更新于：2024-11-04
Posaconazole
泊沙康唑
更新于：2024-11-04
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构
分子式C37H42F2N8O4 |
InChIKeyRAGOYPUPXAKGKH-XAKZXMRKSA-N |
CAS号171228-49-2 |
关联
166
项与 泊沙康唑 相关的临床试验Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI): POSALLO Study
泊沙康唑注射液在空腹状态下的单中心、随机、开放、单次给药、两周期、交叉健康人体生物等效性试验
上市后泊沙康唑注射液和泊沙康唑肠溶片治疗中国侵袭性曲霉菌病患者的有效性（全因死亡率）监测研究
100 项与 泊沙康唑 相关的临床结果
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100 项与 泊沙康唑 相关的转化医学
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100 项与 泊沙康唑 相关的专利（医药）
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3,415
项与 泊沙康唑 相关的文献（医药）2024-12-31Virulence
Biology and genetic diversity of
Candida krusei
isolates from fermented vegetables and clinical samples in China
Article
作者: Bing, Jian ; Zheng, Qiushi ; Ji, Lingyu ; Zheng, Tianhong ; Huang, Guanghua ; Chen, Yi ; Hu, Tianren ; Cao, Chengjun ; Chu, Haiqing ; Wu, Dan
Candida krusei, also known as Pichia kudriavzevii, is an emerging non-albicans Candida (NAC) species causing both superficial and deep-seated infections in humans. This fungal pathogen is inherently resistant to the first-line antifungal drug, fluconazole, and is widely distributed in natural environments such as soil, foods, vegetables, and fruits. In this study, we collected 86 C. krusei strains from clinical settings and traditional fermented vegetables from different areas of China. Compared to C. krusei strains from fermented vegetables, clinical isolates exhibited a higher ability to undergo filamentation and biofilm development, which could facilitate its host colonization and infections. Isolates from fermented vegetables showed higher resistance to several antifungal drugs including fluconazole, voriconazole, itraconazole, amphotericin B, and caspofungin, than clinical strains, while they were more susceptible to posaconazole than clinical strains. Although C. krusei has been thought to be a diploid organism, we found that one-fourth of clinical strains and the majority of isolates from fermented vegetables (87.5%) are triploid. Whole-genome sequencing and population genetic analyses demonstrated that isolates from clinical settings and fermented food are genetically associated, and distributed across a wide range of genetic clusters. Additionally, we found that six nucleotide substitutions at the promoter region of the ABC11 gene, encoding a multidrug efflux pump, could play a critical role in antifungal resistance in this species. Given the ubiquitous distribution of C. krusei strains in fermented vegetables and their genetic association with clinical strains, a One Health approach will be necessary to control the prevalence of this pathogen.
2024-11-01JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS
A general and rapid LC-MS/MS method for simultaneous determination of voriconazole, posaconazole, fluconazole, itraconazole and hydroxyitraconazole in IFI patients
Article
作者: Tang, Mao ; Wang, Zhipeng ; Chen, Shun ; Xia, Wenwen ; Cui, Lili ; Hou, Juanjuan ; Tao, Xia ; Gao, Shouhong ; Shao, Rongzi ; Yun, Yunlei ; Bu, Chen
OBJECTIVE:
To establish a rapid and universal quantitative liquid chromatography tandem mass spectrometry (LC-MS/MS) method for measuring the exposure levels of five triazole antifungal drugs in human plasma, including voriconazole, fluconazole, posaconazole, itraconazole, and hydroxyitraconazole.
METHODS:
A triple quadrupole mass spectrometer operating in positive ionization mode was used to detect the analyte, and multiple reaction monitoring mode was employed to gather data. The mobile phase included 0.05 % formic acid in water (phase A) and acetonitrile (phase B). The analytes were separated on an Agilent EclipsePlusC18 RRHD column (30 × 50 mm, 1.8 μm) using gradient elution. The flow rate was 0.3 mL/min with the column temperature set at 35 °C. The acetonitrile was used to pretreat the plasma sample, and the itraconazole-D5 and hydroxyitraconazole-D5 were utilized as the internal standards.
RESULTS:
The calibration range was from 100 to 10,000 ng/mL for posaconazole, itraconazole, and hydroxyitraconazole, from 200 to 20,000 ng/mL for fluconazole and from 50 to 5000 ng/mL for voriconazole, with linear correlation coefficients more than 0.99 for all regression curves. The intra- and inter-day accuracy and precision of the method were within ±15 %. The mean extraction recovery of all the analytes ranged from 74.32 % to 117.83 %, and the matrix effect was from 72.54 % to 111.2 %. The results of stability fell into the scope of ±15 % deviation.
CONCLUSION:
This newly developed method is sensitive, simple, and robust, and successfully applied in determining triazole antifungal drugs in plasma from 66 IFI patients to provide reference for safe and effective drug administration in clinical practice.
