Пути улучшения диагностики и лечения поражения легких при системной склеродермии на территории Сибирского федерального округа (материалы совместного совета экспертов ревматологов и пульмонологов от 8.12.2019)

The aim of the study was to develop ways to improve the diagnosis and treatment of systemic sclerosis (SSc)-ILD. Interstitial lung disease (ILD) is a common manifestation of SSc. In the territory of the Siberian Federal District (SFD), the number of patients with the progressive phenotype of SSc-ILD is approximately 750 people. When immunosuppressive therapy is ineffective and pulmonary fibrosis progresses, lung transplantation is indicated. The emergence of new possibilities of pathogenetic therapy currently requires studying the possibilities of their applications in real clinical practice on the territory of the SFD.Discussion. The results of a discussion of diagnostics, therapy, and routing of a rheumatology patient during the interdisciplinary observation of SSc-ILD in the SFD are presented. The reason for this discussion was the new data on the use of nintedanib in this category of patientsConclusion. To improve the efficiency of diagnosis and treatment of patients with SSc in the SFD, it is necessary to implement the principle of a multidisciplinary approach with the obligatory involvement of a pulmonologist and a radiologist (a specialist in CT diagnostics), and, if differential diagnosis is necessary in difficult clinical situations, of a pathomorphologist. An urgent task is the introduction of an algorithm for examining patients with SSc for the timely diagnosis of ILD in the territory of the Siberian Federal District. To improve the quality of medical care in the territory of the SFD for patients with ILD-SSc it is necessary to create a reference center in the city of Novosibirsk with the possibility of initiating anti-fibrosis therapy.Введение. Поражение легких у больных ССД является одним из наиболее частых проявлений висцеральной патологии и рассматривается как вариант фиброзирующих диффузных интерстициальных заболеваний легких (ИЗЛ). Несмотря на продемонстрированную эффективность патогенетической иммуносупрессивной терапии, у ряда пациентов фиброзные изменения в легочной ткани имеют прогрессирующее течение, что негативно сказывается на качестве и продолжительности жизни пациента. На территории Сибирского федерального округа (СФО) количество пациентов с ССД, имеющих прогрессирующее поражение легких, составляет приблизительно 750 человек. Таким образом, проблема своевременной диагностики и лечения поражения легких при ССД оказывается весьма актуальной и для СФО. Имеющиеся в настоящее время данные об эффективности современной противофиброзной терапии ИЗЛ при ССД требуют изучения возможности ее применения в реальной клинической практике на территории СФО.Цель. Разработать пути улучшения диагностики и лечения поражений легких при системной склеродермии (ССД).Обсуждение. Представлены результаты междисциплинарного обсуждения вопросов диагностики, терапии, маршрутизации пациентов с ССД и ИЗЛ на территории СФО. Причиной данного обсуждения явилось появление сведений об эффективности нинтеданиба у данной категории пациентов.Заключение. Для повышения эффективности диагностики и лечения больных ССД с поражением легких необходимо реализовать принцип мультидисциплинарного подхода с обязательным привлечением пульмонолога и рентгенолога (специалиста по КТ-диагностике), а при необходимости дифференциальной диагностики в сложных клинических ситуациях – патоморфолога. Актуальной задачей оказывается внедрение на территории СФО алгоритма обследования пациентов с ССД для своевременной диагностики ИЗЛ. Для повышения качества оказания медицинской помощи на территории СФО пациентам с ИЗЛ при ССД необходимо создать референсный центр в г.  Новосибирске с возможностью инициации специалистами этого центра антифибротической терапии

Эффективность и безопасность лефлуномида при ревматоидном артрите: результаты Российского наблюдательного многоцентрового исследования

