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Κυριακή 25 Σεπτεμβρίου 2022

Low‐dose acyclovir for prophylaxis of varicella‐zoster virus reactivation after hematopoietic stem cell transplantation in children

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Abstract

Background

Varicella-zoster virus (VZV) reactivation is a serious complication of hematopoietic stem cell transplantation (HSCT). Although low-dose acyclovir can prevent VZV reactivation after HSCT in adults, the efficacy of a dose of acyclovir lower than the recommended dose, such as 60–80 mg/kg/day in children, is unclear. In this study, we aimed to evaluate the incidence of VZV reactivation after HSCT during and after low-dose acyclovir administration for preventing VZV reactivation in children.

Methods

This single-center retrospective study included children aged ≤15 years who received oral acyclovir (at 15 mg/kg/day) to prevent VZV reactivation after HSCT. We examined the cumulative incidence of VZV reactivation after HSCT, during and after prophylactic acyclovir administration.

Results

Fifty-three eligible patients were included in this study, of whom 37 underwent allogeneic HSCT. The median duration of prophylactic acyclovir therapy was 264 days (range: 69–1140 days). VZV reactivation occurred in 13 patients (24.5%, 95% confidence interval [CI]: 14.9–37.6). The cumulative incidence of VZV reactivation 1 and 2 years after HSCT was 6.26% (95% CI: 1.60–15.5) and 20.9% (95% CI: 10.3–34.0), respectively. While only one patient developed VZV reactivation during the administration of prophylactic acyclovir, the cumulative incidence of VZV reactivation increased to 24.2% (95% CI: 12.5–38.0) 1 year after the cessation of acyclovir.

Conclusion

Low-dose acyclovir (15 mg/kg/day) could be effective for preventing VZV reactivation after HSCT in children because VZV reactivation seldom occurs during the administration of 15 mg/kg/day acyclovir.
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Longitudinal use of patient reported outcomes in pediatric leukemia and lymphoma reveals clinically relevant symptomatic adverse events

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Abstract

Background

Leukemia and lymphoma (LL) are the most common cancer diagnoses of childhood with high survival rates, but not without impact on the child's functioning and quality of life. This study aimed to use patient-reported data to describe the symptomatic adverse event (AE) experiences among children with LL diagnoses.

Methods

Two hundred and fifty seven children and adolescents aged 7–18 years with a first LL diagnosis completed the Pediatric Patient-Reported version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) and Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric measures before starting a treatment course (T1) and after the treatment (T2).

Results

Fatigue was the most severe AE (68.1% at T1; 67% at T2) and caused the most interference over time. Gastrointestinal AEs were also quite common (e.g., nausea 46.3% at T1 and 48.9% at T2; abdominal pain 42.4% at T1; 46.5% at T2). In general, symptoms were present both at T1 and T2 and did not change significantly in severity or interference. The prevalence of AEs varied by LL disease group (e.g., nausea was most common in acute lymphoblastic leukemia (ALL), fatigue was most severe in ALL and Hodgkin Lymphoma (HL), acute myeloid leukemia had the fewest AEs).

Conclusion

Despite current supportive care regimens, many children with LL continue to report fatigue, pain, insomnia, and gastrointestinal symptoms as the most frequent or severe symptoms during therapy.
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Clinical‐based oral rehabilitation programme improved the oral diadochokinesis and swallowing function of older patients with dementia: A randomized controlled trial

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Abstract

Objective

To evaluate the effectiveness of a clinical-based oral function intervention on oral function and care behaviours in older patients with mild dementia.

Method

Participants were randomly assigned to the experimental group (EG) and control group (CG). Both groups received a leaflet on oral health-related knowledge, and the EG also received an oral function intervention, which was a brief one-on-one lesson concerning oral exercise and preventive oral care. Oral exercise included turning the head, pouting lips, bulging cheeks, stretching tongue, articulation exercise, and salivary gland massages. A reminder phone call was made every 2 weeks. Perceived xerostomia and dysphagia, plaque index (PI), Winkel tongue-coating index (WTCI), repetitive saliva-swallowing test (RSST), oral diadochokinesis (DDK), and oral care behaviours were recorded at baseline and at 3-month follow up. Generalized Estimating Equations (GEE) were used to analyze the indicated effects.

Results

The EG(n=59) exhibited greater improvement to the CG(n=55) in RSST [β= 0.7; effect size (ES) = 0.45], the syllables /pa/ (β = 3.1; ES = 0.37) and /ka/ (β = 2.7; ES = 0.40) in oral DDK, PI (β = −0.2; ES = 0.52), and WTCI (β = −0.8; ES = 0.38). Moreover, the EG exhibited better preventive behaviours in regular dental visits [adjusted odds ratio (aOR) = 2.2], daily mouth cleaning frequency (aOR = 1.6), and mouth cleaning before sleep (aOR = 1.3).

