[Rotational technique for emulsification of soft lens nucleus]. / Rotatsionnaya metodika emul'sifikatsii myagkogo yadra khrustalika.

Effective and atraumatic removal of a soft lens nucleus requires different surgical techniques compared to phacoemulsification of a dense nucleus. PURPOSE: This study was conducted to develop a non-ultrasound technique for emulsification of a soft lens nucleus. MATERIAL AND METHODS: Fifty-seven patients (57 eyes) underwent surgery. In 23 cases, early or immature cataracts were detected, and in 34 cases, lens removal was performed for refractive purposes in high myopia and complex myopic astigmatism. Phacoemulsifier Centurion Vision System (Alcon Laboratories, Inc., USA) was used for the surgery. Aspiration of soft lens nucleus was done using a rotational technique. The following aspects were evaluated in the course of the surgery: the volume of the required irrigation solution, and the frequency needing to involve ultrasound for complete emulsification of the lens nucleus. Intraoperative and postoperative complications were also assessed. RESULTS: The surgery was uneventful in all cases. There were no violations of the integrity of capsulorhexis edge. The need for short pulses of minimal power ultrasound during the removal of the soft lens using this technique arose only in 11 (19.3%) cases. The effective ultrasound time was less than 1 second. The required volume of irrigation solution was 33.0 (24.0; 43.0) ml, which does not differ significantly from that in ultrasonic phacoemulsification. CONCLUSIONS: The use of modern phacoemulsifiers providing a high vacuum level allows successful removal of a soft lens without using ultrasound, which prevents its negative impact on the ocular tissues. The use of adequate surgical techniques, including the optimal direction of rotation of the lens nucleus in the rotational technique, improves the efficiency of soft lens nucleus removal.

[Surgical technique for aspiration of soft lens nucleus with preoperative femtosecond laser-assisted fragmentation]. / Khirurgicheskaya tekhnika aspiratsii myagkogo yadra khrustalika s predvaritel'noi femtolazernoi fragmentatsiei.

Fragmentation and aspiration of soft cataracts require different surgical techniques and approaches compared to the removal of dense nuclei, including when using a femtosecond laser. PURPOSE: This study was conducted to develop a non-ultrasound technique for aspiration of a soft lens nucleus after its preliminary femtosecond laser-assisted fragmentation. MATERIAL AND METHODS: The study included 63 patients (63 eyes) aged 23 to 40 years who underwent surgery. In 27 cases, early or immature cataract was observed, and in 36 cases, cataract removal was performed for refractive purposes in high myopia and complex myopic astigmatism. The VICTUS femtosecond laser surgical system (Technolas Perfect Vision GmbH, Germany) was used for preliminary fragmentation of the lens nucleus. Surgeries were performed using the Centurion Vision System phacoemulsifier (Alcon Laboratories, Inc., USA). The volume of the required irrigation solution was evaluated during the surgery. Intraoperative and postoperative complications were assessed. RESULTS: The surgery was performed without complications in all cases. Capsulorhexis edge was completely preserved along its entire circumference. The study showed the fundamental possibility of aspirating a cataract with a nucleus of grade I-II density without low-frequency ultrasound after preliminary femtosecond laser-assisted fragmentation of the nucleus with a "grid" pattern, which ensures minimal fragment size in the central zone of the nucleus. The volume of irrigation solution required for aspiration of the nucleus was 36.0 (27.0; 44.0) ml, which does not significantly differ from the volume of solution during ultrasound phacoemulsification of a nucleus of such density. CONCLUSIONS: Femtosecond laser-assisted fragmentation of the lens nucleus with a "grid" pattern and phacoemulsifier systems with a high vacuum level allow effective aspiration of a soft lens without using low-frequency ultrasound.

[Clinical outcomes of laser activation of hydraulic permeability of the sclera in the treatment of advanced glaucoma]. / Klinicheskie rezul'taty lazernoi aktivatsii gidropronitsaemosti sklery v lechenii patsientov s dalekozashedshei stadiei glaukomy.

