Report on clinical application of Bioprost

REPORT

ABOUT THE CLINICAL APPLICATION OF Bioprost ® MANUFACTURED BY Intelpharm ® BY PATIENTS WITH NON-SPECIFIC CHRONIC PROSTATITIS

The Subject of the study is the patients with non-specific chronic prostatitis.

The study was held on the basis of FGU Urology Research and Development Institute of Roszdrav. The main performers: deputy director of FGU Urology Research and Development Institute of Roszdrav , Professor S.P. Darenkov; a research assistant of the reconstructive uronephrology department FGU Urology Research and Development Institute of Roszdrav , Doctor of Medicine, Yu. V. Samsonov.

INTRODUCTION

The new medicine Bioprost ® is rectal suppositories containing 0.5 g of pumpkin seed oil and 0.1 g of thymic acid and up to 2 g of lipophilic base. It is offered for the treatment of non-specific chronic prostatitis, as well as benign prostatic hyperplasia. Bioprost ® was developed and manufactured by the Intelpharm ® Group of Companies. It meets the medicine requirements (r.003058/01). License No. 64/0363- Л /04 issued on 24.05.2004 by the Ministry of Industrial science and Technologies.

Bioprost ® contains pumpkin seed oil, uniquely extracted with the technology which allows retaining the natural complex of biologically active substances (tocopherols, phytosterins, carotenoids, phospholipids, unsaturated fat acids etc.) and a number of active microelements (zinc, copper etc.). The medicine constituents’ efficacy is enhanced by the anti-inflammatory and anti-bacterium activity of thymic acid.

Biologically active constituents of pumpkin seed oil - tocopherols and carotenoids - have an explicit antioxidant effect. Phytosterins have an anti-inflammatory effect while phospholipids help restore the structure and functions of cell membranes of the prostate gland . Unsaturated fat acids participate in the lipidic exchange and pumpkin seed oil corrects proliferation of the prostate gland cells.

The application of the presently manufactured Russian medicine Bioprost ® for internal use showed its sufficient efficacy against chronic prostatitis and early stages of benign prostatic hyperplasia . Thymic acid has an explicit anti - inflammatory effect . The rectal method of administration is preferable because it provides delivery of the medicine to blood passing the liver barrier which allows a quick therapeutic effect and excludes inactivation of the medicine by the digestive juice and liver. It leads to a higher concentration of the substance in the secret and tissue of the prostate gland.

THE BODY

There were 36 male participants in the study who have non-specific chronic prostatitis in the latent phase.

75 packs of Bioprost ® were used for the study.

The criteria for the participants were as follows:

• Age - from 21 to 72
• Non-specific chronic prostatitis in the subacute and in the latent phase.

Clinical trials of the medicine took several stages. At the introductory phase statistically homogenous groups of patients for the trial were formed. At this stage patients with non-specific chronic prostatitis in the latent phase were involved. The patients were made aware of the goals of the trial, conditions of the experiment, rights and protection of the patients. At the screening of the primary data of the patients considering their age, the disease persistence, the preceding treatment, the degree of the inflammation, concomitant diseases and other factors which, in the doctor’s view, can affect the results of the trials. The integrated survey included compiling the anamnesis, the summary estimation of symptoms of chronic prostatitis, digital rectal examination, prostatic secretion analysis, the 3d portion of the urine, uroflowmetry, prostatic USI, PSA, general and biochemical blood and urine analyses. The groups were randomized according to the average age and the intensity of the inflammation.

The trial involved 36 males with non-specific chronic prostatitis in the latent phase, aged from 21 to 72. All the participants were diagnosed with non-specific chronic prostatitis in the subacute course of the torpid phase and latent course, supported by the USI, uroflowmetry, bacteriological investigation, clinical and laboratory data.

The second stage included a complex non-specific chronic prostatitis treatment for all the patients. All of them were provided with a combination therapy including the use of 1 Bioprost ® suppository rectally 2 times a day for 10 days. With the bout of chronic prostatitis, confirmed by the clinical and laboratory data, the course of antibacterial therapy with the “ Doxycycline” preparation 100 mg 2 times a day and the “Metranidazol” preparation - 0.5 х З times for 5 days.

The follow-up examination of the patients took place after the therapy. The results showed that before the therapy all the men suffered from the symptoms typical of the patients with non-specific chronic prostatitis: dysuria, periodic pains in the perineum. Sponginess of the prostate gland, flattening of the interlobar groove, pain were registered as well as inhomogeneity of structure and edema (registered by USI). The examination of the prostatic secretion showed the decrease of the number of the lecithin grains, and the increase of leucocytes (from 10 to 50 in vision). The bacteriology study of the 3 portion urine showed microflora in the titer of 10000 to 100000 КОЕ ml with 26 patients with the following kinds of agents: Е . coli, Staph. spp., Staph. epidermidis. All the microorganisms were sensible to «Doxycycline». The uroflowmetry was registered at the rate of О max 14.6±2.1 mlsec.

All the patients had a moderate clinical index of chronic prostatitis from 13 to 24 balls. The clinical urine and blood analyses didn’t indicate any reliable change. The study of biochemical parameters of blood didn’t show any disorders of protein, lipidic, and carbohydrate metabolism.

The results of the trial indicated the decrease of the symptoms index sum and the increase of the life quality with 29 patients, as well as a significant decrease of dysuria. The follow-up USI showed positive dynamics. The follow-up uroflowmetry the urine flow increased up to 16,2±1,2 mlsec. The follow-up examination of the 3 portion urine showed elimination of the agent due to the administration of «Doxycycline» and Bioprost ® with 26 patients.

The digital rectal examination showed a reduced edema and pain of the prostate gland. The prostatic secretion study after the treatment stated the increase of leucocyte number and the increase of the level of the lecithin shares with 28 patients. No explicit dynamics was found with 5 patients .

The safety and tolerance assessment didn’t show a single topical change of the skin or the mucous coating. The medicine proved well - tolerated in all cases . No undesirable consequences took place.

CONCLUSION

As the result of the trial we must note that the use of Bioprost ® with patients with non-specific chronic prostatitis is pathogenically reasonable, expedient, safe and effective in the post-surgical period. The results of the treatment were reduction of the inflammatory reaction of the prostatic tissue, quick jugulation of the inflammation, improvement of objective and subjective symptoms. The application of the medicine doesn’t cause any undesirable consequences, is well tolerable, convenient and user-friendly. The medicine can be recommended for patients with non-specific chronic prostatitis.