拉米夫定治疗慢性乙型肝炎2年临床疗效

目的 研究拉米夫定治疗慢性乙型肝炎的临床疗效和安全性。方法 选取72例慢性乙型肝炎病人，第一阶段为随机、双盲、安慰剂对照的研究共12周，分为拉米夫定组（n=54）和安慰剂组（n=18）；第二阶段为开放研究，所有病人均服用拉米夫定100mg/d至104周。观察指标包括临床症状、肝功、乙型肝炎病毒（HBV）血清标志物、HBV DNA和病毒YMDD变异等。结果 拉米夫定治疗12周时，HBV DNA阴转率显著高于安慰剂组（61％对6％，P＜0.01），ALT持续复常率也高于安慰剂组（65％对11％，P＜0.05）；治疗52周时，两组病人总的HBV DNA阴转率为785，ALT持续复常率为39％，HBeAg阴转率和血清转换率分别为8.2%和6.1%；治疗104周时，两组病人总的HBV DNA阴转率36％，ALT持续复常率为33％，HBeAg阴转率和血清转换率分别为12.2%和6.1%。两组病人总的YMDD变异率在52周时为13.7%，104周时为39.7%。第一阶段拉米夫定和安慰剂组不良瓜在的差异不显著（P＞0.05），治疗期间未发生与药物有关的严重不良反应。结论 拉米夫定100mg/d可以迅速降低血清HBV DNA和ALT水平，安全性良好。但应严密监测以及时发现YMDD病毒变异引起的HBV DNA反跳。

Clinical efficacy of lamivudine in the treatment of chronic hepatitis B

Objective To study the clinical efficacy and safety of lamivudine in the treatment of chronic hepatitis B.Methods 72 patients with hepatitis B were randomly assigned into lamivudine ( n =54) and placebo groups ( n =18) for 12 weeks. Then,all the patients received lamivudine 100 mg daily until week 104. Clinical symptoms,liver function tests,serum HBV DNA and YMDD mutation were evaluated.Results HBV DNA response rate of lamivudine group was higher than that of placebo group after 12 weeks treatment (61% vs 6%, P <0.01). ALT sustained normalization rate of lamivudine group was higher than that of placebo group (65% vs 11%, P <0.05). At week 52 and week 104,HBV DNA response rate was 78% and 36% respectively,whereas the normalization rate of ALT was 39% and 33% respectively. Proportion of HBeAg/anti HBe seroconversion was both 6.1% at week 52 and 104. Overall YMDD mutation rate was 13.7% at week 52 and 39.7% at week 104. The incidence of adverse effects was similar for lamivudine and placebo group at week 12. There was no severe drugrelated adverse events during 104 weeks treatment. Conclusion Lamivudine 100mg daily could suppress HBV replication rapidly and be well tolerated. However, in some cases,YMDD mutation may lead to HBV DNA breakthrough.