替比夫定治疗乙型肝炎e抗原阳性慢性乙型肝炎48周疗效观察和安全性评价

Observation of clinical effect and safety evaluation of a 48 week trial of Telbivudine in patients with chronic hepatitis B of hepatitis B e antigen-positive

目的观察比较替比夫定与阿德福韦酯治疗乙型肝炎e抗原(HBeAg)阳性慢性乙型肝炎(CHB)48周的疗效和安全性。方法将100例HBeAg阳性CHB患者按随机分组方法纳入治疗组(49例)和对照组(51例)。治疗组每天口服替比夫定600 mg,对照组每天口服阿德福韦酯10 mg,疗程均为48周。治疗前和治疗第12、24和48周分别检测血清乙型肝炎病毒DNA(HBV DNA)定量、血清乙型肝炎病毒(HBV)标志物和血清丙氨酸转氨酶(ALT)水平。比较两组48周时HBV DNA水平、HBV DNA转阴率、HBeAg血清转换率、ALT复常率和不良事件发生率。结果治疗48周时,治疗组的HBV DNA水平显著低于对照组[(2.94±0.58)vs(3.52±0.97)](P<0.01),HBV DNA转阴率优于对照组(65.3%vs 41.2%)(P<0.01),HBeAg血清转换率无明显差异(18.4%vs 11.8%)(P>0.05),ALT复常率无明显差异(73.5%vs 68.6%)(P>0.05),不良事件发生率无明显差异(53.1%vs 52.9%)(P>0.05)。结论对HBeAg阳性慢性乙型肝炎患者治疗48周,替比夫定对HBV的抑制效果优于阿德福韦酯,而血清HBeAg转换率、ALT复常率和不良反应发生率差异无统计学意义。

Objective To investigate and compare the therapeutic and safety effects of 48 weeks of Telbivudine（LdT） and Adefovir Dipivoxil（ADV） in the treatment of chronic hepatitis B（CHB） patients with HBeAg-positive.Methods Totally one hundred HBeAg-positive CHB patients were randomly divided into the treatment group（n = 49） and the control group（n = 51）.The treatment group was assigned to receive an oral administration of LdT（600 mg once daily） and the control group was given an oral administration of ADV（10 mg once daily） for 48 weeks.Serum HBV DNA values,serum HBV markers and alanine aminotransferase（ALT） levels were detected before the treatment and at week 12,24 and 48 of the treatment.HBV DNA levels,rates of HBV DNA undetectable,HBeAg seroconversion,normalization of ALT and adverse events were compared at week 48 between the two groups.Results At week 48,the average level of the serum HBVDNA in the treatment group was lower than the control group significantly [（2.94±0.58） vs（3.52±0.97）]（P 0.01）,while the rate of HBV DNA undetectable in the treatment group was higher than the control group（65.3% vs 41.2%）（P 0.01）.However,there were no significant differences of ALT normalization rate and HBeAg seroconversion rate between both groups [（18.4% vs 11.8%）,P 0.05 and（73.5% vs 68.6%）,P 0.05].No significant difference was observed in the incidence rate of adverse events（53.1% vs 52.9%）（P 0.05） between both groups.Conclusion In the treatment of HBeAg-positive CHB patients for 48 weeks,Telbivudine is superior to Adefovir Dipivoxil in the suppression of serum HBV DNA level,but there are no significant differences in HBeAg conversion rate,ALT recovery rate and the incidence of side effects.