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1. Prolonged higher dose methylprednisolone vs. conventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS)

Author

Salton, F, Confalonieri, P, Centanni, S, Mondoni, M, Petrosillo, N, Bonfanti, P, Lapadula, G, Lacedonia, D, Voza, A, Carpene, N, Montico, M, Reccardini, N, Meduri, G, Ruaro, B, Confalonieri, M, Citton, G, Bozzi, C, Tavano, S, Pozzan, R, Andrisano, A, Jaber, M, Mari, M, Trotta, L, Mondini, L, Barbieri, M, Ruggero, L, Antonaglia, C, Soave, S, Torregiani, C, Bogatec, T, Baccelli, A, Nalesso, G, Re, B, Pavesi, S, Barbaro, M, Giuliani, A, Ravaglia, C, Poletti, V, Scala, R, Guidelli, L, Golfi, N, Vianello, A, Achille, A, Lucernoni, P, Gaccione, A, Romagnoli, M, Fraccaro, A, Malacchini, N, Malerba, M, Ragnoli, B, Zamparelli, A, Bocchino, M, Blasi, F, Spotti, M, Miele, C, Piedepalumbo, F, Barone, I, Baglioni, S, Dodaj, M, Franco, C, Andrani, F, Mangia, A, Mancini, A, Carrozzi, L, Rafanelli, A, Casto, E, Rogliani, P, Ora, J, Carpagnano, G, Di Lecce, V, Tamburrini, M, Papi, A, Contoli, M, Luzzati, R, Zatta, M, Di Bella, S, Caraffa, E, Francisci, D, Tosti, A, Pallotto, C, De Rosa, F, Pecori, A, Franceschini, M, Carlin, M, Orsini, V, Pollastri, E, Rugova, A, Sabbatini, F, Soria, A, Rossi, M, Santantonio, T, Meli, R, Sauro, S, Fedeli, C, Mangini, E, Biolo, G, Nunnari, A, Pietrangelo, A, Corradini, E, Bocchi, D, Boarini, C, Zucchetto, A, Lanini, S, Salton F., Confalonieri P., Centanni S., Mondoni M., Petrosillo N., Bonfanti P., Lapadula G., Lacedonia D., Voza A., Carpene N., Montico M., Reccardini N., Meduri G. U., Ruaro B., Confalonieri M., Citton G. M., Bozzi C., Tavano S., Pozzan R., Andrisano A. G., Jaber M., Mari M., Trotta L., Mondini L., Barbieri M., Ruggero L., Antonaglia C., Soave S., Torregiani C., Bogatec T., Baccelli A., Nalesso G., Re B., Pavesi S., Barbaro M. P. F., Giuliani A., Ravaglia C., Poletti V., Scala R., Guidelli L., Golfi N., Vianello A., Achille A., Lucernoni P., Gaccione A. T., Romagnoli M., Fraccaro A., Malacchini N., Malerba M., Ragnoli B., Zamparelli A. S., Bocchino M., Blasi F., Spotti M., Miele C., Piedepalumbo F., Barone I., Baglioni S., Dodaj M., Franco C., Andrani F., Mangia A., Mancini A., Carrozzi L., Rafanelli A., Casto E., Rogliani P., Ora J., Carpagnano G. E., Di Lecce V., Tamburrini M., Papi A., Contoli M., Luzzati R., Zatta M., Di Bella S., Caraffa E., Francisci D., Tosti A., Pallotto C., De Rosa F. G., Pecori A., Franceschini M., Carlin M., Orsini V., Pollastri E., Rugova A., Sabbatini F., Soria A., Rossi M., Santantonio T., Meli R., Sauro S., Fedeli C., Mangini E., Biolo G., Nunnari A., Pietrangelo A., Corradini E., Bocchi D., Boarini C., Zucchetto A., Lanini S., Salton, F, Confalonieri, P, Centanni, S, Mondoni, M, Petrosillo, N, Bonfanti, P, Lapadula, G, Lacedonia, D, Voza, A, Carpene, N, Montico, M, Reccardini, N, Meduri, G, Ruaro, B, Confalonieri, M, Citton, G, Bozzi, C, Tavano, S, Pozzan, R, Andrisano, A, Jaber, M, Mari, M, Trotta, L, Mondini, L, Barbieri, M, Ruggero, L, Antonaglia, C, Soave, S, Torregiani, C, Bogatec, T, Baccelli, A, Nalesso, G, Re, B, Pavesi, S, Barbaro, M, Giuliani, A, Ravaglia, C, Poletti, V, Scala, R, Guidelli, L, Golfi, N, Vianello, A, Achille, A, Lucernoni, P, Gaccione, A, Romagnoli, M, Fraccaro, A, Malacchini, N, Malerba, M, Ragnoli, B, Zamparelli, A, Bocchino, M, Blasi, F, Spotti, M, Miele, C, Piedepalumbo, F, Barone, I, Baglioni, S, Dodaj, M, Franco, C, Andrani, F, Mangia, A, Mancini, A, Carrozzi, L, Rafanelli, A, Casto, E, Rogliani, P, Ora, J, Carpagnano, G, Di Lecce, V, Tamburrini, M, Papi, A, Contoli, M, Luzzati, R, Zatta, M, Di Bella, S, Caraffa, E, Francisci, D, Tosti, A, Pallotto, C, De Rosa, F, Pecori, A, Franceschini, M, Carlin, M, Orsini, V, Pollastri, E, Rugova, A, Sabbatini, F, Soria, A, Rossi, M, Santantonio, T, Meli, R, Sauro, S, Fedeli, C, Mangini, E, Biolo, G, Nunnari, A, Pietrangelo, A, Corradini, E, Bocchi, D, Boarini, C, Zucchetto, A, Lanini, S, Salton F., Confalonieri P., Centanni S., Mondoni M., Petrosillo N., Bonfanti P., Lapadula G., Lacedonia D., Voza A., Carpene N., Montico M., Reccardini N., Meduri G. U., Ruaro B., Confalonieri M., Citton G. M., Bozzi C., Tavano S., Pozzan R., Andrisano A. G., Jaber M., Mari M., Trotta L., Mondini L., Barbieri M., Ruggero L., Antonaglia C., Soave S., Torregiani C., Bogatec T., Baccelli A., Nalesso G., Re B., Pavesi S., Barbaro M. P. F., Giuliani A., Ravaglia C., Poletti V., Scala R., Guidelli L., Golfi N., Vianello A., Achille A., Lucernoni P., Gaccione A. T., Romagnoli M., Fraccaro A., Malacchini N., Malerba M., Ragnoli B., Zamparelli A. S., Bocchino M., Blasi F., Spotti M., Miele C., Piedepalumbo F., Barone I., Baglioni S., Dodaj M., Franco C., Andrani F., Mangia A., Mancini A., Carrozzi L., Rafanelli A., Casto E., Rogliani P., Ora J., Carpagnano G. E., Di Lecce V., Tamburrini M., Papi A., Contoli M., Luzzati R., Zatta M., Di Bella S., Caraffa E., Francisci D., Tosti A., Pallotto C., De Rosa F. G., Pecori A., Franceschini M., Carlin M., Orsini V., Pollastri E., Rugova A., Sabbatini F., Soria A., Rossi M., Santantonio T., Meli R., Sauro S., Fedeli C., Mangini E., Biolo G., Nunnari A., Pietrangelo A., Corradini E., Bocchi D., Boarini C., Zucchetto A., and Lanini S.

