2020 NEJM Weight Study Inventory TOP10 Mays reviewed

As libraryhub.nejm.org drew to a close in 2020, Mays Medical took stock of ten major studies published in the journal NEJM in 2020, including research on effective drugs and vaccines for new coronary therapy, antibiotic therapy for appendicitis, and weekly injections of insulin icodec.
take a look at the safety and ability of the 1.BNT162b2 mRNA Covid-19 vaccine Study Details: NEJM: Pfizer/BioNTech New Crown mRNA Vaccine Effectiveness 95%! The FDA authorized emergency applications on December 2nd, and the UK was the first to approve a new crown vaccine developed jointly by Pfizer-BioNTech for emergency use, and this week it was widely vaccinated in the UK.
fact, the UK is based on the results of phase III clinical trials of the vaccine.
the findings were published in NEJM, and the FDA's expert committee voted 17-4 to recommend emergency approval for Pfizer/BioNTech's new crown vaccine, BNT162b2.
previously revealed that the vaccine's phase 3 trial recruited 43,661 volunteers, 170 of whom developed symptomatic new coronavirus infections.
162 of them came from the placebo group, and only eight received the vaccine.
10 cases of severe infection in the trial, 9 of which belonged to the placebo group, suggesting that the vaccine could prevent serious and mild diseases.
, the vaccine showed a 95 percent effective rate in preventing new viral infections with symptoms.
, the study's Data Monitoring Committee (DMC) has not reported any serious vaccine-related safety concerns.
This report is the full version of the data, which is an ongoing cross-border, placebo-controlled, observer-blind, key efficacy trial in which people aged 16 years or older were randomly assigned a 1:1 ratio to receive two placebos or BNT162b2 at 21-day intervals.
candidate vaccine (30 micrograms per dose).
BNT162b2 is a lipid nanoparticle preparation, nucleoside modified mRNA vaccine, can be encoded before fusion stable membrane anchor SARS-CoV-2 full-length prick protein.
end point is the efficacy and safety of the vaccine against laboratory-confirmed Covid-19.
results showed that a total of 43,548 participants were randomly grouped, of whom 43,448 received injections: BNT162b2 injection 21720 and placebo injection 21728.
of the subjects who received BNT162b2 therapy for the second time, at least 7 had Covid-19 at least 7 days after the second dose, and 162 of the subjects who received a placebo.
the effective rate of preventing Covid-19 with BNT162b2 was 95% (confidence interval was 95%, from 90.3 to 97.6).
similar vaccine efficacy (usually 90 to 100 per cent) was observed in subgroups defined by age, sex, race, race, baseline body mass index and coexistence conditions.
subgroup analysis showed that the BNT162b2 vaccine had good protective effect on subjects of different age groups (≥16 years), sex, race and combined underlying diseases.
and from 12 days after the first shot of the vaccine, BNT162b2 can play a certain protective role for the inoculator, but still both injections are the best effect.
of the 10 severe Covid-19 severe cases that occurred after the first dose, 9 were in placebo recipients and 1 in BNT162b2 recipients.
safety characteristics of BNT162b2 are short-term, mild to moderate pain, fatigue and headache at the injection site.
the risk of serious adverse events, similar in the vaccine and placebo groups.
So far, serious adverse events associated with the vaccine (about 1%) have been rarely observed, with the most common adverse events being mild-moderate pain, fatigue and headaches at the injection site, which is normal after vaccination, although in the UK, where the vaccine has been used, there has been news of allergic reactions in patients with a history of allergies.
local/systemic adverse events after vaccination in patients of different ages Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.N Engl J Med . 2020 Dec 10. Doi: 10.1056/NEJMoa2034577 Studies suggest that the two-dose treatment of BNT162b2 provides 95% protection against Covid-19 for people over 16 years of age.
for an average of 2 months is similar to that of other viral vaccines.
