预约演示
更新于：2025-08-12
Fosfomycin Sodium
磷霉素钠
更新于：2025-08-12
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C3H7Na2O4P |
InChIKeyXKMSQWKOGZTAQM-JSTPYPERSA-N |
CAS号26016-99-9 |
关联
24
项与 磷霉素钠 相关的临床试验KCT0009011
(Study comparing the rate of hypophosphatemia and side effect when using Preoperative Ferric Carboxymaltose (FCM) vs Iron isomaltoside in unilateral Total Knee Arthroplasty: Randomized controlled trial)
CTRI/2023/11/059661
Effectiveness, acceptability, feasibility, and mapping of the operational pathway for administration of single dose intravenous ferrous carboxymaltose in moderate-to-severely anemic pregnant and immediate postpartum women in selected districts of Bihar
CTRI/2023/10/058784
Comparison of efficacy and safety of intravenous Ferric carboxymaltose (FCM) with oral iron therapy in pregnant women with mild to moderate iron deficiency anemia (IDA) - An Open Labelled Randomised Controlled Trial - NIL
100 项与 磷霉素钠 相关的临床结果
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100 项与 磷霉素钠 相关的转化医学
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100 项与 磷霉素钠 相关的专利（医药）
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753
项与 磷霉素钠 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Evaluating the cost-utility of ferric derisomaltose versus ferric carboxymaltose in patients with inflammatory bowel disease and iron deficiency anaemia in Norway
Article
作者: Detlie, T. E. ; Karlsen, L. N. ; Pollock, R. F. ; Nanu, N. ; Jørgensen, E.
AIMS:
Iron deficiency anemia (IDA) is among the most common extraintestinal sequelae of inflammatory bowel disease (IBD). Intravenous iron is often the preferred treatment in patients with active inflammation with or without active bleeding, iron malabsorption, or intolerance to oral iron. The aim of the present study was to evaluate the cost-utility of ferric derisomaltose (FDI) versus ferric carboyxymaltose (FCM) in patients with IBD and IDA in Norway.
MATERIALS AND METHODS:
A published patient-level simulation model was used to evaluate the cost-utility of FDI versus FCM in patients with IBD and IDA from a Norwegian national payer perspective. Iron need was modelled based on bivariate distributions of hemoglobin and bodyweight combined with simplified tables of iron need from the FDI and FCM summaries of product characteristics. Patient characteristics and disease-related quality of life data were obtained from the PHOSPHARE-IBD trial. Cost-utility was evaluated in Norwegian Kroner (NOK) over a five-year time horizon.
RESULTS:
Patients required 1.64 fewer infusions of FDI than FCM over five years (5.62 versus 7.26), corresponding to 0.41 fewer infusions per treatment course. The reduction in the number of infusions resulted in cost savings of NOK 5,236 (NOK 35,830 with FDI versus NOK 41,066 with FCM). The need for phosphate testing in patients treated with FCM resulted in further cost savings with FDI (no costs with FDI versus NOK 4,470 with FCM). Total cost savings with FDI were therefore NOK 9,707. FDI also increased quality-adjusted life expectancy by 0.071 quality-adjusted life years (QALYs) driven by reduced incidence of hypophosphatemia and fewer interactions with the healthcare system.
CONCLUSIONS:
FDI resulted in cost savings and improved quality-adjusted life expectancy versus FCM in patients with IDA and IBD in Norway. FDI therefore represents the economically preferable iron formulation in Norwegian patients with IBD and IDA in whom it is indicated.
2025-12-31JOURNAL OF MEDICAL ECONOMICS
A Swedish cost-utility analysis of ferric derisomaltose versus ferric carboxymaltose in the treatment of iron deficiency anemia in patients with inflammatory bowel disease
Article
作者: Manxhuka, Bardh ; Lindgren, Stefan C. ; Strid, Hans ; Nanu, Neesha ; Hjortswang, Henrik ; Pollock, Richard F.
OBJECTIVES:
Iron deficiency anemia (IDA) is a common extraintestinal manifestation of inflammatory bowel disease (IBD), driven by impaired iron absorption, inflammation of intestinal mucosa and blood loss due to intestinal bleeding. Exogenous iron is indicated to correct iron deficiency, with intravenous iron preferred in patients with malabsorption or intolerance of oral iron, active bleeding, systemic inflammation, or a need for rapid iron replenishment. The objective was to assess the cost-utility of two high-dose, rapid-infusion iron formulations-ferric derisomaltose (FDI) and ferric carboxymaltose (FCM)-in the treatment of patients with IBD and IDA in Sweden.
