Henneicke-von Zepelin H H, Mrowietz U, Färber L, Bruck-Borchers K, Schober C, Huber J, Lutz G, Kohnen R, Christophers E, Welzel D
Department of Dermatology, University of Kiel, Germany.
Br J Dermatol. 1993 Dec;129(6):713-7. doi: 10.1111/j.1365-2133.1993.tb03338.x.
We report the results of a multicentre, double-blind, placebo-controlled study of topical therapy with omega-3-polyunsaturated fatty acids (omega-3-PUFA) in 52 patients suffering from moderate plaque-type psoriasis. In each patient, two similar stable psoriatic plaques served as indicator lesions for the study. One indicator lesion was randomly assigned to treatment with topical preparations of highly purified omega-3-PUFA in one of two concentrations (1 or 10%), and the other was treated with placebo. Efficacy assessment was based on changes in local psoriasis severity index, area involved, erythema, desquamation, induration and pruritus. After 8 weeks of treatment, all indicator lesions had improved significantly, compared with baseline. However, no statistically or clinically relevant differences between the omega-3-PUFA-treated and the placebo-treated lesions were found. Therapy was well tolerated and, apart from one patient who developed perilesional eczema, no clinically relevant adverse events occurred. In conclusion, topical omega-3-PUFA were not effective in a randomized, placebo-controlled, double-blind setting. Results of non-blind trials should be (re-)considered with caution.
我们报告了一项多中心、双盲、安慰剂对照研究的结果，该研究对52例中度斑块型银屑病患者进行了ω-3多不饱和脂肪酸（ω-3-PUFA）局部治疗。在每位患者中，选取两个相似的稳定银屑病斑块作为研究的指示性皮损。其中一个指示性皮损被随机分配接受两种浓度（1%或10%）之一的高纯度ω-3-PUFA局部制剂治疗，另一个则接受安慰剂治疗。疗效评估基于局部银屑病严重程度指数、受累面积、红斑、脱屑、硬结和瘙痒的变化。治疗8周后，与基线相比，所有指示性皮损均有显著改善。然而，在接受ω-3-PUFA治疗的皮损和接受安慰剂治疗的皮损之间，未发现统计学或临床相关差异。治疗耐受性良好，除了1例出现皮损周围湿疹的患者外，未发生临床相关不良事件。总之，在随机、安慰剂对照、双盲环境下，局部使用ω-3-PUFA无效。非盲法试验的结果应谨慎（重新）考虑。
