Cornell R C
Department of Dermatology and Cutaneous Surgery, Scripps Clinic and Research Foundation, La Jolla, California 92037-1093.
Int J Dermatol. 1992 Oct;31 Suppl 1:38-40. doi: 10.1111/j.1365-4362.1992.tb04012.x.
It would be desirable to develop an alternative system to clinical studies to evaluate the potency of generic topical corticosteroids and of new formulations of existing innovator corticosteroids. The vasoconstrictor assay is a reliable method for testing potency; however, its results do not always agree with clinical studies. Psoriasis offers an ideal clinical model to evaluate corticoid potency because the ability to perform within-patient comparisons of the treatment of bilateral lesions permits meaningful comparisons with a relatively small sample size. The results of bilateral comparisons in psoriasis agreed with those of the vasoconstrictor assay in 20 of 23 comparisons of active agents and in numerous comparisons of active corticosteroids with a placebo. Eczematous dermatoses do not lend themselves well to bilateral paired comparison studies and therefore require parallel treatment studies with relatively large sample sizes to produce statistically significant comparisons.
开发一种替代临床研究的系统来评估非专利外用皮质类固醇和现有创新皮质类固醇新配方的效力将是可取的。血管收缩测定法是测试效力的可靠方法；然而，其结果并不总是与临床研究一致。银屑病为评估皮质类固醇效力提供了一个理想的临床模型，因为对双侧皮损进行患者内治疗比较的能力允许在相对较小的样本量下进行有意义的比较。在23次活性剂比较中的20次以及活性皮质类固醇与安慰剂的多次比较中，银屑病双侧比较的结果与血管收缩测定法的结果一致。湿疹性皮肤病不太适合进行双侧配对比较研究，因此需要采用样本量相对较大的平行治疗研究来进行具有统计学意义的比较。
