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Antimicrobial therapy is one of the most dynamically developing areas of medicine. The complexity of this aspect lies in the fact that the sensitivity of microflora to antibacterial drugs is constantly changing, and research results quickly become invalid. Currently, recommendations even from five to seven years ago require a critical attitude.

To date, much work has been done to study the effectiveness and safety of antibacterial agents. The evidence base for individual drugs is measured by hundreds of studies at various levels. Thousands of reference books and tens of thousands of articles have been published. However, there are still many unresolved questions regarding antimicrobial therapy.

On the one hand, an overabundance of information, often contradictory, does not help, and often complicates the choice of drug, introducing uncertainty into the situation. This problem is addressed by performing meta-analyses that provide the most reliable information possible. But the meta-analysis technique is very labor-intensive, so they are performed quite rarely and only on the most fundamental issues.

On the other hand, the justified choice of an antibacterial drug in conditions of renal failure, liver failure, immunodeficiency, etc., has not been sufficiently studied and covered in the literature, but at the same time relevant. Not recalculation of the dosage, which today is not any serious problem - just refer to the reference tables, but a choice, and a reasonable one at that. Despite the relatively small number of seriously ill patients, they are found constantly in all clinics, regardless of the profile.

In this article we will consider the problem of antibacterial therapy not according to the classical scheme “from the disease side”, when the diagnosis and treatment of any nosology is discussed, but “from the drug side”, as is customary in general pharmacology. That is, we will analyze the pharmacological properties and evidence base of a specific drug - the natural antibiotic fosfomycin, and determine for whom, when and over what it should have advantages. Indications for use automatically follow from here. Due to the peculiarities of its chemical structure, this drug is not included in any of the pharmacological groups and stands somewhat apart.

PHARMACOLOGICAL PROPERTIES OF FOSFOMYCIN

The mechanism of action of fosfomycin is bactericidal. The effect occurs due to disruption of the synthesis of the bacterial cell wall. Fosfomycin is active primarily against gram-negative pathogens, in particular E. coli, Proteus spp., Salmonella spp., and is capable of suppressing Staphylococcus spp. and Enterococcus spp. It does not have cross-resistance with other antibacterial drugs, so hospital multidrug-resistant strains, including VRE (vancomycin-resistant enterococcus), may be sensitive to fosfomycin.

Despite the fact that fosfomycin has been known since the late 1960s, acquired resistance to it in gram-negative bacilli, especially E. coli, is now relatively rare. In this parameter, fosfomycin is approximately comparable with ceftazidime and is significantly superior to third-generation non-antipseudomonas cephalosporins, inhibitor-protected aminopenicillins and fluoroquinolones.

Non-fermenting gram-negative rods, in particular P. aeruginosa, intracellular pathogens, as well as anaerobes, are naturally resistant to the drug under study. [1].

Fosfomycin trometamol is absorbed from the lumen of the gastrointestinal tract by 60%, is not metabolized, and is excreted unchanged by the kidneys. The half-life of fosfomycin is 4 hours when administered orally, 1.5-2 hours when administered intravenously. The drug creates therapeutic concentrations in various organs, including the kidneys, bladder, and prostate gland. Therapeutic concentrations of fosfomycin in urine can persist for up to 72 hours after a single oral dose of 3 grams [1].

Side effects when using fosfomycin develop relatively rarely. Among the adverse reactions, the most significant is a transient increase in transaminase activity. Sometimes patients report dyspeptic symptoms that disappear soon after discontinuation of the drug and do not require specific therapy. Overall, fosfomycin is one of the safest and most well-tolerated antibacterial drugs.

Due to the characteristics of the spectrum of antibacterial activity, as well as due to the characteristics of pharmacokinetics, fosfomycin is used mainly in urology. The use of this drug in other areas of medicine is in the nature of single and occasional prescriptions. Currently, fosfomycin is supplied to the market in oral (fosfomycin-trometamol) and parenteral (fosfomycin-sodium) forms, the use of which has fundamental differences.

EVIDENCE BASE FOR THE EFFECTIVENESS OF FOSFOMYCIN

Fosfomycin has a fairly extensive evidence base, including 71 clinical studies since 1977.

Fosfomycin is used mainly for the treatment of acute cystitis, so most of the research is devoted to this aspect.

27 randomized studies of the effectiveness of fosfomycin for the treatment of acute cystitis were conducted. Sixteen studies included only non-pregnant women [2–17]. Some studies included a group of adolescent girls in addition to adult women [4, 7, 9–11, 16, 17]. Three studies included groups of men with urinary tract infections [18–20]. Five studies determined the effectiveness and safety of therapy for acute cystitis in pregnant women [21-25].

