RU2295336C2 - Means for correcting urologic andrological pathologies - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: means represents energy exchange regulator.

EFFECT: improved clinical economical efficiency of treatment; restored prostate secret production.

8 cl, 2 dwg, 6 tbl

Description

The invention relates to medicine and relates to urological andrological diseases.

Among uro-andrological disorders, chronic prostatitis, benign prostatic hyperplasia and associated erectile dysfunction are especially distinguished.

Prostatitis is an infectious and inflammatory disease of the prostate gland, often manifested by mild symptoms and therefore difficult to diagnose, which, in turn, can cause the patient to see a doctor late. As a result, chronic prostatitis (CP) can occur, although it can develop on its own.

Recently, an increase in the incidence of prostatitis has been observed. In areas with low seasonal temperatures, with significant differences and high humidity, it is especially large and reaches 70%. Affecting men of a relatively young age (20-50 years), prostatitis can lead to functional disorders of sexual intercourse and is often the cause of male infertility.

Often, a prolonged course of prostatitis is complicated by inflammation of the seminal vesicles, testicle and its appendage, sclerosis of the neck of the bladder or prostate.

Infectious prostatitis can be caused by various bacteria, viruses, chlamydia, ureaplasma, mycoplasmas, fungi, Trichomonas and other microorganisms; moreover, the role of sexually transmitted infections in the occurrence of prostatitis has recently increased significantly. Many doctors believe that prostatitis is closely associated with congestion in the prostate gland. They even distinguish an independent form of prostatitis associated with stasis in the prostate called congestive (congestive) prostatitis, when for all the clinical symptoms of this disease there are no inflammatory changes and infection in the secretion of the prostate.

Among the most common urological diseases in men in the second half of life is also benign prostatic hyperplasia (BPH).

Disorders of the male copulative-reproductive sphere, as a rule, are combined with other psychosomatic disorders and are accompanied by psychiatric syndromes, manifestations of social maladaptation and deviance.

The treatment of these diseases can be a serious problem for urologists and should, as a rule, be comprehensive, including drug therapy against the background of local and sometimes general physiotherapeutic effects, which are often selected individually depending on the clinical manifestations of the disease and the patient's characteristics.

The main medicines currently used to treat urology-andrological pathologies are the following (“State Register of Medicines”, “Register of Russian Medicines” and “Vidal Handbook. Russian Medicines”):

Hormones and their analogues. Hormone therapy is based on the dependence of the growth and development of the prostate gland on sex hormones. In the Russian pharmaceutical market for hormone therapy, there are offers of 7 drugs, four active ingredients. These are progestogens megaises and oxyprogesterone capronate, semisynthetic estrogens synestrol and gonadotropin releasing hormone - synarel. This group of drugs blocks testosterone synthesis in the testes at the level of the hypothalamus-pituitary gland or prevents androgenic effects at the level of the prostate gland. Despite the decrease in the volume of the prostate gland and the improvement of urodynamic parameters, hormonal preparations are currently being used in a limited way due to the high frequency of adverse reactions (impotence, decreased libido, etc.).

Alpha blockers. At the same time, studies of recent decades have shown that alpha-blockers have a significant effect on the vessels of the prostate gland - their condition is normalized, and blood supply improves. The first place among the drugs of this group is taken by the drug tamsulosin (omnik), which has selectivity for alpha ₁ receptors, mainly present in the prostate of men. Omnic has a minimal effect on blood pressure, and the effect of treatment comes quickly. This drug can be prescribed simultaneously with other drugs, which are often used in elderly patients. This fact is especially important for the treatment of elderly patients. The synthetic drug of this group is doxazosin (patent RU 2139053 C1, 10.10.1999).

Antitumor drugs. The studied group of drugs according to the mechanism of action on the prostate gland is similar to hormonal (depostate, zoladex, suprefact, flutamide, etc.). Some of the drugs in this group are used in the treatment of prostate cancer or in the presence of signs suspicious of latent prostate cancer, which cannot be confirmed even with biopsies (fluorouracil).

Antiparkinsonian drugs. Bromocriptine, an antiparkinsonian drug, is currently used. The mechanism of its action is quite complex. The use is mainly based on the ability to reduce the secretion of prolactin.

