更新于：2024-11-04
Fosfomycin Tromethamine
磷霉素氨丁三醇
更新于：2024-11-04
概要
基本信息
原研机构 |
非在研机构- |
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C7H18NO7P |
InChIKeyQZJIMDIBFFHQDW-LMLSDSMGSA-N |
CAS号78964-85-9 |
关联
26
项与 磷霉素氨丁三醇 相关的临床试验江苏联环药业股份有限公司研制的磷霉素氨丁三醇颗粒（3 g）与Zambon Switzerland Ltd.生产的磷霉素氨丁三醇颗粒（3 g）在中国健康受试者中进行的随机、开放、单剂量、两序列、两周期、交叉、空腹状态下的生物等效性研究
Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic Prophylaxis for Urinary Tract Infection Prevention in Post-Urodynamic Examination
A Multicentric, Randomized, Open Label, Controlled, Phase III Clinical Trial to evaluate theEfficacy, Safety and Tolerability of Fosfomycin (Trometamol) Powder 3 g versusCiprofloxacin Tablets 750 mg in patients with Chronic Bacterial Prostatitis and Chronic Pelvic Pain Syndrome
100 项与 磷霉素氨丁三醇 相关的临床结果
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100 项与 磷霉素氨丁三醇 相关的转化医学
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100 项与 磷霉素氨丁三醇 相关的专利（医药）
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259
项与 磷霉素氨丁三醇 相关的文献（医药）2024-03-01The Journal of hospital infection
Comparison of different regimens of short-term antibiotic prophylaxis in transrectal prostate biopsy
Article
作者: Krsakova, E ; Cermak, A ; Fedorko, M
BACKGROUND:
Prostate cancer is the most common malignant solid tumour in men aged >70 years and is the second most common cause of death from oncological circumstances.
AIM:
To evaluate the effect of different short-term prophylactic antibiotic regimens in transrectal prostate biopsy (PB) on the incidence of infectious complications.
METHODS:
Patients who underwent transrectal ultrasound-guided PB between January 2021 and December 2022 were included in the prospective randomized study. According to the regimen of prophylaxis, patients were randomized into three groups: (1) fosfomycin trometamol 3 g, 3 h before the procedure + ciprofloxacin 500 mg, 2 h before the procedure; (2) fosfomycin trometamol 3 g, 3 h before and 24 h after the procedure; (3) ciprofloxacin 500 mg 12, 2 h before the procedure, and 12 h after the procedure. A rectal swab was performed 1-2 weeks before PB to evaluate the culture findings. Complications were evaluated during follow-up visits within one month after PB.
FINDINGS:
In the monitored period, 605 PBs were performed, and 544 patients met the inclusion criteria (184, 161, and 199 in groups 1, 2, and 3). Infectious complications occurred in 10 cases (1.83%), namely 3, 4, and 3 according to patient groups. There was no statistically significant difference between the individual groups. None of the patients required hospitalization and all were free of symptoms of sepsis.
CONCLUSION:
Short-term antibiotic prophylaxis in PB using fosfomycin trometamol, ciprofloxacin, or their combination appears to be effective. Fosfomycin trometamol is a suitable alternative to fluoroquinolone antibiotics.
2023-12-27Urologiia (Moscow, Russia : 1999)
Optimization of prevention of infectious complications during prostate biopsy
Review
作者: Kolontarev K, B ; Pushkar D, Yu ; Stroganov R, V
Prostate cancer (PCa) is one of the most common malignant neoplasms in middle-aged and elderly men. Transrectal ultrasound guided prostate biopsy is the standard method for diagnosing prostate cancer but is associated with a high incidence of infectious compli-cations. A review of the literature on optimizing the prevention of infectious complications when performing transrectal prostate biopsy is presented. The main risk factors and the common measures to prevent the development of complications are discussed, including a study of using fosfomycin trometamol as the preferred drug for antibacterial prophylaxis. Fosfomycin meets the requirements for empirical prophylaxis, but further clinical studies are needed.
