Репозиторий Университета

© 2018 Human Stem Cell Institute. All rights reserved. Cell therapy is one of the most promising directions in the treatment of critical limb ischemia (CLI). In spite of certain advances achieved in this field in the last decades, which are related to application of bone marrow stem cells (BMSC), a large number of problems still remain unsolved. In this review, we discuss the BMSC biology, mechanisms of their therapeutic effect in the CLI treatment and results of the most notable BMSC-based clinical studies in detail.

© 2018 Russian Transplant Society. All rights reserved. Donor organs shortage leads to extending criteria for deceased liver donation in the whole world. Aim: To compare results of deceased donor liver transplantation (DDLT) depending of donor age over 60 years old. Materials and methods: The study includes 390 DDLT from January 2010 to November 2017. All liver donors separated by age for two groups: I - 60 years and older (n = 26); II - younger than 60 years (n = 364). All donors were standardized by demographic, laboratory fi ndings and inotropic drug requirement. Results: no difference between both groups in severity of ischemia-reperfusion injury, ICU or in-hospital staying (median 2 and 7,5 days respectively) was found. There is also no difference between biliary or vascular complication rate. 5-year actuarial survival rate found no difference between both groups (I: 70%: II: 76%, p = 0,54). Conclusion. Using grafts from donors older than 60 years don't worsen early and late results of DDLT. Care should be taken to avoid other risk factors (cold ischemia time, warm ischemia time).

© 2018, Nizhny Novgorod State Medical Academy. All rights reserved. Persistent bronchial inflammation in chronic obstructive pulmonary disease (COPD) is considered the cause of ventilation disorders and related contamination with conditionally pathogenic microorganisms; the latter can proceed and transform into a full infection, which can aggravate and exacerbate COPD. The aim of the study was to evaluate the relations between the oropharyngeal microbiota in patients with COPD and the clinical, functional, and prognostic parameters of the disease. Materials and Methods. 64 patients with COPD were included in the study; the participants were scheduled to visit our clinic on two occasions. In the first visit, their medical history was studied in detail and the major examination procedures were conducted. Those included an assessment of the respiratory function, the 6-minute walk test, the degree of dyspnea by the Medical Research Council scale, body plethysmography, the diffusion capacity of the lungs, and a chest CT scan. The second visit took place 12 months after the first one to assess the changes in the course of the disease. The result was considered negative if, in the second examination, the patient‘s condition was found more severe. Oropharyngeal samples of all patients were sequenced to identify the V3–V4 variable sites of the 16S rRNA gene. Results. It is found that the microbiological oropharyngeal patterns in COPD patients depend on the source of micro-aspiration. In addition, the changes in the oropharyngeal microbiota correlate with the severity and prognosis of the disease, as well as the patient phenotype. Based on the data obtained by sequencing parts of the 16S rRNA gene, the role of oropharyngeal microbiota in determining the course and prognosis of COPD has been elucidated. Conclusion. The presented clinical and functional characteristics associated with oropharyngeal microbiota indicate that microaspirations from other body compartments not only affect the composition of oropharyngeal microbiota in patients with COPD but also have an important prognostic significance.

© Bionika Media Ltd. Objective. To study the features of sexual functioning and the psychopathological pattern of sexual dysfunctions in women with infertility in assisted reproductive technology programs to elaborate treatment and rehabilitation measures and to improve quality of life in a couple. Subjects and methods. An open-label continuous comparative cross-sectional study of sexual functioning and psychopathological and personality characteristics was conducted in 589 women visiting the V.I. Kulakov Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia, for infertility. Clinical, psychopathological, clinicosexological, and psychometric studies were used. Results. 58.9% of the examined patients were found to have non-psychotic mental disorders, among them there was a predominance of anxiety disorders (28.0%); 18.34% had sexual dysfunctions, among which a libido disorder was prevalent (25.0%). There was a high comorbidity of sexual dysfunctions and borderline mental disorders (100.0%). The personal and psychopathological characteristics were revealed in patients with sexual dysfunction (p < 0.05). Conclusion. The studied features of the psychopathological pattern of sexual dysfunctions in infertile women are needed to elaborate differentiated tactics for the treatment and rehabilitation measures and to improve quality of life in a married couple.

