摘要
目的 比较马来酸恩替卡韦与恩替卡韦（ETV）治疗CHB患者的疗效及安全性.方法 随机、双盲、双模拟、阳性药对照的多中心临床研究.入选患者随机分为ETV组和马来酸恩替卡韦组,分别接受ETV 0.5 mg/d或马来酸恩替卡韦0.5 mg/d治疗48周,49周后两组患者均接受马来酸恩替卡韦0.5 mg/d治疗.定期随访患者,检测血清ALT、HBV血清学标志物及HBV DNA,记录不良事件.符合正态分布的计量资料采用t检验,不符合正态分布的计量资料采用秩和检验（Wilcoxon检验）,计数资料组间比较采用卡方检验或Fisher精确概率法.结果 共入组218例HBeAg阳性CHB患者（ETV组110例,马来酸恩替卡韦组108例）及57例HBeAg阴性CHB患者（ETV组26例,马来酸恩替卡韦组31例）.治疗96周时,HBeAg阳性CHB患者中,ETV组与马来酸恩替卡韦组HBV DNA较基线下降值（5.90 lg IU/mL比5.84 lg IU/mL,F=0.07,P=0.785）、HBV DNA低于检测下限率（HBVDNA载量＜20 IU/mL,58.18％比56.48％,x2=0.06,P=0.800）、HBeAg转阴率（29.1％比24.1％,x2=0.70,P=0.402）、HBeAg血清学转换率（12.6％比12.3％,x2=0.01,P=0.938）和ALT复常率（87.5％比85.7％,x2=0.14,P=0.709）的差异均无统计学意义;HBeAg阴性CHB患者中,ETV组与马来酸恩替卡韦组HBV DNA较基线下降值（5.72 lg IU/mL比5.60 lg IU/mL,F=0.10,P=0.758）、HBV DNA低于检测下限率（96.2％比96.8％,P=1.000）、ALT复常率（91.7％比90.3％,P=1.000）的差异亦无统计学意义.治疗96周时,ETV组与马来酸恩替卡韦组不良事件发生率分别为21.32％、18.71％,差异无统计学意义（x2=0.29,P=0.587）.结论 与ETV比较,马来酸恩替卡韦能有效治疗CHB,两者疗效和安全性相似.
Objective To evaluate the efficacy and safety of entecavir （ETV） versus ETV maleate in Chinese patients with chronic hepatitis B （CHB）.Methods This was a randomized,double blind,double-dummy,controlled,multicenter study.Patients were randomly assigned to receive 48 weeks of treatment with 0.5 mg/d ETV or 0.5 mg/d ETV maleate,then all patients received the treatment with 0.5 mg/d ETV maleate since week 49.Patients were regularly followed up.Serum hepatitis B virus （HBV） markers were detected.Adverse events （AE） were recorded.Quantitative data accorded with normal distribution were analyzed by t test.Quantitative data with abnormal distribution were analyzed by Wilcoxon test.Chi square test or Fisher exact test were used for categorical data.Results Two hundred and eighteen patients with hepatitis B e antigen （HBeAg）-positive CHB （110 in ETV group and 108 in ETV maleate group） and 57 patients with HBeAg-negative CHB （26 in ETV group and 31 in ETV maleate group） were enrolled.Baseline characteristics were well balanced between the two groups.For the patients with HBeAg-positive CHB,the mean HBV DNA levels in ETV group and ETV maleate group were similarly decreased from baseline （by 5.90 lg IU/mL vs by 5.84 lg IU/mL; F=0.07,P=0.785） at week 96.Patients who achieved undetectable levels of serum HBV DNA （〈20 IU/mL） at week 96 were similar in the two groups （58.18% vs 56.48%;x2=0.06,P=0.800）.Both groups achieved similar HBeAg loss rates at week 96 （29.1% vs 24.1%; x2 =0.70,P=0.402）.Both groups achieved similar HBeAg seroconversion rates at week 96 （12.6% vs 12.3% ;x2 =0.01,P=0.938）.Both groups achieved similar alanine aminotransferase （ALT） normalization rate at week 96 （87.5% vs 85.7% ; x2 =0.14,P=0.709）.For the patients with HBeAg-negative CHB,the mean HBV DNA levels in both groups were similarly decreased from baseline （by 5.72 lg IU/mL vs by 5.60 lg IU/mL; F=0.10,P=0.758） at week 96.Patients who achieved undetectable levels of serum HBV DNA at week 96 wer
出处
《中华传染病杂志》
CAS
CSCD
北大核心
2014年第10期594-600,共7页
Chinese Journal of Infectious Diseases
