Department of Obstetrics and Gynecology and Reproductive Biology, S. Orsola Hospital, University Alma Mater Studiorum of Bologna, Bologna, Italy.
Gynecol Endocrinol. 2011 Oct;27(10):823-9. doi: 10.3109/09513590.2010.526664. Epub 2010 Nov 30.
The long-term effects and tolerability of flutamide (Flu) in women with acne and seborrhea were evaluated. Over the 15-year period, which spans from January 1991 to January 2006, a total of 230 Caucasian women with acne, 211 of which also with seborrhea, received yearly reducing doses (250, 125, and 62.5 mg/day) of Flu alone or combined with oral contraceptive for a period varying from 3 to 6 years and more. Clinical and endocrine evaluations were performed half-yearly and yearly, respectively, in the first 3 years of the study, and yearly in the following years. Liver function evaluations were performed quarterly. Both the groups of patients under Flu therapy showed a similar, marked decrease in acne and seborrhea scores after 6 months of treatment compared with basal values. The maximum drug effect was observed after 1 year, and it was maintained during the following years of treatment. Androgens were strongly suppressed during treatment. During the first year of treatment with 250 mg/day, 4.8% of patients interrupted the study due to hepatic disorders. During the following years on the 125 and 62.5 mg/day doses, no transaminase elevation was observed. The study supports very low-dose Flu as a first-line therapy for women with acne and seborrhea.
评估了氟他胺（Flu）在痤疮和皮脂溢的女性中的长期效果和耐受性。在 1991 年 1 月至 2006 年 1 月的 15 年期间，共有 230 名白种女性痤疮患者，其中 211 名还伴有皮脂溢，接受了每年剂量递减（250、125 和 62.5 mg/天）的 Flu 单独治疗或与口服避孕药联合治疗，治疗时间从 3 年到 6 年以上不等。在前 3 年的研究中，分别每半年和每年进行临床和内分泌评估，在随后的几年中每年进行一次评估。每季度进行肝功能评估。接受 Flu 治疗的两组患者在治疗 6 个月后，痤疮和皮脂溢评分与基础值相比均有明显下降。最大药物效果在治疗 1 年后观察到，并且在随后的治疗年中保持。治疗期间雄激素被强烈抑制。在每天 250 mg 的治疗的第一年，有 4.8%的患者因肝功能障碍而中断研究。在接下来的 125 和 62.5 mg/天剂量的治疗年中，没有观察到转氨酶升高。该研究支持低剂量 Flu 作为治疗痤疮和皮脂溢的一线药物。
