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Adverse events associated with monoclonal antibodies used for treatment of COVID-19: A systematic review and meta-analysis

Br J Clin Pharmacol. 2025 Mar 6. doi: 10.1002/bcp.70025. Online ahead of print.

ABSTRACT

AIMS: This review aimed to synthesise the evidence related to the incidence of serious and non-serious adverse events with the use of monoclonal antibodies (mAbs) among COVID-19 patients.

METHODS: Databases were searched from January 2020 to September 2023 for randomized clinical trials (RCTs) that used mAbs for the treatment of COVID-19 regardless of disease severity. Study screening, data extraction and data analysis were performed independently by two reviewers. The Cochrane risk of bias 1.0 tool was used for methodological quality assessment.

RESULTS: Sixteen studies were identified for analysis with 9682 participants in the intervention arm and 10 115 participants in the control arm. Seven trials reported hepatoxicity and there was a statistically significant increase in the chance of hepatoxicity among patients treated with mAbs compared to those given standard of care (SoC) or placebo with risk ratio (RR) = 1.70, 95% confidence interval (CI) 1.29-2.24. Five trials reported for neutropenia and there was a statistically significant association of neutropenia with the use of mAbs compared to SoC or placebo with RR = 4.03, 95% CI 1.74-9.34. Ten trials reported any disease-related serious adverse events related to the disease and there was a reduction of risk compared to SoC/placebo, although this reduction was not statistically significant (RR = 0.88, 95% CI 0.70-1.11).

CONCLUSIONS: The use of mAbs was found to be associated with an increased risk of hepatoxicity and neutropenia compared to SoC/placebo among COVID-19 patients with moderate certainty of evidence. Long-term observational studies are recommended to observe post-COVID adverse events related to the use of mAbs.

PMID:40047167 | DOI:10.1002/bcp.70025

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Sexual Dimorphism of Foetal Sheep Skulls During the Second and Third Periods of Pregnancy

Vet Med Sci. 2025 Mar;11(2):e70265. doi: 10.1002/vms3.70265.

ABSTRACT

The skull is a very important structure, and it is the centre of many vital functions. There have been many studies on the skulls of mammals, but not many studies on the prenatal period. The aim of this study is to examine developmental sheep foetal skulls from the last two trimesters of pregnancy. A total of 40 sheep foetuses, 20 in the 2nd trimester (10 females and 10 males) and 20 in the 3rd trimester (10 females and 10 males), were examined. On the basis of CT scans of foetal skulls, morphometric measurements were performed by creating a three-dimensional (3D) model. Total skull length was statistically significant between males and females in the third trimester (p < 0.01). In the second trimester, the tooth length parameter was statistically significant between males and females (p < 0.01). In the second trimester, M3 was found to be statistically significant in the sheep foetus mandible (p < 0.01). It was determined that there was developmental sexual dimorphism between males and females.

PMID:40047137 | DOI:10.1002/vms3.70265

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Iatrogenic Cerebral Amyloid Angiopathy in Patients Treated With Cadaveric Dura Mater During Childhood Neurosurgery: A Retrospective Cohort Study

Eur J Neurol. 2025 Mar;32(3):e70091. doi: 10.1111/ene.70091.

ABSTRACT

BACKGROUND: Iatrogenic cerebral amyloid angiopathy (iCAA) is a recently identified clinico-neuroradiological syndrome associated with medical procedures, particularly neurosurgical treatments involving cadaveric dura mater (e.g., Lyodura). iCAA can manifest as intracerebral hemorrhages, focal seizures, and cognitive impairment, with the risk following exposure currently unknown. We aim to evaluate the risk of developing iCAA in patients who underwent childhood neurosurgical treatment with Lyodura compared to those who did not.

METHODS: This retrospective cohort study analyzed hospital records from the Christian-Doppler University Hospital in Salzburg, along with mortality data provided by the Austrian Federal Institute of Statistics (Statistik Austria). The study included all patients aged 0-18 who underwent neurosurgical procedures between January 1970 and January 1996. The primary endpoint was the diagnosis of iCAA and iCAA-related death.

RESULTS: Of 569 pediatric neurosurgical patients, 388 (68%) were further analyzed. Four patients (1%) were diagnosed with probable iCAA at a median age of 42 years (IQR 40-47), with a median latency from surgery to symptom onset of 38 years (IQR 36-41). Only Lyodura recipients developed iCAA, with an incidence rate of 12% (OR 56, 95% CI: 6-2667). The overall incidence of symptomatic iCAA among recipients of any dura material was 5% (OR 19, 95% CI: 2-903).

