Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database.

Introduction: Improving adverse events following immunisation (AEFI) detection is vital for vaccine safety surveillance, as an early safety signal can help minimize risks. In February 2022, the World Health Organization reported a preliminary signal on sudden sensorineural hearing loss (SSNHL) following coronavirus disease 2019 (COVID-19) vaccination, 54 million persons in France received at least one dose, covering 78.8% of the population within a year.

Framework Development for Reducing Attrition in Digital Dietary Interventions: Systematic Review and Thematic Synthesis.

Background: Dietary behaviors significantly influence health outcomes across populations. Unhealthy diets are linked to serious diseases and substantial economic burdens, contributing to approximately 11 million deaths and significant disability-adjusted life years annually. Digital dietary interventions offer accessible solutions to improve dietary behaviors.

Relationship between changes in the triglyceride glucose-body mass index and frail development trajectory and incidence in middle-aged and elderly individuals: a national cohort study.

Background: Insulin resistance is linked to an increased risk of frailty, yet the comprehensive relationship between the triglyceride glucose-body mass index (TyG-BMI), which reflects weight, and frailty, remains unclear. This relationship is investigated in this study.

Methods: Data from 9135 participants in the China Health and Retirement Longitudinal Study (2011-2020) were analysed.

Drugs associated with reversible cerebral vasoconstriction syndrome: A pharmacovigilance study in vigiBase.

Background: Data on drug-induced reversible cerebral vasoconstriction syndrome (RCVS) are scarce. We aimed to describe RCVS characteristics with drugs previously identified as associated with RCVS and investigate potential signals related to other drugs.

Methods: VigiBase was queried for all reports of RCVS until 31 May 2023.

Sex Differences in the Relationship Between Emotional Support and Self-rated Health among Chinese Elderly.

Purpose: This study aimed to explore sex differences in the association between emotional support and self-rated health among the elderly.

Design: This was a cross-sectional survey based on the sub-project of China's National Basic Public Health Service Project-Health Management Services for the Elderly.

Setting: Participants were recruited from ten rural townships in Jingyuan County, Gansu Province, Northwestern China.

The Effect of Nattokinase-Monascus Supplements on Dyslipidemia: A Four-Month Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Dyslipidemia, a condition implying high cardiovascular risks, has been widely studied on its potential nutrition interventions, including functional foods. This study aims to examine the effect of nattokinase monascus supplements (NMSs) on cardiovascular biomarkers and carotid intima-media thickness (CIMT) in patients with dyslipidemia. A total of 113 eligible subjects were randomly assigned to receive either NMSs or a placebo (55 and 58, respectively).

Formula Milk Supplementation and Bone Acquisition in 4-6 Years Chinese Children: A 12-Month Cluster-Randomized Controlled Trial.

Dairy foods are crucial for adequate calcium intake in young children, but scarce data are available on the effects of formula milk on bone acquisition. This cluster-randomized controlled trial investigated the effects of the supplementation of formula milk on bone health in rural children accustomed to a low-calcium diet between September 2021 and September 2022. We recruited 196 healthy children aged 4-6 years from two kindergartens in Huining County, Northwest China.

High leukocyte-to-lymphocyte ratio is associated with acute relapse in multiple sclerosis patients.

Background: Multiple sclerosis (MS) is an immune-mediated chronic disease characterized by inflammatory demyelination in the central nervous system (CNS).As there is limited evidence on whether leukocyte-to-lymphocyte ratios (LLRs) are associated with MS, we carried out an investigation on the association between LLRs and MS as favorable markers and aimed to determine the cut-off LLR for the identification of early-stage MS patients.

Methods: A matched case-control study enrolled a total of 120 MS inpatients and 120 age- and sex-matched non-MS inpatients from January 2013 to June 2018.

Effect of aqueous extract of seed of broccoli on inflammatory cytokines and Helicobacter pylori infection: a randomized, double-blind, controlled trial in patients without atrophic gastritis.

The purpose of this study was to investigate the anti-inflammatory effect of an aqueous extract of seed of broccoli (AESB) in Helicobacter pylori (HP)-infected patients without atrophic gastritis. This was a double-centre, randomized, double-blind, controlled study. A total of 110 HP-infected subjects were randomized to receive either AESB or placebo for 2 months.

Pharmacology and pharmacovigilance of protein kinase inhibitors.

Protein kinase inhibitors experienced their advent in the 2000s. Their market introduction made it possible to constitute a class of targeted therapies administered orally. This name was chosen to mark a break with conventional chemotherapy drugs, but it is important to stress that these are multi-target drugs with complex affinity profiles.

Anaphylactic reactions to local anesthetics in dental practice: a nationwide French retrospective study.

