Foidart J M, Vervliet J, Buytaert P
Department of Biology, University of Liege, Belgium.
Maturitas. 1991 Jun;13(2):99-107. doi: 10.1016/0378-5122(91)90092-5.
In a double-blind, placebo-controlled study, 109 patients suffering from local and vasomotor postmenopausal complaints were randomly assigned to treatment with either depot vaginal suppositories containing 3.5 mg oestriol (E3) or a placebo. The treatment schedule comprised one vaginal suppository twice weekly for 3 weeks initially, followed by maintenance therapy with one vaginal suppository weekly for the 6-month study period. The effectiveness of the therapy was assessed on the basis of questionnaires (Kupperman index for vasomotor complaints and an original urogenital index for local complaints) and gynaecological examinations which included assessments of vaginal cytology, vaginal pH and Döderlein bacilli. To rule out induced endometrial proliferation, endometrial biopsies were performed in 50 women before and after the study. The vaginal depot (E3) formulation showed highly significant superiority over the placebo with respect to therapeutic effect on local urogenital complaints and alleviation of vasomotor complaints, including hot flushes. Analysis of the endometrial biopsies indicated that the monotherapy used caused no endometrial stimulation. Taking into account the minimal rate of adverse effects, the 3.5 mg E3 depot formulation studied represents a useful variant in the range of preparations available for the treatment of post-menopausal complaints.
在一项双盲、安慰剂对照研究中，109名患有局部和血管舒缩性绝经后不适的患者被随机分配接受含3.5毫克雌三醇（E3）的长效阴道栓剂或安慰剂治疗。治疗方案包括最初3周每周两次，每次一枚阴道栓剂，随后在为期6个月的研究期间每周一枚阴道栓剂进行维持治疗。根据问卷调查（血管舒缩性不适的库珀曼指数和局部不适的原始泌尿生殖指数）以及妇科检查（包括阴道细胞学、阴道pH值和杜德林杆菌评估）对治疗效果进行评估。为排除诱导的子宫内膜增生，在研究前后对50名女性进行了子宫内膜活检。长效阴道（E3）制剂在治疗局部泌尿生殖不适和缓解血管舒缩性不适（包括潮热）方面显示出比安慰剂具有高度显著的优越性。对子宫内膜活检的分析表明，所用的单一疗法未引起子宫内膜刺激。考虑到不良反应发生率极低，所研究的3.5毫克E3长效制剂是可用于治疗绝经后不适的现有制剂范围内的一种有用变体。
