Lipid peroxidation and antioxidant protection systems in pregnant women consuming alcohol in small and moderate doses

The analysis of scientific researches shows that the problem of alcohol consumption (beer, dry wine, champagne), in small doses during pregnancy has been actually disregarded for many years. So the problem has become quite urgent, especially in Russia. In order to determine the effect of alcohol on pregnancy and childbirth, women and babies were divided into three groups. Group 1 (n = 101) (control group) included women who did not use alcohol during pregnancy. Group 2 (n = 75) included drinking women whose alcohol consumption during pregnancy was less than 2 doses or 750 ml. Group 3 (n = 33) included moderately drinking women whose alcohol consumption during pregnancy ranged from 3 to 11 doses (from 750 ml to 3850 ml). The study of the lipid peroxidation-antioxidant protection system as a sensitive marker of integrated health disorders in women, consuming alcoholic beverages in a prenatal period, was conducted. It was indicated that a statistically significant decrease in overall antioxidant activity was found in the context of lipid peroxidation activation in women consuming low-alcohol drinks, which demonstrates a lack of functioning of lipid peroxidation system and oxidative stress regardless of the dose of low-alcohol drinks

Measuring impairments of functioning and health in patients with axial spondyloarthritis by using the ASAS Health Index and the Environmental Item Set : translation and cross-cultural adaptation into 15 languages

Introduction: The Assessments of SpondyloArthritis international society Health Index (ASAS HI) measures functioning and health in patients with spondyloarthritis (SpA) across 17 aspects of health and 9 environmental factors (EF). The objective was to translate and adapt the original English version of the ASAS HI, including the EF Item Set, cross-culturally into 15 languages. Methods: Translation and cross-cultural adaptation has been carried out following the forward-backward procedure. In the cognitive debriefing, 10 patients/country across a broad spectrum of sociodemographic background, were included. Results: The ASAS HI and the EF Item Set were translated into Arabic, Chinese, Croatian, Dutch, French, German, Greek, Hungarian, Italian, Korean, Portuguese, Russian, Spanish, Thai and Turkish. Some difficulties were experienced with translation of the contextual factors indicating that these concepts may be more culturally-dependent. A total of 215 patients with axial SpA across 23 countries (62.3% men, mean (SD) age 42.4 (13.9) years) participated in the field test. Cognitive debriefing showed that items of the ASAS HI and EF Item Set are clear, relevant and comprehensive. All versions were accepted with minor modifications with respect to item wording and response option. The wording of three items had to be adapted to improve clarity. As a result of cognitive debriefing, a new response option 'not applicable' was added to two items of the ASAS HI to improve appropriateness. Discussion: This study showed that the items of the ASAS HI including the EFs were readily adaptable throughout all countries, indicating that the concepts covered were comprehensive, clear and meaningful in different cultures

Повторные короткие курсы нестероидных противовоспалительных препарато в и повреждение почек у пациенто в с дегенеративно-дистрофическими заболеваниями позвоночника

