核苷(酸)类药物对慢性乙型肝炎复发患者的疗效与安全性研究

目的 比较慢性乙型肝炎复发患者使用拉米夫定(LAM)联合阿德福韦酯(ADV)治疗与恩替卡韦(ETV)单药治疗的效果和安全性.方法 研究对象来源于杭州市萧山区第一人民医院及杭州师范大学附属医院门诊和住院的乙型肝炎复发患者,共60例.所有患者分为LAM+ADV治疗组(30例)和ETV治疗组(30例),观察两组治疗96周后病毒学应答和突破率,HBeAg/HBsAg的转阴率和血清学转换率以及肝肾功能等.结果 治疗96周LAM+ADV治疗组的病毒学应答率、HBeAg血清阴转率及转换率分别为92.00％、44.00％和40.00％,均高于ETV治疗组(X2=0.048、0.047、0.041,P＜0.05),病毒突破率为4.00％,低于ETV组(x2=0.029,P＜0.05);HBV DNA 、HBsAg下降绝对值及ALT复常率两组间差异无统计学意义(P＞0.05).两组血清肌酐水平治疗前后比较差异均无统计学意义(P＞0.05).结论 LAM+ADV联合治疗在持续病毒学应答、HBeAg阴转、HBeAg血清转换率方面优于ETV单药治疗,且不会影响肾脏功能.

Efficiency and safety of nucleot(s)ide analogue treatment for chronic hepatitis B relapse patients

Objective To compare the effect and safety of lamivudine(LAM) with adetovir(ADV) combined treatment and entecavir monotherapy (ETV) in hepatitis B recurrence patients.Methods A total of 60 chronic hepatitis B recurrence outpatients and inpatients in First People's Hospital of Xiaoshan District and Affiliated Hospital of Hangzhou Normal University were enrolled.Sixty patients were divided into LAM+ADV group (30 cases) and ETV group(30 cases).The indicators of response and breakthrough rates of virology,negative and seroconversion rates of HBeAg/HBsAg,as well as hepatic function and renal function were detected after 96-week treatment.Results The virological response rate,HBeAg negative conversion rate and sero-conversion rate of LAM+ADV group were 92.00％,44.00％ and 40.00％,and were all higher than ETV group by week 96(x2=0.048,0.047,0.041,P all＜0.05).Virological breakthrough rate of LAM+ADV group which was 4.00％ was lower than ETV group (x2=0.029,P＜0.05).The decline of HBV DNA and HBsAg in absolute terms and ALT normalization rate had no statistical differences between the two groups(P＞0.05).Serum creatinine had no statistical difference in both two groups after 96-week treatment (/P＞0.05).Conclusions The indicators of sustained virological response,HBeAg negative conversion and HBeAg sero-conversion rate in patients with LAM and ADV combined therapy are superior to ETV monotherapy,and have renal safety.