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Vaccine Jul 2023Our near-real-time safety monitoring of 16 adverse events (AEs) following COVID-19 mRNA vaccination identified potential elevation in risk for six AEs following primary...
BACKGROUND
Our near-real-time safety monitoring of 16 adverse events (AEs) following COVID-19 mRNA vaccination identified potential elevation in risk for six AEs following primary series and monovalent booster dose administration. The crude association with AEs does not imply causality. Accordingly, we conducted robust evaluation of potential associations.
METHODS
We conducted two self-controlled case series studies of COVID-19 mRNA vaccines (BNT162b2 and mRNA-1273) in U.S. Medicare beneficiaries aged ≥ 65 years. Adjusted incidence rate ratio (IRRs) and 95 % confidence intervals (CIs) were estimated following primary series doses for acute myocardial infarction (AMI), pulmonary embolism (PE), immune thrombocytopenia (ITP), disseminated intravascular coagulation (DIC); and following monovalent booster doses for AMI, PE, ITP, Bell's Palsy (BP) and Myocarditis/Pericarditis (Myo/Peri).
RESULTS
The primary series study included 3,360,981 individuals who received 6,388,542 primary series doses; the booster study included 6,156,100 individuals with one monovalent booster dose. The AMI IRR following BNT162b2 primary series and booster was 1.04 (95 % CI: 0.91 to 1.18) and 1.06 (95 % CI: 1.003 to 1.12), respectively; for mRNA-1273 primary series and booster, 1.01 (95 % CI: 0.82 to 1.26) and 1.05 (95 % CI: 0.998 to 1.11), respectively. The hospital inpatient PE IRR following BNT162b2 primary series and booster was 1.19 (95 % CI: 1.03 to 1.38) and 0.86 (95 % CI: 0.78 to 0.95), respectively; for mRNA-1273 primary series and booster, 1.15 (95 % CI: 0.94 to 1.41) and 0.87 (95 % CI: 0.79 to 0.96), respectively. The studies' results do not support that exposure to COVID-19 mRNA vaccines elevate the risk of ITP, DIC, Myo/Peri, and BP.
CONCLUSION
We did not find an increased risk for AMI, ITP, DIC, BP, and Myo/Peri and there was not consistent evidence for PE after exposure to COVID-19 mRNA primary series or monovalent booster vaccines. These results support the favorable safety profile of COVID-19 mRNA vaccines administered in the U.S. elderly population.
Topics: United States; Humans; Adult; Aged; 2019-nCoV Vaccine mRNA-1273; BNT162 Vaccine; COVID-19; Medicare; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Vaccination; Bell Palsy; Facial Paralysis; Myocardial Infarction; Myocarditis; Pericarditis; Pulmonary Embolism; RNA, Messenger
PubMed: 37344261
DOI: 10.1016/j.vaccine.2023.06.014 -
Laryngoscope Investigative... Oct 2023To investigate whether machine learning (ML)-based algorithms, namely logistic regression (LR), random forest (RF), k-nearest neighbor (k-NN), and gradient-boosting...
OBJECTIVE
To investigate whether machine learning (ML)-based algorithms, namely logistic regression (LR), random forest (RF), k-nearest neighbor (k-NN), and gradient-boosting decision tree (GBDT), utilizing early post-onset parameters can predict facial synkinesis resulting from Bell's palsy or Ramsay Hunt syndrome more accurately than the conventional statistics-based LR.
METHODS
This retrospective study included 362 patients who presented to a facial palsy outpatient clinic. Median follow-up of synkinesis-positive and -negative patients was 388 (range, 177-1922) and 198 (range, 190-3021) days, respectively. Electrophysiological examinations were performed, and the rate of synkinesis in Bell's palsy and Ramsay Hunt syndrome was evaluated. Sensitivity and specificity were assessed using statistics-based LR; and electroneurography (ENoG) value, the difference in the nerve excitability test (NET), and scores of the subjective Yanagihara scaling system were evaluated using early post-onset parameters with ML-based LR, RF, -NN, and GBDT.
RESULTS
Synkinesis rate in Bell's palsy and Ramsay Hunt syndrome was 20.2% (53/262) and 40.0% (40/100), respectively. Sensitivity and specificity obtained with statistics-based LR were 0.796 and 0.806, respectively, and the area under the receiver operating characteristic curve (AUC) was 0.87. AUCs measured using ML-based LR of "ENoG," "difference in NET," "Yanagihara," and all three components ("all") were 0.910, 0.834, 0.711, and 0.901, respectively.
CONCLUSION
ML-based LR model shows potential in predicting facial synkinesis probability resulting from Bell's palsy or Ramsay Hunt syndrome and has comparable reliability to the conventional statistics-based LR.
LEVEL OF EVIDENCE
3.
