|
Accession number;05A1018895
|
| Title;Clinical trial of Zefix (lamivudine) for HBV related liver cirrhosis-placebo-controlled double blind comparative study and long-term study- |
| Author;
IINO SHIRO
(Seizankai Kiyokawabyoin)
KUMADA HIROMITSU
(Kokkakomuinkyosaikumiairengokai Toranomonbyoin)
SATA MICHIO
(Kurume Univ.)
OKANOUE TAKESHI
(Kyoto Prefectural Univ. Medicine, JPN)
|
Journal Title;Journal of Clinical Therapeutics & Medicines
|
Journal Code:Y0906A
|
ISSN:0910-8211
|
|
VOL.21;NO.11;PAGE.1097-1111(2005)
|
| Figure&Table&Reference;FIG.8, TBL.4, REF.22 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The efficacy and the safety of lamivudine (Zefix Tablets) were evaluated in HBV related liver cirrhosis patients. For this purpose, 24-week, double-blind, placebo-controlled study followed by 52-week long-term open study were conducted. 1) HBV DNA was significantly decreased in the lamivudine group compared to the placebo group in Week 24, and the effect was continued for 52 weeks during the long-term study. 2) ALT tended to decrease in Week 2 in the lamivudine group, and was significantly decreased in the lamivudine group in Week 24 compared to the placebo group. Further decrease was observed at the end of the long-term therapy. 3) Albumin tended to increase in Week 8 in the lamivudine group, and was significantly increased in the lamivudine group in Week 24 compared to the placebo group. The effect was continued to the end of the long-term therapy. 4) Seven of 15 patients (46.7%) for 76-week lamivudine therapy experienced adverse events including abnormal laboratory test. All adverse events were mild or moderate and none of the adverse events showed aggravation for prolonging lamivudine therapy. (author abst.) |
|
|
|
Related Articles;
|
