Ariyanayagam M, Barlow T J, Graham P, Hall-Smith S P, Harris J M
Br J Dermatol. 1985 Mar;112(3):343-8. doi: 10.1111/j.1365-2133.1985.tb04863.x.
A double-blind, group comparison trial of a topical cream containing 4% sodium cromoglycate (SCG) was undertaken in forty-six patients with chronic atopic eczema. A statistically significant improvement was seen after 9 weeks in the actively treated patients compared with the placebo group. However, in general, no benefit was observed in severe eczema, perhaps due in some part to the seemingly late onset of action of SCG. Measurement of total serum IgE before and after the trial showed an increase in levels which was apparently unrelated to treatment with SCG or placebo or to a change in severity of the eczema. The amount of SCG in the urine was small and very variable, indicating low percutaneous absorption. The calculated bioavailability ranged from 0.01% to 2.75% of the applied dose. These results together with follow-up studies suggest that topical SCG as a long-term measure may be useful in the management of mild or moderately severe eczema, reducing the frequency of acute exacerbations.
对46例慢性特应性皮炎患者进行了一项含4%色甘酸钠(SCG)外用乳膏的双盲分组对照试验。与安慰剂组相比,积极治疗的患者在9周后有统计学意义的改善。然而,总体而言,在严重湿疹中未观察到益处,这可能部分归因于SCG起效似乎较晚。试验前后血清总IgE的测量显示水平升高,这显然与SCG或安慰剂治疗无关,也与湿疹严重程度的变化无关。尿中SCG含量少且变化很大,表明经皮吸收低。计算出的生物利用度为给药剂量的0.01%至2.75%。这些结果以及后续研究表明,外用SCG作为一种长期措施可能有助于治疗轻度或中度严重湿疹,减少急性加重的频率。