Objective: to evaluate kidney function in patients with spinal degenerative-dystrophic diseases (SDDDs) who take nonsteroidal anti-inflammatory drugs (NSAIDs) as repeated short cycles of treatment for severe back pain.Patients and methods. The investigation enrolled 97 patients with SDDDs who took NSAIDs for back pain (a study group). A control group consisted of sexand age-matched healthy individuals who had not used NSAIDs within the past year (n=40). Glomerular filtration rate (GFR) was estimated using the CKD-EPI equation and markers of kidney injury (albuminuria and globulinuria) were measured.Results. In the study group, GFR was decreased to <90 ml/min/1.73 m2 in 61 (62.9%) patients, to <60 ml/min/1.73 m2 in 11 (11.3%); the mean GFR was 77.5 [68.0; 89.0] ml/min/1.73 m2; in the control group, a decline in GFR to 89–60 ml/min/1.73 m2 was recorded in 35 (62.5%) cases; this indicator was >90 ml/min/1.73 m2 in the remaining 15 (37.5%) cases; the mean GFR was 82.5 [70.8; 90.0] ml/min/1.73 m2 (p≥0.05 for all pairwise comparisons). A decrease in GFR to <60 ml/min/1.73 m2 was found in 11 (11.3%) patients in the study group and in nobody in the control group (p=0.026). Elevated albuminuria was noted in 74 (76.3%) patients with SDDDs and in 9 (22.5%) healthy individuals (p<0.05). Albumin/creatinine ratio was 57.1 [33.8; 82.4] mg/g in the study group and 25.0 [17.5; 32.9] mg/g in the control group (p<0.0001). Increased globulinuria was established in all the patients with SDDDs and only in 3 (7.5%) healthy examinees. Globulin/creatinine ratio was 134.7 [77.5; 197.7] mg/g in the study group and 12.9 [0.5; 18.1] mg/g in the control group (p<0.0001).Conclusion. A decline in GFR to <60 ml/min/1.73 m2 was more often seen in the patients taking NSAIDs for spine pain caused by SDDDs than in the healthy individuals. In case of comparable GFR, the level of kidney injury markers was significantly higher in the study group than that in the control group, which suggests that patients with SDDDs who take NSAIDs have subclinical tubulointerstitial and glomerular changes.Цель исследования – оценка функции почек у пациентов с дегенеративно-дистрофическими заболеваниями позвоночника (ДДЗП), принимающих нестероидные противовоспалительные препараты (НПВП) повторными короткими курсами по поводу интенсивной боли в спине.Пациенты и методы. В исследование включено 97 пациентов с ДДЗП, принимающих НПВП по поводу боли в спине (основная группа). Группу контроля составили здоровые лица, не использовавшие НПВП в течение последнего года, сопоставимые с пациентами основной группы по возрасту и полу (n=40). Оценивали скорость клубочковой фильтрации (СКФ) по CKD-EPI и маркеры почечного повреждения (альбуминурия и глобулинурия).Результаты. В основной группе СКФ была снижена у 61 (62,9%) пациента до <90 мл/мин/1,73 м2, у 11 (11,3%) – до <60 мл/мин/1,73 м2, средняя величина СКФ – 77,5 [68,0; 89,0] мл/мин/1,73 м2; в контрольной группе уменьшение СКФ до 89– 60 мл/мин/1,73 м2 зарегистрировано в 35 (62,5%) случаях, в остальных 15 (37,5%) наблюдениях этот показатель составил >90 мл/мин/1,73 м2, средняя СКФ – 82,5 [70,8; 90,0] мл/мин/1,73 м2 (p≥0,05 для всех попарных сравнений). Снижение СКФ до <60 мл/мин/1,73 м2 выявлено у 11 (11,3%) больных основной группы и не наблюдалось в контрольной группе (p=0,026). Повышение уровня альбуминурии отмечено у 74 (76,3 %) пациентов с ДДЗП и у 9 (22,5%) здоровых (p<0,05). Отношение альбумин/креатинин в основной группе равнялось 57,1 [33,8; 82,4] мг/г, в контрольной – 25,0 [17,5; 32,9] мг/г (p<0,0001). Увеличение уровня глобулинурии установлено у всех пациентов с ДДЗП и только у 3 (7,5%) здоровых обследованных. Отношение глобулин/креатинин в основной группе составило 134,7 [77,5; 197,7] мг/г, в контрольной – 12,9 [0,5; 18,1] мг/г (p<0,0001).Выводы. Снижение СКФ до <60 мл/мин/1,73 м2 у пациентов, принимающих НПВП по поводу боли в спине, обусловленной ДДЗП, наблюдается чаще, чем у здоровых. При сопоставимой СКФ уровень маркеров почечного повреждения в основной группе был значимо выше, чем в контрольной, что свидетельствует о наличии у больных с ДДЗП, принимающих НПВП, субклинических тубулоинтерстициальных и клубочковых изменений

Возможности фармакологического лечения остеоартрита: фокус на симптоматические медленно действующие препараты (SYSADOA) и индивидуальные особенности пациента. Резолюция международного совещания экспертов

The paper presents the results of the Osteoarthritis (OA) Expert Council held on September 8, 2019, which was attended by Russian and foreign specialists. The experts considered pharmacological treatment options for OA. The expert meeting resolution states that the treatment of patients with OA should be based on an individual assessment of the patient and on a modern evidence base of therapy efficacy.Treatment of patients with OA is based on the principles of evidence-based medicine that requires an integrated approach and the need of SYSADOAs prescription. Combined drugs with therapeutic dosages of chondroitin sulfate and glucosamine in the early stages of the disease are available as basic agents. The place of paracetamol in the anesthetic therapy algorithm in OA needs to be clarified. It is also noted that when choosing nonsteroidal anti-inflammatory drugs for OA treatment, it is important to take into account individual patient characteristics and the presence of comorbidities.Представлены результаты Экспертного совета по остеоартриту (ОА), проходившего 8 сентября 2019 г., в котором приняли участие российские и зарубежные специалисты. Рассматривались возможности фармакологического лечения ОА. В резолюции совещания указано, что лечение больных ОА должно быть основано на индивидуальной оценке состояния пациента и современных доказательствах эффективности терапии. Лечение больных ОА на основании принципов доказательной медицины предполагает комплексный подход и назначение SYSADOA. Комбинированные препараты с терапевтическими дозами хондроитина сульфата и глюкозамина уже на ранних стадиях заболевания рассматриваются в качестве базисных средств. Место парацетамола в алгоритме обезболивающей терапии при ОА требует уточнения. Отмечено также, что при выборе нестероидных противовоспалительных препаратов для лечения ОА важно учитывать индивидуальные особенности пациента и наличие коморбидных состояний

