Hadziyannis S, Bramou T, Makris A, Moussoulis G, Zignego L, Papaioannou C
National Center for Communicable Liver Diseases, Academic Department of Medicine, Hippokration General Hospital, Athens, Greece.
J Hepatol. 1990;11 Suppl 1:S133-6. doi: 10.1016/0168-8278(90)90180-y.
A randomized controlled trial of recombinant interferon alfa-2b has been initiated in patients with chronic active hepatitis who were negative for serum hepatitis B e antigen but positive for serum hepatitis B virus DNA and hepatitis B core antigen expression in the liver. Twenty-five patients received interferon alfa-2b 3 million units thrice weekly for 14-16 weeks and 25 served as untreated controls. Seventeen patients in the treatment and 18 in the control group have already completed a 12-month period of observation. Interferon alfa-2b was well tolerated by all patients. At the end of therapy, complete responses, defined as disappearance of hepatitis B virus DNA from serum and return of alanine aminotransferase to normal, were observed in 10 (59%) of the 17 treated patients compared to none in the control group (p less than 0.01). Twelve months after the onset of interferon alfa-2b therapy, 11 (65%) of the 17 treated patients were complete responders compared to 2 (11%) of 18 in the control group (p less than 0.01). Fifty per cent (4/8) of complete responders to interferon alfa-2b therapy, followed for 16-24 months, experienced reactivations of hepatitis B virus replication with reappearance of serum hepatitis B virus DNA and a return of serum alanine aminotransferase activity. The response to interferon alfa-2b therapy appeared to be independent of pre-treatment serum alanine aminotransferase and hepatitis B virus DNA levels.
一项针对慢性活动性肝炎患者的重组干扰素α-2b随机对照试验已经启动，这些患者血清乙肝e抗原阴性，但血清乙肝病毒DNA阳性且肝脏中有乙肝核心抗原表达。25名患者接受干扰素α-2b，每周三次，每次300万单位，共14 - 16周，25名患者作为未治疗的对照组。治疗组的17名患者和对照组的18名患者已经完成了12个月的观察期。所有患者对干扰素α-2b耐受性良好。治疗结束时，治疗的17名患者中有10名（59%）出现完全缓解，定义为血清中乙肝病毒DNA消失且丙氨酸转氨酶恢复正常，而对照组无一例出现完全缓解（p<0.01）。干扰素α-2b治疗开始12个月后，治疗组的17名患者中有11名（65%）为完全缓解者，而对照组的18名患者中有2名（11%）为完全缓解者（p<0.01）。接受干扰素α-2b治疗的完全缓解者中有50%（4/8）在随访16 - 24个月后出现乙肝病毒复制再激活，血清乙肝病毒DNA再次出现且血清丙氨酸转氨酶活性恢复。干扰素α-2b治疗的反应似乎与治疗前血清丙氨酸转氨酶和乙肝病毒DNA水平无关。