Abstract

Background Dysregulated systemic inflammation is the primary driver of mortality in severe coronavirus disease 2019 (COVID-19) pneumonia. Current guidelines favour a 7-10-day course of any glucocorticoid equivalent to dexamethasone 6 mg daily. A comparative randomised controlled trial (RCT) with a higher dose and a longer duration of intervention was lacking. Methods We conducted a multicentre, open-label RCT to investigate methylprednisolone 80 mg as a continuous daily infusion for 8 days followed by slow tapering versus dexamethasone 6 mg once daily for up to 10 days in adult patients with COVID-19 pneumonia requiring oxygen or noninvasive respiratory support. The primary outcome was reduction in 28-day mortality. Secondary outcomes were mechanical ventilation-free days at 28 days, need for intensive care unit (ICU) referral, length of hospitalisation, need for tracheostomy, and changes in C-reactive protein (CRP) levels, arterial oxygen tension/inspiratory oxygen fraction (PaO2/FIO2) ratio and World Health Organization Clinical Progression Scale at days 3, 7 and 14. Results 677 randomised patients were included. Findings are reported as methylprednisolone (n=337) versus dexamethasone (n=340). By day 28, there were no significant differences in mortality (35 (10.4%) versus 41 (12.1%); p=0.49) nor in median mechanical ventilation-free days (median (interquartile range (IQR)) 23 (14) versus 24 (16) days; p=0.49). ICU referral was necessary in 41 (12.2%) versus 45 (13.2%) (p=0.68) and tracheostomy in 8 (2.4%) versus 9 (2.6%) (p=0.82). Survivors in the methylprednisolone group required a longer median (IQR) hospitalisation (15 (11) versus 14 (11) days; p=0.005) and experienced an improvement in CRP levels, but not in PaO2/FIO2 ratio, at days 7 and 14. There were no differences in disease progression at the prespecified time-points. Conclusion Prolonged, higher dose methylprednisolone did not reduce mortality at 28 days compared with conventional dexamethasone in COVID