PubMed: 37899861
DOI: 10.1002/lio2.1145 -
Medicine Dec 2023Facial neuritis is a common clinical disease with high incidence, also known as Bell palsy or idiopathic facial nerve paralysis, which is an acute onset of peripheral... (Review)
Review
Facial neuritis is a common clinical disease with high incidence, also known as Bell palsy or idiopathic facial nerve paralysis, which is an acute onset of peripheral facial neuropathy. In modern medicine, there have been obstacles to the effective treatment of facial neuritis. At present, the clinical use of Western medicine treatment is also a summary of clinical experience, the reason is that the cause of facial neuritis is unknown. Facial neuritis belongs to the category of "facial paralysis" in traditional Chinese medicine. For thousands of years, Chinese medicine has accumulated a lot of relevant treatment experience in the process of diagnosis and treatment. At the same time, traditional Chinese medicine, acupuncture and the combination of acupuncture and medicine play an important role in the treatment of facial neuritis. This article discusses the treatment of facial neuritis with acupuncture combined with Chinese medicine, based on the research progress of modern medicine. In this review, we provide an overview of the effectiveness of acupuncture and medication combinations and facial neuritis with current studies investigating acupuncture and medication combinations in the treatment of facial neuritis.
Topics: Humans; Facial Nerve Diseases; Acupuncture Therapy; Bell Palsy; Facial Paralysis; Medicine, Chinese Traditional
PubMed: 38134097
DOI: 10.1097/MD.0000000000036751 -
Medicine Jul 2023Although previous studies have suggested that meteorological factors are associated with Bell's palsy, articles on this topic are rare and the results are inconsistent....
Although previous studies have suggested that meteorological factors are associated with Bell's palsy, articles on this topic are rare and the results are inconsistent. We aim to reveal the relationship between exposure to different meteorological factors and the onset of severe Bell's palsy (SBP) with daily data. A case-crossover study based on time-series data was applied, and the minimum risk value of each climatic factor was set as the reference value. We fitted a distributed lag non-linear model (DLNM) which applied quasi-Poisson regression to evaluate the exposure-response association and the lag-response association of meteorological factors on the occurrence of SBP. The mode value and per-decile interval value of each meteorological factor were all included in the analysis. Sensitivity analyses were conducted to test the robustness of results. A total of 863 SBP patients (474 males and 389 females) from 7 hospitals in the Shenzhen Futian District were selected from January 2009 to February 2020. The highest relations effect was tested in the cumulative exposure-response result shown as follows; mean temperature at the minimum value 15.3°C with RR of 10.370 (1.557-69.077) over lag 0 to 13; relative humidity at the 30th value 71% with RR of 8.041 (1.016-63.616) over lag 0 to 14; wind speed at the 90th value 31 (0.1 m/s) with RR of 1.286 (1.038-1.593) over lag 0; mean air pressure at the 30th value 1001.4 (pa) with RR of 9.052 (1.039-78.858) over lag 0 to 5; visibility at the 80th value 26.5 (km) with RR of 1.961 (1.005-1.423) over lag 0 to 2; average total cloud cover at the max value 100 (%) with RR 1.787 (1.014-3.148) over lag 0 to 2; sunshine duration at the 10th value 0.1 (h) with RR of 4.772 (1.018-22.361); daily evaporation shows no relationship in the cumulative result; daily average solar radiation at the minimum value 0 (W/m2) with RR of 5.588 (1.184-26.382). There is a relationship between wind speed and the onset of SBP, while mean air pressure, visibility, and average total cloud cover, especially sunshine duration and solar radiation which showed a strong effect, may be associated with severe clinical symptoms of SBP. Mean temperature and relative humidity may affect the course of SBP.
Topics: Male; Female; Humans; Bell Palsy; Cross-Over Studies; Time Factors; Nonlinear Dynamics; Facial Paralysis; Temperature; China
PubMed: 37478212
DOI: 10.1097/MD.0000000000034400 -
Vaccine Jul 2023On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine... (Review)
Review
BACKGROUND
On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system.
METHODS
VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated.
RESULTS
During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell's Palsy, and Guillain-Barré syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18-64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care.
CONCLUSION
Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis.
Topics: Adolescent; Adult; Child; Humans; Ad26COVS1; Adverse Drug Reaction Reporting Systems; COVID-19; COVID-19 Vaccines; Guillain-Barre Syndrome; United States; Vaccines
PubMed: 37321898
DOI: 10.1016/j.vaccine.2023.06.023 -
BMC Neurology Oct 2023Neurological manifestations of SARS-CoV-2 infection have been reported from many countries around the world, including the South Asian region. This surveillance study...
BACKGROUND
Neurological manifestations of SARS-CoV-2 infection have been reported from many countries around the world, including the South Asian region. This surveillance study aimed to describe the spectrum of neurological disorders associated with COVID-19 in Sri Lanka.
