Tag: nevin manimala

Vopr Virusol. 2025 Mar 12;70(1):57-65. doi: 10.36233/0507-4088-286.

ABSTRACT

INTRODUCTION: The main quality indicator for inactivated influenza vaccines is their potency (the amount of hemagglutinin). The potency test for the influenza vaccine with the SOVIDON adjuvant is carried out in a trivalent bulk vaccine before the addition of the adjuvant. This approach has its fair share of drawbacks. The analysis of the statistical process control and stability by control charts plays an important role in the release of influenza vaccines. The aim of the study is to compare the results of hemagglutinin quanitation in the trivalent bulk vaccine and in the final lots of influenza vaccine with SOVIDON adjuvant; as well as the analysis of the potency test results to evaluate the statistical process control.

MATERIALS AND METHODS: This study covered the inactivated influenza vaccine with the SOVIDON adjuvant. Both the trivalent bulks vaccine before the addition of the adjuvant and the final lots were investigated by single radial immunodiffusion assay. The software SIAMS Photolab was used to calculate the amount of hemagglutinin. Microsoft Excel was used to create the control charts using the data of the manufacturer.

RESULTS: The data of the study confirm the absence of statistically significant differences (p < 0.05) of the content of hemagglutinin in the trivalent bulks and the final lots of the influenza vaccine. The analysis of control charts showed the presence of out-of-control signals.

CONCLUSION: The study has shown the possibility and feasibility of the potency testing of the influenza vaccine with the SOVIDON adjuvant. The presence of out-of-control signals on the control charts is the basis for the identification of the reasons behind the changes and for the analysis of risks of the release of a defective influenza vaccine.

PMID:40233337 | DOI:10.36233/0507-4088-286

Vopr Virusol. 2025 Mar 12;70(1):25-34. doi: 10.36233/0507-4088-271.

ABSTRACT

INTRODUCTION: Predisposition to different courses of the infectious process is largely associated with the polymorphisms in human genome, especially in genes encoding proteins of the immune system. In the early stages of influenza infection such components of innate immunity as interferons I (α/β) and III (λ) type play a significant role in limiting virus replication. The aim of the work was to investigate associations of single nucleotide polymorphism in IFNL3 (rs8099917 T/G) and IFNL4 (rs12979860 C/T) genes with different course of influenza, and identify genetic markers of influenza complicated by community-acquired pneumonia. The genes noted above affect the production of interferon-λ3, which is involved in restriction of the viral replication.

MATERIALS AND METHODS: Samples from 456 patients with mild (n = 150), moderate (n = 173), and severe (n = 133) influenza were studied. The viral RNA was detected by reverse transcription and polymerase chain reaction (RT-PCR). Polymorphisms in IFNL3 (rs8099917 T/G) and IFNL4 (rs12979860 C/T) genes was detected by PCR. Statistical analysis was performed using SNPStats software.

RESULTS: Patients with the C/T or T/T genotype of IFNL4 gene (rs12979860 C/T) were more likely to have pneumonia than those with the C/C genotype (OR 2.47 (1.31-4.63); p = 0.0044; q = 0.0059). The presence of one T allele increased the risk of developing pneumonia (OR 2.02 (1.05-4.02); p = 0.006; q = 0.008). In the presence of the T/T genotype, the risk increased more than twofold: OR 2.14 (1.31-3.48). Analysis of the SNP of IFNL3 gene (rs8099917 T/G) revealed a weak association of the G allele with pneumonia (OR 1.86 (1.04-3.31); p = 0.03; q = 0.045).

CONCLUSION: Genetic markers of increased risk of community-acquired pneumonia in influenza include the presence of the T allele in IFNL4 gene (rs12979860 C/T) and, to a lesser extent, the G allele in IFNL3 gene (rs8099917 T/G). Patients carrying these alleles have an increased risk of developing pneumonia, especially in old age.

PMID:40233334 | DOI:10.36233/0507-4088-271

Pediatr Infect Dis J. 2025 Apr 11. doi: 10.1097/INF.0000000000004832. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to develop population pharmacokinetic (PK) models of cefoperazone and sulbactam through simultaneous analysis of plasma and urine data in pediatric patients and to optimize dosing regimens based on PK/pharmacodynamic (PD) simulation.

METHODS: Population PK models of cefoperazone and sulbactam were separately developed by simultaneously fitting plasma and urine data from pediatric patients described in 9 published articles. Probabilities of attaining the bactericidal target of 70% of free time above minimum inhibitory concentration (70% fT > MIC) for cefoperazone against clinical isolates of common bacteria were estimated based on the final model.