Published
2023

2. Prolonged higher dose methylprednisolone vs. conventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS)

Author

Salton F., Confalonieri P., Centanni S., Mondoni M., Petrosillo N., Bonfanti P., Lapadula G., Lacedonia D., Voza A., Carpene N., Montico M., Reccardini N., Meduri G. U., Ruaro B., Confalonieri M., Citton G. M., Bozzi C., Tavano S., Pozzan R., Andrisano A. G., Jaber M., Mari M., Trotta L., Mondini L., Barbieri M., Ruggero L., Antonaglia C., Soave S., Torregiani C., Bogatec T., Baccelli A., Nalesso G., Re B., Pavesi S., Barbaro M. P. F., Giuliani A., Ravaglia C., Poletti V., Scala R., Guidelli L., Golfi N., Vianello A., Achille A., Lucernoni P., Gaccione A. T., Romagnoli M., Fraccaro A., Malacchini N., Malerba M., Ragnoli B., Zamparelli A. S., Bocchino M., Blasi F., Spotti M., Miele C., Piedepalumbo F., Barone I., Baglioni S., Dodaj M., Franco C., Andrani F., Mangia A., Mancini A., Carrozzi L., Rafanelli A., Casto E., Rogliani P., Ora J., Carpagnano G. E., Di Lecce V., Tamburrini M., Papi A., Contoli M., Luzzati R., Zatta M., Di Bella S., Caraffa E., Francisci D., Tosti A., Pallotto C., De Rosa F. G., Pecori A., Franceschini M., Carlin M., Orsini V., Pollastri E., Rugova A., Sabbatini F., Soria A., Rossi M., Santantonio T., Meli R., Sauro S., Fedeli C., Mangini E., Biolo G., Nunnari A., Pietrangelo A., Corradini E., Bocchi D., Boarini C., Zucchetto A., Lanini S., Salton, F, Confalonieri, P, Centanni, S, Mondoni, M, Petrosillo, N, Bonfanti, P, Lapadula, G, Lacedonia, D, Voza, A, Carpene, N, Montico, M, Reccardini, N, Meduri, G, Ruaro, B, Confalonieri, M, Citton, G, Bozzi, C, Tavano, S, Pozzan, R, Andrisano, A, Jaber, M, Mari, M, Trotta, L, Mondini, L, Barbieri, M, Ruggero, L, Antonaglia, C, Soave, S, Torregiani, C, Bogatec, T, Baccelli, A, Nalesso, G, Re, B, Pavesi, S, Barbaro, M, Giuliani, A, Ravaglia, C, Poletti, V, Scala, R, Guidelli, L, Golfi, N, Vianello, A, Achille, A, Lucernoni, P, Gaccione, A, Romagnoli, M, Fraccaro, A, Malacchini, N, Malerba, M, Ragnoli, B, Zamparelli, A, Bocchino, M, Blasi, F, Spotti, M, Miele, C, Piedepalumbo, F, Barone, I, Baglioni, S, Dodaj, M, Franco, C, Andrani, F, Mangia, A, Mancini, A, Carrozzi, L, Rafanelli, A, Casto, E, Rogliani, P, Ora, J, Carpagnano, G, Di Lecce, V, Tamburrini, M, Papi, A, Contoli, M, Luzzati, R, Zatta, M, Di Bella, S, Caraffa, E, Francisci, D, Tosti, A, Pallotto, C, De Rosa, F, Pecori, A, Franceschini, M, Carlin, M, Orsini, V, Pollastri, E, Rugova, A, Sabbatini, F, Soria, A, Rossi, M, Santantonio, T, Meli, R, Sauro, S, Fedeli, C, Mangini, E, Biolo, G, Nunnari, A, Pietrangelo, A, Corradini, E, Bocchi, D, Boarini, C, Zucchetto, A, Lanini, S, Salton, Francesco, Confalonieri, Paola, Centanni, Stefano, Mondoni, Michele, Petrosillo, Nicola, Bonfanti, Paolo, Lapadula, Giuseppe, Lacedonia, Donato, Voza, Antonio, Carpenè, Nicoletta, Montico, Marcella, Reccardini, Nicolò, Meduri, Gianfranco Umberto, Ruaro, Barbara, MEDEAS Collaborative, Group, and Confalonieri, Marco

