恩替卡韦与阿德福韦治疗慢性乙型肝炎患者48周的临床疗效观察

Comparison of the efficacy of 48 week-Entecavir therapy with that of Adefovir therapy for chronic hepatitis B patients

目的 评估恩替卡韦与阿德福韦治疗慢性乙型肝炎患者48周的疗效和安全性. 方法 125例慢性乙型肝炎患者随机分为恩替卡韦治疗组（56例）和阿德福韦治疗组（69例）,治疗0、24、48周时检测肝功能、HBV DNA水平、HBV血清学标志物,比较两组患者达到血清学应答的比例,比较不同基线HBV DNA水平患者治疗后HBV DNA下降值及低于检测值下限比例,分析两组药物复治患者的疗效差异,同时观察治疗过程中药物的安全性.计数资料采用x2检验,计量资料采用t检验.结果 治疗24周时,恩替卡韦组和阿德福韦组ALT复常率分别为71%和64%（x2=0.457,P＞0.05）,HBV DNA低于检测值下限患者比例分别为68%和35%（x2=0.78,P＜0.05）,HBeAg阳性患者中HBeAg阴转率分别为23%和7%（x2=3.89,P＜0.05）,HBeAg学清学转换率分别为18%和7%（x2=2.07,P＞0.05）.48周时,ALT复常率分别为100%和94%（x2=0.069,P＞0.05）,HBV DNA低于检测下限患者比例分别为84%和49%（x2=0.78,P＜0.05）,HBeAg阴转率分别为44%和15%（x2=8.18,P＜0.05）,HBeAg血清学转换率分别为33%和12%（x2=5.12,P＜0.05）.恩替卡韦复治患者与阿德福韦复制患者相比,48周时HBV DNA达到检测下限的比例分别为79%和34%（x2=7.67,P＜0.05）,HBeAg阴转率分别为42%和17%（x2=3.59,P＞0.05）,HBeAg血清学转换率分别为26%和17%（x2=0.15,P＞0.05）.结论 恩替卡韦治疗慢性乙型肝炎的病毒学和生物化学疗效均优于阿德福韦,是理想的一线抗病毒治疗药物.

Objective To compare the efficacy of 48 week-Entecavir therapy with that of Adefovir therapy for chronic hepatitis B patients. Methods In this open-label study we randomly assigned 125 CHB patients to receive 0.5mg of entecavir （n = 56） or 10mg of adefovir （n = 69） once daily for 48 weeks. HBV DNA, ALT and HBeAg were quantified at baseline and at 0, 24, 48 weeks. Results At week 24 and 48, more patients in entecavir group than in adefovir group achieved undetectable serum HBV DNA level （68% vs 35%, 84% vs 49%, P 〈 0.05）. The percentage of patients with nornal ALT level in the two groups at week 48 was similar （100% vs 94%, P 〉 0.05）. Among the HBeAg positive patients, more patients in entecavir group than in adefovir group had HBeAg loss at week 24 and 48 （23% vs 7%, 44% vs 15%, P 〈 0.05）. The ratio of IIBeAg seroconversion was similar in the two groups at week 24 （18% vs 7%, P 〉 0.05）, but more patients in entecavir group than in adefovir group achieved HBeAg seroconversion at week 48 （33% vs 12%, P 〈 0.05）. The retreated patients in the entecavir group had a higher chance to achieve undetectable serum HBV DNA level （79% vs 34%, P 〈 0.05）, HBeAg loss （42% vs 17%, P 〉 0.05）, and seroconversion （26% vs 17%, P 〉0.05）, than these in the adefovir group. The safety profiles and adverse event profiles were similar in the two groups. Conclusions Compared to adefovir, entecavir is more potent to suppress HBV replication.