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更新于：2026-02-25
Fosfomycin Tromethamine
磷霉素氨丁三醇
更新于：2026-02-25
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/序列
分子式C7H18NO7P |
InChIKeyQZJIMDIBFFHQDW-LMLSDSMGSA-N |
CAS号78964-85-9 |
关联
29
项与 磷霉素氨丁三醇 相关的临床试验NCT06822751
Exploratory Pragmatic Trial of Fosfomycin-trometamol Treatment of Male Urinary Tract Infections in Primary Care
CTIS2025-520452-28-00
Fecal microbiota transfer for the secondary prevention of recurrent urinary tract infections in premenopausal women: a phase II trial (FEMITRANS)
CTR20242961
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
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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253
项与 磷霉素氨丁三醇 相关的文献（医药）2026-01-01CLINICAL PHARMACOKINETICS
Population Pharmacokinetics of a Novel Oral Fosfomycin Prophylactic Scheme in the Plasma and Prostate of Patients Undergoing Endoscopic Surgery for Benign Prostatic Hyperplasia
Article
作者: Bianchi, Lorenzo ; Cojutti, Pier Giorgio ; Brunocilla, Eugenio ; Schiavina, Riccardo ; Berrino, Pasquale Maria ; Viale, Pierluigi ; Pea, Federico ; Rotaru, Valeria
BACKGROUND AND OBJECTIVE:
Fosfomycin trometamol may be a valuable option for antimicrobial prophylaxis before urological surgery for benign prostatic hyperplasia. The objective is to develop a population pharmacokinetic model of a novel oral fosfomycin prophylactic scheme in the plasma and prostate of patients undergoing endoscopic surgery for benign prostatic hyperplasia.
METHODS:
One- and two-compartment plasma pharmacokinetic models were fitted to fosfomycin plasma data, and different plasma-prostate linked models were tested by means of non-linear mixed effects modelling. Monte Carlo simulation was used to obtain 1000-subject concentration-time profiles of fosfomycin in the prostate. Probabilities of target attainment ≥ 90% of an area under the plasma concentration-time curve/minimum inhibitory concentration (MIC) > 83.3 and of a 70%t > MIC in the prostate were considered as optimal. Cumulative fractions of response against both wild-type and extended-spectrum beta-lactamase-producing Escherichia coli were calculated.
RESULTS:
A total of 104 patients, each providing a pair of plasma and prostate concomitant samples were included in the study. A one-compartment pharmacokinetic model was used to describe plasma fosfomycin concentration. Fosfomycin plasma-prostate relationships were adequately described by a direct response model with a power function. Simulations showed that fosfomycin disposition in the prostate was closely related to that in plasma. Optimal probabilities of target attainments were ensured against Enterobacterales having an MIC up to 0.5-1 mg/L in the 12 h vulnerable period after completing the prophylactic scheme.
CONCLUSION:
A prophylactic regimen of two doses of oral fosfomycin trometamol 3 g 12 h apart before undergoing prostatic surgery may grant effective concentrations in the prostatic tissue of patients for a 12 h vulnerable period.
2025-10-01The Journal of the Association of Physicians of India
Fosfomycin Tromethamine: A Urinary Antibiotic.
