[Experience of using genfaxon for treating patients with relapsing-remitting multiple sclerosis in the Russian Federation].

UNLABELLED: Multiple sclerosis (MS) is a chronic autoimmune demyelinating disorder of the central nervous system. Nowadays some disease-modifying drugs (DMD) in the Russian Federation (RF) are biosimilars. Their full spectrum of tolerability and efficacy is to be determined. Here we present results of two retrospective-prospective studies on efficacy and safety of a biosimilar interferon beta-1a (genfaxon) in treatment of MS in the RF. AIMS: determination of safety and efficacy profile of genfaxon in a routine neurological practice in the RF. MATERIALS AND METHODS: Trials were performed in 18 MS centers in the RF. A total of 649 patients aged from 18 to 68 years with the EDSS score no more than 6.0 were treated with genfaxon for 12 months. The first group was comprised of 'naïve' patients without previous history of DMD administration. There were patients in the second group which have already received some of DMD. Statistical analysis was performed with the help of significance criteria (χ-square), t-criteria of Student for analysis of independent samplings. RESULTS: There were no serious adverse events during the period of the study. "Naïve" patients had significantly lower number of adverse events, than patients with previous history of DMD usage. Efficacy results were comparable with results published for the Rebif. CONCLUSIONS: Data, received from the studies show equal efficacy and tolerability of genfaxon compared with original DMD Rebif.

[Posture disorders in patients with multiple sclerosis]. / Osobennosti postural'nykh narushenii u bol'nykh rasseiannym sklerozom.

Impairment of stability in the vertical posture is one of the most common or, sometimes, a key symptom in patients with multiple sclerosis (MS). Reduction of postural control is often correlated with the severity of neurological deficit and is thought to be a leading factor that impacts on social and working activities of the patient with MS. We studied disturbances of postural control depending on the lesion of a functional system and evaluated the involvement of a corresponding system in the functions of postural control in 61 patients with confirmed MS. Patients were stratified into five groups according to lesion location: visual, motor, sensory, cerebellar or spine stem systems. The maximal impairment of static postural control corresponded to the maximal lesion of the sensory system. Compensatory mechanisms of the activation of central and neuromuscular.

[Unified assessment of adverse events of multiple sclerosis disease modifying drugs]. / Unifikatsiia otsenki pobochnykh éffektov terapii preparatami, izmeniaiushchimi techenie rasseiannogo skleroza.

One of the important components of effective treatment оf multiple sclerosis is adherence to therapy and long-term patient compliance, as well as timely detection and correction of adverse events. Using disease modifying drugs (DMD) in general medical practice is very different from that in clinical trials, in particular, there is no uniform approach to identify the adverse events of therapy. The authors developed a form of the Adverse events of DMD questionnaire, and checked its reliability and validity.

[Assessment of the risk of the transition of a monofocal clinically isolated syndrome to clinically definite multiple sclerosis].

We followed up 102 patients with a monofocal clinically isolated syndrome (CIS) during 8 years. Factors determining its transition to definite multiple sclerosis were singled out according to the data of anamnesis and MRI scans. Age of patients at the onset of CIS and the volume of demyelination measured by the first MRI were the most significant predictors of the transition of CIS to definite multiple sclerosis. A mathematical model based on logistic regression analysis for the estimation of the risk of this transition is suggested.

[Assessment of the high cost drug program on an example of the interferon treatment of multiple sclerosis].

Currently in Russia, there is a rather complicated situation with the distribution of expensive disease modifying drugs (DMD) purchased by the state for treatment of patients with multiple sclerosis. In this regard, it is necessary to carry out a serious organizational work in the direction of assessment of equivalence of biosimilars and original drugs concerning, first of all, efficacy and safety. Also, there is a problem of the replacement of one biosimilar by another in connection with organizational problems of shipping DMD to country regions. We present the results of the sociological research on the assessment of expensive drug provision by patients. The research has been carried out in 35 regions of the country. Based on these results, a strategy of the development of the program of provision with DMD should be developed all over the country.

