Outpatient Conditions Research Articles

COMPARATIVE ANALYSIS OF THE INCIDENCE OF SPINAL DISTORTIONS IN ADOLESCENTS FOR THE PERIOD 2009-2021

Purpose: The study objective is to monitor changes in the incidence of spinal distortions in adolescents in the school years 2008/2009 and 2019/2020 in schools within the territory of the town of Kazanlak. The report presents an overview of the manner and organization of preventive screenings of adolescents and options for subsequent treatment. Materials and methods: The study was carried out by specialists in physical and rehabilitation medicine (PRM) in the school physicians’ offices with the consent of the directors, class teachers, parents and the regional education inspectorate. The preventive screenings were carried out completely free of charge for the pupils, and the treatment of newly discovered spinal distortions was carried out in outpatient conditions and was taken over by the National Health Insurance Fund. Results: The study outcomes showed no change in the incidence of spinal distortions of pupils in classes 1 to 4. However, among children from classes 5 to 10, there is a significant increase in the incidence rate over a period of 10 years. Conclusions: The introduction of modern technologies in pupils’ daily lives and their increasingly active lifestyles over the last 10 years has led to an increase in spinal diseases. PRM specialists are the physicians responsible for restoring preventive screenings for spinal distortions in schools. Our study with subsequent treatment and prevention of these conditions shows a successful approach to dealing with the increased number of scoliosis cases in the town of Kazanlak. Our team believes that this approach can be effectively implemented in each region by the PRM specialists and would have a strong social, economic and health effect in the long term for the population of the Republic of Bulgaria.

Ilaser Submucous Destruction in the Treatment of Hemorrhoids

Aim: to improve the results of treatment in patients with hemorrhoids of the 2nd and 3rd stages.Materials and methods. The prospective study included 60 patients with hemorrhoids of the 2nd and 3rd stages. All patients underwent destruction of internal hemorrhoids with a fiber laser with a diode pump with a wavelength of 1940 nm. The technique is based on the effect of laser energy on the cavernous tissue of the internal hemorrhoidal node and on the terminal branches of the upper rectal artery. The efficiency of the destruction of internal hemorrhoids and the frequency of relapses of the disease were evaluated. The effectiveness of the proposed method was evaluated using anoscopy, measurement of the size of internal hemorrhoidal nodes, transrectal ultrasound with dopplerography. The analysis of the intensity of the pain syndrome, the consumption of nonsteroidal anti-inflammatory drugs and the assessment of the quality of life on the SF-36 scale was carried out. Sphincterometry was performed in all patients to determine the possible effect of laser radiation on the rectal locking apparatus. To assess the possible causes of complications, a single-factor analysis of the amount of energy transferred to each hemorrhoidal node and the total amount of energy spent on the operation was conducted.Results. In all patients, by day 7 after surgery, the pain syndrome in 43 patients (75.4 %) corresponded to 0 points according to VAS. In 3 patients (5 %) intraoperative hemorrhage developed. In the early postoperative period, 5 patients (8.3 %) had 7 complications: 5 cases of thrombosis of the external hemorrhoidal node and 2 — of acute urinary retention. The conducted single-factor analysis showed the dependence of the development of complications on the energy transferred to each hemorrhoidal node and its total amount for the entire operation. In terms of up to 6 months, there were no signs of a return of the disease in any case (hemorrhoidal prolapse and blood discharge). The detected hemorrhoids before the operation, a month after the operation, were not visualized, which persisted after 6 months. The performed transrectal ultrasound examination with spectral-wave dopplerography for up to 6 months allowed to diagnose a persistent decrease in blood flow along the terminal branches of the upper rectal artery compared with preoperative values. When performed sphincterometry, there was no change in the parameters of the anal sphincter function compared to preoperative parameters.Conclusion. The proposed method applying a fiber laser with a diode pump with a wavelength of 1940 nm makes it possible to affect transdermally the internal hemorrhoidal node without damaging the mucosa of the anal canal. The absence of postoperative wounds in the anal canal leads to a decrease in pain syndrome, and by day 7 there are no clinical manifestations of hemorrhoids. The method of laser destruction of internal hemorrhoids can be used in outpatient conditions and can improve the quality of life of patients in the early postoperative period.