Долгосрочное влияние нетакимаба на качество жизни, боль в спине и работоспособность пациентов с анкилозирующим спондилитом: результаты международного многоцентрового рандомизированного двойного слепого клинического исследования III фазы BCD-085-5/ASTERA

The article contains the data obtained during the 156-week follow-up of patients with ankylosing spondylitis (AS) in the ASTERA phase III study.Objective: to evaluate the effect impact of netakimab (NTK) on quality of life (QoL), back pain and work capacity in patients with active AS.Material and methods. The study enrolled 228 patients with active AS who were randomized 1:1 to receive NTK 120 mg or placebo. At week 52, patients in Group 1 (NTK) who achieved ASAS20 continued therapy (NTK at a dose of 120 mg once every 2 weeks) until week 156. Patients in Group 2 (placebo/NTK) received the study drug at a dose of 120 mg subcutaneously every 2 weeks from week 20 until week 68, after which the efficacy of therapy was determined (by achieving an ASAS20 response). Patients who achieved ASAS20 received treatment (NTK at a dose of 120 mg once every 2 weeks) until week 172.Results and discussion. Under NTK therapy, a significant improvement in QoL was observed in the assessment of the physical and psychological components of the SF-36 questionnaire, which was maintained during the three years of therapy: increase in indicator by 12.68±9.92; 13.27±10.14; 12.92±10.03; 14.10±10.35; 14.76±9.77 and 6.10±11.59; 5.50±11.82; 6.32±11.01; 5.87±11.45; 5.25±11.98 points at week 52, 76, 104, 128 and 156, respectively. During the extended therapy period, a reduction in the proportion of working hours missed for health reasons, an improvement in work capacity and work efficiency and an increase in daily activity were observed. Back pain (BASDAI question 2) and nocturnal back pain decreased steadily during the entire follow-up period compared to the screening values.Conclusion. NTK is an effective therapy for active AS that improves QoL scores, significantly reduces pain intensity and improves work productivity.В статье приведены данные, полученные в ходе 156 нед наблюдения за пациентами с анкилозирующим спондилитом (АС) в исследовании III фазы ASTERA.Цель исследования – оценить влияние нетакимаба (НТК) на качество жизни (КЖ), боль в спине и работоспособность пациентов с активным АС.Материал и методы. В исследование включено 228 больных активным АС, которые были рандомизированы в соотношении 1:1 в группу НТК 120 мг или группу плацебо. На неделе 52 пациенты группы 1 (НТК), достигшие ASAS20, продолжили получать терапию (НТК в дозе 120 мг 1 раз в 2 нед) до недели 156. Пациенты группы 2 (плацебо/НТК), начиная с недели 20, использовали исследуемый препарат в дозе 120 мг подкожно 1 раз в 2 нед до недели 68, после которой у них была определена эффективность терапии (по достижению ответа ASAS20). Пациенты, достигшие ASAS20, получали лечение (НТК в дозе 120 мг 1 раз в 2 нед) до недели 172.Результаты и обсуждение. На фоне лечения НТК наблюдалось значимое улучшение КЖ при оценке физического и психологического компонентов опросника SF-36, которое сохранялось на протяжении 3 лет терапии: повышение показателя на 12,68±9,92; 13,27±10,14; 12,92±10,03; 14,10±10,35; 14,76±9,77 и 6,10±11,59; 5,50±11,82; 6,32±11,01; 5,87±11,45; 5,25±11,98 балла на неделях 52, 76, 104, 128, 156 соответственно. В течение продленного периода терапии было выявлено снижение доли рабочего времени, пропущенного по состоянию здоровья, улучшение работоспособности и эффективности труда, а также повышение повседневной активности. Боль в спине (вопрос 2 BASDAI) и ночная боль в спине стойко уменьшались на протяжении всего периода наблюдения по сравнению с их показателями на момент скрининга.Заключение. НТК является эффективным методом терапии активного АС. Под действием НТК улучшаются показатели КЖ, в том числе значимо снижается интенсивность боли и улучшается производительность труда

Repeated short cycles of nonsteroidal anti-inflammatory drugs and kidney injury in patients with spinal degenerative-dystrophic diseases

