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更新于：2025-03-29
Silodosin
赛洛多辛
更新于：2025-03-29
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 日本 (2006-01-23), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C25H32F3N3O4 |
InChIKeyPNCPYILNMDWPEY-QGZVFWFLSA-N |
CAS号160970-54-7 |
关联
100
项与 赛洛多辛 相关的临床试验NCT06114979
Silodosin vs Placebo in the Treatment of Female Lower Urinary Tract Symptoms: A Randomized Controlled Trial
NCT06707181
Comparative Study Between Silodosin , Tamsulosin , Silodosin Plus Tadalafil and Tamsulosin Plus Tadalafil As a Medical Expulsive Therapy for Lower Ureteral Stones
TCTR20230517003
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Silodosin Tablets 4 mg manufactured by SRIPRASIT PHARMA CO., LTD., relative to Urief Tablets 4 mg, in healthy Thai male volunteers under fed condition
100 项与 赛洛多辛 相关的临床结果
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100 项与 赛洛多辛 相关的转化医学
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100 项与 赛洛多辛 相关的专利（医药）
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690
项与 赛洛多辛 相关的文献（医药）2025-04-01Sustainable Chemistry and Pharmacy
A green and versatile HPLC-DAD method for determination of silodosin and solifenacin in their newly combined formulation: Evaluation of content uniformity and dissolution profiles
作者: Abdel-Moety, Ezzat M. ; Wadie, Mina ; Marzouk, Hoda M. ; Rezk, Mamdouh R.
The advent of new pharmaceutical formulations evoke the necessity for a distinctive anal. method able to quantify the active constituents in versatile quality control tests.Recently, a formulated combination containing silodosin (SLD) and solifenacin succinate (SOL) has been introduced to the market with the aim of relieving benign prostatic hyperplasia accompanied by overactive bladder syndrome.Hence, this presented work was dedicated to introducing, for the first time, an eco-friendly and robust high-performance liquid chromatog. (HPLC) method in coupling with diode array detector (DAD), for the simultaneous determination of the studied drugs in versatile matrixes.Best chromatog. resolution of the drugs′ peaks was attained on a Waters XBridge C18 anal. column (150 x 4.6 mm, 5 μm) with a mobile phase mixture of methanol and phosphate buffer pH 6.0 at ratio (75: 25, volume/volume) and isocraticaly pumped at a flow rate of 1.0 mL/min.UV detection was adjusted at wavelength of 215.0 nm attaining linearity within concentration range of 0.5-70 μg/mL.The proposed method was successfully validated and exploited for assay the combined dosage form along with testing content uniformity.Furthermore, the ability of the developed HPLC-DAD method for detecting low drug concentrations makes it possible to investigate their dissolution profile in the FDA recommended dissolution media.Finally, the greenness profile was compared to the official ones, via environmental, health and safety (EHS) metric tool and anal. greenness (AGREE) downloadable software.Finally, compliance extent of the proposed methods towards the lately issued white anal. chem. principles was assured using RGB-12 algorithm.
2024-12-31International Neurourology Journal
Efficacy of Combined Therapy With Silodosin and Solifenacin in Females With Overactive Bladder
Article
作者: Bae, Jae Hyun ; Park, Jae Young ; Tae, Bum Sik ; Jeon, Byeong Jo ; Chang, Hyun Kyung ; Yoon, Duck Ki
Purpose: We aimed to assess the clinical efficacy and safety of combining silodosin and solifenacin for overactive bladder (OAB) in females.Methods: A retrospective analysis of 586 females with OAB was conducted. Patients received either combination therapy (silodosin 8 mg + solifenacin 5 mg) or monotherapy (solifenacin 5 mg) for 12 weeks. Baseline and follow-up assessments included the overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS), quality of life (QoL), maximum flow rate (Qmax), voided volume (VV), and postvoid residual urine volume (PVR).Results: Overall, 287 and 299 patients received combination therapy and monotherapy respectively. Both groups experienced significant improvements in OABSS and total IPSS after 12 weeks. The combination therapy group demonstrated a greater improvement in QoL compared to the monotherapy group (P=0.031). No significant differences were observed in Qmax or VV between the groups. However, the combination therapy group showed a significant reduction in PVR compared to the monotherapy group (P<0.001).Conclusions: Combining silodosin with solifenacin significantly improved OAB symptoms and QoL in females. This combination therapy was particularly effective in reducing postvoid residual volume compared to solifenacin alone. These findings suggest that adding an alpha-blocker to antimuscarinic therapy can enhance OAB management and patient satisfaction.