All in all, BNT162b2 represents excellent protection and short-term safety, although this is only about 2 months of follow-up data, and the paper does not mention the relationship between subjects and antibody titration and protective pot, the results of which have yet to be further observed.
2. The safety and immunogenicity of two RNA-based Covid-19 vaccine candidates are detailed: NEJM: Nucleoside modified RNA candidate vaccine BNT162b1, BNT162b2 for the prevention of SARS-CoV-2 infection and the resulting disease COVID-19 has affected millions of people worldwide.
of vaccine candidates are under development, but no vaccines are currently available.
previous trials in Germany and the United States have reported safety and immunogenicity data for the period following the vaccination of young adults with candidate vaccine BNT162b1.
This study is an ongoing, placebo-controlled, incremental Phase I trial in the United States involving healthy adults aged 18 to 55 and 65 to 85 who received a placebo or two lipid nanoparticle formulations with a nucleoside modified RNA candidate vaccine (NSM BNT162b1, which encodes the SARS-CoV-2 receptor domain of the trimer, or BNT162b2, encodes a full-length spike of SARS-CoV-2 anchored by a membrane, which stabilizes in the pre-fusion configuration.
results showed that the systemic reaction rate and severity of BNT162b2 were lower than that of BNT162b1, especially in the elderly.
In both young adults and older adults, the two candidate vaccines induced similar dose-dependent SARS-CoV-2 medium and geometric average titrations, both similar to or higher than the geometric average titration in recovery serum disk samples of SARS-CoV-2-2-infected people.
Pfizer and BioNTech believe BNT162b2 can be a prime candidate based on all available data from preclinical and clinical studies, including immunoresist and tolerance parameters.
3. Redsiway's Final Report on the Therapeutic Effects of COVID-19 Details: The Therapeutic Effects of Redsiway on COVID-19 - Final Report NEJM: Redsywe can Shorten recovery time for patients with neo-coronary pneumonia NEJM: Barrettini United Redsiwe Several treatment options for Covid-19 have been evaluated, but no antiviral agents have been evaluated to accelerate the recovery of SARS-CoV-2 in hospital patients with neocostitis, which was first identified as the cause of respiratory disease in December 2019, known as coronavirus disease or Covid-19 in 2019.
since the publication of the researchers' preliminary report, dexamisson has been shown to reduce mortality (25.7 percent in the conventional care group and 22.9 percent in the dexamisson group ;P and 0.001).
Redsivir is an inhibitor of viral RNA-dependent RNA polymerases that inhibits the activity of SARS-CoV-1 and Middle Eastern Respiratory Syndrome (MERS-CoV) in vitro and was one of the candidates for the early treatment of Covid-19.
to assess its clinical efficacy and safety, the researchers designed a randomized double-blind, placebo-controlled trial in patients hospitalized with lower respiratory symptoms.
patients were randomly assigned to two groups receiving rydesiwe (200 mg load dose on the first day, 100 mg per day for a maximum of 9 consecutive days) or a placebo for up to 10 consecutive days.
indicators of observation are recovery time, which is based on discharge from hospital or hospitalization for infection control purposes only.
in this clinical trial, a total of 1,062 patients were randomly grouped (541 of whom were classified as Redsiwell and 521 as placebos).
the medium recovery time was 10 days for patients receiving Redsyve (95% confidence interval (CI) was 9 to 11), while the medium recovery time for patients receiving placebo was 15 days (95% CI was 13 to 18).
In an analysis using a proportional odd model of the ratio of eight types of prologues, they found that patients who received redsiwe were more likely to see clinical improvement on the 15th day than those who received a placebo (the advantage ratio was 1.5; 95 percent CI (1.2 to 1.9, adjusted for the severity of the actual disease).
Kaplan-Meier estimates that by the 15th day, Redsyway had a mortality rate of 6.7 per cent, a placebo group of 11.9 per cent, Redsyway a mortality rate of 11.4 per cent and a placebo group of 15.2 per cent (risk ratio, 0.73; 95 per cent CI, 0.52 to 1.03).
