Frontiers in medicine
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Pulmonary embolism (PE) is a frequent, life-threatening COVID-19 complication, whose diagnosis can be challenging because of its non-specific symptoms. There are no studies assessing the impact of diagnostic delay on COVID-19 related PE. The aim of our exploratory study was to assess the diagnostic delay of PE in COVID-19 patients, and to identify potential associations between patient- or physician-related variables and the delay. ⋯ The overall diagnostic delay significantly correlated with the physician-related delay (p < 0.0001), with the tendency to a worse outcome in long physician-related diagnostic delay (p = 0.04). The delay was related to the presence of fever, respiratory symptoms and high levels of lactate dehydrogenase. It is important to rule out PE as soon as possible, in order to start the right therapy, to improve patient's outcome and to shorten the hospitalization.
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Frontiers in medicine · Jan 2021
Paediatric Medicines in Europe: The Paediatric Regulation-Is It Time for Reform?
Objectives: In this paper, we investigated the effects of the European Paediatric Regulation (EC) N° 1901/2006 with respect to satisfying the paediatric therapeutic needs, assessed in terms of the increased number of paediatric medicinal products, new therapeutic indications in specific high-need conditions (neonates, oncology, rare disease, etc.) and increased number of paediatric clinical studies supporting the marketing authorisation. Methods: We analysed the paediatric medicinal products approved by the European Medicines Agency in the period January 2007-December 2019, by collecting the following data: year of approval, active substance, legal basis for the marketing authorisation, type of medicinal product (i.e., chemical, biological, or ATMP), orphan drug status, paediatric indication, Anatomical Therapeutic Chemical code (first-level), number and type of paediatric studies. Data were compared with similar data collected in the period 1996-2006. ⋯ The analysis of the clinical studies revealed that drugs with a Paediatric Investigational Plan were supported by 3.5 studies/drug while drugs without a Paediatric Investigational Plan were supported by only 1.6 studies/drug. Discussion: This report confirms that the expectations of the European Paediatric Regulation (EC) N° 1901/2006 have been mainly satisfied. However, the reasons for the limited development of paediatric medicines in Europe, should be further discussed, taking advantage of recent initiatives in the regulatory field, such as the Action Plan on Paediatrics, and the open consultation on EU Pharmaceutical Strategy.
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Frontiers in medicine · Jan 2021
Predictors of Failed Intrauterine Balloon Tamponade in the Management of Severe Postpartum Hemorrhage.
To identify the factors predicting intrauterine balloon tamponade (IUBT) failure for severe postpartum hemorrhage (PPH) after delivery, we conducted a retrospective cohort study of women who underwent IUBT for severe PPH after delivery from October 1, 2016 until September 30, 2017. The failure of IUBT was defined as the need of additional surgical procedures or uterine embolization. A total of 99,650 deliveries occurred during the study period. ⋯ Ultimately, these models identified multiple gestation, EBL, and PAS as independent risk factors for IUBT failure. In conclusion, IUBT is an effective method for severe PPH. The presence of factors affecting IUBT failure should be recognized early, and other modalities of management should be anticipated.
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Frontiers in medicine · Jan 2021
Measuring Core Body Temperature Using a Non-invasive, Disposable Double-Sensor During Targeted Temperature Management in Post-cardiac Arrest Patients.
Background: Precisely measuring the core body temperature during targeted temperature management after return of spontaneous circulation is mandatory, as deviations from the recommended temperature might result in side effects such as electrolyte imbalances or infections. However, previous methods are invasive and lack easy handling. A disposable, non-invasive temperature sensor using the heat flux approach (Double Sensor), was tested against the standard method: an esophagus thermometer. ⋯ Influences on the measurements of the Double Sensor by drugs administered could also be ruled out. Conclusions: This study could demonstrate that measuring the core body temperature with the non-invasive, disposable sensor shows excellent reliability during targeted temperature management after survived cardiac arrest. Nonetheless, clinical research concerning the implementation of the sensor in other fields of application should be supported, as well as verifying our results by a larger patient cohort to possibly improve the limits of agreement.
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Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is manifested by an acute respiratory distress syndrome (ARDS) with intense inflammation and endothelial dysfunction leading to particularly severe hypoxemia. We hypothesized that an impaired hypoxic pulmonary vasoconstriction aggravates hypoxemia. The objective of the study was to test the effect of two pulmonary vasoactive drugs on patient oxygenation. ⋯ Conclusion: Combining iNO and infused almitrine improved the short-term oxygenation in patients with COVID-19-related ARDS. This combination may be of interest when first-line therapies fail to restore adequate oxygenation. These findings argue for an impaired pulmonary hypoxic vasoconstriction in these patients.