Hirvonen E, Cacciatore B, Wahlström T, Rita H, Wilén-Rosenqvist G
Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, Finland.
Br J Obstet Gynaecol. 1997 Nov;104 Suppl 16:26-31. doi: 10.1111/j.1471-0528.1997.tb11564.x.
To compare the efficacy, safety and tolerability of an oestradiol gel (1.0 mg of oestradiol daily, Divigel/Sandrena) with those of an oestradiol delivering patch (delivering 50 micrograms oestradiol/24 h, Estraderm TTS) in hormone replacement therapy of postmenopausal women. Dydrogesterone tablets (Terolut), 10 mg daily for the first 12 days of every month, were used as the progestogen component of the therapy.
The effect of treatment on clinical symptoms and on endometrium, total body bone mineral density and lipid metabolism as well as the tolerability of the treatments with special emphasis on skin irritation and compliance were evaluated.
An open, randomised, controlled, parallel-group trial of 12 months' duration.
The Medical Clinic of Kalevankatu, Helsinki, Finland.
One hundred twenty postmenopausal women were treated with transdermal oestradiol combined with dydrogesterone. In addition, 25 women without HRT served as a reference group for the bone mineral density measurements.
Both treatment regimens were equally effective in alleviating climacteric symptoms, preserving bone mineral density and were equally safe. A trend towards heavier bleeding was detected in patients treated with the oestradiol delivering patch. A statistically nonsignificant decrease of total cholesterol and triglyceride concentrations but no change in high-density lipoprotein cholesterol concentration was observed in both groups. The acceptability of the treatment was higher in the gel group (96.4%) than in the patch group (90.7%). Only two (3.3%) women using the oestradiol gel complained of skin irritation whereas 28 patients (46.7%, P < 0.001) using the oestradiol delivering patch reported this adverse effect.
Both the oestradiol gel and the oestradiol delivering patch are equally effective in hormone replacement therapy but the gel preparation is less irritative to the skin.
比较雌二醇凝胶（每日1.0毫克雌二醇，Divigel/Sandrena）与雌二醇释放贴片（每24小时释放50微克雌二醇，Estraderm TTS）在绝经后女性激素替代治疗中的疗效、安全性和耐受性。治疗的孕激素成分采用地屈孕酮片（Terolut），每月前12天每日10毫克。
评估治疗对临床症状、子宫内膜、全身骨矿物质密度和脂质代谢的影响，以及治疗的耐受性，特别强调皮肤刺激和依从性。
一项为期12个月的开放、随机、对照、平行组试验。
芬兰赫尔辛基卡莱万卡图医疗诊所。
120名绝经后女性接受经皮雌二醇联合地屈孕酮治疗。此外，25名未接受激素替代治疗的女性作为骨矿物质密度测量的参照组。
两种治疗方案在缓解更年期症状、维持骨矿物质密度方面同样有效，且安全性相同。在使用雌二醇释放贴片治疗的患者中检测到有出血增多的趋势。两组均观察到总胆固醇和甘油三酯浓度有统计学意义的非显著性下降，但高密度脂蛋白胆固醇浓度无变化。凝胶组的治疗可接受性（96.4%）高于贴片组（90.7%）。使用雌二醇凝胶的女性中只有两名（3.3%）抱怨有皮肤刺激，而使用雌二醇释放贴片的28名患者（46.7%，P<0.001）报告了这种不良反应。
雌二醇凝胶和雌二醇释放贴片在激素替代治疗中同样有效，但凝胶制剂对皮肤的刺激性较小。
