Evaluation of the effectiveness of various regimens of the immunomodulatory drug Superlimf® in the prevention of relapses of chronic abacterial prostatitis

Introduction. Immune defense mechanisms, including a decrease in the functional activity of monocytes/macrophages, neutrophils, as well as a violation of the balance of pro- and anti-inflammatory cytokines, are important in the development of chronic abacterial prostatitis (CAP). The discovery of the cytokine system and the determination of their biological role in the development and functioning of the immune system and in the pathogenesis of a wide range of human diseases led to the development of a new direction in immunotherapy – cytokine therapy.

The aim of the study was to evaluate the effectiveness of various regimens of the use of the immunomodulatory drug Superlimf^® in the prevention of recurrence of CAP.

Materials and methods. The study included 90 patients with category IIIa CAP (NIH, 1995). All patients underwent basic complex therapy was performed, which included behavioral therapy, taking an α1-adrenoblocker, an antibacterial drug from the fluoroquinolone group for 28 days, as well as the drug Superlimph^® 10 ME 1 suppository rectally 2 times a day for 20 days. Dynamic follow-up was recommended for patients of group (CG) in the next 12 months. In the main group 1 (MG1), patients underwent basic complex therapy, after which a preventive courses of Superlimph^® 10 ME 1 suppository 1 time per day for 10 days every three months for 12 months was prescribed. In the main group 2 (MG2), patients also underwent basic complex therapy, after which a preventive courses of Superlimph^® 10 ME of 1 suppository was prescribed 2 times a day for 10 days every three months for 12 months. The effectiveness of the treatment was evaluated after 4 weeks (visit 2). Long-term treatment results were assessed after 3 months (visit 3), 6 months (visit 4), and 12 months (visit 5).

Results. The study groups were homogeneous, and the results of examinations obtained before treatment did not differ statistically significantly (p>0.05). At visit 2, 4 weeks after the start of therapy, a statistically significant positive dynamics of the studied indicators in the main groups and CG was recorded. Thus, the average score on the IPSS scale decreased by 56.4% from the initial value, on the Qol scale – by 57.7%, on the NIH-CPSI scale – 70.2%. The number of leukocytes in the prostate secretion decreased to the normal level to 7.9 in the field of vision, which is 86.2% less than the initial value. The average Qmax value also increased to a normal value of 15.2ml/s, which is 51.3% higher than the initial value (p<0.001). In this study, for the first time, a comparative analysis of two different regimens of preventive administration of the drug Superlimf^® was carried out. In MG1, the drug was prescribed to patients at a dose of 10 ME 1 time a day, in MG2 – 10 ME 2 times a day. The data obtained indicate a comparable effectiveness of both dosage regimens after 3 months of therapy. However, after 6 months and 12 months, the results in MG2 were statistically significantly better than in MG1. In addition, during 12 months of therapy, the number of relapses in MG2 was 2.3 times less. According to ultrasound examination, the volume of the prostate gland in CG, after a significant (p<0.001) decrease against the background of basic complex therapy, increased by 24.6% from visit 2 to visit 5, whereas in MG2 the average value of this indicator did not significantly change. And according to the Doppler study, by the end of the observation period at visit 5, hemodynamic parameters in CG were statistically significantly worse than in MG1 and MG2.

Conclusion. Thus, the use of Superlymph^® in patients with CAP as a preventive therapy every 3 months results to a longer preservation of the therapeutic effect and improved hemodynamics in the prostate. In addition, preventive courses of Superlymph^® 10 units 2 times a day for 10 days led to an increase in the duration of the relapse-free period and a decrease in the number of recurrences within 12 months by 7 times, while preventive courses of Superlymph^® 10 units 1 time per day for 10 days decreased risk of recurrence by 3 times. According to our results, the most effective preventive scheme in patients with CAP is the use of Superlymph^® 10 units, 1 suppository 2 times a day for 10 days every 3 months.