Herbal remedies. Since ancient times, medicinal plants have been widely used to treat urological diseases. In the ancient Sumerian lists dating back to 1750 BC, there are indications of their use for the treatment of urinary disorders in men. These were mainly collections containing plants such as parsley, celery, St. John's wort, lingonberry, nettle, pumpkin, etc. According to modern concepts, the effectiveness of phytotherapeutic agents used in this area is determined by the content of phytosterols in them, the most important of which are sitosterols. Their mechanism of action is multifunctional: inhibition of prostaglandin synthesis in the prostate gland and providing anti-inflammatory effect; cytotoxic effect on hyperplastic cells of the prostate gland; inhibitory effect against a number of enzymes involved in hormonal metabolism; blocking effect on androgen receptors; effect on tissue growth factors. It is widely known, for example, the drug Prostanorm (patent RU 2171106 C1, 07.27.2001). At present, they also use pumpkin, koprivit and speman, plant preparations: Serenoa repens - fan-palm (American), Cucurbita rero - ordinary pumpkin, Pygeum africanum - African plum, Urtica dioica - dioica nettle, Xanthium strumarium - common gooseberry. Phytopreparations can be widely used in urological practice as prophylactic agents and in patients with the initial stage of diseases.

Polyene antibiotics. Antibiotics such as levorin, mepartricin, bind sterols in the intestines, inhibit their absorption and resorption processes and affect the exchange of cholesterol and lipids. In this case, there is a decrease in the level of serum estrogens, which contributes to an improvement in urodynamic parameters and a decrease in the volume of residual urine.

Antimicrobial agents. Pipemidic acid preparations have been widely used in the domestic pharmaceutical market. They are used to eliminate urinary tract infections and normalize urination.

5-alpha reductase inhibitors. Finasteride (Proscar, Finast) is a promising drug. The mechanism of its action is due to the following: in prostate cells, testosterone is metabolized under the influence of the enzyme 5-alpha reductase into 5-alpha-dihydrotestosterone; in the cytoplasm of the cell, it binds to the androgen protein receptor and forms the androgen receptor complex. This complex penetrates the cell nucleus and activates DNA, which, in turn, leads to the growth and differentiation of prostate cells. Finasteride blocks the conversion of testosterone to dihydrotestosterone (patent RU 2200558 C1, 03.20.2003).

Polypeptides. prostatilen and vitaprost isolated from the prostate gland of bulls represent a complex of peptides. Peptides improve microcirculation in patients with complications. Synthetic preparations of this group are also described, for example, a new decapeptide (patent RU 2084458 C1, 07.20.1997).

Homeopathic remedies. The mechanism of action of homeopathic remedies is not fully understood, but they have a diuretic effect, an anti-inflammatory effect on the prostate gland.

However, it should be noted that the search for new tools remains an urgent task for specialists in this field of research.

Nevertheless, modern realities are such that increasing the effectiveness of new treatment methods lags behind their cost growth, does not guarantee the absence of relapses, and does not always facilitate the rehabilitation efforts of an andrologist. Therefore, the problem of finding adjuvant drugs available to most patients and significantly potentiating the effectiveness of known methods of treatment of a wide range of andrological nosologies exists.

The objective of the present invention is to develop tools that increase the clinical and economic effectiveness of the treatment of urological andrological diseases.

The problem is solved by the use of a regulator of energy metabolism as a means for the correction of uro-andrological pathology. The tool can also be used in combination with ciprofloxacin, simultaneously or sequentially.

Regulators of energy metabolism (REO) - a new class of drugs that appeared in the last decade. These drugs are able to optimize energy supply processes both in a healthy and in an organism weakened by pathology.

The importance of energy, strength for maintaining human health has long been understood by people. Widespread use of the so-called "stimulants", "adaptogens." However, their effect is difficult to control, and such intensification can lead to tension in the leading regulatory systems of the body, making it difficult to form short-term and long-term adaptation and sometimes leading to the opposite effect. REOs have certain targets - cells with a disrupted energy supply process, regardless of their location. They restore the energy potential of mitochondria, support the activity of their fast metabolic cluster.

In the course of the research, it was unexpectedly found that the use of REO has a beneficial character in complex uro-andrological disorders; there is the possibility of significant correction by drugs that regulate energy metabolism (REO), dysfunctional, inflammatory and degenerative processes in the prostate gland.

