关键词: 乙肝转移因子, 慢性乙型肝炎, I、Ⅱ期试验

Abstract: Aim The phase I and A clinical trials were to evaluate the efficacy and safety of HBeAg transfer factor (HBV-TF) in healthy volunteers and chronic hepatitis B(CHB) patients. Methods Phase I trial: Tolerance srudy was conducted in 15 healthy volun-teers in fine groups, by intramuscular injection of 0.25、0.5、1.0、2.0 mg and 4.0 mg HBV-TF very day for 14 days respectively. Cellular immune response tests including specific lymphocyte proliferation and macrophage migration inhibition, were carried out in other 14 healthy volunteer who received 2 mg HBV-TF every day for 14 days. And the dose selection trial was performed in 18 patients with CHB. Phase II trial: 109 cases of chronic hepatitis patients were given randomly HBV-TF 1 mg or placebo and other 309 cases received 1 mg or 2 mg every other day for 3 months respectively. Results 15 healthy volunteers could tolerate HBV-TF well and no adverse reactions were observed. The stimulating index of lymphocyte proliferation in 14 healthy volunteers were increased from 0.77±0.21 to 1.57±0.69 after receiving HBV-TF(P<0.01）.The macrophage migration inhibition index was decreased from 0.926 ± 0.06 to 0.784±0.089 (P<0.05). Dose seleclion study showed that both 1 mg and 2 mg were effective in the clearance of serum HBeAg and HBV-DNA.In 54 HBV-TF treated cases of the 109 cases, the clearance rate of HBeAg and HBV-DNA were 44.4% and 46.9% respectively; while in 55 placebo cases the clearance rate of HBeAg and HBV-DNA were 14.4% and 7.5% (P<0.01).309 patients were randomized into 1 mg and 2 mg treatment groups. After 3 months treatment, the HBeAg and HBV DNA clearance rate in 149 cases of 1 mg treated group were 33.6% and 29.69% respectively, while in 160 cases of 2 mg treated group the clearance rate were 46.3 and 36.2% (P<0.05).After 3 months followed up period, the efficacy in about 70% patients could still be maintained. No prominent adverse drug reaction has been observed during treatment. Conclusion HBsAga specific transfer factor, is effective and safe in the treatment of chronic hepatitis B.

Key words: HBeAg transfer factor, chionic hepatitis B, I and II chlinical trials