99 research outputs found

    КЛІНІЧНІ ПРОЯВИ ВЕГЕТАТИВНОГО ДИСБАЛАНСУ У КЛІМАКТЕРИЧНОМУ ПЕРІОДІ ТА МОЖЛИВОСТІ ЇХ КОРЕКЦІЇ

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    Актуальність проблеми. Вегетативні порушення, які виявляють майже у 80 % жінок, є найбільш ранніми проявами клімактеричного синдрому.Кардіальна і церебральна симптоматика значно погіршує якість життя і є передумовою тяжких ускладнень, які погіршують якість життята зменшують його тривалість

    A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy

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    To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS:This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured. RESULTS: 596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was -9.41% to 4.98%, which is completely contained within the predefined equivalence margin of -15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%). CONCLUSIONS:SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN

    Magnetic force microscope tip-induced remagnetization of CoPt nanodisks with perpendicular anisotropy

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    We report on the results of a magnetic force microscopy investigation of remagnetization processes in arrays of CoPt nanodisks with diameters of 35 and 200 nm and a thickness of 9.8 nm fabricated by e-beam lithography and ion etching. The controllable magnetization reversal of individual CoPt nanodisks by the magnetic force microscope (MFM) tip-induced magnetic field was demonstrated. We observed experimentally two essentially different processes of tip-induced remagnetization. Magnetization reversal of 200 nm disks was observed when the probe moved across the particle while in case of 35 nm nanodisks one-touch remagnetization was realized. Micromagnetic modeling based on the Landau-Lifshitz-Gilbert (LLG) equation demonstrated that the tip-induced magnetization reversal occurs through the essentially inhomogeneous states. Computer simulations confirmed that in case of 200 nm disks the mechanism of embryo nucleation with reversed magnetization and further dynamic propagation following the probe moving across the particle was realized. On the other hand one-touch remagnetization of 35 nm disks occurs through the inhomogeneous vortexlike state. Micromagnetic LLG simulations showed that magnetization reversal in an inhomogeneous MFM probe field has a lower energy barrier in comparison with the mechanism of coherent rotation, which takes place in a homogeneous external magnetic field

    Діагностика, профілактика і лікування НПЗП-гастропатій

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    У монографії узагальнені результати власних клінічних спостережень і дані літератури щодо діагностики, профілактики та лікування уражень слизової оболонки гастродуоденальної зони нестероїдними протизапальними препаратами. Особлива увага надається питанням ранньої діагностики завдяки ретельному вивченню скарг хворих, цілеспрямованому проведенню клінічних та лабораторно-інструментальних обстежень, використанню безпечних протизапальних засобів вітчизняного виробництва та використанню локальної навколосуглобової терапії з метою зменшення побічної дії НПЗП на слизову оболонку гастродуоденальної зони. Монографія рекомендується сімейним лікарям, ревматологам, гастроентерологам, лікарям-інтернам, студентам старших курсів вищих навчальних медичних закладів ІІІ-ІУ рівнів акредитації

    Організація комплексного підходу до первинної профілактики хвороб системи кровообігу

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    В сучасних умовах проблема хвороб системи кровообігу посідає одну із основних позицій у превентивній медицині. Це зумовлено тим, що в реаліях сьогодення у світі спостерігається епідемія неінфекційних захворювань, саме до складу яких відносяться хвороби системи кровообігу. Неінфекційні захворювання становлять понад 46% всіх випадків хвороб в світі та спричиняють близько 59% смертей, що зумовлені медичними причинами. В самій групі неінфекційних захворювань провідну позицію займають серцево-судинні захворювання, які є однією з головних медико-соціальних проблем для всього людства, оскільки вони мають найвищій рівень поширеності, інвалідизації та смертності, протікають із тяжкими ускладненнями та призводять до значних незворотних соціально-економічних втрат. В современных условиях проблема болезней системы кровообращения занимает одну из основных позиций в превентивной медицине. Это обусловлено тем, что в реалиях в мире наблюдается эпидемия неинфекционных заболеваний, именно в состав которых относятся болезни системы кровообращения. Неинфекционные заболевания составляют более 46% всех случаев болезней в мире и вызывают около 59% смертей, обусловленных медицинскими причинами. В самой группе неинфекционных заболеваний ведущую позицию занимают сердечно-сосудистые заболевания, которые являются одной из главных медико-социальных проблем для всего человечества, поскольку они имеют самый высокий уровень распространенности, инвалидизации и смертности, протекают с тяжелыми осложнениями и приводят к значительным необратимым социально-экономических потерь. In modern conditions the problem of diseases of the circulatory system is one of the main positions in preventive medicine. This is due to the fact that in the realities of today in the world there is an epidemic of non-communicable diseases, which include diseases of the circulatory system. Noncommunicable diseases make up more than 46% of all cases in the world and account for about 59% of deaths due to medical causes. In the group of noncommunicable diseases, cardiovascular diseases, which are one of the major medical and social problems for all of humanity, occupy a leading position, as they have the highest prevalence, disability and mortality rates, occur with severe complications and lead to significant irreversible economic