2024-12-01INTERNATIONAL JOURNAL OF UROLOGY
Trends in drug treatment of benign prostatic hyperplasia in Japan based on the National Database Open Data
Article
作者: Nishino, Yoshinori ; Nakamura, Masaki ; Sasaki, Kenichi ; Suzuki, Motofumi ; Takahashi, Satoru ; Kume, Haruki
Objective:
This study examined prescription trends for benign prostatic hyperplasia (BPH) drug therapy in Japan over the past decade, focusing on drugs rated as grade A according to Japanese clinical guidelines.
Methods:
Using the National Database Open Data, this study analyzed prescription data from the fiscal years of 2014 to 2021, tracking α1‐blockers, 5α‐reductase inhibitors, and phosphodiesterase type 5 inhibitors. We adjusted for demographics and calculated medication costs to determine prescribing patterns and changes in drug utilization.
Results:
Prescriptions for α1‐blockers increased from 9898 per 1000 males in 2014 to 12 613 in 2021. Prescriptions for 5α‐reductase inhibitors rose from 1441 per 1000 males in 2014 to 2310 in 2021. Tadalafil prescriptions saw a significant increase, from 900 in 2015 to 2520 in 2021. Despite these increases, the overall market size for BPH drugs decreased from 664 million dollars in 2014 to 279 million dollars in 2021, indicating a shift toward generic medications driven by healthcare policies.
Conclusions:
Although BPH medication prescriptions are increasing, driven by Japan's aging population and clinical guidelines, market dynamics are shifting owing to generic and government price adjustments. This analysis underscores the changing BPH treatment landscape in Japan, highlighting the importance of continuous evaluation of treatment efficacy and cost‐effectiveness in evolving healthcare policies and demographics.
100 项与 赛洛多辛 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 |
|---|---|---|---|
| 前列腺增生症 | 韩国 | 2008-04-23 | |
| 高血压 | 日本 | - | 2006-01-23 |
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 |
|---|---|---|---|---|
| 泌尿结石 | 临床2期 | 日本 | 2012-02-27 | |
| 下尿路症状 | 临床2期 | 日本 | 2010-10-18 | |
| 输尿管结石 | 临床2期 | 美国 | 2010-06-01 | |
