普罗雌烯胶囊用于绝经后萎缩性阴道炎的安全性

Sun Ai-jun, Lin Shou-qing, Jing Lian-hong, Wang Zi-yi, Ye Jia-lin, Zhang Ying

Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.

Zhonghua Fu Chan Ke Za Zhi. 2009 Aug;44(8):593-6.

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 self-control 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 (E(2)) 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 E(2) was (71 +/- 3) U/L and (41 +/- 18) pmol/L, the mean thickness of endometrium was (2.4 +/- 0.9) mm. After treatment, the mean level of FSH and E(2) 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 cases 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.

目的

探讨普罗雌烯胶囊治疗绝经后萎缩性阴道炎的安全性和有效性。

方法

选取53例年龄在45 - 75岁（绝经1年以上）、诊断为绝经后萎缩性阴道炎的女性进行自身对照研究。她们均有典型的绝经后阴道炎症状。采用连续给药20天，然后维持治疗8周（每周2次，每次1片）的方式给予普罗雌烯。检测治疗前后血清卵泡刺激素（FSH）和雌二醇（E₂）水平以及子宫内膜厚度。以常规生化检查作为监测安全性的指标。采用阴道成熟指数（VMI）、萎缩性阴道炎评估评分和阴道健康评估评分来评价治疗效果。同时记录不良反应。

结果

（1）安全性：在普罗雌烯治疗期间，未观察到不良反应病例。治疗前，FSH和E₂的平均水平分别为（71±3）U/L和（41±18）pmol/L，子宫内膜平均厚度为（2.4±0.9）mm。治疗后，FSH和E₂的平均水平分别为（67±22）U/L和（43±37）pmol/L，子宫内膜平均厚度为（2.5±1.3）mm。差异无统计学意义（P＞0.05）。（2）治疗效果：治疗前VMI为42±15，治疗后为54±8。萎缩性阴道炎评估评分治疗前为3.4±1.7，治疗后为1.5±1.4。阴道健康评估评分治疗前为7.8±2.4，治疗后为12.0±2.4。差异均有统计学意义（P＜0.01）。（3）不良反应：观察到6例阴道出血、3例乳腺结节和1例宫颈息肉，但不确定这些事件是否与使用普罗雌烯有关。