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Nevin Manimala Statistics

Ocular Adverse Events After Influenza Vaccination in Older Adults: Self-Controlled Case Series Using a Large Database in Japan

Ophthalmic Epidemiol. 2023 Dec 12:1-6. doi: 10.1080/09286586.2023.2289990. Online ahead of print.

ABSTRACT

BACKGROUND: To clarify the risk of adverse ocular events following influenza vaccination.

METHODS: This self-controlled case series study used a claims database linked to vaccination records of a large city in Japan between April 2014 and September 2021. Individuals aged ≥ 65 years who developed adverse ocular events during the follow-up period were included. The exposure was influenza vaccination. The primary outcome was defined as the occurrence of at least one of the following five eye diseases: uveitis, scleritis, retinal vein occlusion, retinal artery occlusion, or optic neuritis. Conditional Poisson regression was used to estimate the within-subject incidence rate ratio of ocular adverse events during the risk period (0-56 days after vaccination) compared to the control period.

RESULTS: A total of 4,527 cases were eligible for the study (median age, 74 years; male, 42%). The incidence rate ratio for the outcome during the risk period was 0.99 (95% confidence interval, 0.87 to 1.14). No increased risk was observed for individual components of the outcome either; the incidence rate ratio was 0.94 (0.78 to 1.13) for uveitis, 1.17 (0.86 to 1.59) for scleritis, 0.98 (0.76 to 1.27) for retinal vein occlusion, 0.89 (0.42 to 1.87) for retinal artery occlusion, and 0.87 (0.44 to 1.70) for optic neuritis.

CONCLUSIONS: This self-controlled case series showed no apparent increase in the risk of adverse ocular events after influenza vaccination among older adults. These results mitigate the concerns of older adults who may hesitate to receive influenza vaccination for fear of adverse ocular events.

ABBREVIATION: HR = hazard ratio; CI = confidence interval; RVO = retinal vein occlusion; SCCS = self-controlled case series.

PMID:38085757 | DOI:10.1080/09286586.2023.2289990

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A Model of Immediate Implant Placement to Evaluate Early Osseointegration in 129/Sv Diabetic Mice

Int J Oral Maxillofac Implants. 2023 Dec 12;38(6):1200-1210. doi: 10.11607/jomi.10335.

ABSTRACT

PURPOSE: To analyze the process of early oral osseointegration of titanium (Ti) implants in diabetic 129/Sv mice through microCT and histologic and immunohistochemical analysis.

MATERIALS AND METHODS: A group of 30 male 129/Sv mice was equally subdivided into two groups: (1) nondiabetic (ND), in which mice did not undergo systemic alterations and received a standard diet, and (2) diabetic (D), in which mice were provided a high-fat diet from the age of 6 weeks until the conclusion of the study and received two intraperitoneal (IP) injections of streptozotocin (STZ) at a concentration of 100 mg/Kg each. Each mouse underwent extraction of a maxillary first molar, and customized Ti screws (0.50 mm diameter, 1.5 mm length) were placed in the residual alveolar sockets of the palatal roots. At 7 and 21 days after implant placement, the animals were euthanized for maxilla and pancreas collection. Maxillae containing Ti implants were analyzed with microCT, histology, and immunohistochemistry for cells that were positive for F4/80, CD146, runt-related transcription factor 2 (Runx2), and proliferating cell nuclear antigen (PCNA). Pancreata were histologically analyzed. Quantitative data were statistically analyzed with a significance level at 5% (P < .05).

RESULTS: ND mice presented successful healing and osseointegration, with a significantly higher fraction of bone volume compared to D mice, both at the alveolar sockets (53.39 ± 5.93 and 46.08 ± 3.18, respectively) and at the implant sites (68.88 ± 7.07 and 44.40 ± 6.98, respectively) 21 days after implant placement. Histologic evaluation revealed that the ND mice showed a significant decrease in inflammatory infiltrate and a significant increase in newly formed bone matrix at 21 days, whereas peri-implant sites in the D mice were predominantly encapsulated by fibrous tissue and chronic inflammatory infiltrate. Immunohistochemical characterization revealed higher Runx2 osteoblast differentiation and higher cell proliferation activity in the ND mice at 7 days, while higher amounts of macrophages were present in D mice at 7 and 21 days. Interestingly, no differences were found in CD146-positive cells when comparing ND and D mice.