METHODS:
The analysis used a previously-published micro-simulation model. Phosphate monitoring was modeled based on the product labelling, while iron need and disease-related quality of life (QoL) were modeled based on data from the PHOSPHARE-IBD randomized controlled trial. Cost-utility was evaluated from the national healthcare payer perspective over a five-year time horizon. Sensitivity and scenario analyses were performed.
RESULTS:
For each iron treatment course, patients treated with FDI required 0.41 fewer infusions than those treated with FCM. The reduced number of infusions resulted in savings of SEK 9,876 over five years from iron administration costs alone (SEK 44,216 with FCM versus SEK 34,340 with FDI). Phosphate monitoring in patients treated with FCM cost SEK 2,776 over five years versus no monitoring costs with FDI. Total cost savings with FDI were SEK 14,962. FDI also resulted in a 0.076 quality-adjusted life year (QALY) improvement versus FCM driven primarily by the QoL improvements reported in PHOSPHARE-IBD, and FDI was therefore the dominant intervention.
LIMITATIONS:
The analysis did not capture costs or outcomes associated with hypophosphatemic osteomalacia or fractures.
CONCLUSION:
Relative to FCM, fewer infusions of FDI were required, there was no need for phosphate monitoring, and disease-related QoL was improved, while overall costs were reduced.
2025-07-01EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
Signal detection of ferric carboxymaltose-induced serious adverse events: disproportionality analysis of FAERS and VigiBase data and systematic review of case reports
Review
作者: Hasik, P N ; Undela, Krishna ; Prakash, Jai ; Ray, R S ; Thomas, Christy ; Galigutta, Reddikumar Reddy ; Rathod, Mahesh
PURPOSE:
The recent surge in serious adverse events (SAEs) and deaths associated with ferric carboxymaltose (FCM) underscores the importance of evaluating its safety profile.
METHODS:
We conducted a retrospective case/non-case study from Q4 of 2003 to Q4 of 2024 data on FCM in the FDA Adverse Event Reporting System (FAERS) and VigiBase databases. Signal detection was performed using proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The influence of concomitant medication on the identified signal was assessed and refined using Open Vigil 2.1. Additionally, to identify case reports on FCM-induced adverse events, a comprehensive search was performed in PubMed, Google Scholar, and Scopus databases from inception to April 12, 2025.
RESULTS:
In the FAERS database, 46 deaths were reported in connection with FCM, though no significant death signal was observed (PRR = 0.3, LB (lower bound) ROR = 0.2, IC025 = - 2.3). Nonetheless, positive safety signals emerged for SAEs such as anaphylactic shock (PRR = 3.9, LB ROR = 2.3, IC025 = 1.0), circulatory collapse (PRR = 14.6, LB ROR = 10.5, IC025 = 3.1), respiratory distress (PRR = 9.6, LB ROR = 7.1, IC025 = 2.6), hypophosphatemia (PRR = 520.7, LB ROR = 530.1, IC025 = 8.0), and arrhythmia (PRR = 3.3, LB ROR = 2.2, IC025 = 1.0). After meticulously refining our analysis to account for the influence of concomitant medications, we observed that the strength of all signals remained unchanged, except for respiratory distress, bradycardia, hypotension, abdominal pain, and urticaria. Analysis of VigiBase data revealed 42 reported fatal cases and potential signals for hypersensitivity (PRR = 4.5, LB ROR = 4.4, IC025 = 2.1), anaphylactic shock (PRR = 2.3, LB ROR = 1.9, IC025 = 0.9), circulatory collapse (PRR = 7.2, LB ROR = 6.0, IC025 = 2.5), respiratory distress (PRR = 6.9, LB ROR = 5.7, IC025 = 2.5), and hypophosphatemia (PRR = 245.1, LBROR = 234.8, IC025 = 7.5) with Ferinject. The systematic review of 11 case reports emphasized SAEs linked to FCM, thereby strengthening this association.
