重组干扰素γ治疗慢性乙型肝炎肝纤维化临床研究

Clinical study of anti-hepatic fibrosis effect of IFN-γ in patients with chronic hepatitis B

目的 评估干扰素 (IFN) γ治疗慢性乙型肝炎肝纤维化的疗效以及不良反应。方法 临床研究共入选慢性乙型肝炎肝纤维化病例 2 89例 ,其中试验组 1 53例 ,对照组 1 36例。分为肝活检组和非肝活检组 2部分。所有患者均接受慢性肝炎常规治疗 ,试验组同时接受rhIFN γ注射 ,对照组不使用IFN γ。IFN γ治疗方案 :1 0 0万IU/支 ,肌注 ,9个月为一疗程。前 3个月每日一次 ,每次 1支 ,后 6个月隔日 1次 ,每次 1支 ,停药后观察 3个月。观察指标包括组织学、血清学、影像学及症状体征等。疗效判定标准 :肝活检组以治疗前后组织学改变为主要依据 ,采用半定量计分标准评价 ;非肝活检组以血清肝纤维化指标和影像学改变为主要依据。结果 肝活检组 :试验组总有效率为 63 %(其中显效率为 2 7 8% ) ,对照组总有效率为 2 4 1 % (显效率为 1 3 8% )。非肝活检组 :试验组总有效率为 67 7% (其中显效率为 2 2 2 % ) ,对照组总有效率为 1 4 0 % (显效率为 5 6 % )。综合比较IFN γ治疗慢性乙型病毒性肝炎肝纤维化试验组总有效率为 66 % (其中显效率为 2 4 2 % ) ,对照组总有效率为 1 6 2 % (显效率为 7 4% ) ,两组比较差异非常显著 (P <0 0 0 1 )。临床研究未出现严重不良反应。结论 rhIFN

Objective This was an open, random, control and multicenter clinical trial In the study, the anti hepatic fibrosis effect of rhIFN γ 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 γ 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 Conclusion The results confirmed that rhIFN γ have a better anti hepatic fibrosis effect to patients with chronic hepatitis B