摘要
目的评价国产阿德福韦酯(ADV)治疗HBeAg阳性慢性乙型肝炎患者的组织学改变。方法采用随机、双盲、安慰剂平行对照的研究方法,将HBeAg阳性慢性乙型肝炎患者按照1:1的比例分为A、B二组,A组120例服用ADV 10 mg每日1次,连续口服48周;B组120例服用安慰剂10 mg每日1次,口服12周,12周后改为口服ADV 36周。对其中21例患者完成了48周治疗,并行两次肝穿刺。按照Knodell肝组织学活动指数(HAI)评分法和Ishak评分系统,盲法评价两次肝穿切片的组织学和纤维化改变。结果21例患者治疗前后两次肝组织学观察表明:治疗前Knodell炎症评分和Ishak纤维化评分中位数分别为11分和3分,治疗48周后中位数分别下降为5分和2分,治疗前后比较差异有统计学意义(P<0.05)。ADV治疗48周后组织学改善率为43%,纤维化改善率为52%。结论国产ADV(商品名:名正)治疗HBeAg阳性慢性乙型肝炎患者48周,可以明显改善肝组织炎症、坏死和纤维化病变。
Objective To evaluate the hepatic histological changes of patients with HBeAgpositive chronic hepatitis B treated with domestic made adefovir dipivoxil（ADV）. Methods It was a randomized, double blind, placebo-controlled, muhicenter clinical trial. Patients with HBeAgpositive chronic hepatitis B were randomly assigned into group A（ADV was given orally at the dose of 10 mg once a day for 48 weeks） and group B（placebo was given for 12 weeks, followed by ADV at the dose of 10 mg once a day for 36 weeks） in a 1 ： 1 ratio. Of 21 patients paired liver biopsy samples were taken before and after therapy, then were evaluated and scored according to Knodell＇s histological activity index（HAD and Ishak fibrosis evaluation. Results According the paired liver biopsy samples of 21 patients, median Knodell＇s HAl score and Ishak score were 11 and 3 points at baseline, 5 and 2 points at the end of 48 weeks ADV treatment, respectively. There were significant reductions of HAI score and Ishak fibrosis scores after ADV treatment comparing with the baseline. Histological improvement rate after 48 weeks ADV treatment was 43 %, while the fibrotic amelioration rate was 52%（P 〈 0.05）. Conclusions In the patients with HBeAg-positive chronic hepatitis B, 48 weeks ADV treatment can significantly improve liver histological condition, including both necroinflammation and fibrosis status.
出处
《中华传染病杂志》
CAS
CSCD
北大核心
2007年第8期480-483,共4页
Chinese Journal of Infectious Diseases
