恩替卡韦联合参仙乙肝灵治疗e抗原阳性慢性乙型肝炎患者48周的疗效观察

作者	单位
张涛	湖南中医药大学第一附属医院传染科国家中医(肝病)临床研究基地
王雅	湖南中医药大学第一附属医院传染科国家中医(肝病)临床研究基地
孙克伟	湖南中医药大学第一附属医院传染科国家中医(肝病)临床研究基地
陈斌	湖南中医药大学第一附属医院传染科国家中医(肝病)临床研究基地
欧松	湖南中医药大学第一附属医院传染科国家中医(肝病)临床研究基地

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中文摘要:

目的比较恩替卡韦(entecavir,ETV)联合参仙乙肝灵和单纯ETV治疗乙型肝炎病毒e抗原(hepatitis B virus e antigen,HBeAg)阳性慢性乙型肝炎(chronic hepatitis B patients,CHB)患者48周的疗效和安全性。方法 164例患者按队列研究方法分为ETV联合参仙乙肝灵治疗组及单纯ETV治疗的对照组。观察治疗前后患者ALT复常率、HBV DNA低于检测值下限率、HBeAg阴转率和HBeAg血清转换率。结果治疗48周时,ETV联合参仙乙肝灵组和ETV组ALT复常率分别为67.61%和70.00%(P>0.05),HBV DNA低于检测值下限患者比例分别为73.24%和72.50%(P>0.05);HBeAg阴转率分别为39.44%和23.75%(P<0.05);HBeAg血清转换率分别为32.39%和15.00%(P<0.05)。结论 ETV联合参仙乙肝灵可能通过对机体免疫功能的恢复从而促进HBeAg血清转换率的提高。

英文摘要:

Objective To evaluate of the efficacy and safety of entecavir(ETV) combined with Shenxian Yiganling(SY) versus ETV therapy on patients with HBeAg-positive chronic hepatitis B(CHB) for 48 weeks.Methods One hundred and sixty-four CHB patients were assigned to two groups with the cohort study:the ETV combined with SY treatment group and the ETV control group.The alanine aminotransferase(ALT),the undetectable HBV DNA level,and HBeAg negative conversion rate,and HBeAg serological negative conversion rate were observed before and after treatment.Results At week 48,there was no significant difference in the normalization of ALT levels(70.00% vs 67.61%,P>0.05) and undetectable HBV DNA levels(72.50% vs 73.24%,P>0.05) between the two groups.There was significant difference in the HBeAg negative conversion rate(39.44% vs 23.75%) and HBeAg serological negative conversion rate(32.39% vs 15.00%)(both P<0.05).Conclusion ETV combined with SY promoted the HBeAg serological negative conversion rate possibly through the recovery of the immune functions.

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