Ellis C N, Gorsulowsky D C, Hamilton T A, Billings J K, Brown M D, Headington J T, Cooper K D, Baadsgaard O, Duell E A, Annesley T M
JAMA. 1986 Dec 12;256(22):3110-6.
In a double-blind trial, 21 patients with severe plaque psoriasis were randomly assigned to receive oral cyclosporine, 14 mg/kg/d, or its vehicle. After four weeks of therapy the 11 cyclosporine recipients had the following response to treatment: two had total clearing and six improved markedly, two moderately, and one minimally; whereas ten vehicle-treated patients showed no change or minimal improvement. Vehicle-treated patients, after a switch to cyclosporine for four weeks, demonstrated impressive improvement similar to that seen in patients who initially received only cyclosporine. Moderate or marked improvement or total clearing was noted in 17 (81%) of 21 and 20 (95%) of 21 after one and four weeks of therapy, respectively. Mitotic figures and leukotriene B4 levels in lesions decreased 86% and 64%, respectively, after seven days of cyclosporine therapy. Mononuclear (including activated T cells) and polymorphonuclear leukocyte infiltrates were markedly reduced in lesions of all patients after seven days of cyclosporine therapy. These results suggest that psoriasis may have an immunologic basis mediated by activated T cells and/or other immune cells; if a long-term regimen with a favorable efficacy-side effect ratio can be determined, cyclosporine would be a significant advance in the treatment of psoriasis.
在一项双盲试验中,21例重度斑块状银屑病患者被随机分配接受口服环孢素(14mg/kg/d)或其赋形剂。治疗四周后,11例接受环孢素治疗的患者对治疗的反应如下:2例完全清除,6例显著改善,2例中度改善,1例轻度改善;而10例接受赋形剂治疗的患者无变化或仅有轻微改善。接受赋形剂治疗的患者在改用环孢素治疗四周后,显示出与最初仅接受环孢素治疗的患者相似的显著改善。治疗一周和四周后,21例患者中分别有17例(81%)和20例(95%)出现中度或显著改善或完全清除。环孢素治疗七天后,皮损中的有丝分裂象和白三烯B4水平分别下降了86%和64%。环孢素治疗七天后,所有患者皮损中的单核细胞(包括活化T细胞)和多形核白细胞浸润均明显减少。这些结果表明,银屑病可能有由活化T细胞和/或其他免疫细胞介导的免疫基础;如果能确定一种疗效-副作用比良好的长期治疗方案,环孢素将是银屑病治疗的一项重大进展。