Methotrexate or leflunomide is used as a first-line synthetic disease-modifying anti-rheumatic drug in the therapy of rheumatoid arthritis (RA). In 2011, the Russian Federation registered and since it has been successfully using leflunomide**.Objective: to evaluate the efficacy and tolerability of leflunomide** used to treat RA in routine clinical practice.Subjects and methods.The investigation enrolled patients with varying duration of RA that met the 1987 classification criteria. The patients were followed up in 33 healthcare facilities of Russia from March 2013 to October 2014. A total of 235 patients were randomized; the data of 196 patients were statistically processed. The mean age of the patients was 52.4±11.8 years; the mean duration of the disease was 75.4±69.1 months. The disease activity estimated by DAS28 and CDAI were 5.5±1.2 and 35.1±14.3 scores, respectively. 105 and 57 patients had X-ray Stages II and III disease, respectively. 80.1% of the patients were positive for rheumatoid factor and anti-cyclic citrullinated peptide antibodies. According to the instruction of its use, leflunomide was administered in a dose of 100 mg/day during the first 3 days and then in that of 20 mg/day. When adverse reactions (ARs) occurred, it was recommended that the daily dose of the drug was decreased to 10 mg. The patients were examined before and 1, 3, and 6 months after treatment. The investigators measured the number of tender joints (NTJ) and that of swollen joints (NSJ), and visual analog scale (VAS) pain intensity, performed a laboratory examination involving clinical blood test, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP), in patients during their visits to physicians. The disease activity was assessed with DAS28 and CDAI and ARs were recorded.Results. Six-month therapy reduced the mean NSJ from 10.9 to 7.5%, NTJ from 12.3 to 8.9, VAS pain intensity from 64.1 to 39.3 mm, on average, ESR from 37.04 to 23.6 mm/hr, and CRP from 27.8 to 12.35 mg/l. By 6 months of therapy, low and moderate RA activities estimated by DAS28 were noted in 70.9% of cases and those by CDAI in 61.2%. No serious ARs were detected during the study.Conclusion. The findings suggest that leflunomide shows a good clinical efficacy and tolerability.В терапии ревматоидного артрита (РА) в качестве первого синтетического базисного противовоспалительного препарата используют метотрексат или лефлуномид. С 2011 г. в Российской Федерации зарегистрирован и успешно применяется лефлуномид (ЛЕФ)*.Цель настоящего наблюдательного исследования – оценить эффективность и переносимость ЛЕФ* в обычной клинической практике при РА.Материал и методы. В исследование вошли пациенты, соответствующие классификационным критериям РА 1987 г. с различной длительностью заболевания. Наблюдение пациентов проводилось в 33 лечебных учреждениях России с марта 2013 г. по октябрь 2014 г. Рандомизировано 235 пациентов, статистической обработке подвергнуты данные 196 пациентов. Средний возраст пациентов составил 52,4±11,8 года, средняя длительность болезни – 75,4±69,1 мес. Активность заболевания по DAS28 – 5,5±1,2, по CDAI – 35,1±14,3. У 105 пациентов была II рентгенологическая стадия болезни, у 57 – III. 80,1% пациентов были позитивны по ревматоидному фактору и антителам к циклическому цитруллинированному пептиду. Согласно инструкции по применению, ЛЕФназначали в дозе 100 мг/сут в первые 3 дня, затем по 20 мг/сут. При возникновении неблагоприятных реакций (НР) было рекомендовано снижение суточной дозы препарата до 10 мг. Больные проходили обследование до назначения препарата, а также после 1, 3 и 6 мес лечения. При визитах к врачу оценивали число болезненных суставов (ЧБС), число припухших суставов (ЧПС), выраженность боли по визуальной аналоговой шкале (ВАШ), проводили лабораторное обследование: клинический анализ крови, СОЭ и уровень СРБ. Определяли активность РА по индексу DAS28 и CDAI, регистрировали НР.Результаты. За 6 мес терапии среднее ЧПС снизилось с 10,9 до 7,5, а ЧБС – с 12,3 до 8,9; интенсивность боли по ВАШ уменьшилась в среднем с 64,1 до 39,3 мм; СОЭ – с 37,04 до 23,6 мм/ч, уровень СРБ – с 27,8 до 12,35 мг/л. К 6-му месяцу терапии низкая и умеренная активность РА по DAS28 отмечена в 70,9% случаев, по CDAI – в 61,2%. В ходе исследования не выявлено серьезных НР.Заключение. Полученные результаты свидетельствуют о хорошей клинической эффективности и переносимости ЛЕФ

Резолюция Совета экспертов от 20 мая 2023 г. «Вопросы безопасности лечения ревматологического пациента»

