ABSTRACT
Rationale: Fibrotic hypersensitivity pneumonitis (FHP) is an irreversible lung disease with high morbidity and mortality. We sought to evaluate the safety and effect of pirfenidone on disease progression in such patients.Methods: In a phase 2 double-blind, single-center trial, we randomly assigned, in a 2:1 ratio, adults with FHP to receive either oral pirfenidone (2403 mg/day) or placebo for 52 weeks. Patients had to have CT lung fibrotic abnormalities affecting ≥5%, worsening respiratory symptoms, and either an increase in the extent of fibrosis on CT or relative decline in the FVC% of ≥5% within the 24-months before screening. The primary endpoint was the mean change from baseline to week 52 in %FVC. Secondary endpoints included progression-free survival (PFS, time to the first occurrence of any one of the following: a relative decline of ≥10% in FVC and/or DLCO, acute exacerbation, a decrease of ≥50 m in the 6-minute walk distance, increase in background prednisone by ≥10 mg or introduction of corticosteroids and/or steroid-sparing drugs, or death), change from baseline to week 52 in FVC slope and mean %DLCO, all-cause hospitalizations, CT progression of lung fibrosis, and safety. Results: After 40 patients had been randomized (mean age 67.1 years, 42.5% males) the study was stopped due to slow recruitment due to the COVID-19 pandemic. At baseline, demographics, smoking and inciting antigen exposure history, lung function, 6-minute walk distance, extent of CT lung fibrosis, and immunosuppressive therapy were balanced in both groups. There was no significant difference between the pirfenidone and placebo groups after adjusting for baseline %FVC and concomitant immunosuppressive therapy (p=0.88) in mean change from baseline to week 52 in %FVC. Secondary endpoints showed no difference between groups in change from baseline to week 52 in FVC slope, mean %DLCO, all-cause hospitalization and CT progression of lung fibrosis. However, a decrease in PFS favored pirfenidone (Table). The percentages of patients with any adverse events (AE) were similar in both groups. Nausea and rash, respectively, led to transient dose reduction of study treatment in 2 patients in the pirfenidone group. There were no treatment-related serious AE or AE leading to discontinuation of study treatment. No death occurred in the pirfenidone group and one death (respiratory) occurred in the placebo group. Conclusions: The trial was under powered to detect a difference in the primary endpoint. Pirfenidone was found to be tolerable and safe and compared to placebo reduced PFS in patients with FHP.
ABSTRACT
Background and importanceWhen there were still some doubts in the population about the efficacy and safety of the approved vaccines for SARS-CoV-2, healthcare professionals were among the first to be vaccinated in our country.Aim and objectivesTo analyse the level of knowledge and motivation in hospital staff for getting vaccinated against SARS-CoV-2 with the administered COVID-19 mRNA vaccine.Material and methodsDescriptive, observational and retrospective study. All hospital staff vaccinated with COVID-19 mRNA vaccine and who had signed the informed consent for data collection were included. Through telephone interview, sociodemographic data (sex, age) were collected and also questions about: (1) motivation for getting vaccinated;(2) previous knowledge about the possible AEFI (Adverse Event Following Immunisation);(3) technical information (TI) about the vaccine prior to first dose, to second dose and after the second one;(4) anxiety/fear/worry about being vaccinated;(5) probability of being vaccinated again, if necessary and (6) if medication was taken to alleviate symptoms. The level of agreement or disagreement with the question made was considered using a Likert scale. Related qualitative variables were analysed using the Chi-square technique. p<0.05 was established as statistically significant.ResultsAbout 108 (88.5%) hospital staff were vaccinated. About 66 (61.1%) workers (81.8% women) with a mean ages of 42.7±10.7 years completed the interview and were included in the study. About 65 (98.5%) belonged to the 18–65 years age group.About 40 (60.6%) workers took medication for alleviate symptoms. Correlations were significant between (1) level of knowledge about AEFI and level of motivation for getting vaccinated, (2) level of TI and taking medication to alleviate symptoms and (3) level of motivation and probability of being vaccinated again if necessary. It seems that (1) more knowledge about AEFI means to be more motivated to be vaccinated (p= 0.037) and (2) more level of TI means to have more desire to get vaccinated again, if necessary (p=0.001) and also less use of drugs to relieve symptoms (p=0.027).Conclusion and relevanceNearly 90% of our hospital staff were vaccinated against SARS-CoV-2. Knowledge about the AEFI determined the motivation for getting vaccinated. Besides, the level of the staff’s motivation determined less consumption of medication to alleviate symptoms, as well as a greater trend to receive a new vaccine dose, if necessary.References and/or acknowledgementsConflict of interestNo conflict of interest
ABSTRACT
The COVID-19 pandemic is clearly showing the importance for the surveillance and protection of human health of acting in all settings of life: family, community, education, leisure or work, among others, as well as addressing the multiple determinants that influence the health and well-being of the population: demographic, healthcare, environmental, social, economic, cultural or occupational, among others. With respect to occupational health and the work-related determinants of health, the potential of occupational health services acting at the company level is clear, and could be generalized to almost any public health action setting. This article reflects on the opportunities for coordination between the occupational health system in Spain (including resources from mutual insurance companies, companies themselves and administrations) and the public health system, including both health care (primary care, hospital) and public health services. We examine this in the context of health crises, like the present one, but also with a broader vision, commensurate with the necessary comprehensive care for human health, guaranteeing health as a fundamental and universal right in all life circumstances. To advance along these lines, we propose the incorporation of the "occupational health perspective" in all actions and services of the public healthcare system, especially with respect to public health services under the purview of the health administration.