Πέμπτη 22 Σεπτεμβρίου 2022

Maternal health, pregnancy and offspring factors, and maternal thyroid cancer risk

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Abstract
Thyroid cancer incidence is higher in women than men, especially during the reproductive years, for reasons that remain poorly understood. Using population-based registry data from four Nordic countries through 2015, we examined associations of perinatal characteristics with risk of maternal thyroid cancer. Cases were women diagnosed with thyroid cancer ≥2 years after last birth (n=7,425, 83% papillary). Cases were matched to controls (n=67,903) by mother's birth year , country, and county of residence. Odds ratios (ORs) were estimated using conditional logistic regression models adjusted for parity. Older age at first pregnancy, postpartum hemorrhage (OR=1.18, 95% CI 1.08−1.29), and benign thyroid conditions (ORs ranging from 1.64 for hypothyroidism to 10.35 for thyroid neoplasms) were associated with increased thyroid cancer risk, as were higher offspring birth weight (per 1-kg increase, OR=1.17, 95% CI 1.12−1.22) and large-for-gestational-age (OR=1.26, 95% CI 1.11−1.43). Unmarried/non-cohabiting status (OR=0.91, 95% CI 0.84−0.98), maternal smoking (OR=0.75, 95% CI 0.67−0.84), and preterm birth (OR=0.90, 95% CI 0.83−0.98) were associated with reduced risk. Several factors (e.g., older age at first pregnancy, maternal smoking, goiter, benign neoplasms, postpartum hemorrhage, and hyperemesis gravidarum, neonatal jaundice) were associated with advanced thyroid cancer. These findings suggest that some perinatal exposures may influence m aternal thyroid cancer risk.
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Positive SARS‐CoV‐2 RT‐qPCR of a nasal swab spot after 30 days of conservation on filter paper at room temperature

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Abstract

We tested the use of nasal swabs spotted onto filter paper (Whatman 3M, Germany) for the molecular diagnosis of SARS-CoV-2 infection. Spots of a positive nasal swab in conservation medium (B.1.177 strain, 21Ct) were still positive (duo E-gene/IP4) after 10, 20, and 30 days of conservation at room temperature, with Ct values of 28, 27, and 26, respectively. Direct spotting of the swab at bedside (omicron strain) still gave a positive result after 10 days in two RT-qPCR systems: 33.7 Ct using duo E-gene/IP4, and 34.8 using a specific Omicron system. Spotting of a dilution range of media spiked with the Delta (strain 2021/FR/0610, lineage B 1.617.2) and Omicron strains (strain UVE/SARS-CoV-2/2021/FR/1514) showed a threshold of 0.04 TCID50 after 10 days of conservation. We show, for the first time, that this simple and low-cost conservation method can be used to store samples for RT-qPCR against SARS-CoV-2 for up to at least one month.

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Vaccine‐induced binding and neutralizing antibodies against Omicron 6 months after a homologous BNT162b2 booster

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Abstract

Introduction

Evidence about the long-term persistence of the booster-mediated immunity against Omicron is mandatory for pandemic management and deployment of vaccination strategies.

Methods

A total of 155 healthcare professionals (104 COVID-19 naive and 51 with a history of SARS-COV-2 infection) received a homologous BNT162b2 booster. Binding antibodies against the spike protein and neutralizing antibodies against Omicron were measured at several time points before and up to 6 months after the booster. Geometric mean titers of measured antibodies were correlated to vaccine efficacy against symptomatic disease.

Results

Compared to the highest response, a significant 10.2 and 11.5-fold decrease in neutralizing titers was observed after 6 months in participants with and without history of SARS-CoV-2 infection. A corresponding 2.5 and 2.9-fold decrease in binding antibodies was observed. The estimated T1/2 of neutralizing antibodies in pa rticipants with and without history of SARS-CoV-2 infection was 42 (95%CI, 25–137) and 36 days (95%CI, 25–65). Estimated T1/2 were longer for binding antibodies: 168 (95%CI, 116–303) and 139 days (95%CI, 113–180), respectively. Both binding and neutralizing antibodies were strongly correlated to vaccine efficacy (r = 0.83 and 0.89). However, binding and neutralizing antibodies were modestly correlated, and a high proportion of subjects (36.7%) with high binding antibody titers (i.e. > 8,434 BAU/mL) did not have neutralizing activity.

Conclusion

A considerable decay of the humoral response was observed 6 months after the booster, and was strongly correlated with vaccine efficacy. Our study also shows that commercial assays available in clinical laboratories might require adaptation to better predict neutralization in the Omicron era.

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Rapid infusion of infliximab biosimilars and the incidence and severity of infusion‐related reactions in patients with inflammatory bowel disease

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Rapid infusion of infliximab biosimilars and the incidence and severity of infusion-related reactions in patients with inflammatory bowel disease

This manuscript adds to the limited literature regarding the safety of rapid infusions (≤60 min) of infliximab biosimilars in patients with inflammatory bowel disease. In our study, rapid infusions of infliximab biosimilars were not associated with an increase in the incidence of infusion reactions compared with rapid infusions of infliximab reference product. Additionally, we compared the incidence of infusion reactions of rapid infusions of infliximab biosimilars to standard infusions (120 min) of infliximab biosimilars and reference product, and showed no difference in these prespecified outcomes; this demonstrates the overall safety of infliximab infusions. We believe this manuscript can aid institutions to move towards initiating rapid infusions in patients on infliximab biosimilars. Shorter infusion administration times provide cost-saving opportunities by increasing the number of available appointments at infusion centres, and may improve patient experience by reducin g the amount of time spent at a facility. Payers and health plans are increasingly preferring biosimilars on their formularies, which may result in more frequent utilization of infliximab biosimilar agents.