RESULTS: Seventy-eight pediatric patients were the subjects for PK modeling (0.83-14.6 years old and 6-51.6 kg of body weight). A total of 439 plasma concentrations and 138 urinary excretions up to 7 hours after administration were used for population PK modeling. The data were adequately described by 2-compartment models for cefoperazone and sulbactam. Age was not a statistically significant covariate in the PK of both drugs. For empiric therapy of community-acquired pneumonia, the PK/PD breakpoint of 0.5-hour infusion of 20 mg/kg (cefoperazone-sulbactam dose ratio of 1:1) 4 times daily was 0.13 μg/mL and could cover MIC90 of Streptococcus pneumoniae (MIC90 = 0.125 μg/mL) and Haemophilus influenzae (MIC90 = 0.125 μg/mL). However, since MIC90 values for nosocomial pathogens are high (MIC90 = 2 μg/mL for Staphylococcus aureus and MIC90 = 4 μg/mL for Morganella morganii), a 4-hour infusion of 60 mg/kg (cefoperazone-sulbactam dose ratio of 2:1) 4 times daily might be better to cover many pathogens.

CONCLUSIONS: This study described population PK models of cefoperazone and sulbactam detailing the excretion process with urine data in pediatric patients and developed optimal dosing regimens of cefoperazone-sulbactam including extended infusion in consideration with pathogens, based on PK/PD simulation.

PMID:40233330 | DOI:10.1097/INF.0000000000004832

J Craniofac Surg. 2025 Apr 15. doi: 10.1097/SCS.0000000000011389. Online ahead of print.

ABSTRACT

BACKGROUND: Financial toxicity refers to the economic burden of treatment on patients, families, and caregivers of those with chronic medical conditions. The authors sought to add to the literature regarding the financial burden on families with children undergoing cleft palate reconstruction.

METHODS: A survey assessing income, debt, and other indicators of financial impact, such as out-of-pocket (out of pocket) costs, was sent to the parents of patients who had cleft palate repair at age 18 or younger identified through CPT codes from the authors’ institution’s electronic medical record.

RESULTS: One hundred eighty-six began the survey; however, only 64 (9%) respondents completed the survey and were included in the statistical analysis. The average total out-of-pocket cost was $45,140 (range: $0-$400,000). Eleven respondents (17%) reported that their debt balance had increased after treatment, whereas only 3 respondents (5%) reported an improvement in their debt. However, there was no significant association between increased debt balance and increased out-of-pocket costs. Twenty-five respondents (39%) reported a reduction in their working hours. Over half (53%) reported that they and their partner missed more than 3 weeks of work cumulatively throughout their child’s treatment. Thirty respondents (47%) reported a reduction in essential household expenses and 40 respondents (63%) reported a reduction in non-essential spending.

CONCLUSIONS: Costs associated with cleft palate care results in significant financial toxicity for families of children with cleft palate. Pending legislation, including the Ensuring Lasting Smiles Act, could ameliorate out-of-pocket costs and reduce financial toxicity for cleft patients and their families.

PMID:40233308 | DOI:10.1097/SCS.0000000000011389

J Craniofac Surg. 2025 Apr 15. doi: 10.1097/SCS.0000000000011402. Online ahead of print.

ABSTRACT

The masseter and temporal muscles are primary jaw muscles vital for chewing and speaking, which work in tandem for effective mastication. On the basis of the reported studies that masseter botulinum toxin A injection causes masseter muscle atrophy without impairing chewing function in most patients, this study explores whether the temporal muscle thickens compensatively after injection of botulinum toxin A into masseter muscle. In this prospective study, the authors analyzed data from 10 patients who were treated with botulinum toxin A injection into the masseter. Ultrasonographic images of the masseter and temporal muscles were obtained to measure the muscle thickness at rest and in contraction before and 1, 2, 4, 8, and 12 weeks after the injection. Repeated measures one-way ANOVA was used to compare the statistical significance of the data and simpler linear regression to find the relationship of thickness changes between the masseter and temporal muscles. During the 3-month follow-up, there was a statistically significant decrease in masseter thickness and a corresponding increase in temporalis thickness. Masseter thickness decreased from 14.21±2.95 to 10.42±1.59 mm at rest, and from 15.08±3.11 to 11.30±1.8 mm in contraction (P<0.0001). Temporalis thickness increased from 9.27±2.18 to 13.05±1.49 mm at rest and from 10.12±2.44 to 13.74±1.59 mm in contraction (P<0.0001). There was a negative linear relationship between the thickness of masseter and temporal muscles. No serious complications occurred. Temporal muscle thickness increased after the injection of botulinum toxin A into the masseter.

