Report on the treatment of adenoma with Bioprost by V.P. Avdoshine

MINISTRY OF EDUCATION AND SCIENCE OF THE RUSSIAN FEDERATION STATE EDUCATIONAL ESTABLISHMENT OF PROFESSIONAL EDUCATION RUSSIAN UNIVERSITY OF NATIONALITIES (RUN)

THE REPORT OF THE SCIENTIFIC-RESEARCH WORK CLINICAL RESEARCH OF PRODUCT Bioprost®. (final)

Head of theme Avdoshin V.P.

Executor Avdoshin V.P.

Moscow - 2005

LIST OF PARTICIPANTS .

Avdoshin V.P., the head of faculty of urology of the medical department, doctor of medical sciences, professor.

REPORT

CLINICAL RESEARCH OF PRODUCT Bioprost®.

The object of the research are the patients afflicted with benign prostatic hyperplasia.

PURPOSE OF RESEARCH

The purpose of the present research is to evaluate efficiency and safety of product Bioprost® CJSC «Intelpharm».

Clinical assessment of impact of complex product Bioprost® to clinical development of benign prostatic hyperplasia and influence to the prostate gland tissue in the zone of inflammation have been carried out at research.

The assessment of clinical efficiency of product Bioprost® for the patients afflicted with BPH has been carried out for the first time in Russia.

The main constructive and technical-operational properties. The product is characterized by high therapeutic activity for the patients afflicted with BPH and chronic prostatitis.

The degree of promotion – the product may be brought in general therapeutic application.

The product efficiency is determined with positive impact to clinical development of BPH.

The product may be brought in general therapeutic application.

LIST OF LEGEND, SYMBOLS, UNITS AND TERMS:

BPH - benign prostatic hyperplasia

IPSS – index of symptoms of the prostate gland

TRUSI – trans-rectum ultrasound investigation

INTRODUCTION.

Benign prostatic hyperplasia and non-specific prostatitis are rather typical for men of medium and advanced age. In spite of promoted introduction in clinical application of new pharmaceuticals, including anti-infective products, the problem of the above-mentioned diseases is still far to be solved and a challenge for modern urology. Products of natural origin (2) have been applied more often in the past few years to treat benign prostatic hyperplasia and attendant chronic prostatitis. Besides, one should consider that such medicines are applied seldom in spite of their efficiency and safety. Hence, the present research seems to be relevant, reasonable and acute.

Bioprost® - is a complex product presented in rectum suppositories with the following composition: pumpkin seeds oil, thymol, lipophilic suppository basis. The product was produced to impact positively the development of pathological process in the prostate gland tissue, revealed at BPH. Pumpkin seeds oil, that contains a great number of unsaturated rich acids and antioxidatic substances, is an effective anti-infective component, thymol is also characterized by vivid anti-infective effect. The way to apply the product in rectum allows to penetrate the components of the medicine in the prostate gland tissue directly, and thus, the therapeutic effect is vividly achieved. The above-mentioned elements work good in combination and influence many BPH and non-specific prostatitis symptoms rather effectively. Contraindication against application of the product is high sensitivity to individual components of the product.

Benign prostatic hyperplasia (BPH) is the most wide-spread disease of men at the age over 50 years old and its frequency is increasing (1). 40 % of men at the age from 50 up to 80 years old are afflicted with the symptoms of lower urinary tracts (3). BPH is benign proliferative process of stroma and epithelium frames of the prostate gland (4). The reason for hyperplasia has not been found out yet and might depend on many aspects.

The symptoms of BPH are decreasing of the hole of urethra and slow reduction of the urinary bladder functioning, thus, incomplete urinary takes place. The most frequent symptoms are as follows: weak urine stream, urinary desire, frequent urinary, especially at night.

Heavy infra- vesical obstruction is not in proportional relation to the dimension of the prostate gland all the time, so not all the men with the increased prostate gland have clinical implications.

THE MAIN PART.

The object of the research were 35 patients afflicted with BPH, judging by the purpose of the research. The criteria of participation in the research were:

• age – over 45 years old;
• BPH presence;
• Symptoms of urinary disorder (as per the IPSS scale).

All the patients have been given product Bioprost® in rectum per one suppository twice a day, for 14 days, as mono-therapy.

Before the research of product Bioprost® efficiencyand 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;
• TRUSI of the prostate 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.

It was revealed at research that 35 patients afflicted with BPH, had clinical implication of the disease, proved by urinary disorder and its increased frequency. All the patients had increased prostate gland, leveling of interlobar groove was observed at pulping examination in rectum. The majority of the patients had dissimilarity of echostructure of the prostate gland, its increasing as per the results of TRUSI. After the therapeutic course with product Bioprost® in suppositories the index of symptoms of the prostate gland (IPSS) reduced from 18,53±1,7 up to 16,3±0,9. 4 patients had index without any changes. Index of quality of life (OQL) regarding 31 patients reduced from 4,32 up to 3,78 . Volume of the prostate gland changed a little, before the therapeutic course it was 58,74 cm3, after finishing the course it was 53,05ml. One should underline, that vivid decrease of volume of the rest urine was revealed at application of the product. Before therapy the average volume of the rest urine was 47,58 ml, after finishing the course it was 38,16 ml. Pursuant the results of uroflowmetria, the maximal speed of urinary was approximately 9,23 ml/s before the therapeutic course, after the therapeutic course with product Bioprost® it was 10,1 ml/s. At pulping examination in rectum the decrease of swelling of the prostate gland tissue and painful syndrome was determined. No changes were revealed in the prostate gland tissue at control ultrasound investigation. No changes were determined regarding protein, lipid, carbohydrate exchange at clinical blood examination.

Thus, no cases of excellent results were determined as the result of the research (3 points), proving the complete disappearance of all the disease symptoms and normalization of the data of tool examination.

7 patients (20%) demonstrated good results; they had improvement of state, regression of the features of the disease and significant positive dynamics of the data of the objective and tool examinations (2 points).

24 patients demonstrated satisfactory results (68,6%) with 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. 4 patients (11,4%) had no therapeutic effect (0 points).

There were no cases of aggravation caused by therapy.

No cases of local changes, skin and mucous reactions were observed at safety and acceptability assessment. The patients accepted the product well. No undesirable phenomena took place at research.

CONCLUSION.

Thus, Application of product Bioprost® by the patients afflicted with benign prostatic hyperplasia and chronic prostatitis, is safe and effective, that is proved by improvement of urinary process, decrease of the rest urine quantity and reduction of inflammatory reaction of the prostate gland secretion.

The product does not cause serious unnecessary by-effects; patients accept is rather good in the produced form, it and may be recommended for general therapeutic application in urology.

LITERATURE

• Вепу SJ, Coffey DS, Walsh PC, Ewing LL:
  The development of human benign prostatic hyperplasia with age. J Urol 1984, 132.-p.474-479.
• Cheng E, Lee C, Grayhack J: Endocrinology of the prostate.
  Prostate diseases. W.B. Saunders Company, 1993. -p.57-71.
• LeporH: Pharmacological management of BPH.
  Urology Annual, Norwalk, Appleton and Lange, 1991.- p. 1-19.

Peters CA, Walsh PC:
The effect of nafarelin acetate, a luteinizing-hormone-releasing hormone agonist, on benign prostatic hyperplasia. N Engl J Med 1987, 317.- p.599-604.