Efficiency of application of product Bioprost® at therapy of prostate diseases

V.P. AVDOSHIN, S.B. ARTIFEKSOV,
D.Y. VOLKOV, O.Z. KLOCHIKHIN,
F.A. SEVRYUKOV

Russian University of Nationalities, Moscow;
State Medical Academy, Nizhny Novgorod

EFFICIENCY OF APPLICATION OF PRODUCT Bioprost® AT THERAPY OF PROSTATE DISEASES

Application of product Bioprost® results in decrease of inflammatory reaction of the prostate gland tissue, improves the quality of life of patients and is accompanied with decrease or complete disappearance of clinical features and complaints.

The most often disease of the prostate gland (PG) is its inflammation. Prostatitis may appear at penetration of microorganisms into the gland, especially at changed general and local reactivity, but non- infectious prostatitis (prostatosis), caused by urine passage disorder, stagnation and dissolution of the prostate gland secretion in its follicles can be observed more often. The development of the disease is stimulated by irregular sexual life, overcooling, traumas, decrease of immune protection of the organism, disorder of blood and lymph circulation in organs of small pelvis, hormonal disorders (absolute or relative androgenic insufficiency).

Dystrophic processes, that result in functioning disorder of the organ, develop in the prostate gland on the background of stagnation. Prostatitis is frequently combined with urethritis, vesiculitis, and adenomaof the prostate gland in an advanced age. The quality of sperm may be spoiled at long current of prostatitis. Occurrence of sexual disorders stimulates the development of neurosis that makes the process of treatment more difficult. The clinical implications of chronic prostatitis are mosaic: from asymptomatic current up to presence of separate syndromes (painful, sexual, dysuric) which can be performed simultaneously, but of different intensiveness.

Treatment of chronic prostatitis stipulates the patient and the doctor to work hard and intends application of wide range of pharmacological products. Some of them, for example, antibiotics and other anti-infective products, can cause the decrease of quality of life, including microecological disorders (dysbacteriosis) of the intestines and mucous coats of the urinogenital system, disorders of kidneys and liver function, etc. Extremely widespread polypragmasy can be referred to disadvantages of treatment of chronic prostatitis, that results in significant increase of treatment cost, but often without any vivid effect.

Nowadays the researchers pay special attention to products of the combined effect that impact the main aspects of pathogenesis of chronic prostatitis. Product Bioprost® (CJSC Intelpharm) can be related to such pharmaceuticals.

The purpose of the research is many-central randomized placebo controlled study of efficiency of application of product Bioprost® at treatment of chronic prostatitis by simple blind method.

Materials and methods. The patients, afflicted with chronic prostatitis, have been taken under control and informed the purposes of the present research, the conditions of the experiment performance, provision of rights and protection of the patients. The age, the degree of activity of inflammation, attendant diseases, preceding treatment, duration of the disease have been accounted at screening of primary data about the patients.

Anamnesis, evaluation pursuant the scale of chronic prostatitis, pulping of prostate, prostate secretion analysis, analysis of the 3-d portion of urine, uroflowmetria, general urinoscopy, ultrasound investigation of prostate, general and biochemical blood examination have been carried out as the result of the combined inspection.

Then randomization of the groups was executed pursuant the following criteria: average age, the number of the participants and the activity of inflammation. The first group consisted of 60 men with prostatitis aggravation, the second group included 60 patients at the stage of remission. Therapy with product Bioprost® or placebo has been carried out for 14 days, one candle twice a day along with traditional medicine therapy. The repeated combined investigation was performed after finishing of the treatment in the period from 4 up to 8 years to evaluate the results of therapy.

The third group included 55 men with benign prostatic hyperplasia (BPH). The criteria of including in the group are as follows: age over 45 years old, features of urinary difficulty (pursuant the scale of index of features of the prostate gland IPSS). All the patients of the third group have been given product Bioprost® candles in rectum, one candle twice a day, for 14 days, as mono-therapy. Before the research and immediately after its finishing the patients, afflicted with BPH, underwent the combined inspection, including: anamnesis, the prostate investigation in rectum, filling in of the IPSS scale, uroflowmetria, ultrasound investigation of the prostate trans-rectum with determination of rest urine quantity, general clinical methods of assessment (general blood examination and urinoscopy).

Assessment of the results of therapy has been carried out pursuant efficiency criteria:

• Excellent – disappearance of all the features of the disease, normalization of the data of laboratory and tool examinations - 3 points;
• Good - improvement of state of the patient, regression of the features of the disease and significant positive dynamics of the data of the objective and tool examinations - 2 points;
• Satisfactory - moderate improvement of state of the patient, regression of the features of the disease and positive dynamics of the data of the objective and tool examinations - 1 point;
• Absence of the effect - 0 points;
• Aggravation of the state of the patient – minus 1 point.

Besides, after finishing of treatment the assessment of therapy safety was executed that stipulated the assessment of general state of the patient, local skin reactions and reactions in straight intestine, the state of stool, the features of hemadynamics. Efficiency and acceptability assessment of product Bioprost®was carried out as per absolute changes of IPSS in comparison with the initial values, urinary bladder and the prostate gland USI data, and also pursuant clinical-laboratory blood examination and urinoscopy.

