.72-5.78; Diarrhea, rr=5.78,95%ci:3.96-8.44; liver dysfunction, rr=2.47,95%ci:1.69-3.62; fatigue, rr=2.6,95%ci:1.74-3.87). Conclusion Solafenil combined with transcatheter arterial chemoembolization for advanced hepatocellular carcinoma can effectively improve and prolong the objective response rate, disease control rate, total survival time and progression risk of advanced hepatocellular carcinoma. More common adverse reactions, hypertension and diarrhea, and hand-foot skin syndrome, patients with better tolerance and easy to control.
【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】：2016
【分類號】：R735.7

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