© Bionika Media Ltd. Different factors caused by both equipment and the course of surgery (conditions under which the operation is performed, the location of incision, the characteristics of suture material, the type of surgical suture, and the amount of blood loss), by the course of the postoperative period, and the peculiarities of repair of damaged tissues influence wound healing of the uterus during cesarean section. Objective. To establish the value of premature amniorrhea and uterine inertia as predictors of impaired myometrial repair after cesarean section, by using clinical and morphological analyses. Subjects and methods. The investigation enrolled 129 patients who had given birth via cesarean section. Of them, 44 patients had delivery before birth activity, 85 during the first stage of labor. 49 and 80 women delivered before and after amniorrhea, respectively. During cesarean section, uterine tissue was taken from the upper edge of the wound after uterine incision. The myometrial biopsy specimens obtained during cesarean section were morphologically and immunohistochemically examined. The patients were divided into 4 groups according to the level of birth activity and the preservation of amniotic fluid at the time of cesarean section. Group 1 included patients with regular labor activity and amniorrhea at the time of caesarean section; Group 2 consisted of those with labor activity in the presence of whole amniotic fluid; Group 3 comprised those without birth activity in the presence of whole amniotic fluid; Group 4 included patients with premature amniorrhea without uterine contractions. 36 cases (9 in each group) were selected by random sampling for morphological and immunohistochemical examinations. The biopsy specimens were fixed in 10% neutral formalin and embedded in paraffin. The serial paraffin-embedded sections underwent histological examination and immunohistochemical tests for the following markers: TGF-β, VEGF, MMP2, TIMP1, types I and III collagen, TNF, and PDGF. Results. The morphological and immunohistochemical analyses revealed the most pronounced signs of myometrial damage during cesarean section in Group 4 patients having premature amniorrhea without uterine contractions. There were decreased VEGF, PDGF, MMP2, and TIMP levels and simultaneously increased TNF-α expression in leiomyocytes, vascular endothelium, and myometrial stromal cells. The findings may indicate the relatively lower reparative potential of the myometrium and the increased readiness for an inflammatory response in the group of women undergoing cesarean section in the presence of premature amniorrhea without uterine contractions. Conclusion. Clinical, morphological, and immunohistochemical analyses have revealed differences in the myometrial status in relation to typical clinical factors, such as amniorrhea and birth activity. Wound healing occurs under the influence of growth factors and the ratio of expression levels for growth factors can vary in different pathological conditions. The reduced expression of VEGF, MMP2, TIMP, and PDGF and the increased expression of TNF in the group having amniorrhea without uterine contractions (P-B+) suggest that there are pronounced inflammatory processes and impaired myometrial repair with the longer latency period in the absence of labor activity, which may refer these women to a group at risk for incompetent scar formation.

© 2018 Ima-Press Publishing House. Objective: to compare the efficacy of methotrexate (MTX) and colchicine in patients with chronic arthritis in calcium pyrophosphate crystal deposition disease (CPPDD). Subjects and methods. Data from a controlled prospective cross-sectional study of 10 patients (8 women and 2 men) with chronic arthritis in CPPDD are presented. In the initial period of treatment, all the patients were given colchicine 1 mg/day for 3 months, followed by a wash-out period for 1 month and then subcutaneous MTX 20 mg/week for 3 months. The diagnosis of CPPDD was made if there were calcium pyrophosphate crystals in synovial fluid and signs of chondrocalcinosis, as evidenced by joint X-ray and/or ultrasonography. DAS44, the swollen joint count (SJC) and tender joint count (TJC), pain intensity on a visual analog scale (VAS), the Health Assessment Questionnaire (HAQ) index, and serum C-reactive protein (CRP) levels were determined in all the patients at baseline, 3 months after the beginning of treatment with colchicine, after a wash-out period, and 3 months after the beginning of MTX treatment. Results and discussion. At baseline, mean DAS44 value was 2.47}0.27; SJC and TJC were 2.0}0.6 and 2.4}1.1, respectively; pain intensity was 55.2}12.3 mm; serum CRP level-3.89}3.82 mg/l; HAQ-1.1}0.3. Three months after colchicine therapy initiation, mean DAS44 value decreased to 1.76}0.28 (p = 0.004), SJC-to 1.4}0.5 (p = 0.048), TJC-to 1.6}1.35 (p = 0.023), pain intensity-to 42.0}13.2 mm (p = 0.023), CRP level-to 3.13}2.85 mg/l (p = 0.75), HAQ-to 0.95}0.3 (p = 0.041). Good response was achieved in 7 patients after 3 months of colchicine therapy. After the wash-out period, the mean DAS44 value was 2.08}0.26; SJC and TJC-1.6}0.5 and 1.7}1.4, respectively; pain intensity-46.5}9.8 mm; CRP level-3.38}1.74 mg/l; HAQ-1.3}0.34. Following 3 months of MTX therapy, mean DAS44 value decreased to 1.39}0.45 (p = 0.027), SJC-to 0.7}0.5 (p = 0.023), TJC-to 0.6}0.5 (p = 0.007), pain intensity-to 26.0}18.97 mm (p = 0.045), CRP level-to 2.87}2.06 mg/l (p = 0.75), HAQ-to 0.8}0.6 (p = 0.045). Two of the 3 patients with an insufficient effect of colchicine achieved DAS44 remission after MTX treatment; two patients attained remission after therapy with colchicine and developed an exacerbation of the disease when this drug was replaced by MTX. Conclusion. MTX 20 mg/week is as effective as colchicine in most cases and can be the drug of choice in patients with chronic arthritis in CPPDD if colchicine therapy is ineffective.