CONCLUSIONS: This study evaluated the effects of immediate dental implant placement in 129/Sv diabetic mice by using specific healing markers to identify changes in cellular events involved in early oral osseointegration. This approach may serve as tool to evaluate new materials and surface coatings to improve osseointegration in diabetic patients.

PMID:38085752 | DOI:10.11607/jomi.10335

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Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials

JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.

ABSTRACT

BACKGROUND: Wearable sensors in digital health may pose a risk for skin irritation through the use of wearable patches. Little is known about how patient- and product-related factors impact the risk of skin irritation. Aripiprazole tablets with sensor (AS, Abilify MyCite; Otsuka America Pharmaceutical, Inc) is a digital medicine system indicated for the treatment of patients with schizophrenia, bipolar I disorder, and major depressive disorder. AS includes aripiprazole tablets with an embedded ingestible event marker, a wearable sensor attached to the skin through a wearable patch, a smartphone app, and a web-based portal. To continuously improve the final product, successive iterations of wearable patches were developed, including raisin patch version 4 (RP4), followed by disposable wearable sensor version 5 (DW5), and then reusable wearable sensor version 2 (RW2).

OBJECTIVE: This analysis pooled safety data from clinical studies in adult participants using the RP4, DW5, and RW2 wearable patches of AS and evaluated adverse events related to the use of wearable patches.

METHODS: Safety data from 12 studies in adults aged 18-65 years from May 2010 to August 2020 were analyzed. All studies evaluated safety, with studies less than 2 weeks also specifically examining human factors associated with the use of the components of AS. Healthy volunteers or patients with schizophrenia, bipolar I disorder, or major depressive disorder were enrolled; those who were exposed to at least 1 wearable patch were included in the safety analysis. Adverse events related to the use of a wearable patch were evaluated. Abrasions, blisters, dermatitis, discoloration, erythema, irritation, pain, pruritus, rash, and skin reactions were grouped as skin irritation events (SIEs). All statistical analyses were descriptive.

RESULTS: The analysis included 763 participants (mean [SD] age 42.6 [12.9] years; White: n=359, 47.1%; and male: n=420, 55%). Participants were healthy volunteers (n=269, 35.3%) or patients with schizophrenia (n=402, 52.7%), bipolar I disorder (n=57, 7.5%), or major depressive disorder (n=35, 4.6%). Overall, 13.6% (104/763) of the participants reported at least 1 SIE, all of which were localized to the wearable patch site. Incidence of ≥1 patch-related SIEs was seen in 18.1% (28/155), 14.2% (55/387), and 9.2% (28/306) of participants who used RP4, DW5, and RW2, respectively. Incidence of SIE-related treatment discontinuation was low, which is reported by 1.9% (3/155), 3.1% (12/387), and 1.3% (4/306) of participants who used RP4, DW5, and RW2, respectively.

CONCLUSIONS: The incidence rates of SIEs reported as the wearable patch versions evolved from RP4 through RW2 suggest that information derived from reported adverse events may have informed product design and development, which could have improved both tolerability and wearability of successive products.

TRIAL REGISTRATION: Clinicaltrials.gov NCT02091882, https://clinicaltrials.gov/study/NCT02091882; Clinicaltrials.gov NCT02404532, https://clinicaltrials.gov/study/NCT02404532; Clinicaltrials.gov NCT02722967, https://clinicaltrials.gov/study/NCT02722967; Clinicaltrials.gov NCT02219009, https://clinicaltrials.gov/study/NCT02219009; Clinicaltrials.gov NCT03568500, https://clinicaltrials.gov/study/NCT03568500; Clinicaltrials.gov NCT03892889, https://clinicaltrials.gov/study/NCT03892889.

PMID:38085556 | DOI:10.2196/44768

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The relationship between echocardiographic parameters and albumin bilirubin score in patients with acute pulmonary thromboembolism

Perfusion. 2023 Dec 12:2676591231221706. doi: 10.1177/02676591231221706. Online ahead of print.