CONCLUSIONS: Cadaveric dura mater, especially Lyodura, poses a long-term risk for developing iCAA. Further research is needed to determine susceptibility factors in Lyodura-exposed individuals.

PMID:40047134 | DOI:10.1111/ene.70091

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Comparison of encrustation between silicon-covered and polytetrafluoroethylene-covered metallic stent, in vitro experimental study

Investig Clin Urol. 2025 Mar;66(2):137-143. doi: 10.4111/icu.20240410.

ABSTRACT

PURPOSE: To compare encrustation resistance between silicon- and polytetrafluoroethylene (PTFE)-covered metallic ureteral stents (MUS) in an in vitro infection model and to determine the most effective material for reducing biofilm formation and encrustation.

MATERIALS AND METHODS: A total of 52 MUS were prepared: 26 silicon-covered and 26 PTFE-covered stents. Each sample was immersed in artificial urine inoculated with Proteus mirabilis in a biofilm reactor for 48 hours. After immersion, the stents were weighed to measure their encrustation level. Scanning electron microscopy (SEM) and energy dispersive X-ray spectroscopy (EDS) were used to assess the surface morphology and elemental composition of the encrustation deposits.

RESULTS: Silicon-covered stents showed a statistically significant reduction in weight gain due to encrustation compared to PTFE-covered stents (9.50±5.77 mg vs. 16.75±10.61 mg; p=0.004). Additionally, encrustation per unit length was lower in silicon-covered stents (0.76±0.45 mg/mm vs. 1.30±0.81 mg/mm; p=0.004). SEM and EDS analyses demonstrated lower calcium salt deposition on the silicon-covered stents, indicating greater resistance to encrustation.

CONCLUSIONS: Silicon-covered MUS demonstrated superior resistance to encrustation compared to PTFE-covered stents, supporting silicon as a more suitable covering material for long-term MUS applications. This finding may lead to extended stent lifespans and a reduced frequency of stent replacements, benefiting both patients and healthcare systems.

PMID:40047127 | DOI:10.4111/icu.20240410

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Psoriatic Arthritis – A Mortality Abstract

J Insur Med. 2025 Jul 1;52(1):3-5. doi: 10.17849/insm-52-1-3-5.1.

ABSTRACT

OBJECTIVE.—: To analyze a published study on all-cause mortality between psoriatic arthritis and matched population comparator-subjects to derive comparative mortality statistics applicable to life insurance underwriting.

METHOD.—: The pixel method was employed for extracting cumulative survivals. It was chosen for its capability to extract data from published graphs despite potential precision and reliability limitations.

RESULTS.—: The mortality analysis indicated an increase in mortality starting in year 4, aligning with the Table rating for Psoriatic arthritis. Pharmacological treatment data from the study revealed only 28% were on advanced therapies such as targeted synthetic or biologic DMARDs. This low percentage suggests most of the cohort had milder PsA, as advanced treatments are generally reserved for moderate to severe psoriatic arthritis. The distribution of treatment regimens provides essential insights into disease severity and its implications for mortality assessment.

CONCLUSION.—: The comparative mortality findings correspond to Table rating for psoriatic arthritis. This finding underscores the importance of understanding treatment profiles and disease severity in life insurance underwriting to accurately assess risk.

PMID:40047113 | DOI:10.17849/insm-52-1-3-5.1

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The Psychosocial Impact on Gingival Aesthetics Questionnaire (PIGAQ): The Effect of Sociodemographic Variables on Results in a Spanish Adult Population. An Observational and Cross-Sectional Study

J Esthet Restor Dent. 2025 Mar 6. doi: 10.1111/jerd.13449. Online ahead of print.

ABSTRACT

OBJECTIVES: (1) Describe and categorize the scores obtained by the study sample for the PIGAQ as a whole and each of its subscales; (2) compare the psychosocial impact of self-perceived gingival aesthetics shown by the results for each subscale, determining which subscale shows the greatest impact, in relation to each of the following variables: gender, age, educational level, and involvement with the dentistry profession (non-professionals/professionals).

METHODS: This observational and cross-sectional study is based on in-person interviews conducted by 10 trained operators, who administered the PIGAQ and collected data on gender, age, educational level, and connections to the dental profession in an adult (18-85 years) Spanish population. The data were collected over a 6-month period in 2024 in several regions of Spain. The main research outcome was the PIGAQ questionnaire (Likert scale) comprising 20 items in four subscales: gingival self-confidence (GSC), social impact (SI), psychological impact (PI), and aesthetic concern (AC), with a total score of 0-80 points. Data were analyzed using SPSS (v.28).

