Fierlbeck G, Rassner G
Department of Dermatology, University of Tübingen, F.R.G.
J Invest Dermatol. 1990 Dec;95(6 Suppl):138S-141S. doi: 10.1111/1523-1747.ep12875040.
In a placebo-controlled double-blind randomized study, 24 patients with psoriatic arthritis were given 28 d of treatment, and in an open study, 56 patients were treated for 9 months. We treated patients with 100 micrograms IFN gamma per subcutaneous injections, which were given daily for the first 2 weeks and then 3 times per week. The principal criterion for evaluation of therapeutic success on arthritis was improvement of the Ritchie joint pain index by at least 25% in the double-blind and 30% in the long-term study. In the double-blind study, the interferon arm was superior to the placebo arm with a statistically significant, one-side error probability of less than 5% in the chi-square test. In the long-term study, IFN gamma caused an improvement in a portion of patients in the first 3 months of therapy. No further improvement was observed after the third month, and patients classified as responders in the first months showed a deterioration of the disease by continuing treatment. The humoral inflammatory parameters did not normalize during therapy. Regression of the skin manifestations could not be observed. IFN gamma is evidently capable of inducing a psoriasis on the injection site. Investigations of IFN gamma serum levels, IFN antibodies, 2'-5' A synthetase levels in serum, and mononuclear blood cells and NK cell activity under long-term therapy showed no explanation for the loss of efficacy after 3 months treatment.
在一项安慰剂对照双盲随机研究中,24例银屑病关节炎患者接受了28天的治疗,在一项开放性研究中,56例患者接受了9个月的治疗。我们给患者皮下注射100微克γ干扰素,最初2周每天注射,之后每周注射3次。评估关节炎治疗成功的主要标准是,在双盲研究中里奇关节疼痛指数改善至少25%,在长期研究中改善30%。在双盲研究中,干扰素组优于安慰剂组,在卡方检验中,单侧误差概率具有统计学意义且小于5%。在长期研究中,γ干扰素在治疗的前3个月使部分患者病情有所改善。3个月后未观察到进一步改善,在最初几个月被归类为有反应者的患者,继续治疗后病情恶化。治疗期间体液炎症参数未恢复正常。未观察到皮肤表现的消退。γ干扰素显然能够在注射部位诱发银屑病。对长期治疗期间γ干扰素血清水平、干扰素抗体、血清中2'-5' A合成酶水平、单核血细胞和NK细胞活性的研究,无法解释治疗3个月后疗效丧失的原因。