CAJ | 학술논문

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.
목적 평고은체잡위여아덕복위치료만성을형간염환자48주적료효화안전성. 방법 125례만성을형간염환자수궤분위은체잡위치료조(56례)화아덕복위치료조(69례),치료0、24、48주시검측간공능、HBV DNA수평、HBV혈청학표지물,비교량조환자체도혈청학응답적비례,비교불동기선HBV DNA수평환자치료후HBV DNA하강치급저우검측치하한비례,분석량조약물복치환자적료효차이,동시관찰치료과정중약물적안전성.계수자료채용x2검험,계량자료채용t검험.결과 치료24주시,은체잡위조화아덕복위조ALT복상솔분별위71%화64%(x2=0.457,P＞0.05),HBV DNA저우검측치하한환자비례분별위68%화35%(x2=0.78,P＜0.05),HBeAg양성환자중HBeAg음전솔분별위23%화7%(x2=3.89,P＜0.05),HBeAg학청학전환솔분별위18%화7%(x2=2.07,P＞0.05).48주시,ALT복상솔분별위100%화94%(x2=0.069,P＞0.05),HBV DNA저우검측하한환자비례분별위84%화49%(x2=0.78,P＜0.05),HBeAg음전솔분별위44%화15%(x2=8.18,P＜0.05),HBeAg혈청학전환솔분별위33%화12%(x2=5.12,P＜0.05).은체잡위복치환자여아덕복위복제환자상비,48주시HBV DNA체도검측하한적비례분별위79%화34%(x2=7.67,P＜0.05),HBeAg음전솔분별위42%화17%(x2=3.59,P＞0.05),HBeAg혈청학전환솔분별위26%화17%(x2=0.15,P＞0.05).결론 은체잡위치료만성을형간염적병독학화생물화학료효균우우아덕복위,시이상적일선항병독치료약물.
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.