Evaluation of the Efficiency of Comprehensive Rehabilitation of Patients with Diabetic Polyneuropathy in Outpatient Conditions

The study was carried out on the basis of a medical rehabilitation center — a branch of the Kyrgyz Research Institute of Balneology and Rehabilitation Treatment. 155 patients with type 2 diabetes mellitus with diabetic neuropathy of the lower extremities were observed before and after the course of rehabilitation. The effectiveness of rehabilitation is most pronounced after 3 months and is about 75%. For long-term preservation of the positive effect and prevention of diabetic foot, repeated courses are recommended after 6 months.

Analysis of integration processes in provision of medical care in rural health care of the region (on the material of Saratov region)

Chronic diseases, which form the somatic and social deprivation of patients, imply the provision of integrated medical and social care. National health care systems are actively pursuing processes aimed at overcoming the fragmentation of health care delivery and forming a model of integrated health care. The purpose of the study. Analysis of interaction of medical organizations and continuity in the treatment of patients in rural health care in the Saratov region.Material and methods. The authors conducted a comparative sociological study, which involved 319 physicians working in the district medical organizations of the Saratov region. The study was preceded by the construction of the medical and social portrait of the respondents.Results. The majority (73.7 %) of the respondents assessed the degree of continuity of patient care between inpatient and outpatient facilities in the district of the region as average.Conclusion. The study reveals the peculiarities of the organization of medical care for the rural population, which consist in the limited implementation of the principles of continuity in the management of patients, the presence of barriers to digitalization. The analysis of the degree of interaction between doctors when providing medical care to the rural population in inpatient and outpatient conditions reveals the fragmentation of rural and regional health systems.

Percutaneous release for trigger thumb in children under local anesthesia.

Trigger thumb surgery can be performed through open surgery or percutaneous release. Open surgery often requires hospitalization, an operating room, a surgical incision, and postoperative wound care; however, percutaneous release does not require hospitalization or surgery, and is relatively easier and faster. We aimed to assess the results of percutaneous A-1 pulley release using local anesthesia without hospitalization for the treatment of pediatric trigger thumb. In this retrospective study, we included patients operated on between March 2013 and August 2020 with the diagnosis of trigger thumb. The percutaneous release under local anesthesia was applied to all the children by one orthopedic surgeon. All percutaneous release procedures were performed in outpatient clinic conditions. There were 183 children (218 thumbs) who were enrolled in the clinic. Eighty-seven patients were male (47.5%) and 96 were female (52.5%). The average follow-up duration was 5 years (1-8.5 years). Among the 218 trigger thumb cases, 211 were satisfactory (successful result rate 96.8%). Relapse was seen in only 3 thumbs in the early postoperative period. No patient experienced neurovascular deficit or infection. The percutaneous surgical release in pediatric trigger thumb treatment is a simple, minimally invasive procedure that can be done in an outpatient setting under local anesthesia. In addition, the procedure duration is short and has minimal complication rates and maximum patient satisfaction. Level of Evidence III.

Anxiety and depressive disorders in patients with Covid-19

IntroductionCoronavirus infection has shown a significant impact not only on physical health but also on mental health. Among the long-term consequences in the post-COVID period, depressive and anxiety disorders are well observed. A potential mechanism for developing mental disorders after undergoing SARS-CoV-2 is a neuroinflammatory process in the central nervous system.ObjectivesThis study aimed to discover the features of anxiety and depressive disorders in people who suffered from COVID-19.MethodsThe study was conducted from October 2021 to September 2022 in outpatient and inpatient conditions of the S. S. Korsakov Psychiatric Clinic of Sechenov University. 58 patients (17 (29.3%) men and 41 (70.7%) women) with a diagnosis of F32, F34.1, F41-F48.0, or F06.3-06.4 according to ICD-10 who underwent COVID-19, mainly of mild and moderate severity (46 (79,3%) and (8 (13,8%) consequently), were examined clinically.ResultsThe median age among the respondents was 34 years. Mental illness in the family history had 38 (65.5%) people. Among the examined patients, 21 ((36.2%) people had psychasthenic traits premorbid, 13 (22.4%) – hyperthymic, 9 (15.5%) – hysterical. 15 patients (25.9%) had a history of maternal disorders during pregnancy and childbirth – 16 (27,6%) had neurotic disorders in childhood, 27 (46.6%) had a traumatic brain injury or general anesthesia. 2 patients (3.4%) reported substance abuse, 7 (12.1%) abused alcohol. The median period from somatic well-being after infection to the onset of mental illness was 3 months. The duration from the onset of symptoms of a mental disorder to treatment with a psychiatrist was 3 months. The main symptoms in the clinical picture were impaired concentration (100.0%), decreased productivity (98.3%), sleep disorders (96.6%), decreased mood (98.3%), anxiety (89.7%), anhedonia (75.9%), decreased appetite (65.5%), asthenia (65.5%), emotional lability (44.8%), self-blame ideas (43.1%), obsessive thoughts (39.7%), irritability (37.9%), suicidal thoughts (19.0%).ConclusionsAbout two-thirds of respondents were female. The main reasons for consulting a psychiatrist were decreased concentration, sleep disorders, and reduced productivity. In addition, symptoms of anxiety, asthenia, and low mood were revealed, and more than half of the patients complained of apathy. Although the severity of depression was moderate, and the level of anxiety was mild, all these disorders were accompanied by clinically significant fatigue.Disclosure of InterestNone Declared