METHODS
COVID-19 patients manifesting neurological disorders one week prior and up to six weeks after infection were recruited from all the neurology centres of the government hospitals in Sri Lanka from May 2021 - May 2022. Data was collected using a structured data form that was electronically transmitted to a central repository. All patients were evaluated and managed by a neurologist. Data were analysed using simple descriptive analysis to characterise demographic and disease related variables, and simple comparisons and logistic regression were performed to analyse outcomes and their associations.
RESULTS
One hundred and eighty-four patients with neurological manifestations associated with COVID-19 were recruited from all nine provinces in Sri Lanka. Ischaemic stroke (31%) was the commonest neurological manifestation followed by encephalopathy (13.6%), Guillain-Barre syndrome (GBS) (9.2%) and encephalitis (7.6%). Ischaemic stroke, encephalitis and encephalopathy presented within 6 days of onset of COVID-19 symptoms, whereas GBS and myelitis presented up to 10 days post onset while epilepsy and Bell palsy presented up to 20 - 40 days post onset. Haemorrhagic stroke presented either just prior to or at onset, or 10 - 25 days post onset of COVID-19 symptomatic infection. An increased frequency of children presenting with encephalitis and encephalopathy was observed during the Omicron variant predominant period. A poor outcome (no recovery or death) was associated with supplemental oxygen requirement during admission (Odds Ratio: 12.94; p = 0.046).
CONCLUSIONS
The spectrum and frequencies of COVID-19 associated neurological disorders in Sri Lanka were similar to that reported from other countries, with strokes and encephalopathy being the commonest. Requiring supplemental oxygen during hospitalisation was associated with a poor outcome.
Topics: Child; Humans; COVID-19; SARS-CoV-2; Brain Ischemia; Sri Lanka; Stroke; Nervous System Diseases; Encephalitis; Guillain-Barre Syndrome; Ischemic Stroke; Oxygen
PubMed: 37794324
DOI: 10.1186/s12883-023-03399-w -
Cureus Apr 2024This study aims to investigate the contribution of monocyte/high-density lipoprotein (HDL) ratio (MHR) and monocyte/lymphocyte ratio (MLR) to the inflammatory process...
OBJECTIVE
This study aims to investigate the contribution of monocyte/high-density lipoprotein (HDL) ratio (MHR) and monocyte/lymphocyte ratio (MLR) to the inflammatory process and the severity and prognosis of the disease in patients with Bell's palsy.
MATERIALS AND METHODS
The study was designed retrospectively by analyzing our electronic database. A study group consisted of 48 patients who were referred to our clinic with Bell's palsy between January 2018 and June 2020. The control group consisted of 45 healthy individuals. Monocyte, HDL, neutrophil, lymphocyte, and platelet values were recorded. The hematological parameters obtained from the blood tests of the patients in the study group at the time of admission were statistically compared with the values in the control group. Radiologic images were also collected.
RESULTS
The MHR value of the study group was 12.85±1.02, while the MHR value of the control group was 12.29±1.33, and it showed a statistically significant difference (p=0.027). However, no statistically significant difference between the groups was found in other parameters, including MLR, neutrophil/lymphocyte ratio (NLR), and platelet/lymphocyte ratio (PLR). A positive correlation was found between the MHR value and the House-Brackmann stage. The NLR value of the patients who showed contrast enhancement in facial nerves on MRI was found to be statistically significant compared to those without contrast enhancement.
CONCLUSION
High MHR values in patients with Bell's palsy support the role of inflammatory and ischemic processes in etiopathogenesis. Further studies are needed to confirm our results in a multi-center manner with larger patient populations.
PubMed: 38716000
DOI: 10.7759/cureus.57770 -
Cureus Feb 2024This narrative review examines the role of vitamin D as a biomarker in ear disorders, including benign paroxysmal positional vertigo (BPPV), otitis media, bell's palsy,... (Review)
Review
This narrative review examines the role of vitamin D as a biomarker in ear disorders, including benign paroxysmal positional vertigo (BPPV), otitis media, bell's palsy, Meniere's disease, and hearing loss. PubMed, The Cochrane Library, and Google Scholar were utilized to conduct a comprehensive literature search, and findings were combined from studies from 2014 to 2024. As highlighted in this review, there is a consistent association between vitamin D deficiency and an increased risk and recurrence of disease especially in BPPV and otitis media. Its importance as a prognostic biomarker is emphasized in Bell's palsy, where higher levels of deficiencies in vitamin D are associated with higher grades of severity on the House Brackmann grading system. Vitamin D deficiency can also lead to sensorineural hearing loss due to its receptors present in the inner ear or its effect on calcium metabolism. Serum levels of vitamin D have also been shown to influence treatment outcome of sensorineural hearing loss. The role of vitamin D in Meniere's disease is unclear as no cause has been identified for the increase in endolymphatic fluid. The findings of this review emphasize the importance of serum vitamin D as a biomarker in ear disorders and advocate for more studies to be conducted to assess the importance of optimal dosing of vitamin D for the progression and outcome of these diseases.
