Category: Nevin Manimala

Int Urol Nephrol. 2023 May 19. doi: 10.1007/s11255-023-03584-3. Online ahead of print.

ABSTRACT

INTRODUCTION: To decrease complication rate, we developed a novel MG needle for kidney puncture consisting of a pointed cannula, an atraumatic mandrin-bulb and a spring mechanism pushing the mandrin-bulb forward.

AIM OF THE STUDY: To assess efficacy and safety of kidney puncture during percutaneous nephrolithotomy (PCNL) using a novel less-traumatic MG needle within a clinical trial.

MATERIALS AND METHODS: We conducted a prospective randomized single-center study. In the experimental group, kidney puncture was performed with a novel MG needle while in the control group, standard Trocar or Chiba puncture needles were used.

PRIMARY ENDPOINT: hemoglobin drop.

RESULTS: A total of 67 patients were enrolled. Patients who underwent standard puncture (n = 33) had higher hemoglobin drop in the early postoperative period (p = 0.024). Although there was no statistical difference in overall complication rate between the two groups (p = 0.351), two severe Clavien-Dindo IIIa complications with urinoma occurred in patients from the control group.

CONCLUSION: Less-traumatic needle for kidney puncture may reduce hemoglobin drop and prevent the development of severe complications. At the same time, in terms of stone-free rate (SFR), the efficacy of PCNL remains the same regardless of the needle used for renal access.

PMID:37204679 | DOI:10.1007/s11255-023-03584-3

BioDrugs. 2023 May 19. doi: 10.1007/s40259-023-00600-x. Online ahead of print.

ABSTRACT

BACKGROUND: The US Food and Drug Administration (FDA) interchangeability guidelines state that the primary endpoint in a switching study should assess the impact of switching between the proposed interchangeable product and the reference product on clinical pharmacokinetics (PK) and pharmacodynamics (if available), as these assessments are generally sensitive to changes in immunogenicity and/or exposure that may arise due to switching. In addition, interchangeability designation requires no clinically meaningful difference in safety and efficacy of switching between the biosimilar and reference, compared with when using the reference product alone.

OBJECTIVES: The aim of this study was to investigate the PK, immunogenicity, efficacy, and safety in participants undergoing repeated switches between Humira^® and AVT02 as part of a global interchangeable development program.

METHODS: This multicenter, randomized, double-blind, parallel-group study in patients with moderate-to-severe plaque psoriasis comprises three parts: lead-in period (weeks 1-12), switching module (weeks 12-28), and the optional extension phase (weeks 28-52). Following the lead-in period during which all participants received the reference product (80 mg in week 1, followed by 40 mg every other week), participants with a clinical response of ≥ 75% improvement in the Psoriasis Area and Severity Index (PASI75) were randomized 1:1 to receive AVT02 alternating with the reference product (switching arm) or reference product only (non-switching arm). At week 28, participants who were PASI50 responders could opt to take part in an open-label extension phase receiving AVT02 up to week 50, with an end of study visit at week 52. PK, safety, immunogenicity, and efficacy were evaluated at various timepoints throughout the study for both switching and non-switching arms.

RESULTS: In total, 550 participants were randomized to switching (277) and non-switching arms (273). The switching versus non-switching arithmetic least square means ratio [90% confidence intervals (CIs)] was 101.7% (91.4-112.0%) for the area under the concentration-time curve over the dosing interval from weeks 26-28 (AUC_{tau, W26-28}) and 108.1% (98.3-117.9%) for maximum concentration over the dosing interval from weeks 26-28 (C_{max, W26-28}). The 90% CIs for the switching versus non-switching arithmetic means ratio for primary endpoints AUC_{tau, W26-28} and C_{max, W26-28} were within the prespecified limits of 80-125%, demonstrating comparable PK profiles between groups. In addition, the PASI, Dermatology Life Quality Index, and static Physician’s Global Assessment efficacy scores were highly similar for both treatment groups. There were no clinically meaningful differences between the immunogenicity and safety assessments of repeated switching between AVT02 and the reference product, versus the reference product alone.

CONCLUSIONS: This study demonstrated that the risk, in terms of safety or diminished efficacy of switching between the biosimilar and the reference product, is not greater than the risk of using the reference product alone, as required by the FDA for interchangeability designation. Beyond the scope of interchangeability, a consistent long-term safety and immunogenicity profile, with no impact on the trough levels up to 52 weeks, was established.

CLINICAL TRIAL REGISTRATION: NCT04453137; date of registration: 1 July 2020.

PMID:37204631 | DOI:10.1007/s40259-023-00600-x

Sports Med. 2023 May 19. doi: 10.1007/s40279-023-01836-x. Online ahead of print.

ABSTRACT

Blood-based biomarkers can provide an objective individualized measure of training load, recovery, and health status in order to reduce injury risk and maximize performance. Despite enormous potentials, especially owing to currently evolving technology, such as point-of-care testing, and advantages, in terms of objectivity and non-interference with the training process, there are several pitfalls in the use and interpretation of biomarkers. Confounding variables such as preanalytical conditions, inter-individual differences, or an individual chronic workload can lead to variance in resting levels. In addition, statistical considerations such as the detection of meaningful minimal changes are often neglected. The lack of generally applicable and individual reference levels further complicates the interpretation of level changes and thus load management via biomarkers. Here, the potentials and pitfalls of blood-based biomarkers are described, followed by an overview of established biomarkers currently used to support workload management. Creatine kinase is discussed in terms of its evidence for workload management to illustrate the limited applicability of established markers for workload management to date. We conclude with recommendations for best practices in the use and interpretation of biomarkers in a sport-specific context.

