Method of treating chronic prostatitis

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to urology, and can be used for treating chronic bacterial non-Chlamidia prostatitis. That is ensured by the integrated treatment that involves antibacterial therapy and administration of Interferon A in the form of ointments or suppositories. The therapeutic course is 7 days to be repeated in a week.

EFFECT: higher clinical effectiveness in chronic prostatitis ensured by administration of Interferon which both provides immunomodulating action, and promotes arresting of symptomatic manifestations of prostatitis.

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The invention relates to medicine, more specifically to urology and treatment of chronic prostatitis.

The purpose of the invention is to create an effective method of complex treatment of prostatitis.

The invention consists in the use of local immunomodulatory therapy preparations of interferon adjuvant therapy.

The technical result is to increase the effectiveness of treatment of chronic prostatitis due to the use of interferons, which have not only immunomodulatory effects, but also promote symptomatic relief of symptoms of prostatitis.

Description of the invention

The invention relates to medicine, more specifically to urology and treatment of chronic prostatitis.

Chronic prostatitis is the most common urological disease in men younger than 50 years and the third frequency urological diagnosis in men older than 50 years (Collins et al., 1998; Diokno et al., 2003, Krieger et al., 2004).

Today for the treatment of chronic prostatitis used combined therapy, namely in addition to antibiotic therapy massage prostate, physiotherapy, together with immunomodulating therapy, lifestyle adjustments. Due to the fact that when prostatitis is marked abnormalities in humoral and local immunity (Drannik et al., 1986), in a comprehensive Ter the FDI prostatitis is crucial to the use of immunomodulators (Guskov et al., 1998), for example according to the latest published data assumes high intensity interferons (Ding, et al, 2006).

Known effects of interferons: antiproliferative, antitumor, antiviral, immunomodulatory. Immunomodulatory effect due to the ability of interferons modulate the interaction of immune cells. This mechanism is implemented through the regulation of expression of HLA proteins and sensitivity to cytokines. Interferons are able to stimulate the activity of natural killer cells, macrophages, prostaglandin and corticosteroid systems, as well as to suppress the activity of b-lymphocytes. The result is increased phagocytic and cytotoxic reactions in the area of inflammatory focus, which leads to effective elimination of the infectious agent (Kuhen et al., 1999).

Interferon preparations, especially genetic engineering of origin, increasing pressures are being implemented in public health practice, not only in our country but also abroad. Extensive research and experience in the practical application reasonably proved that not all diseases are useful parenteral administration of interferon. Drugs local applications (ointments, suppositories, drops, etc.) when the number of nosological forms are more effective as capable of providing higher the s concentration of the drug directly into the lesion in the absence of side effects, inherent in the parenteral administration of high doses of interferon.

Of particular interest suppozitornoj forms of interferon, an experience which testifies to their effectiveness to treat a variety of infections. A significant proportion of patients with urogenital infections there is a tendency to chronicity of the process or persistence of the pathogen in the body, which is determined by the characteristics of the microorganism and the state of the defenses of the person (secondary immunodeficiencies, disruption of microflora of the lower genitals etc).

Described and used suppositories with interferon, with different concentrations of the active substance and with various auxiliary components (Viferon (Registration certificate 000017/01), Generon (Registration certificate 001812/01)) for the prevention and treatment of infections of various etiologies, in particular sexually transmitted diseases.

In the patent of the Russian Federation 2147843 described suppositories for the prevention and treatment of sexually transmitted infections, which contains an inducer of interferon or interferon, or a combination in the ratio of 2:1-3:1. In the embodiments disclosed cases of clinical application of vaginal suppositories in the treatment of chronic inflammatory diseases of mixed viral-chlamydial-Miko is lazenay etiology.

The closest analogue may be considered a method of treatment of prostatitis, described in the patent of the Russian Federation 2307656. According to the formula of this invention claims a method for the treatment of chlamydial prostatitis etiology by adjuvant therapy, including as etiotropic therapy the introduction of azithromycin 1 g 1 once a week for 3 weeks and the implementation of the third day the complex therapy of rectal therapy No. 10, characterized in that it further in serum define the content of the^γ-interferon (^γ-IFN) IU/ml, interleukin 1^β(IL-1^β) PG/ml, interleukin-4 (IL-4) PG/ml, interleukin-6 (IL-6) PG/ml, lactoferrin (LF) ng/ml, and in the reduction of^γ-IFN less than 45 IU/ml; the increase in IL-1^βmore than 50 PG/ml; IL-4 more than 45 PG/ml; IL-6 more than 60 PG/ml; LF more than 300 ng/ml is administered rectally candles Gepirone for 500000 ME 2 times a day for 14 days, a second course of Gepirone after 10 days from 21 days of complex therapy to provide massage of the prostate gland No. 10.

