UNASSIGNED: This study was a post hoc analysis of data from two phase 3, double-blind studies. Postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg, E1 mg/D5 mg (not included in this analysis) or placebo for 13 weeks (European study), or randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks (Chinese study). Endpoints assessed in ethnicity subgroups (European and Chinese) included changes from baseline in number of hot flushes, number of moderate-to-severe hot flushes and Menopause Rating Scale (MRS) score.
UNASSIGNED: Overall, 579 women were included in the analysis (E0.5 mg/D2.5 mg, n = 288; placebo, n = 291). European and Chinese women receiving E0.5 mg/D2.5 mg experienced greater reductions from baseline in mean daily number of hot flushes and mean daily number of moderate-to-severe hot flushes at week 4, week 8 and end of treatment versus those receiving placebo. Significant improvements in the \'hot flushes, sweating\' MRS item score were reported in both European and Chinese women.
UNASSIGNED: Oral, ultra-low-dose continuous combined 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone improved VMS compared with placebo in European and Chinese postmenopausal women, with a positive impact on health-related quality of life.
■本研究是对来自两个3期双盲研究的数据的事后分析。绝经后妇女以2:1:2随机接受E0.5mg/D2.5mg,E1mg/D5mg(不包括在本分析中)或安慰剂13周(欧洲研究),或随机1:1接受E0.5mg/D2.5mg或安慰剂12周(中国研究)。在种族亚组(欧洲和中国)中评估的终点包括潮热次数相对于基线的变化,中重度潮热次数和更年期评定量表(MRS)评分。
■总的来说,579名女性被纳入分析(E0.5mg/D2.5mg,n=288;安慰剂,n=291)。与接受安慰剂的女性相比,接受E0.5mg/D2.5mg的欧洲和中国女性在第4周,第8周和治疗结束时,平均每日潮热次数和平均每日中度至重度潮热次数均较基线减少。在潮热方面有了显著的改善,在欧洲和中国女性中报告了出汗\'MRS项目评分。
■口头,在欧洲和中国绝经后妇女中,与安慰剂相比,超低剂量连续联合0.5mg17β-雌二醇和2.5mg地屈孕酮可改善VMS,对健康相关生活质量有积极影响。