In all of these studies, fosfomycin was administered as a single dose of 3 grams. Comparators are extremely diverse. Most often, various fluoroquinolones played this role, in particular norfloxacin [10, 11, 16, 17]. This is the most reasonable choice, since in view of the pharmacokinetics, norfloxacin in modern urological practice is used mainly for the treatment of primary cystitis in women. In addition, other fluoroquinolones were used as comparison drugs: ciprofloxacin [2, 3], ofloxacin [14], pefloxacin [6]. There are also variants of comparison drugs that are exotic from a pharmacological point of view. For example, non-fluorinated quinolone - pipemidic acid [9], aminopenicillin - amoxicillin [15], sulfonamide - sulfamethoxazole/trimethoprim [12] and even monotherapy with aminoglycosides - amikacin [18] and netilmicin, the latter being prescribed to children [26, 27]. Five of 27 studies compared single doses of fosfomycin with single doses of ofloxacin [14], norfloxacin [17], trimethoprim [13], and amikacin [18]. In the remaining studies, therapy with the comparator drug lasted from three to seven days.

In studies involving non-pregnant women suffering from acute cystitis, the effectiveness of fosfomycin therapy was high (up to 95%), but without statistically significant differences compared with the above-mentioned antibacterial agents, with the exception of trimethoprim [13]. There were no differences between fosfomycin and other antibacterial drugs in the effectiveness of pathogen eradication, either when compared with each of the antibiotics or when conducting a cumulative analysis [2, 4-7, 9-14, 16]. A similar picture is observed in groups of men who suffered from urinary tract infections, as well as teenage girls.

There were no significant differences in the incidence of side effects in the groups of patients receiving fosfomycin and patients taking comparator drugs.

The reader can obtain more comprehensive and comprehensive information on antibacterial therapy for acute cystitis in a recently published meta-analysis (2013), devoted to a comparative analysis of the effectiveness and safety of various methods of drug treatment for this disease. The main conclusion of the authors of this work is that in the treatment of acute cystitis, the oral form of fosfomycin has comparable efficacy and higher safety compared to fluoroquinolones, cephalosporins and aminoglycosides [28].

Meta-analysis by Falagas ME. et al. including 27 controlled randomized trials, also examined the effectiveness of fosfomycin for the treatment of cystitis in various clinical situations. Both clinical and microbiological effectiveness of this antibacterial agent was noted. The authors concluded that it is advisable to use fosfomycin as a first-line drug in the treatment of acute cystitis, including in pregnant women, as well as in children [29]. Along with original works, fosfomycin appears in a number of authoritative recommendations, both domestic and foreign. Let's list some of them.

T.S. Perepanov and P.L. Khazan (Research Institute of Urology) recommends fosfomycin and furazidin as basic drugs for the treatment of uncomplicated lower urinary tract infections (that is, cystitis in young women without concomitant diseases) [31].

The American Association of Obstetricians and Gynecologists (2008) considers it appropriate to use fosfomycin, sulfamethoxazole/trimethoprim, trimethoprim monotherapy, ciprofloxacin, levofloxacin, norfloxacin, gatifloxacin, nitrofurantoin for the treatment of uncomplicated urinary tract infections in non-pregnant women. The duration of therapy with nitrofurantoin is 7 days, with fosfomycin - once, with other drugs - 3 days. Unfortunately, criteria for selecting a specific drug are not specified [32].

The American Antimicrobial Association recommends fosfomycin, sulfamethoxazole/trimethoprim, and nitrofurantoin for the treatment of acute cystitis. Fluoroquinolones are indicated only as reserve drugs [33]. The 2013 American recommendations outline similar drugs of choice for the treatment of acute cystitis [34].

The 2010 European Urological Association guidelines, in contrast to earlier releases, tended to limit the use of fluoroquinolones. The drugs of choice for initial empirical treatment of uncomplicated lower urinary tract infection are fosfomycin, nitrofurans and pivmecillinam (the latter is not registered in Russia). Fluoroquinolones are considered only as a reserve [35].

It can be noted that there is more clarity regarding the pharmacotherapy of various forms of cystitis than in relation to other diseases of the genitourinary system, for example, pyelonephritis. The vast majority of researchers recommend fosfomycin and fluoroquinolones as basic drugs. However, a number of authoritative sources, including the European Urological Association and the American Association of Antimicrobial Therapy, oppose the widespread use of fluoroquinolones, explaining this by the progressive increase in the number of resistant strains of E. coli.

