分泌性重组人干扰素α-2a治疗慢性乙型肝炎患者疗效和安全性的研究

Abstract

目的观察国产分泌性干扰素治疗慢性乙型肝炎的疗效与安全性.方法采用随机、开放、对照、多中心的研究方法,以国产普通干扰素作为对照药物,观察分泌性干扰素治疗慢性乙型肝炎6个月,停药随访6个月的疗效与安全性.结果分泌性干扰素在治疗24周时,丙氨酸氨基转移酶(ALT)复常率为48.3%,优于对照组(35.7%),但随访结束时两组差异无显著性.治疗后分泌性干扰素组的H BV DNA下降幅度优于对照组,但转阴率两组间差异无显著性.治疗结束时分泌性干扰素组与对照组的乙型肝炎e抗原(HBeAg)转阴率分别为26.5%和19.4%,HBeAg血清转换率分别为13.5%和12.0%;随访结束时两组的HBeAg转阴率继续增加,分别为32.5%与27.2%,HBeAg血清转换率分别为19.0%和18.4%.两种干扰素的安全性良好.结论分泌性干扰素治疗结束时在ALT复常率、HBV DNA下降幅度方面优于普通干扰素,随访结束时两组间差异无显著性.在HB eAg转阴率和HB eAg血清转换率方面两种干扰素差异无显著性.两种干扰素安全性良好.

To investigate the efficacy and safety of secreted interferon in treatment of chronic hepatitis B.A multi-center randomized open-label controlled clinical trial was carried out. The patients of the study group were treated by secretory human interferon alpha-2a, and the patients of the control group were treated with an ordinary interferon.ALT normalization rate in the secreted interferon group was 48.3% and it was higher at the end of treatment than that of the control group, but there was no difference between the two groups at the end of the follow-up. HBV DNA dropped more in the study drug group, but there was no difference in the normalization rate between the two groups. HBeAg seroconversions in secreted interferon group and in the control interferon group were 19.0% and 18.4% respectively. The safety of the two types of interferon was satisfactory.Secreted interferon was superior to ordinary interferon in ALT normalization and HBV DNA drop at the end of treatment in chronic hepatitis B patients, but there was no difference at the end of the follow-up. There was also no difference in HBeAg negative and HBeAg seroconversion between the two groups.