CONCLUSION:
This study reveals that FCM carries SAEs. Providers must weigh the benefits and risks on a case-by-case basis, considering patient-specific factors. Continuous monitoring and further research are crucial for the safe use of FCM in iron deficiency anemia.
100 项与 磷霉素钠 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 |
|---|---|---|---|
| 子宫旁组织炎 | 韩国 | 2024-09-09 | |
| 盆腔炎 | 韩国 | 2024-09-09 | |
| 脓毒症 | 韩国 | 2024-09-09 | |
| 菌血症 | 加拿大 | 2019-05-01 | |
| 复杂下尿路感染 | 加拿大 | 2019-05-01 | |
| 下呼吸道感染 | 加拿大 | 2019-05-01 | |
| 细菌性脑膜炎 | 加拿大 | 2019-05-01 | |
| 骨髓炎 | 加拿大 | 2019-05-01 | |
| 外耳炎 | 日本 | 1989-06-30 | |
| 中耳炎 | 日本 | 1989-06-30 | |
| 附件炎 | 日本 | 1985-01-28 | |
| 子宫内感染 | 日本 | 1985-01-28 | |
| 急性支气管炎 | 日本 | 1980-10-25 | |
| 膀胱炎 | 日本 | 1980-10-25 | |
| 脓胸 | 日本 | 1980-10-25 | |
| 出血性败血症 | 日本 | 1980-10-25 | |
| 肺脓肿 | 日本 | 1980-10-25 | |
| 腹膜炎 | 日本 | 1980-10-25 | |
| 肺炎 | 日本 | 1980-10-25 | |
| 肾盂肾炎 | 日本 | 1980-10-25 |
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 |
|---|---|---|---|---|
| 复杂的尿路感染 | 申请上市 | 爱尔兰 | 2022-01-30 | |
| 复杂腹腔感染 | 临床1期 | 爱尔兰 | 2022-01-30 | |
| 医院获得性肺炎 | 临床1期 | 爱尔兰 | 2022-01-30 | |
| 细菌性肺炎 | 临床1期 | 爱尔兰 | 2022-01-30 |
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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2期 | 120 | SOC-F (ampicillin, gentamicin, and fosfomycin) | 顧糧壓積選窪簾範齋構(窪繭醖選餘襯願淵蓋憲): events/100 infant-days = -0.95 (95% CI, -2.1 ~ 0.2) 更多 | - | 2022-01-25 | ||
SOC (ampicillin and gentamicin) | |||||||
临床2/3期 | 465 | 衊遞觸蓋膚衊艱鬱艱艱(襯願範壓鏇艱淵範網遞) = 鏇淵廠艱糧願鏇壓窪齋 製遞窪獵網觸鑰餘觸鹽 (鑰築壓壓膚鹹淵膚繭衊 ) 更多 | 积极 | 2019-11-27 | |||
衊遞觸蓋膚衊艱鬱艱艱(襯願範壓鏇艱淵範網遞) = 簾齋遞鏇窪鹹簾壓鹹築 製遞窪獵網觸鑰餘觸鹽 (鑰築壓壓膚鹹淵膚繭衊 ) 更多 | |||||||
临床2/3期 | 465 | (ZTI-01) | 膚蓋壓網選窪願觸範鬱 = 網襯築觸鏇醖獵鬱繭艱 窪製壓遞願餘餘壓醖廠 (積鬱夢窪選鏇範廠製窪, 醖網製窪顧鬱壓艱窪鑰 ~ 鏇簾繭網鹽鹽遞憲積鬱) 更多 | - | 2018-12-11 | ||
(Piperacillin Tazobactam) | 膚蓋壓網選窪願觸範鬱 = 窪觸艱鹽餘鬱鑰顧鑰簾 窪製壓遞願餘餘壓醖廠 (積鬱夢窪選鏇範廠製窪, 鑰醖積齋構醖築鬱願鏇 ~ 選醖襯鹹構窪膚艱鹽膚) 更多 | ||||||
临床4期 | 50 | 觸夢獵願膚鹹製鏇鑰艱(淵築獵襯積網鹽願簾鏇) = 獵鏇繭鏇廠憲鏇築艱夢 壓淵繭艱淵鬱遞襯鏇醖 (廠繭憲壓艱網餘顧夢築 ) | 积极 | 2014-10-15 |
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