更新于：2024-09-06
Tibolone
替勃龙
更新于：2024-09-06
概要
基本信息
原研机构- |
最高研发阶段批准上市 |
首次获批日期 (1988-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C21H28O2 |
InChIKeyWZDGZWOAQTVYBX-XOINTXKNSA-N |
CAS号5630-53-5 |
关联
32
项与 替勃龙 相关的临床试验Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
中国绝经后健康女性受试者空腹/餐后单次口服替勃龙片和利维爱®的单中心、随机、开放、两序列、四周期、完全重复交叉设计的生物等效性试验
A Prospective Randomized Controlled Study of the Effects of Different Therapy Regimens on Menopausal Sleep Disorders
100 项与 替勃龙 相关的临床结果
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100 项与 替勃龙 相关的转化医学
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100 项与 替勃龙 相关的专利（医药）
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1,100
项与 替勃龙 相关的文献（医药）2024-06-01Journal of the Formosan Medical Association = Taiwan yi zhi
Effect of tibolone versus hormone replacement therapy on lower urinary tract symptoms and sexual function
Article
作者: Hsiao, Sheng-Mou ; Chang, Shiow-Ru
BACKGROUND:
Few studies have compared the effects of tibolone versus hormone replacement therapy (HRT) on lower urinary tract symptoms and female sexual function. The current study aimed to compare these treatments.
METHODS:
Women with climacteric symptoms were recruited consecutively and allocated to receive tibolone (2.5 mg) or estradiol valerate (1 mg) and medroxyprogesterone acetate (2.5 mg). Patients were followed up at 4 weeks and 12 weeks after treatment.
RESULTS:
Overall, there were no significance of improvement in the International Prostate Symptoms Score (IPSS) scores in the HRT group. However, nocturia and the IPSS storage score improved after tibolone treatment. In addition, orgasm, satisfaction and pain improved after HRT. However, desire, lubrication, and Female Sexual Function Index (FSFI) total scores improved after tibolone treatment. There was a between-group difference in the change from baseline in the nocturia score after 4 weeks of treatment (0.1 ± 0.9 for HRT vs. -0.4 ± 1.2 for tibolone, p = 0.02). Nonetheless, there were no significant differences of the changes from baseline in the other IPSS and FSFI domains between the tibolone and HRT groups.
CONCLUSION:
Despite the limited effect, tibolone seems to have more benefit in nocturia than HRT. In addition, tibolone seems to have benefits on overall low urinary tract storage symptoms; and both tibolone and HRT seem to have beneficial effects on female sexual function, despite there were no significant differences between tibolone and HRT.
Journal of the Chinese Medical Association : JCMA
Effect of tibolone versus hormone replacement therapy on climacteric symptoms and psychological distress
Article
作者: Liao, Shih-Cheng ; Hsiao, Sheng-Mou
Background::
The objective was to elucidate the effect of tibolone versus hormone replacement therapy (HRT) on climacteric symptoms and psychological distress.
Methods::
All consecutive women with climacteric symptoms were allocated to receive tibolone (2.5 mg) or estradiol valerate (1 mg) and medroxyprogesterone acetate (2.5 mg).
Results::
The improvement in “feeling dizzy or faint” after tibolone treatment was more prominent than that after HRT (-0.7±0.8 vs. -0.0±0.9, p=0.004). In addition, other climacteric symptoms, including anxiety, depression, somatic symptoms, and vasomotor symptoms, and sexual function improved after tibolone and HRT, but there were no between-group differences. Psychological distress assessment demonstrated that somatic complaints, obsessive-compulsive symptoms, depressive symptoms, hostility, additional symptoms, and the General Symptom Index improved after tibolone treatment and HRT, but there were no between-group differences. Personality traits assessment revealed that neuroticism improved after tibolone treatment.
Conclusion::
Tibolone seems more beneficial than HRT in treating symptoms of dizziness and faintness. Both tibolone and HRT could improve psychological distress.
2024-01-03European journal of endocrinology
Breast cancer risk association with postmenopausal hormone therapy: Health Insurance Database in South Korea–based cohort study
Article
作者: Kim, Taeran ; Cho, Hyunjin ; Yuk, Jin-Sung ; Gwak, Geumhee
Abstract:
Context:
Although many physicians have been concerned that the menopausal hormones used currently in clinical practice may affect the risk of breast cancer, there are currently few informative updated studies about the associations between menopausal hormone therapy (MHT) and the risk of breast cancer.
Objective:
This study aims to evaluate the association between the risk of breast cancer and MHT using the National Health Insurance Database in South Korea (HISK) cohort between 2002 and 2019 retrospectively.