© 2018, Peter the Great St. Petersburg Polytechnic University. The magnetomodulation differential weak magnetic-field sensor, based on the Bi-2223 high-temperature superconducting ceramics has been investigated. The high magnetic-field resolution (∼20 pT) and wide measurement range (125-140 dB) have been obtained. The possibility of using this sensor for noninvasive control of magnetic particles or implanted medical electronic devices in biological objects at a distance of up to 30 mm from the skin surface is discussed.

© 2018 Ima-Press Publishing House. Mental disorders (MDS) of the anxiety-depressive spectrum (ADS) and cognitive impairment (CI) substantially deteriorate the course and efficiency of therapy for rheumatoid arthritis (RA). There have been practically no studies on the impact of psychopharmacotherapy (PPT) for MDS on the efficacy of standard disease-modifying antirheumatic drugs (DMARDs) and biological agents (BAs). Objective: to investigate the impact of adequate PPT for MDS of ADS on the efficacy of DMARDs and BAs in patients with RA. Subjects and methods. The investigation included 128 patients (13% men and 87% women) with documented RA in accordance with the 1987 American College of Rheumatology (ACR) criteria. The patients' mean age was 47.4}0.9 years; the median duration of RA was 96 [48; 228] months. DAS28 averaged 5.34}0.17. 75.1% of the patients received DMARDs. The diagnosis of MDS was based on the ICD-10 codes, by applying a semi-structured interview and the Hospital Anxiety and Depression Scale. Changes in the pattern and severity of ADS were evaluated using the Hamilton Anxiety Scale and the Montgomery-Asberg Depression Rating Scale. Clinical and psychological procedures were used to diagnose CI. At baseline, ADS was detected in 123 (96.1%) patients: major depression in 41 (32.1%), minor depression in 53 (41.4%), and anxiety disorders in 29 (22.6%). CI was diagnosed in 88 (68.7%). PPT was offered to all the patients with MDS; 52 agreed to treatment and 71 refused. The following therapeutic groups were identified according to the performed therapy: 1) DMARDs (n = 39); 2) DMARDs + PPT (n = 43); 3) DMARDs + BAs (n = 32); 4) DMARDs + BAs + PPT (n = 9). The dynamics of MDS and the outcomes of RA were estimated in 112 (91.0%) and in 83 (67.5%) of the 123 patients at one-and five-year follow-ups, respectively. The efficiency of RA therapy was evaluated from the changes in DAS28 and SDAI. Results and discussion. One year later, the patients who had received the complete cycle of PPT and took DMARDs achieved a satisfactory effect twice more frequently (58.1 and 32.3%, respectively; relative risk (RR) = 0.53; 95% confidence interval (CI), 0.2-1.39; p = 0.024) and did not respond to therapy 3 times less often (21.0 and 58.1%, respectively; RR = 2.41; 95% CI, 0.87-6.71; p = 0.001) according to the EULAR criteria than those who had refused PPT. The patients with MDS who received DMARDs + PPT during one year were unresponsive to therapy significantly less frequently than those who received DMARDs and BAs without PPT (21 and 44.8%, respectively; RR = 0.6; 95% CI, 0.21-1.7; p = 0.029). After 5 years of follow-up, the probability of no response to RA therapy in MD patients who received only DMARDs was 3.6 times higher than in those who had PPT (66.7% and 10.4%, respectively; RR = 3.58; 95% CI 0.82-15.5; p < 0.001). The patients adequately treated with DMARDs and BAs for MDS according to the DAS28 showed 1.3-fold more frequently good and satisfactory results (100 and 76.2%, respectively; p = 0.14) than those who refused PPT, but these differences were not statistically significant because the DMARD+BA+PPT group was small. Five-year follow-up indicated that DAS28 remission was more common in the patients receiving DMARDs and PPT than in those who had DMARDs and no PPT (34.5 and 8.3%, respectively; RR = 1.79; 95% CI, 0.34-9.24; p = 0.024). DAS28 remission was somewhat more frequently observed among the patients receiving DMARDs, BAs, and PPT than among those taking DMARDs and BAs (33.3 19.0%, respectively; RR = 1.64; 95% CI, 0.28-9.57; p = 0.34), but these differences were insignificant. Remissions according to the 2011 ACR/EULAR criteria were achieved by only the patients having DMARDs and PPT (6.9% and 13.8% after 1 and 5 years, respectively). Conclusion. Adequate treatment of MDS in RA patients results in a significant increase in the efficiency of antirheumatic therapy.

