松奇贴片治疗围绝经期综合征124例疗效分析

Efficacy of Estradiol Hemihydrate Patches used in 124 postmenopausal women

目的探讨半水合雌二醇贴片(商品名松奇)治疗围绝经期综合征的临床疗效。方法 2009年12月至2011年6月应用多中心前瞻性研究方法在全国4家医院共纳入124例绝经后妇女,给予松奇贴片24周治疗,有子宫者加用孕激素,于治疗第4、12、24周检测血清雌二醇(E2)水平,并进行Kupperman评分以评价更年期症状,同时记录乳房胀痛、阴道流血和皮肤过敏等不良反应。结果 (1)生殖激素水平:E2在治疗前为(61.09±50.33)pmol/L,治疗4周时上升为(198.85±307.29)pmol/L(P=0.0003);治疗12周时进一步上升至(258.87±220.40)pmol/L(P=0.0001);治疗24周时为(219.86±190.21)pmol/L(P=0.0000)。(2)Kupperman评分:治疗前Kupperman评分为23.91±8.11,治疗4周后,Kupperman评分较基线时大大下降,为9.05±7.56(P=0.0000);治疗12周时,Kupperman评分又进一步下降,为5.73±5.42(P=0.0000);治疗24周时,Kupperman评分基本维持不变,为5.76±7.03(P=0.0000)。(3)研究期间未观察到严重副反应。结论松奇贴片单独使用或加用口服微粒化孕酮或地屈孕酮能安全有效缓解围绝经期综合征。

Objective To investigate the clinical efficacy of Estradiol Hemihydrate Patches （Fem7） in menopausal women.Methods This multicenter （4 hospitals） prospective study enrolled a total of 124 cases of postmenopausal wom- en, who received 24 weeks of Fem7. Progestin was added to those who had intact uterus. Changes in the serum levels of E2 and Kupperman Index were assessed on the time of visits （at the 4th week, the 12th week and the 24th week）. Breast tenderness, vaginal bleeding and adverse reactions such as skin allergy were recorded simultaneously.Results （ 1 ） Se- rum levels of E2： Serum levels of E2 significantly increased with the treatment, （61.09±50.33）pmol/L （before treatment）, （198.85±307.29）pmol/L（on the 4th week ,P=0.0003）, （258.87±220.40）pmol/L（on the 12th week ,P=0.0001 ） ,（219.86±190.21）pmol/L（on the 24th week , P=0.0000）. （2） Kupperman Index ： Kupperman Index significantly decreased with the treatment, 23.91±8.11 （before treatment）, 9.05±7.56 （on the 4th week , P=0.0000）, 5.73±5.42 （on the 12th week , P=0.0000）, 5.76±7.03 （on the 24th week , P=0.0000）. （3） No serious side effects were observed during the study. Conclusion Estradiol Hemihydrate Patches （Fem7） are well tolerated, providing rapid and effective relief of meno- pausal symptoms with or without oral mieronized progesterone or dydrogesterone.