Another generally recognized, albeit minor, niche of fosfomycin in urological practice is antibacterial prophylaxis. The issues of prophylactic use of fosfomycin during surgical interventions on the genitourinary system have been studied significantly less than the use of this drug for acute cystitis.

According to Yu.L. Alyaev and A.Z. Vinarov, when performing endoscopic surgical interventions on the lower urinary tract, antibacterial prophylaxis with fosfomycin/trometamol is highly effective. The drug was prescribed only twice - before the operation and the next day after the intervention. 92.3% of patients passed without infectious and inflammatory complications [36].

Research results by Z.K. Gadzhieva indicate that when conducting a comprehensive urodynamic study, a single prophylactic administration of an oral form of fosfomycin is advisable. Efficiency exceeds 85% [37].

The Urology Clinic of the University of Tokyo and Kyoto Medical College recommend prophylaxis with one dose of an antibacterial drug, in particular fosfomycin or cefotiam (not registered in Russia), especially with “pure” urological interventions and invasive research methods [38, 39, 40].

Systematic review by Falagas ME. et al., evaluates data on the use of fosfomycin as a drug of choice in the treatment of infectious diseases caused by members of the Enterobacteriaceae family with increased resistance to antimicrobial agents, including those producing extended-spectrum β-lactamases (ESBLs) [41]. Seventeen antibacterial susceptibility studies were identified and included in the review, including a total of 5057 clinical isolates of Enterobacteriaceae with increased resistance to antibacterial drugs (4448 ESBL-producing); 11 of 17 studies reported that 90% of isolates were susceptible to fosfomycin. When 64 mg/L was used as a preliminary minimum inhibitory concentration, 96.8% of 1657 BRLS-producing Escherichia coli isolates were susceptible to fosfomycin. Similarly, 608 (81.3%) of 748 BRLS-producing Klebsiella pneumoniae isolates were susceptible to fosfomycin. In two clinical studies, oral fosfomycin trometamol was effective in the treatment of complicated or uncomplicated lower urinary tract infections caused by ESBL-producing E. coli in a total of 75 (93.8%) of 80 patients observed. Preliminary clinical evidence supports the use of fosfomycin in the treatment of urinary tract infections caused by similar pathogens, although research is needed [41].

PHARMACOLOGY. RATIONALE FOR THE USE OF FOSFOMYCIN

Having considered the pharmacological properties of fosfomycin and the results of the studies, we will determine possible indications for prescribing this antibacterial drug in the treatment of urological patients.

Due to the relatively low level of acquired resistance in the E. coli population, fosfomycin trometamol is the drug of choice for the treatment of acute cystitis. A single or double dose is sufficient. Also, this drug in the same dosage regimen can be used as antibacterial prophylaxis for short-term interventions on the urinary tract and invasive research methods.

It is not advisable to use the oral form for the treatment of pyelonephritis or prostatitis, since therapeutic concentrations in the tissues of these organs are not achieved.

The parenteral form of fosfomycin (fosfomycin sodium) is a complete alternative to third-generation non-antipseudomonas cephalosporins, and in some cases to fluoroquinolones and aminoglycosides, when it is impossible to prescribe these drugs, for example, due to allergies. Fosfomycin sodium demonstrates acceptable results both in the treatment of pyelonephritis and in the regimen of antibacterial prophylaxis during surgical interventions on the genitourinary system.

There are two significant limitations to the parenteral form of fosfomycin. Firstly, the drug must be administered intravenously 3 times a day, which creates certain inconvenience for both the staff and the patient. Secondly, despite the sensitivity of many multidrug-resistant gram-negative strains, the lack of activity against P. aeruginosa practically excludes the use of fosfomycin as a reserve drug in the empirical treatment regimen.

The lack of activity against intracellular substances is not significant, since the drug is used in a hospital, and postoperative prostatitis and epididymo-orchitis are caused, as a rule, by gram-negative bacilli with a moderate or high level of acquired resistance.

The use of fosfomycin in conditions of renal failure requires special discussion. Fosfomycin is the drug of choice for the treatment of cystitis, so the above question is usually due to the difficulties in choosing an antibacterial agent for the treatment of cystitis against the background of renal failure. There are two fundamental options here. Exacerbation of chronic cystitis in a patient with an abnormality of the lower urinary tract or with neurogenic bladder dysfunction. In this case, the cause of chronic renal failure is chronic pyelonephritis, often in combination with vesicoureteral reflux. It is much less common to encounter a situation where chronic renal failure and cystitis are not externally related to each other.

