替比夫定与恩替卡韦治疗e抗原阳性慢性乙型肝炎的近期疗效比较

目的 观察替比夫定与恩替卡韦治疗HBeAg阳性慢性乙型肝炎患者近期疗效及安全性. 方法 80例患者随机分为替比夫定治疗组和恩替卡韦治疗组,分别在治疗前,治疗第12周和24周检测患者血清HBV DNA水平、ALT复常率、HBeAg阴转率和HBeAg/抗-HBe转换率,并比较不同基线血清HBV DNA水平患者治疗12周和24周时的血清HBV DNA下降值,HBV DNA低于检测值率,HBV DNA＜104拷贝/ml患者的比例.观察治疗过程中药物使用的安全性.结果 替比夫定和恩替卡韦组患者的基础人口学、临床和病毒学特征均具有可比性.治疗12周时,替比夫定组和恩替卡韦组患者HBV DNA低于检测值率均为50.0%,ALT复常率分别为52.5%和60.0%(P＞0.05),HBeAg阴转率分别为30.0%和5.0%(P＜0.01),HBeAg血清学转换率分别为20.0%和5.0%(P＜0.05);在治疗24周时,两组HBV DNA低于检测值率分别为80%和70%,(P＞0.05),ALT复常率分别为77.5%和75.0%(P＞0.05),HBeAg阴转率分别为45.0%和32.5%(P＞0.05),HBeAg血清学转换率分别为27.5%和17.5%(P＞0.05),两组均未发现明显不良反应.结论 替比夫定与恩替卡韦治疗HBeAg阳性的慢性乙型肝炎的近期HBV DNA水平低于检测值率,ALT复常率无明显差异;12周时替比夫定HBeAg血清学转换率高于思替卡韦组,但24周时两组间差异无统计学意义.

Short-term results of telbivudine versus entecavir treatments in HBeAg-positive chronic hepatitis B patients in China

OBJECTIVE: To evaluate the efficacy and safety of telbivudine (LDT) versus entecavir treatments in hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) patients. METHODS: Eighty HBeAg-positive compensated CHB patients with HBV DNA more than 6 log10 copies/ml and serum ALT 2 x ULN were divided into two groups: a telbivudine treatment group, and a entecavir treatment group. HBV DNA, ALT and HBeAg were surveyed at baseline and at 12 and 24 weeks. The efficacy and safety of the two nucleoside analogues were assessed at 12 and 24 weeks. RESULTS: Undetectable serum HBV DNA levels of the telbivudine group (50% and 80%) were similar to those of the entecavir B group (50% and 70%) according to the polymerase-chain-reaction assay at week 12 and 24. There were no significant differences in the normalization of alanine aminotransferase levels between the two groups at week 12 and 24 (52.5% vs 60.0%, 77.5% vs 75.0%). The mean reductions in serum HBV DNA from the baseline levels at week 12 and 24 were similar between the two groups 5.27 vs.5.36, 6.49 vs.6.18 log (on a base-10 scale) copies per milliliter]. More patients in the telbivudine group had HBeAg seroconversion at week12 than those in the entecavir group (20.0% vs 5.0%, P = 0.043); however, there was no significant difference between the two groups at week 24 (27.5% vs 17.5%). No adverse reactions were found in either group. CONCLUSION: There was no significant difference in HBV DNA undetectable rates and the ALT normalization rates between the two groups in a short-term therapy (24 weeks), but the telbivudine group had a higher rate in HBeAg seroconversion than that in the entecavir group at week 12.