|Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women|
|Lin, S-Q.1; Sun, L-Z.2; Lin, J-F.3; Yang, X.4; Zhang, L-J.5; Qiao, J.6; Wang, Z-H.7; Xu, Y-X.8; Xiong, Z-A.9; Zhou, Y-Z.1; Wang, M-L.2; Zhu, J.3; Chen, S-R.4; Su, H.5; Yang, C-S.6; Wang, S-H.7; Zhang, Y-Z.8; Dong, X-J.9|
|关键词||Drospirenone Estradiol Hormone Replacement Therapy Hormone Therapy Menopause Vasomotor Symptoms Randomized Controlled Trial|
|WOS标题词||Science & Technology|
|类目[WOS]||Obstetrics & Gynecology|
|研究领域[WOS]||Obstetrics & Gynecology|
|关键词[WOS]||QUALITY-OF-LIFE ; MENOPAUSAL SYMPTOMS ; DOUBLE-BLIND ; AGE ; DETERMINANTS ; PROGESTOGENS ; MULTICENTER ; POPULATION ; EFFICACY ; ESTROGEN|
Objectives Drospirenone is a novel progestogen that, combined with 17 beta-estradiol, reduces the frequency and severity of menopausal vasomotor symptoms (VMS) in different populations. This double-blind, multicenter study compared the efficacy, safety and tolerability of 2 mg drospirenone/1 mg estradiol (DRSP/E2) vs. placebo in Chinese postmenopausal women with moderate to severe VMS.
Methods Women, aged 45-65 years, were randomized to DRSP/E2 (n = 183) or placebo (n = 61) once daily for four 28-day cycles. Changes in the frequency and severity of hot flushes were analyzed as primary variables, together with other climacteric and urogenital symptoms, clinical global improvement, adverse events and physical/gynecological parameters.
Results Relative changes in numbers of hot flushes/week were -80.4% for DRSP/E2 vs. -51.9% for placebo (treatment difference -28.5%, p < 0.0001). There were trends toward a greater reduction in severity of hot flushes with DRSP/E2 treatment. Patients treated with DRSP/E2 were more often free from sweating episodes (p < 0.0001) and vaginal dryness (p = 0.0008). Other climacteric symptoms, including nervousness and pollakisuria, followed a trend of greater response with DRSP/E2. Similar to other combination HRT regimens, DRSP/E2 increased occurrences of bleeding, but these decreased over time. Adverse events in patients treated with DRSP/E2 were mostly mild to moderate and withdrawal rates were low.
Conclusions Daily treatment of postmenopausal Chinese women with DRSP/E2 for 16 weeks significantly reduced the incidence of hot flushes and demonstrated advantages vs. placebo for other climacteric symptoms. These results indicate that DRSP/E2 is effective, safe and well tolerated in postmenopausal Chinese women.
|资助机构||Bayer Schering Pharma AG|
|作者单位||1.Peking Univ, Hosp 1, Beijing 100871, Peoples R China|
2.Peking Chao Yang Hosp, Beijing, Peoples R China
3.Peking Univ, Hosp 3, Beijing 100871, Peoples R China
4.Shandong Univ, Qilu Hosp, Jinan 250100, Peoples R China
5.Beijing Union Med Coll Hosp, Beijing, Peoples R China
6.Nanjing Med Univ, Affiliated Hosp 1, Nanjing, Peoples R China
7.Fudan Univ, Obstet & Gynecol Hosp, Shanghai 200433, Peoples R China
8.Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Wuhan 430074, Peoples R China
9.Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China
|Lin, S-Q.,Sun, L-Z.,Lin, J-F.,et al. Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women[J]. CLIMACTERIC,2011,14(4):472-481.|
|APA||Lin, S-Q..,Sun, L-Z..,Lin, J-F..,Yang, X..,Zhang, L-J..,...&Dong, X-J..(2011).Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women.CLIMACTERIC,14(4),472-481.|
|MLA||Lin, S-Q.,et al."Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women".CLIMACTERIC 14.4(2011):472-481.|