摘要
目的 :评估双环醇治疗慢性乙型肝炎的疗效和安全性。方法 :慢性乙型肝炎病人随机分成双环醇组 (2 69例 )和联苯双酯组 (1 3 8例) ,分别服用双环醇或联苯双酯 2 5mg,tid,共 2 4wk。结果 :经双环醇治疗后 ,临床症状有较大程度的改善。ALT和AST的复常率分别为 5 3 .5 %和 48.7% ,停药 1 2wk后分别为 40 .2 %和 48.7%。与联苯双酯组(61 .6%和 44.2 % ;45 .7%和 5 0 .0 % )比较 ,P >0 .0 5。治疗结束和停药 1 2wk后 ,双环醇组血清HBeAg阴转率分别为 2 0 .8%和 2 9.0 % ,HBeAg/抗HBe血清转换率分别为 1 5 .6%和 2 0 .8% ,HBV DNA阴转率分别为 3 9.0 %和 45 .7% ,上述指标均高于联苯双酯组。双环醇组治疗前ALT水平≥ 2 0 0U·L-1者 ,在停药 1 2wk时HBeAg阴转率和血清转换率分别为 48%和 3 8% ,显著高于联苯双酯组 (2 2 %和 1 2 % ) ,(P <0 .0 5 )。病人在治疗期间未出现明显不良反应。结论 :双环醇对改善乙肝病人临床症状和降低转氨酶有很好的疗效 ,不良反应少 。
AIM: To evaluate the efficacy and safety of bicyclol for chronic hepatits B(CHB). METHODS: CHB patients were randomly divided into bicyclol group and bifendate group on the ratio of 2∶1. Each group of patients received bicyclol or bifendate 2 mg tid for 24 wk, then stopped treatment and followed up 12 wk. Investigating items included clinical symptoms, liver function tests, serum hepatitis B (HBV) markers and safety profile. Efficacy evaluation was based on Intent To Treat (ITT) principle. RESULTS: Bicyclol or bifendate were given to two hundred and sixty nine and one hundred and thirty eight patients, respectively. The demographic and baseline features were similar in both groups. After bicyclol therapy, both clinical symptoms and serum ALT, AST levels were improved markedly. The normalization rates of ALT and AST were 53.5 % and 48.7 % at wk 24, and kept sustained normal in 40.2 % and 48.7 % at 12 wk after stop of treatment. In bifendate group, the ALT and AST normalization rates were 61.6 % and 44.2 % at wk 24, and 45.7 % and 50.0 % at 12 wk after stop of the treatment, respectively. The improvement of serum ALT and AST showed no statistical difference between two groups ( P >0.05). Regarding the HBV markers, in bicyclol group the negativity of HBeAg, HBeAg/Anti HBe seroconversion and negativity of HBV DNA at wk 24 were 20.8 % 15.6 % and 39.0 %, respectively, and then 29.0 %, 20.8 % and 45.7 % and 12 wk after stop of treatment. Whereas in bifendate group, those parameters were 15.2 %, 9.4 % and 37.7 % at wk 24, and 21.0 %, 14.5 % and 38.4 % at 12 wk after stop of treatment. These results between bicyclol and bifendate groups showed no significant statistical difference. However, in patients whose baseline ALT levels were higher than 5 times of upper limit of normal (>200 U·L -1 ), the HBeAg negative rates and seroconversion rates at 12 wk after stop of treatment were significant higher in bicyclol group than those in bifendate group, those were 48 % versus 22 %( P = 0.015) and 38 % versus 12 % ( P =0.01). The adverse reactions of bicyclol group were mild and uncommon, only skin rash and dizzeness were occurred in one patient each; and skin rashes occurred in two and loss of appetite and nausea occurred in one patient who received bifendate. CONCLUSION: Bicyclol is effective for the improvement of the clinical symptoms and serum ALT and AST. Bicyclol is superior to bifendate on the clearance of serum HBeAg and seroconversion. It is well tolerated and safety throughout the course of trial.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2002年第8期457-462,共6页
Chinese Journal of New Drugs and Clinical Remedies
基金
"九五"国家重点科技攻关基金资助 (96 90 1 0 1 45)
荣获由国家科技部
国家计委
财政部和国家经贸委授予的优秀科技成果奖 (2 0 0 1年 2月 )
关键词
双环醇
治疗
慢性乙型肝炎
临床研究
疗效评价
bicyclol
hepatitis B
hepatitis, chronic active
clinical trial
bifendate