Subjects
Pulmonary and Respiratory Medicine, glucocorticoids, Settore MED/10 - Malattie dell'Apparato Respiratorio, pneumonia, COVID-19, glucocorticoid, dexamethasone, ARDS, acute respiratory distress syndrome, methylprednisolone
Abstract

BackgroundDysregulated systemic inflammation is the primary driver of mortality in severe coronavirus disease 2019 (COVID-19) pneumonia. Current guidelines favour a 7–10-day course of any glucocorticoid equivalent to dexamethasone 6 mg daily. A comparative randomised controlled trial (RCT) with a higher dose and a longer duration of intervention was lacking.MethodsWe conducted a multicentre, open-label RCT to investigate methylprednisolone 80 mg as a continuous daily infusion for 8 days followed by slow taperingversusdexamethasone 6 mg once daily for up to 10 days in adult patients with COVID-19 pneumonia requiring oxygen or noninvasive respiratory support. The primary outcome was reduction in 28-day mortality. Secondary outcomes were mechanical ventilation-free days at 28 days, need for intensive care unit (ICU) referral, length of hospitalisation, need for tracheostomy, and changes in C-reactive protein (CRP) levels, arterial oxygen tension/inspiratory oxygen fraction (PaO2/FIO2) ratio and World Health Organization Clinical Progression Scale at days 3, 7 and 14.Results677 randomised patients were included. Findings are reported as methylprednisolone (n=337)versusdexamethasone (n=340). By day 28, there were no significant differences in mortality (35 (10.4%)versus41 (12.1%); p=0.49) nor in median mechanical ventilation-free days (median (interquartile range (IQR)) 23 (14)versus24 (16) days; p=0.49). ICU referral was necessary in 41 (12.2%)versus45 (13.2%) (p=0.68) and tracheostomy in 8 (2.4%)versus9 (2.6%) (p=0.82). Survivors in the methylprednisolone group required a longer median (IQR) hospitalisation (15 (11)versus14 (11) days; p=0.005) and experienced an improvement in CRP levels, but not inPaO2/FIO2ratio, at days 7 and 14. There were no differences in disease progression at the prespecified time-points.ConclusionProlonged, higher dose methylprednisolone did not reduce mortality at 28 days compared with conventional dexamethasone in COVID-19 pneumonia.

Published
2022

3. Is early detection of late-onset Pompe disease a pneumologist's affair? A lesson from an Italian screening study

Author

Confalonieri M, Vitacca M, Scala R, Polverino M, Sabato E, Crescimanno G, Ceriana P, Antonaglia C, Siciliano G, Ring N, Zacchigna S, Salton F, Vianello A, Mattei A, De Michele F, Triolo L, Culla G, Canessa P, Girbino G, Lusuardi M, Perretta E, De Michelis C, Renda T., Confalonieri, Marco, Vitacca, Michele, Scala, Raffaele, Polverino, Mario, Sabato, Eugenio, Crescimanno, Grazia, Ceriana, Piero, Antonaglia, Caterina, Siciliano, Gabriele, Ring, Nadja, Zacchigna, Serena, Salton, Francesco, and Vianello, Andrea

