-
1.
COVID-19 mRNA Vaccination in Lactation: Assessment of Adverse Events and Vaccine Related Antibodies in Mother-Infant Dyads.
Golan, Y, Prahl, M, Cassidy, AG, Gay, C, Wu, AHB, Jigmeddagva, U, Lin, CY, Gonzalez, VJ, Basilio, E, Chidboy, MA, et al
Frontiers in immunology. 2021;:777103
Abstract
BACKGROUND Data regarding symptoms in the lactating mother-infant dyad and their immune response to COVID-19 mRNA vaccination during lactation are needed to inform vaccination guidelines. METHODS From a prospective cohort of 50 lactating individuals who received mRNA-based vaccines for COVID-19 (mRNA-1273 and BNT162b2), blood and milk samples were collected prior to first vaccination dose, immediately prior to 2nd dose, and 4-10 weeks after 2nd dose. Symptoms in mother and infant were assessed by detailed questionnaires. Anti-SARS-CoV-2 antibody levels in blood and milk were measured by Pylon 3D automated immunoassay and ELISA. In addition, vaccine-related PEGylated proteins in milk were measured by ELISA. Blood samples were collected from a subset of infants whose mothers received the vaccine during lactation (4-15 weeks after mothers' 2nd dose). RESULTS No severe maternal or infant adverse events were reported in this cohort. Two mothers and two infants were diagnosed with COVID-19 during the study period before achieving full immune response. PEGylated proteins were not found at significant levels in milk after vaccination. After vaccination, levels of anti-SARS-CoV-2 IgG and IgM significantly increased in maternal plasma and there was significant transfer of anti-SARS-CoV-2-Receptor Binding Domain (anti-RBD) IgA and IgG antibodies to milk. Milk IgA levels after the 2nd dose were negatively associated with infant age. Anti-SARS-CoV-2 IgG antibodies were not detected in the plasma of infants whose mothers were vaccinated during lactation. CONCLUSIONS COVID-19 mRNA vaccines generate robust immune responses in plasma and milk of lactating individuals without severe adverse events reported.
-
2.
A mouth rinse based on a tea solution of Salvia officinalis for oral discomfort in palliative cancer care: a randomized controlled trial.
Monsen, RE, Herlofson, BB, Gay, C, Fjeld, KG, Hove, LH, Malterud, KE, Saghaug, E, Slaaen, J, Sundal, T, Tollisen, A, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(9):4997-5007
-
-
Free full text
-
Abstract
BACKGROUND Few clinical studies evaluate interventions to reduce oral discomfort among patients in palliative care. AIM: This study examines the efficacy of a Salvia officinalis (SO) based herbal mouth rinse compared to conventional normal saline (NS) in order to improve oral health. DESIGN A block-randomized controlled trial. Data were collected before and after a 4-day intervention with either SO (n=44) or NS (n=44). Numerical rating scales (NRS, 0-10) and 12 items from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Oral Health 17 (EORTC QLQ-OH17) measured patient-reported oral symptoms. An oral examination was performed before and after the intervention. SETTING/PARTICIPANTS This study included adult patients with late-stage cancer in an inpatient hospice unit. RESULTS Of the 88 patients included (mean age=63.9 years, SD=10.6), 73 (83%) completed the study. At baseline, 78% reported dry mouth on the EORTC QLQ-OH17, and 80% rated dry mouth ≥4 on the NRS. Total oral health scores based on the 12 EORTC QLQ-OH17 items improved similarly in both groups (p<0.001). However, dry mouth ratings on both the EORTC QLQ-OH17 (p=0.036) and NRS (p=0.045) improved more in the SO group than in the NS group. Plaque on the teeth improved in both the SO (p=0.008) and NS (p=0.018) groups, but plaque on the tongue and erythema only improved with NS. CONCLUSIONS This study did not detect an overall significant difference between SO and NS. Both mouth rinses improved oral health parameters, indicating that systematic assessment and oral care may reduce oral discomfort. TRIAL REGISTRATION NCT02067572.
-
3.
Sarcopenia and visceral obesity assessed by computed tomography are associated with adverse outcomes in patients with Crohn's disease.