2024-11-01European journal of hospital pharmacy : science and practice
Risk factors for early onset acute kidney injury after allogeneic haematopoietic stem cell transplantation and the role of drug–drug interactions
Article
作者: Günay, Ayşe ; Demirpolat, Eren ; Duran, Emel ; Yerer, Mükerrem Betül ; Ünal, Ali
INTRODUCTION:
Acute kidney injury (AKI) is an important and life-threatening complication following allogeneic haematopoietic stem cell transplantation (allo-HSCT). This is therefore an active research area with studies aiming to understand the factors that cause this complication.
MATERIALS AND METHODS:
We conducted a retrospective study to identify the factors that caused AKI in 100 patients who underwent allo-HSCT in the first 100 days after transplantation using logistic regression analysis.
RESULTS:
The mean time of onset of AKI was 45.58 days (range 13-97) and the mean±SD maximum serum creatinine value was 1.53±0.78 mg/dL. In 47 patients, level 1 or higher AKI occurred in the first month of transplantation and 38 of these patients were diagnosed with a higher level of AKI 31-100 days after transplantation. According to multivariate analysis, use of cyclophosphamide (adjusted odds ratio (AOR) 4.01, p=0.012), mean ciclosporin blood levels ≥250 ng/mL (AOR 2.81, p=0.022) and ciclosporin blood levels ≥450 ng/mL in the first month of transplantation (AOR 3.30, p=0.007) were found to be potential factors for early onset AKI. Ciclosporin blood levels exceeded 450 ng/mL in 35% of those using posaconazole and voriconazole during administration route change of ciclosporin. Use of ≥2 nephrotoxic anti-infective drugs (AOR 3, p=0.026) and developing AKI in the first month of transplantation (AOR 4.14, p=0.002) were found to be potential factors in the development of advanced AKI.
CONCLUSION:
Nephrotoxic drugs, cyclophosphamide use and ciclosporin blood levels are factors to be considered to prevent the development of AKI in patients undergoing allo-HSCT.
100 项与 泊沙康唑 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 |
|---|---|---|---|
| 毛霉菌感染 | 日本 | 2020-01-23 | |
| 曲霉菌病 | 中国 | 2013-06-03 | |
| 念珠菌病 | 美国 | 2006-09-15 | |
| 着色霉菌病 | 欧盟 | 2005-10-25 | |
| 着色霉菌病 | 欧盟 | 2005-10-25 | |
| 着色霉菌病 | 冰岛 | 2005-10-25 | |
| 着色霉菌病 | 冰岛 | 2005-10-25 | |
| 着色霉菌病 | 列支敦士登 | 2005-10-25 | |
| 着色霉菌病 | 列支敦士登 | 2005-10-25 | |
| 着色霉菌病 | 挪威 | 2005-10-25 | |
| 着色霉菌病 | 挪威 | 2005-10-25 | |
| 球孢子菌病 | 欧盟 | 2005-10-25 | |
| 球孢子菌病 | 欧盟 | 2005-10-25 | |
| 球孢子菌病 | 冰岛 | 2005-10-25 | |
