目的 研究恩替卡韦(ETV)治疗慢性乙型肝炎的近期疗效和安全性.方法 30例HBeAg阳性慢性乙型肝炎患者为治疗组,给予恩替卡韦0.5 mg,1次/d,口服,疗程＞48周.选择同期接受阿德福韦酯(ADV)治疗的30例HBeAg阳性慢性乙型肝炎患者为对照组,给予阿德福韦酯10 mg,1次/d,口服,疗程＞48周.观察治疗4周、12周、24周时肝功能、HBV DNA水平、乙型肝炎病毒血清标志物的应答效果及肾功能、血液分析的变化.结果 治疗4周、12周、24周时,治疗组与对照组HBV DNA转阴率分别为57%、0%(P＜0.01),90%、57%(P＜0.05),93%、63%(P＜0.05). 治疗组1例患者在疗程24周时HBV DNA定量＜1 log10,改用干扰素治疗.治疗组与对照组ALT复常率分别为43%、20%(P＞0.05),77%、50%(P＞0.05),87%、73%(P＞0.05).HBeAg阴转率分别为3%、0%(P＞0.05),3%、0%(P＞0.05),10%、0%(P＞0.05).两组患者肾功能均未出现异常,对照组 1例患者在治疗6周时出现外周血白细胞减少症(WBC 2.2×109/L),给予苦参素治疗后,WBC未进一步减少,现仍在治疗中.其余患者均未发现明显不良反应.结论 恩替卡韦治疗HBeAg阳性慢性乙型肝炎时,可在病毒学应答方面取得显著疗效,早期具有显著的抗病毒活性.其抗乙型肝炎病毒活性明显优于阿德福韦酯,HBV DNA转阴率明显优于阿德福韦酯.在生物化学应答方面,在4周、12周、24周时ALT复常率较对照组为高,但经统计学处理,其差异无显著性.在免疫学应答方面,治疗组在24周时3例患者HBeAg阴转,无血清学转换病例.恩替卡韦临床应用过程中未见明显不良反应.
Objective A study of short term efficacy and safety of entecavir(ETV)in chronic hepatitis B patients.Methods Thirty cases of HBeAg positive chronic hepatitis B were selected randomly as treatment group,and treated with ETV 0.5 mg daily for over 48 weeks.Another 30 cases of HBeAg positive chronic hepatitis were selected as observation group and treated with adefovir(ADV)10 mg daily for over 48 weeks.Patient's liver function,HBV DNA level,hepatitis B serology marker,renal function,and full blood count were assessed at 4 weeks,12 weeks and 24 weeks.!Results At 4 week,12 week and 24 weeks,the percentage of patients had undetectable HBV DNA in ETV group and ADV group were 57% versus 0%(P<0.01),90% versus 57%(P<0.5),93% versus 63%(P<0.05),respectively.The percentage of patients achieving alanine aminotransferase normalization were 43% versus 20%(P>0.05),77% versus 50%(P>0.05),87% versus 73%(P>0.05),respectively.HBeAg seroconversion rate in the two groups were 3% versus 0%(P>0.05),3% versus 0%(P>0.05),10% versus 0%(P>0.05),respectively.There is no abnormal renal function observed in both groups.There was one case of neuthocytopenia(WBC 2.2×103/L)after 6 weeks in observation group which has been treated with Kushengsu with no further white cell reduction.Conclusions ETV can be used as first line antivirus drug in chronic hepatitis B as it has superior antiviral effects as well as HBeAg seroconversion than ADV in early stage.The group treated with ETV had higher rate of alanine aminotransferase normalization than the group treated with ADV.However,there is no significant difference.There were 3 cases in the ETV treated group who had HBeAg reduction after 24 weeks,but there was no one presented HBeAg seroconversion.There was no significant side effect observed in ETV treated group.
Chinese Journal of Experimental and Clinical Infectious Disease(Electronic Version)
Chronic hepatitis B
Short term clinical research
李保明 Email: firstname.lastname@example.org 通讯作者