Grillot, J, D'Engremont, C, Parmentier, AL, Lakkis, Z, Piton, G, Cazaux, D, Gay, C, De Billy, M, Koch, S, Borot, S, et al
Clinical nutrition (Edinburgh, Scotland). 2020;(10):3024-3030
Abstract
BACKGROUND Altered body composition may impact on the clinical course of Crohn's disease (CD) but is not detected by the simple body mass index (BMI) assessment. AIM: To assess the prevalence of sarcopenia and visceral obesity by a single computed tomography (CT) slice, and its association with adverse events in an adult hospitalized CD cohort. METHODS 88 CD patients who had abdominal CT scans during hospitalization were retrospectively enrolled. The skeletal muscle index (SMI) at the third lumbar vertebra level was used to assess sarcopenia. Sarcopenia was defined as a SMI <38.5 cm2/m2 in women, <52.4 cm2/m2 in men and visceral obesity as a visceral fat area ≥130 cm2. Clinical malnutrition was defined by a BMI <18.5 kg/m2. Univariate analysis was performed, and predictors for surgery in the follow-up were entered in a stepwise logistic regression model for multivariate analysis. RESULTS The prevalence of sarcopenia was 58%, malnutrition 21.6%, and visceral obesity 19.3%. Among sarcopenic patients, 49% had a normal BMI, 13.7% were overweight, and 1(2%) was obese. Sarcopenic CD patients had significantly more abscesses (51% vs 16.7%, p = 0.001), hospitalizations (61.2% vs 36.1%, p = 0.022) and digestive surgery (63.3% vs 27.8%, p = 0.001) than non-sarcopenic patients during the follow-up, whereas usual malnutrition assessment was not correlated with disease outcomes. In multivariate analysis, both sarcopenia and visceral obesity were associated with further occurrence of digestive surgery. CONCLUSION Both sarcopenia and visceral obesity were associated with adverse outcomes in severe CD patients whereas usual nutritional assessment was not.
-
4.
Betaine anhydrous in homocystinuria: results from the RoCH registry.
Valayannopoulos, V, Schiff, M, Guffon, N, Nadjar, Y, García-Cazorla, A, Martinez-Pardo Casanova, M, Cano, A, Couce, ML, Dalmau, J, Peña-Quintana, L, et al
Orphanet journal of rare diseases. 2019;(1):66
Abstract
BACKGROUND The Registry of Adult and Paediatric Patients Treated with Cystadane® - Homocystinuria (RoCH) is a non-interventional, observational, multi-centre, post-authorization safety study that aimed to identify safety of betaine anhydrous (Cystadane®) in the treatment of patients with inborn errors of homocysteine metabolism (homocystinuria) in order to minimise the treatment associated risks and establish better knowledge on its clinical use. The registry included patients of all ages with homocystinuria who were treated with betaine anhydrous in conjunction with other therapies. Clinical data were collected retrospectively from 2007 to 2013, then prospectively up to February 2014. All adverse events (AEs) reported during the study were recorded. The clinical and biological status of patients was monitored at least once a year. RESULTS A total of 125 patients with homocystinuria (adults [> 18 years]: 50; paediatric [≤18 years]: 75) were enrolled at 29 centres in France and Spain. Patients were treated with betaine anhydrous for a mean duration of 7.4 ± 4.3 years. The median total daily dose of betaine anhydrous at the first and last study visits was 6 g/day for cystathionine β-synthase (CBS)-deficient vitamin B6 responders and 9 g/day for methylenetetrahydrofolate reductase-deficient patients, while the median daily dose increased in CBS-deficient B6 non-responders (from 6 to 9 g/day) and cobalamin metabolism-defective patients (from 3 to 6 g/day) between the first and last visits. Treatment caused a mean overall reduction of 29% in plasma homocysteine levels in the study population. A total of 277 AEs were reported during the study, of which two non-serious AEs (bad taste and headache) and one serious AE (interstitial lung disease) were considered to be drug related. Overall, betaine anhydrous was well tolerated with no major safety concerns. CONCLUSIONS Data from the RoCH registry provided real-world evidence on the clinical safety and efficacy of betaine anhydrous in the management of homocystinuria in paediatric and adult patients.
-
5.
Pharmacokinetic drug-drug interactions of tyrosine kinase inhibitors: A focus on cytochrome P450, transporters, and acid suppression therapy.
Gay, C, Toulet, D, Le Corre, P
Hematological oncology. 2017;(3):259-280
Abstract
The extensive use of tyrosine kinase inhibitors (TKI's) in hematology and oncology has shown that these drugs have a significant potential for drug-drug interactions. Since these drugs have a rather low therapeutic window, some drug interactions are of particular clinical relevance either on drug toxicity or on patient's response. Significant interactions occur with concomitant use of acid-suppressive therapy leading to a decreased oral bioavailability. However, such interactions are drug dependent according to their solubility pattern and to the duration of action of acid-suppressive therapy, which is coprescribed. Significant interactions occur by inhibition or induction of CYP450 3A4 which is the main metabolic pathway of TKIs. However, minor metabolic pathways should also be paid attention to. Interactions involving efflux and influx transporters should also be considered occurring for some TKIs. Genetic polymorphism in drug metabolism as well as in drug transport is a factor of variability in drug exposure, which could modulate the magnitude of drug-drug interactions (DDIs). It should be noticed that TKIs can also be at the origin of drug interactions by altering the pharmacokinetics of coprescribed drugs. Since cancer patients are given many drugs either for supportive care or for the treatment of drug toxicity, and to the fact that the oldest patients are polymedicated, a clear understanding of DDIs with TKIs is of interest. The objectives of this review are to provide an overview of the mechanisms of DDIs with TKIs and to provide to physicians and pharmacists recommendations to manage these DDIs in their clinical practice.