PURPOSE: This study evaluates the hypotensive effect and the outcomes of intravital morphological changes in the intervention site after laser activation of scleral hydro-permeability (LASH) by pulsed-periodic radiation from an Er-glass fiber laser (λ=1.56 µm) in patients with advanced glaucoma. MATERIAL AND METHODS: LASH surgery was performed in 19 patients (19 eyes) aged 48 to 73 years with uncompensated advanced stage (IIIb-c) glaucoma. In addition to standard methods of investigation, all patients were examined with optical coherence tomography (OCT) and laser confocal microscopy of sclera and conjunctiva (CMSC) at the laser treatment sites, and electronic tonography. RESULTS: The hypotensive effect after LASH in patients with advanced glaucoma was observed in 94.7% (n=18) of cases. The decrease in intraocular pressure (IOP) averaged 24.4% from baseline one month after intervention and 32.96% after six months of follow-up. In 15.7% (n=3) of cases, the recorded IOP decrease was insufficient as its target values were not achieved. However, in the vast majority of patients (n=16), the recorded IOP decrease corresponded to the target values and indicated compensation of the process. Results of complex morphological evaluation after LASH revealed structural changes indirectly indicating possible laser-induced influence on the processes of increased transscleral filtration and uveoscleral outflow. A high positive correlation dependence (r=0.848) was also revealed between the degree of IOP lowering and the increase in the coefficient of ease of aqueous humor outflow, attesting to the fact that IOP lowering was mainly due to the improvement of intraocular fluid outflow. CONCLUSION: The demonstrated efficacy of LASH technology indicates the possibility of its successful application as an independent method of IOP reduction in patients with advanced glaucoma.

[Pudov Surgical care in a multi-field hospital during the new coronavirus infection pandemic (SARS-COVID-19): a 5-year experience]. / Okazanie khirurgicheskoi pomoshchi v mnogoprofil'nom «nekovidnom¼ statsionare v period pandemii novoi koronavirusnoi infektsii (SARS-COVID-19). Pyatiletnii opyt.

OBJECTIVE: To analyze the 5-year experience of surgical care in a multi-field hospital during the coronavirus pandemic and before infection. MATERIAL AND METHODS: We assessed «non-traumatic¼ surgery and the main indicators in a multi-field hospital during the coronavirus pandemic and surgical work in the «pre-COVID¼ period. RESULTS: The number of discharged patients was the same between 2018 and 2021. In 2020-2021, mortality increased by 2.8 times, the number of deceased patients - by 2.5 times, hospitalizations for emergency surgical indications - by 2.1 times. Elective care decreased by 2.5 times. The number of adverse vascular events increased by 3 times. CONCLUSION: Acute increase in emergency surgery and decrease in elective care create the prerequisites for growth of «neglect¼ with subsequent postoperative complications. We observed significant increase in mortality. It is advisable to create a backup emergency surgical service in infectious disease hospitals to provide care in obviously infected patients.

[Management of patients with atrial fibrillation and minor bleeding during therapy with direct oral anti-coagulants].

The recommended tactics for prevention of thromboembolic complications of atrial fibrillation (AF) is the oral anticoagulant (OAC) treatment. The drugs of choice for preventing stroke for most patients with AF, excluding some valvular defects, are direct OACs (DOACS). Regardless of the drug class, all anticoagulants, even at appropriate doses, increase the risk of bleeding. However, the development of minor bleedings is not an absolute indication for DOAC withdrawal. This review presents a tactics for management of patients with minor bleeding associated with the DOAC treatment.

[Atrial Fibrillation and Mortality: Prognostic Factors and Direction of Prevention].

