The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1–2) and 57 (11.3%) as serious (grade 3–5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.
Background and objective: According to the World Health Organization (WHO), more than 100 million people have already recovered from SARS-CoV-2 infection. Therefore, it is imperative to understand the possible outcomes of COVID-19. The aim of our study was to evaluate pulmonary function, exercise capacity, residual radiological changes, and health-related quality of life (HRQoL) at follow-up in a cohort of SARS-CoV-2 pneumonia survivors. Materials and Methods: Patients with SARS-CoV-2 infection and radiologically confirmed lung injury, with no chronic lung disease prior to this infection, were included in the study. Patients’ evaluation 2 months after their discharge from hospital included spirometry (FVC, FEV1, FEV1/FVC), determination of lung volume (TLC, VC, RV) and diffusing capacity of lung for carbon monoxide (DLCO, adjusted for hemoglobin), 6-Minute Walk Test (6MWT), chest CT scan, and 36-Item Short Form General Health Survey (SF-36). Results: Fifty-one patients (25 men, 26 women) were included. The mean age was 56 years (SD-11,72). Eighteen patients (35.3%) had experienced moderate COVID-19, 21 (41.2%) severe COVID-19, and 12 (23.5%) were critically ill. The mean follow-up visit time after the discharge from hospital was 60 days (SD-17). Pulmonary function at follow-up was impaired in 24 (47.2%) patients. Reduced lung volume was observed in 15 (29.4%) patients, DLCO reduction in 15 (29.4%) patients, and only one patient displayed obstruction. Twelve patients out of 51 (12/51, 27.3%) showed reduced physical capacity in the 6 MWT, and 3/51 (9.1%) showed desaturation, with SO2 < 90%. Different levels of abnormality were found in 49/51 (96,1%) patients on follow-up chest CT; the median radiological score was 10.9 (SD ± 8.87, possible maximal score, 25). Ground-glass opacity was the most common radiological feature, found in 45 (88.2%) patients. The SF-36 scores demonstrated a reduction in health status across all domains, with the lowest scores for limitations in social activities because of physical problems, vitality, and general health. Conclusion: In the group of COVID-19 pneumonia survivors 2 months after hospital discharge, residual changes in the lungs on chest CT and in lung function and reduced physical and HRQoL status were found in a significant number of patients. To evaluate COVID-19 long-term consequences, a longer follow-up period is needed.
Background: The aim of the present study was to identify specious radiologic and/or physiologic prognostic marker(s), which lead to optimize of the patient follow-up frequency. Methods: Eighty consecutive patients with newly diagnosed pulmonary sarcoidosis. Patients underwent chest radiography, high-resolution computed tomography (HRCT) examination, pulmonary function tests (PFT), bronchoscopy with bronchoalveolar lavage (BAL) and lung biopsy, and bronchoalveolar lavage fluid (BALF) cell examination. Results: The reduction in PFT values seen in radiological sarcoidosis stage III was greater than that seen in stages I and II. The percentage of neutrophils in the lungs was found to increase in stages II and III. PFT indices were correlated negatively with the consolidation and ground glass opacities CT scores, but not with the micronodule or macronodule scores. The rise in the percentage of BALF lymphocytes was associated with the restriction pattern of PFT. The diagnostic value of BALF for sarcoidosis was higher when the typical radiologic patterns of stage I disease were found and that smoking decreased the diagnostic value of CD4/CD8 ratio. Conclusions: This study supports the opinion that the staging of the pulmonary sarcoidosis with chest X-rays is still valuable from the prognostic point of view, because significant correlations between the radiologic stages of sarcoidosis and PFT parameters were found. Chest HRCT was significantly superior to chest X-ray in detecting mediastinal and pulmonary parenchymal changes. However, the prognostic role of HRCT needs to be better investigated evaluating serial examinations. Only consolidation and ground glass scores (neither of which are frequently found in sarcoidosis) hold prognostic value, since these were negatively correlated with PFT parameters.
