预约演示
更新于：2025-05-16
Fosfomycin Tromethamine
磷霉素氨丁三醇
更新于：2025-05-16
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
27
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
CTIS2024-513465-39-00
Clinical Efficacy of oral Fosfomycin Trometamol and Cefixime in the Treatment of Acute Bacterial Prostatitis (CEFOSPROST): a comparative, randomized, open, multicenter trial. - CEFOSPROST
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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346
项与 磷霉素氨丁三醇 相关的文献（医药）2025-03-01Prostate International
Single-dose vs prolonged antibiotic prophylaxis of fosfomycin for transrectal prostate biopsy: a single-center prospective, randomized, controlled trial
Article
作者: Bajory, Zoltán ; Rárosi, Ferenc ; Fehér, Ádám Miklós ; Köves, Béla ; Burián, Katalin ; Czimbalmos, Nándor ; Lázár, Andrea ; Fehér, Ádám M
Background:
Transrectal prostate biopsy is a commonly performed urological procedure in which antibiotic prophylaxis is recommended. Fluoroquinolone-type antibiotics are no longer acceptable in the EU. Fosfomycin-trometamol may be used, but there is no evidence regarding its ideal dose and administration time.
Methods:
Patients who underwent prostate biopsy between 2021 and 2023 were evaluated prospectively. 204 patients were randomized into two arms: 102 patients (Arm A) received a single-dose of fosfomycin-trometamol one hour before surgery, and 102 patients (Arm B) received one additional dose of fosfomycin-trometamol 48 hours after the first dose. Urine tests and questionnaires were administered during the postoperative period and the subsequent four weeks to identify any symptoms, infectious, or other complications.
Results:
There was no statistical difference in the rate of asymptomatic bacteriuria (4.90% (5) vs. 8.82% (9), P = 0.27) symptomatic urinary tract infection (0% (0) vs. 1.96% (2), P = 0.50), or febrile urinary tract infection (0% (0) vs. 0.98% (1), P = 1) between the groups. Only hematuria was significantly more common in Arm B (6.86% (7) vs. 16.67% (17), P = 0.03), whereas other complications did not differ significantly. There was no statistical difference in hospitalization (0.98% (1) vs. 2.94 (3), P = 0.62) or mortality rate (0 % (0) vs. 0.98% (1), P = 1). Sub-group analysis of previous antibiotic users showed no difference in terms of complications.
Conclusion:
There is no significant difference in infectious complications between single-dose and prolonged prophylaxis of fosfomycin-trometamol for transrectal prostate biopsy. A single-dose of fosfomycin one hour before biopsy is an ideal choice with a better ecological impact compared with prolonged antibiotic prophylaxis for transrectal prostate biopsy.
2025-01-01ENVIRONMENTAL RESEARCH
A phenotypic study of the resistome in a peri-urban ecosystem
Article
作者: González Domenech, Carmen María ; López Guarnido, Olga ; González Román, Ana Carmen ; García Valdés, Luz María ; Espigares Rodríguez, Elena ; Dib, Amira Leila ; Román, Ana Carmen González
Since the discovery of antibiotics, the dispersion of resistance genes has increased exponentially, leading to the current state in which it has become increasingly difficult to achieve an effective treatment for infectious diseases. The enormous capacity for genetic exchange between microorganisms is causing resistance genes to be able to reach all environments, even those where there is no anthropogenic impact or exposure to these drugs. In this work, a phenotypic study of the resistome has been conducted in a peri-urban ecosystem (Granada, Spain), wherein the resistance to 32 antibiotics of 710 bacterial strains isolated from 70 samples from different ecological niches with varying levels of exposure to antibiotics and anthropic action has been determined. The study of resistances using phenotypic procedures constitutes a very useful and complementary alternative to genomic methods. The obtained results show a high percentage of resistance in all the subsystems analysed, stating high multi-resistance profiles. Vancomycin and erythromycin were the antibiotics to which the highest levels of resistance were observed, whereas the lowest levels were obtained in chloramphenicol. Regarding the environments studied, the highest percentages of resistance were found in wastewater, farms and food. It should be noted that in natural soil samples (not exposed to antibiotics or anthropogenic activities), worrying levels of resistance to practically all the groups of antibiotics analysed were detected. These results support the generally accepted conclusion that an appropriate control and management of wastewater and solid waste that may contain antibiotics or resistant bacteria is really important to prevent the wide propagation of the resistome in the environment.