Subjects
Adult, Lung Diseases, Male, 0301 basic medicine, medicine.medical_specialty, Biopsy, Maximal Respiratory Pressures, lcsh:Medicine, Late onset, Disease, 030105 genetics & heredity, Acute respiratory failure, Late Onset Disorders, 03 medical and health sciences, FEV1/FVC ratio, 0302 clinical medicine, Internal medicine, Diagnosis, Pulmonary Medicine, medicine, Humans, Pharmacology (medical), Respiratory system, Letter to the Editor, Genetics (clinical), Aged, Glycogen Storage Disease Type II, business.industry, Muscles, lcsh:R, Muscle weakness, alpha-Glucosidases, General Medicine, Middle Aged, Dried blood spot, Late-onset Pompe disease, Respiratory high dependency care unit, Noninvasive ventilation, Early Diagnosis, Italy, Respiratory failure, Female, Dried Blood Spot Testing, medicine.symptom, business, 030217 neurology & neurosurgery, Diagnosi
Abstract

Background Late-onset Pompe disease (LOPD) is a recessive disease caused by α-glucosidase (GAA) deficiency, leading to progressive muscle weakness and/or respiratory failure in children and adults. Respiratory derangement can be the first indication of LOPD, but the diagnosis may be difficult for pneumologists. We hypothesize that assessing the GAA activity in suspected patients by a dried blood spot (DBS) may help the diagnosis of LOPD in the pneumological setting. Population and methods We performed a multicenter DBS survey of patients with suspected LOPD according to a predefined clinical algorithm. From February 2015 to December 2017, 140 patients (57 ± 16 yrs., 80 males) were recruited in 19 Italian pneumological units. The DBS test was performed by a drop of blood collected on absorbent paper. Patients with GAA activity

Published
2019
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6. Low Arousal Threshold Estimation Predicts Failure of Mandibular Advancement Devices in Obstructive Sleep Apnea Syndrome

Author

Caterina Antonaglia, Gabriele Vidoni, Luca Contardo, Fabiola Giudici, Francesco Salton, Barbara Ruaro, Marco Confalonieri, Martina Caneva, Antonaglia, C., Vidoni, G., Contardo, L., Giudici, F., Salton, F., Ruaro, B., Confalonieri, M., and Caneva, M

Subjects
mandibular advancement devices (MADs), low arousal threshold (low ArTH), obstructive sleep apnea syndrome (OSAS), Clinical Biochemistry
Abstract

Introduction: The treatment of choice for obstructive sleep apnea syndrome (OSAS) is continuous positive airway pressure (CPAP). However, CPAP is usually poorly tolerated and mandibular advancement devices (MADs) are an alternative innovative therapeutic approach. Uncertainty still remains as to the most suitable candidates for MAD. Herein, it is hypothesized that the presence of low arousal threshold (low ArTH) could be predictive of MAD treatment failure. Methods: A total of 32 consecutive patients, with OSAS of any severity, who preferred an alternate therapy to CPAP, were treated with a tailored MAD aimed at obtaining 50% of their maximal mandibular advancement. Treatment response after 6 months of therapy was defined as AHI < 5 events per hour or a reduction of AHI ≥ 50% from baseline. Low ArTH was predicted based on the following polysomnography features, as previously shown by Edwards et al.: an AHI of 82.5% and a hypopnea fraction of total respiratory events of >58.3%. Results: There were 25 (78.1%) responders (p-value < 0.01) at 6 months. Thirteen patients (40.6%) in the non-severe group reached AHI lower than 5 events per hour. MAD treatment significantly reduced the median AHI in all patients from a median value of 22.5 to 6.5 (74.7% of reduction, p-value < 0.001). The mandibular advancement device reduced AHI, whatever the disease severity. A significant higher reduction of Delta AHI, after 6 months of treatment, was found for patients without low ArTH. Conclusions: Low ArTH at baseline was associated with a poorer response to MAD treatment and a lower AHI reduction at 6 months. A non-invasive assessment of Low ArTH can be performed through the Edwards’ score, which could help to identify an endotype with a lower predicted response to oral appliances in a clinical setting.

Published
2022
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7. A novel technique for conducting flexible bronchoscopy cryobiopsy under conscious sedation: An observational study.