At the meeting of the Expert Council on May 20, the safety of treatment for patients with osteoarthritis (OA), the most common form of joint disease, was discussed. The first step in the treatment of OA should be the administration of symptomatic delayed-acting agents (SYSADOA) and nonsteroidal anti-inflammatory drugs (NSAIDs). However, given the current understanding of the pathogenesis of inflammation, as well as the fact that it is an active process involving multiple proinflammatory and pro-resolving mediators, it is reasonable to limit the cyclooxygenase-2 suppressive treatment and to include medications with multipurpose effects that contribute to the resolution of inflammation, in particular Zeel® T and Traumeel® S. Traumeel® S affects all stages of inflammation, mostly on the pro-resolving mediators synthesis, and Zeel® T affects chondrogenesis, inflammation, metabolic processes in cartilage tissue and prevents angiogenesis.It was found that it is advisable to use Traumeel® S when it is not possible to prescribe systemic NSAIDs for pain relief. The combination of the proven therapeutic efficacy of Zeel® T and Traumeel® S with a minimal number of adverse events and the absence of interactions with other drugs allows them to be used as an independent treatment regimen for OA.На заседании Совета экспертов 20 мая 2023 г. были рассмотрены вопросы безопасности лечения пациентов с остеоартритом (ОА) — самой распространенной формой заболеваний суставов. Первым шагом терапии ОА должно быть назначение симптоматических средств замедленного действия (SYSADOA) и нестероидных противовоспалительных препаратов (НПВП). Однако, учитывая современные представления о патогенезе воспаления, а также то, что это активный процесс с участием большого числа провоспалительных и проразрешающих медиаторов, представляется актуальной тактика ограничения терапии с подавлением циклооксигеназы 2 и включения в схемы лечения лекарственных средств с многоцелевым действием, способствующих разрешению воспаления, в частности препаратов Цель® Т и Траумель® С. Траумель® С оказывает воздействие на все этапы воспаления, в большей степени на синтез проразрешающих медиаторов, а Цель® Т влияет на хондрогенез, воспаление, метаболические процессы в хрящевой ткани и предотвращает ангиогенез.Отмечено, что при невозможности назначения системных НПВП для купирования боли целесообразно применение препарата Траумель® С. Сочетание доказанной терапевтической эффективности препаратов Цель® Т и Траумель® С с минимальным числом нежелательных явлений и отсутствием взаимодействий с другими лекарственными средствами позволяет использовать их как самостоятельную схему терапии при ОА

HYALURONIC ACID FORMULATIONS IN OSTEOARTHRITIS: POSSIBILITIES FOR IMPORT SUBSTITUTION

<p class="MsoNormal"><span lang="EN-US">The paper discusses the possibilities of administering hyaluronic acid in osteoarthritis.  It is noted that the therapeutic efficacy of this drug class has been demonstrated in experimental and clinical studies and confirmed by the practical activities of specialists dealing with issues of arthrology. Along with the use of foreign hyaluronic acid solutions, Russian rheumatologists  can prescribe high-quality Russian analogues that include INTRAJECT®. The authors pres ent their own clinical observations that confirm that the drug may be administered.  The paper is illustrated with photos and radiographs.</span></p

Ultraphonophoresis with a hyaluronic acid-containing gel for knee osteoarthritis with periarthritis