This review focuses on major causes and risk factors for death of patients with atrial fibrillation (AF). The authors analyzed current therapeutic strategies for managing patients with AF with respect of their effects on prediction and mortality. Special attention is paid to the strategy of rhythm control and the clinical significance of catheter ablation in the treatment of patients with AF and heart failure.

[Treatment and secondary prevention of venous thromboembolism in cancer patients].

Oncological patients are a high-risk group for venous thromboembolic complications. These complications significantly impair the outcome of antitumor treatment and take a leading place in the structure of mortality. Treatment of venous thromboembolic complications in oncological patients is a serious challenge. When selecting an anticoagulant, the physician should consider its efficacy and safety and possible drug interactions. Based on results of multiple studies presented in this article, physicians will be able to choose an optimum therapeutic tactics and secondary prevention of thromboembolic complications for this group of patients.

[Prevention of intraoperative miosis in femtosecond laser-assisted phaco surgery]. / Preduprezhdenie intraoperatsionnogo mioza v fakokhirurgii c primeneniem femtosekundnogo lazera.

INTRODUCTION: Prevention of intraoperative miosis in hybrid (femtosecond laser-assisted) phacoemulsification is a relevant problem of cataract surgery. PURPOSE: Development and clinical study of an effective method for preventing intraoperative miosis in hybrid (femtosecond laser-assisted) phacoemulsification. MATERIAL AND METHODS: Hybrid phacoemulsification was performed in 300 patients (300 eyes). The first group (100 eyes) 3 days prior to the surgery was prescribed instillations of 0.1% indomethacin 3 times a day and 3 times in 2 hours before surgery at 30 minute intervals. The second group (100 eyes) 3 days prior to the surgery was prescribed instillations of 0.1% indomethacin 3 times a day, 3 times in 2 hours before the surgery at 30 minute intervals, and 1 hour before the surgery an additional intramuscular injection of diclofenac. The third group (control, 100 eyes) 2 hours before the operation was prescribed instillations of 0.1% indomethacin, 3 times at 30 minute intervals. The diameter of the pupil was evaluated before the beginning of femtosecond laser stage and before the opening of anterior chamber during the second stage of the operation. RESULTS: When the interval between the femtosecond laser stage and emulsification of the nucleus fragments was maintained at less than 15 minutes, pronounced decrease of the pupil (more than 2 mm) was noted in 8.2% of cases in the first group, 6.7% in the second group and 14.1% in third (control) group; mean values of pupil narrowing were 0.68±0.27 mm in the 1st group, 0.63±0.25 mm in the 2nd group, and 0.93±0.39 mm (p<0.05) in the third group. CONCLUSION: The clinical study showed high efficiency of the proposed methods for prevention of intraoperative miosis in hybrid (femtosecond laser-assisted) phaco surgery. An important factor affecting intraoperative narrowing of the pupil is the time interval between the femtolaser stage of the operation and emulsification of the nucleus fragments, which should not exceed 15 minutes.

[The integral estimation of health problems and effectiveness of stage rehabilitation in patients after ischemic stroke]. / Integral'naia otsenka narushenii zdorov'ia i éffektivnosti étapnoi reabilitatsii bol'nykh posle ishemicheskogo insul'ta.

