目的 观察抗病毒治疗对乙肝病毒(hepatitis B virus,HBV)DNA阴性的乙肝相关肝细胞癌(hepatitis B virus related hepatocellular carcinoma,HBVR-HCC)行TACE术后HBV再激活的预防及预后影响。方法 选取2012-05-01至2014-05-01在武警上海总队医院行肝动脉化疗栓塞术(transarterial chemoembolization,TACE)HBVR-HCC患者60例(血清HBV DNA<500 U/ml),随机分为治疗组(TACE前行抗病毒治疗)30例和对照组(仅行TACE治疗,HBV再激活后行抗病毒治疗)30例。比较两组患者治疗前后血清HBV DNA、肝功能、凝血功能、甲胎蛋白(α-fetoprotein,AFP)及Child-pugh评分变化情况及生存状况。结果 两组患者基线特征差异无统计学意义,治疗组中未出现患者血清HBV DNA转为阳性,对照组中有6例患者血清HBV DNA转为阳性,两组比较差异有统计学意义(χ2=6.486,P=0.011);术后随访期间,肝功能指标与Child-pugh评分在治疗组与对照组之间差异无统计学意义;术后24周及48周,凝血酶原时间(prothrombin time,PT)与AFP在治疗组与对照组之间差异无统计学意义;术后72周及96周,治疗组明显低于对照组,两组比较差异有统计学意义(P<0.05)。治疗组和对照组客观缓解率(objective response rate, ORR)分别为56.7%和50.0%,两组比较差异无统计学意义(χ2=0.268,P=0.605);治疗组和对照组患者疾病控制率(disease control rate,DCR)分别为86.7%和83.3%,两组比较差异无统计学意义(χ2=0.131,P=0.718)。治疗组与对照组1年生存率分别为76.7%和70.0%,两组比较差异无统计学意义(χ2=0.341,P=0.559);2年生存率分别为70.0%和43.3%,两组比较差异有统计学意义(χ2=4.344,P=0.037)。治疗组与对照组中位生存期(median overall survival,mOS)分别为26.1[95%可信区间(confidence interval,CI):23.9~28.1]个月与22.7(95%CI:6.2~39.6)个月,两组比较差异有统计学意义(χ2=4.857,P=0.021);中位疾病无进展生存期(median progression-free survival,mPFS)分别为16.4(95%CI:14.8~17.6)个月与15.1(95%CI:4.6~26.0)个月,两组比较差异有统计学意义(χ2=4.561,P=0.027)。结论 血清HBV DNA阴性的HBVR-HCC患者TACE术前行抗病毒治疗可以防止乙肝病毒再激活,延长患者生存时间,改善预后。
Abstract
Objective To study plan to observe the effect of antiviral therapy on hepatitis B virus (HBV) DNA negative HBV related hepatocellular carcinoma(HBVR-HCC), prevention of HBV reactivation and prognosis after transarterial chemoembolisation.Methods Sixty patients with HBVR-HCC (serum HBV DNA<500 IU/ml) were recruited during the period of 2012-05-01~2014-05-01 from Shanghai Corps Hospital of Chinese Pepole’s Armed Police Force, randomly assigned into study group (n=30, antiviral before TACE) and control group (n=30, TACE alone, antiviral unless HBV reactivation). The serum HBV DNA, liver function, coagulation function, α-fetoprotein (APF), and Child-Pugh score of the two groups before and after treatment were analyzed, and survival status between the two groups were compared.Results The characteristics of the two groups had no statistically significant differentce in the baseline. No HBV reactivation was found in the study group, while six were found in control group, there was statistically significant difference between the two group(χ2=6.486,P=0.011).During the follow-up for two years, the liver function and Child-Pugh score had no statistical significant difference between the two groups. Prothrombin time (PT) and AFP had no statistically significant difference between the two groups at 24 and 48 weeks after TACE(P>0.05), while in the study group were significantly lower than in the control group at 72 and 96 weeks(P<0.05). The Objective response rate (ORR) and disease control rate (DCR) had no statistically significant difference between the study group and the control group, there were 56.7% vs 50.0% (χ2=0.268,P=0.605) and 86.7% vs 83.3% (χ2=0.131,P=0.718), respectively. The survival rate of in the study group and the control group had no statistically significant difference at 1 year after TACE (76.7% vs 70.0%, χ2=0.341,P=0.559), while had statistically significant difference at 2 years (70.0% vs 43.3%,χ2=4.344, P=0.037). The median overall survival (mos) and median progression-free survival (mpfs) in the study group and the control group had statistically significant difference, there were 26.1 (95%CI: 23.9-28.1 ) months vs 22.7 (95%CI: 6.2-39.6) months (χ2=4.857,P=0.021) and 16.4 (95%CI:14.8-17.6) months vs 15.1 (95%CI:4.6-26.0)months (χ2=4.651,P=0.027), respectively.Conclusions Antiviral therapy of HBV DNA negative HBVR-HCC before TACE can prevent HBV reactivation, prolong survival and improve prognosis.
关键词
乙型肝炎 /
再激活 /
肝细胞癌 /
抗病毒 /
动脉化疗栓塞
Key words
hepatitis B /
reactivation /
hepatocellular carcinoma /
antiviral /
transarterial chemoembolization
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