Dış Kulak Yolunda Yabancı Cisim Bulunan Çocuk Hastaların Değerlendirilmesi

Aim: The aim of this study is to investigate the demographic characteristics, foreign body (FB) types, treatment approaches and complications of pediatric patients with FB detected in the external ear canal. Methods: The files of pediatric patients who were found to have FBs in the external auditory canal by ENT specialists between December 2020 and February 2022 were retrospectively reviewed. The age, gender, type of FBs, treatment methods and complications of the patients were recorded. Results: A total of 108 patients (66 male (61.1%) and 42 female (38.9%) patients) with FB detected in the external ear canal were included in the study. The patients' ages ranged from 1 to 17 years and the median age was 5.0 (4.0) years. FBs were detected in the right ear in 64 (59.3%) patients, in the left ear in 41 (38.0%) patients, and in both ears in 3 (2.8%) patients. The most common FBs were beads (31.5%), insects (9.3%), pencil tips (8.3%) and cotton (8.3%). Complications were observed in 9.3% of the cases. FBs were removed under outpatient conditions in 100 (92.6%) patients, while they were removed under general anesthesia in 8 (7.4%) patients. Conclusion: FBs in the external ear canal were frequently seen in children aged 5 years and younger. Most of the FBs consisted of inorganic materials such as beads. In order to avoid complications, especially in the presence of a round and hard FB that cannot be removed with simple applications, consultation from an ENT specialist should be requested.

Third mobile window syndrome (literature review and own series)

The report presents modern views on the “third mobile window syndrome”, starting with the anatomical and physiological features of the inner ear function, both in normal conditions and in the presence of an additional opening in the bony labyrinth, which changes the hydrodynamic resistance of fluid flow in the perilymphatic space. Characteristic symptoms and modern views (sometimes hypothesis) on the causes of its occurrence are described in detail. Attention focused on diagnostic methods at the outpatient and clinical conditions of a highly specialized department. The latest data on the modern classification of this syndrome and the conclusions of the consensus of the International Barani Society in 2021 are presented. Own series with a detailed description of the features of each case, illustration of the audiometric and tomographic images and successful results of surgical treatment are presented. In the conclusions, the attention of practicing doctors is focused on the signs of the “third mobile window syndrome” which can be detected at the outpatient service – pressure or sound-induced vertigo, bone conduction hyperacusis, and pulsatile tinnitus.

Evaluation of the effectiveness of complex therapy of cutaneous leishmaniasis

The article presents the results of a new complex method of therapy for сutaneous leishmaniasis, especially its complicated forms, with the use of a derivative of gossipol of the drug gosalidone in combination with the administration of an antibiotic and enzyme drug by indirect endolymphatic means. This method is applicable in outpatient conditions, helps to increase therapeutic efficiency, accelerate the healing time of ulcerative elements and resorption of inflammatory infiltrates, as well as earlier elimination of the pathogen from lesions.