PMID:40233307 | DOI:10.1097/SCS.0000000000011402

PLoS One. 2025 Apr 15;20(4):e0310578. doi: 10.1371/journal.pone.0310578. eCollection 2025.

ABSTRACT

BACKGROUND: People with Parkinson’s (PwP) can experience both physical and psychological symptoms, and understanding the perspectives of people affected is crucial for improved management, and clinical outcomes.

OBJECTIVES: This online survey aimed to gain a better understanding of the relationship between the subjectively experienced physical and psychological symptoms by PwP and their carers, while also considering the influence of personal roles and past symptom experiences.

METHODS: A UK-wide survey of 251 PwP and 62 carers was conducted. The survey focused on reported diagnosed and non-diagnosed psychological symptoms experienced, their onset, and the perceived impact of physical and psychological symptoms on one another. Responses were summarised using descriptive statistics.

RESULTS: A substantial proportion of respondents reported at least one diagnosed psychological condition (38.5%) or undiagnosed psychological symptoms (44.6%) such as anxiety and depression. Half of respondents reported perceiving a bi-directional interaction between physical and psychological symptoms, with this perception most reported in people with prior experience of psychological symptoms. Our sample shows that while PwP and carers have similar views on the impact of psychological symptoms, carers perceive the impact of physical symptoms to be greater than PwP.

CONCLUSIONS: PwP and carers appear to perceive an interaction between physical and psychological symptoms in Parkinson’s, noting that psychological symptoms frequently precede Parkinson’s diagnosis but are often under-recognised. Improved awareness of the potential link between physical and psychological symptoms in PwP may help to improve assessment, and onward referral processes to enhance care. Further research may assist in identifying potential disease subtypes and allow the prediction of changes in physical and psychological presentation.

PMID:40233306 | DOI:10.1371/journal.pone.0310578

JCO Clin Cancer Inform. 2025 Apr;9:e2400235. doi: 10.1200/CCI-24-00235. Epub 2025 Apr 15.

ABSTRACT

PURPOSE: Access to cancer-related data in online patient portals is not uniform. Perspectives of pediatric patients with cancer and caregivers on their desires and experiences accessing cancer-related data via an online patient portal have been poorly described. These perspectives are crucial for informing both hospital-level policies and governmental regulations. This study aims to explore the preferences of pediatric oncology patients and their caregivers regarding the timing of medical test result release into online portals.

METHODS: A cross-sectional survey was conducted at a tertiary academic pediatric center in Toronto, Canada. English-speaking pediatric patients with cancer age 12 years and older, as well as their caregivers, were invited to participate. A 59-question survey was administered to participants between June and August 2024.

RESULTS: A total of 105 participants, including 40 patients and 65 caregivers, completed the survey. Forty-one (53.9%) participants reported that a health care provider had discussed with them the possibility that they might be viewing test results online before their care team had reviewed the result. Immediate release of test results was preferred across most testing domains, with >80% of participants favoring immediate access, even for sensitive oncology-related results. Less than 1% of participants believed that genetic or cancer recurrence results should be withheld until reviewed by an oncology provider. No participants reported increased worry as a result of viewing test results online.

CONCLUSION: This study reveals a strong preference among pediatric oncology patients and their caregivers for immediate access to test results, challenging traditional concerns about the psychological impact of early release. These findings suggest that oncology practices should consider aligning their policies with patient and caregiver preferences.

PMID:40233297 | DOI:10.1200/CCI-24-00235

Pediatr Infect Dis J. 2025 Apr 4. doi: 10.1097/INF.0000000000004807. Online ahead of print.

ABSTRACT

BACKGROUND: Acute bacterial skin and skin structure infections (ABSSSI) are serious infections of the skin and subcutaneous tissue that include major cutaneous abscesses, cellulitis/erysipelas, and wound infections. ABSSSI caused by gram-positive pathogens are common in children, who tend to experience high rates of morbidity and hospitalization due to ABSSSI, including those caused by antibacterial-resistant pathogens.

METHODS: This phase 3 study (NCT03176134) investigated the safety of tedizolid phosphate and its ability to treat ABSSSI in pediatric participants 28 days to <12 years of age. A total of 100 participants were randomized 3:1 to intravenous and/or oral tedizolid phosphate for 6-10 days or intravenous and/or oral comparator for 10-14 days; participants were stratified and enrolled by age cohort. The primary objective was to evaluate the safety of tedizolid phosphate versus comparators using descriptive statistics. The secondary objective was to evaluate clinical response at the test-of-cure (TOC) visit in the intent-to-treat and clinically evaluable populations.

