目的 观察阿德福韦酯(ADV)初始抗病毒治疗应答不佳的HBeAg阳性慢性乙型肝炎(CHB)患者换用或加用恩替卡韦(ETV)后的疗效及安全性。方法选取2010年1月至2013年6月浙江省金华市中心医院就诊且ADV初始抗病毒治疗应答不佳的CHB患者82例,按数字表法将患者随机分为两组,换用ETV组(34例)和加用ETV组(48例),分别观察两组患者在治疗12、24、48、72和96周时血清丙氨酸转氨酶(ALT)、总胆红素(TBil)复常率,HBeAg转阴率及血清学转换率,HBVDNA转阴率,以及治疗过程中出现的不良反应。采用,检验或t检验对数据进行比较。结果治疗至96周时,换用ETV组血清AIJT及TBil复常率分别为97.06%(33/34)和94.12%(32/34),加用ETV组为97.92%(47/48)和97.92%(47/48),两组差异无统计学意义(X2=0.000和0.093,P值均〉0.05);换用ETV组HBeAg转阴率及血清学转换率、HBVDNA转阴率分别为23.53%(8/34)、11.76%(4/34)和94.12%(32/34),加用ETV组分别为22.92%(11/48)、14.58%(7/48)和97.92%(47/48),两组差异均无统计学意义(X2=0.004、0.093和0.093,P值均〉0.05);治疗期间患者均未出现明显药物不良反应,且换用ETV组人均治疗费用(20035.2元)少于加用ETV组(30636.96元)。结论对ADV应答不佳的CHB患者,采取换用或加用ETV的治疗方案均能取得较好的临床疗效,但换用ETV治疗可明显减轻患者经济负担,是较为合理的选择。
Objective To observe the efficacy and safety of entecavir (ETV) monotherapy and combination of ETV and adefovir dipivoxil (ADV) in treatment of HBeAg-positive chronic hepatitis B (CHB) patients with suboptimal response to ADV. Methods A total of 82 CHB patients with HBeAgpositive who demonstrated suboptimal responses to ADV monotherapy were enrolled from Jinhua Central Hospital in Zhejiang Proince during January 2010 and June 2013. Patients were randomly divided into ETV group (n=34) and ETV + ADV group (n =48 ). Normalization rates of alanine aminotransferase (ALT) and total bilirubin (TBil), negative conversion rates of HBeAg and HBV DNA, seroconversion rate of HBeAg and adverse reactions were observed at 12-, 24-, 48-, 72- and 96-week of treatment. Chi-square test or t-test was used for data analysis. Results At 96-week of treatment, the normalization rates of ALT and TBil in ETV group were 97.06% (33/34) and 94.12% (32/34) , while those in ETV + ADV group were 97.92% (47/48) and 97.92% (47/48), respectively (X2 = 0. 000 and 0. 093, all P 〉 0.05 ). The negative conversion rates of HBeAg, HBV DNA, and the seroconversion rate of HBeAg in ETV group were 23.53% (8/34), 94. 12% (32/34) and ll. 76% (4/34), while those in ETV + ADV group were 22. 92% ( 11/48), 97.92% (47/48) and 14.58% (7/48), respectively (X2 =0. 004, 0. 093 and 0. 093, all P 〉 0.05 ). No obvious adverse reaction was observed during the treatment in both groups, but the average medical cost in ETV group (20 035.2 Yuan) was lower than that in ETV + ADV group (30 636.96 Yuan). Conclusion Both ETV monotherapy and combined use of ETV and ADV have satisfactory clinical efficacy for HBeAg-positive CHB patients with suboptimal response to ADV, and ETV monotberapy is a better option since it is more economical.