Nilsson K, Heimer G
Department of Obstetrics and Gynaecology, Orebro Medical Center Hospital, Sweden.
Maturitas. 1992 Oct;15(2):121-7. doi: 10.1016/0378-5122(92)90246-z.
Twenty-four postmenopausal women with vaginal atrophy due to oestrogen deficiency were treated with 17 beta-oestradiol administered as vaginal tablets containing 10 and 25 micrograms, respectively, in a slow-release system (Vagifem, Novo Nordisk, Denmark). All the women were treated for 2 weeks with each dose in a double-blind, cross-over study. Plasma concentrations of unconjugated oestradiol and unconjugated oestrone were measured at regular intervals for 24 h on days 1 and 14 of each treatment regimen. Cytological and clinical evaluations of the vaginal and urethral epithelium were also carried out. Initially, when the epithelium was still atrophic, dose-dependent absorption of oestradiol was demonstrated. After 14 days of treatment maturation of the vaginal epithelium was seen with both regimens and the absorption of oestradiol then declined significantly on both the 10 and the 25 micrograms dose. Oestrone levels remained unchanged and gonadotrophin levels were unaffected during treatment. Vaginal cytology showed maturation on both the 10 and the 25 micrograms dose, whereas urethral cytology showed a reduction in parabasal cells that was significant only on 25 micrograms. Clinical and subjective improvement was apparent on both doses and acceptance of treatment was good.
24名因雌激素缺乏导致阴道萎缩的绝经后女性，接受了分别含10微克和25微克17β - 雌二醇的阴道缓释片（丹麦诺和诺德公司的Vagifem）治疗。在一项双盲交叉研究中，所有女性每种剂量均治疗2周。在每个治疗方案的第1天和第14天，每隔一定时间测量24小时内未结合雌二醇和未结合雌酮的血浆浓度。还对阴道和尿道上皮进行了细胞学和临床评估。最初，当上皮仍处于萎缩状态时，显示出雌二醇的剂量依赖性吸收。治疗14天后，两种治疗方案均可见阴道上皮成熟，然后10微克和25微克剂量的雌二醇吸收均显著下降。治疗期间，雌酮水平保持不变，促性腺激素水平未受影响。阴道细胞学显示10微克和25微克剂量均有成熟表现，而尿道细胞学显示基底旁细胞减少，仅在25微克剂量时显著。两种剂量均有明显的临床和主观改善，且治疗接受度良好。