© 2018 Vserossiiskoe Obshchestvo Kardiologov. All rights reserved. Recently, development of medicine leads to the increase of the number and complexity of surgical interventions, explaining high significance of the risk assessments for post-surgical complications and probability of fatal outcome; this requires participation of internist in patients management with correction of therapy. The article is focused on the main scores and indexes utilized in clinical practice for prediction of possible complications, incl. cardial. A detailed description provided, for every calculator, features and limitations for usage and results interpretation.

© 2018 Dynasty Publishing House. All rights reserved. A clinical case of a patient, 34-35 weeks pregnant with melanoma stage V (tumour growing into fatty tissues), complicated by severe paraneoplastic symptoms including secondary thrombophilia, marantic endocarditis, disseminated arterial thrombosis. A lethal outcome was stated 8 months after preterm delivery due to thromboembolism and severe multiple organ failure.

© 2018 Ima-Press Publishing House. All rights reserved. Chronic cerebral ischemia (CCI) is one of the most common diagnoses in middle-aged and elderly patients in the practice of an outpatient neurologist. Unfortunately, the diagnosis of CCI in these patients is often established only on the basis of complaints of headache, dizziness, instability during walking, and lower mood. At the same time, other diseases that cause these symptoms are not diagnosed, patients do not receive treatment, which considerably worsens quality of life and leads to anxiety and depression. A variety of diseases, such as headache, peripheral vestibular vertigo, depression, Alzheimer's disease, and Parkinson's syndrome, are frequently hidden under the diagnosis of CCI. The leading neurological syndrome in CCI is cognitive impairment that can be both moderate and reach the level of dementia. Approximately 40% of patients with chronic cerebrovascular disease complain of headache that is usually caused by mixed primary headache. The management tactics for a CCI patient suffering from headache is aimed at treating primary headache, modifying vascular risk factors, and managing cognitive impairment. The paper discusses the use of choline alphoscerate in patients diagnosed with CCI.

© 2018 by the authors. Exosomes are small vesicles which are produced by the cells and released into the surrounding space. They can transfer biomolecules into recipient cells. The main goal of the work was to study the exosome involvement in the cell transfer of hormonal resistance. The experiments were performed on in vitro cultured estrogen-dependent MCF-7 breast cancer cells and MCF-7 sublines resistant to SERM tamoxifen and/or biguanide metformin, which exerts its anti-proliferative effect, at least in a part, via the suppression of estrogen machinery. The exosomes were purified by differential ultracentrifugation, cell response to tamoxifen was determined by MTT test, and the level and activity of signaling proteins were determined by Western blot and reporter analysis. We found that the treatment of the parent MCF-7 cells with exosomes from the resistant cells within 14 days lead to the partial resistance of the MCF-7 cells to antiestrogen drugs. The primary resistant cells and the cells with the exosome-induced resistance were characterized with these common features: decrease in ERα activity and parallel activation of Akt and AP-1, NF-κB, and SNAIL1 transcriptional factors. In general, we evaluate the established results as the evidence of the possible exosome involvement in the transferring of the hormone/metformin resistance in breast cancer cells.