Different types of so-called “congestion”, intraprostatic urine reflux and growth of benign hyperplasia nodes lead to metabolic disorders in tissue complexes of various zones of the genital organs. Sympathetic-tonic circulatory hypoxia of smooth muscle elements of the lower urinary tract and stromal components of the prostate gland plays an important role in the development of uro-andrological disorders.

Sympathetic (stress and ischemic) lesions affect primarily the local circulatory system and the energy metabolism of detrusor, trigonum, posterior urethra, and prostate. Since tissue bioenergetic disorders play an important role in the pathogenesis of uro-andrological nosologies, the need is objectively forming for the introduction of drugs with a metabolite energetic type of action into everyday clinical practice, which may have a clinical, social as well as economic perspective.

There is reason to assume the effect of REO on the "central" links in the pathogenesis of andrological diseases (primarily the psychogenic mechanisms of erectile dysfunction).

As regulators of energy metabolism, natural substances are used - metabolites of plants and animals that can prolong the activity of the fast metabolic cluster of mitochondria. These include mitochondrial substrates (isolimonic, malic, fumaric, alpha-ketoglutaric acids and their pharmaceutically acceptable compounds; most preferably, succinic acid and its physiologically active salts, for example, potassium, sodium, calcium, magnesium, lithium, ammonium, zinc, selenium succinate and the like; substances that eliminate the inhibition of the key enzyme of the fast metabolic cluster of mitochondria succinate dehydrogenase - alpha-glycerophosphate and beta-hydroxybutyric acid. items such as glutamic, aspartic and their metabolic precursors, cofactors enzymes transaminases, e.g. vitamin B _6, involved in the production of endogenous succinic acid can be used compounds such as ubiquinone, capable of participating in the donor-acceptor reactions and provide mitochondria stability or shunt portions respiratory chains on which electron transfer is difficult.For the same purpose, xenobiotic substances with a similar effect can be used.

The mentioned components can be used separately or in a mixture, for example, succinic acid or its pharmacologically acceptable salt together with one or more of the components from the group: malic, isolimonic, glutamic, ketoglutaric acid, vitamin B ₆ . Perhaps the additional introduction of vitamins, such as A, C, E, contributing to increased stability of mitochondrial membranes due to the antioxidant effect and their structural analogues (for example, carotenoids), other antioxidants.

REO can be used both independently and with a pharmaceutically acceptable carrier, which includes excipients, taking into account the form for administration. Tablets, powders, capsules, solutions, suppositories, creams, gels can be used. Effective doses depend on the age, severity of the disease, the presence of concomitant diseases and range from fractions of a milligram, for example for vitamin B ₆ , to 2 g per dose, preferably 100-500 mg.

The possibility of carrying out the invention is confirmed by the following examples.

Example 1

Materials and methods. A general assessment of the clinical efficacy of the additional metabolite energy-stimulating effect of REO was carried out in a controlled randomized open clinical trial of a group of men with a recognized need for andrological care.

Criteria for inclusion in the study: all respondents in the comparison groups equally had pain and urination disorders characteristic of prostate diseases, as well as signs of ED and the associated need to improve the quality of intimate life.

Exclusion criteria: Severe BPH (benign prostatic hyperplasia) of 2-3 degrees, severe ED (erectile dysfunction) of organic origin with a poor prognosis of the effectiveness of conservative therapy. Patients without fail underwent a standard set of examinations: transrectal ultrasound (TRUS), superficial and deep palpation of the prostate, as well as questionnaires on ICF, SOS-CP and the Russified version of IPSS. At the end of the diagnostic step, prostate express in a dark field was microscopically analyzed. After that, a simple randomization was carried out according to the design of the study according to the plan of parallel groups. The clinical characteristics of the comparison groups are given in table 1.

Table 1
Characterization of comparison groups according to the main clinical signs Indicators Group receiving PTP Group receiving REO Average age, years 49.3 ± 5.3 (11.3) 46.4 ± 7.4 (15.5) The volume of the prostate gland, cm ³ (according to TRUS) 24.9 ± 5.9 (12.4) 21.32 ± 6.3 (13.2) Total ICF points 28.8 ± 4.6 (9.7) 32.3 ± 3.5 (7.4) White blood cells in the express (count in the field of view) 23.4 ± 9.4 (19.7) 19.3 ± 8.5 (17.9) Quality of Life (QOL), points 4.5 ± 0.9 (1.9) 3.8 ± 1.2 (2.5) Total IPSS Scores 24.7 ± 5.6 (10.3) 21.3 ± 4.2 (8.8) Clinical index for SOS-CP (points) 22.9 ± 5.2 (11.0) 18.5 ± 6.4 (13.4) Note: average values of indicators are indicated, their 95% confidence intervals, in brackets - standard deviation.