PubMed: 38529449
DOI: 10.7759/cureus.54812 -
Quantitative Imaging in Medicine and... Jul 2023The most common cause of lower motor neuron facial palsy is Bell's palsy (BP). BP results in partial or complete inability to automatically move the facial muscles on...
BACKGROUND
The most common cause of lower motor neuron facial palsy is Bell's palsy (BP). BP results in partial or complete inability to automatically move the facial muscles on the affected side and, in some cases, to close the eyelids, which can cause permanent eye damage. This study investigated changes in brain function and connectivity abnormalities in patients with BP.
METHODS
This study included 46 patients with unilateral BP and 34 healthy controls (HCs). Resting-state brain functional magnetic resonance imaging (fMRI) images were acquired, and Toronto Facial Grading System (TFGS) scores were obtained for all participants. The fractional amplitude of low-frequency fluctuation (fALFF) was estimated, and the relationship between the TFGS and fALFF was determined using correlation analysis for brain regions with changes in fALFF in those with BP versus HCs. Brain regions associated with TFGS were used as seeds for further functional connectivity (FC) analysis; relationships between FC values of abnormal areas and TFGS scores were also analyzed.
RESULTS
Activation of the right precuneus, right angular gyrus, left supramarginal gyrus, and left middle occipital gyrus was significantly decreased in the BP group. fALFF was significantly higher in the right thalamus, vermis, and cerebellum of the BP group compared with that in the HC group (P<0.05). The FC between the left middle occipital gyrus and right angular gyrus, left precuneus, and right middle frontal gyrus increased sharply, but decreased in the left angular gyrus, left posterior cingulate gyrus, left middle frontal gyrus, inferior cerebellum, and left middle temporal gyrus. Furthermore, the fALFF in the left middle occipital gyrus was negatively correlated with TFGS score (=0.144; P=0.008).
CONCLUSIONS
The pathogenesis of BP is closely related to functional reorganization of the cerebral cortex. Patients with BP have altered fALFF activity in cortical regions associated with facial motion feedback monitoring.
PubMed: 37456292
DOI: 10.21037/qims-22-911 -
Frontiers in Neurology 2024Bell's palsy is an acute peripheral facial neuropathy, which is one of the most common causes of facial palsy of lower motor neurons. Facial nerve swelling is commonly...
BACKGROUND
Bell's palsy is an acute peripheral facial neuropathy, which is one of the most common causes of facial palsy of lower motor neurons. Facial nerve swelling is commonly observed in Bell's palsy. Acupuncture therapy has been widely used in the treatment of Bell's palsy. However, whether acupuncture can be effectively used in the acute stage is still controversial. There are no clinical trials conducted previously to evaluate the effect of acupuncture on facial nerve edema in Bell's palsy patients. The study aims to evaluate the potential efficacy of different acupuncture modalities on Bell's palsy patients in the acute phase, its effect on facial nerve edema, and to preliminarily explore its possible mechanism.
METHODS AND ANALYSIS
In this randomized, controlled trial, 165 Bell's palsy patients with unilateral onset within 3 days will be recruited and randomly assigned to either the electroacupuncture group ( = 33), the acupuncture group ( = 33), the sham acupuncture group ( = 33), the blank control group ( = 33), or the acupuncture control group ( = 33) in a 1:1:1:1:1 ratio. The participants will receive 4 weeks of treatment and 8 weeks of follow-up. The five groups of participants will receive the following treatments: A: Electroacupuncture + Medication (prednisone acetate tablets, mecobalamin tablets, and vitamin B1 tablets); B: Acupuncture + Medication; C: Sham Acupuncture + Medication; D: Medication only; and E: Acupuncture only. The primary outcome will be the effectiveness rate of different acupuncture modalities in improving facial nerve function after the intervention period. The secondary outcomes will be the recovery speed, the diameter of the facial nerve, the echo intensity and thickness of facial muscles, blood flow parameters of the facial artery, the serum inflammatory level, safety evaluation, and adverse events. Preliminary exploration of its mechanism of action occurs through inflammation and immune response. The difference between groups will be assessed using repeated measure analysis of covariance (ANCOVA) and trend chi-square.
DISCUSSION
The trial will evaluate the efficacy and facial nerve edema of acupuncture for Bell's palsy patients in the acute phase and preliminarily explore its possible mechanism. The results thus may provide evidence for clinical application.
CLINICAL TRIAL REGISTRATION
https://www.chictr.org.cn/bin/project/edit?pid=133211, identifier ChiCTR2100050815.
PubMed: 38689877
DOI: 10.3389/fneur.2024.1327206