Management of patients with knee osteoarthritis (OA) in the presence of comorbidity causes significant difficulties associated with the limitations of pharmacotherapy.Objective: to evaluate the clinical efficacy of ultraphonophoresis with a hyaluronic acid (HA)-containing gel in patients with knee OA complicated by periarthritis.Patients and methods. The open observational comparative study included 30 patients with a reliable diagnosis of knee OA, who were divided into two groups: 1) 15 patients who had undergone ultraphonophoresis with a HA-containing gel for 10 days (a study group); 2) 15 patients who had received ultraphonophoresis with an intact gel (a control group). To determine the clinical efficiency of HA-containing gel ultraphonophoresis, the investigators conducted a survey of patients and a clinical examination with knee joint palpation to detect synovitis and periarthritis, ultrasonography, and an assessment of initial pain and pain on walking on a 100-mm visual analog scale (VAS) for pain.Results and discussion. HA-containing gel ultraphonophoresis was found to lead to a significant relief from both pain in the knee joints on walking from 50 [40; 50] to 20 [10; 20] mm (p = 0.0003) and from initial pain from 50 [40; 50] to 10 [0; 10] mm VAS (p = 0.0003). Ultrasonography revealed a reduction or even complete disappearance of the local inflammatory process in the anserine bursa from 5.5 [4.5; 6.4] to 0 [0; 3.0] mm (p = 0.0003). There were no statistically significant pre- and postoperative differences in Group 2 patients.Conclusion. HA-containing gel ultraphonophoresis in knee OA with periarthritis was shown to contribute to a significant reduction in knee joint pain and to the resolution of periarthritis.Management of patients with knee osteoarthritis (OA) in the presence of comorbidity causes significant difficulties associated with the limitations of pharmacotherapy.Objective: to evaluate the clinical efficacy of ultraphonophoresis with a hyaluronic acid (HA)-containing gel in patients with knee OA complicated by periarthritis.Patients and methods. The open observational comparative study included 30 patients with a reliable diagnosis of knee OA, who were divided into two groups: 1) 15 patients who had undergone ultraphonophoresis with a HA-containing gel for 10 days (a study group); 2) 15 patients who had received ultraphonophoresis with an intact gel (a control group). To determine the clinical efficiency of HA-containing gel ultraphonophoresis, the investigators conducted a survey of patients and a clinical examination with knee joint palpation to detect synovitis and periarthritis, ultrasonography, and an assessment of initial pain and pain on walking on a 100-mm visual analog scale (VAS) for pain.Results and discussion. HA-containing gel ultraphonophoresis was found to lead to a significant relief from both pain in the knee joints on walking from 50 [40; 50] to 20 [10; 20] mm (p = 0.0003) and from initial pain from 50 [40; 50] to 10 [0; 10] mm VAS (p = 0.0003). Ultrasonography revealed a reduction or even complete disappearance of the local inflammatory process in the anserine bursa from 5.5 [4.5; 6.4] to 0 [0; 3.0] mm (p = 0.0003). There were no statistically significant pre- and postoperative differences in Group 2 patients.Conclusion. HA-containing gel ultraphonophoresis in knee OA with periarthritis was shown to contribute to a significant reduction in knee joint pain and to the resolution of periarthritis

Efficiency and safety of leflunomide in rheumatoid arthritis: Results of a Russian observational multicenter of trial

Methotrexate or leflunomide is used as a first-line synthetic disease-modifying anti-rheumatic drug in the therapy of rheumatoid arthritis (RA). In 2011, the Russian Federation registered and since it has been successfully using leflunomide**.Objective: to evaluate the efficacy and tolerability of leflunomide** used to treat RA in routine clinical practice.Subjects and methods.The investigation enrolled patients with varying duration of RA that met the 1987 classification criteria. The patients were followed up in 33 healthcare facilities of Russia from March 2013 to October 2014. A total of 235 patients were randomized; the data of 196 patients were statistically processed. The mean age of the patients was 52.4±11.8 years; the mean duration of the disease was 75.4±69.1 months. The disease activity estimated by DAS28 and CDAI were 5.5±1.2 and 35.1±14.3 scores, respectively. 105 and 57 patients had X-ray Stages II and III disease, respectively. 80.1% of the patients were positive for rheumatoid factor and anti-cyclic citrullinated peptide antibodies. According to the instruction of its use, leflunomide was administered in a dose of 100 mg/day during the first 3 days and then in that of 20 mg/day. When adverse reactions (ARs) occurred, it was recommended that the daily dose of the drug was decreased to 10 mg. The patients were examined before and 1, 3, and 6 months after treatment. The investigators measured the number of tender joints (NTJ) and that of swollen joints (NSJ), and visual analog scale (VAS) pain intensity, performed a laboratory examination involving clinical blood test, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP), in patients during their visits to physicians. The disease activity was assessed with DAS28 and CDAI and ARs were recorded.Results. Six-month therapy reduced the mean NSJ from 10.9 to 7.5%, NTJ from 12.3 to 8.9, VAS pain intensity from 64.1 to 39.3 mm, on average, ESR from 37.04 to 23.6 mm/hr, and CRP from 27.8 to 12.35 mg/l. By 6 months of therapy, low and moderate RA activities estimated by DAS28 were noted in 70.9% of cases and those by CDAI in 61.2%. No serious ARs were detected during the study.Conclusion. The findings suggest that leflunomide shows a good clinical efficacy and tolerability

The ten-year probability of fractures with the FRAX tool: which threshold for intervention to be used and how?