-
6.
Evaluation of the efficacy of a short-course, personalized self-management and intensive spa therapy intervention as active prevention of musculoskeletal disorders of the upper extremities (Muska): a research protocol for a randomized controlled trial.
Lanhers, C, Pereira, B, Gay, C, Hérisson, C, Levyckyj, C, Dupeyron, A, Coudeyre, E
BMC musculoskeletal disorders. 2016;(1):497
Abstract
BACKGROUND Musculoskeletal disorders (MSDs) constitute a major occupational health problem in the working population, substantially impacting the quality of life of employees. They also cause considerable economic cost to the healthcare system, with, notably, the reimbursement of treatments and compensation for lost income. MSDs manifest as localized pain or functional difficulty in one or more anatomical areas, such as the cervical spine, shoulder, elbow, hand, and wrist. Although prevalence varies depending on the region considered and the method of assessment, a prevalence of 30% is found in different epidemiological studies. The disease needs to be prevented, not only for medical and economic reasons, but also for legal reasons, owing to the requirement of assessing occupational risks. The strategy envisaged may thus revolve around active, multimodal prevention that has employees fully involved at the heart of their care. Although physical exercise is widely recommended, few studies with a good level of evidence have enabled us to base a complete, well-constructed intervention on exercise that can be offered as secondary prevention in these disorders. METHODS A prospective, multicenter, comparative (intervention arm vs. control arm), randomized (immediate vs. later treatment) study using Zelen's design. This study falls under active prevention of MSDs of the upper extremities (UE-MSDs). Participants are workers aged between 18 and 65 years with latent or symptomatic MSDS, with any type of job or workstation, with or without an history of sick leave. The primary aim is to show the superiority at 3 months of a combination of spa therapy, exercise, and self-management workshops for 6 days over usual care in the management of MSDs in terms of employee functional capacity in personal and professional daily life. Secondary aims are to assess the benefit of the intervention in terms of pain, quality of life, and accumulated duration of sick leave. DISCUSSION This randomized controlled trial is the first that will aim to evaluate multidisciplinary management of UE-MSDs using nonpharmacological treatment combining exercise, self-management, and spa therapy. The originality of this intervention lies, in its short, intensive format, which is compatible with remaining in work; and in its multidisciplinary approach. This trial has the potential to demonstrate, with a good level of evidence, the benefits of a short course of spa therapy combined with a personalized self-management program on the functional capacity, pain, and quality of life of employees in their daily life. TRIAL REGISTRATION Clinical trial.gov NCT02702466 retrospectively registered. PROTOCOL Version 4 of 9/10/2015.
-
7.
Educating patients about the benefits of physical activity and exercise for their hip and knee osteoarthritis. Systematic literature review.
Gay, C, Chabaud, A, Guilley, E, Coudeyre, E
Annals of physical and rehabilitation medicine. 2016;(3):174-183
Abstract
OBJECTIVES Highlight the role of patient education about physical activity and exercise in the treatment of hip and knee osteoarthritis (OA). METHODS Systematic literature review from the Cochrane Library, PubMed and Wiley Online Library databases. A total of 125 items were identified, including 11 recommendations from learned societies interested in OA and 45 randomized controlled trials addressing treatment education and activity/exercise for the treatment of hip and knee osteoarthritis. RESULTS In the end, 13 randomized controlled trials and 8 recommendations were reviewed (1b level of evidence). Based on the analysis, it was clear that education, exercise and weight loss are the pillars of non-pharmacological treatments. These treatments have proven to be effective but require changes in patient behaviour that are difficult to obtain. Exercise and weight loss improve function and reduce pain. Education potentiates compliance to exercise and weight loss programs, thereby improving their long-term benefits. Cost efficiency studies have found a reduction in medical visits and healthcare costs after 12 months because of self-management programs. CONCLUSION Among non-surgical treatment options for hip and knee osteoarthritis, the most recent guidelines focus on non-pharmacological treatment. Self-management for general physical activity and exercise has a critical role. Programs must be personalized and adjusted to the patient's phenotype. This development should help every healthcare professional adapt the care they propose to each patient. Registration number for the systematic review: CRD42015032346.
-
8.
Rapid Plateau border size variations expected in three simple experiments on 2D liquid foams.
