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.

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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.