Sommer S, Bojar R, Cunliffe W J, Holland D, Holland K T, Naags H
Department of Dermatology, Leeds General Infirmary.
Clin Exp Dermatol. 1997 Sep;22(5):211-5.
We describe the results of a single-centre, double-blind, vehicle-controlled, parallel group study on the quantitative effects of 2% fusidic acid lotion (Fucidin lotion) in facial acne vulgaris. The trial was completed by 52 patients aged 15-25 years with mild to moderate acne who had been randomized to either Fucidin Lotion (n = 25) or its base (n = 27). Primary outcome measures included colony counts of Propionibacterium acnes and micrococcaceae and measurements of skin surface lipid free fatty acids and sebum excretion rate. Clinical assessment was based on the acne grade, count of inflamed and non-inflamed lesions and evidence of a primary irritant dermatitis. There was a variable but gradual reduction in lesion counts with the maximum improvement at 12 weeks for inflamed lesions, where the reduction was 19.9% for fusidic acid and 24.7% for the placebo. The non-inflamed lesions decreased by 10.8% in the fusidic acid group and increased by 15.9% in the placebo group; this difference was not statistically significant. Although the fusidic acid reduced the micrococcaceae count by 1 log cycle, inferring adequate compliance, there was no reduction in the counts of P. acnes, surface free fatty acids or sebum excretion rate. This study has failed to explain the mechanism of action of topical fusidic acid.
我们描述了一项单中心、双盲、赋形剂对照、平行组研究的结果，该研究旨在探讨2%夫西地酸洗剂（肤轻松洗剂）对面部寻常痤疮的定量影响。该试验由52名年龄在15至25岁之间、患有轻度至中度痤疮的患者完成，他们被随机分为肤轻松洗剂组（n = 25）或其基质组（n = 27）。主要观察指标包括痤疮丙酸杆菌和微球菌科的菌落计数，以及皮肤表面脂质游离脂肪酸和皮脂排泄率的测量。临床评估基于痤疮分级、炎性和非炎性皮损计数以及原发性刺激性皮炎的证据。皮损计数有不同程度但逐渐的减少，炎性皮损在12周时改善最大，夫西地酸组减少19.9%，安慰剂组减少24.7%。夫西地酸组非炎性皮损减少10.8%，安慰剂组增加15.9%；这种差异无统计学意义。虽然夫西地酸使微球菌科计数减少1个对数周期，表明依从性良好，但痤疮丙酸杆菌计数、表面游离脂肪酸或皮脂排泄率均未降低。这项研究未能解释外用夫西地酸的作用机制。
