摘要
目的观察恩替卡韦联合肝动脉化疗栓塞（transarterial chemoembolization,TACE）治疗乙型肝炎相关原发性肝癌患者的疗效。方法选取2011-05-02-2013-05-28山东省肿瘤医院乙型肝炎相关原发性肝癌患者145例,采用随机数字表法分为对照组（仅行TACE治疗）69例和观察组（TACE联合恩替卡韦抗病毒治疗）76例。随访监测治疗后4、12、24及48周肝功能、HBV DNA水平、HBeAg阴转率及转换率。疗效判断采用修正后的实体瘤治疗疗效评价标准（mRECIST）,观察患者TACE治疗后的无进展时间（progression-free survival,PFS）和总生存期（overall survival,OS）。结果两组患者ALT水平随治疗时间延长明显改善,观察组患者ALT水平在治疗24周后较对照组明显降低,P〈0.05。观察组患者HBV DNA不可测率在治疗后第4、12、24和48周分别为27.3%、36.4%、45.5%和72.7%。对照组患者HBV DNA水平无明显变化。第48周时,观察组患者HBeAg阴转率为42.9%,HBeAg转换率为14.3%;对照组患者均未出现HBeAg阴转或转换。随访至2013-11,观察组41例（53.95%）患者生存,35例（46.05%）患者死亡;对照组19例（27.53%）患者生存,50例（72.46%）患者死亡。观察组客观缓解率（objective response rate,ORR）为46.05%,对照组ORR为26.08%,两组比较差异有统计学的意义,χ2=6.216,P=0.013;观察组疾病控制率（disease control rate,DCR）为86.84%,对照组DCR为60.86%,两组比较差异有统计学意义,χ2=12.836,P=0.001。中位OS观察组为18.5个月（95%CI：15.5-21.5）,对照组为12.3个月（95%CI：9.8-14.9）,两者比较差异有统计学意义,χ2=6.857,P=0.009;中位PFS观察组为8.4个月（95%CI：6.9-9.9）,对照组为5.9个月（95%CI：4.9-6.8）,两者比较差异也有统计学意义,χ2=8.570,P=0.003。结论乙型肝炎相关的原发性肝癌患者TACE治疗后,接受恩替卡韦治疗能有效提高近期疗效,延长患者生存期,减轻TACE后肝损害,改善患者预后。
OBJECTIVE：To study the therapeutic efficacy of Entecavir with TACE for patients with hepatitis B virus related unresectable hepatocellular carcinoma.METHODS From May 2011 to May 20l3,145 patients with intermediate or advanced HCC were randomly assigned into control group（n=69,TACE alone）or treatment group（n=76,TACE＋Entecavir）.The liver function,HBV DNA level,HBeAg seroconversion rate and conversion rate were determined in a11 the patients and compared between the 2groups respectively in 4th,12 th,24th and 48 th weeks.To assess the treatment effect based on mRECIST,the time for progression-free survival（PFS）,overall survival（OS）time and adverse events were recorded.RESULTS The ALT levels of the two groups patients were improved significantly during the follow-up,and in 24 weeks the ALT levels were significantly decreased in treatment group than that in control group（P〈0.05）.The 4,12,24,48 weeks of HBV DNA undetectable rate after treatment were 27.3%,36.4%,45.5% and72.7%respectively in the treatment group,while the HBV DNA levels had no significant change in the control group.After 48 weeks the HBeAg seroconversion rate in the observation group was 42.9%,and the HBeAg conversion rate was14.3%;while the patients of control group had no HBeAg seroconversion or conversion.Till November 2013,41patients（53.95%）survived and 35patients（include patients lost to visit）died（46.05%）among the treatment group,19 patients survived（27.53%）and 50patients（include patients lost to visit）died（72.46%）among the control group.The disease control rate（DCR）and ORR（objective response rate）had statistical significance in the two groups（P〈0.05）.The median overall survival time（mOS）of treatment group and control group were 18.5（95%CI：15.5-21.5）months and 12.3（95%CI：9.8-14.9）months respectively,and the difference had statistical significance（2χ=6.857,P=0.009）.The median progression-free survival（mPFS）of treatment group and control group were 8.4（95%CI：
出处
《中华肿瘤防治杂志》
CAS
北大核心
2014年第20期1617-1622,共6页
Chinese Journal of Cancer Prevention and Treatment
关键词
肝肿瘤
恩替卡韦
复发
动脉化疗栓塞
liver neoplasms
Entecavir
recurrence
transarterial chemoembolization
