Lucrezia Dell’Olio

Background: Spasticity is a common feature of Upper Motoneuron Syndrome and is frequently treated with intrathecal baclofen (ITB) when oral therapy is ineffective or poorly tolerated. Different baclofen formulations are available for intrathecal use, but evidence regarding their clinical equivalence in patients requiring high daily doses remains limited. Methods: Thirty adult patients (mean age 37 ± 5.8 years) receiving long-term ITB therapy were switched from four vials of baclofen 10 mg/5 mL to a single vial of baclofen 40 mg/20 mL, while maintaining the same total drug amount and reservoir concentration. Patients were divided into two groups: in 15 patients, the daily baclofen dose was maintained unchanged, while in the remaining 15 patients a 10% dose reduction was attempted. Clinical outcomes were assessed at baseline and during follow-up using validated scales for spasticity, pain, and functional status. Results: In patients with unchanged daily dosing, no clinically relevant differences were observed in spasticity, pain, or functional independence after switching formulation, supporting clinical equivalence between the two preparations. Conversely, the 10% dose reduction proved clinically unsustainable in patients requiring high daily doses and required restoration of baseline dosing in all cases. No adverse events or formulation-related complications were observed. Conclusions: Switching to baclofen 40 mg/20 mL is safe and clinically equivalent to the conventional 10 mg/5 mL formulation when the daily dose is maintained unchanged. Dose reduction appears unsuitable in patients requiring high daily intrathecal baclofen doses.

Discovering novel risk and prognostic factors for COVID-19 may help not only in reducing severity and mortality but also in creating targeted therapies considering patients’ individual features. Liver fibrosis is considered a complication in Non-alcoholic Fatty Liver Disease (NAFLD), it is a feature of steatohepatitis (NASH), and it has already been related to an increased risk for a wide range of diseases. Here, we aimed to define if any parameter assessing metabolic status has predictive power in identifying inpatients at risk for poorer prognosis and an increased mortality from COVID-19. This retrospective study was conducted at the Sub-Intensive Medicine Care Unit of the Presidio Maxi-Emergenze Fiera del Levante, Azienda Ospedaliero-Universitaria Policlinico di Bari, Italy. We evaluated 271 inpatients with moderate-to-severe SARS-CoV-2-related respiratory failure by comparing biochemical features and non-invasive liver fibrosis scores among discharged, transferred to Intensive Care Units (ICU) and non-survivor patients. Moreover, by performing ROC curves, we defined cut-off values to predict mortality and disease severity for each score. We found that non-invasive scores of liver fibrosis, obtained at day of admission, such as AAR (p < 0.001), FIB-4 and mFIB-4, FORNS, and AARPRI (p < 0.05) strongly predict not only in-hospital mortality but also the length of hospitalization and eventual admission to ICU. FIB-4 was the best score to identify non-survivor patients (sensitivity of 80% and specificity of 63%) and predict the need for ICU or mortality (71% of sensitivity and 65% of specificity), with a cut-off value of 1.94. Therefore, we present the predictive power and the cut-off values of several liver fibrosis scores here for disease severity and mortality in SARS-CoV-2 in-patients and we proposed the use of the present scores to identify ab initio the clinical therapeutic and diagnostic protocols for high-risk patients.