普罗雌烯治疗绝经后萎缩性阴道炎的安全性

Safety of promestriene capsule used in postmenopausal atrophic vaginitis

目的评价普罗雌烯治疗妇女绝经后萎缩性阴道炎的安全性。方法采用自身对照临床观察方法，对53例年龄45～75岁、自然绝经1年以上，有绝经后萎缩性阴道炎临床症状的妇女，连续普罗雌烯阴道给药治疗20d，每天1次，每次1粒；然后维持治疗8周（每周用药2次，每次1粒）；用药前及用药结束后测定血清卵泡刺激素（FSH）及雌二醇水平、B超监测子宫内膜厚度、常规血生化检查作为安全性指标，采用阴道脱落细胞成熟值评分、阴道萎缩症状评分与阴道健康评分作为疗效指标，同时记录治疗中发生的小良事件（用药期间任何与药物相关或不相关的不良事件）。结果（1）安伞性：治疗前平均FSH为（71±3）U／L，雌二醇为（41±18）pmol／L，子宫内膜厚度为（2．4±0．9）mm；治疗后平均FSH为（67±22）U／L，雌二醇为（43±37）pmol／L，子宫内膜厚度为（2．5±1．3）mm，治疗前后各指标比较，差异均尤统计学意义（P〉0．05）。（2）疗效：阴道脱落细胞成熟值评分治疗前为（42±15）分，治疗后12周为（54±8）分；阴道萎缩症状评分治疗前为（3．4±1．7）分，治疗后12周为（1．5±1．4）分；阴道健康评分治疗前为（7．8±2．4）分，治疗后12周为（12．0±2．4）分，各指标治疗前后比较，筹异均有统计学意义（P〈0．01）。（3）不良事件：主要包括阴道出血6例、乳房结节3例、宵颈息肉1例，与用药关系不明确。结论普罗雌烯可以安全、可靠地治疗妇女绝经后萎缩性阴道炎。

Objective To investigate the safety and efficacy of promestriene capsule used in the treatment of postmenopausal atrophic vaginitis. Methods Fifty-three women at age of 45 -75 years （more than one year history of menopause） diagnosed with postmenopausal atrophic vaginitis were enrolled in selfcontrol study. They all had typicalsymptoms of postmenopausal vaginitis. Promestriene was given by continuous therapy for 20 days, then maintenance therapy for for 8 weeks （ 1 pill two times per week used）. The level of follicle stimulation hormone （FSH） and estradiol （E2 ） in serum was and thickness of endometrium were detected before and after treatment. The routine biochemical test was used as index to monitoring the safety. The vaginal mature index（VMI） , the atrophic vaginitis evaluating score and vaginal healthy evaluating score were evaluated for therapeutic effect. In the mean time, adverse effect was recorded. Results （1） Safety： during promestriene treatment, no case with adverse effect was observed. Before treatment, the mean level of FSH and E2 was （71 -＋3） U/L and （41 _＋ 18） pmol/L, the mean thickness of endometrium was （2. 4 ±0. 9） ram. After treatment, the mean level of FSH and Ez was （67 ± 22） U/L and （43 ±37） pmol/L, the mean thickness of endometrium was （2.5± 1.3） mm. No significant difference was observed （P 〉 0. 05）. （2） Therapeutic effect： VMI were 42 ± 15 before and 54 ±8 after treatment. The atrophic vaginitis evaluating score were 3.4 ± 1.7 before and 1.5 ±1.4 after treatment. Vaginal healthy evaluating score were 7.8 ± 2.4 before and 12.0 ± 2.4 after treatment. They all showed significant difference （ P 〈 0. 01 ）. （3） Adverse effect ： six eases with vaginal bleeding, 3 cases with breast nodules and 1 case with cervical polyp was observed, however, it was uncertain whether those events were associated with promestriene use. Conclusion The premestriene capsule was safe and effective in the treatment of postmenopausal atrophic vaginitis.