The primary purposes of the study are to evaluate the effectiveness of Ingaron in the complex therapy of chronic prostatitis, to assess the safety of using Ingaron in patients with chronic prostatitis.
Literature data and the results of preclinical studies of interferon-gamma, as well as the features of the immunopathogenesis of chronic prostatitis, show the expediency of studying the use of Ingaron in this pathology. The study was conducted to compare the efficacy and safety of Ingaron in combination with standard therapy with its subcutaneous administration and standard therapy in patients with chronic prostatitis. The study was planned to include 50 male patients aged at least 18 years with a confirmed diagnosis of chronic prostatitis. In the course of the study, Ingaron was administered at a dose of 500,000 IU once a day, every other day. In addition to Ingaron, patients received antibiotic therapy, anti-inflammatory drugs, alpha-blockers (if necessary). Magnetic laser therapy and prostate massage were also provided. The patients were divided into 2 groups: main and control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
Dynamics of the total score and improvement in the quality of life on the scale IPSS.
The sum of points was assessed, as well as the symptom complex on the basis of the "IPSS" questionnaire - the international system for the total assessment of symptoms of prostate diseases in points (WHO, 1992). The severity of symptoms was assessed from 0 to 6 points. symptoms of prostate diseases in points (WHO, 1992). The severity of symptoms is rated from 0 to 6 points.
Time frame: Day 13
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
Content of polymorphonuclear leukocytes in prostate secretion.
Time frame: Day 14
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
The content of lymphocytes in prostate secretion.
Time frame: Day 14
Evaluation of cytological parameters of prostate secretion.
The number of lecithin grains.
Time frame: Day 14
Evaluation of cytological parameters of prostate secretion.
The number of epithelial cells.
Time frame: Day 14
Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
The effect of interferon-gamma on T-lymphocytes.
Time frame: Day 14
Evaluation of cytological parameters of prostate secretion.
The content of polymorphonuclear leukocytes in prostate secretion.
Time frame: Day 90
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Immunohistochemical study of prostate secretion with assessment of cytological parameters.
The content of lymphocytes in prostate secretion.
Time frame: Day 90
Evaluation of cytological parameters of prostate secretion.
The number of lecithin grains.
Time frame: Day 90
Evaluation of cytological parameters of prostate secretion.
The number of epithelial cells.
Time frame: Day 90
Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
The effect of interferon-gamma on T-lymphocytes.
Time frame: Day 90
Evaluation of indicators of urination. Ultrasound of the prostate gland.
Ultrasound of the prostate gland.
Time frame: Day 90
Evaluation of indicators of urination. Urofluometry.
Urofluometry.
Time frame: Day 90
Evaluation of indicators of urination. General urine analysis.
General urine analysis.
Time frame: Day 90
Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
Time frame: Month 3
Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease.
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
Time frame: Month 3
Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
Time frame: Month 6
Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease.
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
Time frame: Month 6