© 2018 Publishing House of the Union of Pediatricians. All rights reserved. Background. There are limited data on the efficacy of long-term enzyme replacement therapy (ERT) in children with mucopolysaccharidosis (MPS). Objective. Our aim was to study the efficacy and safety of long-term ERT in children with MPS type I, II and VI. Methods. We analyzed the results of ERT with laronidase, idursulfase and galsulfase in children with MPS type I, II and VI admitted to the federal research center from January 2007 to November 2016. The response rate was assessed by the level of normalized urinary excretion of glycosaminoglycans (GAGs) (the ratio of GAGs concentration to urine creatinine) recalculated in percent (%) exceedance of the upper limit of normal for the corresponding age. Data on the administered therapy and its results, including adverse events, is extracted from the medical records of in-patients. Results. The results of treatment (intravenous infusions, intervals between administrations from 4 to 10 days) were studied in 33 children (5 of them were girls) with MPS type I (n =4; laronidase at a dose of 0.58 mg/kg), II (n =26; idursulfase at a dose of 0.5 mg/kg), and VI (n =3; galsulfase at a dose of 1 mg/kg). A decrease in the normalized urinary excretion of GAGs from 376% (172; 791) to 54% (0; 146) exceedance of the upper limit of normal for the age (p <0.001) was noted in the course of ERT lasting (median) 27 (14; 41) months. A decrease in the normalized GAGs excretion below the upper limit of normal for the age was established in 12/33 (36%) patients. ERT-associated adverse events were identified in 12 patients; one case required a two-fold therapy interruption. The development of nephrotic syndrome in the course of ERT in patients with severe MPS II was first described. Conclusion. Long-term ERT in children with MPS type I, II and VI is characterized by acceptable efficacy and safety.

© 2018 Media Sphera Publishing Group. All Rights Reserved. The characteristics of mortality in the Russian Federation are that the greatest years of potential life lost are due to deaths among 50-60-year-old men. Objective - to investigate the characteristics of nutrition patterns in a sample of 41-44-year-old Moscow residents with overweight and obesity, by taking into account the role and significance of overweight in the development of cardiovascular diseases and events. Material and methods. Actual nutrition was evaluated according to the special computer program 1C. Value of Nutrition through a 24-hour dietary recall, by applying a special food atlas. A constructed mathematical model and tables of the chemical composition of nutrients were used to obtain information about the energy value of a diet and the pattern of nutrition. Results. A total of 301 men aged 41-44 years were examined. 38.3% of them were overweight. 29% of the men were found to be obese; 83 (28.6%) men had abdominal overweight. Comparative analysis showed that overweight and obese persons consumed statistically significantly more protein and total fat than normal weight ones and people with abdominal obesity ate more saturated fats and cholesterol. There was a paradoxical decrease in the intake of simple and complex carbohydrates with increases in both weight and waist circumference. Conclusion. The findings can be used to improve methods for nutrition assessment and differentiated technology for overweight correction in primary health care facilities.

The paper deals with the mechanisms of a T-cell immune response, which depends on the balance between costimula-tory and coinhibitory signals that have been called as immune checkpoints (ICP). The imbalance of T-cell activation within ICTs (CTLA4/CD28 and PD1/PD1L) is considered to be a fundamental mechanism not only of autoimmune disease, but also impaired antitumor immunity underlying the development of malignant tumors. The use of monoclonal antibodies against negative regulatory ICTs (CTLA4, PD1, and PD1L) is a major achievement in the treatment of malignant neoplasms in the early 21st century. However, since CTLA4 and PD1 control the activation of auto-reactive T cells, the inhibition of these ICTs is associated with the development of autoimmune disease that is defined as immune-mediated adverse even. The paper considers the clinical manifestations of IMAR, primarily rheumatic ones and discusses the prospects of pharmacotherapy from the standpoint of achievements of modern rheumatology.

© 2018 Media Sphera Publishing Group. All rights reserved. The objective of the present study was to determine the biological age of the unrecognized individuals based on the analysis of CT-scanograms of the skull and the craniovertebral region in the sagittal projection. We investigated the structure of the spongy substance of the clinoid plate of the sella turcica and the clivus of the cranium, involution of the vertebrae configuration in the medial atlantoaxial articulation, frontal and sphenoidal sinuses. A total of 80 skulls of Caucasoid individuals at the age ranging from 4 to 84 years belonging to an Eastern Slavonic population (free from the pathological lesions in the above cranial structures) were available for the examination. The results of the multifactorial analysis gave evidence of the possibility to estimate the age of individual subjects based on the comprehensive aggregate qualitative and quantitative characteristic in the framework of the linear regression model by making use of the age-related changes in the frontal and sphenoidal sinuses, the sella turcica and the clivus of the cranium, the first and the second cervical vertebrae with an accuracy to within 6 years. It is concluded that the application of the systems for the automated statistical analysis of the images for the purposes of forensic medical expertise would allow to obtain the results of great practical and scientific value.

