ABSTRACT
Background: Sars-CoV- 2 infections are hazardous, especially to the elderly and patients with comorbidities. With no efficient treatment available, newly developed vaccines are the only way to change the course of the pandemic. However, reports of allergic reactions resulted in some patients and practising physicians being concerned about the safety of vaccine administration, particularly in people with severe anaphylactic reactions to multiple or unknown factors in their medical history. This study aimed to develop an allergic workup protocol based on skin prick tests (SPT), intradermal testing (IDT) and intramuscular provocations, and desensitization which may contribute to diagnosis and management of anti-COVID- 19 vaccine allergy. Method(s): 285 patients were enrolled. 205 of them entered the study based on severe anaphylactic reaction to unknown or multiple factors in their medical history which disqualified them for standard treatment. Another 80 patients were enrolled after developing an allergic reaction to the first dose of one such vaccine. In all subjects, SPT and IDT were performed with one of 4 available vaccines. Result(s): 277 patients with negative tests were given a vaccine without complications. Six patients with positive skin tests received desensitization with a reasonable tolerance. One patient did not consent to desensitization and one patient resigned despite negative tests. All in all, 283 (99%) patients were vaccinated using this newly developed protocol. Patients with adverse reactions to the first dose of the vaccine before the study had a significantly lower basal serum tryptase concentration (p = 0.001). Conclusion(s): Skin tests with anti-COVID- 19 vaccines are a useful tool in the vaccination protocol. This protocol enables safe immunization of high-allergy- risk patients even cases of positive skin tests.
ABSTRACT
RATIONALE. Duchenne muscular dystrophy (DMD) is the most common and severe muscular dystrophy recognized in childhood. Genetically determined progressive dystrophin dysfunction in skeletal and multiple organ muscles is fatal before the age of 20 years without multi-specialized care. The most common cause of death is respiratory muscle failure. The primary task in caring for patients with DMD is the early monitoring of pulmonary functions. This has become difficult during the pandemic SARS-CoV-2 as the procedures generate aerosols, i.e. high risk of SARS-CoV-2 virus transmission. The aim of the study was to evaluate the capacity of the patients with DMD to perform longitudinal daily spirometry examinations at home. METHODS. The patients with DMD were recruited from the Rare Disease Centre, Medical University of Gdask, Poland (a member of the TREAT NMD Alliance Neuromuscular Network). Physical examination with anthropometry measurement, Vignos scale (VS), Brooke scale (BS), and Pulmonary Function Tests were measured during 3 months of monitoring. Participants used home spirometry (AioCare System, Healthup), twice every day. The adherence and correctness (separately for FEV1 and FVC) of spirometry examinations were evaluated. RESULTS. We recruited 20 boys with mean age 11.7(3.0) years (range 7-16 years) and BMI 22.3(5.5) kg/m∧2 with a median VS of 2.5 (IQR 6.5) and BS of 2 (IQR 4.0). During 3 months of monitoring 1301 spirometry examinations were performed;32% of them meet ATS/ERS criteria for FEV1 and FVC, 35% for FEV1 and 33% for FVC, however 50% of patients performed examinations with at least one maneuver with correct FVC. The mean adherence considering performance spirometry examinations twice a day was 39(26)% (range: 6%-98%). We observed a significant increase of FVC values during the monitoring period in 4/20 of patients based on linear regression model estimation. The study is still ongoing. CONCLUSIONS. The systematic pulmonary function monitoring at home in patients with restrictive diseases is an innovative project. The results showed that patients with DMD are able to monitor the lung function using a mobile spirometry system. We observed that in some cases, based on patient feedback, systematic spirometry tests were a form of pulmonary exercises and could be one of the factors that increase FVC after 3 months of monitoring. Personal spirometers could be used as a part of the therapy of patients with muscular dystrophy.