Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial.

Post-COVID-19 interstitial lung disease (ILD) is a new entity that frequently causes pulmonary fibrosis and can become chronic. We performed a single-center parallel-group open-label pilot randomized clinical trial to investigate the efficacy and safety of cyclosporine A (CsA) in the development of ILD in the medium term among patients hospitalized with COVID-19 pneumonia. Patients were randomized 1:1 to receive CsA plus standard of care or standard of care alone. The primary composite outcome was the percentage of patients without ILD 3 months after diagnosis of pneumonia and not requiring invasive mechanical ventilation (IMV) (response without requiring IMV). The key secondary composite outcomes were the percentage of patients who achieve a response requiring IMV or irrespective of the need for IMV, and adverse events. A total of 33 patients received at least one dose of CsA plus standard of care (n = 17) or standard of care alone (n = 16). No differences were found between the groups in the percentage of patients who achieved a response without requiring IMV or a response requiring IMV. A higher percentage of patients achieved a response irrespective of the need for IMV in the CsA plus standard of care group although the RR was almost significant 2.833 (95% CI, 0.908-8.840; p = 0.057). No differences were found between the groups for adverse events. In hospitalized patients with COVID-19 pneumonia, we were unable to demonstrate that CsA achieved a significant effect in preventing the development of ILD. (EU Clinical Trials Register; EudraCT Number: 2020-002123-11; registration date: 08/05/2020).

Valor diagnóstico de la poligrafía respiratoria en pacientes con baja probabilidad de síndrome de apneas e hipopneas durante el sueño / Diagnostic value of respiratory polygraphy in patients with low probability of obstructive sleep apnea syndrome

Introducción y objetivo: La polisomnografía (PSG) es el método estándar para el diagnóstico del síndrome de apneas e hipopneas del sueño (SAHS). Es una técnica cara, compleja y de poca disponibilidad, por lo que la poligrafía respiratoria (PR) es de uso habitual. La PR no está validada en casos de baja probabilidad; sin embargo, la normativa vigente contempla el tratamiento conservador en caso de PR negativa. Nos hemos propuesto estudiar la prevalencia y gravedad del SAHS mediante PSG, en una muestra de pacientes con baja probabilidad y PR negativa. Material y métodos: Estudio retrospectivo, observacional, descriptivo y analítico de pacientes con baja probabilidad de SAHS y PR negativa a los que se les realizó posteriormente una PSG. Se registraron datos antropométricos, clínicos y características del sueño. Resultados: Ochenta y dos pacientes fueron incluidos. En el registro de la PSG se observó un incremento de hipopneas (137,8 ± 70,1 frente a 51,2 ± 38,4 [p < 0,05]) y del índice de apneas e hipopneas (27,8 ± 15,6 frente a 11,7 ± 7,1 [p < 0,05]), así como un aumento del 17% en la prevalencia de SAHS, de un 35% de casos graves y una disminución de un 41% de los casos leves. Conclusión: De acuerdo con los resultados de este estudio, la PR subestima de forma estadísticamente significativa la prevalencia y gravedad del SAHS en pacientes con baja probabilidad. Es necesario un adecuado proceso de estratificación de riesgo para la correcta indicación de pruebas diagnósticas, y recomendable realizar una PSG cuando se ha realizado una PR con resultado negativo en estos pacientes (AU)

Introduction and objective: Polysomnography (PSG) is the gold standard technic for the diagnosis of obstructive sleep apnea syndrome (OSAS). It is an expensive, complex and not always available technic, meaning that respiratory polygraphy (RP) has become usual. Although RP is not validated in low probability patients, Spanish guidelines recommend conservative treatment in patients with negative RP. We intended to study the prevalence and severity of OSAS through PSG in a sample of patients with low probability and negative RP. Material and methods:Retrospective, observational, descriptive and analytic study of low probability OSAS patients with negative RP in whom a PSG was performed. Anthropometric, clinical and sleep data were collected. Results: Eighty-two patients were included. After PSG, a greater number of hypopneas (137.8 ± 70.1 vs. 51.2 ± 38.4 [P < .05]) and apnea hypopnea index (27.8 ± 15.6 vs. 11.7 ± 7.1 [P < .05]) was observed, as well as an increment in OSAS prevalence of 17%, which was 35% in severe OSAS. In mild OSAS, there was a decrement of 41%. Conclusion: According with the results of this study, RP significantly underestimates the prevalence and severity of OSAS in low probability patients. While it is necessary to adequately stratify the OSAS probability in order to correctly indicate diagnosis tests, we recommend performing a PSG in low probability patients with negative RP (AU)

[Diagnostic value of respiratory polygraphy in patients with low probability of obstructive sleep apnea syndrome]. / Valor diagnóstico de la poligrafía respiratoria en pacientes con baja probabilidad de síndrome de apneas e hipopneas durante el sueño.

INTRODUCTION AND OBJECTIVE: Polysomnography (PSG) is the gold standard technic for the diagnosis of obstructive sleep apnea syndrome (OSAS). It is an expensive, complex and not always available technic, meaning that respiratory polygraphy (RP) has become usual. Although RP is not validated in low probability patients, Spanish guidelines recommend conservative treatment in patients with negative RP. We intended to study the prevalence and severity of OSAS through PSG in a sample of patients with low probability and negative RP. MATERIAL AND METHODS: Retrospective, observational, descriptive and analytic study of low probability OSAS patients with negative RP in whom a PSG was performed. Anthropometric, clinical and sleep data were collected. RESULTS: Eighty-two patients were included. After PSG, a greater number of hypopneas (137.8±70.1 vs. 51.2±38.4 [P<.05]) and apnea hypopnea index (27.8±15.6 vs. 11.7±7.1 [P<.05]) was observed, as well as an increment in OSAS prevalence of 17%, which was 35% in severe OSAS. In mild OSAS, there was a decrement of 41%. CONCLUSION: According with the results of this study, RP significantly underestimates the prevalence and severity of OSAS in low probability patients. While it is necessary to adequately stratify the OSAS probability in order to correctly indicate diagnosis tests, we recommend performing a PSG in low probability patients with negative RP.