Meyer K H
Dtsch Med Wochenschr. 1978 May 26;103(21):887-92. doi: 10.1055/s-0028-1104782.
The effect of prednisone (15 mg/day) or azathioprine (2 mg/kg daily) or a combination of prednisone (10 mg/day) and azathioprine (2 mg/kg daily) was assessed in a controlled multi-centre trial of chronic-active hepatitis. Since 1st January, 1972, a total of 162 patients were registered, 81 previously untreated. Fifty-two of them (30 HBs-antigen negative and 22 positive) fulfilled the criteria for admission to the treatment trial. 27 of 29 patients not fulfilling the criteria had HBs-antigen positive chronic-active hepatitis. All 29 untreated patients had slight active non-progressive chronic-active hepatitis over an observation period of one to four years by clinical, biochemical and histological criteria. Taking into account clinical, biochemical and histological findings, a treatment effect independent of treatment form was noted in 23 of 30 of the HBs-antigen negative patients. In 18 of the 23 successfully treated patients auto-antibodies were demonstrable. In contrast, in 18 of 22 patients with HBs-antigen positive chronic-active hepatitis no objective improvement or influence on the clinical course was observed, independent of form of treatment, and three died. It is concluded that HBs-antigen negative, auto-antibody positive chronic-active hepatitis is an indication for immunosuppressive treatment with prednisone or azathioprine or the two combined.
在一项慢性活动性肝炎的对照多中心试验中,评估了泼尼松(15毫克/天)或硫唑嘌呤(2毫克/千克/天)或泼尼松(10毫克/天)与硫唑嘌呤(2毫克/千克/天)联合使用的效果。自1972年1月1日起,共登记了162例患者,其中81例此前未接受过治疗。其中52例(30例乙肝表面抗原阴性和22例阳性)符合进入治疗试验的标准。29例不符合标准的患者中有27例患有乙肝表面抗原阳性慢性活动性肝炎。根据临床、生化和组织学标准,所有29例未治疗的患者在1至4年的观察期内均患有轻度活动性非进行性慢性活动性肝炎。综合临床、生化和组织学结果,30例乙肝表面抗原阴性患者中有23例出现了与治疗方式无关的治疗效果。在23例成功治疗的患者中,有18例可检测到自身抗体。相比之下,22例乙肝表面抗原阳性慢性活动性肝炎患者中,有18例无论治疗方式如何,均未观察到客观改善或对临床病程的影响,且有3例死亡。结论是,乙肝表面抗原阴性、自身抗体阳性的慢性活动性肝炎是使用泼尼松或硫唑嘌呤或两者联合进行免疫抑制治疗的指征。