ΠΦΥ -Εκπαίδευση > Συζητήσεις πάνω σε ιατρικά θέματα
Κορονοϊός ( COVID-19 )
Argirios Argiriou:
NEJM Journal Watch.
January 29, 2021
Tocilizumab for Patients with Severe COVID-19: The Confusion Continues
Rajesh T. Gandhi, MD reviewing Veiga VC et al. BMJ 2021 Jan 20
In a small Brazilian trial, tocilizumab did not improve clinical outcomes and might have increased mortality.
Elevated interleukin-6 (IL-6) levels are linked to worse outcomes in patients with COVID-19, but it remains unclear whether blocking this cytokine confers clinical benefit. Although large randomized trials have failed to show that tocilizumab, an anti–IL-6 receptor antibody, reduces mortality, some studies have suggested that the agent lowers risk for progression to mechanical ventilation (NEJM JW Infect Dis Jan 4 2021; [e-pub] and N Engl J Med 2020 Dec 17; [e-pub]) and shortens time to hospital discharge. Now, a small randomized trial in Brazil adds to the confusion.
In all, 129 patients requiring supplemental oxygen or mechanical ventilation who also had elevated inflammatory biomarkers were randomized to receive tocilizumab plus standard care or standard care alone. The trial was stopped early because of substantially higher mortality at day 15 in the tocilizumab group (17%) compared with the standard care group (3%). By day 28, the difference in mortality between the tocilizumab group and standard care group was no longer statistically significant (21% and 9%; P=0.07).
COMMENT
This small study did not demonstrate any benefit of tocilizumab and raised the possibility of increased mortality. Notably, standard care in this trial often included corticosteroids, but also drugs now known to lack benefit (e.g., hydroxychloroquine, azithromycin); remdesivir was not available. Larger trials have not shown excess risk for death or adverse events with tocilizumab, so the current study appears to be an outlier. We eagerly await publication of the REMAP-CAP trial results (preliminary findings from this large randomized trial indicate a reduction in mortality when tocilizumab is administered within 24 hours of initiating organ support in an intensive care unit). Whether tocilizumab has clinical benefit when given to the right patient at the right time is still being fiercely debated.
EDITOR DISCLOSURES AT TIME OF PUBLICATION
Disclosures for Rajesh T. Gandhi, MD at time of publication
Consultant/Advisory Board Scientific advisory board: Merck
Grant/Research Support NIH
Editorial Boards UpToDate; Partners ID Images
Leadership Positions in Professional Societies Department of Health and Human Services, Antiretroviral Guidelines for Adults and Adolescents (Scientific Member);HIV Medicine Association (Chair-Elect); International Antiviral Society-USA (Guidelines Committee)
CITATION(S):
Veiga VC et al. Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: Randomised controlled trial. BMJ 2021 Jan 20; 372:n84. (Δεν είναι ορατοί οι σύνδεσμοι (links).
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Argirios Argiriou:
02/02/2021
Αν και δικό τους εμβόλιο (ΑγγλοΣουηδικό), το Σουηδικό Υπουργείο Υγείας συνιστά το εμβόλιο της Astra Zeneca να ΜΗΝ δίδεται σε > 65 ετών. Θεωρούν ότι δεν είναι αρκετά αποτελεσματικό για τις ηλικίες άνω των 65 ετών.
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GirousisN:
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Εγγραφή ή Είσοδος02/02/2021
Αν και δικό τους εμβόλιο (ΑγγλοΣουηδικό), το Σουηδικό Υπουργείο Υγείας συνιστά το εμβόλιο της Astra Zeneca να ΜΗΝ δίδεται σε > 65 ετών. Θεωρούν ότι δεν είναι αρκετά αποτελεσματικό για τις ηλικίες άνω των 65 ετών.
Δεν είναι ορατοί οι σύνδεσμοι (links).
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--- Τέλος παράθεσης ---
Τα στοιχεία που δημοσίευσε το Lancet για το εμβόλιο της Astra δεν χωράνε αμφισβήτηση.
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Το ένα μετά το άλλο τα ευρωπαϊκά κράτη και όπως φαίνεται θα ακολουθήσει και η Ελλάδα ,δεν θα προσφέρουν το συγκεκριμένο εμβόλιο σε > 65 ετών.