Patients of the first group (n = 20) for a month were treated with drugs of typical practice (PTP) according to the scheme: ciprofloxacin 0.5 g 2 times a day, pentoxifylline 0.4 g 2 times a day, methyluracil 0.5 g 3 once a day and alpha-tocopherol acetate 0.3 g per day. Terazosin and tamsulosin were recommended for patients to correct dysuria, but due to the high cost of drugs, only a few patients were able to use them. Subsequently, their indicators were not included in the observation matrices of this study. Patients of the second group (n = 20) during the entire period of treatment received REO amber-antitox (the drug was developed by the Scientific Research Institute of Pharmacology TNTs SB RAMS and produced by NFC, Tomsk), 1 tablet (0.1 g of succinic acid) 2 times a day or sodium isocitrate mixed with ammonium succinate. A month later, all patients repeated the standard set of examinations.

The cost of drugs per treatment course (at the average prices of pharmacies in Kirov for the study period) in the group of anti-TB drugs was 882 ± 125 rubles, in the group of anti-TB drugs + REO - 948 ± 102 rubles.

The totality of the set of parameter values that judged the effectiveness of pharmacotherapy met the criteria for normality of distribution according to Kolmogorov-Smirnov, Lilliefors and Shapiro-Wilk (p> 0.05). This made it possible to quantify the energy support of drug intervention of succinic acid as one of the independent factors using multivariate analysis of variances and multiple comparisons (according to the LSD test) in the ANOVA / MANOVA modules, as well as on the matrices of the full factorial experiment (PFE) 2 * 2 SPT STATISTICA 6.0 (Stat Soft, USA). Independent quality factors A (drug intervention) and B (type of pharmacotherapy) varied at two levels. Factor A levels: Before - before treatment. After - after a month of treatment; factor B levels: PTP - drugs of typical practice, PTP + REO - drugs of typical practice with energy support of the energy metabolism regulator. Information on N = 80 observations was included in the PFE matrix. The array, subjected to multivariate statistical analysis, consisted of 1440 values of response parameters characterizing the clinical efficacy of PTP and REO in the studied uro-andrological syndromes.

Results and its discussion. The used medical intervention made it possible to achieve a noticeable mitigation of the symptoms of uro-andrological disorders in both groups of patients according to most parameters of clinical effectiveness.

During the observation period, the severity of signs of CP, according to the questionnaire on the questionnaire SOS-CP, decreased (figure 1). A group of patients taking PTP showed a clear tendency to decrease in the values of CI (clinical index) by an average of 13.4%, IP (symptom index) by 16.2%, and Pain (pain in in the inguinal and genital areas, in the anus during the day spontaneously or in connection with coitus - by 29%, "Dysuria" (irritative and obstructive urination disorders) - by 10%, "QOL" (quality of life) - by 13.6% However, in a pairwise comparison of patients “before” and “after” treatment with only typical drugs, it was not possible to achieve the accepted in this study, the level of statistical significance of differences indicating the reliability of the clinical effect for the observation period (p <0.05).

Along with this, the use of REO allowed us to achieve more pronounced clinical dynamics according to SOS-CP: a decrease in CI by 40.7% (p = 0.001), IS by 42% (p = 0.001). Indicators of pain decreased by 42% (p = 0.02), dysuria - by 39% (p = 0.02). The degree of dissatisfaction with the quality of life (QOL) in SOS-CP decreased by 43% (p = 0.001).

table 2
Quantitative assessment of the strength and significance of the energy support of REO during the pharmacotherapy of CP (according to SOS-CP) SOS-HP indicator Independent factors The magnitude and direction of the effect F R Clinical Index (CI) BUT -5.4 11.2 0.0013 AT -5.5 11.6 0.0010 Symptom Index (IP) BUT -4.1 12.64 0,00065 AT -3.5 8.96 0.0037 Pain BUT -2.2 8.57 0.0045 AT -1.0 1.82 0.181 Dysuria BUT -2.0 4.79 0,032 AT -3.5 11.14 0.0013 Quality of life (QoL) BUT -1.97 9.7 0.003 AT -1.48 5,4 0,022 Note: according to the PFE 2 * 2 algorithm [16], the value of the effect of independent factors A and B was estimated by the absolute values of the regression coefficients, and its statistical significance was assessed by the Fisher F-test. The uniformity of the dispersions was checked by Levene and Brown-Forsythe tests.

