恩替卡韦初治慢性乙型肝炎患者临床疗效和复发研究  

Initial treatment of chronic hepatitis B with entecavir:efficacy and relapse

作　　者：钟少华[1] 江建宁[1] 苏明华[1] 刘志红[1] 谢榕[1] 何丽霞[1] 符武岛[1] 李仕华[1] 王保健[1] 吴晓莉[1] 梁延秀[1] 郭稳稳[1] 陈喆[1] 

机构地区：[1]广西医科大学第一附属医院,广西南宁530021

出　　处：《中国病毒病杂志》2013年第1期46-50,共5页Chinese Journal of Viral Diseases

基　　金：广西自然科学基金(2010GXNSFD013046;桂科自0832117;桂科青0832037);广西医学科学实验中心开放基金(KFJJ2010-20)

摘　　要：目的分析HBeAg阳性、阴性慢性乙型肝炎(CHB)患者初次使用恩替卡韦(ETV)的3年疗效和停药复发情况。方法 79例CHB患者(HBeAg阳性37例、阴性42例),接受ETV治疗0.5mg/d,定期随访监测HBV DNA、HBeAg和抗-HBe、丙氨酸氨基转移酶(ALT),观察其病毒学应答率、血清学转换率、病毒学突破率和复发率;分析基线ALT、6个月时HBeAg下降幅度与HBeAg血清学转换的关系。结果 79例CHB患者6个月累计病毒学应答率为98.73%(78/79),1年为100.00%。HBeAg阳性者1、2、3年累计HBeAg血清学转换率分别为27.03%(10/37)、38.71%(12/31)、52.00%(13/25)。基线ALT≥5×正常值上限(ULN)的患者3年发生HBeAg血清学转换率高于基线ALT<5×ULN的患者(85.71%vs 38.89%,χ2=4.427,P=0.035);6个月时HBeAg水平较基线下降幅度≥75%的患者3年发生HBeAg血清学转换率高于下降幅度<75%的患者(83.33%vs 23.08%,χ2=9.077,P=0.003)。79例患者在治疗过程均未出现病毒学突破。达我国《慢性乙型肝炎防治指南(2010年版)》(简称《指南(2010年版)》)停药标准停药患者复发率为42.86%(6/14),未达标患者停药复发率为85.71%(6/7),10例复发患者ETV再治,均在1个月内获得病毒学应答,再治期间未出现病毒学突破。结论 ETV对初治CHB患者有强效且低耐药的抗病毒作用;基线ALT水平、6个月时HBeAg下降幅度可作为3年HBeAg血清学转换预测指标;我国《指南(2010年版)》治疗终点标准仅仅是基本的停药标准,部分病人达标后仍有复发风险。Objective To analyze the efficacy and relapse of initial treatment of entecavir for chronic hepatitis B（CHB）patients.Methods CHB patients initially treated with entecavir for more than one year were enrolled in the study.HBV DNA,HBV serological markers and alanine aminotransferase（ALT）were measured regularly.The rate of viral response,HBV e antigen（HBeAg）conversion,rates of viral breakthrough and relapse were calculated.Baseline ALT level and the serum HBeAg titer at 6 months were used to predict the 3-year HBeAg conversion.Results The accumulated viral response at 6-month and 12-month following entecavir treatment were 98.73%（78/79）and 100.00%,respectively.The accumulated HBeAg conversion at 1-,2-and 3-year of treatment were 27.03%（10/37）,38.71%（12/31）and 52.00%（13/25）,respectively.The HBeAg seroconversion rate at 3-year treatment in patients with baseline ALT≥5×ULN（upper limit of normal） was higher than that with ALT5×ULN（85.71% vs 38.89%,χ2 =4.427,P=0.035）.The accumulated HBeAg seroconversion rate at 3 years of treatment in patients whose serum HBeAg titer dropped ≥75% at 6-month time point was higher than that in those of serum HBeAg titer decreased75%（83.33% vs 23.08%,χ2=9.077,P=0.003）.No viral breakthrough was found during the whole process of treatment of all patients.The viral relapse rate was 42.86%（6/14）in patients who stopped using entecavir after meeting the endpoint criteria of 2010 China CHB guideline;the relapse rate was 85.71%（6/7）in those who did not meet the guideline criteria.Viral response occurred within one month after stopping entecavir and no viral breakthrough in the relapsed patients was found.Conclusions Entecavir could inhibit HBV replication quickly and potently with low relapse rate when used as the initial treatment for CHB.ALT level at baseline and the serum HBeAg titer at 6-month time point following entecavir treatment can predict the HBeAg seroconversion for the 3-year treatment.The endpoint criteria of the 2010 China CHB g

关 键 词：肝炎 乙型 慢性 恩替卡韦 初治 复发 

分 类 号：R512.62[医药卫生—内科学]