Methods:
Postmenopausal women over 40 years of age from 2003 to 2011 were selected as the subject population, and their follow-up data were collected until 2019. We analyzed the risk and mortality of breast cancer according to the type of MHT received, namely, tibolone, combined estrogen plus progestin by manufacturer (CEPM), oral estrogen, combined estrogen plus progestin by physician (CEPP), or topical estrogen.
Results:
The risk of breast cancer increased in the CEPM group [hazard ratio (HR) 1.439, 95% CI 1.374-1.507, P-value < .001] in comparison with the non-MHT group. However, no significant associations were found between the use of tibolone, oral estrogen, CEPP, or topical estrogen and breast cancer risk in comparison with the non-MHT group (HR 0.968, 95% CI 0.925-1.012; HR 1.002, 95% CI 0.929-1.081; HR 0.929, 95% CI 0.75-1.15; HR 1.139, 95% CI 0.809-1.603). The mortality rate from breast cancer is lower in the MHT group in comparison with the non-MHT group, indicating that significant associations were found for tibolone, CEPM, and oral estrogen (HR 0.504, 95% CI 0.432-0.588; HR 0.429, 95% CI 0.352-0.522; HR 0.453 95% CI 0.349-0.588, P-value < .001).
Conclusions:
This study suggests that the risk of breast cancer is increased by drugs in the CEPM group but not by tibolone, oral estrogen, CEPP, or topical estrogen. The mortality rate from breast cancer is lower with MHT (tibolone, CEPM, oral estrogen) than without MHT.
5
项与 替勃龙 相关的新闻（医药）2024-08-14
·米内网
临床2期申请上市
100 项与 替勃龙 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 绝经期后骨质疏松 | 阿根廷 | - | 2006-02-16 |
| 更年期综合症 | 澳大利亚 | 2000-05-19 | |
| 雌激素缺乏症状 | 中国 | 1990-11-26 | |
| 内分泌系统疾病 | - | - | 1988-01-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 性功能障碍 | 临床3期 | - | 2004-03-23 | |
| 生理性性功能障碍 | 临床3期 | - | 2004-03-23 | |
| 乳腺癌 | 临床3期 | - | 2002-05-01 | |
| 乳腺癌 | 临床3期 | - | 2002-05-01 | |
| 绝经期综合征 | 临床3期 | - | 2001-10-01 | |
| 骨质疏松症 | 临床3期 | - | 2001-07-01 | |
| 脊柱骨折 | 临床3期 | - | 2001-07-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 3,148 | 壓鏇網鹽憲鬱鹹壓鹹鏇(膚膚觸蓋窪蓋顧獵積鹹) = 顧簾餘構獵膚衊鬱醖醖 構鏇壓齋淵積鹽壓顧襯 (鏇鹽願蓋遞繭醖醖壓鏇 ) 更多 | - | 2011-12-01 | |||
Placebo | 壓鏇網鹽憲鬱鹹壓鹹鏇(膚膚觸蓋窪蓋顧獵積鹹) = 膚鹽壓夢齋膚簾膚夢窪 構鏇壓齋淵積鹽壓顧襯 (鏇鹽願蓋遞繭醖醖壓鏇 ) 更多 | ||||||
临床3期 | VMS 辅助 | 3,148 | 廠製鑰蓋蓋遞餘鏇襯築(廠簾遞鏇鹹窪簾鬱襯膚): HR = 1.4 (95% CI, 1.14 ~ 1.7), P-Value = 0.001 | 不佳 | 2009-02-01 | ||
Placebo | |||||||
临床3期 | - | 4,538 | 範齋觸壓淵憲範繭夢艱(淵壓範鏇鑰夢窪憲鹽簾): relative hazard = 0.31 (95% CI, 0.1 ~ 0.96), P-Value = 0.04 更多 | - | 2008-08-14 | ||
Placebo | |||||||
临床3期 | - | 102 | 積窪糧餘積夢齋範鑰築(壓壓築憲夢憲廠鏇淵鹹) = 鑰艱醖範鹹壓鏇鬱窪齋 繭範遞鬱鹽餘積觸蓋窪 (製觸壓積壓鏇夢繭獵獵 ) | 不佳 | 2007-07-15 | ||
Placebo | 積窪糧餘積夢齋範鑰築(壓壓築憲夢憲廠鏇淵鹹) = 築繭廠鬱蓋願憲網築鏇 繭範遞鬱鹽餘積觸蓋窪 (製觸壓積壓鏇夢繭獵獵 ) 更多 |
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