替比夫定初治慢性乙型肝炎患者疗效与安全性观察  

Efficacy and safety of initial telbivudine treatment in chronic hepatitis B patients

作　　者：谢榕[1] 江建宁[1] 苏明华[1] 刘志红[1] 钟少华[1] 何丽霞[1] 梁延秀[1] 胡家光[1] 黄小红[1] 郭稳稳[1] 符武岛[1] 祝美琴[1] 王保健[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：《临床肝胆病杂志》2012年第6期422-424,427,共4页Journal of Clinical Hepatology

基　　金：广西自然科学基金(2010GXNSFD013046;桂科自0832117;桂科自0542092;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)患者初次使用替比夫定的疗效及安全性。方法 73例CHB患者(HBeAg阳性50例,阴性23例),接受替比夫定治疗至少1年,于治疗基线、病毒学应答前每个月、病毒学应答后每3个月检测HBV DNA、ALT、HBV血清标志物,观察治疗期间累计病毒学应答率、血清学转换率和耐药率;分析12、24周HBeAg下降幅度对预测血清学转换的价值;根据患者的情况不定期检测肌酸激酶(CK)。结果 (1)HBeAg阳性、阴性累计病毒学应答率1年分别为96%、100%,2年分别为96%、100%,其中90%HBeAg阳性、95%阴性患者在24周获得病毒学应答;(2)HBeAg阳性者1、2年累计血清学转换率分别为48%、61%;(3)HBeAg阳性、阴性累计耐药率1年分别为2%、4%,2年分别为24%、11%;(4)12、24周HBeAg下降幅度预测血清学转换的cut-off值分别为0.2557、0.3844log PEIU/ml,12周HBeAg下降幅度≥0.2557log PEIU/ml、24周≥0.3844log PEIU/ml的患者较低于该值者2年累计血清学转换率高,χ2值分别为28.996、15.036,P均=0.000(log-rank);(5)186人次查CK,78.8%数值超过参考范围(>140 IU/L),其中95.6%升高值在2级内,3级以上仅占4.4%。CK升高者无明显肌痛、肌炎,3～6个月内能自行下降至正常,无因CK升高而停药者。结论替比夫定对初治HBeAg阳性、阴性CHB患者疗效佳、安全性好。12、24周HBeAg下降幅度可作为2年血清学转换预测指标。Objective To analyze the efficacy and safety of initial telbivudine treatment in chronic hepatitis B（CHB） patients.Methods Seventy-three consecutive CHB patients treated with initial telbivudine treatment for at least one year were enrolled in the study between September 2007 and February 2012.Measurements were made of alanine aminotransferase（ALT）,hepatitis B virus（HBV） DNA,and HBV serological markers at baseline,then every month before virological response（HBV DNA〈1.0×103 copies/ml） was reached,and every three months after virological response.The cumulative rate of virological response,hepatitis B e antigen（HBeAg） conversion,and resistance were calculated.The value of the HBeAg（PEIU/ml） descending amplitude（log） for predicting HBeAg conversion at 12 and 24 weeks was evaluated.Creatine kinase（CK） levels were measured at intervals according to the patient condition.Results Of the 73 CHB cases,50 were HBeAg-positive and 23 were HBeAg-negative.The cumulative rate of virological response within one year of treatment was 96% in the HBeAg-positive group and 100% in the HBeAg-negative group,and the rate within two years of treatment was 96% in the HBeAg-positive group and 100% in the HBeAg-negative group.Among the patients achieving virological response,90% in the HBeAg-positive group and 95% in the HBeAg-negative group occurred within 24 weeks.The cumulative rates of HBeAg conversion within one and two years of treatment were 48% and 61%,respectively.The cumulative rates of resistance for the HBeAg-positive group and the HBeAg-negative group were 2% and 4%,respectively,in one year,and 24% and 11%,respectively,in two years.The cutoff values of HBeAg descending amplitude at 12 and 24 weeks for predicting HBeAg conversion were 0.2557 and 0.3844.The cumulative rate of HBeAg conversion in the cases with HBeAg descending amplitude ≥0.2557 log PEIU/ml at 12 weeks and ≥0.3884 log PEIU/ml at 24 weeks were significantly higher than those from the two years group（χ2=28.996 and 15.036,bo

关 键 词：肝炎 乙型 慢性 抗病毒药 替比夫定 治疗 

分 类 号：R512.62[医药卫生—内科学]