Abstract
Twenty-four patients with primary biliary cirrhosis were entered into a prospective, randomized trial of chlorambucil therapy. Thirteen patients received chlorambucil (0.5-4 mg/day) and 11 patients received no therapy; all have been followed for 2-6 yr (mean, 4.1 yr). Two control but no treated patients died. Average serum bilirubin, serum aspartate aminotransferase activities, and albumin levels improved or remained unchanged in treated patients but worsened in controls. Serum alkaline phosphatase levels did not change in either group. Immunoglobulin M levels decreased and became normal in all treated patients but in only 3 control patients. Liver biopsy histology revealed an improvement in inflammatory cell infiltrate in treated patients in comparison with controls, but no significant change in degree of fibrosis or the histologic stage of disease. Side effects of therapy included bone marrow suppression necessitating discontinuation of the drug in 4 patients. These findings indicate that chlorambucil therapy may retard the progression of primary biliary cirrhosis. Whether such therapy will ultimately decrease morbidity and improve survival in this disease can only be demonstrated by large-scale, placebo-controlled trials.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1327-1334 |
| Number of pages | 8 |
| Journal | Gastroenterology |
| Volume | 91 |
| Issue number | 6 |
| DOIs | |
| State | Published - Dec 1986 |
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ASJC Scopus subject areas
- Hepatology
- Gastroenterology
Cite this
Randomized trial of chlorambucil for primary biliary cirrhosis. / Hoofnagle, Jay H.; Davis, Gary L.; Schafer, Daniel F.; Peters, Marion; Avigan, Mark I.; Pappas, S. Chris; Hanson, Reginald G.; Minuk, Gerald Y.; Dusheiko, Geoffrey M.; Campbell, Gregory; MacSween, Roderick N.M.; Jones, E. Anthony.
In: Gastroenterology, Vol. 91, No. 6, 12.1986, p. 1327-1334.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Randomized trial of chlorambucil for primary biliary cirrhosis
AU - Hoofnagle, Jay H.
AU - Davis, Gary L.
AU - Schafer, Daniel F.
AU - Peters, Marion
AU - Avigan, Mark I.
AU - Pappas, S. Chris
AU - Hanson, Reginald G.
AU - Minuk, Gerald Y.
AU - Dusheiko, Geoffrey M.
AU - Campbell, Gregory
AU - MacSween, Roderick N.M.
AU - Jones, E. Anthony
PY - 1986/12
Y1 - 1986/12
N2 - Twenty-four patients with primary biliary cirrhosis were entered into a prospective, randomized trial of chlorambucil therapy. Thirteen patients received chlorambucil (0.5-4 mg/day) and 11 patients received no therapy; all have been followed for 2-6 yr (mean, 4.1 yr). Two control but no treated patients died. Average serum bilirubin, serum aspartate aminotransferase activities, and albumin levels improved or remained unchanged in treated patients but worsened in controls. Serum alkaline phosphatase levels did not change in either group. Immunoglobulin M levels decreased and became normal in all treated patients but in only 3 control patients. Liver biopsy histology revealed an improvement in inflammatory cell infiltrate in treated patients in comparison with controls, but no significant change in degree of fibrosis or the histologic stage of disease. Side effects of therapy included bone marrow suppression necessitating discontinuation of the drug in 4 patients. These findings indicate that chlorambucil therapy may retard the progression of primary biliary cirrhosis. Whether such therapy will ultimately decrease morbidity and improve survival in this disease can only be demonstrated by large-scale, placebo-controlled trials.
AB - Twenty-four patients with primary biliary cirrhosis were entered into a prospective, randomized trial of chlorambucil therapy. Thirteen patients received chlorambucil (0.5-4 mg/day) and 11 patients received no therapy; all have been followed for 2-6 yr (mean, 4.1 yr). Two control but no treated patients died. Average serum bilirubin, serum aspartate aminotransferase activities, and albumin levels improved or remained unchanged in treated patients but worsened in controls. Serum alkaline phosphatase levels did not change in either group. Immunoglobulin M levels decreased and became normal in all treated patients but in only 3 control patients. Liver biopsy histology revealed an improvement in inflammatory cell infiltrate in treated patients in comparison with controls, but no significant change in degree of fibrosis or the histologic stage of disease. Side effects of therapy included bone marrow suppression necessitating discontinuation of the drug in 4 patients. These findings indicate that chlorambucil therapy may retard the progression of primary biliary cirrhosis. Whether such therapy will ultimately decrease morbidity and improve survival in this disease can only be demonstrated by large-scale, placebo-controlled trials.
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UR - http://www.scopus.com/inward/citedby.url?scp=0023026217&partnerID=8YFLogxK
U2 - 10.1016/0016-5085(86)90183-6
DO - 10.1016/0016-5085(86)90183-6
M3 - Article
C2 - 3533699
AN - SCOPUS:0023026217
VL - 91
SP - 1327
EP - 1334
JO - Gastroenterology
JF - Gastroenterology
SN - 0016-5085
IS - 6
ER -