    Efficacy, patient-reported outcomes, and safety of the anti-granulocyte macrophage colony-stimulating factor antibody otilimab (GSK3196165) in patients with rheumatoid arthritis: a randomised, phase 2b, dose-ranging study

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    The human monoclonal antibody otilimab inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a key driver in immune-mediated inflammatory conditions. We aimed to evaluate the efficacy, safety, and key patient-reported outcomes related to pain in patients with active rheumatoid arthritis receiving otilimab. Methods. This phase 2b, dose-ranging, multicentre, placebo-controlled study was done at 64 sites across 14 countries. Patients aged 18 years or older with rheumatoid arthritis who were receiving stable methotrexate were randomly assigned (1:1:1:1:1:1) to subcutaneous placebo or otilimab 22·5 mg, 45 mg, 90 mg, 135 mg, or 180 mg, plus methotrexate, once weekly for 5 weeks, then every other week until week 50. The randomisation schedule was generated by the sponsor, and patients were assigned to treatment by interactive response technology. Randomisation was blocked (block size of six) but was not stratified. Investigators, patients, and the sponsor were blinded to treatment. An unblinded administrator prepared and administered the study drug. The primary endpoint was the proportion of patients who achieved disease activity score for 28 joints with C-reactive protein (DAS28-CRP) 3·2 (week 24) escaped to otilimab 180 mg. Patients who escaped were treated as non-responders in their original assigned group. Safety endpoints were incidence of adverse events and serious adverse events, infections, and pulmonary events. Efficacy and safety outcomes were assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02504671. Findings.Between July 23, 2015, and Dec 29, 2017, 222 patients were randomly assigned (37 to each group). 86 (49%) of 175 escaped to otilimab 180 mg at week 12 and 57 (69%) of 83 at week 24. At week 24, the proportion of patients with DAS28-CRP <2·6 was two (5%) of 37 in the otilimab 22·5 mg group, six (16%) of 37 in the 45 mg group, seven (19%) of 37 in the 90 mg group, five (14%) of 37 in the 135 mg group, five (14%) of 37 in the 180 mg, and one (3%) of 37 in the placebo group. The largest difference was achieved with otilimab 90 mg (16·2%; odds ratio [OR] 8·39, 95% CI 0·98–72·14; p=0·053). Adverse events were reported pre-escape in 19–24 (51–65%) patients and post escape in 10–17 (40–61%) patients across otilimab dose groups and in 18 (49%) of 37 and 22 (67%) of 33 in the placebo group. The most common adverse event was nasopharyngitis: 3–9 (8–24%) in otilimab groups and one (3%) in the placebo group pre-escape and 1–3 (4–10%) in otilimab groups and seven (21%) in the placebo group post escape. Pre-escape serious adverse events were foot fracture (otilimab 45 mg); arthralgia, myocardial infarction, dizziness (otilimab 90 mg); oesophageal spasm, acute pyelonephritis (otilimab 22·5 mg), and uterine leiomyoma (otilimab 135 mg). Post-escape serious adverse events were ankle fracture (placebo) and rheumatoid arthritis (otilimab 135 mg). There were no deaths or pulmonary events of clinical concern, and rates of serious infection were low. Interpretation. Otilimab plus methotrexate was well tolerated and, despite not achieving the primary endpoint of DAS28-CRP remission, there were improvements compared with placebo in disease activity scores. Of note, patients reported significant improvement in pain and physical function, supporting further clinical development of otilimab in rheumatoid arthritis

