Therapeutic Efficacy And Safeness Of Entecavir In Chronic HBV-infected Patients

Objective:Entecavir capsule, the effectiveness and safeness of curing Chronic Hepatitis B CHB after48weeks which produced from Jiangxi QingFeng pharmaceutical Co., LTD, comparing with LAM(lamivudine) which the trade name is Heptodin, produced from GlaxoSmithKline Pharmaceuticals (Suzhou) Co., Ltd.Methods:A randomized double-blind double-dummy design, the program enrolled260cases, the subjects according to the random number generator using their own drugs, and48weeks of treatment. Unblinding medication after the first random number corresponding group classified as A, B groups, the observed virologic response rates (HBV-DNA<500copy/ml), HBV-DNA load changes, virology, anti-jump rate (HBV-DNA compared with the lowest value increased more than1log10copy/ml), HBeAg negative conversion rate of HBeAg/HBeAb and conversion rates, the ALT normalization rates, as well as in patients with adverse reactions. Statistical analysis after the end of the second unblinded to determine the experimental group and control group.Results:the virological response rates of group A was92.98%,64.29%in Group B, Group A more effective than group B (P<0.0001); of HBV-DNA load:2.69±0.37in group A, group B3.48±1.45; virology anti-jump rate of0.90%in group A, B,15.74%, the occurrence of a rebound in group A, less than group B (P<0.0001); HBeAg negative rate:12,24,36,48weeks, group were28.95%,33.04%,33.33%,40.57%in group B were27.03%,28.44%,32.11%,31.48%at each time point between the two groups was no significant difference; HBeAg/HBeAb and conversion rate:in12,24,36,48weeks, group A was14.81%,14.68%,16.19%,18.81%, group B,14.42%,13.73%,14.56%,15.69%, no statistical difference between each time point group significance; ALT normalization rates:12,24,36,48weeks, in group A were61.74%,78.95%,83.19%,84.40%in group B were47.32%,70.91%,78.70%,78.90%, at each time point between the two groups the difference was not statistically significant; the two groups (A and B) are adverse events were judged to be possible drug-related. A group for the experimental group, group B for the comparing group.Conclusion:Compare with Entecavir capsule and lamivudine tablet, Entecavir is superior to lamivudine by the evaluation of HBV-DNA. There are no differences from these aspects, such as HBeAg negative conversion rate, HBeAg/HBeAb conversion rates, both the efficacy of ALT After often rate. There are Both good safety in the treatment of Chronic Hepatitis B CHB.