De Aloysio D, Rovati L C, Giacovelli G, Setnikar I, Bottiglioni F
Department of Obstetrics and Gynecology, University of Bologna, Italy.
Arzneimittelforschung. 2000 Mar;50(3):293-300. doi: 10.1055/s-0031-1300202.
Two estradiol (E2) transdermal patches releasing 25 micrograms/day E2 (D-25) or 37.5 micrograms/day E2 (D-37.5) were compared to a placebo patch on 156 patients in natural or surgical menopause suffering from at least 5 hot flushes per day, randomly and blindly assigned to three parallel groups of 52 patients each, to be treated continuously for 12 weeks, without progestin opposition. "Responders" (patients with less than 3 hot flushes per day at the end of treatment), were 82% and 90% under D-25 or D-37.5, respectively, both significantly (p < 0.001) more than under placebo (44%). Comparable efficacy was observed on severity of hot flushes, Kupperman Index and on the self-rated efficacy. Systemic adverse events occurred in 10%, 10% and 8% of patients, respectively, under D-25, D-37.5 or placebo. Occasional mild and transient itching and/or erythema on the site of application was reported by few patients and did never require discontinuation of application. In conclusion D-25 and D-37.5 were significantly more effective than placebo in relieving climacteric symptoms and were systemically and locally as well tolerated as placebo. D-25 (Demestril 25) releasing 25 micrograms/day E2 can therefore be recommended for low-dosed estrogen replacement therapy.
将每日释放25微克雌二醇（E2）的两种经皮雌二醇贴片（D - 25）或每日释放37.5微克雌二醇的贴片（D - 37.5）与安慰剂贴片进行比较，研究对象为156名处于自然绝经或手术绝经状态、每日至少有5次潮热的患者，这些患者被随机、盲法分配到三个平行组，每组52名患者，持续治疗12周，且无孕激素拮抗。“有反应者”（治疗结束时每日潮热少于3次的患者）在D - 25或D - 37.5治疗组中的比例分别为82%和90%，两者均显著高于安慰剂组（44%，p < 0.001）。在潮热严重程度、库珀曼指数和自我评估疗效方面观察到了类似的效果。全身不良事件在D - 25、D - 37.5或安慰剂治疗组中的发生率分别为10%、10%和8%。少数患者报告在贴片应用部位偶尔出现轻度和短暂的瘙痒和/或红斑，但从未需要停止应用。总之，D - 25和D - 37.5在缓解更年期症状方面比安慰剂显著更有效，并且在全身和局部的耐受性与安慰剂相当。因此，每日释放25微克E2的D - 25（地美雌醇25）可推荐用于低剂量雌激素替代疗法。
