替比夫定联合阿德福韦酯与PEG-IFN联合恩替卡韦治疗慢性乙型肝炎的效果比较

Efficacy of telbivudine combined with adefovir dipivoxil and pegylated interferon combined with entecavir as antiviral therapy for chronic hepatitis B: a comparative analysis

目的观察替比夫定联合阿德福韦酯与PEG-IFNα-2a联合恩替卡韦治疗HBe Ag阳性的高病毒载量的慢性乙型肝炎患者的疗效差异。方法选取2012年11月-2015年11月在青岛市第六人民医院就诊的HBe Ag阳性、高病毒载量的慢性乙型肝炎初治患者共80例,随机分成两组,每组40例。A组为替比夫定联合阿德福韦酯抗病毒组,B组为PEG-IFNα-2a联合恩替卡韦抗病毒组。观察两组患者分别服药12、24、48周时生化学、病毒学及血清学转换率有无差异。观察两组患者病毒耐药率及不良反应发生情况。计量资料组间比较采用t检验,计数资料组间比较采用χ~2检验。结果两组患者在12、24、48周时病毒学、生化学应答率差异均无统计学意义（P值均〉0.05）。12、24周时两组血清学转换率无明显差异,而48周时B组HBe Ag阴转率及血清学转换率均高于A组且差异均有统计学意义（45.0%vs 67.5%,22.5%vs 45.0%,χ~2值分别为4.114 3、4.528 3,P值均〈0.05）。B组患者出现的不良反应高于A组。结论 PEG-IFNα-2a联合恩替卡韦和替比夫定联合阿德福韦酯均可有效抑制高载量HBV DNA的复制,延缓病情进展,实现HBe Ag的血清学转换。但两种方案各有利弊,需根据临床实际情况加以选择。

Objective To investigate the efficacy of telbivudine combined with adefovir dipivoxil and PEG- IFN- α- 2a combined with entecavir as the antiviral therapy for HBe Ag- positive patients with chronic hepatitis B（ CHB） and a high viral load. Methods A total of 80 previously untreated HBe Ag- positive CHB patients with a high viral load who were treated in The Sixth People＇s Hospital of Qingdao from November2012 to November 2015 were enrolled and randomly divided into two groups. The patients in group A were treated with telbivudine combined with adefovir dipivoxil,and those in group B were treated with PEG- IFN- α- 2a combined with entecavir. Biochemical and virologic response rates and seroconversion rate were observed at weeks 12,24,and 48 of administration. The drug resistance rate and incidence rates of adverse events were observed in both groups. The Chi- square test was applied for comparision of categorical data between the two groups,and the t- test was applied for comparision of continuous data between the two groups. Results Biochemical and virologic response rates at weeks 12,24,and 48 of administration showed no significant differences between the two groups. The seroconversion rates at weeks 12 and 24 of administration showed no significant differences between the two groups,while at week 48 of administration,group B had significantly higher HBe Ag clearance rate and seroconversion rate than group A（ 45. 0% vs 67. 5%,22. 5% vs 45. 0%,χ~2= 4. 114 3 and 4. 528 3,both P 0. 05）. Group B had significantly higher incidence rates of adverse events than group A. Conclusion Telbivudine combined with adefovir dipivoxil and PEG- IFN- α- 2a combined with entecavir can effectively inhibit the replication of high- load HBV DNA,delay disease progression,and realize HBe Ag seroconversion. However,the two regimens have their own advantages and disadvantages and should be selected according to clinical situation.