The multidisciplinary assessment of health problems after stroke should take into account not only motor, speech disorders, disability, but also postural balance, type and level of mental disorders, degree of working hand dysfunctions, cortical motor neuron functional indicators, and risk factors for recurrent stroke. OBJECTIVE: To develop a methodology for the integrated assessment of health problems and the effectiveness of stage rehabilitation in patients after ischemic stroke (IS) and risk factors for recurrent stroke. MATERIAL AND METHODS: Examinations were made in 101 patients (mean age 59.78±8.63 years) after IS in the middle cerebral arterial bed in the early recovery period. Of them, 62 patients were examined in the early and late recovery periods of stroke. The investigators assessed neurological disorders using National Institutes of Health Stroke Scale (NIHSS), Ashworth Spasticity Scale, dysarthria scale, Medical Research Council Scale and wrist dynamometry, Frenchay Arm Test), Self-Care Rating Scale (Barthel index) and social and living activities (Rehabilitation Activities Profile Scale), psychological status (procedures of Memory for Pictures and Ten Words, Schulte-Platonov Tables, Luscher Color Test, Hospital Anxiety and Depression Scale (HADS), Recovery Locus of Control Scale) questionnaire, functional (stabilography, transcranial magnetic stimulation) and laboratory (lipid profile test) results. The integrated assessment of health problems was defined as the sum of ranks of the signs studied; the effectiveness of stage rehabilitation in patients was defined as the coefficient of the dynamics of the sum of ranks of informative indicator. RESULTS: There was a preponderance of moderate motor impairments; the high incidence of cognitive impairment and paretic hand dysfunctions; a change in the temporal parameters of the nerve impulse through the corticospinal tract; obvious balance dysfunctions; and the relationship between equilibrium and the visual analyzer. The integral indicator of the level of health correlated with clinical and functional findings. After the rehabilitation, severe arm/hand paresis was not detected; paretic arm/hand function improved; the number of patients with moderate paresis declined; impaired vital and social activities reduced significantly; the proportion of patients with low dependence on others was as much as 86%; balance and psychological functions improved; the mean blood pressure reached the target values. An integrated effectiveness evaluation showed that 33, 58, and 9% of patients were discharged with a significant improvement, improvement, and a slight improvement, respectively. CONCLUSION: The integrated approach to evaluating health problems and the effectiveness of rehabilitation makes it possible to comprehensively estimate (taking into account neurological, psychological, functional disorders, risk factors for recurrent stroke) the harm to a patient's health and activity, which is associated with prior stroke and its reversal due to rehabilitation.

[Robot-assisted atrial septal defect closure in adults: first experience in Russia]. / Robot-assistirovannoe zakrytie defekta mezhpredserdnoi peregorodki u vzroslykh: pervyi opyt v Rossii.

AIM: To analyze immediate results of minimally invasive robot-assisted atrial septal defect (ASD) closure in adults. MATERIAL AND METHODS: For the period from March 2012 to November 2016 sixty patients with contraindications to endovascular procedure have undergone robot-assisted atrial septal defect closure at Meshalkin Siberian Federal Biomedical Research Center. Mean age was 34.5±11.3 years, body mass index - 24.6±4.0 kg/m2. 48 (80%) patients had NYHA class II before surgery. In 37 (61.7%) patients isolated ASD with deficiency or absence of one edge was diagnosed, isolated ASD with primary septum aneurysm - in 16 (26.7%) cases, 7 (11.6%) patients had reticulate ASD. 5 (8.3%) patients had concomitant tricuspid valve insufficiency required surgical repair (suture annuloplasty). All operations were performed under cardiopulmonary bypass with peripheral cannulation. Right-sided anterolateral mini-thoracotomy was used in the first 43 patients. Following 17 patients underwent completely endoscopic procedure. Depending on the shape, size and anatomical features of the defect we performed suturing (14 patients, 23.3%) or repair with xenopericardial patch (46%, 76.6%). RESULTS: Mean CPB and aortic cross-clamping time was 89.1±28.7 and 24.8±9.5 min, respectively. Postoperative variables: mechanical ventilation 3.3±1.5 hours, ICU-stay - 18.2±3.7 hours, postoperative hospital-stay - 13.4±5.7 days. There were no mortality and any life-threatening intra- and postoperative complications. Cases of conversion to thoraco-/sternotomy and postoperative bleeding followed by redo surgery were also absent. 23 patients were followed-up within 1 year, 6 patients - within 2 years, 3 patients - within 3 years. All patients were in NYHA class I-II with 100% freedom from ASD recanalization and redo surgery. According to echocardiography data there were decreased right heart, pulmonary artery pressure and preserved left ventricular function in early postoperative period and 1 year after surgery. CONCLUSION: In view of favorable course of postoperative period, no significant specific complications and encouraging immediate results we can talk about endoscopic robot-assisted ASD closure in adults as a safe and effective alternative to surgical treatment.