In this patent as a part of complex therapy is therapy with interferon Alfa-2b (active principle suppositories Generon), interferon therapy is prescribed when there are indicators in the blood than normal (at lower γ-IFN less than 45 IU/ml; the increase in IL-1β more than 50 PG/ml; IL-4 more than 45 PG/ml; IL-6 more than the 60 PG/ml; LF more than 300 ng/ml).

Thus, in the prior art there is no detailed information about the role of interferons in the treatment of chronic prostatitis and indirectly the importance of immunomodulatory therapy.

In accordance with the present invention for solving this problem through clinical research has revealed the role of interferons in the treatment of chronic prostatitis and proposed effective treatment of this disease. In addition, revealed a significant decrease in inflammation, itching, burning sensation, difficulty with urination and ejaculation, often characteristic of this disease.

To identify the essence of the invention were conducted clinical studies of patients with confirmed chronic bacterial prostatitis, the purpose of which was to study clinical and immunological aspects of chronic bacterial prostatitis in the background of immunomodulatory therapy.

The purpose of this study was (a) the study of clinical and immunological parameters in patients with chronic bacterial prostatitis, b) study of the efficacy and safety of interferon-alpha (Ifnα) in chronic bacterial prostatitis.

On the basis of statistical data, in accordance with the invention describes a method for the treatment of chronichepbcorrecti, includes (a) treatment with antibiotics; b) together with immunomodulating therapy and other methods. In accordance with one embodiments of the invention a number of antibiotics for treatment of prostatitis include erythromycin, roxithromycin, pefloxacin, ciprofloxacin. As a rule, the course of antibiotics is prescribed for the period from 1 week to 10 days. The second aspect of the treatment, together with immunomodulating therapy carried out locally. Rectal administration interferometeric drugs provides a higher concentration in the pelvic organs, in particular in the prostate gland, in comparison with the concentration after the injection of interferon directly into the blood (Korsunsky et al., 2007).

In accordance with the invention, complementary treatments are physical therapy, magnetic therapy, and others.

Further, the invention is illustrated by examples of implementation, not limiting the scope of invention.

Examples of carrying out the invention

As a source of interferon-α was selected Generon (suppositories with recombinant Ifnα, taurine and benzocaine, CJSC BIOCAD, Russia).

The study was set the task to explore the clinical and immunological parameters in patients with chronic bacterial prostatitis, secondly, to study the efficacy and safety of applying online is herana-alpha (Ifnα) in chronic bacterial prostatitis, namely, to determine the influence of the drug Generon (suppositories with recombinant Ifnα, taurine and benzocaine, CJSC BIOCAD, Russia) on the severity of inflammation in the prostate gland and clinical symptoms of chronic prostatitis, to study the influence of the drug of IFN-α on the immune system of the patient, and also to find out the frequency and severity of undesirable effects when used.

Example 1.

The study included 29 patients with chronic phlomidis prostatitis in age from 24 to 65 years, disease duration ranged from 3 to 15 years, while 23 patients had previously has received a variety of treatment for chronic chlamydial prostatitis. The scheme of treatment included:

1. Sumamed on 1.0 g 1 once a week (at the rate of 3 grams).

2. Massage of the prostate gland.

3. Enzyme therapy chymotrypsin/m to 5.0 mg daily No. 10).

4. Instillation of the urethra instillagel.

5. Generon (rectal for ME 1000000 2 times a day for 7 days, repeated seven-day course, a week).

Already in the first days of therapy the majority of patients showed a significant reduction of unpleasant subjective sensations: as a feeling of heaviness in the perineum, burning and pain during urination was observed cessation of mucopurulent discharge from the urethra, considerable is decreased hyperemia and swelling of the urethral sponge. 5-8 days of treatment with palpation of the study, prostate cancer was detected normalization of its consistency. As a result of treatment, taking into account held in the month of control, clinical recovery (with the normalization condition of the prostate according to palpation studies, ultrasound, studies of prostate fluid) occurred in 24 patients. Elimination of chlamydia according to the DFA and PCR occurred in 27 patients.

Example 2.

