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Home pharmacological therapy in early COVID-19 to prevent hospitalization and reduce mortality: Time for a suitable proposal.
Pandolfi, S, Chirumbolo, S, Ricevuti, G, Valdenassi, L, Bjørklund, G, Lysiuk, R, Doşa, MD, Lenchyk, L, Fazio, S
Basic & clinical pharmacology & toxicology. 2022;(2):225-239
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Abstract
The COVID-19 pandemic is a highly dramatic concern for mankind. In Italy, the pandemic exerted its major impact throughout the period of February to June 2020. To date, the awkward amount of more than 134,000 deaths has been reported. Yet, post-mortem autopsy was performed on a very modest number of patients who died from COVID-19 infection, leading to a first confirmation of an immune-thrombosis of the lungs as the major COVID-19 pathogenesis, likewise for SARS. Since then (June-August 2020), no targeted early therapy considering this pathogenetic issue was approached. The patients treated with early anti-inflammatory, anti-platelet, anticoagulant and antibiotic therapy confirmed that COVID-19 was an endothelial inflammation with immuno-thrombosis. Patients not treated or scarcely treated with the most proper and appropriate therapy and in the earliest, increased the hospitalization rate in the intensive care units and also mortality, due to immune-thrombosis from the pulmonary capillary district and alveoli. The disease causes widespread endothelial inflammation, which can induce damage to various organs and systems. Therapy must be targeted in this consideration, and in this review, we demonstrate how early anti-inflammatory therapy may treat endothelia inflammation and immune-thrombosis caused by COVID-19, by using drugs we are going to recommend in this paper.
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The Problem of Home Therapy during COVID-19 Pandemic in Italy: Government Guidelines versus Freedom of Cure?
Fazio, S, Cosentino, M, Marino, F, Pandolfi, S, Zanolin, E, Bellavite, P
Journal of pharmacy and pharmacology research. 2022;(3):100-114
Abstract
After starting in late 2019, COVID-19 spread worldwide, and Italy was one of the first Western nations to be seriously affected. At that time, both the virus and the disease were little known and there were no Evidence-Based Medicine indications for treatment. The Italian Health Ministry guidelines claimed that, unless oxygen saturation fell to <92%, no pharmacological treatment was necessary during the first 72 hours, other than on a purely symptomatic basis, preferably with paracetamol. As later confirmed, that delay in therapeutic intervention may have been responsible for numerous hospital admissions and a very high lethality (3.5 %). To try to remedy this situation, several volunteer groups were formed, managing to promptlycure thousands of patients at home with non-steroidal anti-inflammatory drugs and a variety of re-purposed drugs (principally hydroxychloroquine, ivermectin) and supplements (such as antioxidants, polyphenols and vitamin D). Although not documented by any randomized controlled studies, these approaches were nonetheless based on the best available evidence, were aimed at addressing otherwise unmet major needs and produced a significant reduction of hospitalizations, of symptom duration, and a complete recovery from the disease compared with late treatment, according to some retrospective observational studies and the clinical experience of many physicians. A prompt discussion, with a clear and open exchange between healthcare Institutions and the said groups of voluntary physicians, could clarify the most effective approaches to reduce the number of hospitalizations and the lethality of this disease.
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COVID-19 Medical and Pharmacological Management in the European Countries Compared to Italy: An Overview.
Pandolfi, S, Valdenassi, L, Bjørklund, G, Chirumbolo, S, Lysiuk, R, Lenchyk, L, Doşa, MD, Fazio, S
International journal of environmental research and public health. 2022;(7)
Abstract
(1) Background: Italy accounts for more than 150,000 deaths due to the COVID-19 pandemic, leading the top rank in SARS-CoV-2-caused deceases in Europe. A survey on the different ways by which the COVID-19 pandemic emergency was managed in the foreign European countries compared to Italy is the purpose of this paper. (2) Methods: A literature search and various mathematical algorithms to approach a rank scoring scale were used to describe in detail the different approaches used by European countries to manage the COVID-19 pandemic emergency. (3) Results: The study showed that Italy stands at the bottom ranking for COVID-19 management due to its high mortality rate. Possible causes of the observed huge numbers of hospitalization and deaths were (a) the demographic composition of the European country; (b) its decentralized healthcare system organization; (c) the role of correct pharmacology in the early stages before hospitalization. Post-mortem examinations were of paramount importance to elucidate the etiopathogenesis of COVID-19 and to tailor a suitable and proper therapy in the early symptomatic stages of COVID-19, preventing hospitalization. (4) Conclusions: Factors such as the significant impact on elderly people, the public health organization prevalently state-owned and represented mainly by hospitals, and criticism of the home therapy approach toward SARS-CoV-2-infected people, may have concurred in increasing the number of COVID-19 deaths in Italy.
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Evolution of Extra Virgin Olive Oil Quality under Different Storage Conditions.