Conclusion

The brief clinical-based intervention was effective in improving the swallowing function, oral DDK, and plaque control of older patients with mild dementia at 3-month follow-up.
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Association of growth patterns during infancy and puberty with lung function, wheezing and asthma in adolescents aged 17.5 years: evidence from ‘Children of 1997’ Hong Kong Chinese Birth Cohort

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Abstract
BackgroundRapid growth is related to adverse respiratory outcomes although possibly confounded or limited by growth modelling methods. We investigated the association of infant and pubertal growth with lung function, wheezing and asthma in a non-Western setting.
Methods
In Hong Kong's 'Children of 1997' Chinese birth cohort (n = 8327), weight during infancy and weight, height and body mass index (BMI) during puberty were modelled using a super-imposition by translation and rotation model to identify (larger or smaller) size, (earlier or later) tempo and (slower or faster) velocity. Sex-specific associations with forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), FEV1/FVC (Global Lung function Initiative z-score) and self-reported wheezing and asthma at ∼17.5 years were assessed.
Results
For each fraction higher than average weight growth velocity during infancy, FVC w as higher in boys (0.90 SD, 95% CI 0.35; 1.44) and girls (0.77 SD, 95% CI 0.24; 1.30), FEV1/FVC was lower (–0.74 SD, 95% CI –1.38; –0.10) and wheezing was higher (odds ratio 6.92, 95% CI 1.60; 29.99) in boys and an inverse association with FVC was observed for tempo but not for size. Associations for weight growth velocity in puberty were similar but weaker. Greater size and higher velocity of BMI growth was associated with higher FVC, lower FEV1/FVC and higher asthma and wheezing risk.
Conclusion
Accelerated infant and pubertal weight growth were associated with disproportionate lung size and airway growth, and higher risk of asthma; optimizing early-life growth patterns could be important.
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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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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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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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Tracking Occupational Voice State with a Visual Analog Scale: Voice Quality, Vocal Fatigue, and Effort

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Tracking Occupational Voice State with a Visual Analog Scale: Voice Quality, Vocal Fatigue, and Effort

This study aimed to determine if the concurrent and construct validity of three visual analog scales (VASs) of voice quality and symptoms could be used as a screening tool in call center agents. VAS as a self-report instrument of vocal symptoms was related to psychosocial voice impairment and alterations of acoustic voice parameters in call center workers. Such instruments could be easily implemented to identify voice complaints in these populations.


Background

Due to elevated vocal health risk in industries such as call centers, there is a need to have accessible and quick self-report tools for voice symptoms. This study aimed to determine if the concurrent and construct validity of three visual analog scales (VASs) of voice quality and symptoms could be used as a screening tool in call center agents.

Methods

A cross-sectional study was carried out in three call center companies. The Voice Handicap Index-10 (VHI-10) and a vocal hygiene and symptoms survey were administered to 66 call center workers. Further, acoustic parameters including harmonics-to-noise ratio (HNR), smoothed cepstral peak prominence (CPPs), L1-L0 slope, and Alpha ratio were collected. Finally, workers completed three VASs capturing self-perception of vocal effort (VAS-1), voice quality (VAS-2), and vocal fatigue (VAS-3). Linear regression models with bootstrapping evaluated the possible relationship between the three VASs measurements, self-perceived vocal symptoms, and acoustic parameters.

Results

VAS-1 scores were associated with HNR and voice breaks, VAS-2 with voice breaks, and VAS-3 with Alpha ratio. Using the area under a receiver operating characteristic curve (AUC), the highest AUC for detecting an altered VHI-10 questionnaire score was observed for the three VASs. Also, the highest AUC for detecting altered CPPs was reached for the VAS-1.

Conclusions

VAS as a self-report instrument of vocal symptoms is related to psychosocial voice impairment and alterations of acoustic voice parameters in call center workers. Such instruments could be easily implemented to identify voice complaints in these populations.

Level of Evidence

Level 2 (Diagnosis research question) Laryngoscope, 2022
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Longitudinal Effects of Base of Tongue Concurrent Chemoradiation Therapy in a Pre‐Clinical Model

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Longitudinal Effects of Base of Tongue Concurrent Chemoradiation Therapy in a Pre-Clinical Model

We present a clinically relevant animal model quantifying the effects of concurrent chemoradiation therapy (CCRT) on tongue strength and elasticity over time. This study demonstrates an increasing difference in tongue strength over time between control animals and those exposed to CCRT. Tongue elasticity was not significantly affected by CCRT, suggesting that changes in strength may not be caused by fibrosis during the time period studied.


Background/Objectives

Base of tongue (BOT) dysfunction is common following oropharyngeal concurrent chemoradiation therapy (CCRT). We present a clinically relevant animal model quantifying the effects of CCRT on tongue strength and elasticity over time.

Methods

Fifty-three male and 53 female Sprague–Dawley rats were randomized to control or experimental groups. Experimental animals received cisplatin, 5-fluorouracil, and 5 fractions of 7 Gy directed to the BOT. Controls received no intervention. At 2 weeks, 5 months, or 10 months after CCRT, animals underwent non-survival surgery to measure twitch and tetanic tongue strength, which were analyzed using multivariate linear mixed effects models. Tongue displacement, a surrogate for tongue elasticity, was also determined via stress–strain testing and analyzed via a multivariate linear mixed effects model.

Results

Reporting the combined results of both sexes, the estimated experimental group mean peak twitch forces became more divergent over time compared to controls, being 8.3% lower than controls at 2 weeks post-CCRT, 15.7% lower at 5 months, and 31.6% lower at 10 months. Estimated experimental group mean peak tetanic forces followed a similar course and were 2.9% lower than controls at 2 weeks post CCRT, 20.7% lower at 5 months, and 27.0% lower at 10 months. Stress–strain testing did not find CCRT to have a significant effect on tongue displacement across experimental timepoints.

Conclusions

This study demonstrates an increasing difference in tongue strength over time between controls and animals exposed to CCRT. Tongue elasticity was not significantly affected by CCRT, suggesting that changes in strength may not be caused by fibrosis.

Level of Evidence

NA Laryngoscope, 2022
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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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