The first option assumes a long history, a severe recurrent course of the disease and insufficient effectiveness, otherwise chronic renal failure would not have developed. A significant proportion of such patients have long-standing drainages. The role of causative agents of exacerbation of chronic cystitis and pyelonephritis is usually played by multidrug-resistant gram-negative bacilli, including microorganisms of the genus Pseudomonas, which makes the prescription of fosfomycin in an empirical regimen pointless, since this drug does not have antipseudomonas activity.

In a situation where the existing nephropathy, complicated by chronic renal failure, and cystitis are not externally related in any way, and the patients did not receive massive antibacterial therapy, fosfomycin is completely justified from a microbiological point of view. The main limiting factor is not possible toxic reactions, but the expected lack of effect from insufficient concentration of the drug in the urine, which in turn is associated with low glomerular filtration and a decrease in the concentrating ability of the tubules, characteristic of the late stages of chronic renal failure. Hence the conclusion: if chronic renal failure is non-terminal, fosfomycin can be used. In case of severe kidney damage (glomerular filtration rate below 30-35 ml/min), for safety reasons it is advisable to prescribe the drug not at 3 grams, but at 1.5 grams orally.

By the same principle, the parenteral form of fosfomycin can be used to treat pyelonephritis, which can be justified in cases of allergy to betalactams.

SUMMARY

When deciding on drug therapy, the greatest difficulty in most cases is the justified intragroup choice of a drug. In modern clinical pharmacology, it is extremely rare to make a choice between a “good” and a “bad” drug. As a rule, the choice is made between a “good” and a “very good” drug. This line is often quite weakly expressed, in addition, it varies greatly depending on the clinical situation. Cefotaxime or ceftriaxone, ciprofloxacin or ofloxacin - how do they fundamentally differ, when and who to give preference to? And most importantly, on what basis? Or maybe in this particular situation they are not different at all? Then the economic component comes into force - preference is given to the more financially accessible drug. By the way, there are very few studies comparing the effectiveness of drugs within the same pharmacological group, although, in our opinion, this is very important.

The formulation “intragroup choice” for fosfomycin is meaningless due to the lack of drugs with similar chemical and pharmacological properties, but the problem of choice is still relevant. We will try to briefly and concisely outline when and to whom, from a pharmacological point of view, it is advisable to prescribe fosfomycin preparations.

Fosfomycin/trometamol is the drug of choice for empirical treatment of acute cystitis in young and middle-aged women, superior in ease of use to fluoroquinolones, nitrofurans, and inhibitor-protected aminopenicillins.

Fosfomycin/trometamol is used for antibacterial prophylaxis for small-scale and duration of interventions on the lower urinary tract and invasive methods of examining the genitourinary system.

Fosfomycin/trometamol is not advisable to prescribe if the patient has pyelonephritis, prostatitis, epididymitis and epididymo-orchitis.

Fosfomycin/trometamol is not advisable to prescribe for suspected sexually transmitted infections, as well as empirically for secondary cystitis associated with repeated surgical interventions, neurogenic dysfunction of the pelvic organs, abnormalities of the lower urinary tract and external genitalia due to the high likelihood of the presence of P. aeruginosa ; According to the antibiogram, such use of fosfomycin is quite acceptable.

Fosfomycin sodium can act as a full-fledged alternative to non-antipseudomonal cephalosporins, fluoroquinolones, and second-generation aminoglycosides in the treatment of pyelonephritis, for example, in the case of polyvalent allergies.

Fosfomycin sodium can be prescribed empirically in different ways in the absence of effect from non-antipseudomonal cephalosporins and fluoroquinolones due to the lack of activity of fosfomycin against P. aeruginosa. If another pathogen is identified according to the antibiogram, such an appointment is possible.

Fosfomycin has clinically significant activity against Enterococcus spp., which is important for allergies to aminopenicillins. The use of fosfomycin in identifying strains of Enterococcus spp. resistant to aminopenicillins and even vancomycin is possible, but only according to the antibiogram.

Fosfomycin has no inherent nephrotoxicity. When prescribing fosfomycin in conditions of renal failure, it is necessary to recalculate the dosage according to the glomerular filtration rate.

Fosfomycin has hepatotoxicity, although mild, so in case of liver failure, the use of this drug should be very measured.

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