The study involved 35 patients aged 20 to 60 years with a diagnosis of chronic bacterial and abacterial prostatitis who had pain in the pelvis, perineum and/or the urogenital system lasting at least 3 months. All patients after the comprehensive examination and confirmation of diagnosis was carried out with standard combination therapy, including antibacterial therapy (taking into account the results of antibiogram) and rectal administration suppositories Generon containing 1000000 ME alpha-2 human recombinant, 2 times a day for 10 days. In 71,4% of patients the pain was completely absent on day 7, and 10 days of therapy in all patients treated with Generon. According to the transrectal us the volume of the prostate was reduced on average of 1.35 cm³in 30 patients. Final cut is ltati diagnostic PCR talk about a complete reorganization from an infectious agent in 93.8% of patients. The number of cells in the prostate gland secretion fell to 4-8 in the field of view in 87.4% of patients.

The results of the immunological profile: significant increase in the number of CD3+, increased levels of IRI, the increase in the index bactericides, and the number of neutrophils. Observed activation of the NBT-test, the decrease in serum IFN and increased production of IFN-α on the PHA. The effects of Gepirone on indicators of semen and prostate fluid can be regarded as very good (in the process of follow-up in 26 patients increased concentration and sperm motility).

Example 3.

The duration of the study was 4 months, during which was held on 3 visits. The study included 40 patients aged 20 to 54 years (mean age 38,8±9,1 years). The vast majority of the subjects (17 men - 42,5%) was at the start of the study from 40 to 49 years.

The severity of symptoms of chronic prostatitis were evaluated on the scale of the National Institute of health, USA NIH-CPSI. At the screening visit total score averaged 26 points. During treatment, the level of severity of symptoms of chronic bacterial prostatitis decreased in both groups. In the first group, the total score of the NIH-CPSI on the 2nd and 3rd visit was statistically significant what about the below, than in the control (p<0,05). Thus, in group 1 reduced severity of symptoms of chronic bacterial prostatitis has progressed faster than in the standard therapy group, which indicates greater efficacy of combination antibiotic therapy and use of the drug Generon.

Literature

1. Korsunsky, VN, Briskin A.B., Denisov L.A., Ivanov R.A., "a Comparative study of the pharmacokinetics of various dosage forms of interferon-alpha-2b, Effective Pharmacotherapy in obstetrics and gynecology (2007), No. 1, 24-29.

2. Collins, N.M., Crowbar M.J., "Epidemiology of chronic prostatitis", Curr Opin Urol (1998), Vol.8(1), pp.33-7.

3. Diokno A.C., Homma Yu., Sekiguchi Yu., Suzuki Ya., “Interstitial cystitis, gynecologic pelvic pain, prostatitis, and their epidemiology", Int J Urol (2003), 10 (s1), pp.S3-S6.

4. Krieger, J.N. "Classification, epidemiology and implications of chronic prostatitis in North America, Europe and Asia", Minerva Urol Nefrol (2004), Vol.56(2), pp.99-107.

5. Drannik, G.N., "Local immunity of chronic prostatitis patients", Vestn Dermatol Venerol (1986), Vol.9, pp.66-70.

6. Guskov A.R. Gorlina N.K., "Immunocorrection Therapy in Complex Treatment of Prostatitis", Russ J Immunol (1998), Vol.3(2), pp.159-166.

7. Ding, X.G., Li S.W., X.M. Zheng, L.Q. Hu "IFN-gamma and TGF-betal, levels in the expressed prostatic secretions of patients with chronic abacterial prostatitis", Zhonghua Nan Ke Xue (2006), Vol.12(11), pp.982-984.

8. Kuhen, K.L., Samuel C.E., "Mechanism of interferon action: functional characterization of positive and negative regulatory domains that modulate transcriptional activation of the human RNA-dependent protein kinase Pkr promoter", Virology (1999), Vol.254 (1), pp.182-195.

1. A method for the treatment of chronic bacterial prostatitis achlamydeous etiology, lies the present in the complex therapy with the use of immunomodulating agents including: a) antibiotics b) Interferon α in the form of ointments or suppositories within 7 days, a second seven-day course of a week.

2. The method according to claim 1, wherein the Interferon-α is used in the form of suppositories "Generon" 1000000 ME 2 times a day.

3. The method of treatment according to any one of claims 1 and 2, including antibiotic therapy in the adjuvant therapy.

4. The method of treatment according to any one of claims 1 and 2, including prostate massage as a part of complex therapy.