Динамика показателей спирограммы больных хронической обструктивной болезнью легких в стадии обострения на фоне гипотиреоза при включении в комплексное лечение лиотиронина

Хронічна обструктивна хвороба легень (ХОЗЛ) є однією з найбільш поширених причин захворюваності та смертності і, як наслідок, однією з найважливіших проблем охорони здоров'я. Останнім десятиліттям ХОЗЛ посідає 5-те місце серед провідних причин непрацездатності та 3-тє – серед причин смерті. Основним методом діагностики, документування тяжкості, моніторування та оцінки ефективності терапії ХОЗЛ є спірометрія. Дана методика дозволяє виявити обструктивні й рестриктивні вентиляційні порушення. Залежно від цілей і вихідних параметрів спірометрії доцільно проведення бронходилатаційного або бронхоконстрикторного тестів. Мета роботи – визначити динаміку показників функції зовнішнього дихання (ФЗД) у хворих на ХОЗЛ в стадії загострення на тлі гіпотиреозу при включенні у комплексне лікування ліотироніну як замісної терапії.Lyothyronin in patients with chronic obstructive pulmonary disease (COPD) in the state of exacerbation with hypothyroidism provides substitution-stimulating anti-inflammatory action and contributes to the restoration of the functional state of the bronchopulmonary system with a reduction in the course of treatment for 3–6 days. We prescribed a lyotyronin at a dose of 50% per day contributes to the restoration of the level of thyroid hormones secretion in patients with COPD in the state of exacerbation with concomitant hypothyroidism. We proved that the rehabilitation improved due to changes in "high-speed" indicators in addition to the basic rehabilitation treatment with lyothyronin in patients with COPD in the state of exacerbation in combination with hypothyroidism.У больных хронической обструктивной болезнью легких (ХОБЛ) в состоянии обострения, осложненной гнойно-некротическим поражением бронхолегочной системы на фоне сниженного синтеза эндогенного трийодтиронина, лиотиронин оказывает заместительное стимулирующее противовоспалительное действие и способствует восстановлению функционального состояния бронхолегочной системы при сокращении лечебного курса на 3–6 сут. Назначение лиотиронина в дозе 50 % от суточной способствует восстановлению уровня секреции гормонов щитовидной железы у больных ХОБЛ в состоянии обострения с сопутствующим гипотиреозом. Доказано, что при дополнении базового восстановительного лечения лиотиронином больным ХОБЛ в состоянии обострения в сочетании с гипотиреозом наблюдалась тенденция к улучшению функции внешнего дыхания за счет изменений «скоростных» показателей

Adapted evidence-based clinical guidelines: bronchial asthma (Part 1)

Клінічна настанова є результатом узгодженого рішення експертів, прийнятого на підставі ретельного аналізу даних літератури, а також рекомендацій зарубіжного керівництва GINA: Global Strategy For Asthma Management And Prevention. Updated 2019. У документі представлено оновлене визначення бронхіальної астми (БА), дані нові підходи до класифікації та діагностиці захворювання, запропоновані сучасні схеми лікування, які засновані на результатах багатоцентрових міжнародних клінічних досліджень, що обґрунтовує високу доказовість такої терапевтичної тактики. Викладено нові принципи розподілу хворих на фенотипи, які слід враховувати при виборі схем лікування, представлені алгоритми початкової і підтримуючої терапії, нові підходи до лікування загострень захворювання. У першій частині публікації керівництва представлено оновлене визначення та патогенетичні механізми БА, викладені нові підходи до класифікації та діагностиці захворювання, дані принципи комплексної оцінки контролю БА з урахуванням контролю за симптомами астми, інтерпретації змін показників функції зовнішнього дихання і ризику загострень. Настанова адресована лікарям всіх ланок надання медичної допомоги — сімейним лікарям, терапевтам, пульмонологам, алергологам, кардіологам, реабілітологам.Clinical guideline is the result of an agreed decision of experts, adopted on the basis of a thorough analysis of literature data, as well as recommendations of foreign guideline GINA: Global Strategy For Asthma Management And Prevention. Updated 2019. The document provides an updated definition of bronchial asthma (BA), gives new approaches to the classification and diagnosis of the disease, proposes modern treatment regimens based on the results of multicenter international clinical trials, which justifies the high evidence for such therapeutic tactics. New principles for the distribution of patients to phenotypes, which should be taken into account when choosing treatment regimens, are presented, algorithms for initial and maintenance therapy, and new approaches to the treatment of exacerbations of the disease are presented. The first part of the publication presents an updated definition and pathogenetic mechanisms of BA, outlines new approaches to the classification and diagnosis of the disease, gives principles for a comprehensive assessment of asthma control, taking into account the control of BA symptoms, the interpretation of changes in pulmonary function tests and the risk of exacerbations. The guideline is addressed to doctors at all levels of medical care — family doctors, general practitioners, pulmonologists, allergists, cardiologists, rehabilitologists

Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

Background Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown. Methods Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding. Results A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55). Conclusions Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218. opens in new tab.

Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely III Medical Patients: An APEX Trial Substudy

BACKGROUND: Extended-duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. METHODS AND RESULTS: This was a post hoc analysis of the APEX trial-a multicenter, double-blind, randomized controlled trial comparing extended-duration betrixaban versus standard-of-care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time-to-first event analysis. In patients with positive D-dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [P=0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [P=0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [P=0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [P=0.002]). CONCLUSIONS: Among hospitalized medically ill patients, extended-duration betrixaban demonstrated an ≈30% reduction in fatal or irreversible ischemic or bleeding events compared with standard-duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01583218.status: publishe

Comparison of fatal or irreversible events with extended-duration betrixaban versus standard dose enoxaparin in acutely Ill medical patients: An APEX trial substudy

Background-Extended-duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results-This was a post hoc analysis of the APEX trial-a multicenter, double-blind, randomized controlled trial comparing extended-duration betrixaban versus standard-of-care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time-to-first event analysis. In patients with positive D-dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [P=0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [P=0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [P=0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [P=0.002]). Conclusions-Among hospitalized medically ill patients, extended-duration betrixaban demonstrated an 48 30% reduction in fatal or irreversible ischemic or bleeding events compared with standard-duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin

Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone

BACKGROUND: The safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. METHODS: In this multicenter, randomized, double-blind trial, adolescent and adult patients (age, ≥12 years) with persistent asthma were assigned to receive either fluticasone with salmeterol or fluticasone alone for 26 weeks. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month. Patients were excluded from the trial if they had a history of life-threatening or unstable asthma. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization). Noninferiority of fluticasone-salmeterol to fluticasone alone was defined as an upper boundary of the 95% confidence interval for the risk of the primary safety end point of less than 2.0. The efficacy end point was the first severe asthma exacerbation. RESULTS: Of 11,679 patients who were enrolled, 67 had 74 serious asthma-related events, with 36 events in 34 patients in the fluticasone-salmeterol group and 38 events in 33 patients in the fluticasone-only group. The hazard ratio for a serious asthma-related event in the fluticasone-salmeterol group was 1.03 (95% confidence interval [CI], 0.64 to 1.66), and noninferiority was achieved (P=0.003). There were no asthma-related deaths; 2 patients in the fluticasone-only group underwent asthma-related intubation. The risk of a severe asthma exacerbation was 21% lower in the fluticasone-salmeterol group than in the fluticasone-only group (hazard ratio, 0.79; 95% CI, 0.70 to 0.89), with at least one severe asthma exacerbation occurring in 480 of 5834 patients (8%) in the fluticasone-salmeterol group, as compared with 597 of 5845 patients (10%) in the fluticasone-only group (P<0.001). CONCLUSIONS: Patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher risk of serious asthma-related events than did those who received fluticasone alone. Patients receiving fluticasone-salmeterol had fewer severe asthma exacerbations than did those in the fluticasone-only group