RESULTS: Tedizolid phosphate was well tolerated, and adverse events were comparable between the tedizolid phosphate and comparator groups. Clinical success rates at the TOC visit in the intent-to-treat and clinically evaluable populations were high (>90%) and comparable between groups. All participants in the tedizolid phosphate treatment group who had skin culture results at baseline experienced favorable microbiological response at the TOC visit.

CONCLUSIONS: The results of this study provide evidence to support the use of tedizolid phosphate to treat ABSSSI caused by gram-positive pathogens in pediatric patients from 28 days to <12 years of age.

PMID:40233296 | DOI:10.1097/INF.0000000000004807

J Clin Oncol. 2025 Apr 15:JCO2402119. doi: 10.1200/JCO-24-02119. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this open-label, multicenter, randomized controlled trial was to determine the efficacy and safety of sequential umbilical cord-derived mesenchymal stem cell (UC-MSC) infusion for graft-versus-host disease (GVHD) prevention within 3 months of haploidentical hematopoietic stem cell transplantation (haplo-HSCT).

METHODS: This open-label study evaluated UC-MSC infusion (administer 1 × 10⁶/kg 4 hours before the commencement of day 0, once weekly for the first month after transplantation, once every 2 weeks for the second month, and once during the third month, totaling eight doses). The primary end point was the 2-year cumulative incidence of severe chronic GVHD (cGVHD).

RESULTS: In the primary analysis, 192 qualified participants between age 18 and 60 years with haplo-HSCT in three transplant centers in China were enrolled and randomly assigned to the MSC and control groups. In the primary analysis, the estimated 2-year cumulative incidence of severe cGVHD and all grades of cGVHD was lower in the MSC group than in the control group (P = .033 and P = .022). The cumulative incidence of grade 1 to 4, 2 to 4, and 3 to 4 acute GVHD (aGVHD) in patients in the MSC group significantly decreased (all P < .001). The 3-year GVHD-free and relapse-free survival (GRFS) rate in the MSC group was 62.4%, which was significantly higher than that in the control group (32.0%, hazard ratio [HR], 0.34, P < .001). MSC infusion did not influence the cumulative incidence of relapse (P = .34) and nonrelapse mortality (P = .45).

CONCLUSION: Our findings suggest that sequential infusion of MSCs within 3 months after haplo-HSCT significantly reduced both the incidence and severity of cGVHD and aGVHD, manifesting as a better GRFS rate for patients.

PMID:40233291 | DOI:10.1200/JCO-24-02119

J Asthma. 2025 Apr 15:1-6. doi: 10.1080/02770903.2025.2490106. Online ahead of print.

ABSTRACT

OBJECTIVE: This real-world study evaluates the improvement in asthma control, drug burden reduction, and physical and mental health in patients with severe eosinophilic asthma treated with biologicals.

METHODS: We enrolled 127 patients with severe eosinophilic asthma from two centers, treating them with add-on biological therapy. The asthma control test (ACT) and the Short-form Health Survey-12 (SF-12), including Physical Component Summary (PCS) and Mental Component Summary (MCS), were used, assessing drug history at baseline (T0) and after 32 weeks of biological therapy (T1).

RESULTS: A significant improvement in asthma control was observed after the biological treatment (ACT score: 11(8) vs 23(3), p < 0.0001), with most patients achieving asthma control at T1 (110, 86.6%). There was a statistically significant reduction in the use of non-biological drugs at T1, such as oral corticosteroids (40.2% vs 17.3%, p < 0.0001), inhalation therapy (75.6% vs 57.5%, p = 0.001), leukotriene receptor antagonists (34.6% vs 25.2%, p < 0.0001), and antihistamines (42.5% vs 18.1%, p < 0.0001). ACT and PCS scores at T1 had a strong positive correlation (r = 0.749, p < 0.0001), as did ACT and MCS scores (r = 0.744, p < 0.0001). Our study shows that the biological treatments for severe eosinophilic asthma, properly characterized through a careful phenotypic assessment, significantly improve asthma control and reduce drug burden (notably oral corticosteroids, inhalation therapy, leukotriene receptor antagonists, and antihistamines), as well as enhance both physical and mental health irrespective of age and sex.

PMID:40233270 | DOI:10.1080/02770903.2025.2490106