Objective: to evaluate kidney function in patients with spinal degenerative-dystrophic diseases (SDDDs) who take nonsteroidal anti-inflammatory drugs (NSAIDs) as repeated short cycles of treatment for severe back pain.Patients and methods. The investigation enrolled 97 patients with SDDDs who took NSAIDs for back pain (a study group). A control group consisted of sexand age-matched healthy individuals who had not used NSAIDs within the past year (n=40). Glomerular filtration rate (GFR) was estimated using the CKD-EPI equation and markers of kidney injury (albuminuria and globulinuria) were measured.Results. In the study group, GFR was decreased to <90 ml/min/1.73 m2 in 61 (62.9%) patients, to <60 ml/min/1.73 m2 in 11 (11.3%); the mean GFR was 77.5 [68.0; 89.0] ml/min/1.73 m2; in the control group, a decline in GFR to 89–60 ml/min/1.73 m2 was recorded in 35 (62.5%) cases; this indicator was >90 ml/min/1.73 m2 in the remaining 15 (37.5%) cases; the mean GFR was 82.5 [70.8; 90.0] ml/min/1.73 m2 (p≥0.05 for all pairwise comparisons). A decrease in GFR to <60 ml/min/1.73 m2 was found in 11 (11.3%) patients in the study group and in nobody in the control group (p=0.026). Elevated albuminuria was noted in 74 (76.3%) patients with SDDDs and in 9 (22.5%) healthy individuals (p<0.05). Albumin/creatinine ratio was 57.1 [33.8; 82.4] mg/g in the study group and 25.0 [17.5; 32.9] mg/g in the control group (p<0.0001). Increased globulinuria was established in all the patients with SDDDs and only in 3 (7.5%) healthy examinees. Globulin/creatinine ratio was 134.7 [77.5; 197.7] mg/g in the study group and 12.9 [0.5; 18.1] mg/g in the control group (p<0.0001).Conclusion. A decline in GFR to <60 ml/min/1.73 m2 was more often seen in the patients taking NSAIDs for spine pain caused by SDDDs than in the healthy individuals. In case of comparable GFR, the level of kidney injury markers was significantly higher in the study group than that in the control group, which suggests that patients with SDDDs who take NSAIDs have subclinical tubulointerstitial and glomerular changes

Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study

Netakimab (NTK) is a humanized anti-interleukin-17А (IL-17A) monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Here, we present the results of the 24-weeks double blind period of the PATERA study.Objective. The objective of the study was to evaluate the efficacy and safety of NTK compared to placebo in patients with psoriatic arthritis (PsA).Patients and methods. 194 patients with active PsA with an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs, were randomized in a 1:1 ratio to receive subcutaneous 120 mg NTK or placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 ACR20 (20% improvement in the American College of Rheumatology response criteria) non-responders in placebo group were reassigned to NTK in a blinded manner. The primary endpoint was the proportion of patients achieved ACR20 response at week 24.Results. 82,5% of patients in the NTK group and 9.3% of patients in the placebo group achieved ACR20 at week 24 with the 95% CI [0,63; 0,84] (p < 0,0001). Skin manifestations and axial disease significantly improved with NTK. The safety profile of NTK was comparable to placebo. The most frequent treatment-related AEs were expected and common for all other IL-17 inhibitors: increased alanine aminotransferase (ALT), infections, lymphopenia.Conclusion. NTK in the dose of 120 mg has superior efficacy over placebo in patients with active psoriatic arthritis. The safety profile is consistent with other IL-17 inhibitors

Patient-defined flares and disease activity worsening in 222 patients with psoriatic arthritis from 14 countries

Objectives: To explore patient-defined flares in psoriatic arthritis (PsA), compared to an increase in Disease Activity in Psoriatic Arthritis (DAPSA), and to analyze the validity of a patient-reported flare question. Methods: ReFlap (NCT03119805) was a longitudinal study in 14 countries of consecutive patients with definite PsA. Patients were seen twice in the context of usual care, 4.5±2.2 months apart. Flares were reported by patients and physicians at the second visit using a single question. DAPSA worsening was defined as a change to a higher DAPSA category. Agreement between the definitions of worsening was calculated by prevalence adjusted bias adjusted kappa (PABAK). Validity of patient-reported flare was assessed by comparing patients with versus without flare and transition to flares. Results: In 222 patients, mean disease duration 10.8±8.3 years, 127 (58.8%) males: disease activity was low (mean DAPSA 11.5±14.0); 63.3% received a bDMARD. Patient-reported flares between the 2 visits were seen in 27.0% patients (for these patients, mean 2.2±3.7 flares per patient, mean duration 12.6±21.0 days per flare). Physician- reported flares were seen in 17.6% and worsening in DAPSA in 40.1% of patients. Agreement between definitions was moderate (PABAK=0.32-0.59). Patients in flare had significantly more active disease than patients not in flare for all outcomes (all p<0.001). At the patient-level, transition to flare state was associated to a worsening in disease activity and impact outcomes. Conclusions: Patient flares were frequent and were associated with active and symptomatic disease. These findings provide preliminary validation for patient-reported flares in PsA