[Sociological research in Samara Oblast: a role of social organizations of patients in the improvement of quality of medical and social care].

Results of a sociological research studying characteristics of reintegration of people with multiple sclerosis (MS) in a society are presented. During the research, people with MS living in the territory of the Samara region and experts, representatives of a region profile medical community, have been interrogated. The analysis of medical and social factors influencing the process of rehabilitation of the target group of patients is given. The role of Samara regional public organization of disabled people with MS (structural division of the All-Russian Multiple Sclerosis Society) in the improvement of quality of medical and socially-psychological help to people with MS is studied.

[Some problems in rehabilitating disabled people with multiple sclerosis in agencies for social protection].

The state social policy with regard to disable people in the Russian Federation is developed in accordance with international instruments which include the "Declaration on the Rights of People with Disabilities" adopted by the UN General Assembly, the ILO Convention (No159) "Vocational Rehabilitation and Employment of Disabled Persons", the "Standard Rules on the Equalization of Opportunities for Persons with Disabilities" adopted by the UN General Assembly, the World Program of Action Concerning Disabled Persons etc. All these instruments mainly focus on the issue of social rehabilitation of people with health disabilities in order to offer them "equal opportunities" in different areas of their life. The paper is devoted to research of some backbone arrangements of rehabilitation of people with multiple sclerosis (MS) and major lines of proficiency training and retraining of professionals on issues of social rehabilitation of people with health disabilities as well as methods of rehabilitation of MS patients.

[Influence of complex rehabilitation on the social adaptability and quality of life in people with multiple sclerosis].

The article presents results of complex rehabilitation in people with multiple sclerosis. We have studied the effect of rehabilitation measures on quality of life and self-sustenance adaptability of patients with multiple sclerosis as compared to standard therapeutic interventions. Factors influencing the effectiveness of rehabilitation measures are discussed.

[Some problems in assessing the quality of rendering medical assistance to people with multiple sclerosis].

To solve the problem of medical and social assistance to people with multiple sclerosis (MS) is possible in employing a system/ comprehensive approach which involves appropriate material basis and appropriate structures, systems, sub-systems with a definite area of their activities and functional interrelations between them. The quality of medical services is a complicated category that is defined by many characteristics. One needs certain equipment to manage in order to obtain the quality while based on the system approach. Experts in the area of quality management inform that, currently, the Russian healthcare is mostly characterized by primary level of quality, which is represented by unsystematic management of the quality and unsystematic (unstable) quality. The methodology of improving the quality is a multistage one. In accordance with the management cycle of Deming-Schuchart or the cycle of PDCA ('P' is for 'plan', 'D' is for 'deed', 'C' is for 'control' and checking the conformity of the result planned to that in the end, and, 'A' is for 'adjustment' of actions depending on the results achieved), the methodology comprises certain problems, an analysis of the system, an action plan development, testing proposed changes in pilot institutions, and practical application in the healthcare system. The article attempts to analyze basic problems and difficulties in setting up medical assistance for a resource-consuming group of patients, by the example of 382 patients with MS, taking into account the experience acquired in a test of application of management systems for medical assistance quality, which is based on international standards (ISO 9000), in order to find possible ways to overcome the existing negative processes and facts.

[Rehabilitation in multiple sclerosis: complexity, continuity and efficacy]. / Reabilitatsionnyi protsess pri rasseiannom skleroze: kompleksnost', nepreryvnost', éffektivnost'.

Multiple sclerosis (MS) today is a wide-spread disease of young adults of 22-25 years of age, which influences their everyday life, affecting movement, behavior and family life. After 2-5 years of untreated MS the patients become complete invalids. The organization of the process of rehabilitation for these patients includes the activity to restore MS patients' ability to work, serve themselves, continue education. Taking into consideration the increasing support from the state of different organizations of disabled patients, a new infrastructure of the system of rehabilitation of these disabled patients, new approaches to their organizations, law and information support should be introduced. Rehabilitation process in MS has five main directions--psychosocial, sociomedical, family, professional and legal.