国产基因工程干扰素α1治疗慢性乙型肝炎的临床研究

A CLIN1CAL STUDY ON TREATMENT OF CHRONIC VIRAL HEPATITIS B USING DOMESTIC RECOMBINANT HUMAN INTERFERON ALPHA-1

２２５例慢性乙型肝炎分三组治疗，Ａ和Ｂ组７４例配对随机用干扰素α１及安慰剂双盲对照观察，Ｃ组１５１例为干扰素α１４０微克连用三个月，ＨＢｅＡｇ、ＨＢＶ－ＤＮＡ、ＨＢｅＡｇ和ＨＢＶ－ＤＮＡ双转阴率及抗ＨＢｅ转阳率分别为４０．５％、５７．１％、３９．３％及２９．７％，与对照组差异有非常显著性（Ｐ＜０．０１）。扩大治疗组结果与Ａ组相似，均明显优于对照组。治疗组随访半年和一年ＨＢｅＡｇ及ＨＢＶ－ＤＮＡ转阴率与治疗结束时相似，表明有较持久的效果。

25 patients with chronic viral hepatits B entered into the study for the effect ofrecombinant human IFN-a1.These patients were allocated into 3 groups. A randomized dubleblind sequential clinical trial in the matched pairs was designed.74 patients were allocatedinto Group A treatment and Group B control,and they were treated with IFN-al and placebo,respectively. Group C was the extended treatment group, including l5l patients. The resultsshowed the negative-convertion rates of HBeAg, HBV DNA,both HBeAg and HBV-DNA,andthe positive-convertion rate of anti-HBe in Group A were 40.5%,57.1%,39.3%and 29.7%respective,those in Group B were 8.1%,24%,8% and 2.7% respectively,and those in GroupC57.6%, 64%, 45.3%and 33%, which were similar to those in the Group A. These resultssuggest that there were significant difference between the treatment groups and the controlgroups (P<0.01).The results of the follow-up survery showed the negative-convertion rates ofHBeAg and HBV DNA after 6 months of treatment were 54% and 50.9%, after l2 months59.8% and 56.9%,respectively。These results indicated a strong inhibition of the replicationof HBV. The HBeAg negative-convertion rate induced by IFN-αl was 5 times higher than thatof natural convertion.