A RANDOMIZED, CONTROLLED TRIAL OF INTERFERON ALFA-2B ALONE AND AFTER PREDNISONE WITHDRAWAL FOR THE TREATMENT OF CHRONIC HEPATITIS-B

被引:700
作者
PERRILLO, RP
SCHIFF, ER
DAVIS, GL
BODENHEIMER, HC
LINDSAY, K
PAYNE, J
DIENSTAG, JL
OBRIEN, C
TAMBURRO, C
JACOBSON, IM
SAMPLINER, R
FEIT, D
LEFKOWITCH, J
KUHNS, M
MESCHIEVITZ, C
SANGHVI, B
ALBRECHT, J
GIBAS, A
机构
[1] WASHINGTON UNIV,ST LOUIS,MO 63130
[2] UNIV MIAMI,MIAMI,FL 33152
[3] UNIV FLORIDA,GAINESVILLE,FL 32611
[4] RHODE ISL HOSP,PROVIDENCE,RI 02902
[5] BROWN UNIV,PROVIDENCE,RI 02912
[6] UNIV CALIF LOS ANGELES,LOS ANGELES,CA 90024
[7] RUSH PRESBYTERIAN ST LUKES MED CTR,CHICAGO,IL 60612
[8] MASSACHUSETTS GEN HOSP,BOSTON,MA 02114
[9] HOSP UNIV PENN,PHILADELPHIA,PA 19104
[10] CORNELL UNIV,MED CTR,NEW YORK HOSP,NEW YORK,NY 10021
[11] VET AFFAIRS MED CTR,TUCSON,AZ
[12] UNIV ARIZONA,TUCSON,AZ 85721
[13] COLUMBIA UNIV,NEW YORK,NY 10027
[14] ABBOTT LABS,N CHICAGO,IL 60064
[15] SCHERING PLOUGH CORP,KENILWORTH,NJ
关键词
D O I
10.1056/NEJM199008023230503
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background and Methods Chronic hepatitis B is a common and often progressive liver disorder for which there is no accepted therapy. To assess the efficacy of treatment with interferon, we randomly assigned patients with chronic hepatitis B to one of the following regimens: prednisone for 6 weeks followed by 5 million units of recombinant interferon alfa-2b daily for 16 weeks; placebo followed by 5 million units of interferon daily for 16 weeks; placebo followed by 1 million units of interferon daily for 16 weeks; or observation with no treatment. Results. Hepatitis B e antigen and hepatitis B viral DNA disappeared from serum significantly more often in the patients given prednisone plus interferon (16 of 44 patients, or 36 percent) or 5 million units of interferon alone (15 of 41; 37 percent) than in the untreated controls (3 of 43; 7 percent; P<0.001); the difference between those given 1 million units of interferon (7 of 41; 17 percent) and the controls was not significant. The strongest independent predictor of a response to treatment was the amount of hepatitis B viral DNA in serum at entry (P<0.0001). Of the 38 patients who responded to interferon, 33 (87 percent) had normal serum aminotransferase levels after therapy; 11 patients who responded (29 percent), but no controls, lost the hepatitis B surface antigen. Blinded histologic assessment revealed a significant improvement in periportal necrosis in the treated patients (P = 0.03). Conclusions. In chronic hepatitis B, treatment with interferon alfa-2b (5 million units per day for 16 weeks) was effective in inducing a sustained loss of viral replication and achieving remission, assessed biochemically and histologically, in over a third of patients. Moreover, in about 10 percent of the patients treated with interferon, hepatitis B surface antigen disappeared from serum. (N Engl J Med 1990;323:295–301.). © 1990, Massachusetts Medical Society. All rights reserved.
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页码:295 / 301
页数:7
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