ABSTRACT

PURPOSE: The Albumin-Bilirubin (ALBI) score is useful and easy-to-use for objectively assessing liver function. We investigated whether the ALBI score, a parameter indicating liver stiffness, congestion and fibrosis, has any relationship with echocardiographic parameters in patients with acute pulmonary thromboembolism (PTE).

MATERIAL AND METHODS: A total of 140 patients diagnosed with acute PTE were retrospectively analyzed. These patients were divided into three groups according to the hemodynamic severity of acute PTE: Group I [Low risk]; Group II [Submassive or intermediate-risk]; and Group III [Massive or high-risk]. Biochemical data obtained from venous blood samples taken at admission were analyzed. In addition, data were also analyzed from transthoracic echocardiography and pulmonary computed tomographic angiography performed at admission. ALBI, Bova, and PESI scores were calculated.

RESULTS: ALBI scores (-3.32 ± 0.21 vs -2.86 ± 0.15 vs -2.46 ± 0.2, p < .001) were statistically significantly higher in Group III than Groups I and II. There was a significant difference between the three groups in terms of echocardiographic parameters, and LVEF and TAPSE values tended to decrease from group I to group III. In multivariate linear regression analysis, sPAP, RV/RA diameter, and NT-pro-BNP were found to be significantly associated with the ALBI score. An ALBI score higher than -2.87 was associated with Bova stage II-III in patients with Group I and Group II PTE, with a sensitivity of 87% and a specificity of 62% (AUC = 0.804; 95% CI 0.713-0.895; p < .001).

CONCLUSION: The ALBI score, which is a common, easy-to-use, and inexpensive method, may be beneficial to select intermediate and high-risk patients in patients with acute PTE. Additionally, it may have prognostic value in distinguishing low and intermediate-risk acute PTE patients.

PMID:38085551 | DOI:10.1177/02676591231221706

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Unraveling the Dynamic Helicity Inversion and Chirality Transfer by the Iterative Exponential Growth Synthesis of Azobenzene Discrete Oligomers

Angew Chem Int Ed Engl. 2023 Dec 12:e202315686. doi: 10.1002/anie.202315686. Online ahead of print.

ABSTRACT

Unraveling the chirality transfer mechanism of polymer assemblies and controlling their handedness is beneficial to exploring the origin of hierarchical chirality and developing smart materials with desired chiroptical activities. However, polydisperse polymers often lead to an ambiguous or statistical evaluation of the structure-property relationship, it remains unclear how the iterative number of repeating units can function in the helicity inversion of polymer assemblies. Herein, we report the macroscopic helicity and dynamic manipulation of the chiroptical activity of supramolecular assemblies from discrete azobenzene-containing oligomers (Azooligomers), together with the helicity inversion and morphological transition achieved solely by changing the iterative chain lengths. The chiral supramolecular assemblies of the iterative Azooligomers were collectively characterized by CD, UV-vis, small-angle X-ray scattering (SAXS), and wide-angle X-ray diffraction (WAXD) spectroscopy, transmission electron microscopy (TEM), and ultrasonic uncoiling experiments, revealing that their helicity inversions are governed by distinct stacking modes and delicate balance of kinetics and thermodynamics. The corresponding assemblies also differ from their polydisperse counterparts in terms of thermodynamic properties, chiroptical activities, and morphological control.

PMID:38085492 | DOI:10.1002/anie.202315686

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Detection of atmospheric aerosols and terrestrial nanoparticles collected in a populous city in southern Brazil

Environ Sci Pollut Res Int. 2023 Dec 12. doi: 10.1007/s11356-023-31414-7. Online ahead of print.