Objectives: The primary aims of the present study were (1) to quantify and characterize anaphylactic type I reactions related to local anesthetics (LAs) drawing on the French Pharmacovigilance Database System over a 35-year period and (2) to focuse on reactions associated with dental procedures. The secondary aim was to infer an incidence rate in dental practice.

Materials And Methods: All cases of anaphylactic reactions were selected using the algorithmic Standardized MeDRA Query "anaphylactic reaction.

Leukoencephalopathy with transient splenial lesions related to 5-fluorouracil or capecitabine.

Background: 5-Fluorouracil (5-FU) and its oral prodrug capecitabine have been rarely but consistently associated with acute central nervous system toxicity, including transient leukoencephalopathies involving the splenium of the corpus callosum.

Methods: We performed a retrospective search in the French Pharmacovigilance database (FPDB) (January 1985-July 2020) for adult patients affected by solid cancers who developed acute toxic leukoencephalopathies with splenial lesions following treatment with 5-FU or capecitabine. A comprehensive review of the literature helped to circumstantiate our findings.

Fatal and life-threatening ADRs associated with paliperidone palmitate: an observational study in the French pharmacovigilance database.

Introduction: Paliperidone palmitate (PP), a long-acting intramuscular formulation of paliperidone, has been marketed in Europe within the last 10 years and provides an important treatment option for patients with schizophrenia.Our aim was to describe PP-related adverse drug reactions (ADRs) leading to death or life-threatening events, specifying their main clinical and pharmacological characteristics.

Methods: This observational study was a retrospective review of PP-related ADRs in the French pharmacovigilance database between January 1, 2013, and December 31, 2019.

RNF170-Related Hereditary Spastic Paraplegia: Confirmation by a Novel Mutation.

Background: Spastic paraparesis and biallelic variants functionally characterized as deleterious in the RNF170 gene have recently been reported by Wagner et al. 2019, strongly supporting the involvement of this gene in hereditary spastic paraplegia.

Methods: Exome sequencing was performed on 6 hereditary spastic paraplegia families previously tested on an hereditary spastic paraplegia-specific panel.

Ibrutinib, a Bruton's tyrosine kinase inhibitor, a new risk factor for cryptococcosis.

Purpose: Invasive fungal diseases and especially Cryptococcus neoformans infections are increasingly reported in patients with hematological malignancies receiving ibrutinib, a Bruton's tyrosine kinase inhibitor.

Patients And Method: We reported three additional cases and reviewed 16 previous published cases together with cases from the international pharmacovigilance database.

Results: Patients were mainly treated for chronic lymphocytic leukemia.

Interactions of aggregating peptides probed by IR-UV action spectroscopy.

Peptide aggregation, the self-assembly of peptides into structured beta-sheet fibril structures, is driven by a combination of intra- and intermolecular interactions. Here, the interplay between intramolecular and formed inter-sheet hydrogen bonds and the effect of dispersion interactions on the formation of neutral, isolated, peptide dimers is studied using infrared action spectroscopy. Therefore, four different homo- and heterogenous dimers resulting from three different alanine-based model peptides have been formed under controlled and isolated conditions.

Conformational assignment of gas phase peptides and their H-bonded complexes using far-IR/THz: IR-UV ion dip experiment, DFT-MD spectroscopy, and graph theory for mode assignment.

The combined approach of gas phase IR-UV ion dip spectroscopy experiments and DFT-based molecular dynamics simulations for theoretical spectroscopy reveals the 3D structures of (Ac-Phe-OMe)1,2 peptides using their far-IR/THz signatures. Both experimental and simulated IR spectra are well-resolved in the 100-800 cm-1 domain, allowing an unambiguous assignment of the conformers, that could not be achieved in other more congested spectral domains. We also present and make proofs-of-principles for our newly developed theoretical method for the assignment of (anharmonic) vibrational modes from MD simulations based on graph theory coupled to APT-weighted internal coordinates velocities DOS spectra.

Antibiotic prophylaxis for the prevention of infective endocarditis for dental procedures is not associated with fatal adverse drug reactions in France.

Background: One of the major reasons to stop antibiotic prophylaxis (AP) to prevent infective endocarditis (IE) in the United Kingdom but not in the rest of the world was that it would result in more deaths from fatal adverse drug reactions (ADRs) than the number of IE deaths. The main aim of this study was to quantify and describe the ADRs with amoxicillin or clindamycin for IE AP. The second aim was to infer a crude incidence of anaphylaxis associated with amoxicillin for IE AP.

Immediate-Type Hypersensitivity Cross-Reactions to Proton Pump Inhibitors: A Descriptive Study of Data from the French National Pharmacovigilance Database.

Background: Proton pump inhibitors (PPIs) can trigger immediate-type hypersensitivity reactions (HSRs). Three main patterns of cross-reactivity have been identified: reactions to a single PPI, selective cross-reactions, and cross-reactions with all PPIs. Several hypotheses have been advanced, but no consensus has been reached.