Review
作者: Trailokya, Abhijit A ; Tiwaskar, Mangesh
Urinary tract infection (UTI) is the second most common type of infection in the human body. It is one of the most prevalent conditions in medical practice, with approximately 150 million cases occurring globally each year. Approximately 50% of women will experience at least one episode of UTI during their lifetime, and between 20 and 40% will have recurrent episodes. The discovery of a broad-spectrum antibiotic, fosfomycin tromethamine, occurred in Spain in 1969 and is prominently used in the management of uncomplicated UTIs. As a phosphonic acid derivative, fosfomycin acts by disrupting bacterial cell wall synthesis by inhibiting the enzyme MurA, demonstrating effective activity against a wide variety of gram-negative and gram-positive pathogens, comprising multidrug-resistant strains such as Escherichia coli and Klebsiella pneumoniae. Fosfomycin is not metabolized and is predominantly excreted unchanged in the urine through glomerular filtration. Mean peak urinary concentrations of fosfomycin ranging from 1053 to 4415 mg/L occur within 4 hours of administration of a single oral dose of fosfomycin tromethamine correspondent to fosfomycin 3 gm. Urinary concentrations >128 mg/L, which are adequate to inhibit most urinary pathogens, are maintained for 24-48 hours following a single oral dose of fosfomycin tromethamine. This makes it particularly advantageous for uncomplicated UTIs, where it offers a convenient and effective single-dose treatment option. Clinical trials and observational studies have consistently shown high cure rates and patient compliance, attributing this to its minimal side effects and broad-spectrum efficacy. A single oral dose of fosfomycin tromethamine, equivalent to 3 gm of fosfomycin, is indicated for treating acute uncomplicated lower UTIs in adults. It is classified as pregnancy category B. Various clinical guidelines, such as the Infectious Diseases Society of America (IDSA), European Association of Urology (EAU), and National Institute for Health and Care Excellence (NICE), also recommend fosfomycin tromethamine for the treatment of UTI. In conclusion, fosfomycin tromethamine remains a robust and indispensable antibiotic in the management of uncomplicated UTIs, with a distinct pharmacological profile that ensures both efficacy and safety, and patient compliance due to its single-dose regimen.
2025-05-05Urologiia (Moscow, Russia : 1999)
Results of treatment of acute uncomplicated cystitis in 440 women of working age in a large industrial city
Article
作者: Davidov M, I ; Zaitsev A, V
INTRODUCTION:
Lower urinary tract infections (UTIs) affect nearly two-thirds of all women during their lifetime, and many suffer from recurrent infections. There are evidence-based guidelines from several international societies and RSU for the evaluation and treatment of UTIs; however, adherence to these guidelines is not always optimal.
AIM:
To study the immediate outcomes of treating acute uncomplicated cystitis in working-age women living in a large industrial city under unfavorable environmental and climatic conditions.
MATERIALS AND METHODS:
A multicenter, randomized, open-label study was carried out in 4 outpatient clinics in Perm involving 440 women with acute uncomplicated cystitis. Depending on the treatment, the patients were divided into 4 groups. The main drug was the antibiotic fosfomycin trometamol, which was given at a single dose of 3 g to all 440 patients. In the group 1, monotherapy with fosfomycin trometamol was used. Patients in groups 2-4 received basic antibacterial therapy (3 g of fosfomycin trometamol), supplemented with symptomatic and herbal remedies. In the group 2, drotaverine was used at 80 mg 3 times a day for 2 days, in the group 3 phenazopyridine at a dose of 200 mg 3 times a day for 2 days was given, while in the group 4, Canephron N at 2 tablets 3 times a day for 6 days was administered. The symptoms of cystitis were assessed using the ACSS scale, visual analog scale (VAS) of pain, urinalysis with microscopic examination of urinary sediment, bacteriological examination of urine and other methods. The results were assessed after 6, 12, 24, 48 hours, 3 and 6 days.
RESULTS:
The sensitivity of microorganisms to fosfomycin in bacteriological studies was 97.2%. In group 1, recovery was achieved in 92.5%, improvement in 6.6%, and the bacteriological cure was 95.3%; however, the ACSS and VAS scales indicated insufficiently rapid elimination of pain and other symptoms. In the group 2, improvement in results was insignificant. However, results were significantly better in groups 3 and 4, with rapid resolution of pain, dysuria, and other symptoms. In group 3, recovery was achieved in 97.3%, bacteriological cure and disability period were 96.8% and 5.1+/-0.5 days, respectively. In group 4, recovery was observed in 96.4%, bacteriological cure was 96.6%, and disability period was 5.2+/-0.4 days, respectively. In total, for 440 patients, when using fosfomycin trometamol, recovery occurred in 95.2%, improvement in 4.6%, bacteriological cure was 96.4%, side effects of fosfomycin trometamol were noted only in 1.1% of cases.
CONCLUSIONS:
Currently, even in unfavorable environmental and climatic conditions, fosfomycin trometamol remains a highly effective and safe antibacterial agent for the treatment of acute uncomplicated cystitis. It is recommended to combine the use of fosfomycin trometamol with a urinary analgetic drug and herbal preparation based on extracts of centaury, lovage and rosemary (Kanefron N).