Example 2

A study was also conducted on the effect of REO on increasing the effectiveness of ciprofloxacin (PTP). The results of applying the combination are presented in figure 2.

The quality of life index (QOL) in the PTP group decreased by only 7%, while in the PTP + REO group - by 32% (p = 0.03). In both groups, drug intervention led to a significant decrease in leukocytosis of the express (by 37%, p = 0.037 when using PTP and by 66%, p = 0.0001 when adding REO), which indicated a decrease in the intensity of the inflammatory reaction in the tissue of the prostate gland or complete relief of inflammation. The number of lecithin grains increased by only 10% (p = 0.37) per month of typical treatment, that is, in this case, the functional state of the prostate improved slightly. But against the background of the use of REO, this indicator increased on average by 20% (p = 0.057), reaching a level of 4.2 points and approaching the characteristics of the secretion of the normal prostate (the best score is 5). Noteworthy is a significant increase in the number of macrophages in the secretion of the prostate under the influence of REO (by 88%, p = 0.0001).

The ratio of the strength of the contributions of PTP and REO factors to the variability of the studied QOL parameters and the characteristics of the prostate secretion is shown in Table 3.

Bioenergetic support of REO (factor B) more clearly and at a high level of statistical significance reflected on the quality of life and a decrease in the number of leukocytes in the secretion of the prostate. In terms of their influence on macrophage activation and the number of lecithin grains, both factors turned out to be almost equal in absolute magnitude of the strength of influence and its direction, but the contribution of the factor of drug intervention in general (factor A) did not reach the level of statistical significance.

Table 3
A quantitative assessment of the strength and significance of the effects of REO in the pharmacotherapy of uro-andrological disorders in CP on quality of life (QOL) and characteristics of prostate secretion Indicator Independent Factors Magnitude of effect F R QOL BUT -0.55 1.94 0.167 AT -1.1 7.77 0.007 White blood cells BUT -0.37 0,03 0.85 AT -6.83 21,2 0,000 Macrophages BUT 0.5 2,53 0.116 AT 0.6 3.65 0.059 Lecithin grains BUT 0.43 3.2 0,077 AT 0.48 4.0 0,049 Note: designations of factors and assessment of effects - as in Table 2.

The data presented (Table 4) indicate a clear improvement in male copulative function (MKF) under the influence of PTP and REO. If in the group of patients treated with the PTP complex, only tendencies (statistically insignificant effects in the range of 4.2-18.6%) towards improvement of MKF were observed, then against the background of additional administration of REO amber-antitox, the increment of the clinical effect increased by 20-30% by compared with the group of anti-TB drugs and acquired statistical significance (p≤0.05).

Table 4
The effect of REO on ED (according to the MKF questionnaire scale) with complex pharmacotherapy of CP MKF indicator (points) PTP PTP + REO Before treatment After treatment Effect R Before treatment After treatment Effect R Mental component 4.3 + 1.5 (3.2) 5.1 + 1.5 (3.2) 18.6 0.37 5.1 + 1.1 (2.3) 7.2 + 1.1 (2.4) 41 0.018 Neurohumoral component 7.1 + 1.2 (2.5) 7.8 + 1.2 (2.6) 10.6 0.35 6.8 + 1.1 (2.4) 9.4 + 1.1 (2.4) 37.5 0.002 Erection component 6.0 + 1.3 (2.8) 6.3 + 1.4 (2.8) 4.2 0.77 6.4 + 1.2 (2.4) 8.8 + 1.3 (2.8) 38.1 0.006 Ejaculatory component 6.6 + 2.0 (4.3) 7.2 + 2.1 (4.2) 9.1 0.59 6.7 + 1.4 (2.9) 10.2 + 1.2 (2.6) 52,2 0.003 Functioning in general 5.3 + 1.3 (2.8) 6.1 + 1.4 (2.9) 16,2 0.34 6.5 + 1.2 (2.5) 9.7 + 1.4 (2.9) 47 0.001 The total amount of the IFF (points on issues No. 1-12) 28.8 + 4.6 (9.7) 30.9 + 4.0 (8.5) 6.9 0.44 32.3 + 3.5 (7.5) 40.0 + 3.7 (7.8) 24.2 0.005 Note: average values of MKF indicators and their 95% confidence intervals are indicated (in brackets is the standard deviation); effect = (MKF indicator after treatment / MKF indicator before treatment - 1) * 100%; p is the statistical significance of differences between groups according to the multiple LSD test.