RESULTS: In the sample, the subscale where self-perceived gingival aesthetics showed the highest negative impact was GSC, whereas the lowest negative impact was recorded for the SI subscale (with 36.5% and 1.0% of participants’ scores representing a large negative impact, respectively). Significant psychosocial engagement with their gingival aesthetics was recorded for 5% of the study population (41-80). Total PIGAQ scores were significantly (p < 0.05) higher (a greater negative psychosocial impact) in participants who were male (21.23), aged 60 or over (23.83), not involved with the dental profession (19.90) and had only completed compulsory education (25.08). A significantly higher negative impact (p < 0.05) was recorded for participants aged 60 or over in the GSC (13.13), PI (4.88), and AC (2.96) subscales than for other age groups.

CONCLUSIONS: The negative psychosocial impact of self-perceived gingival aesthetics is low, with the highest impact recorded for the GSC subscale, and lower impacts experienced by participants who were female, aged under 26, had university-level education, and were involved with the dental profession.

CLINICAL SIGNIFICANCE: Data are lacking on the psychological and social impacts suffered by patients who are dissatisfied with their gingival aesthetics, and how these impacts relate to sociodemographic variables. To date, no research has been published addressing this issue in the Spanish population. Only 5% of the population gained high scores on the PIGAQ, with most negative impacts related to self-confidence in their gingival aesthetics. The variable that most negatively affected PIGAQ scores was age, although this effect was limited. Particular attention should be paid to male patients over 60 years with compulsory-level education only, as this group has a greater tendency to present with psychosocial distress caused by a negative self-assessment of gingival aesthetics.

PMID:40047106 | DOI:10.1111/jerd.13449

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Optimisation of the manufacturing process of a paediatric omeprazole enteric pellets suspension: Full Factorial Design

Drug Dev Ind Pharm. 2025 Mar 6:1-17. doi: 10.1080/03639045.2025.2476651. Online ahead of print.

ABSTRACT

OBJECTIVE: The propose of the present study was to apply the design of experiments (DoE) to develop an omeprazole enteric pellets suspension for use in the paediatric population.

METHODOLOGY: This experimental study employed a Full Factorial Design for drug development, encompassing three factors (Aerosil® R972, cetostearyl alcohol, and Span 80) at two levels (2% and 6% for factor A (Aerosil® R972) and 2% and 4% for factors B and C (cetostearyl alcohol and Span 80, respectively)).

RESULTS: Following the statistical optimization, the suspension F10 was formulated and subjected to a stability study for one month. The dissolution test results were suboptimal, achieving only an 22% release. Subsequently, eight additional suspensions were devised using hydrophilic oily vehicles (Labraphac Hydrophile WL 1219, Labrafil M2125 CS and Labrafil M 1944 CS) and excipients (Gelucire 44/14 and Aerosil® 200) to enhance the dissolution profile. Suspension F17 showed over 75% within 30 minutes, displaying superior sedimentation time when compared to all other formulations, along with effortless resuspension.

CONCLUSION: The findings suggest that the optimal vehicle for the administration of omeprazole enteric pellets in suspension is the formulation comprising Labrafil M 1944 CS, Span 80, and Aerosil® 200. This study has paved the way for an oily suspension vehicle, opening new avenues of research for developing paediatric omeprazole formulations that fulfil gastro-resistance requirements.

PMID:40047104 | DOI:10.1080/03639045.2025.2476651

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A robust signal processing program for nanopore signals using dynamic correction threshold with compatible baseline fluctuations

Analyst. 2025 Mar 6. doi: 10.1039/d4an01384k. Online ahead of print.

ABSTRACT

Solid-state nanopores represent a powerful platform for the detection and characterization of a wide range of biomolecules and particles, including proteins, viruses, and nanoparticles, for clinical and biochemical applications. Typically, nanopores operate by measuring transient pulses of ionic current during translocation events of molecules passing through the pore. Given the strong noise and stochastic fluctuations in ionic current recordings during nanopore experiments, signal processing based on the statistical analysis of numerous translocation events remains a crucial issue for nanopore sensing. Based on parallel computational processing and efficient memory management, we developed a novel signal processing procedure for translocation events to improve the signal identification performance of solid-state nanopores in the presence of baseline oscillation interference. By using an adaptive threshold within a sliding window, we could correct the baseline determination process in real time. As a result, the features of translocation event signals could be identified more accurately, especially for the intermittent occurrence of high-density complex signals. The program also demonstrated good signal differentiation. As a ready-to-use software, the data program is more efficient and compatible with diverse nanopore signals, making it suitable for more complex nanopore applications.