ABSTRACT

The main objective of this study is to analyze hazardous elements in nanoparticles (NPs) (smaller than 100 nm) and ultrafine particles (smaller than 1 µm) in Porto Alegre City, southern Brazil using a self-made passive sampler and Sentinel-3B SYN satellite images in 32 collection points. The Aerosol Optical Thickness proportion (T550) identification was conducted using images of the Sentinel-3B SYN satellite at 634 points sampled in 2019, 2020, 2021, and 2022. Focused ion beam scanning electron microscopy analyses were performed to identify chemical elements present in NPs and ultrafine particles, followed by single-stage cascade impactor to be processed by high-resolution transmission electron microscopy. This process was coupled with energy-dispersive X-ray spectroscopy and later analysis via secondary ion mass spectrometry. Data was acquired from Sentinel-3B SYN images, normalized to a standard mean of 0.83 µg/mg, at moderate spatial resolution (260 m), and modeled in the Sentinel Application Platform (SNAP) software v.8.0. Statistical matrix data was generated in the JASP software (Jeffreys’s Amazing Statistics Program) v.0.14.1.0 followed by a K-means cluster analysis. The results demonstrate the presence of between 1 and 100 nm particles of the following chemical elements: Si, Al, K, Mg, P, and Ti. Many people go through these areas daily and may inhale or absorb these elements that can harm human health. In the Sentinel-3B SYN satellite images, the sum of squares in cluster 6 is 168,265 and in cluster 7 a total of 21,583. The use of images from the Sentinel-3B SYN satellite to obtain T550 levels is of great importance as it reveals that atmospheric pollution can move through air currents contaminating large areas on a global scale.

PMID:38085483 | DOI:10.1007/s11356-023-31414-7

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Monitoring agricultural drought in Peshawar Valley, Pakistan using long -term satellite and meteorological data

Environ Sci Pollut Res Int. 2023 Dec 12. doi: 10.1007/s11356-023-31345-3. Online ahead of print.

ABSTRACT

Monitoring agricultural drought across a large area is challenging, especially in regions with limited data availability, like the Peshawar Valley, which holds great agricultural significance in Pakistan. Although remote sensing provides biophysical variables such as precipitation (P), land surface temperature (LST), normalized difference vegetation index (NDVI), and relative soil moisture (RSM) to assess drought conditions at various spatiotemporal scales, these variables have limited capacity to capture the complex nature of agricultural drought and associated crop responses. Here, we developed a composite drought index named “Temperature Vegetation ET Dryness Index” (TVEDI) by modifying the Temperature Vegetation Precipitation Dryness Index (TVPDI) and integrating NDVI, LST, and remotely sensed evapotranspiration (ET) using 3D space and Euclidean distance. Several statistical techniques were employed to examine TVPDI and TVEDI trends and relationships with other commonly used drought indices such as the standardized precipitation index (SPI), standardized precipitation evapotranspiration index (SPEI), and standardized soil moisture index (SSI), as well as crop yield, to better understand how these indices captured the spatial and temporal distribution of agricultural drought in the Peshawar valley between 1986 and 2018. Results indicated that while the temporal patterns of the 3-month SPI, SPEI, and SSI generally align with those of TVEDI and TVPDI, TVEDI was more strongly correlated with these indices (e.g., correlation coefficient, r = 0.78-0.84 from TVEDI and r = 0.73-0.79 from TVPDI). Moreover, the crop yield, a measure of crop response to agricultural drought, demonstrated a significant positive correlation with TVEDI (r = 0.60-0.80), much higher than its correlation with TVPDI (r = 0.30-0.48). These outcomes indicate that the inclusion of ET in TVEDI effectively captured changes in soil moisture, crop water status, and their impact on crop yield. Overall, TVEDI exhibited enhanced capability to identify drought impacts compared to TVPDI, showing its potential for characterizing agricultural drought in regions with limited data availability.

PMID:38085478 | DOI:10.1007/s11356-023-31345-3

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Natural history of renal angiomyolipoma in a high-volume center: our experience during more than 15 years of follow up

Int Urol Nephrol. 2023 Dec 12. doi: 10.1007/s11255-023-03839-z. Online ahead of print.

ABSTRACT

OBJECTIVES: To describe the natural history of AML, the clinical results and the need for treatment during long-term follow-up of renal AML.

METHODS: Retrospective study of patients diagnosed with AML by computed tomography or nuclear magnetic resonance between 2001 and 2019, with at least two follow-up images. Clinical and imaging variables, need for intervention, complications and follow-up time were recorded. Statistical analysis was performed using SPSS 22.0.

