Application of peptide bioregulators to maintain the function of the male reproductive system

Application of peptide bioregulators to maintain the function of the male reproductive system

Relevance. Men’s reproductive health is an important aspect of overall well-being and has a significant impact on both the personal life of an individual and public health in general. As men age, changes occur in the male reproductive system that can affect fertility, quality of sex life, and overall physical health. These changes are often gradual and may not be noticeable for a long time, but their long-term impact on health and well-being cannot be underestimated. One of the areas of pharmacocorrection of male reproductive health disorders is testosterone replacement therapy. But such therapy can cause disturbances in the cellular composition of the blood, has a toxic effect on the liver, and can cause gynecomastia and other side effects. Therefore, the development of schemes for the use of bioregulatory therapy is relevant for the preservation of men’s health. Peptide bioregulators of the male reproductive system include Libidon and Testoluten.

Libidon is a complex of peptides isolated from the prostate gland of cattle. It is a regulator of the functions of the prostate gland and the male reproductive system.

Testoluten is a complex of peptides isolated from the testes of mature bulls and pigs, which belongs to the group of cytomedins.

Impaired pancreatic function (insulin resistance) adversely affects testosterone synthesis in men. In this regard, Suprefort, a complex of peptides isolated from the pancreas of cattle, can be used to comprehensively support the functions of the male reproductive system.

Also, to maintain the function of the male reproductive system, Glandokort, a complex of peptides isolated from the adrenal glands of cattle, will be useful. Glandocort has a stress-protective effect.

Vesugen is a KED tripeptide (lysyl-glutamyl-aspartic acid), a vasoprotector, the active substance of Ventfort, which is a polypeptide complex isolated from the blood vessels of cattle.

All these bioregulators are produced in the form of biologically active additives (BAA). These are capsules and drops under the tongue.

Also GPL@Man is a bioregulator of the male reproductive system. It is a product based on polypeptide complexes and other biologically active substances, produced in capsules. 1 capsule contains 60 mg of peptides (epiphysis, brain, blood vessels, liver, pancreas, testes), as well as alpha-lipoic acid.

Peptide bioregulators of the male reproductive system have demonstrated their safety and effectiveness in a number of in vitro and in vivo studies.

Studies of acute, subacute and chronic toxicity of Testoluten have shown the absence of side effects with single and long-term use in doses exceeding the therapeutic dose by 300-3000 times. When Testoluten (100 ng/ml) was added to an organotypic culture of rat testes, it stimulated the growth of explants by 35% compared to the control [Khavinson et al., 2006].

Testoluten was studied in a clinical study involving 36 patients aged 43 to 61 years. 17 of them were in the control group, which received intramuscular injections of saline daily for 10 days. The main group, consisting of 19 patients, received intramuscular injections of Testoluten (2.5 mg/ml) daily for 10 days. Before treatment, patients complained of a deterioration in quality of life, including sexual weakness. Patients’ complaints were assessed over time, and general clinical examination of blood and urine, biochemical blood test were performed. Using the radioimmunological method, the content of sex hormones in the blood serum of patients was determined. A palpation assessment of the prostate gland and laboratory examination of its secretions and ejaculate were performed. The use of Testoluten contributed to the improvement of the general well-being of patients. All patients noted improved sexual function, a decrease in symptoms of sexual weakness and an increase in libido. In addition, a significant increase in the concentration of testosterone in the blood of patients taking Testoluten was noted — this indicator increased by 26% during treatment [Khavinson et al., 2006].