2024-09-02Urologiia (Moscow, Russia : 1999)
New Prospects for Conservative Treatment of Chronic Recurrent Cystitis in Women: Experience with the Drug Superlymph®
Article
作者: Khanaliev B, V ; Gankovskaya L, V ; Gankovskaya, Gankovskaya L.V. ; Khasanova, Khasanova E.M. ; Sudilovskaya, Sudilovskaya V.V. ; Tevlina E, V ; Sudilovskaya V, V ; Tevlin, Tevlin K.P. ; Nasaeva E, D ; Nasaeva, Nasaeva E.D. ; Tevlin K, P ; Khasanova E, M ; Khanaliev, Khanaliev B.V. ; Tevlina, Tevlina E.V.
INTRODUCTION:
Chronic recurrent cystitis is a common and difficult problem of modern urology. Traditional use of antimicrobial drugs often cannot lead to the long-term remission.
AIM:
To evaluate the efficacy and safety of using different dosages and routes of the drug Superlymph in rectal and vaginal suppositories 10 U and 25 U in patients with chronic recurrent cystitis.
MATERIALS AND METHODS:
A randomized comparative clinical study in parallel groups included 60 patients aged from 18 to 80 years with a diagnosis of chronic recurrent bacterial uncomplicated cystitis. All study participants were randomized into three groups. In Group 1 (n=25), Superlymph suppositories 25 U were prescribed rectally once a day for 20 days. In group 2 (n=25), Superlymph suppositories 10 U were administered vaginally 2 times a day, for 20 days. In accordance with the prescription information, Superlymph 10 U/25 U can be used vaginally or rectally depending on the gender. In addition, it is possible to change the route of administration, for example, Superlymph 25 U one suppository once a day or Superlymph 10 U, one suppository 2 times a day in the morning and in the evening. The duration of the course is from 10 to 20 days. The main aim of the study was to compare an influence of various route of administration of Superlymph in women with frequent relapses of cystitis on the urothelium according to biopsy results, as well as on the symptoms of recurrent cystitis. The reparative effect of Superlymph was evaluated as well. In the control group (n=10), standard therapy was administered (fosfomycin trometamol 3.0 g once, and then, on the next day from the start of therapy, nitrofurantoin 100 mg three times a day for 5 days). The study consisted of screening, therapy and follow-up stages. The duration of therapy was 20 days. All groups did not differ significantly in the main baseline characteristics.
RESULTS:
The drug Superlymph demonstrated efficacy as monotherapy of uncomplicated lower urinary tract infection in women compared with standard treatment. Rectal administration of the drug was more effective than vaginal. This was primarily manifested by a decrease in the level of urothelial metaplasia by the end of the study by 41% in the group of rectal suppositories and by 9% for the vaginal suppositories. In the control group, no changes in the level of metaplasia were found. A symptom scale showed an improvement of 36% in the group of rectal suppositories, 25% in the group of vaginal suppositories, and 19% in the control group. Improvements in the quality-of-life score were 50.8%, 33.9%, and 31.1%, respectively. The mean pelvic pain symptom scale score improved by 30%, 23%, and 13%, while a decrease in the mean leukocytes level in urine was most significant in the group of vaginal suppositories, by 39%. The respective indicators in the group of rectal suppositories and the control group were 27% and 21%, respectively. Innate immune factors were also assessed. The evaluation of gene expression levels in the bladder mucosa after using Superlymph was also performed. A significant decrease in TLR4 gene expression by 3 times, TNF gene expression by 4.2 times, and HBD1 expression by 2.7 times was found, which indicates a significant decrease in the level of inflammation in the bladder mucosa.
