索拉菲尼联合TACE治疗晚期肝细胞肝癌的荟萃分析

发布时间：2018-12-29 16:27

【摘要】：背景靶向药物—索拉非尼联合经导管肝动脉化疗栓塞术(transcatheter arterial chemoembolization,TACE)治疗晚期或不可手术切除的肝细胞肝癌,临床多中心虽已对此治疗进行多项试验研究,但就这一治疗方案的安全性和远期疗效尚存有争议,且目前尚无统一的循证医学依据。目的评价索拉非尼联合经导管肝动脉化疗栓塞术治疗晚期肝细胞肝癌的临床有效性和安全性,为临床研究和实践提供直接而可靠的参考依据。方法电脑检索并收集索拉非尼联合经导管肝动脉化疗栓塞术治疗晚期HCC的临床研究文献。文献检索来源:EMbase、中国生物医学文献、PubMed、中国期刊全文、Cochrane Library、维普、万方等数据库。检索时间截止到2015年12月。运用meta分析方法研究评价指标包括客观反应率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、疾病进展时间(time to progression,TTP)以及总生存期(overall survival,OS)等。采用RevMan5.0和Stata12.0软件通过固定效应或随机效应模型对相对危险比(riskratio,rr)、风险比(hazardratio,hr)及其95%置信区间(confidenceinterval,ci)等数据进行统计学分析,并探讨研究该其异质和敏感性及发表偏倚。结果本研究所纳入的9篇研究文献,累计晚期hcc患者1122例,其中505例接受索拉非尼联合tace,单纯tace617例。经meta分析研究其结果显示,索拉非尼联合tace治疗显著改善和提高了晚期肝细胞肝癌orr(其固定效应模型:hr=1.55,95%ci:1.12-2.15,p定效应模型:hr=0.59,95%ci:0.46-0.73,p0.001)和ttp,降低疾病进展风险(固定效应模型:hr=0.56,95%ci:0.47-0.65,p0.001)。本研究显示:索拉非尼联合经导管动脉化疗栓塞术较单纯经导管肝动脉化疗栓塞术治疗组,其部分毒性反应发生率明显增高,统计学差异显著。(手足皮肤反应,rr=11.32,95%ci:7.85-16.32;高血压rr=4.36,95%ci:2.86-6.66;脱发,rr=3.15,95%ci:2.24-4.45;皮疹,rr=3.96,95%ci:2.72-5.78;腹泻,rr=5.78,95%ci:3.96-8.44;肝功能异常,rr=2.47,95%ci:1.69-3.62;疲劳,rr=2.6,95%ci:1.74-3.87)。结论索拉非尼联合经导管肝动脉化疗栓塞术治疗晚期肝细胞肝癌,患者客观反应率和疾病控制率以及总生存期、疾病进展时间得到有效提高和延长,进展风险显著降低。较常见不良反应,高血压和腹泻及手足皮肤综合征,患者耐受性较好且易控制。
[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.
【学位授予单位】：重庆医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R735.7

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