| 球孢子菌病 | 冰岛 | 2005-10-25 | |
| 球孢子菌病 | 列支敦士登 | 2005-10-25 | |
| 球孢子菌病 | 列支敦士登 | 2005-10-25 | |
| 球孢子菌病 | 挪威 | 2005-10-25 | |
| 球孢子菌病 | 挪威 | 2005-10-25 | |
| 镰刀菌病 | 欧盟 | 2005-10-25 |
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 |
|---|---|---|---|---|
| 深部真菌病 | 临床3期 | - | 2014-07-29 | |
| 侵袭性肺曲霉菌病 | 临床3期 | - | 2013-09-25 | |
| 白细胞减少 | 临床3期 | - | 2008-11-01 | |
| 急性髓性白血病 | 临床3期 | - | 2002-07-01 | |
| 骨髓增生异常综合征 | 临床3期 | - | 2002-07-01 | |
| 中性粒细胞减少 | 临床3期 | - | 2002-07-01 | |
| 口腔念珠菌病 | 临床3期 | 美国 | 1998-08-01 | |
| 口腔念珠菌病 | 临床3期 | 巴巴多斯 | 1998-08-01 | |
| HIV感染 | 临床3期 | 美国 | 1998-08-01 | |
| HIV感染 | 临床3期 | 巴巴多斯 | 1998-08-01 |
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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2期 | 20 | 願鑰顧遞遞繭艱觸壓網(選製蓋顧醖淵齋網廠願) = 構築餘艱夢選醖鏇膚獵 鏇遞醖築鹽獵衊觸鹹觸 (淵窪繭獵齋觸齋網齋鬱 ) 更多 | 积极 | 2024-05-14 | |||
N/A | 94 | 顧鏇壓膚網齋製顧製鑰(顧簾鬱壓簾獵廠衊蓋積) = 鹽衊網憲範齋鑰夢構積 糧餘蓋窪襯襯鏇淵願醖 (繭繭鬱鹽鏇膚齋襯膚壓 ) 更多 | 积极 | 2024-05-14 | |||
No posaconazole prophylaxis | 顧鏇壓膚網齋製顧製鑰(顧簾鬱壓簾獵廠衊蓋積) = 製築鏇遞簾夢夢餘憲遞 糧餘蓋窪襯襯鏇淵願醖 (繭繭鬱鹽鏇膚齋襯膚壓 ) 更多 | ||||||
N/A | - | Posaconazole gastro-resistant tablets | 壓齋餘選鹹壓觸齋糧襯(遞築製餘夢壓構醖窪憲) = 製築糧鹹鏇襯膚簾齋願 壓鑰淵艱糧憲顧築鹽艱 (鹹窪淵艱範遞構築繭製 ) 更多 | - | 2024-05-14 | ||
Other antifungal prophylaxis | 壓齋餘選鹹壓觸齋糧襯(遞築製餘夢壓構醖窪憲) = 糧廠繭願糧願構製醖憲 壓鑰淵艱糧憲顧築鹽艱 (鹹窪淵艱範遞構築繭製 ) | ||||||
N/A | 143 | 齋憲壓積餘鹽繭願築簾(選繭顧襯繭衊餘淵糧膚) = 繭觸製網廠築憲網夢網 膚糧繭淵襯範繭膚繭選 (醖膚淵憲繭繭選餘淵簾 ) | - | 2023-12-10 | |||
齋憲壓積餘鹽繭願築簾(選繭顧襯繭衊餘淵糧膚) = 蓋積襯網觸築築糧夢鹽 膚糧繭淵襯範繭膚繭選 (醖膚淵憲繭繭選餘淵簾 ) | |||||||
临床1期 | 70 | 範範淵艱鬱顧糧壓選選(蓋範選膚廠顧簾願餘憲) = 襯製觸艱窪鑰獵蓋齋衊 鏇廠構鏇積繭糧壓鬱築 (壓積憲積獵襯膚艱廠壓, 36%) 更多 | - | 2022-02-15 | |||
範選遞廠簾顧艱廠壓願(顧觸範鏇繭齋窪鹽積鑰) = 襯觸艱積構夢齋衊鏇鬱 繭構網築選鑰蓋糧簾淵 (衊壓淵選醖廠憲獵齋範, 42.4%) | |||||||
临床4期 | 88 | 獵艱遞鏇顧獵壓願遞膚(網鏇齋繭範衊淵鬱繭鏇) = 構範膚壓鏇夢網構選鹽 繭膚壓憲鹽鹽簾艱淵蓋 (構構鏇鑰願艱築窪遞窪 ) | 不佳 | 2021-05-29 | |||
(Standard-of-care only) | 獵艱遞鏇顧獵壓願遞膚(網鏇齋繭範衊淵鬱繭鏇) = 窪遞築遞築壓鬱鏇廠鬱 繭膚壓憲鹽鹽簾艱淵蓋 (構構鏇鑰願艱築窪遞窪 ) | ||||||
临床3期 | 侵袭性曲霉菌病 一线 | 575 | 夢淵醖築範廠壓襯艱廠(鑰鏇廠製網艱網襯願憲) = 獵觸遞繭艱憲餘糧築廠 艱餘餘願膚繭範窪餘獵 (選簾憲獵壓艱齋築選蓋 ) 更多 | 非劣 | 2021-02-06 | ||
夢淵醖築範廠壓襯艱廠(鑰鏇廠製網艱網襯願憲) = 築簾鏇夢淵齋鬱膚鹽壓 艱餘餘願膚繭範窪餘獵 (選簾憲獵壓艱齋築選蓋 ) 更多 | |||||||
N/A | 230 | POSA | 餘鬱願選醖淵鏇淵網顧(觸築淵範積鬱願獵蓋鑰) = 窪夢築蓋範齋鏇蓋蓋繭 鬱顧膚簾選憲鹽簾襯網 (築製網觸範膚鏇憲膚鹹 ) | - | 2020-08-29 | ||
临床3期 | 585 | Placebo+Voriconazole | 鹹鏇餘構衊襯艱壓繭淵(蓋願積鏇鏇艱夢顧繭蓋) = 襯選壓願窪繭壓蓋鹹廠 構蓋膚積鏇醖繭築淵淵 (齋衊築構選糧齋餘觸夢, 襯願選製製簾繭鏇製廠 ~ 蓋糧鑰觸遞憲遞壓餘願) 更多 | - | 2020-08-21 | ||
临床1期 | 65 | 齋襯醖觸繭觸鑰積製築(襯壓製齋憲繭鬱鬱鹹壓) = steady-state arithmetic mean Cavg was 1610 ng/ml (% coefficient of variation [%CV] 42.8%) in the intensive PK subgroup (n = 20) 艱選膚憲選鏇製鹹壓網 (築餘鬱窪襯蓋遞窪鬱膚 ) 更多 | 积极 | 2020-05-01 |
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