Author

Salton F, Biolo M, Trotta L, Mondini L, Andrisano AG, Reccardini N, Confalonieri P, Antonaglia C, Confalonieri M, and Ruaro B

Subjects
Humans, Male, Female, Middle Aged, Aged, Cryosurgery methods, Cryosurgery instrumentation, Lung Diseases, Interstitial diagnosis, Lung Diseases, Interstitial pathology, Biopsy methods, Biopsy adverse effects, Biopsy instrumentation, Lung pathology, Bronchoscopy methods, Bronchoscopy adverse effects, Conscious Sedation methods
Abstract

Transbronchial lung cryobiopsy (TBCB) is a reliable method for obtaining histopathological findings in interstitial lung diseases. TBCB is traditionally performed during rigid bronchoscopy, positioning an endobronchial balloon blocker to facilitate bleeding management. Therefore, it can be challenging to implement in Centers without access to anesthesiologic support or dedicated beds for endoscopic procedures. We present a series of 11 patients who underwent 12 TBCBs using a flexible bronchoscope and a 5 Fr endobronchial blocker passing through an uncuffed endotracheal tube, under moderate sedation and spontaneous breathing. All procedures were carried out in an endoscopy suite, using fluoroscopy guidance but without requiring anesthesiologic assistance. TBCB was feasible in all cases, and it demonstrated similar or improved diagnostic yield (90.1%) and safety compared to rigid bronchoscopy. In 1 case, it was successfully repeated due to an inconclusive histological definition at the first attempt. The size of the samples was consistent with the literature, as it was the incidence of pneumothorax (16.6%). Four cases of moderate bleeding and 4 cases of severe bleeding were managed without further complications. To our knowledge, this is the first description of a technique allowing to perform TBCB through an artificial airway without need for either rigid bronchoscopy or general anesthesia. We believe this technique could make TBCB faster, cost-effective, and feasible even in resource-limited settings without compromising on safety. However, further studies are needed to validate these findings., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Published
2024
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8. Prolonged higher dose methylprednisolone versus conventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS).

Author

Salton F, Confalonieri P, Centanni S, Mondoni M, Petrosillo N, Bonfanti P, Lapadula G, Lacedonia D, Voza A, Carpenè N, Montico M, Reccardini N, Meduri GU, Ruaro B, Confalonieri M, Citton GM, Lapadula G, Bozzi C, Tavano S, Pozzan R, Andrisano AG, Jaber M, Mari M, Trotta L, Mondini L, Barbieri M, Ruggero L, Antonaglia C, Soave S, Torregiani C, Bogatec T, Baccelli A, Nalesso G, Re B, Pavesi S, Barbaro MPF, Giuliani A, Ravaglia C, Poletti V, Scala R, Guidelli L, Golfi N, Vianello A, Achille A, Lucernoni P, Gaccione AT, Romagnoli M, Fraccaro A, Malacchini N, Malerba M, Ragnoli B, Zamparelli AS, Bocchino M, Blasi F, Spotti M, Miele C, Piedepalumbo F, Barone I, Baglioni S, Dodaj M, Franco C, Andrani F, Mangia A, Mancini A, Carrozzi L, Rafanelli A, Casto E, Rogliani P, Ora J, Carpagnano GE, Di Lecce V, Tamburrini M, Papi A, Contoli M, Luzzati R, Zatta M, Di Bella S, Caraffa E, Francisci D, Tosti A, Pallotto C, De Rosa FG, Pecori A, Franceschini M, Carlin M, Orsini V, Spolti A, Inannace M, Santantonio T, Meli R, Sauro S, Fedeli C, Mangini E, Biolo G, Nunnari A, Pietrangelo A, Corradini E, Bocchi D, Boarini C, Zucchetto A, and Lanini S

Subjects
Adult, Humans, Methylprednisolone, SARS-CoV-2, COVID-19 Drug Treatment, Dexamethasone, Oxygen, Treatment Outcome, COVID-19
Abstract

