替诺福韦酯治疗慢性乙型肝炎初治和核苷类似物经治耐药患者48周的疗效分析

Efficacy of 48-weeks of tenofovir disoproxil fumarate on initial treatment and nucleoside analogues-experienced resistant CHB patients

目的 探讨替诺福韦酯（TDF）治疗慢性乙型肝炎（CHB）初治和其他核苷类似物（NAs）经治耐药患者48周的疗效.方法 回顾性分析2014年7月至2015年6月CHB初治患者（30例）和NAs经治患者（36例）的临床资料.所有患者均使用替诺福韦酯治疗,方法为300 mg,1次/d,疗程为48周.所有患者均在服药前和治疗后第4、12、24、36、48周检测生物化学、病毒学指标.采用独立样本t检验比较各组基线水平的差异,采用生存分析Kaplan-Meier方法和log-rank检验比较各组在病毒性应答（VR）率、HBeAg阴转率、ALT复常率等方面的差异.结果 TDF治疗48周后,初治组达到病毒学应答率、ALT复常率和HBeAg阴转率分别为83.3%、73.3%、30.0%;拉米夫定/替比夫定耐药组、恩替卡韦耐药组的病毒学应答率、ALT复常率、HBeAg阴转率结果与初治患者相比差异未见统计学意义;相比之下,阿德福韦酯耐药组与初治组相比病毒性应答率在4周、12周、24周、36周、48周均明显降低,但差异未见统计学意义;阿德福韦酯耐药组ALT复常率和HBeAg阴转率与初治组相比差异未见统计学意义.结论 TDF对于初治和核苷类似物经治耐药的CHB患者均具有显著抗病毒作用.

Objective To evaluate the efficacy of 48-weeks of tenofovir disoproxil fumarate （TDF） therapy on initial treatment and nucleoside analoguese（NAs）-experienced resistant chronic hepatitis B （CHB） patients.Methods The data of 66 CHB patients included 30 cases of initial treatment and resistant 36 cases with NAs-experienced CHB patients were collected from July 2014 to June 2015.All the patients received TDF 300 mg/d for 48 weeks.Biochemical and virological indexes at baseline,week 4,week 12,week 24,week 36 and week 48 during treatment were collected for evaluation.The differences of the baseline characteristic between initial treatment group and NA-experienced group were evaluated by independent t test;The cumulative incidences of virological response （VR）, HBeAg loss and serum alanine aminotransferase （ALT） normalization rate were determined using the Kaplan-Meier method with the log-rank test.Results Among the initial treatment patients, the cumulative incidences of VR, HBeAg loss and ALT normalization at weeks 48 were 83.3%, 73.3%, 30.0% respectively.The cumulative incidences of VR, HBeAg loss and ALT normalization in initial treatment patients had no difference with lamivudine/telbivudine resistant mutants patients and entecavir-resistant mutant patients;In contrast, patients previously infected with adefovir-resistant mutant showed lower rates of VR at week 4, week 12, week 24, week 36, week 48 than initial treatment patients, but the difference was not significant.The cumulative incidences of HBeAg loss and ALT normalization between initial treatment patients and adefovir-resistant mutant patients had no significant difference.Conclusions TDF is effective for initial treatment and NA-experienced CHB patients.