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阿帕替尼联合TACE术治疗中晚期肝癌有效性与安全性的Meta分析
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篇名: 阿帕替尼联合TACE术治疗中晚期肝癌有效性与安全性的Meta分析
TITLE: Efficacy and Safety of Apatinib Combined with TACE in the Treatment of Moderate and Advanced Liver Cancer : A Meta-analysis
摘要: 目的:系统评价阿帕替尼联合经动脉化疗栓塞术(TACE)治疗中晚期肝癌的有效性和安全性,旨为临床合理用药提供循证参考。方法:计算机检索Cochrane图书馆、Embase、PubMed、WebofScience、中国生物医学文献服务系统、中国知网、万方数据、维普网等数据库,收集阿帕替尼联合TACE术(试验组)对比TACE术(对照组)治疗中晚期肝癌的随机对照试验(RCT),检索时限均为建库起至2019年9月。筛选文献、提取资料并采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具和改良Jadad量表评价纳入文献的质量后,采用Stata12.0App进行Meta分析。结果:共纳入16项RCT,合计1043例患者。Meta分析结果显示,试验组患者客观有效率[OR=3.10,95%CI(2.38,4.03),P<0.001]、疾病控制率[OR=3.56,95%CI(2.62,4.83),P<0.001]、生存率[OR=2.40,95%CI(1.86,3.10),P<0.001]以及腹泻[OR=2.27,95%CI(1.21,4.24),P=0.011]、血压升高[OR=6.97,95%CI(1.21,40.15),P=0.030]、蛋白尿[OR=12.44,95%CI(2.51,61.71),P=0.002]、手足综合征[OR=32.50,95%CI(12.03,87.77),P=0.001]发生率均显著高于对照组,而治疗后血清血管内皮细胞生长因子[SMD=-3.64,95%CI(-5.06,-2.22),P<0.001]、基质金属蛋白酶9[SMD=-3.21,95%CI(-4.31,-2.10),P<0.001]、甲胎蛋白[SMD=-3.54,95%CI(-7.03,-0.06),P=0.046]水平以及骨髓抑制[OR=0.61,95%CI(0.39,0.97),P=0.035]、发热[OR=0.63,95%CI(0.42,0.95),P=0.027]、恶心呕吐[OR=0.70,95%CI(0.51,0.97),P=0.030]发生率均显著低于对照组;两组患者腹痛[OR=0.87,95%CI(0.54,1.39),P=0.547]、皮肤瘙痒[OR=1.63,95%CI(0.36,7.50),P=0.530]发生率比较,差异均无统计学意义。结论:阿帕替尼联合TACE术能显著提高中晚期肝癌患者的临床疗效、延长生存时间、减少肿瘤复发及转移,并降低骨髓抑制等TACE术后相关不良反应的发生,但会增加腹泻等阿帕替尼相关不良反应的发生。
ABSTRACT: OBJECTIVE:To systematically evaluate the efficacy an d s afety of apatinib combined with transcatheter arterial chemoembolization(TACE)in the treatment of moderate and advanced liver cancer ,and to provide evidence-based reference for rational drug use in the clinic. METHODS :Retrieved from Cochrane Library ,Embase,PubMed,Web of Science ,SinoMed, CNKI,Wanfang,VIP database ,RCTs about apatinib combined with TACE (trial group )versus TACE (control group )in the treatment of moderate and advanced liver cancer were collected from inception to Sep. 2019. After screening the literature and extracting the data ,the quality of included literatures was evaluated by using bias risk assessment tool recommended by the Cochrane system evaluator manual 5.1.0 and the modified Jadad scale. Meta-analysis was carried out by using Stata 12.0 software. RESULTS:Totally 16 RCTs were included ,involving 1 043 patients. Results of Meta-analysis showed that objective response rate [OR =3.10,95%CI(2.38,4.03),P<0.001],disease control rate [OR =3.56,95%CI(2.62,4.83),P<0.001] and survival rate [OR =2.40,95% CI(1.86,3.10),P<0.001],the incidence of diarrhea [OR =2.27,95% CI(1.21,4.24),P=0.011], hypertension [OR =6.97,95% CI(1.21,40.15),P=0.030], proteinuria [OR =12.44,95%CI(2.51,61.71),P=0.002] and com hand foot syndrome [OR =32.50,95%CI(12.03,87.77),P= 0.001] of trial group were significantly higher than those of control group. The serum level of VEGF [SMD =- 3.64, 95%CI(-5.06,-2.22),P<0.001],MMP-9 [SMD=-3.21,95%CI(-4.31,-2.10),P<0.001],AFP [SMD =-3.54, 95%CI(-7.03,-0.06),P=0.046] after treatment ,the incidence of myelosuppression [OR =0.61,95%CI(0.39,0.97),P= 0.035],fever [OR =0.63,95%CI(0.42,0.95),P=0.027],nausea and vomiting [OR =0.70,95%CI(0.51,0.97),P=0.030] in trial group were significantly lower than those of control group. There was no statistical significance in the incidence of abdominal pain [OR =0.87,95%CI(0.54,1.39),P=0.547] and skin itching [OR =1.63,95%CI(0.36,7.50),P=0.530] between 2 groups. CONCLUSIONS:Apatinib combined with TACE can significantly improve clinical efficacy ,prolong survival time ,reduce tumor recurrence and metastasis. It can reduce the occurrence of related ADR as diarrhea after TACE ,but increase the occurrence of apatinib-related ADR as myelosuppression.
期刊: 2020年第31卷第12期
编辑: 唐贵菊,田塬,王继婷,苏松,李亚玲
AUTHORS: TANG Guiju,TIAN Yuan,WANG Jiting,SU Song,LI Yaling
关键字: 阿帕替尼;经动脉化疗栓塞术;中晚期肝癌;有效性;安全性;Meta分析
KEYWORDS: Apatinib;Transcatheter arterial chemoembolization ;Moderate and advanced hepatocellular carcinoma ;Efficacy;
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