CAJ | 학술논문

目的评价国产阿德福韦酯片治疗成人HBeAg阳性慢性乙型肝炎的有效性和安全性.方法采用多中心、开放试验方法,入选1930例患者服用阿德福韦酯片10 mg/d.随访观察采用标准操作规程(SOP),观察12周、24周、36周、52周的生化、病毒学指标及不良反应.结果 1930例患者治疗12周、24周、36周、52周,HBV DNA阴转率分别为16.42％、28.55％、37.25％、43.32％,ALT复常率分别为29.69％、49.02％、56.42％、62.95％.治疗24周、52周HBeAg阴转率分别为12.59％、19.38％.随着疗程延长,HBV DNA阴转率、ALT复常率、HBeAg阴转率越高.治疗52周时耐药率为0.17％.不良反应率0.72％,极少数病例出现尿常规轻微异常,未发现肾功或生殖系统受损.结论国产阿德福韦酯片治疗HBeAg阳性慢性乙型肝炎具有良好的有效性及安全性.
목적 평개국산아덕복위지편치료성인HBeAg양성만성을형간염적유효성화안전성.방법 채용다중심、개방시험방법,입선1930례환자복용아덕복위지편10 mg/d.수방관찰채용표준조작규정(SOP),관찰12주、24주、36주、52주적생화、병독학지표급불량반응.결과 1930례환자치료12주、24주、36주、52주,HBV DNA음전솔분별위16.42％、28.55％、37.25％、43.32％,ALT복상솔분별위29.69％、49.02％、56.42％、62.95％.치료24주、52주HBeAg음전솔분별위12.59％、19.38％.수착료정연장,HBV DNA음전솔、ALT복상솔、HBeAg음전솔월고.치료52주시내약솔위0.17％.불량반응솔0.72％,겁소수병례출현뇨상규경미이상,미발현신공혹생식계통수손.결론 국산아덕복위지편치료HBeAg양성만성을형간염구유량호적유효성급안전성.
Objective To evaluate the efficacy and safety of domestic adefovir dipivoxil in the treatment of chronic hepatitis B with e antigen-positive.Methods The multicenter open clinical trial was conducted,the 1930 patients received oral adefovir dipivoxil 10 mg/d.Follow-up observations by standard operating procedures(SOP).The changes in biochemical,virological parameters and adverse reactions were observed after treatment on 12 weeks,24 weeks,36 weeks and 52 weeks.Results After 12 weeks,24 weeks,36 weeks and 52 weeks of treatment,the rates of the serum HBV DNA negative-conversion and alanine aminotransferase(ALT) renormalization were 16.42％,28.55％,37.25％,43.32％ and 29.69％,49.02％,56.42％,62.95％ respectively.After 24 weeks and 52 weeks of treatment,the rates of HBeAg negative-conversion were 12.59％,19.38％ respectively.After that,as the treatment duration prolonged,there was an increase in the serum HBV DNA negative-conversion,ALT renormalization and HBeAg negative-conversion rate resistance rate was 0.17％ during the treatment of 52 weeks period.The adverse reaction rate of 0.72％,very few cases of urine routine showed mild abnormality,no impairments of renal function or reproductive system were emerge.Conclusions Domestic adefovir dipivoxil for treating chronic hepatitis B with e antigen-positive is safe and effective.