The object of the research were the patients, afflicted with
chronic non-specific prostatitis. Open placebo-controlled research
in parallel groups has been executed on the bases of:
- Urology department of Russian University of Nationalities, Moscow,
- Urology department MLPU «Hospital ¹ 30», Nizhny Novgorod,
- Urology department of Railway hospital of Ministry of transport,
Nizhny Novgorod
- Surgery department of municipal hospital ¹ 3, Nizhny Novgorod.
Introduction
A new product Bioprost® - rectum suppositories
with pumpkin oil 0.5 g. and thymolum 0.1 g. and lipophilic basis up to 2 g – has
been developed to treat chronic non-specific prostatitis by CJSC «Intelpharm»,
Nizhny Novgorod. Pumpkin oil contains many unsaturated rich acids and antioxidatic
components, trace substances, to be rather effective to stop inflammation of
the prostate gland. Thymolum is characterized by anti-infective effect. Application
of the product in rectum at chronic prostatitis is more preferable, taking
into account that it provides penetration of the medicine substances in blood, omitting
lever. Besides, therapeutic effect is performed quickly and possibility of inactivation
of the product by digestive juice and lever is excluded. It results in therapeutic
concentration of medicine substances in secretion and tissue of the prostate.
The main part
- 100 patients afflicted with chronic non-specific prostatitis participated
in the research.
The criteria of participation in the research were:
- Age – from 18 up to 55 years old.
- Chronic non-specific prostatitis (CNP) in the phase of subacute running
in a torpid phase, and also in the phase of latent inflammation.
Clinical research was divided into 3 stages. The patients were
examined, the homogeneous groups were arranged at the first stage. Participation
in the research was voluntary, rights and protection of the patients were provided
and observed. The patients were informed on the purpose and the conditions of the
research at the first stage. The age, the degree of inflammation activity, attendant
diseases, preceding treatment and other aspects were accounted. The combined examination
included: anamnesis, evaluation pursuant the ÑÎÑ-ÕÏ scale, pulping examination in
rectum (PER), the prostate secretion examination and the analysis of the
3-d portion of urine, uroflowmetria (UFM), the prostate USI, clinical and
biochemical blood examination and urinoscopy. Randomization of the groups was executed
pursuant the following criteria: average age, the activity of inflammation.
100 men at the age from 18 up to 60 years old participated in the research. All
the patients were divided into 2 groups. The first group consisted of 61 patients,
average age 44.5 + 4.5, the duration of the disease from 1 up to 5 years. The second
group included 39 patients at the age from 19 up to 53 years old (average age 36.3
+ 7.3). All the participants of the research were afflicted with CNP in the phase
of subacute running in a torpid phase, and also in the phase of latent inflammation,
approved by the data of USI, bacteriological examination, PER, clinical-laboratory
data, UFM results. All the results were registered in an individual paper of the
patient. The combined therapy of CNP was performed at the second stage. The patients
of the first group underwent the combined therapy, with application of product
Bioprost® series 50702, marked with a green line on the package.
The patients of the second group underwent therapy course with application of product
Bioprost® series 40702, marked with a yellow line on the box.
The period of the therapeutic course was 1 suppository in rectum twice a day for
14 days. The patients with aggravation of CNP were given «Ophlocsacyne» in the dose
200 mg. 2 times within 10 days. There were 18 patients in the first group, and 8
patients in the second group.
After finishing the therapeutic course the third period took place that stipulated
the control examination of the participants. Finally, the control of therapy safety
was carried out with the account of general state of the patients, the state of
skin structure and mucous coats, the state of stool, evaluation of hemadynamics
features.
Efficiency assessment was carried out pursuant the following
criteria:
- excellent – disappearance of all the features of the disease, normalization
of the data of objective, laboratory and tool examinations;
- good – improvement of state of the patient, regression of the symptoms and
significant positive dynamics of the data of the objective, laboratory and tool
examinations;
- satisfactory – moderate improvement of state of the patient, regression
of the features of the disease and positive dynamics of the data of the objective,
laboratory and tool examinations.
- Absence of the effect
- Aggravation of the state of the patient.
The results of the research at the first stage were as follows:
all the men had complaints. Pastose effect of the prostate gland, leveling
of interlobar groove were observed, pains took place. Dissimilarity of echostructure
was revealed at USI. Qmax. of the patients in the first group was 15.9+2.4 ml/s.,
in the second group it was 18.4+2.6 as per UFM results. All the patients had a reduced
number of lecithine grains, the increased number of leukocyte at examination of
the prostate secretion. In cases of aggravation of CNP the number of leukocyte was
from 10-15 up to 60-80 in the scope of observation. Bacteriological examination
of the 3-d portion of urine determined that all the patients had microflora available.
Causal bacteria were as follows: 14 patients had E. Coli, 10 – Proteus mirabilis,
7 - Staphyloccocus spp. Clinical index ÑÎÑ-ÕÏ was 18.9+2.6 and 20.3+2.7 for the
two groups correspondently. No reasonable changes were revealed at clinical investigation
of blood examination and urinoscopy. At control examination, when therapeutic course
was finished, 52 patients (85%) had reduction of
leukocyte number and the increased number of lecithine grains, 9 (15%) patients
of the first group demonstrated no dynamics. There was no dynamics of the prostate
juice regarding 34 men (87%) of the second group, 5 participant (13%) demonstrated
positive dynamics.
PER and USI of the prostate revealed positive dynamics regarding 51 patients
(83%) and no changes with 10 participants (17%). In the second group no changes
were observed regarding 29 patients (74%), positive dynamics demonstrated 10 patients
(26%).
It was revealed at the analysis of the questionnaire ÑÎÑ-ÕÏ, that the average point
was reduced up to 10.9+2.7 and up to 19.7+3.3 in the first and the second group
correspondently.
Disappearance of all cause bacteria was specified at control urinoscopy of the 3-d
portion of urine regarding all the patients applied «Ophlocsacyne». The following
parameters were revealed at therapeutic efficiency assessment:
|
First |
Second |
| Excellent |
5 (8.1%) |
|
| Good |
42 (68.8%) |
3 (7.6%) |
| Satisfactory |
14 (23.1%) |
16 (41%) |
| Absence of effect |
|
20 (51.4%) |
No cases of local changes of skin structures and mucous coats,
negative hemodynamics features and blood examination and urinoscopy were observed
at safety and acceptability assessment. There were no cases of taking the product
back caused by refusal to continue therapy or by negative by-effects. All the participants
accepted the product well. Conclusion
It has been determined as the result of our research that application
of product Bioprost® by the patients afflicted with chronic
non-specific prostatitis, is relevant, reasonable, safe and effective from the
point of view of pathogenesis in the period of latent inflammation and in the phase
of subacute running in a torpid phase. The reduction of inflammation reaction of
the prostate gland tissue and stop of inflammation take place. The product
does not cause undesirable phenomena, is well-acceptable, comfortable and simple
to apply. The product may be recommended for general clinical application at therapy
of chronic non-specific prostatitis.