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
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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
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临床2/3期 | 70 | (Fosbretabulin Tromethamine) | 餘網範糧鏇鏇壓願壓鏇(齋鹽簾顧鬱齋鏇遞簾鬱) = 艱齋衊獵築壓鬱蓋繭窪 鑰獵製夢繭願簾簾鹽襯 (醖廠範醖築齋淵築淵構, 簾鑰夢簾廠醖願憲齋鹹 ~ 壓鏇簾積範膚壓繭醖構) 更多 | - | 2025-03-24 | ||
Placebo (Placebo) | 餘網範糧鏇鏇壓願壓鏇(齋鹽簾顧鬱齋鏇遞簾鬱) = 壓選遞鹹醖淵膚觸鬱範 鑰獵製夢繭願簾簾鹽襯 (醖廠範醖築齋淵築淵構, 夢窪繭鑰鏇衊艱餘壓醖 ~ 選廠襯齋簾憲壓網選鬱) 更多 | ||||||
临床1/2期 | 126 | (Pre-urodynamic Fosfomycin) | 範遞壓範築鹽鹹網齋蓋: Odds Ratio (OR) = 0.8 (95% CI, 0.4 ~ 1.95), P-Value = 0.660 | - | 2024-10-09 | ||
(Pre-urodynamic Levofloxacin) | |||||||
临床2期 | - | - | 積構衊壓膚憲顧獵範鏇(選鏇繭構積鹽願廠餘簾) = 蓋糧鑰鹹簾窪膚製獵鏇 鏇鬱顧廠網壓網壓築積 (蓋衊願遞廠範鬱製鏇壓 ) 更多 | 积极 | 2023-04-01 | ||
Preoperative Amikacin 1 gr I.V. | 積構衊壓膚憲顧獵範鏇(選鏇繭構積鹽願廠餘簾) = 艱蓋選積齋夢遞蓋築網 鏇鬱顧廠網壓網壓築積 (蓋衊願遞廠範鬱製鏇壓 ) 更多 | ||||||
临床4期 | 62 | (Strategy 1) | 簾廠夢選網糧壓製繭鏇 = 淵簾範鬱選顧觸簾壓窪 觸簾鏇構觸窪夢廠選鹹 (膚夢廠鏇網憲鑰鬱顧鹹, 鏇壓膚製醖夢艱廠廠築 ~ 廠齋願築製鏇鬱膚積蓋) 更多 | - | 2020-12-19 | ||
(Strategy 2) | 簾廠夢選網糧壓製繭鏇 = 觸廠積壓鑰襯選齋鬱範 觸簾鏇構觸窪夢廠選鹹 (膚夢廠鏇網憲鑰鬱顧鹹, 積憲網蓋鑰遞夢餘憲廠 ~ 觸膚鹽憲選獵膚簾願膚) 更多 | ||||||
临床4期 | - | Fosfomycin trometamol + trimethoprim-sulfamethoxazole (Group 1) | 選窪窪淵遞鏇膚淵鏇夢(廠膚廠蓋簾蓋襯顧鹹網) = 遞顧鹹艱衊襯築鹹廠壓 蓋遞窪壓齋餘鑰齋廠繭 (鹹廠鏇積築鏇觸艱鬱願 ) | - | 2018-10-01 | ||
Trimethoprim-sulfamethoxazole (Group 2) | 選窪窪淵遞鏇膚淵鏇夢(廠膚廠蓋簾蓋襯顧鹹網) = 窪醖艱觸鹽艱鏇選襯願 蓋遞窪壓齋餘鑰齋廠繭 (鹹廠鏇積築鏇觸艱鬱願 ) | ||||||
临床2期 | 18 | 築構積網繭糧膚餘鹹淵 = 鏇襯獵齋醖餘襯艱蓋窪 鬱壓簾齋鑰鏇觸遞窪鹹 (願繭膚願糧獵鑰鹹鏇願, 構衊壓製醖鏇壓膚構鹹 ~ 製艱鑰鏇艱壓艱餘製憲) 更多 | - | 2017-10-19 |
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