Results. The patients of the first and the second groups had complaints, typical for chronic prostatitis. Smoothly expressed pastose effect of the prostate gland, leveling of interlobar groove were observed, in cases of aggravation of the disease moderate pains took place. The patients of the first and the second group had dissimilarity of echostructure along with the increase of the gland dimensions. The maximal speed of urinary was 11,8±2,1 ml/s at urinary volume 130+20 ml. The decrease of the number of lecithine grains, presence of amyloid parties in the prostate gland secretion. Leukocyte number in the first group was from 10-15 up to 60-80 cells in the scope of observation, but it left normal for the patients of the second group. Microflora from 10000 up to 100000 КОЕ/ml was specified in cases of aggravation of inflammation. Besides, 60% of the patients demonstrated Е. соП, 10% - Proteus mirabilis, 30% - Staphylococcus spp. Clinical index of chronic prostatitis was performed moderately regarding all the patients and was from 12 up to 28 points. No reasonable changes were revealed at clinical investigation of blood examination and urinoscopy. There was no pathology regarding protein, lipid, carbohydrate exchange, the activity of АлАТ, АсАТ was normal.

After therapy with application of product Bioprost®, all the patients of the first and the second groups demonstrated the decrease of the sum of features of the disease and improving of the index of quality of life up to 8 points, disappearance of pain, swelling of the prostate gland tissue, normalizing of echostructure of the prostate gland tissue, thus the dimension of the prostate gland was on the way to be reduced. The decrease of leukocyte number and the increase of the number of lecithin grains were revealed in the prostate gland secretion (PG). Disappearance of causal organism was specified at control bacteriological examination of the 3-d portion of urine. The maximal speed of urinary increased up to 13,5+1,6 ml/s, urinary volume – up to 165±28 ml.

No cases of aggravation or absence of the therapeutic effect were revealed at assessment of therapy efficiency. 60% of the patients of the second group demonstrated satisfactory results of therapy, 30% of the patients of the second group and 50% of the patients of the first group demonstrated good results of therapy, 10% of patients of the second group and 50% of the patients of the first group demonstrated excellent results of therapy. There were no cases of local changes, changes of skin and mucous coats at safety and acceptability assessment of the product. Good acceptability of the product was determined in all the cases of application.

There were clinical features of the disease regarding the patients of the third group, such as urinary disorder, or its frequency. The increase of the prostate gland, leveling of interlobar groove was specified. The majority of the patients had dissimilarity of echostructure of the prostate gland and its increasing.

After the therapeutic course with product Bioprost®IPSS decreased from 18,53±1.7 up to 16,3+ 0,9. 4 patients had the same index. Index of quality of life regarding 31 patients decreased from 4,32 up to 3,78. Volume of the prostate gland changed insignificantly: it was 58,74 cm before treatment, and 53,05 cm after treatment. One should underline, that volume of the left urine decreased at product application. Thus, average volume of the rest urine was 47,58 ml before therapeutic course, and it was 38,16 ml after finishing the course. The maximal speed of urinary before therapy was approximately 9,23 ml/s, and it was 10,1 ml/s after the therapeutic course with product Bioprost®. Decrease of swelling of the prostate gland tissue and pain was specified. No changes were revealed in the prostate gland tissue at control ultrasound investigation. There was no pathology regarding protein, lipid, carbohydrate exchange.

No cases of excellent results were determined in the third group. Good result was observed regarding 11 patients (20%), satisfactory results were specified regarding 37 patients (68,6%). 7 patients (11,4%) demonstrated no therapeutic effect. There were no cases of aggravation caused by therapy.

Discussion. They have determined that the possible solution of the prostatitis problem, including benign prostatic hyperplasia (BPH), is application of herbal (phytotherapy) products, the leading are the products made of oil of pumpkin seeds. Product Bioprost®(CJSC Intelpharm) is related to such products and is one of the latest developments.

They know, that its efficiency, the same as the efficiency of the other products of this group, is determined by contents of phytosterols, the most important is vsytosterine, campesterol, sigmasterol, that decrease concentration of prostaglandins Е2 and Еа- in PG tissue by making slow the synthesis of cyclooxigenasis and leukotriens, so, it is accompanied by rather a quick anti-inflammatory effect.

It is significant that Bioprost® is not characterized by androgenic properties and doesn't change the quantity of testosterone in blood serum. Besides, its components improve microcirculation in the prostate and, hence, prevent swelling (congestion) of PG decreasing its dimension, removing pain, normalizing urinary and, what is rather important, increasing brightness of sexual sensations at ejaculation, that comes rather slowly under these conditions.

They know, that the components of oil of pumpkin seeds, containing in product Bioprost® such as tocopherol and carotenoids, are characterized by antioxidatic effect, decreasing the processes of peroxide oxidation of membrane lipids, preventing their damage at inflammation and, hence, reserving PG structure. The preventing effect of product Bioprost®, determined regarding 31 patient seems to be explained by this property to prevent the development of sharp urinary delay that can be observed after any, even not rather serious surgeries (internal urethral actions).

It is rather important, that Bioprost® contains phospholipids, that are the elements of a cell membrane, and namely they go after adsorption, together with the prostate, in other organs, including lever and kidneys, providing rather a vivid detoxification effect, necessary at intensive application of antibiotics and other pharmaceuticals.

Bioprost® also contains extremely important elements, such as phosphor and zinc, to be provided for stimulation of sexual activity of men and metabolism normalization in the PG, and hence for prevention of the development of inflammatory in PG tissues. Introduction of thymolum in pharmacological composition of product Bioprost® providing anti-infective effect stimulates normalization of myxobacterium picture of sexual tracts, accelerates regeneration processes of the prostate function.

The advantage of product Bioprost® is the form of production – rectum suppositories (candles), providing the most effective way of penetration of active components in the PG.

Conclusion. Application of product Bioprost® by the patients afflicted with chronic non-specific prostatitis and benign prostatic hyperplasia, is safe and effective both in the period of aggravation of the disease and in the period of remission. It seems to be relevant and reasonable from the point of view of pathogenesis and results in decrease of the inflammatory reaction of the prostate gland tissue, it provides conditions to stop inflammation. The product does not cause unnecessary by-effects; patients accept is rather good in the produced form, it may be recommended for general therapeutic application in urology.

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