Background: The mechanisms driving the transition from inflammation to fibrosis in sarcoidosis patients are poorly understood; prognostic features are lacking. Immune cell profiling may provide insights into pathogenesis and prognostic factors of the disease. This study aimed to establish associations in simultaneous of lymphocyte subset profiles in the blood, bronchoalveolar lavage fluid (BALF), and lung biopsy tissue in the patients with newly diagnosed sarcoidosis.Methods: A total of 71 sarcoid patients (SPs) and 20 healthy controls (HCs) were enrolled into the study. CD31, CD38, CD44, CD103 positive T lymphocytes in blood and BALF were analysed. Additionally, the densities of CD4, CD8, CD38, CD44, CD103 positive cells in lung tissue biopsies were estimated by digital image analysis. Results: Main findings: (I) increase of percentage of CD3 + CD4 + CD38 + in BALF and blood, and increase of percentage of CD3 + CD4 + CD44 + in BALF in Löfgren syndrome patients comparing with patients without Löfgren syndrome, (II) increase of percentage of CD3 + CD4 + 103 + in BALF and in blood in patients without Löfgren syndrome (comparing with Löfgren syndrome patients) and increase of percentage of CD3 + CD4 + 103 + in BALF and in blood in more advanced sarcoidosis stage. (III) Increasing percentage of BALF CD3 + CD4 + CD31 + in sarcoidosis patients when comparing with controls independently of presence of Löfgren syndrome, smoking status or stage of sarcoidosis. Several significant correlations were found. Conclusions: Lymphocyte subpopulations in blood, BALF, and lung tissue were substantially different in SPs at the time of diagnosis compared to HCs. CD3 + CD4 + CD31 + in BALF might be a potential supporting marker for the diagnosis of sarcoidosis. CD3 + CD4 + CD38 + in BALF and blood and CD3 + CD4 + CD44 + in BALF may be markers of the acute immune response in sarcoidosis patients. CD4 + CD103 + T-cells in BALF and in blood are markers of the persistent immune response in sarcoidosis patients and are potential prognostic features of the chronic course of this disease.
Background/Aim: The prognostic role of thyroid transcription factor-1 (TTF1) in advanced lung cancer is not clearly established. The present study aimed to evaluate the associations between clinicopathological characteristics, TTF1 expression, and overall survival (OS) of patients with advanced lung adenocarcinoma. Materials and Methods: One hundred and seventy-two patients were enrolled in this retrospective study. OS was assessed according to immunohistochemical TTF1 expression in lung adenocarcinoma tissue, age, gender, performance status (PS), smoking history and status, disease stage, tumor differentiation, epidermal growth factor receptor (EGFR) mutation and EGFR tyrosine kinase inhibitor (TKI) treatment status. Results: The OS time was longer (p<0.001) for patients with TTF1 expression than for patients without TTF1 expression (13.0 vs. 5.0 months, respectively). A multivariate analysis confirmed that worse PS [hazard ratio (HR)=2.13, p<0.001], poor histological differentiation (HR=2.02, p=0.001), wild-type EGFR status (HR=3.08, p<0.001) and negative TTF1 expression (HR=1.97, p=0.001) were independent predictors of worse prognosis. Conclusion: TTF1 expression is an independent predictor of survival of patients with advanced lung adenocarcinoma.
Introduction: Bronchoscopic lung biopsy (BLB) is a widely used procedure. As the world’s population is ageing, more BLBs are performed for older people with comorbidities. The aim of the study was to investigate if an older age is a risk factor for BLB related complications. Materials and Methods: A prospective study at the Centre of Pulmonology and Allergology of Vilnius University Hospital Santaros klinikos was conducted. Seven hundred and eighty-six patients (male 60.6%), mean age 57 ± 16, who underwent BLB, were included. The complications that occurred due to BLB were evaluated. Bleeding and pneumothorax were classified into I° or II° grades depending on their severity. Potential determinants, which may increase the risk of complications, emphasizing on age, were analyzed. Results: Fifty-seven (7.2%) BLB-related complications occurred. There were 27 (3.4%) pneumothoraxes, and 19 (70%) of them required thoracic drainage. Thirty (3.8%) bleeding complications occurred, and four (16%) of them were severe. Higher rates of bleeding were found in the age group ≥65 years, p = 0.001. The risk of bleeding in older patients was 3.2 times higher (95% CI 1.51–6.87). Conclusions: Older age is related to a higher incidence of mild bleeding during BLB. However, the risk of life-threatening complications is low despite the age, and older age should not be considered as a contraindication for the procedure if needed.
Acute myocardial infarction caused by a bronchogenic cyst is a very rare pathology. It occurs as a result of external compression of the coronary artery by the cyst, leading to myocardial ischemia. The present case illustrates that a bronchogenic cyst, which is generally considered to be a chronic disease entity with gradual onset of symptoms, can manifest acutely as a life-threatening condition. Timely invasive coronary intervention is critical in the acute management of this complication while multimodality imaging assessment is essential in the subsequent management of the underlying etiology.
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