It is assumed that a decrease in the level of free testosterone in men with distress syndrome is associated with an increase in the level of insulin resistance and a disruption in the synthesis of prohormones by the adrenal glands, while normal levels of cortisol and blood sugar. is normal. In this regard, in another clinical study, regimens for correcting sex hormone levels in men with altered insulin resistance using various peptide complexes were developed and tested. The study included 105 men aged 38-45 years with erectile dysfunction after long-term stress. All patients were divided into several groups and received various combinations of peptide drugs of the adrenal glands (Glandocort), prostate (Libidon), testes (Testoluten) and pancreas (Suprefort) for 6 weeks. All subjects were examined for the quality of erections, indicators of glucose, insulin, cortisol, dehydroepiandrosterone sulfate (DHEA-S), sex hormones, and the insulin resistance index (HOMA-R). All patients had moderately elevated levels of the insulin resistance index and dehydroepiandrosterone sulfate. Levels of free and total testosterone, sex hormone binding globulin (SHBG), follicle-stimulating hormone (FSH), luteinizing hormone (LH), and cortisol were normal. The use of prostate and testicular peptides did not have a strong effect on the quality of erections. The insulin resistance index and adrenal hormone levels did not change, and the levels of total and free testosterone increased by 4.6% and 18%, respectively. The combination of adrenal, prostate and testicular peptides moderately reduced dehydroepiandrosterone sulfate levels and increased free testosterone levels by 54%. Total testosterone levels increased by 24%. Cortisol levels decreased by 8%. The insulin resistance index and sex hormone binding globulin levels did not change. The quality of erections has improved. A significant improvement in the quality of erections was achieved with a combination of peptides from the adrenal glands, pancreas, prostate and testes. The quality of erections has increased even more. Insulin resistance, dehydroepiandrosterone sulfate and cortisol levels decreased significantly. The level of bound testosterone increased by 1.9 times. The values of sex hormone binding globulin increased slightly. Thus, the complex use of polypeptides from the testes, prostate, adrenal glands and pancreas makes it possible to achieve maximum improvement in hormonal status in men with distress syndrome [Gorgiladze D.A. et al., 2022].

Tripeptide Vesugen was also studied in a clinical study involving 41 patients with ischemia of the lower extremities aged 65 to 82 years, which corresponds to elderly and senile age according to the WHO classification [Kitachev K.V. et al., 2014]. 15 patients were included in the control group, and 26 patients were included in the main group, which received Vesugen 1 capsule per day for 1 month. The study included patients with ischemia stage no more than IIB (assessed by pain-free walking distance and ankle-brachial index, reflecting the state of blood flow in the lower extremities). Before and after treatment, the patients’ condition was assessed using the International Index of Erectile Function, as well as measuring the linear velocity of blood flow through the arteries of the penis using Doppler ultrasound scanning of the arteries of the penis. Vesugen statistically significantly increased the quality of sleep of patients (from 45 to 55 points), as well as indicators of mental health (by 8 points), lower limb function (by 13 points) and sexual function (by 7 points), compared with indicators before treatment. After 4 months of use, Vesugen also significantly increased the systolic blood flow velocity in the penile arteries — by 53% and 61% compared to the control values. In this regard, the following conclusions can be drawn:

1. The use of the vascular peptide Vesugen in elderly and senile patients with erectile dysfunction can improve the quality of sexual life, which is confirmed by an increase in the ultrasonic characteristics of blood flow in the penile arteries.
2. Vesugen can be considered as a promising drug for the prevention and treatment of arteriogenic erectile dysfunction.
3. The inclusion of Vesugen in the complex of therapy for systemic manifestations of atherosclerosis can improve treatment results in patients of older age groups.

A clinical study involving 60 patients assessed the effectiveness of a drug analogue of Libidon in the treatment of benign prostatic hyperplasia (BPH). The study included patients with BPH with moderate bladder outlet obstruction (maximum urinary flow rate 5.0–15.0 ml/s). The patients were divided into two groups of 30 people. Group 1 received the drug in the form of rectal suppositories: one suppository once a day for 30 days. Group 2 also received one suppository once a day for 30 days, and then a drug in tablet form: one tablet twice a day for 90 days. The study included 4 visits. At the first visit, patients underwent diagnostic procedures, including a physical examination; questionnaire via IPSS (International Prostate Symptom Severity Scale); clinical and biochemical blood tests; general urine analysis; determination of the level of prostate specific antigen in blood serum; transrectal ultrasound examination of the prostate and seminal vesicles; uroflowmetry; determination of residual urine volume. Patients received suppositories for 30 days. At the next visit (day 30), the same diagnostic procedures were carried out, and group 2 received the drug in tablets for 90 days. At the 3rd and 4th visits (days 60 and 120, respectively), diagnostic procedures were also performed, and the effectiveness of treatment was assessed. Already at the second visit, the indicators in patients of both groups changed significantly: the total IPSS score decreased by an average of 3 values. By the end of the study, the total IPSS score in both groups also remained reduced compared to the score before treatment, but in the second group, which received longer therapy with various forms of the drug, the decrease in IPSS was more pronounced — 2 times with the score before treatment and on 36% compared to group 1. Also, in patients of both groups at the second visit, the maximum urine flow rate and the amount of residual urine improved. Prostate specific antigen, which is a tumor marker, was not detected in the patients’ blood from the second visit until the end of the study. It is worth noting that by the 4th visit, all studied parameters improved more markedly in the second group of patients. Thus, in the first group, the volume of the prostate gland did not differ from the value before treatment, while in the second group it significantly decreased [Teodorovich O.V. et al., 2016]. These data indicate that:

