van der Rhee H J, Tijssen J G, Herrmann W A, Waterman A H, Polano M K
Br J Dermatol. 1980 Feb;102(2):203-12. doi: 10.1111/j.1365-2133.1980.tb05693.x.
In a multicentre double-blind trial the effect of three therapy regimens was studied for 6 weeks in ninety psoriasis patients: (1) aromatic retinoid (Ro 10-9359) orally (0.50-0.66 mg/kg body weight) and placebo cream topically; (2) aromatic retinoid (Ro 10-9359) (same dosage) with 0.1% triamcinolone acetonide and 5% salicylic acid in lanette wax cream; (3) placebo capsules with 0.1% triamcinolone acetonide and 5% salicylic acid in lanette wax cream. Regimen 1 had virtually no effect and regimen 2 gave better results than regimen 3 for almost all parameters, although statistical significance was reached for only some of them. The 6 week double-blind period was followed by an open study in which all patients were treated according to regimen 2. The clinical result could be maintained up to the end of the study (18 weeks), when more than 60% of the patients showed good to excellant (80-100%) improvement. Most of the side-effects of retinoid were mild and relatively rare. It is concluded that the combination of the aromatic retinoid (Ro 10-9359) given in low dosage orally with corticosteroids topically is as effective as therapy with the retinoid in high dosage alone, but with markedly less side-effects.
在一项多中心双盲试验中,对90名银屑病患者进行了为期6周的三种治疗方案效果研究:(1)口服芳香维甲酸(Ro 10-9359)(0.50-0.66毫克/千克体重)并外用安慰剂乳膏;(2)芳香维甲酸(Ro 10-9359)(相同剂量)与0.1%曲安奈德和5%水杨酸加入羊毛脂蜡乳膏中;(3)安慰剂胶囊与0.1%曲安奈德和5%水杨酸加入羊毛脂蜡乳膏中。方案1几乎没有效果,方案2在几乎所有参数上都比方案3效果更好,尽管只有部分参数达到统计学显著性。6周双盲期后进行了一项开放性研究,所有患者均按照方案2进行治疗。临床效果可持续到研究结束(18周),此时超过60%的患者显示出良好至极佳(80%-100%)的改善。维甲酸的大多数副作用较轻且相对罕见。结论是,低剂量口服芳香维甲酸(Ro 10-9359)与局部使用皮质类固醇联合治疗与单独高剂量使用维甲酸治疗效果相同,但副作用明显更少。