Objective To evaluate the effect of lamivudine on the loss of serum he patitis B virus (HBV) DNA, HBeAg/antiHBe seroconversion and ALT levels in chron ic hepatitis B patients and its safety profile and tolerance comp...Objective To evaluate the effect of lamivudine on the loss of serum he patitis B virus (HBV) DNA, HBeAg/antiHBe seroconversion and ALT levels in chron ic hepatitis B patients and its safety profile and tolerance compared with place bo.Methods Four hundred and twenty nine patients with chronic HBV infecti on as defined by positive HBsAg, HBeAg and HBV DNA were enrolled and randomized into lamivudine and placebo groups. Three hundred and twenty two patients recei ved lamivudine 100?mg daily and 107 patients received placebo treatment for 12 weeks. Then, all patients were offered a further 9 month open label lamivudine treatment. The efficacy and safety were evaluated with clinical, biochemical, hematological and virological parameters. Results During the 12 week treatment period, 92.2% of lamivudine t reate d patients became HBV DNA negative (below 1.6?pg/ml) compared with only 14.1% o f those receiving placebo (P<0.01). At the end of 12 week, the sust ained negative rate for HBV DNA in the lamivudine treated group was 78.5% compar ed with the placebo group (11.1%; P< 0.01). There was a trend to a high proportion of patients treated with lamivudine to lose HBeAg (8.1%) and d evelop antiHBe (10.2%) than treated with placebo (5.3% and 6.4% respectively), b ut this difference was not statistically significant. Patients with elevated AL T levels at baseline became normal in 60.3% of the lamivudine treated group comp ared with the placebo group where only 27.5% were normal (P<0.01). L amivudine was well tolerated in a dose of (100?mg daily) and the overall incide nce of adverse events was similar to that of the placebo. Conclusions Lamivudine (100 mg daily) is very effective in the inhibiti on of HBV replication, indicated by the rapid loss of serum HBV DNA, and often acco mpanied by a decrease of serum ALT levels. Lamivudine is well tolerated withou t severe adverse events during treatment.展开更多
文摘Objective To evaluate the effect of lamivudine on the loss of serum he patitis B virus (HBV) DNA, HBeAg/antiHBe seroconversion and ALT levels in chron ic hepatitis B patients and its safety profile and tolerance compared with place bo.Methods Four hundred and twenty nine patients with chronic HBV infecti on as defined by positive HBsAg, HBeAg and HBV DNA were enrolled and randomized into lamivudine and placebo groups. Three hundred and twenty two patients recei ved lamivudine 100?mg daily and 107 patients received placebo treatment for 12 weeks. Then, all patients were offered a further 9 month open label lamivudine treatment. The efficacy and safety were evaluated with clinical, biochemical, hematological and virological parameters. Results During the 12 week treatment period, 92.2% of lamivudine t reate d patients became HBV DNA negative (below 1.6?pg/ml) compared with only 14.1% o f those receiving placebo (P<0.01). At the end of 12 week, the sust ained negative rate for HBV DNA in the lamivudine treated group was 78.5% compar ed with the placebo group (11.1%; P< 0.01). There was a trend to a high proportion of patients treated with lamivudine to lose HBeAg (8.1%) and d evelop antiHBe (10.2%) than treated with placebo (5.3% and 6.4% respectively), b ut this difference was not statistically significant. Patients with elevated AL T levels at baseline became normal in 60.3% of the lamivudine treated group comp ared with the placebo group where only 27.5% were normal (P<0.01). L amivudine was well tolerated in a dose of (100?mg daily) and the overall incide nce of adverse events was similar to that of the placebo. Conclusions Lamivudine (100 mg daily) is very effective in the inhibiti on of HBV replication, indicated by the rapid loss of serum HBV DNA, and often acco mpanied by a decrease of serum ALT levels. Lamivudine is well tolerated withou t severe adverse events during treatment.