RESULTS: 111 patients and 145 AML were included. The median follow-up was 6.17 years (range 0.7-18.1, IQR 11.8-12.2). The median tumor size at diagnosis was 13 mm (IQR 7.5-30), with 24 (16.4%) being ≥ 4 cm. Most presented as an incidental finding (85.5%); in 3 (2.1%) cases, the presentation was as a spontaneous retroperitoneal hematoma. The main indication for intervention was size ≥ 4 cm in 50%. Eighteen (12%) patients received a first intervention, being urgent in 3. Embolization was performed in 15 cases and partial nephrectomy in 3. The need for reintervention was recorded in five: two underwent partial nephrectomy and two total nephrectomy; one patient required a new urgent embolization. Of the non-operated patients, 43% decreased in size or did not change, while 57% increased, with the median annual growth being 0.13 mm (IQR – 0.11 to 0.73). There were no differences in the median growth in tumors measuring ≥ 4 cm (0.16 mm) at diagnosis vs. < 4 cm (0.13 mm) (p = 0.9).

CONCLUSIONS: The findings of this study suggest that AML typically demonstrate a slow-progressing clinical course during long-term follow-up. Moreover, our observations, which cast doubt on tumor size as a reliable predictor of adverse clinical outcomes, advocate for a less intensive monitoring strategy in both monitoring frequency and choice of imaging modality.

PMID:38085409 | DOI:10.1007/s11255-023-03839-z

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Serum and salivary Cu/Zn ratio as a diagnostic biomarker for oral submucosal fibrosis: an analysis of trace metals and LOX gene variants

Biometals. 2023 Dec 12. doi: 10.1007/s10534-023-00561-2. Online ahead of print.

ABSTRACT

This study aimed to analyze the serum and salivary levels of copper (Cu), zinc (Zn), iron (Fe), chromium (Cr), manganese (Mn) and the Cu/Zn ratio and investigate the association between LOX gene variants (rs18800449 and rs2288393) and oral submucosal fibrosis (OSMF). A total of 250 subjects were included in the study: OSMF patients (n = 50), areca nut chewers without OSMF (n = 100) and controls (n = 100). Trace metals were measured using an atomic absorption spectrophotometer, while LOX gene variants were genotyped using the tetra primer amplification refractory mutation system (tetra ARMS) polymerase chain reaction (PCR) method. The results showed significant variations in serum and salivary Cu, Zn, Fe and Cr levels and serum Mn concentrations among the three groups (p < 0.0001). Serum Cu levels were significantly higher in OSMF patients, while serum Zn levels were significantly lower. Both serum and salivary Cu/Zn ratios demonstrated a statistically significant difference (p < 0.0001) and diagnostic potential to differentiate OSMF from chewers and controls. However, LOX gene variants did not show an association between OSMF and chewers, except for rs1800449 genotypes, which showed a significant and increased risk with the AA genotype in OSMF patients compared to controls (OR = 7.58; 95%CI 2.30-24.97). The study suggests that trace elements and genetic variants may impact the etiology of OSMF. The findings may aid in early diagnosis, suitable treatment, and as a prognostic indicator for disease progression.

PMID:38085405 | DOI:10.1007/s10534-023-00561-2

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Soluble B7-H3 in Colorectal Cancer

Bull Exp Biol Med. 2023 Dec 12. doi: 10.1007/s10517-023-05972-2. Online ahead of print.

ABSTRACT

We present the results of comparative ELISA of the concentration of soluble form of immunity checkpoint B7-H3 (sB7-H3) in the serum of patients with colorectal cancer (CRC) at different stages before treatment and healthy control donors. The analysis revealed a statistically significant difference between the median levels of sB7-H3 in the blood serum of CRC patients (19.66 ng/ml) and healthy donors (16.76 ng/ml) (p=0.0025). ROC analysis showed 62.9% sensitivity and 56.7% specificity for CRC patients (cut-off 17.62 ng/ml; p=0.0028). An association of sB7-H3 levels with tumor progression was revealed. We demonstrated that sB7-H3 levels were significantly lower in patients with regional metastases than in patients without metastases (p=0.039) and that sB7-H3 concentration tends to decrease at the late stages of the disease. Thus, high serum level of sB7-H3 in CRC patients can be a favorable prognostic factor in future.

PMID:38085395 | DOI:10.1007/s10517-023-05972-2