Медико-социальный портрет будущей матери в мегаполисе

Aim: to present a medical and social portrait of an expectant mother living in a metropolis. Patients and Methods: 400 expectant mothers underwent a sociological survey, which included several blocks of closed and open questions covering a wide range of life activities in expectant mothers who sought medical help on an outpatient basis in the profile "Obstetrics and Gynecology". Results: according to the data obtained, the portrait of the modern expectant mother in the metropolis is: 30.5 years old; officially married; has her first sexual experience before adulthood; higher or incomplete higher education; actively participates in public life; family income level is approx. 50 thousand rubles per person; leads a healthy lifestyle; uses contraceptives for protection from an unwanted pregnancy; plans to have two children. Conclusion: the following obtained data showed the need for extensive information and preventive activities in the medical care provision (according to the profile «Obstetrics and Gynecology») in outpatient settings which can bring enrichment knowledge and communication skills for medical specialists: increase in the expectant mother age up to 30 years, sexual relationship debut in half of women before adulthood, knowledge acquisition concerning STDs from medical professionals in only a third of the surveyed female patients, as well as the preference for barrier methods of contraception. KEYWORDS: medical and social portrait, expectant mother, pregnancy, reproductive health, metropolis, outpatient conditions. FOR CITATION: Bryzgalova O.E., Armashevskaya O.V. Expectant mother in the metropolis: medical and social portrait. Russian Journal of Woman and Child Health. 2023;6(3):247–252 (in Russ.). DOI: 10.32364/2618-8430-2023-6-3-5.

Pacientes ginecológicas diferem de pacientes do pré-natal na apreciação da participação de estudantes de medicina nos atendimentos ambulatoriais

Abstract Introduction: The participation of students in clinical consultations is essential for their medical education. This experience allows for the acquisition of technical skills and the transmission of ethical and professional values. Objective: To evaluate how differences in outpatient conditions (gynecological or prenatal care), appraisal of previous experience, and sociodemographic profiles influence women’s willingness to accept student participation in their consultations. Methods: We selected 743 cases (45.1% prenatal) with previous experience in student participation of 893 women attending outpatient gynecological (52.6%) or prenatal (47.4%) clinics at Brasilia University Hospital from 2016 to 2019. Scales were adopted for women’s appraisal of student interpersonal communication, willingness to accept, and unwillingness to accept student participation. We used t tests to assess differences, chi-square statistics to compare proportions between outpatient groups, correlations between key variables, and linear regression to estimate variables predicting the willingness outcome. Results: Odds ratios over 1 (p< 0.01) emerged for age older than 35 years, not married, less than higher education, multiparity, discomfort with students, and lower acceptance of gender equality in relation to the Ob-Gyn gender for the gynecological group. Women in the gynecological group offered a better appraisal (from one to five) of interpersonal communication (4.75 vs. 4.43, effect size g= 0.605), showed more willingness (4.58 vs. 4.26, g= 0.625), and conveyed less unwillingness to accept student participation (2.35 vs. 2.47, g= 0.143) than women in the prenatal group. In the linear regression analysis (N= 743), a higher willingness to accept student participation was significantly related (in decreasing impact) to better appraisal of student interpersonal communication (p< 0.001), lower unwillingness (p< 0.001), gynecological group (p< 0.001), tolerance to pelvic examination by a student (p= 0.017), and age older than 35 years (p= 0.016). Conclusions: The experience of supportive interpersonal communication, especially regarding the gynecological group, had a predominant impact on the patient’s willingness to accept the participation of students in consultations. Overall, the willingness to accept this participation differs depending on the patient’s (reason for consultation, lower unwillingness, age) and student’s (communication, gender) factors. Hopefully, the findings can contribute to fostering student-patient partnerships from the perspective of the articulation between service and teaching in medicine.

ОРГАНИЗАЦИОННЫЕ И ТЕХНОЛОГИЧЕСКИЕ ОСОБЕННОСТИ ПРИ ЛЕЧЕНИИ ПАЦИЕНТОВ С ВЫВИХОМ ПЛЕЧА (ОБЗОР ЛИТЕРАТУРЫ)