Background: Dysregulated systemic inflammation is the primary driver of mortality in severe coronavirus disease 2019 (COVID-19) pneumonia. Current guidelines favour a 7-10-day course of any glucocorticoid equivalent to dexamethasone 6 mg daily. A comparative randomised controlled trial (RCT) with a higher dose and a longer duration of intervention was lacking., Methods: We conducted a multicentre, open-label RCT to investigate methylprednisolone 80 mg as a continuous daily infusion for 8 days followed by slow tapering versus dexamethasone 6 mg once daily for up to 10 days in adult patients with COVID-19 pneumonia requiring oxygen or noninvasive respiratory support. The primary outcome was reduction in 28-day mortality. Secondary outcomes were mechanical ventilation-free days at 28 days, need for intensive care unit (ICU) referral, length of hospitalisation, need for tracheostomy, and changes in C-reactive protein (CRP) levels, arterial oxygen tension/inspiratory oxygen fraction ( P aO 2 / F IO 2 ) ratio and World Health Organization Clinical Progression Scale at days 3, 7 and 14., Results: 677 randomised patients were included. Findings are reported as methylprednisolone (n=337) versus dexamethasone (n=340). By day 28, there were no significant differences in mortality (35 (10.4%) versus 41 (12.1%); p=0.49) nor in median mechanical ventilation-free days (median (interquartile range (IQR)) 23 (14) versus 24 (16) days; p=0.49). ICU referral was necessary in 41 (12.2%) versus 45 (13.2%) (p=0.68) and tracheostomy in 8 (2.4%) versus 9 (2.6%) (p=0.82). Survivors in the methylprednisolone group required a longer median (IQR) hospitalisation (15 (11) versus 14 (11) days; p=0.005) and experienced an improvement in CRP levels, but not in P aO 2 / F IO 2 ratio, at days 7 and 14. There were no differences in disease progression at the prespecified time-points., Conclusion: Prolonged, higher dose methylprednisolone did not reduce mortality at 28 days compared with conventional dexamethasone in COVID-19 pneumonia., Competing Interests: Conflict of interest: F. Salton, P. Confalonieri, S. Centanni, M. Mondoni, N. Petrosillo, D. Lacedonia, A. Voza, N. Carpenè, M. Montico, N. Reccardini, G.U. Meduri, B. Ruaro and M. Confalonieri have no conflicts of interest to disclose. P. Bonfanti received personal fees from ViiV Healthcare, Gilead, Janssen, Merck and Pfizer, not related to this work. G. Lapadula received personal fees from ViiV Healthcare and Pfizer, not related to this work., (Copyright ©The authors 2023.)

Published
2023
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9. Low Arousal Threshold Estimation Predicts Failure of Mandibular Advancement Devices in Obstructive Sleep Apnea Syndrome.

Author

Antonaglia C, Vidoni G, Contardo L, Giudici F, Salton F, Ruaro B, Confalonieri M, and Caneva M

Abstract

Introduction: The treatment of choice for obstructive sleep apnea syndrome (OSAS) is continuous positive airway pressure (CPAP). However, CPAP is usually poorly tolerated and mandibular advancement devices (MADs) are an alternative innovative therapeutic approach. Uncertainty still remains as to the most suitable candidates for MAD. Herein, it is hypothesized that the presence of low arousal threshold (low ArTH) could be predictive of MAD treatment failure. Methods: A total of 32 consecutive patients, with OSAS of any severity, who preferred an alternate therapy to CPAP, were treated with a tailored MAD aimed at obtaining 50% of their maximal mandibular advancement. Treatment response after 6 months of therapy was defined as AHI < 5 events per hour or a reduction of AHI ≥ 50% from baseline. Low ArTH was predicted based on the following polysomnography features, as previously shown by Edwards et al.: an AHI of 82.5% and a hypopnea fraction of total respiratory events of >58.3%. Results: There were 25 (78.1%) responders (p-value < 0.01) at 6 months. Thirteen patients (40.6%) in the non-severe group reached AHI lower than 5 events per hour. MAD treatment significantly reduced the median AHI in all patients from a median value of 22.5 to 6.5 (74.7% of reduction, p-value < 0.001). The mandibular advancement device reduced AHI, whatever the disease severity. A significant higher reduction of Delta AHI, after 6 months of treatment, was found for patients without low ArTH. Conclusions: Low ArTH at baseline was associated with a poorer response to MAD treatment and a lower AHI reduction at 6 months. A non-invasive assessment of Low ArTH can be performed through the Edwards’ score, which could help to identify an endotype with a lower predicted response to oral appliances in a clinical setting.

Published
2022
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11. Laser Speckle Contrast Analysis: Functional Evaluation of Microvascular Damage in Connective Tissue Diseases. Is There Evidence of Correlations With Organ Involvement, Such as Pulmonary Damage?