© 2018 Media Sphera Publishing Group. All rights reserved. The objective of the present study was to elucidate the characteristic features of the injuries inflicted to the victims of a road traffic accident inside the passenger compartment of a moving car equipped with the modern personal safety systems. The materials available for the present work included the lesions documented in 210 drivers and 150 occupants of the car passenger compartments. Both comparative, morphometric and statistical methods were used to analyze the data obtained. The morphometric analysis included identification of the form of the injury, such as extravasation, wounds, fractures, and lesions of the internal organs (e.g. hemorrhages, ruptures, etc.), their number and localization. Special attention was given to the specific features of the injuries to the occupants of the cars equipped with the modern personal safety systems. The study has demonstrated that the form, frequency, and localization of the injuries inflicted to the victims of a road traffic accident inside the passenger car compartment (including the drivers and other occupants) can be used for determining the positions of the victims at the moment of the accident.

© 2018 Media Sphera Publishing Group. All rights reserved. The detection of grade II-III central obesity on a corpse in conjunction with the identification of two additional criteria (such as arterial hypertension and impaired glucose tolerance) provides, if combined with the autopsy data (including the visual reduction of muscular mass, the increased total amount of the adipose tissue, gynecomastia in men together with hypertrophied abdominal adipose tissue accumulation, decreased face and body pilosis), a basis for diagnostics of metabolic syndrome (MS). The objective parameters for this purpose are waist circumference measurements, corpse weight and height, the degree of visceral obesity, narrowing of the renal arteries as a result of their compression by the surrounding adipose tissue, and accumulation of epicardial fat confirmed by the results of the biochemical analysis. The signs of plasmorrhagia combined with fibrinoid degeneration of the vascular walls in the microcirculatory bed make it possible to suspect, with a high degree of probability, the development of hypertensive crisis that may result in a sudden death of the patients presenting with metabolic syndrome.

© 2018 Media Sphera Publishing Group. All rights reserved. This article presents an overview of the literature publications concerning pathological changes in the cerebral blood vessels and the factors underlying the development of hemorrhagic complications leading to sudden death of young people. The special emphasis is placed on the most important causes behind the changes in the vascular wall (including the congenital ones) responsible for the high risk of rupture of the intracerebral vessels associated with the development of hemorrhagic complications.

© 2018, Polish Urological Association. All rights reserved. Introduction In order to investigate the efficacy and safety of Afalaza in men with benign prostatic hyperplasia (BPH) at risk of progression, this multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to prostate-specific antigen (PSA) and endothelial nitric oxide synthase (eNOs), Afalaza was previously proved to modulate its molecular targets. The mechanism of action of the drug is associated with the modulating effect of the antibiodies (RA-Abs) on the molecular targets (PSA and eNOS) by way of conformational changes. Material and methods A total of 249 patients aged 45–60 years with BPH and moderate lower urinary tract symptoms (LUTS), total prostate volume (TPV) ≥30 cm3, Qmax 10–15 ml/s, and serum PSA<4 ng/ml were randomly assigned to receive either Afalaza (n = 125) or placebo (n = 124) for 12 months. Changes in BPH/LUTS symptoms (according to the International Prostate Symptom Score), Qmax, TPV, PSA, BPH clinical progression, occurrence of acure urinary retention (AUR) events or BPH-related surgery were estimated as the study endpoints. Results IPSS mean change was-3.7 ±3.0 (95% CI-4.3 to-3.2) after 12 months of Afalaza (vs.-2.9 ±2.4; 95% CI-3.3 to-2.4 in placebo; р = 0.02). Qmax growth was 2.5 ±4.3 ml/s (vs. 1.4 ±3.3 in placebo; p = 0.049), TPV reduced by 11.8 ±16.0% (vs. 6.5 ±14.7%; p = 0.01, and PSA remained unchanged. Afalaza therapy resulted in a significant decrease in the total sum of BPH progression symptoms (p = 0.01). The maximum effect of Afalaza was registered after 12 months without a tendency to form a ‘plateau’. During the study, no patients experienced AUR or BPH-related surgery. Conclusions A 12-month course of Afalaza therapy is effective and safe for patients with BPH. The results of end points measurements revealed asignificant advantage of Afalaza compared to placebo in the overall symptoms benefit and a decline in the risk of BPH progression. ClinicalTrials.gov: NCT01716104.