PMID:40047096 | DOI:10.1039/d4an01384k

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What is cancer pain? Investigating attitudes of patients, carers, and health professionals: A cross-sectional survey

Pain Pract. 2025 Mar;25(3):e70018. doi: 10.1111/papr.70018.

ABSTRACT

BACKGROUND: Cancer pain is a prevalent and debilitating symptom that impacts quality of life. Pain management remains challenging; however, due to various barriers, including stigma associated with opioid use, ambiguous roles of clinicians, and diverse attitudes toward pain management among healthcare professionals, patients, and carers.

OBJECTIVE: To explore the attitudes surrounding cancer pain among patients, carers, and health professionals at a tertiary cancer hospital.

METHODS: A cross-sectional online survey was conducted at the Peter MacCallum Cancer Centre. The survey included demographic measures and statements assessing attitudes toward cancer pain management. Data was analyzed using descriptive statistics in IBM SPSS 29. Ethics approval was granted by the Peter MacCallum HREC.

RESULTS: 308 participants (153 patients and carers, 155 health professionals) completed the survey. The results revealed significant variability in attitudes surrounding cancer pain and its management. Discrepancies in understanding between health professionals and patients/carers were observed. Differing views on the goals of pain management were revealed, with 51.6% of patients/carers expecting pain elimination compared to 20.6% of health professionals. The roles of clinicians in pain management were also perceived differently, highlighting a lack of clarity in responsibilities. Both groups emphasized the need for increased education on cancer pain and its management.

CONCLUSIONS: The study revealed substantial variability in attitudes toward cancer pain management among patients, carers, and health professionals. Discrepancies emerged in understanding, with many patients and carers uncertain about the nature of cancer pain, contrasting with health professionals’ recognition of its complexity. The terminology distinguishing “cancer pain” from “non-cancer pain” may contribute to this confusion, suggesting a need to reconsider these semantics. Divergent views on clinician roles and opioid use underscored uncertainties, especially regarding specialist access and prescribing practices. Both groups emphasized the need for education to bridge these gaps, with clearer communication and revised guidelines potentially improving patient outcomes.

PMID:40047077 | DOI:10.1111/papr.70018

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ApoM and Major Adverse Cardiovascular Events in Chronic Kidney Disease: A Prospective Cohort Study

Arterioscler Thromb Vasc Biol. 2025 Mar 6. doi: 10.1161/ATVBAHA.124.322367. Online ahead of print.

ABSTRACT

BACKGROUND: Cardiovascular disease is the leading cause of mortality in patients with chronic kidney disease (CKD). APOM plays a critical role in reverse cholesterol transport by facilitating the formation of pre-β-HDL (high-density lipoprotein) and enabling the binding of S1P (sphingosine-1-phosphate) to HDL, a complex involved in several antiatherogenic processes. In this study, we sought to investigate the potential association between plasma APOM levels and the risk of adverse cardiovascular outcomes in individuals with CKD.

METHODS: Plasma APOM levels were quantified using a sandwich ELISA-based assay. Plasma S1P levels were measured by high-performance liquid chromatography. The primary end point was a composite of major adverse cardiovascular events (MACE) and all-cause mortality.

RESULTS: In this secondary analysis of the CARE FOR HOMe study (Cardiovascular and Renal Outcome in CKD 2-4 Patients-The Fourth Homburg Evaluation), 463 nondialysis patients with CKD stages G2 to G4 were included. Plasma APOM levels exhibited a significant inverse association with the risk of MACE (standardized hazard ratio, 0.60 [95% CI, 0.49-0.75]; P<0.001) and all-cause mortality (standardized hazard ratio, 0.63 [95% CI, 0.48-0.83]; P<0.001). This inverse association with MACE remained robust after adjusting for established cardiovascular and renal risk factors. These findings were further corroborated in an independent cohort of 822 patients with CKD from the Copenhagen CKD study. Plasma S1P levels showed an inverse association with MACE in univariable analyses; however, this relationship lost statistical significance after multivariable adjustments.

CONCLUSIONS: Our findings demonstrate a significant association between low plasma APOM levels and an increased risk of MACE in patients with CKD. These results suggest that APOM may play a role in cardiovascular protection in this vulnerable population.

PMID:40047074 | DOI:10.1161/ATVBAHA.124.322367