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双环醇序贯治疗拉米夫定停药患者的临床试验 |
Clinical Study of Sequential Treatment of Bicyclo-ethanol in Patients after Treatment of Lamivudine |
投稿时间:2005-03-31 |
DOI: |
中文关键词: 慢性乙型肝炎 双环醇 拉米夫定 临床试验 |
英文关键词:Chronic hepatitis B Bicyclo-ethanol Lamivudine Clinical trial |
基金项目: |
黄元成 喻国萍 许东 张振纲 田德英 齐俊英 |
[1]华中科技大学同济医学院附属同济医院感染科,武汉430030 [2]湖南省华容县人民医院内一科,武汉430030 |
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中文摘要: |
目的:观察双环醇序贯治疗拉米夫定停药患者肝功能及HBV-DNA变化情况,评价其序贯治疗拉米夫定停药患者的临床应用价值。方法:将60例服用拉米夫定〉6个月的慢性乙型肝炎轻型患者分为治疗组(A组):停用拉米夫定的同时开始服用双环醇(50mg,tid),疗程6个月;对照组(B组):停药观察6个月。两组患者每月检测肝功能,每3个月观察HBV-DNA的变化情况。结果:患者肝功能异常多发生在拉米夫定停药2~5个月,其中对照组患者ALT异常率分别为46.7%,83.3%,76.6%,34.5%,显著高于双环醇治疗组的10.0%,30.0%,20.0%,6.67%(P〈0.05),停药3,4个月时,两组差异显著(P〈0.001);而SB异常率停药4个月时为27.6%,显著高于治疗组的3.4%;ALB异常率停药4~6个月分别为34.5%,24.1%和20.7%,显著高于治疗组(P〈0.05);治疗组HBV-DNA停药3个月、6个月时,略低于对照组,但差异无统计学意义。结论:双环醇能够明显改善拉米夫定停药患者的临床症状,显著降低肝功能异常率,而对HBV-DNA的转阳率没有明显影响,可作为拉米夫定停药患者序贯治疗的有效药物之一。 |
英文摘要: |
Objective:To evaluate its effects on HBV replication, we conducted a sequential administration of lamivudine and to observe the change of liver function and HBV-DNA. Method:60 HBV patients with at least six months history of lamivudine administration were randomly assigned into 2 groups. Group A (treatment group) was treated with a sequential administration of lamivudine and bicyclo-ethanol, group B ( control group) was treated only with lamivudine for six months and the groups were observed for another 6 months. The serum samples were assayed for Alamine aminotrans-ferase(ALT) monthly and the quantity of HBV-DNA (quantitative PCR) every three months. Result:Increased ALT levels were observed from the second to the fifth month after the drug was withdrawn. The activity indexes of the liver function were 46. 7% , 83. 3% , 76. 6% and 34.5% in group B and 10.0% , 30.0% , 20.0% and 6.67% in group A. The change rate of ALT in group B increased significantly ( P <0. 05) , especially in the 3rd and 4th month ( P <0. 001) . In the forth month, SB was 27. 6% and 3.4% in group A and group B respectively:ALB was 34. 5% , 24. 1 % and 24. 7% in 4th, 5th and 6th respectively after the treatment. There was some significant difference between the two groups (P < 0. 05 ) . Conclusion:This sequential administration of lamivudine and bicyclo-ethanol can improve the clinical symptom and decrease the change rate of ALT, but there is no significant effect on the quantity of HBV-DNA. Bicyclo-ethanol may be used as one of the effective drugs after the stoppage of the administration of the Lamivudine. |
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