TY - JOUR
T1 - Beneficial effect of prednisolone withdrawal followed by human lymphoblastoid interferon on the treatment of chronic type B hepatitis in Asians
T2 - a randomized controlled trial
AU - Liaw, Yun Fan
AU - Lin, Shi Ming
AU - Chen, Tong Jong
AU - Chien, Rong Nan
AU - Sheen, I. Shyan
AU - Chu, Chia Ming
PY - 1994
Y1 - 1994
N2 - To evaluate the effect of interferon and the benefit of prednisolone pretreatment in Oriental patients with chronic active hepatitis B, 120 male Chinese patients were randomly allocated to receive: 1) group A: a 4-week course of prednisolone followed by 2 weeks of no treatment and then a 12-week course of human lymphoblastoid interferon, 4 to 6 MU/m2 intramuscularly; 2) group B: as group A, but with placebo given instead of prednisolone; 3) group C: an 18-week course of placebo. Clearance of serum hepatitis B virus-DNA and HBeAg (complete response) was achieved in 21% of group A, 5% of group B and none of group C at the end of therapy (A vs B: p=0.054; A vs C: p<0.01). When assessed 12 months after the end of therapy, the complete response rate was 46% in group A, 24% in group B and 25% in group C (p<0.05). Those with baseline alanine transaminase ≤200 U/l showed a better response to interferon following prednisolone withdrawal (48%) than with interferon therapy alone (20%, p=0.056) and no treatment (9%, p<0.01). Those with a baseline serum hepatitis B virus-DNA ≤1000 pg/ml also showed a higher complete response rate when pretreated with prednisolone (59%) than when treated with interferon alone (29%, p=0.084) or untreated (22%, p<0.03). The strongest independent predictor of a response to treatment was prednisolone withdrawal (p<0.05). None of the responders lost hepatitis B surface antigen. Blinded histologic assessment showed a significant improvement, particularly in lobular necroinflammation (p<0.02). These results suggest that prednisolone withdrawal followed by interferon therapy is effective and safe in Chinese patients with chronic active hepatitis B, particularly those with lower pretreatment serum alanine transaminase and hepatitis B virus-DNA levels.
AB - To evaluate the effect of interferon and the benefit of prednisolone pretreatment in Oriental patients with chronic active hepatitis B, 120 male Chinese patients were randomly allocated to receive: 1) group A: a 4-week course of prednisolone followed by 2 weeks of no treatment and then a 12-week course of human lymphoblastoid interferon, 4 to 6 MU/m2 intramuscularly; 2) group B: as group A, but with placebo given instead of prednisolone; 3) group C: an 18-week course of placebo. Clearance of serum hepatitis B virus-DNA and HBeAg (complete response) was achieved in 21% of group A, 5% of group B and none of group C at the end of therapy (A vs B: p=0.054; A vs C: p<0.01). When assessed 12 months after the end of therapy, the complete response rate was 46% in group A, 24% in group B and 25% in group C (p<0.05). Those with baseline alanine transaminase ≤200 U/l showed a better response to interferon following prednisolone withdrawal (48%) than with interferon therapy alone (20%, p=0.056) and no treatment (9%, p<0.01). Those with a baseline serum hepatitis B virus-DNA ≤1000 pg/ml also showed a higher complete response rate when pretreated with prednisolone (59%) than when treated with interferon alone (29%, p=0.084) or untreated (22%, p<0.03). The strongest independent predictor of a response to treatment was prednisolone withdrawal (p<0.05). None of the responders lost hepatitis B surface antigen. Blinded histologic assessment showed a significant improvement, particularly in lobular necroinflammation (p<0.02). These results suggest that prednisolone withdrawal followed by interferon therapy is effective and safe in Chinese patients with chronic active hepatitis B, particularly those with lower pretreatment serum alanine transaminase and hepatitis B virus-DNA levels.
UR - http://www.scopus.com/inward/record.url?scp=0028347933&partnerID=8YFLogxK
U2 - 10.1016/S0168-8278(05)80055-8
DO - 10.1016/S0168-8278(05)80055-8
M3 - 文章
C2 - 8006397
AN - SCOPUS:0028347933
SN - 0168-8278
VL - 20
SP - 175
EP - 180
JO - Journal of Hepatology
JF - Journal of Hepatology
IS - 2
ER -