1. The use of the polypeptide complex prostate in the form of rectal suppositories for 30 days as monotherapy has a positive effect on the subjective and objective symptoms of benign prostatic hyperplasia.
2. The prostate polypeptide complex reduces the severity of clinical manifestations of the disease and bladder outlet obstruction, reduces the volume of the prostate gland and improves the quality of life of patients.
3. Subsequent intake of the prostate polypeptide complex in tablets allows for long-term improvement in the achieved results.
4. Combined treatment of benign prostatic hyperplasia. with a prostate polypeptide complex in the form of rectal suppositories followed by its administration in tablets allows one to achieve more pronounced clinical results and slow down the progression of the disease in the absence of side effects.

Based on the above results, the following conclusions can be drawn:

1. The polypeptide complex of the testes Testoluten increases the level of testosterone in the blood and is effective for male menopause.
2. The use of a combination of polypeptides from the adrenal glands (Glandocort), pancreas (Suprefort), prostate (Libidon) and testes (Testoluten) normalize hormonal status in men with distress syndrome.
3. Vascular tripeptide Vesugen is effective for vasculogenic erectile dysfunction in elderly and senile men.
4. The combined intake of the prostate polypeptide complex helps slow the progression of benign prostatic
hyperplasia.

Based on the available data, we can recommend the following scheme for the use of peptide bioregulators to restore hormonal status in men of the reproductive period:

• Glandocort (adrenal peptides) — 1 capsule daily
• Testoluten (testis peptides) — 1-2 capsules daily
• Libidon (prostate peptides) — 1-2 capsules daily
• Suprefort (pancreatic peptides) — 1-2 capsules daily if there is impaired glucose tolerance

Course from 3 to 6 months. Compatible with any drug therapy.

As an alternative or as an alternation with this regimen, use the complex preparation GPL@Man. It is recommended to start taking GPL@Man 1 capsule once every 3 days (10 days), then increase the dosage to 1 capsule per day (10 days) and then take one capsule for the first two days, and on the third day 2 capsules (10 days). You can also choose any of these three reception options.

To correct age-dependent pathology in men, peptide bioregulators are recommended to be used according to the following scheme:

• Revilab SL09/ML07 — 8-12 drops or 1-2 capsules daily or every other day
• Vesugen — 1-2 capsules daily
• Libidon — 1-2 capsules daily
• Crystagen — 1-2 capsules daily
• Cartalax — 1-2 capsules daily in preparation for surgery

Course from 3 to 6 months. Compatible with any drug therapy.

Revilab SL 09 contains short peptides of pineal gland, testes, bladder, prostate, licorice, propolis, mint extract, chamomile and clove essential oils. Revilab ML 07 contains short peptides of pineal gland, vascular wall, testes, bladder, omega-3 polyunsaturated fatty acids, L-carnitine, zinc citrate. Vesugen (vascular tripeptide), Crystagen (thymus tripeptide) and Cartalax (connective tissue tripeptide) will help normalize blood circulation and the function of prostate fibroblasts and have an anti-inflammatory effect on the organs of the male reproductive system.

References

1. Khavinson V.Kh., Malinin V.V., Ryzhak G.A. A drug that normalizes reproductive function in men and a method for obtaining it. RF Patent RU 2 302 874 C1 dated June 22, 2006 (In Russian). https://yandex.ru/patents/doc/RU2302874C1_20070720
2. Gorgiladze D.A., Kalendzhyan V.V., Aleksandrov V.A., Pinaev R.N. Features of the use of gender-specific peptides in middle-aged men. Abstracts of the XXII World Congress of the International Association of Gerontology and Geriatrics. Buenos Aires, Argentina. June 12–16, 2022. (In Russian)
3. Kitachev K.V., Sazonov A.D., Kozlov K.L. and others. The effectiveness of a peptide bioregulator of blood vessels in the complex therapy of vasculogenic erectile dysfunction in elderly and senile people. Advances in gerontology. 2014. T. 27. N. 1. P. 156-159. (In Russian) http://www.gersociety.ru/PDF_YG/AG_2014-27-01.pdf
4. Teodorovich O.V., Shatokhin M.N., Borisenko G.G., Krasnov A.V. The use of various dosage forms of the drug Vitaprost^® in endourology. Effective pharmacotherapy. Urology and nephrology. 2016. Issue 33. N. 4. P. 10-16. (In Russian) https://umedp.ru/upload/iblock/740/vitaprost.pdf