Holdaway I M, Croxson M S, Ibbertson H K, Sheehan A, Knox B, France J
Acta Endocrinol (Copenh). 1985 Aug;109(4):522-9. doi: 10.1530/acta.0.1090522.
Thirty-four patients with hirsutism were treated for 9 months with 100 mg cyproterone acetate (CA) given on days 5-15 of the menstrual cycle together with a combination oral contraceptive containing 2 mg CA and 50 micrograms ethinyloestradiol (Diane) given on days 5-25 of the cycle. After 9 months treatment patients were randomised to a 12 month double-blind cross-over trial comparing Diane plus 25 mg CA with Diane plus placebo, to test the efficacy of low-dose CA as maintenance therapy. Thirty-one patients (92%) experienced moderate or good subjective improvement in hirsutism on high-dose CA, associated with a 40% mean overall improvement in objective hirsutism grade and 13% overall reduction in hair growth rate measured by a photographic technique. Minor or moderate side effects were experienced by 64% of patients and severe side effects by 11% at this dosage. There was a mean subjective relapse rate of 33% when patients were changed to low dose CA, and relapse rates were not significantly different between the two regimens with 28% relapsing on 25 mg CA + Diane and 48% on placebo and Diane (P less than 0.05). Despite significant subjective relapse with low-dose treatment there was no significant deterioration in objective hirsutism grade or hair growth rate determined photographically. Levels of plasma testosterone, sex hormone binding globulin, free testosterone (derived) and androstenedione fell significantly on high dose CA and this reduction was maintained during low dose therapy.(ABSTRACT TRUNCATED AT 250 WORDS)
34名多毛症患者在月经周期的第5 - 15天接受100毫克醋酸环丙孕酮(CA)治疗9个月,同时在周期的第5 - 25天服用含2毫克CA和50微克乙炔雌二醇的复方口服避孕药(达英)。9个月治疗后,患者被随机分为12个月的双盲交叉试验,比较达英加25毫克CA与达英加安慰剂,以测试低剂量CA作为维持治疗的疗效。31名患者(92%)在高剂量CA治疗下多毛症有中度或良好的主观改善,客观多毛症等级平均总体改善40%,通过摄影技术测量毛发生长率总体降低13%。此剂量下64%的患者出现轻微或中度副作用,11%出现严重副作用。当患者改用低剂量CA时,平均主观复发率为33%,两种治疗方案的复发率无显著差异,25毫克CA + 达英组复发率为28%,安慰剂 + 达英组为48%(P < 0.05)。尽管低剂量治疗有明显主观复发,但客观多毛症等级或摄影测量的毛发生长率无显著恶化。高剂量CA治疗时血浆睾酮、性激素结合球蛋白、游离睾酮(计算值)和雄烯二酮水平显著下降,且在低剂量治疗期间维持这种降低。(摘要截选至250字)