2023-12-01International journal of antimicrobial agents
Rediscovering the value of fosfomycin trometamol in the era of antimicrobial resistance: A systematic review and expert opinion
Review
作者: Tascini, Carlo ; Cai, Tommaso ; Novelli, Andrea ; Stefani, Stefania
The worldwide prevalence of uncomplicated lower urinary tract infections (uUTIs) caused by multidrug-resistant Escherichia coli is increasing. To address this emergency, international guidelines recommend reducing administration of fluoroquinolones, in the context of growing resistance and the long-lasting and potentially disabling side effects of these drugs. The favoured drug to replace fluoroquinolones is fosfomycin trometamol (FT), a well-known derivate of phosphonic acid with broad-spectrum activity against Gram-negative and Gram-positive bacteria, including multidrug-resistant (MDR) strains. The European Committee on Antimicrobial Susceptibility Testing (EUCAST) recently reduced the susceptibility breakpoint for E. coli from 32 mg/L to 8 mg/L regarding FT used for uUTIs. This might lead to increased appropriate use of oral fosfomycin target therapy against E. coli and other microorganisms, and may be associated with a high likelihood of success. For species such as Klebsiella spp, particularly MDR strains, the absence of clinical breakpoints might lead to reduced use of oral fosfomycin, particularly if minimum inhibitory concentration is not available. To address this issue, this review presents an overview of the preclinical evidence on the activity of FT, and a systematic review of the clinical activity of FT in uUTIs in women, and in the prevention of infectious complications after prostate biopsy. The findings indicate that the safety and microbiological and clinical effectiveness of a single oral dose of FT are similar to that for comparator regimens with longer treatment schedules in women with uUTI, and FT can be considered a viable alternative to fluoroquinolones for antimicrobial prophylaxis in prostate biopsy. These observations and a broad clinical experience support the empirical use of FT for treating uUTI and indicate that FT is a promising candidate to effectively counteract antibiotic-resistant uUTIs throughout Europe.
100 项与 磷霉素氨丁三醇 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| 泌尿道感染 | - | 1988-01-01 |
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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1/2期 | 126 | (Pre-urodynamic Fosfomycin) | 餘齋鹹鏇艱獵範顧製襯(製膚構膚醖餘膚膚獵構): Odds Ratio (OR) = 0.8 (95% CI, 0.4 ~ 1.95), P-Value = 0.660 | - | 2024-10-09 | ||
(Pre-urodynamic Levofloxacin) | |||||||
临床4期 | 62 | (Strategy 1) | 鏇蓋襯選顧選鹽餘鑰膚(願憲餘衊遞築齋積鏇顧) = 構餘遞衊廠觸觸積襯糧 簾構製壓蓋遞範築築衊 (窪艱齋鏇窪餘獵鹹願窪, 遞鑰構艱鑰糧糧鑰繭廠 ~ 遞醖遞艱窪構鹽簾鏇壓) 更多 | - | 2020-12-19 | ||
(Strategy 2) | 鏇蓋襯選顧選鹽餘鑰膚(願憲餘衊遞築齋積鏇顧) = 膚窪膚艱願齋淵願膚餘 簾構製壓蓋遞範築築衊 (窪艱齋鏇窪餘獵鹹願窪, 鹽醖鹽淵衊窪糧鏇鏇淵 ~ 衊衊製廠遞壓淵鹹鬱簾) 更多 | ||||||
临床2期 | 18 | 鏇廠選範憲夢膚積醖顧(網襯遞蓋積壓蓋積壓壓) = 顧鏇壓繭築築衊襯蓋糧 壓膚繭齋蓋鏇壓衊構願 (繭簾壓鹹築夢齋鬱淵鹽, 鹹築壓襯鏇鏇齋獵構繭 ~ 衊繭築範夢網願網範壓) 更多 | - | 2017-10-19 |
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