[A new approach in the compression therapy of postoperative scars]. / Novyi podkhod v kompressionnoi terapii posleoperatsionnykh rubtsov.

The aim of the study was to evaluate the effectiveness of compression therapy with a prolonged plaster of Contractubex in the formation of skin scarring in children after surgery. MATERIAL AND METHODS: In a prospective open-label randomized trial, 109 patients aged 5.3±2.1 years after surgery: boys - 73, girls - 36. Patients were divided into 2 groups: in the main group (54 children) the application of the prolonged plaster Contractubex was performed; in the control group (55 patients) - dynamic observation. The scar deformation was assessed according to the Vancouver scale for 10, 30 and 90 postoperative days. RESULTS: 94.4% patients had good compliance; in 2 (3.7%) - satisfactory; in 1 (1.9%) - unsatisfactory compliance. In our study, the formation of hypertrophic scars in the main group was significantly less frequent than in the control group (1 and 8 patients, respectively, χ2=4.241, p=0.042). CONCLUSION: Thus, the use of the prolonged plaster Contractubex in the near and distant period a good cosmetic and functional result in the formation of a postoperative scar was provided.

[Long-term results of different approaches to revascularization in non-ST-segment elevation acute coronary syndrome and multiple coronary atherosclerosis]. / Otdalennye rezul'taty razlichnykh podkhodov k revaskuliarizatsii pri ostrom koronarnom sindrome bez pod''ema segmenta ST i mnozhestvennom koronarnom ateroskleroze.

AIM: To assess the long-term results of different approaches to treating patients with non-ST-segment elevation acute coronary syndrome (NSTE ACS) and multivessel coronary artery disease (MVCAD). SUBJECTS AND METHODS: A total of 150 patients with NSTE ACS, in whom coronary angiography revealed MVCAD, were examined. The patients were divided into 3 groups according to the selected treatment policy: 1) percutaneous coronary intervention (PCI) (n=91 (60.6%)); 2) coronary artery bypass grafting (CABG) (n=40 (26.6%)); and 3) only medical treatment (n=9 (6%)). The mean follow-up was 27.6±3.5 months. RESULTS: The medical treatment policy in this patient sample demonstrates the worst results, with the majority of cardiovascular events developing in the hospital period. PCI in patients with NSTE ACS and multiple coronary atherosclerosis has a number of objective limitations in this patient sample, leading to suboptimal treatment outcome. CONCLUSION: The use of CABG or PCI as a myocardial revascularization technique in patients with NSTE ACS and MVCAD is characterized by a comparable satisfactory survival in the hospital and long-term follow-up periods. 12% of patients do not receive revascularization due to the extremely high risk from any of coronary blood restoring methods, which results in very many deaths largely occurring during the hospital period.

[Morphological and clinical aspects of anterior capsulotomy in femtosecond laser-assisted cataract surgery]. / Morfologicheskie i klinicheskie aspekty perednei kapsulotomii v fakokhirurgii c primeneniem femtosekundnogo lazera.

The review covers morphological and clinical aspects of femtosecond laser-assisted anterior capsulotomy in cataract surgery. Literature data suggests that femtosecond laser-assisted capsulotomy is more accurate in size, shape, and centration than manual. Femtosecond laser-assisted anterior capsulotomy improves the accuracy of IOL positioning within the capsular bag.

[Effectiveness of Reamberin in orthopedic knee surgery]. / Effektivnost' primeneniya reamberina pri ortopedicheskikh operatsiyakh na kolennom sustave.