Author

Ruaro B, Bruni C, Wade B, Baratella E, Confalonieri P, Antonaglia C, Geri P, Biolo M, Confalonieri M, and Salton F

Abstract

Laser speckle contrast analysis (LASCA) is a non-contact technique able to quantify peripheral blood perfusion (PBP) over large skin areas. LASCA has been used to study hand PBP in several clinical conditions. These include systemic sclerosis (SSc) and systemic lupus erythematosus (SLE) and LASCA showed that PBP was significantly lower in these conditions than in healthy subjects (HS). Moreover, it has been demonstrated that LASCA is a safe technique also able to monitor digital ulcer perfusion and their evolution in SSc patients, during systemic and local treatment. The use of LASCA, coupled with reactivity tests is commonplace in the field of microvascular function research. Post-occlusive hyperemia reactivity (POHR) and local thermal hyperemia, associated with laser techniques are reliable tests in the evaluation of perfusion in SSc patients. Other studies used laser speckled techniques, together with acetylcholine and sodium nitroprusside iontophoresis, as specific tests of endothelium function. In conclusion, LASCA is a safe, non-contact reliable instrument for the quantification of PBP at skin level and can also be associated with reactivity tests to monitor disease progression and response to treatment in different connective tissue diseases., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Ruaro, Bruni, Wade, Baratella, Confalonieri, Antonaglia, Geri, Biolo, Confalonieri and Salton.)

Published
2021
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12. The Plasminogen System and Transforming Growth Factor-β in Subjects With Obstructive Sleep Apnea Syndrome: Effects of CPAP Treatment.

Author

Steffanina A, Proietti L, Antonaglia C, Palange P, Angelici E, and Canipari R

Subjects
Aged, Case-Control Studies, Continuous Positive Airway Pressure, Female, Humans, Male, Middle Aged, Oxygen blood, Severity of Illness Index, Sleep Apnea, Obstructive complications, Thrombophilia blood, Thrombophilia etiology, Plasminogen Activator Inhibitor 1 blood, Sleep Apnea, Obstructive blood, Sleep Apnea, Obstructive therapy, Tissue Plasminogen Activator blood, Transforming Growth Factor beta blood, Urokinase-Type Plasminogen Activator blood
Abstract

Background: Obstructive sleep apnea syndrome (OSAS) has emerged as a risk factor for cardiovascular disease. A prothrombotic state may affect coagulation and participate in the atherosclerotic process in subjects with OSAS. These alterations in coagulation seem to involve the plasminogen activation system. We evaluated the imbalances of the plasminogen activation system related to OSAS, and we assessed the effects of CPAP on the plasminogen activation system., Methods: Thirty-nine subjects were submitted to a home-based cardiorespiratory sleep study, and 14 healthy subjects (apnea-hypopnea index < 5) were used as controls. Serum levels of urokinase-type plasminogen activator (uPA), tissue-type plasminogen activator (tPA), plasminogen activator inhibitor-1 (PAI-1), and active transforming growth factor-β (TGF-β) were measured. These molecules were reassessed in only 17 of the subjects after 1 month of CPAP., Results: PAI-1 and tPA were significantly higher in the subjects with OSAS compared with the controls, whereas TGF-β and uPA levels were lower. PAI-1 showed a significant positive correlation with the apnea-hypopnea index, percentage of time spent at O2 saturation < 90%, and oxygen desaturation index, whereas TGF-β was inversely related to all 3 of these parameters. After the CPAP therapy, PAI-1 significantly decreased, whereas TGF-β showed a significant increase, although the values did not reach those of the controls. uPA and tPA did not show significant differences after the treatment., Conclusions: Our results suggest an imbalance of fibrinolysis related to OSAS and an improvement of the prothrombotic state after the CPAP treatment., (Copyright © 2015 by Daedalus Enterprises.)

Published
2015
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13. Keratin-14 expression in pneumocytes as a marker of lung regeneration/repair during diffuse alveolar damage.

Author

Ficial M, Antonaglia C, Chilosi M, Santagiuliana M, Tahseen AO, Confalonieri D, Zandonà L, Bussani R, and Confalonieri M

Subjects
Acute Lung Injury pathology, Acute Lung Injury physiopathology, Alveolar Epithelial Cells physiology, Animals, Biomarkers, Female, Humans, Male, Mice, Pulmonary Alveoli cytology, Pulmonary Alveoli physiopathology, Keratin-14 metabolism, Pulmonary Alveoli injuries, Regeneration, Respiratory Distress Syndrome pathology, Stem Cells physiology
Published
2014
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