Introduction. Shoulder dislocation currently continues to be the most common among dislocations of all localizations - about 45%. Over the years of observation, this indicator has been decreasing in different countries. More than 50 methods of correcting shoulder dislocation have been described. Methods of correction and organizational features of the treatment of injured are the subject of discussions on scientific forums and on the pages of specialized magazines. The review is dedicated to the analysis of organizational and technological features shoulder dislocation. Results. The existing methods of correcting shoulder dislocation can be divided into three groups: lever; physiological methods based on muscle stretching (traction); methods involving pushing the head of the humerus into the joint cavity (push methods). Despite the many ways, the recurrence shoulder dislocation is noted in almost every second victim. Most often, relapse is stated by young patients. Many specialists note the shortcomings of the methods of correcting the primary traumatic shoulder dislocation as in terms of the choice of the method of correction, and in terms of the organization of the therapeutic and diagnostic process. Among the complications of shoulder dislocation reduction, instability of the shoulder joint, habitual dislocation, restriction of shoulder movement are most often verified. The review analyzes the main methods of conservative correction of shoulder dislocation, provides data on the frequency and structure of complications. Separately, information about anesthesia for the reduction of shoulder dislocation is noted. The features of treatment of injured with shoulder dislocation in outpatient conditions and during hospitalization are shown. Presented overview the literature allows you to orientate yourself in the state of the issue of conservative correction of shoulder dislocation today.

Post-COVID syndrome

The aim is to study the frequency and symptoms of post-COVID syndrome in patients with pneumonia caused by SARS-CoV-2, who were treated in an outpatient setting. Materials and methods. Personal monitoring results of the health state of 62 patients who suffered pneumonia caused by the SARS-CoV-2 and were treated in the outpatient setting between May 2020 and September 2021 were analyzed. The patients were divided into 3 clinical groups depending on age, concomitant diseases, and extent of the process in the lungs. The examination results were processed on a personal computer using the statistical package Statistica program, version 10. Results. The prevalence of post-COVID syndrome with the symptoms that characterize it is significantly higher in patients who have not been vaccinated with the COVID-19 vaccine, who have suffered pneumonia caused by SARS-CoV-2 of a moderate-to-severe course with the process extent in the lungs from 25 % to 50 %, with its repeated cases, regardless of age and the presence of concomitant pathologies. Prolonged COVID-19 (early post-COVID syndrome) and post-COVID syndrome are main complications of COVID-19 with the most common symptoms such as general fatigue, depression, impaired memory concentration, sleep disorder, myalgia/arthralgia. Conclusions. Even a mild course of pneumonia caused by SARS-CoV-2 is accompanied by post-COVID syndrome, which requires long-term supervision and practice of rehabilitation techniques for such patients. Treatment of pneumonia caused by the SARS-CoV-2 with the moderate-to-severe course in outpatient conditions leads to an increase in the frequency and severity of the post-COVID syndrome course. Vaccination with a vaccine against COVID-19 to prevent the development of a severe course of pneumonia caused by the SARS-CoV-2 remains an urgent issue. Identified dental manifestations (stomatitis, periodontitis, and periodontal disease) should be considered by dentists in the early period of post-COVID syndrome, and dental pathology examination should be continued during the treatment of pneumonia caused by SARS-CoV-2 in post-COVID syndrome.

The algorithm of planning the needs in medical care provided in out-patient conditions to elderly age groups of population using mathematical models

The purpose of the study is to develop algorithm for planning the need in medical care provided in out-patient conditions to elderly groups of population based on mathematical modeling methods. Research materials and methods. As a source of information, data on cases of medical care provided to the population of elderly age groups (60 years and older) were used. The probability of access was studied in each one-year age interval, starting from the age of 60 years. The principle of mathematical modeling was based on functional approach applying algebraic functions by least squares method (regression analysis). The final choice of mathematical model was made in favor of mathematical function having largest value of approximation coefficient. The degree of influence of analyzed variable "age" was evaluated by residual variance calculation.It is established that overall need for out-patient care is higher in women. The maximum consumption in both women and men falls on the age of 76 years. After this age, frequency of visits decreases regardless of gender. Minimal levels of need are observed in the oldest age groups (95-100 and older). The variability of the indicator is higher in men, both at the area of need increasing and at the stage of need decreasing. The existence of common mechanisms and factors underlying the formation of the need for out-patient care confirms the use of the identical functions in modeling process. The character of modeling function has no gender differences. The age dynamics is described optimally by polynomial functions. The proposed models of age dynamics of out-patient visit rates of representatives of elder age groups in more than 90% describe existing fluctuations using non-smoothed data.