AIM: To study an efficacy of Reamberine in complex therapy in early postoperative period after knee-joint surgery. MATERIAL AND METHODS: It was analyzed treatment of 108 patients (47 men and 61 women) with degenerative diseases of knee-joint in postoperative period. Periarticular osteotomy of tibia and knee-joint replacement were performed. Patients were divided into 2 groups. Main group consisted of 43 patients who received Reamberine 400-800 ml with infusion rate 4-5 ml/min during 1-1,5 hours for 4-8 days postoperatively. Control group (65 patients) had conventional therapy with daily volume 400-800 ml. RESULTS: It was revealed that Reamberine increased efficacy of postoperative treatment. There were earlier (by 52.6% compared with control group) improvement of health including weakness disappearance, sleep and appetite recovery. Hemodynamic parameters were also improved (stabilization of blood pressure and pulse). It was observed earlier disappearance of pain and edematous syndrome (by 32.3%). There were also earlier postoperative wound healing (by 21.3%) and reducing of rehabilitation terms (by 72%, i.e. 2.1 ± 0.7 vs. 7.5 ± 0.9 days respectively).

Removable uterine compression sutures for postpartum haemorrhage.

In 1997, B-Lynch and colleagues introduced the B-Lynch uterine compression suture for postpartum haemorrhage. Since then, various uterine compression sutures have been used and postpartum hysterectomy has been avoided in many women. However, some complications have emerged in years. In this article we discuss two types of uterine compression sutures in which stitches can be removed. The procedures have been successfully applied with no problems and no observed complications to date. This is a novel concept, with the potential to reduce morbidity related to compression sutures, but needs further evaluation.

[Analysis of Cases of Thrombolytic Therapy Administration for Acute Thrombosis of Mechanical Prosthetic Valves].

Mechanical prosthetic valve thrombosis is a life-threatening complication that in most cases requires urgent re-intervention. A significant risk of intraoperative complications, death and presence of a small fresh thrombus suggest thrombolytic therapy to be an alternative option of treatment because of a relatively low risk of the procedure. This article presents successful experience of systemic thrombolysis in patients with acute thrombosis of mechanical prosthetic valves.

[Analysis of blood pressure measurement among Chinese adults in 2018].

Objective: To analyze the blood pressure measurement of Chinese adult residents in 2018 and provide a scientific basis for early detection and intervention of hypertension. Methods: In 2018, China Chronic Disease and Risk Factor Surveillance were conducted in 298 counties (districts) of 31 provinces (autonomous regions, municipalities) across the country, using a multi-stage stratified cluster random sampling method to survey permanent residents aged 18 years and above. We selected 184 509 people and carried out a face-to-face questionnaire survey and body measurement method to collect demographic data, major chronic diseases, and blood pressure measurement information of the survey subjects. Blood glucose and blood lipid-related indicators were obtained by laboratory testing. There were 170 551 adult residents included in the study after excluding abnormal and missing data for key variables. After complex weighting, blood pressure detection rates and detection times in people with different blood pressure levels and other diseases were analyzed. SAS 9.4 software was used to perform the χ2-test and trend test. Results: Among adult residents in China, the proportions of those with normal blood pressure, commonly recognized 'high' blood pressure, and newly detected hypertension who had their blood pressure tested within three months were 44.4%, 50.4%, and 52.6%, respectively. The proportions all appeared higher in women than in men (all P<0.05), in urban than in rural areas (all P<0.05), and showed an increasing trend with age (all P<0.001); The proportion of these three populations who had never had their blood pressure measured was 27.6%, 24.2%, and 23.5% respectively. The proportion of people with diagnosed hypertension who had their blood pressure tested within seven days was 44.0%, 51.4% in urban areas, higher than 37.7% in rural areas (P<0.001), and the proportion of people who had their blood pressure tested increased with education, per capita annual income and BMI (all P<0.001). Conclusions: The behavior of regular self-monitoring of blood pressure among adult residents in China still needs to be improved, especially among men and rural areas. Relevant health promotion and education should be strengthened. More targeted policies and measures should be developed to improve blood pressure measurement behavior in people with normal high blood pressure and other high-risk groups to control elevated blood pressure effectively.

