Hepasphere载药微球栓塞治疗中晚期肝细胞肝癌的安全性及疗效分析

The safety and efficacy of Hepasphere microspheres in the treatment of advanced hepatocellular carcinoma

目的:采用Hepasphere载药微球栓塞(DEB-TACE)治疗中晚期肝细胞癌(HCC),观察该疗法的安全性及疗效。方法:评估接受DEB-TACE治疗HCC患者术前术后肝功能,血清AFP水平变化以及术后不良反应、短期疗效和生存期。结果:从2014年7月到2017年10月纳入研究HCC患者24人(男21人,女3人),中位年龄为57(24～82)岁,肿瘤平均最长径为(9.3±4.0)cm。根据BCLC分期,包括B期5人,C期19人。合计接受DEB-TACE治疗31人次,成功率100%。DEB-TACE术前、后ALB、ALT、AST、T.BIL和AFP无统计学意义(P>0.5)。DEB-TACE术后30天内未见肝梗死等严重并发症,不良反应包括发热6例(19.4%)、恶心1例(3.2%),肝区疼痛4例(12.9%)。随访时间范围从3.9～40.0个月,平均随访13.2个月。根据改良RECST标准,治疗后1、3、6个月获得的疾病缓解率为58.3%、45.8%和40.9%,疾病控制率为91.7%、83.3%和86.4%。1、2年的存活率为87.5%和58.3%。截止到研究终点,中位生存期为25.6个月。结论:DEB-TACE对治疗中晚期HCC安全好,短期疗效稳定。

Objective：To explore the efficacy and safety of drug-eluting bead（ DEB） embolization（ DEB-TACE） in the treatment of advanced hepatocellular carcinoma（ HCC）.Methods：The liver function,AFP,adverse reactions,tumor response and overall survival in patients with HCC undergoing DEB-TACE treatment were assessed.Results：There were 24 HCC patients（ 21 males and 3 females） were enrolled into this study from July 2014 to October2017,with a median age of 57（ 24 ～ 82） years and a mean lesion size of（ 9.3 ± 4.0） cm.According to the BCLC staging,5 patients were in stage B and 19 patients were in stage C.The operative success rates were 100% with a total treatment of 31 times.Preoperative and postoperative ALB,ALT,AST,T.BIL and AFP were not statistically significant（ P〈0.5）.There were no serious complications such as hepatic infarction within 30 days after DEB-TACE,and adverse reactions included fever in 6 cases（ 19.4%）,nausea in 1 case（ 3.2%）,and pain in the liver area in 4 cases（ 12.9%）.The follow-up period ranged from 3.9 to 40.0 months,with an average follow-up time of 13.2 months.According to the mRECST standard,1,3,and 6 months after treatment,the tumor remission rate was 58.3%,45.8%and 40.9% and the tumor control rates were 91.7%,83.3% and 86.4%.The 1,and 2 year survival percentages were 87.5% and 58.3%,respectively.The median overall survival was 25.6 months when the study was censored.Conclusion：DEB-TACE with Hepasphere beads is safe for treatment of advanced HCC,and the short-term effect is stable.