    Cardiovascular disease associated with osteoporosis as a polymorbidity problem

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    В статті наведені результати вивчення особливостей перебігу кардіоваскулярної патології у хворих на остеопенію та остеопороз. Встановлена тісна залежність між показниками мінеральної щільності кісткової тканини та товщини інтими-медіа сонних артерій, швидкості проходження пульсової хвилі, показниками ліпідограми (концентрації загального холестерину, індексу атерогенності), що підтверджувалось результатами клінічних та функціональних методів обстеження. Отримані дані доводять необхідність ранньої діагностики ураження ендотелію судин та процесів резорбції кісткової тканини задля попередження розвитку ускладнень коморбідної патології; В статье приведены результаты изучения особенностей течения кардиоваскулярной патологии у больных с остеопенией и остеопорозом. Установлена тесная зависимость между показателями минеральной плотности костной ткани и толщины интимы-медиа сонных артерий, скорости прохождения пульсовой волны, показателями липидограммы (концентрации общего холестерина, индекса атерогенности), что подтверждалось результатами клинических и функциональных методов обследования. Полученные данные доказывают необходимость ранней диагностики поражения эндотелия сосудов и процессов резорбции костной ткани для предупреждения развития осложнений коморбидной патологии; Osteoporosis (ОР) and atherosclerosis, the effects of which are respectively skeletal fractures and cardiovascular catastrophe – the most frequent causes of reduced quality of life and mortality in persons older than 50 years. Older women are characterized by polymorbidity, namely osteoporosis in associated with cardiovascular pathology. This justifies the advisability to study the mechanisms of syntropy and elaborate non-invasive diagnostic methods of vascular lesions and differential therapy. Objective: To study the features of osteoporosis associated with cardiovascular pathology in postmenopausal women. Object and methods. We screened the women aged 50 to 69 years (average age was 63,4±3,7 years). All patients were divided into the following groups: I group (n=23) – persons who do not have osteoporosis by ultrasound densitometry; the second group (n=19) – patients with osteopenia according ultrasound densitometry, III group (n=29) – patients in whom osteoporosis confirmed by ultrasound densitometry data. Determining the thickness of the intima-media (TIM) performed on the «Toshiba Nemio» device in B-mode. In conducting ultrasound densitometry assessed changes in BMD within one standard deviation (SD). Measurement of central blood pressure and arterial stiffness parameters were performed using the Sphygmocor system (ArtCor, Aus-tralia). Pulse wave velocity in the aorta was measured by pulse wave consistent registration on carotid and femoral arteries while recording ECG. Was conducted mathematical and statistical analysis to prove the reliability of the results. Results and discussion. Groups of patients were representative by the age, but different by duration of menopause. Patients of the first group had a menopause 11,23 ±2,17 years, in the second group – 13,54±3,84 years, the third group – 16,8±3,9 years. A detailed analysis of blood pressure showed that the systolic blood pressure (SBP) was more than 1.3 times higher (p < 0.05) and diastolic blood pressure (DBP) was average 1.2 times higher in the second group, and 1.4 (p<0.02) and 1.3 (p<0.02) times higher in III group compared to the comparison group. Arterial hypertension III stage was in 13.04 % of patients II group and 36% of patients III group. The study of the vascular wall in comorbid patients found that in patients of the II group the intima-media thickness (IMT) index on the bifurcation of the common carotid artery was 1.4 times (p <0.01) higher. In the III group was found the increasing of IMT on the bifurcation of the common carotid artery 1.6 times (p<0.01) in comparison with control group. Definition speed of the pulse wave, which is the hardness vessels gold standard, showed that it was higher 1.8 times (p<0.001) in the second group and 2.4 times (p <0.001) in the third group in comparison with first control group. Ultrasound densitometry showed that the bone mineral density (BMD) T-test in the first group was 0,62±0,29 SD, in the second group was 1,9±0,49 SD and in the third group was 3,15±0,38 SD. The study found a direct correlation between pulse wave velocity (PWV) and BMD (r =+0,69; p<0,01). And it was reliably established a highly highly sensitivity of PWV data in compared to IMT. In patients with osteopenia and osteoporosis data of atherogenic dyslipidemia was increased and established a strong negative correlation between total cholesterol indices and BMD (r=-0,71; p<0,01). Conclusions. The osteoporosis and cardiovascular disease comorbidity enhance bone resorption, reduce the elasticity of blood vessels, increase atherosclerotic process in the vascular wall and calcification of blood vessels, which leads to the increasing of the frequency and intensity of cardiovascular diseases in patients with osteoporosis
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