131 (24.6 per cent) of the 532 patients treated with Redsyve had severe adverse events, while 163 of the 516 patients receiving placebo had serious adverse events (31.6 per cent).
the cumulative recovery rate analyzed by Kaplan-Meier, Remdesivir for The Treatment of Covid-19 - Final Report.NEJM.DOI: 10.1056/NEJMoa2007764 The results of this study confirm that Redsivir can effectively shorten the recovery time of Covid-19 hospitalized patients with symptoms of lower respiratory tract infections.
4.AHA Heavyweight: Devasalban for Atrial Fibrillation patients using biological valves for two-tip valves See: NEJM: The efficacy of Deva Saban after catheter aortic valve replacement was published simultaneously with NEJM at the 2020 Annual Meeting of the American Heart Association (AHA) a multi-center, non-poor, randomized controlled clinical trial results from Brazil.
The paper suggests that in patients with atrial fibrillation using biological valves, devassalban is no better than huafarin in terms of the average time to the on-the-course occurrence of major outcomes (death at 12 months, major cardiovascular events, or haemorrhage).
Devasalban has been effective in preventing venous thrombosis (VTE), treating deep vein thrombosis (DVT) in adults, reducing the risk of DVT recurrence and pulmonary embolism (PE) after acute DVT, and can also be used to prevent stroke and systemic embolism in high-risk populations, the researchers examined The efficacy of devassalban in cardiovascular events in patients with atrial fibrillation using biological valves The study involved 1,005 patients in 49 medical centres in Brazil, and devassalbans experienced the first major endpoint events after an average of 347.5 days of treatment vs. an average of 340.1 days in the Huafarin group.
17 deaths from cardiovascular causes or thromboembolism in patients in the Devasa group (3.4%) vs 26 cases in the Huafarin group (5.1%).
devassal group had a stroke rate of 0.6% vs Huafarin group of 2.4%.
7 cases (1.4%) of patients in the Devasa group and 13 cases (2.6%) in the Huafarin group.
the occurrence of other serious adverse events between the two groups is similar.
the main results of Kaplan-Meier's analysis, Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve. New England Journal of Medicine, (), NEJMoa2029603–. DOI:10.1056/NEJMoa2029603 In patients with atrial fibrillation using biological valves, Devasalban therapy was superior to warfarin in reducing the risk of death, major cardiovascular events, or haemorrhage within 12 months.
Devasalban is a promising alternative to this type of patient because it does not require monitoring of INR and is more anticoagulant and less affected by food or accompanying drugs than warfarin.
5.ADAURA study oghithinib significantly prolongs disease-free survival Details: NEJM: Oghidini as EGFR mutation-positive NSCLC postoperative ancillary therapy, patients significantly benefit from third-generation EGFR-TKI Oghithini is a clinical first-line treatment for patients with EGFR mutation-positive late NSCLC, and ADAURA studies have shifted the role of Oghithini to postoperative ancillary therapy, adding more clinical roles to Oghitini and benefiting more patients.
On September 20, the results of the ADAURA study were published at the 2020 ESMO Annual Meeting in the form of Latitude Breaking Abstracts (LBA), and the full text of the study was officially published online at NEJM, attracting the attention of experts in the field of lung cancer worldwide.
ADAURA study is the first phase 3 clinical study of EGFR TKIs to be conducted globally in contrast to placebo-assisted therapy, and the first large sample study of three generations of EGFR TKI-assisted therapy.
study included 682 IB-IIIA EGFR mutation-positive NSCLC patients in the study group, whether they received complementary chemotherapy or not, receiving oxytinib (339 cases) and placebo (343 cases), respectively, with the main endpoint being DFS in phase II-IIIA patients.
DFS, OS, and safety for patients with phase IB-IIIA.
based on the breakthrough efficacy of oxytini, the results were revealed ahead of time and preliminary results were first reported at the 2020 ASCO annual meeting.