Improving surgical site infection prevention in Asia-Pacific through appropriate surveillance programs: Challenges and recommendation.

BACKGROUND: Surgical site infections (SSIs) represent a substantial clinical and economic burden on patients and the healthcare system. The prevention of SSIs entails surveillance activities which lead to effective mitigation strategies, which are lacking across Asia Pacific (APAC). This manuscript aims to document gaps and challenges across APAC that affect the undertaking of a successful SSI surveillance activities and to provide recommendations on overcoming such challenges. METHODS: A targeted literature review with relevance to APAC identified a series of salient points pertaining to SSI prevention guidelines, implementation, surveillance and outcomes, which was discussed in July 2019 at the APAC Surgical Site Infection Prevention Symposium. An expert panel, comprising eight multidisciplinary experts from APAC and the USA, subsequently amalgamated the key discussion points from the Symposium and their clinical experiences in developing this article. RESULTS: The barriers to implementing a successful and effective APAC SSI surveillance program were identified as: (a) lack of standardized definitions, reporting methodology and accountability, (b) lack of fiscal resources, (c) reporting variability and under-reporting, and (d) lack of safety culture. Implementing an effective surveillance program in APAC will require countries to develop a well-designed and robust surveillance plan and ensure adequate training for staffs involved. CONCLUSION: To improve SSI prevention in the region, it is imperative to encourage implementation of national programs with standardized methodologies and accountabilities. An ongoing APAC information exchange, including data and methodologies, will enable continuous learning within the APAC region.

Clinical efficiency and tolerability of artrofoon in patients with rheumatoid arthritis associated with osteopenic syndrome.

Clinical, laboratory, densitometric, and prognostic parameters were evaluated in 50 patients with rheumatoid arthritis complicated with osteopenic syndrome, 30 of these received artofoon for 12 months in addition to basis therapy. Antiinflammatory and analgesic effects of artrofoon were demonstrated and the possibility of using this preparation in pharmacotherapy of rheumatoid arthritis associated with osteopenic syndrome was proven.

[Efficacy, tolerability and safety of the treatment with teberif: the results of a 2-year randomized clinical trial of treatment naïve patients with remitting multiple sclerosis, who have not received DMT, after switching from other interferon ß-1a]. / Éffektivnost', perenosimost' i bezopasnost' terapii preparatom teberif: rezul'taty dvukhletnego klinicheskogo issledovaniia u patsientov s remittiruiushchim rasseiannym sklerozom, ranee ne poluchavshikh PITRS, i pri perekliuchenii s drugogo interferona ß-1a.

OBJECTIVES: To evaluate efficacy, safety, and tolerability of the treatment with teberif/interferon ß-1a, to analyze safety, tolerability and dynamics of key efficacy variables after switching from referent drug rebif to biosimilar teberif in patients with remitting multiple sclerosis (RMS). MATERIAL AND METHODS: During the main period of the international multicenter randomized study patients were randomized to receive treatment with teberif for 52 weeks, or rebif for 52 weeks, or placebo for 16 weeks to evaluate efficacy and safety of treatment. After the main study period, patients were group-independently switched to take open-label teberif treatment during the next 48 weeks. RESULTS AND CONCLUSION: The analysis of multiple evaluation parameters of the efficiency during the 1st study period (blinded) and the 2nd study period (open-label) has shown that teberif and rebif demonstrate equivalent efficacy and stable 2-year efficacy of teberif was proven. There were no significant differences between teberif and rebif for all safety, and tolerability parameters. Switching from rebif to teberif didn't influence treatment efficacy. The 2-year study results confirmed a biosimilar teberif's benign tolerability and expected safety profile to other interferons ß-1a in patients with RMS.