Abstract

What Is Known and Objective

Infliximab is an anti-tumour necrosis factor agent used in the treatment of inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis. While the use of infliximab is well established in the treatment of IBD, there are now four recently FDA-approved infliximab biosimilars that are increasingly used due to their cost-benefit for patients, institutions and payors. In addition, shortening the length of infliximab infusions from 120 min (standard infusion) to 60 min or less (rapid infusion) has been shown to safely provide further cost-benefit while also improving patient convenience. The safety of rapid infusions has been well-established for the infliximab reference product, however, there are limited data available regarding the safety of rapid infusions for infliximab biosimilars. The purpose of this study was to compare the incidence and severity of infusion reactions among patients with IBD receiving rapid infusion of infliximab reference product compared with infliximab biosimilar.

Methods

This was a retrospective analysis of electronic health record data of patients with a diagnosis of IBD receiving an infliximab reference product or infliximab biosimilar infusion between December 2020 and December 2021. Patient-level variables included demographics, immunomodulator use, IBD-related hospitalization and infliximab trough concentration and antibody levels. Infusion-related variables of interest included total number of infusions, drug, dose, dosing interval, infusion time and use of pre-medications. Infusion-related reactions were defined as safety concerns documented by the administering nurse (anaphylaxis, shortness of breath, hypotension, swelling, rash, pruritus, hives, flushing, chest pain, muscle pain, joint pain, fevers, chills, headache or hypertension) or administration of emergency medications. Fisher's exact test was used to compare reaction rates.

Results and Discussion

A total of 188 patients met inclusion criteria for analysis, and a total of 1124 infusions were administered during the study period. There were no statistically significant differences among any of the pre-specified outcomes. There were no differences in the incidence of infusion reactions among rapid infusion (60 min) infliximab and infliximab biosimilars (p = 0.863). Additionally, there were no differences in the incidence of infusion reactions among standard infusion (120 min) infliximab and infliximab biosimilars (p = 0.993). Finally, there were no differences among the rate of infusion reactions between rapid infusion of infliximab biosimilars and standard infusion of infliximab biosimilars (p = 0.536). Eight patients experienced safety issues, with three patients requiring emergency medications (1.6% of 188 patients).

What Is New and Conclusions

Rapid infusions of infliximab biosimilars were not associated with an increase in the incidence of infusion reactions compared with: rapid infusion of infliximab reference product, standard infusion of infliximab biosimilars, or standard infusion of infliximab reference product. This should reassure clinicians that rapid infusions of infliximab biosimilars are safe in clinical practice.

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Cetuximab-Based vs Carboplatin-Based Chemoradiotherapy for Patients With Head and Neck Cancer

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This cohort study compares survival with cetuximab-based and carboplatin-based chemoradiotherapy in locally advanced head and neck squamous cell carcinoma.
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Validation of Pain Catastrophizing Scale on Breast Cancer Survivor

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Abstract

Introduction

Pain Catastrophizing Scale (PCS) is the most used scale to measure pain catastrophizing. In breast cancer survivors (BCS), pain catastrophizing is related to upper-limbs dysfunction and disability. This study aimed to assess the internal consistency, internal structure and convergent validity of the Spanish version of the PCS in Spanish BCS

Material and Methods

BCS were recruited from the service of Medical Oncology of the University Clinical Hospital Virgen de la Victoria, in Málaga (Spain). The psychometric properties were evaluated with analyses factor structure by maximum likelihood extraction (MLE), internal consistency, and construct validity by confirmatory factor analysis (CFA).

Results

Factor structure was three-dimensional, and one item was removed due to cross-loading. The new 12-items PCS showed a high internal consistency for the total score (α=0.91) and a good homogeneity, and CFA revealed a satisfactory fit. PCS showed an acceptable correlation with FACS (r=0.53, p<0.01)

Conclusion

PCS is a valid and reliable instrument to evaluate pain catastrophizing in Spanish BCS. This tool may help clinicians in the management of pain by assessing pain and by measuring the effect of interventions.

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Perspectives from recent advances of Helicobacter pylori vaccines research

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Abstract

Background

Helicobacter pylori (H. pylori) infection is the main factor leading to some gastric diseases. Currently, H. pylori infection is primarily treated with antibiotics. However, with the widespread application of antibiotics, H. pylori resistance to antibiotics has also gradually increased year by year. Vaccines may be an alternative solution to clear H. pylori.

Aims

By reviewing the recent progress on H. pylori vaccines, we expected it to lead to more research efforts to accelerate breakthroughs in this field.

Materials & Methods

We searched the research on H. pylori vaccine in recent years through PubMed®, and then classified and summarized these studies.

Results

The study of the pathogenic mechanism of H. pylori has led to the development of vaccines using some antigens, such as urease, catalase, and heat shock protein (Hsp). Based on these antigens, whole-cell, subunit, nucleic acid, vector, and H. pylori exosome vaccines have been tested.

Discussion

At present, researchers have developed many types of vaccines, such as whole cell vaccines, subunit vaccines, vector vaccines, etc. However, although some of these vaccines induced protective immunity in mouse models, only a few were able to move into human trials. We propose that mRNA vaccine may play an important role in preventing or treating H. pylori infection. The current study shows that we have developed various types of vaccines based on the virulence factors of H. pylori. However, only a few vaccines have entered human clinical trials. In order to improve the efficacy of vaccines, it is necessary to enhance T-cell immunity.

Conclusion

We should fully understand the pathogenic mechanism of H. pylori and find its core antigen as a vaccine target.

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