RESUMO
BACKGROUNDHyperimmune plasma from Covid-19 convalescent is a potential treatment for severe Covid-19. METHODSWe conducted a multicenter one arm proof of concept interventional study. Patients with Covid-19 disease with moderate-to-severe Acute Respiratory Distress Syndrome, elevated C-reactive Protein and need for mechanical ventilation and/or CPAP were enrolled. One to three 250-300 ml unit of hyperimmune plasma (neutralizing antibodies titer [≥]1:160) were administered. Primary outcome was 7-days hospital mortality. Secondary outcomes were PaO2/FiO2, laboratory and radiologic changes, as well as weaning from mechanical ventilation and safety. RESULTSThe study observed 46 patients from March, 25 to April, 21 2020. Patients were aged 63, 61% male, 30 on CPAP and 7 intubated. PaO2/FiO2 was 128 (SD 47). Symptoms and ARDS duration were 14 (SD 7) and 6 days (SD 3). Three patients (6.5%) died within 7 days. The upper one-sided 90%CI was 13.9%, allowing to reject the null hypothesis of a 15% mortality. PaO2/FiO2 increased by 112 units (95%CI 82 to142) in survivors, the chest radiogram severity decreased in 23% (95%CI 5% to 42%); CRP, Ferritin and LDH decreased by 60, 36 and 20% respectively. Weaning from CPAP was obtained in 26/30 patients and 3/7 were extubated. Five serious adverse events occurred in 4 patients (2 likely, 2 possible treatment related). CONCLUSIONSHyperimmune plasma in Covid-19 shows promising benefits, to be confirmed in a randomized controlled trial. This proof of concept study could open to future developments including hyperimmune plasma banking, development of standardized pharmaceutical products and monoclonal antibodies.
RESUMO
Some recent studies evaluated the introduction of diffusion-weighted magnetic resonance imaging (DW-MRI) in the diagnosis of bladder pain syndrome/interstitial cystitis (BPS/IC). OBJECTIVE: To evaluate whether DW-MRI can contribute to noninvasive diagnosis of BPS/IC. The agreement between two raters (2 radiologists involved in the study) was also evaluated, the relevance of the "operator-dependent" factor defined. PATIENTS AND METHODS: Twenty-two female patients with a diagnosis of BPS-IC were recruited and performed DW-MRI. The same investigation was also performed in 20 patients with pelvic gynecological diseases and no BPS-IC. RESULTS: A significant difference was found between BPS-IC and no-BPS-IC since 17 out of 22 subjects of the first group were positive, compared to 3 out of 20 no-IC subjects, with a P value of .001 to highlight the statistical significance. The sensitivity of the exam was 77%, while the specificity was 85%. There was good agreement between the 2 raters in the evaluation of MRI results. CONCLUSION: DW-MRI helps to obtain a noninvasive diagnosis of BPS/IC, by providing useful information on the choice of which patients may be more appropriately submitted to cystoscopy and bladder biopsy.