The analysis of human resources of medical workers by profile "Stomatology" providing out-patient medical care to population of megalopolis within the framework of mandatory medical insurance

The statistical report for 2017-2020 demonstrated that in outpatient conditions of multidisciplinary dental clinic providing services under compulsory medical insurance of population of megalopolis, there is increase in the number of physicians of the analyzed profile up to 304.5% and paramedical personnel up to 256.3% at the expense of young personnel. The direct relationship between increasing of the number of top- and middle-level dentists and quality of medical care provided within the framework of compulsory medical insurance was established.

Profile of pediatric out-patients managed by physiotherapists at Federal Medical Center, Abeokuta: a retrospective review

BackgroundPediatric physiotherapists help children to achieve their optimal physical development. The present study was aimed to evaluate the out-patient pediatric conditions managed by physiotherapists in Federal Medical Centre, Abeokuta, Nigeria (FMCA).MethodsThe present study included all children attended to at Pediatric Unit (outpatient) of FMCA in the period between the beginnings of May 20121 to the end of May 2022. The clinic runs every Tuesdays and Thursdays. All children below and equals to 15 years of age were included. Complete clinical, socio-demographic characteristics of patients and parents were manually scrapped from the electronic medical records (EMR) of the hospital. Descriptive statistics was used to present the results.ResultsDuring this period a total of 160 patients presented with different disorders were seen. There were 100 males (62.5%) and 60 females (37.5%). Cerebral palsy which can be classified as a neurological disorder was the most common condition managed (63.7%). Obstetric brachial palsy injury (OBPI), injection palsy, post-immobilization stiffness, congenital talipes equinivarus, and among others were managed during this period. Cerebral palsy was common among males, obstetric brachial palsy injury, and injection palsy. Cerebral palsy patients had late presentation for physiotherapy (1–5 years). Only 2 patients out of 11 with OBPI came for early physiotherapy. There is higher risk for cerebral palsy and OBPI among primiparous mothers.ConclusionsIt was concluded that neurological disorders are the most common pediatric cases managed by physiotherapists in Federal Medical Centre, Abeokuta, with cerebral palsy having higher prevalence.

The Effectiveness of an Intensive Inpatient Psychotherapy Program for Chronic Depression: A naturalistic comparison with wait list

BackgroundPatients with chronic depression (CD) typically have an early symptom onset, more psychiatric comorbidities, more treatment attempts, and more frequent and longer inpatient hospitalizations than patients with major depressive disorders. The main purpose of this study was to investigate the effectiveness of an intensive inpatient psychotherapy program for patients with chronic depression (CD). The primary research question was whether two intensive psychodynamic inpatient treatments, affect phobia therapy (APT) and VITA, were superior to an outpatient wait list condition, receiving treatment as usual (TAU), at completion of treatment. To investigate if a potential difference between the intensive treatment and the wait list control group was dependent on a specific psychotherapeutic model, the study contrasted two therapies with similar intensity, but different theoretical rationales.MethodsTwo hundred eighty patients with CD were included in a naturalistic study. Patients were assessed at four time points; assessment, start of therapy, end of therapy and 1-year follow-up. Three comparisons were performed with patients matched across groups; Intensive inpatient treatment program (APT + VITA) vs wait list during treatment, APT vs VITA during treatment and APT vs VITA during follow-up. The outcome measure was the BDI-II.ResultsIntensive inpatient treatment program vs. wait list showed a significant difference in favor of the intensive treatment. No significant differences were found between APT and VITA during therapy or follow-up; but both groups had large effect sizes during treatment, which were maintained during follow-up.ConclusionsThe intensive inpatient psychotherapy program showed superior effect on chronic depression over an outpatient wait list condition receiving treatment as usual (TAU), but no significant differences were found between the two intensive inpatient psychodynamic treatments. The results provide support for the effectiveness of an intensive inpatient psychotherapy program in treatment of chronic and severe disorders, such as CD, which could be of benefit for policymakers and the health care sector as they are allocating recourses efficiently.Trial registrationThis study has been retrospectively registered on ClinicalTrials.gov (NCT05221567) on February 3rd, 2022.

Revised service metrics partially explain variation in outcomes across facilities in a state-wide advanced practice public musculoskeletal service.

Revised service metrics partially explain variation in outcomes across facilities in a state-wide advanced practice public musculoskeletal service.