The presence of a reliable beneficial effect of REO on satisfaction with the quality of life according to the MKF, QOL and SOS-CP scales made it possible to evaluate the pharmacoeconomic effect of the energetic effect of amber-antitox in urol-andrological disorders accompanying CP. For this, the cost-effectiveness coefficient was calculated in the comparison groups (Table 5). The additional costs of acquiring amber-antitox REO for energy support of the monthly course of pharmacological correction of uro-andrological CP disorders amounted to 66 rubles, or an average of 7.5% of the cost of PTP.

Table 5
Pharmaco-economic evaluation of the effectiveness of REO amber-antitox in urol-andrological disorders accompanying CP Clinical performance indicator CER (rub /% effect) CER (rub / self-assessment score QOL) PTP PTP + REO PTP PTP + REO QOL 126 29.6 3528 1115 Total IFF 126 39.5 441 122 QOL by SOS-HP 64.8 22.1 882 321

Comparison of the values of the cost / effectiveness coefficient in the comparison groups showed that the addition of REO to the DTP leads to a decrease in the cost of 1% effect by 66-76%, and the cost of an additional point of satisfaction with quality - by 64-72%. Moreover, the achievement of 1% of the additional effect (satisfaction with the quality of life) in the PTP + REO group compared to the PTP group, according to the analysis of incremental cost-effectiveness (CER incr), required an additional investment of only 2.2-3.8 rubles per month.

In general, clinical and economic calculations showed that the clinical effectiveness of the use of REO is accompanied by an economic effect, which consists in reducing the cost of 1 unit of effectiveness when patients self-assess the quality of life on the scales of three independent scales of SOS-CP, ICF, QOL.

Thus, REO significantly and significantly increased the clinical and economic effectiveness of PTP in the treatment of chronic prostate diseases and erectile dysfunction in men of different ages. The results allow us to recommend the use of drugs that normalize energy metabolism for the treatment and rehabilitation of a number of complex andrological pathologies; they indicate the prospect of further development of drug technologies to increase clinical efficacy and reduce the cost of treatment of urological andrological diseases using REO.

Examples of compositions of the REO preparations are shown in table 6.

Table 6
An example of possible combinations of active substances and excipients in preparations regulating energy metabolism Ingredients mg Example 1 Example 2 Example 3 Example 4 Example 5 succinic acid one hundred fifty - 500 fifty Apple acid - 150 200 - 70 Ketoglutaric acid - - - fifty - Isolimonic acid one hundred - fifty - - Glutamic acid fifty - one hundred - - Vitamin B ₆ 5 - 2 - - Glucose one hundred 200 - fifty 375 Cellulose - one hundred fifty fifty - Vitamin C - - - 10 - Starch one hundred - 140 - - Magnesium stearate 5 - 10 - 5

These examples are provided to illustrate the invention, but do not limit it.

Claims (8)

1. The use of energy metabolism regulator as a means for the correction of uro-andrological pathology. 2. The use according to claim 1, in which the regulator of energy metabolism is succinic acid or its pharmacologically acceptable salt. 3. The use according to claim 1 or 2, in which the tool further comprises at least one of the vitamins selected from the group comprising vitamins A, C, E, or their structural analogues. 4. The use according to claim 1, in which the energy metabolism regulator is succinic acid or a pharmacologically acceptable salt thereof in conjunction with one or more of the components from the group: malic, isolimonic, glutamic, ketoglutaric acid, vitamin B ₆ . 5. The use according to claim 1 or 2, in which the uro-andrological disease is chronic prostatitis. 6. The use according to claim 1 or 2, in which the uro-andrological disease is benign prostatic hyperplasia. 7. The use according to claim 1 or 2, in which the tool further comprises a pharmaceutically acceptable carrier. 8. The use according to claim 1 or 2, in which the tool is administered simultaneously or sequentially with ciprofloxacin.

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