CONCLUSION:
The immunomodulator Superlymph, representing a complex of natural antimicrobial peptides and cytokines, has demonstrated efficacy as monotherapy of chronic recurrent cystitis in women compared to standard treatment. Rectal route of administration was more effective than vaginal. This was primarily manifested by a decrease in the level of urothelial metaplasia by the end of the study. Therefore, the rectal suppositories should be used in older patients with a long history of the cystitis as intermittent therapy.
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) | 築膚鏇壓遞壓壓顧襯餘(蓋艱膚選繭膚觸顧選鏇) = 鑰廠積蓋鏇鏇獵壓鏇壓 網夢網窪齋鏇製壓遞願 (壓膚願範齋範觸積築鹽, 糧鹹鬱鑰壓獵夢獵餘積 ~ 鏇醖糧蓋鬱網衊獵憲網) 更多 | - | 2025-03-24 | ||
Placebo (Placebo) | 築膚鏇壓遞壓壓顧襯餘(蓋艱膚選繭膚觸顧選鏇) = 鑰願願衊鬱醖遞獵鹽製 網夢網窪齋鏇製壓遞願 (壓膚願範齋範觸積築鹽, 鬱襯簾膚夢願製觸衊襯 ~ 襯築鹽膚膚衊淵鬱壓構) 更多 | ||||||
临床1/2期 | 126 | (Pre-urodynamic Fosfomycin) | 遞繭餘簾廠夢網餘壓選: 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 | - | - | 餘鏇餘艱窪膚齋衊獵廠(齋獵網鹹繭憲襯憲鹽築) = 構願鹹窪憲顧衊衊窪艱 膚憲顧衊壓齋範糧艱衊 (網襯範願製壓構夢構壓 ) 更多 | 积极 | 2023-04-01 | ||
Preoperative Amikacin 1 gr I.V. | 餘鏇餘艱窪膚齋衊獵廠(齋獵網鹹繭憲襯憲鹽築) = 製觸窪構鏇範淵積鑰構 膚憲顧衊壓齋範糧艱衊 (網襯範願製壓構夢構壓 ) 更多 | ||||||
临床4期 | 62 | (Strategy 1) | 壓觸顧築憲選鏇壓遞網 = 蓋襯蓋餘鹹醖齋襯顧顧 憲蓋膚憲淵鑰醖觸憲築 (積獵築選膚膚獵淵膚餘, 積廠遞遞蓋網夢選衊蓋 ~ 獵簾顧壓糧選繭鑰遞夢) 更多 | - | 2020-12-19 | ||
(Strategy 2) | 壓觸顧築憲選鏇壓遞網 = 憲衊壓選築夢衊鏇鑰衊 憲蓋膚憲淵鑰醖觸憲築 (積獵築選膚膚獵淵膚餘, 繭襯遞選淵獵餘鬱製鑰 ~ 製繭夢廠齋艱衊願選夢) 更多 | ||||||
临床4期 | - | Fosfomycin trometamol + trimethoprim-sulfamethoxazole (Group 1) | 壓餘築膚齋獵製淵遞膚(觸淵積選觸壓顧夢壓鹽) = 積願襯艱獵衊網築築壓 壓選獵構願顧鏇遞衊獵 (糧鏇鹹獵夢鑰窪蓋鏇鬱 ) | - | 2018-10-01 | ||
Trimethoprim-sulfamethoxazole (Group 2) | 壓餘築膚齋獵製淵遞膚(觸淵積選觸壓顧夢壓鹽) = 繭遞積鹹壓夢憲淵鹹遞 壓選獵構願顧鏇遞衊獵 (糧鏇鹹獵夢鑰窪蓋鏇鬱 ) | ||||||
临床2期 | 18 | 觸鬱鬱網壓選齋鑰醖衊 = 選願餘鹹壓艱鹽築繭選 淵積廠網築膚鹹衊醖鏇 (顧觸鑰醖遞網製憲壓顧, 艱壓膚製鹹鑰製憲簾夢 ~ 衊鏇艱齋觸鏇衊淵艱繭) 更多 | - | 2017-10-19 |
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