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Telbivudine combined with bicyclol treatment in HBeAg positive chronic hepatitis
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摘要: 目的研究替比夫定联合双环醇片治疗HBeAg阳性慢性乙型肝炎(CHB)患者的疗效和安全性。方法选择133例未应用其他抗病毒药物的HBeAg阳性CHB患者,随机分两组接受治疗。试验组67例,每日口服替比夫定600 mg,同时每日服用双环醇片75 mg;对照组66例,仅给予每日口服替比夫定600 mg,两组均连续用药104周。观察治疗前后血清ALT水平及病毒学指标方面的改变。结果两组血清均明显下降,试验组更为显著(P<0.01)。治疗12周时,两组患者在HBeAg转阴率及血清学转换方面比较,差异均无统计学意义,随治疗时间延长,在治疗24、52、104周各时间点,实验组HBeAg转阴率及血清学转换均高于对照组,差异均有统计学意义。两组HBV DNA水平均出现明显下降,但各治疗时间点HBV DNA下降水平及检测不到比率比较,差异无统计学意义(P>0.05)。治疗52周时,治疗组和对照组各出现2例和3例耐药,耐药率分别为4.69%和7.81%,两组比较,差异无统计学意义(P>0.05),治疗104周时,治疗组耐药5例,对照组耐药13例,耐药率分别为7.81%和20.31%,两组比...Abstract: Objective To evaluate the efficacy and safety of telbivudine combined with bicyclol in the treatmentof patients with chronic hepatitis B.Methods 133 untreated cases of HBeAg-positive chronic hepatitis B patients were selected and randomly divided into 2 groups as experiment group and control group.In the experiment group 67 cases were given 600 mg of telbivudine orally combined with 75 mg of bicyclol once-daily, whereas in the control group 66 cases were only treated with oral dose of 600 mg telbivudine daily.Both the groups were on continuous medication for 104 weeks.serum aminotransferase levels and virological indicators were observed.Results serum aminotransferase were significantly in both groups, and more significant change in the experimental group (P<0.01) at 12W, the HBeAg seroconversion rate and seroconversion in both the groups were compared.There were no statistically significant differences between the groups.with prolonged treatment, at 24W, 52W, 104W, serum HBeAg negative conversion rate in the experimental group were higher than that of the control group.HBV DNA levels of the two groups were significantly decreased, but there were not statistically significant difference on HBV DNA undetectable rate at different time point. (P>0.05) .At 52 weeks, 2 cases and 3 cases of drug resistance occurred in the treatment group and control group respectively.The resistance rates were 4.69% and 7.81%, respectively, there was no statistically significant difference (P>0.05) .At 104 weeks, resistance in the treatment group were in 5 cases and resistance in the control group were in 13 cases and resistance rates were 7.81% and 20.31%, respectively, there was statistically significant difference (P<0.05) .The two groups did not observe any drug-related adverse reactions.Conclusion telbivudine in combination with bicyclol treatment for HbeAg positive chronic hepatitis B is effective and safe.
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Key words:
- hepatitis B /
- chronic /
- hepatitis B e antigens
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