Mousavi, S, Mariotti, R, Stanzione, V, Pandolfi, S, Mastio, V, Baldoni, L, Cultrera, NGM
Foods (Basel, Switzerland). 2021;(8)
Abstract
The extent and conditions of storage may affect the stability and quality of extra virgin olive oil (EVOO). This study aimed at evaluating the effects of different storage conditions (ambient, 4 °C and -18 °C temperatures, and argon headspace) on three EVOOs (low, medium, and high phenols) over 18 and 36 months, analyzing the main metabolites at six time points. The results showed that low temperatures are able to maintain all three EVOOs within the legal limits established by the current EU regulations for most compounds up to 36 months. Oleocanthal, squalene, and total phenols were affected by storage temperatures more than other compounds and degradation of squalene and α-tocopherol was inhibited only by low temperatures. The best temperature for 3-year conservation was 4 °C, but -18 °C represented the optimum temperature to preserve the organoleptic properties. The present study provided new insights that should guide EVOO manufacturers and traders to apply the most efficient storage methods to maintain the characteristics of the freshly extracted oils for a long conservation time.
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Retrospective Study of Outcomes and Hospitalization Rates of Patients in Italy with a Confirmed Diagnosis of Early COVID-19 and Treated at Home Within 3 Days or After 3 Days of Symptom Onset with Prescribed and Non-Prescribed Treatments Between November 2020 and August 2021.
Fazio, S, Bellavite, P, Zanolin, E, McCullough, PA, Pandolfi, S, Affuso, F
Medical science monitor : international medical journal of experimental and clinical research. 2021;:e935379
Abstract
BACKGROUND This retrospective study aimed to investigate outcomes and hospitalization rates in patients with a confirmed diagnosis of early COVID-19 treated at home with prescribed and non-prescribed treatments. MATERIAL AND METHODS The medical records of a cohort of 158 Italian patients with early COVID-19 treated at home were analyzed. Treatments consisted of indomethacin, low-dose aspirin, omeprazole, and a flavonoid-based food supplement, plus azithromycin, low-molecular-weight heparin, and betamethasone as needed. The association of treatment timeliness and of clinical variables with the duration of symptoms and with the risk of hospitalization was evaluated by logistic regression. RESULTS Patients were divided into 2 groups: group 1 (n=85) was treated at the earliest possible time (<72 h from onset of symptoms), and group 2 (n=73) was treated >72 h after the onset of symptoms. Clinical severity at the beginning of treatment was similar in the 2 groups. In group 1, symptom duration was shorter than in group 2 (median 6.0 days vs 13.0 days, P<0.001) and no hospitalizations occurred, compared with 19.18% hospitalizations in group 2. One patient in group 1 developed chest X-ray alterations and 2 patients experienced an increase in D-dimer levels, compared with 30 and 22 patients, respectively, in group 2. The main factor determining the duration of symptoms and the risk of hospitalization was the delay in starting therapy (P<0.001). CONCLUSIONS This real-world study of patients in the community showed that early diagnosis and early supportive patient management reduced the severity of COVID-19 and reduced the rate of hospitalization.
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Cooperative integration between HEDGEHOG-GLI signalling and other oncogenic pathways: implications for cancer therapy.
Pandolfi, S, Stecca, B
Expert reviews in molecular medicine. 2015;:e5
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Abstract
The HEDGEHOG-GLI (HH-GLI) signalling is a key pathway critical in embryonic development, stem cell biology and tissue homeostasis. In recent years, aberrant activation of HH-GLI signalling has been linked to several types of cancer, including those of the skin, brain, lungs, prostate, gastrointestinal tract and blood. HH-GLI signalling is initiated by binding of HH ligands to the transmembrane receptor PATCHED and is mediated by transcriptional effectors that belong to the GLI family, whose activity is finely tuned by a number of molecular interactions and post-translation modifications. Several reports suggest that the activity of the GLI proteins is regulated by several proliferative and oncogenic inputs, in addition or independent of upstream HH signalling. The identification of this complex crosstalk and the understanding of how the major oncogenic signalling pathways interact in cancer is a crucial step towards the establishment of efficient targeted combinatorial treatments. Here we review recent findings on the cooperative integration of HH-GLI signalling with the major oncogenic inputs and we discuss how these cues modulate the activity of the GLI proteins in cancer. We then summarise the latest advances on SMO and GLI inhibitors and alternative approaches to attenuate HH signalling through rational combinatorial therapies.
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Physical exercise with weight reduction lowers blood pressure and improves abnormal left ventricular relaxation in pharmacologically treated hypertensive patients.
Cocco, G, Pandolfi, S
Journal of clinical hypertension (Greenwich, Conn.). 2011;(1):23-9
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Abstract
In spite of appropriate pharmacologic therapy, many hypertensive patients develop an abnormal left ventricular relaxation with preserved systolic function. This cardiac dysfunction increases the risk of cardiovascular complications. The authors assessed the therapeutic effects of an intervention with exercise training and weight reduction in patients with pharmacologically well-treated hypertension who had abnormal left ventricular relaxation with normal systolic function. Eighty-eight (44%) of 202 medically treated hypertensive patients had abnormal ventricular relaxation with normal ejection fraction. These patients were randomized to either a 6-month intervention program (cycle ergometer training twice a day for 5 days a week and a hypocaloric diet) or a control program (unchanged pharmacologic therapy without exercise and diet. Body weight, blood pressure, New York Heart Association class, glomerular filtration rate, and exercise capacity and workload were measured. Cardiac function was assessed by measuring N-terminal pro-B-type natriuretic peptide values, the electrocardiographic QT dispersion interval, and echocardiography (left atrial size, Doppler-derived E/A ratio, and mitral deceleration time). Physical exercise with weight reduction reduced blood pressure, decreased cardiovascular risks, and improved abnormal left ventricular relaxation. Measuring left atrial size is the best method for assessing changes in left ventricular relaxation with preserved systolic function.