[Clinical study of anti-hepatic fibrosis effect of IFN-gamma in patients with chronic hepatitis B].
OBJECTIVE
This was an open, random, control and multicenter clinical trial. In the study, the anti-hepatic fibrosis effect of rhIFN-gamma and its side reactions were evaluated.


METHODS
A total of 289 patients enrolled in clinical trial, 153 patients in trial group and 136 patients in control group. The routine strategy is given in all patients. In addition, every patient in trial group received rhIFN-gamma at a dose of 1 MU intramuscularly daily for the first three months and 1 MU every other day for the following six months. Patients of two groups were followed up for another three months after the treatment. Histological indices, serum hepatic fibrosis indices, ultrasound B and symptoms and signs evaluated the effect. For patients who accepted two liver biopsies before and after treatment, the effect was determined by semiquantitative score system while for patients who did not accepted liver biopsy, serum hepatic fibrosis indices and ultrasound B were major criteria.


RESULTS
The efficient of treatment were 66% in trial group vs. 16.2% in control group and the obviously efficient of treatment was 27.8% in trial group vs. 7.4% in control group (P < 0.001). For patients who accepted two liver biopsies before and after treatment, the efficient of treatment was 63% in trial group vs. 24.1% in control group and the obviously efficient of treatment was 27.8% in trial group vs. 13.8%. For patients who did not accepted liver biopsy, the efficient of treatment was 67.7% in trial group vs. 14.0% in control group and the obviously efficient of treatment was 22.2% in trial group vs. 5.6%. None of patients emerged serious side reactions during clinical trial.


CONCLUSIONS
The results confirmed that rhIFN-gamma have a better anti-hepatic fibrosis effect to patients with chronic hepatitis B.
Weng
Hong-lei
HL
Institute of Infectious Diseases, First Affiliated Hospital, Medical School, Zhejiang University, Hangzhou 310003, China.
Cai
Wei-min
WM
Wang
Bao-en
BE
Jia
Ji-dong
JD
Zhou
Xia-qiu
XQ
Shi
Dong-mei
DM
Zhang
Ding-feng
DF
Zhao
You-rong
YR
Hao
Lian-jie
LJ
Wang
Si-yuan
SY
Wu
Wan-fen
WF
Xian
Jian-zhong
JZ
D000328:Adult; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007371:Interferon-gamma / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins
D011994:Recombinant Proteins; D007371:Interferon-gamma