Performance results of medical organizations providing medical care in the field of dermatovenereology in 2019–2021 in the Russian Federation

The article presents the results of analysis of resources and performance rates of medical organizations providing medical care in the field of dermatovenereology over 20192021 in the Russian Federation. The changes in the rates of provision of the population of the Russian Federation with dermatovenereologists are reflected. The rates of provision of the population of the Russian Federation with round-the-clock and daytime dermatovenereological beds are presented. The rates of dermatovenereologic medical care provided to the population of the Russian Federation in 2021 in outpatient, inpatient and day hospital conditions were compared with those before the pandemic. The dynamics of incidence of sexually transmitted infections as well as dynamics of prevalence and incidence of skin and subcutaneous tissue disorders among the population of the Russian Federation, and specifically in different age groups, during the period under review is presented.

Interim Phase I Clinical Data of FT576 As Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma

Introduction: Despite the recent FDA approval of autologous chimeric antigen receptor (CAR) T-cell therapies targeting B-cell maturation antigen (BCMA), multiple myeloma (MM) remains incurable and relapsed/refractory (R/R) disease remains an area of high unmet medical need. Additionally, patient access to autologous CAR T-cell therapies is currently limited due to manufacturing constraints, the need for bridging therapy, and potentially life-threatening toxicities including cytokine release syndrome and neurologic toxicities (Munshi et al. 2021). Off-the-shelf natural killer (NK) cell therapies may offer an improved therapeutic profile and broader patient access than autologous CAR T-cell therapies. FT576 is a first-of-kind, multiplexed-engineered BCMA CAR NK cell therapy generated from a clonal master engineered induced pluripotent stem cell line, which can be used as a renewable source for the mass production of off-the-shelf NK cells of uniform composition. FT576 is engineered with 4 modalities to combine multifaceted innate immunity with multi-antigen-targeting capability: (1) high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor for augmented antibody-dependent cellular cytotoxicity; (2) IL-15/IL-15 receptor fusion that promotes NK cell persistence; (3) CD38 knockout to mitigate NK cell fratricide by CD38-directed monoclonal antibodies (mAbs) and that provides improved metabolic fitness and resistance to oxidative stress within the tumor microenvironment; and (4) a BCMA-directed CAR to target plasma cells. These modalities are designed to enhance the potency and persistence of FT576 and to enable multi-antigen targeting when combined with tumor-targeting mAbs. In preclinical studies, FT576 combined with the anti-CD38 mAb daratumumab demonstrated highly effective tumor control compared to either treatment alone or to primary CAR T cells in a disseminated MM xenograft model (Goodridge et al. 2021), suggestive that limitations in MM treatment confounded by clonal heterogeneity and antigen loss can be overcome with a dual antigen-targeting approach. Methods: This is a Phase I trial of FT576 in patients with R/R MM. The primary objectives are to assess safety and tolerability and to determine the recommended Phase II dose of FT576, given as single or multiple doses, as monotherapy and in combination with daratumumab in R/R MM. Key secondary objectives include anti-tumor activity and pharmacokinetics. The dose-escalation stage of the trial has the following 4 arms: single-dose FT576 monotherapy on Day 1 (Regimen A); multi-dose FT576 monotherapy on Days 1 and 15 (Regimen A1); single-dose FT576 + daratumumab on Day 1 (Regimen B); and multi-dose FT576 + daratumumab on Days 1 and 15 (Regimen B1). Dose levels of FT576 starting from 100 million cells/dose are being evaluated using a modified toxicity probability interval dose-escalation design. Daratumumab is administered per approved dose and schedule. Outpatient conditioning chemotherapy consists of 3 consecutive days of fludarabine and cyclophosphamide administered prior to the first dose of FT576. Results: As of a data cutoff date of 18 Jul 2022, 9 patients with R/R MM were treated and evaluable for safety and efficacy, in the first 2 dose levels of Regimen A (n = 6) and in the first dose level of Regimen B (n = 3). No dose-limiting toxicities, and no events of any grade of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease (GvHD), were observed. Conclusions: Administration of a single dose of FT576 at 100 or 300 million cells/dose alone or in combination with daratumumab is safe and well tolerated thus far without CRS, neurotoxicity, or GvHD. Interim clinical data, including safety and tolerability and initial anti-tumor activity, from the ongoing Phase I dose-escalation study of FT576 will be presented at the conference.