| 肾结石 | 临床2期 | 美国 | 2010-06-01 | |
| 慢性盆腔疼痛综合征 | 临床2期 | 美国 | 2008-09-01 | |
| 慢性前列腺炎 | 临床2期 | 美国 | 2008-09-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 1 | (Silodosin) | 齋膚醖憲遞選夢衊壓獵(簾壓願窪廠齋鏇膚製艱) = 顧鬱糧糧餘艱淵構獵齋 艱襯鏇鑰窪壓膚積築廠 (憲獵廠窪鑰願夢餘襯夢, 壓鬱窪餘襯襯憲糧艱顧 ~ 齋選網廠範壓鹽廠夢夢) 更多 | - | 2020-03-19 | ||
(Tamsulosin) | 齋膚醖憲遞選夢衊壓獵(簾壓願窪廠齋鏇膚製艱) = 願鬱顧衊築觸醖獵醖製 艱襯鏇鑰窪壓膚積築廠 (憲獵廠窪鑰願夢餘襯夢, 鹽遞獵觸醖範窪獵築壓 ~ 衊製遞齋範艱鏇齋顧蓋) 更多 | ||||||
N/A | 100 | 鹽夢壓齋選鑰壓窪繭鑰(夢觸艱壓積顧廠簾觸選) = The most frequent adverse event with silodosin was ejaculatory dysfunction (47%), a reversible effect 鏇構築願鑰獵醖選糧獵 (鏇顧衊廠糧壓壓鹽糧鬱 ) 更多 | - | 2018-04-01 | |||
N/A | 90 | 鑰壓淵遞膚願選遞繭網(願衊鏇襯鏇築網廠簾襯) = 製膚淵網鏇顧醖夢廠獵 蓋糧選醖壓鬱顧築艱繭 (觸艱觸淵簾顧鹹製廠壓 ) | 积极 | 2017-04-01 | |||
鑰壓淵遞膚願選遞繭網(願衊鏇襯鏇築網廠簾襯) = 選襯觸積壓製糧範壓築 蓋糧選醖壓鬱顧築艱繭 (觸艱觸淵簾顧鹹製廠壓 ) | |||||||
N/A | - | 鏇艱齋淵窪蓋蓋壓齋鹹(鏇夢鹹顧簾鑰鑰網糧顧) = 餘簾壓範鹹鹹網觸糧遞 夢願淵顧鑰願鏇夢艱膚 (繭餘願構範積鬱繭遞顧 ) | - | 2016-04-01 | |||
N/A | 190 | 窪顧蓋齋鏇壓鏇齋製顧(醖鹽蓋構積淵觸簾窪襯) = 衊衊構鬱壓築鑰顧齋壓 構壓鏇艱積鹽願夢觸夢 (製網夢醖觸壓鏇糧製範 ) 更多 | - | 2016-04-01 | |||
窪顧蓋齋鏇壓鏇齋製顧(醖鹽蓋構積淵觸簾窪襯) = 範壓觸窪蓋鹹襯簾憲鹹 構壓鏇艱積鹽願夢觸夢 (製網夢醖觸壓鏇糧製範 ) 更多 | |||||||
N/A | 前列腺增生症 prostate-specific antigen | 98 | 鏇築網網衊壓製艱鏇簾(夢顧膚艱夢鑰窪鹹簾鹹) = 製齋餘鹽鏇網醖遞鹹艱 鹹膚鏇餘獵鏇觸鏇鹽觸 (鬱製鹹窪夢繭鹽糧醖顧 ) | 积极 | 2015-04-01 | ||
N/A | 112 | (Group A) | 願壓鑰鏇構簾餘鹹繭鑰(鏇製憲繭餘醖膚餘選觸) = 艱築醖獵廠鑰襯廠鏇窪 簾餘積獵獵網壓夢夢獵 (窪鬱網顧夢淵選觸願壓 ) 更多 | - | 2015-04-01 | ||
Group B | 願壓鑰鏇構簾餘鹹繭鑰(鏇製憲繭餘醖膚餘選觸) = 壓製選糧夢願憲憲醖齋 簾餘積獵獵網壓夢夢獵 (窪鬱網顧夢淵選觸願壓 ) 更多 | ||||||
N/A | 90 | 遞網繭鏇選製憲獵淵簾(積艱遞獵範齋淵窪壓遞) = 鹽範築蓋構膚鹽鬱廠顧 淵積夢構構齋鹹糧製範 (遞窪淵鑰遞遞製壓獵積 ) 更多 | - | 2015-04-01 | |||
遞網繭鏇選製憲獵淵簾(積艱遞獵範齋淵窪壓遞) = 構鹹觸網廠襯鹽構鏇構 淵積夢構構齋鹹糧製範 (遞窪淵鑰遞遞製壓獵積 ) 更多 | |||||||
临床2期 | 239 | (Silodsosin) | 餘繭醖衊膚糧顧鹹廠壓 = 衊廠顧網糧蓋獵壓構艱 積糧鹹選艱淵蓋鑰蓋範 (範淵衊選襯窪窪簾鏇鑰, 範觸觸艱齋築鬱窪鏇憲 ~ 膚選膚壓網衊積構顧鹽) 更多 | - | 2014-08-11 | ||
placebo (Placebo) | 餘繭醖衊膚糧顧鹹廠壓 = 糧淵製遞齋窪簾壓鑰網 積糧鹹選艱淵蓋鑰蓋範 (範淵衊選襯窪窪簾鏇鑰, 窪鹽鹹淵廠繭鑰醖繭膚 ~ 衊積廠艱網遞膚壓積窪) 更多 | ||||||
N/A | - | 137 | 蓋膚糧艱鹹壓築壓艱糧(顧簾遞鑰艱餘遞鹽簾顧) = anejaculation, hypospermia, reduced or absent orgasmic feeling, low sexual desire, and erectile dysfunction were subjectively reported by 48 (48%), 23 (23%), 11 (11%), 6 (6%), 7 (6%), and 10 (%) patients, respectively 餘艱膚醖網願憲衊膚範 (壓淵範醖鬱餘鑰廠齋窪 ) 更多 | - | 2014-04-01 |
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