Μένει να καθορισθεί το μεσοδιάστημα των 2 δόσεων.
Argirios Argiriou:
Η πρηνής (μπρούμυτα) θέση όσων είναι στην ΜΕΘ με COVID-19 ναι μεν έχει πλεονεκτήματα αλλά όμως αυξάνει και τον κίνδυνο για Meralgia Paresthetica.
Meralgia paresthetica after prolonged prone position at the intensive care unit among COVID-19 patients. A case report
Meralgia paresthetica (MP) is an entrapment syndrome that may cause loss of sensation, numbness, paresthesia and pain within the distribution of the lateral femoral cutaneous nerve. This condition is more common in persons with diabetes mellitus, obesity and in old age. MP has previously been described in patients that have undergone surgery in the prone position (PP) and in a case report of a patient with ARDS (Acute Respiratory Distress Syndrome) who was cared for in the intensive care unit (ICU). Due to the COVID-19 pandemic PP has been widely used for periods of 12-16 hours to improve oxygenation. At the rehabilitation unit at our hospital, we have identified cases of MP in patients with COVID-19 that have required this type of positioning for long periods in the ICU. We would like to draw attention to the fact that there is a risk of peripheral nerve injury in the event of prolonged PP and recommend extra controls, careful positioning and extra padding at the areas where peripheral nerves may be exposed to pressure.
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Σχετικά με το τι είναι η Meralgia Paresthetica:
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Argirios Argiriou:
Μια νέα μελέτη στο MMWR αναφέρει 21 περιπτώσεις αναφυλαξίας στις πρώτες 1.9 εκατ. δόσεις Pfizer που χορηγήθηκαν στις Ηνωμένες Πολιτείες. Αυτό μεταφράζεται σε 11.1 περιπτώσεις αναφυλαξίας ανά 1 εκατομμύρια δόσεις εμβολίου COVID. Για να το βάλουμε σε πλαίσιο, για εμβολιασμό γρίπης, το ποσοστό αναφυλαξίας είναι μόνο 1.3 ανά εκατομμύριο. Το εμβόλιο της Moderna έχει συνδεθεί και αυτό με την αναφυλαξία.
27/01/2021 Medscape.
The First 30 Minutes: Anaphylaxis After COVID Vaccination
We now have two mRNA COVID vaccines.
For both, a two-dose series of the same vaccine is more than 90% effective. Pfizer/ BioNTech's mRNA COVID vaccine is FDA authorized for those 16 and older. Moderna's mRNA COVID vaccine is authorized for those 18 and older.
The phase 3 studies on both vaccines are huge: nearly 44,000 for the Pfizer vaccine and 30,000 participants for the Moderna vaccine. In these large trials, no cases of anaphylaxis were observed following administration of either vaccine. But remember the headlines about severe allergic reactions to Pfizer's vaccine in the UK? We're seeing them here in the US, too.
A new study in MMWR reports on 21 cases of anaphylaxis in the first 1.9 million Pfizer doses administered in the United States. This translates to 11.1 cases of anaphylaxis per 1 million COVID vaccine doses. To put this into context, for flu vaccination, the anaphylaxis rate is only 1.3 per million. Moderna's vaccine has been linked to anaphylaxis, too.
CDC's Dr Nancy Messonnier says that "even at 11 cases per million doses administered, it's a very safe vaccine... it's still a good value proposition for someone to get vaccinated."
Here's a head-to-head comparison of mRNA vaccine components. The ingredients for each are a little different (Table 1).
Each vaccine has four lipid ingredients that make up its protective lipid nanoparticle, forming a cushion around fragile mRNA to protect it and give it time to do its job.
Each vaccine also contains an array of salts, sugars, and buffers. Sugars keep the vaccine from clumping in the vial.
Neither vaccine contains eggs, gelatin, latex, or preservatives. Vaccine vial stoppers don't contain latex either.
Both vaccines contain polyethylene glycol (PEG).
Precautions and Contraindications
Here is CDC's guidance on COVID vaccines for patients with a history of allergies. This color-coded table provides a nice, quick-look summary (Table 2).
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