Objective: to analyze the clinical and organizational feasibility of using different intervention thresholds for the Russian population.Subjects and methods. The probability of fractures using the Russian FRAX model was calculated on a sample of 3,866 postmenopausal female residents from 6 cities of the Russian Federation. Different intervention thresholds, including fixed (20% for major fractures and 3% for hip fractures), age-dependent (European and Russian) ones, as well as alternative models, were analyzed. The proportion of women to be treated was estimated using different intervention thresholds.Results and discussion. The analysis of the effectiveness of the thresholds showed that the European threshold was the least appropriate one for the formed sample, since more than half (53.6%) of the women to be treated using the threshold, while the vast majority (90%) of the patients were in the younger age groups (50—54 years). There were very similar results of the effectiveness analysis of the fixed threshold (according to the USA National Osteoporosis Foundation — NOF) recommendations and that of the age-dependent threshold for Russia (in the context of the national clinical recommendations). Using the NOF approach in our sample could identify 47.8% of the postmenopausal women to be treated for osteoporosis. Their proportion rose from 29.6% of the patients aged 50—54 years to 80.6% of those aged 85 years and older. The alternative analyses of age-dependent thresholds showed great effectiveness when the fracture was considered not as a risk factor for future fractures, but as a clinical disease manifestation that was sufficient to recommend that the patient should be treated without FRAX counting. However, with their use, the proportion of older people to be treated remains not high enough. In this connection, there remains a need to search for the more adequate application of the existing intervention threshold or to develop a new, for example, hybrid variant of the age-dependent threshold

PREVALENCE AND RISK FACTORS OF LOW-ENERGY SKELETAL FRACTURES IN PATIENTS WITH CHRONIC INFLAMMATORY DISEASES. THE RESULTS OF A MULTICENTER STUDY OF THE RUSSIAN ASSOCIATION ON OSTEOPOROSIS GLUKOST

Objectives. This study is a part of GLUKOST study hosted and organized by the Russian Association of Osteoporosis. The aim was to estimate the incidence and risk factors of fractures in patients with chronic inflammatory diseases. Materials and Methods. A specially designed questionnaire was introduced to patients with chronic inflammatory diseases in different regions of Russia. The study included 2342 patients aged 18 to 89 years (mean age 53.02 ± 14.03 years, 591 men and 1181 women). The patients were allocated into two groups: group 1 (n = 1402) - patients never prescribed oral long acting glucocorticoids (OGC); group 2 (n = 929) - patients who received oral long acting glucocorticoids for more than 2 months or continue to take at the time of the survey. The median duration of OGC therapy was 3 years, the median daily dose - 10 mg of prednisone or equivalent. Results. Low-energy fractures of the skeleton were identified in 9.0% of patients not receiving therapy OGC, and 15.5% of patients receiving or previously treated with this therapy. Significant risk factor for fractures was the length of a chronic inflammatory disease. OGC therapy increased the risk (adjusted odds ratio (95% confidence interval (95% CI)) of osteoporotic fractures, regardless of their location by 2.2-fold (95% CI 1.63-3.02, p <0,001), vertebral fractures - by 5.0 - fold (95% CI 2.05-12.37, p <0.001), distal forearm 1.8-fold (95% CI 1.10-2.84, p = 0.02). The frequency of fractures in group 2 was increased in men and women of different age groups, but a significant increase in risk was demonstrated only in postmenopausal women and men 50 years and older. We were unable to identify a relationship of fractures with a daily dose of OGC. Conclusion. The main risk factors for osteoporotic fractures in patients with chronic inflammatory diseases are age, duration of the underlying disease, and long-term use of oral glucocorticoids