RESUMO
The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has triggered a serious global health crisis, resulting in millions of reported deaths since its initial identification in China in November 2019. The global disparities in immunization access emphasize the urgent need for ongoing research into therapeutic interventions. This study focuses on the potential use of molecular dihydrogen (H2) inhalation as an adjunctive treatment for COVID-19. H2 therapy shows promise in inhibiting intracellular signaling pathways associated with inflammation, particularly when administered early in conjunction with nasal oxygen therapy. This phase I study, characterized by an open-label, prospective, monocentric, and single ascending-dose design, seeks to assess the safety and tolerability of the procedure in individuals with confirmed SARS-CoV-2 infection. Employing a 3 + 3 design, the study includes three exposure durations (target durations): 1 day (D1), 3 days (D2), and 6 days (D3). We concluded that the maximum tolerated duration is at least 3 days. Every patient showed clinical improvement and excellent tolerance to H2 therapy. To the best of our knowledge, this phase I clinical trial is the first to establish the safety of inhaling a mixture of H2 (3.6%) and N2 (96.4%) in hospitalized COVID-19 patients. The original device and method employed ensure the absence of explosion risk. The encouraging outcomes observed in the 12 patients included in the study justify further exploration through larger, controlled clinical trials. CLINICAL TRIALS: This study is registered with ClinicalTrials.gov as NCT04633980.
RESUMO
INTRODUCTION: Pharmaceutical permanence (PP), outside the working hours of an in-house pharmacy (PUI), allows to guarantee the continuity of care in health-care institutions. A retrospective review of urgent drug dispensing was carried out in the light of changes in the drug circuit. MATERIALS AND METHOD: The analysis of drug dispensations was performed over a period from 2011 to 2019. The average number of drugs dispensed per shift, annual dispensations, and their variation by day of the week were studied. The increase is statistically significant and is found on both weekdays and weekends. Each drug was identified according to its Anatomical Therapeutic Chemical (ATC) classification. Data on the activities of our institution (number of hospitalizations, average length of stay) were also collected. RESULTS: In 2011, an average of 36 medications were dispensed per on-call period, compared with 77 in 2019 (a doubling of activity). The increase is statistically significant and is found on both weekdays and weekends. Neurological drugs and anti-infectives represent on average 43 % of the drugs dispensed. At the same time, there was a decrease in average length of stay and an increase in hospitalizations (-10 % and +16 % respectively). DISCUSSION: The increase in the average number of medications dispensed per shift is notable. It reflects a strong and gradual increase in activity, which was increased when the full vacuum cabinets (FVCs) were introduced, which improved the quality and safety of the pharmaceutical circuit. The revision of the allocations and the information of prescribers on the drug circuit will optimize the activity and refocus it on the pharmaceutical analysis of urgent needs.