Gay, C, Rognon, P, Reinelt, D, Molino, F
The European physical journal. E, Soft matter. 2011;(1):2
-
-
Free full text
-
Abstract
Up to a global scaling, the geometry of foams squeezed between two solid plates (2D GG foams) essentially depends on two independent parameters: the liquid volume fraction and the degree of squeezing (bubble thickness to diameter ratio). We describe it in two main asymptotic regimes: fully dry floor tiles, where the Plateau border radius is smaller than the distance between the solid plates, and dry pancakes, where it is larger. We predict a rapid variation of the Plateau border radius in one part of the pancake regime, namely when the Plateau border radius is larger than the inter-plate distance but smaller than the geometric mean of that distance and the bubble perimeter. This rapid variation is not related to any topological change in the foam: in all the regimes we consider, the bubbles remain in mutual lateral contact through films located at mid-height between both plates. We provide asymptotic predictions in different types of experiments on such 2D GG foams: when foam is being progressively dried or wetted, when it is being squeezed further or stretched, when it coarsens through film breakage or through inter-bubble gas diffusion. Our analysis is restricted to configurations close to equilibrium, as we do not include stresses resulting from bulk viscous flow or from non-homogeneous surfactant concentrations. We also assume that the inter-plate distance is sufficiently small for gravity to be negligible. The present work does not provide a method for measuring small Plateau border radii experimentally, but it indicates that large (and easily observable) Plateau borders should appear or disappear rather suddenly in some types of experiments with small inter-plate gaps. It also gives expected orders of magnitude that should be helpful for designing experiments on 2D GG foams.
-
9.
New developments in the management of hypertension.
Magill, MK, Gunning, K, Saffel-Shrier, S, Gay, C
American family physician. 2003;(5):853-8
Abstract
The management of hypertension has evolved over the past decade. Isolated systolic blood pressure elevation, the most common form of uncontrolled hypertension, is recognized as a significant risk factor for vascular complications in patients with hypertension. Nutritional management of hypertension has moved beyond simply restricting sodium intake to ensuring that patients consume adequate amounts of the major food groups, particularly those containing calcium, potassium, and magnesium. Selective aldosterone receptor blockers are a new class of antihypertensive medication, and the angiotensin-receptor blocker class has several new additions. However, the main-stay of treatment remains a diuretic or a combination of a diuretic and either a beta blocker or an angiotensin-converting enzyme inhibitor. Hypertension is a significant risk factor for vascular complications of diabetes, and the target blood pressure in patients with diabetes or chronic renal disease and hypertension should be lower than that in patients with hypertension alone. Controlling hypertension in elderly patients can reduce their complications at least as much as it does those of younger patients with hypertension.
-
10.
[Epidemiology of cervical papillomavirus infections. Recent knowledge].
Mougin, C, Dalstein, V, Prétet, JL, Gay, C, Schaal, JP, Riethmuller, D
Presse medicale (Paris, France : 1983). 2001;(20):1017-23
Abstract
GENERAL DATA There is now considerable evidence that high risk human papillomaviruses (HPV), such as HPV 16, are closely associated with cancer of the cervix. HPVs that are primarily transmitted through sexual contact, are found in over 99% of the cases of invasive cervical cancer. Although most women can be infected during their sexual life, a small minority is at risk for developing cancer. The long latency period between primary infection and cancer emergence suggests that additional factors are involved in the process of tumor development: sexual behavior, immune status, genetic predispositions, nutritional status, tobacco use, socio-economical level. NATURAL HISTORY HPVs infect epithelial cells of the transformation zone of the cervix. As with other sexually transmitted diseases, the incidence of HPV infection is highest among young women. However, this viral infection is more often than not transient, because most individuals develop an effective type-specific immune response. Approximately 1% of the population has genital warts and 4% of women have cervical precancerous lesions: low grade squamous intraepithelial lesion (LGSIL) or high grade SIL. These last lesions preferentially observed in women aged 35-40 yrs are at high risk of progression towards an invasive cancer. ONCOGENIC POTENTIAL OF HPV Pre-malignant and malignant cells arise as a result of HPV DNA integration in the host cellular genome, and overexpression of the viral E6 and E7 oncogenes. Cells acquire a proliferative advantage by escaping growth control exerted by p53 and p 105Rb. Both cellular proteins are indeed inactivated respectively by E6 and E7 proteins. Aneuploidy and karyotypic abnormalities are also key events in the tumor progression. A PREVENTABLE DISEASE Cervical cancer is more than ever a preventable disease. While waiting for clinically applicable vaccination programs, strategies to prevent cervical cancer include 1) improved screening covering the widest possible population and using HPV testing, 2) close management and follow-up of women with precancerous lesions.