PMID:37204619 | DOI:10.1007/s40279-023-01836-x

Int J Clin Pharm. 2023 May 19. doi: 10.1007/s11096-023-01584-y. Online ahead of print.

ABSTRACT

BACKGOUND: Conbercept and ranibizumab have been used to treat retinopathy of prematurity (ROP). However, the clinical effectiveness of conbercept and ranibizumab remains controversial.

AIM: This meta-analysis aimed to compare the effectiveness of conbercept and ranibizumab for treating ROP.

METHOD: We systematically searched Pubmed, Web of Science, Embase, the Cochrane Library, Ovid, Scopus, China National Knowledge Infrastructure, Wanfang Database, CQVIP, Duxiu Database, SinoMed, and X-MOL to screen relevant studies up to November 2022. Retrospective cohort studies and randomized controlled trials (RCTs) evaluating the effectiveness of conbercept and ranibizumab in treating patients with ROP were selected. The outcomes assessed were the rates of primary cure, ROP recurrence, and retreatment. Statistical analysis was performed using Stata.

RESULTS: Seven studies (n = 989) were selected in the meta-analysis. There were 303 cases (594 eyes) treated with conbercept and 686 patients (1,318 eyes) treated with ranibizumab. Three studies reported the primary cure rate. Compared to ranibizumab, conbercept had a significantly higher primary cure rate (odds ratio [OR] 1.91, 95% confidence interval [CI] 1.05-3.49, P < 0.05). Five studies reported the rate of ROP recurrence, and there were no significant differences between conbercept and ranibizumab (OR 0.62, 95% CI 0.28-1.38, P > 0.05). Three studies reported the rate of retreatment, and the rates were not significantly different between conbercept and ranibizumab (OR 0.78, 95% CI 0.21-2.93, P > 0.05).

CONCLUSION: Conbercept had a higher rate of primary cure in ROP patients. More RCTs are needed to compare the efficacy of conbercept and ranibizumab in treating ROP.

PMID:37204617 | DOI:10.1007/s11096-023-01584-y

Surg Endosc. 2023 May 19. doi: 10.1007/s00464-023-10139-1. Online ahead of print.

ABSTRACT

BACKGROUND: Research presentation has benefits, including CV building, networking, and collaboration. A measurable standard for achievement is publication in a peer-reviewed journal. Expectations regarding the likelihood of publication are unknown for studies presented at a national surgical scientific meeting. This study aims to evaluate predictors of manuscript publication arising from abstracts presented at a national surgical scientific meeting.

METHODS: Abstracts presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Meeting 2019 were reviewed. Identification of published manuscripts was completed using MedLine, Embase, and Google Scholar 28 months after the presentation to allow for time for publication. Factors evaluated for association with publication included author and abstract measures. Descriptive analyses and multivariable statistics were performed.

RESULTS: 724 abstracts (160 podiums, 564 posters) were included. Of the podium presentations, 128 (80%) were published in a median of 4 months after the presentation. On univariable and multivariable analyses, there was no association between publication and abstract topic, gender, degree, number of publications, or H-indices of first and senior authors. 154 (27.3%) poster presentations were published with a median of 13 months. On univariable analysis, there was a statistically significant difference regarding the abstract topic (p = 0.015) and senior author degree (p = 0.01) between published and unpublished posters. Multivariable analysis demonstrated that colorectal surgery (OR 2.52; CI 1.02-6.23) and metabolic/obesity (OR 2.53; CI 1.09-5.84) are associated with an increased odd of publication. There was an inverse association with female senior authors (OR 0.53; CI 0.29-0.98), while additional degrees (e.g., doctorate and/or master’s degree) of the senior authors were associated with an increased publication rate (OR 1.80; CI 1.00-3.22).

CONCLUSION: 80% of podiums but only 27% of posters were ultimately published. While some predictors of poster publication were noted, it is unclear if these are why these projects fail to publish. Future research is warranted to determine if there are effective strategies to increase poster publication rates.

PMID:37204602 | DOI:10.1007/s00464-023-10139-1

Environ Sci Pollut Res Int. 2023 May 19. doi: 10.1007/s11356-023-27694-8. Online ahead of print.

ABSTRACT

In this cross-sectional study, it was aimed to investigate the relationship between sustainable and healthy eating behaviors such as nutritional insecurity and a healthy and balanced diet, interest in regional and organic food products, consumption of seasonal food and avoidance of food waste, preference for locally produced foods, reduction of meat consumption, preference for eggs from free-range chickens, and sustainable fishery products, and consumption of low-fat food products in adults. The study included 410 adults who were reached through social media applications. Data were collected through an online questionnaire including the Descriptive Information Form, the Household Food Insecurity Access Scale (HFIAS), and the Sustainable Healthy Eating Behaviors Scale (SHEBS). The proportion of participants determined as mildly food insecure, moderately food insecure, and severely food insecure was 10.2%, 6.6%, and 7.6%, respectively. Linear regression analysis revealed that in Models 1, 2, and 3, there was a statistically significant negative association between food insecurity and the components of sustainable and healthy eating behaviors such as healthy and balanced diet (β – 0.226, p < 0.001), quality labels (β – 0.230, p < 0.001), seasonal foods, which are of avoidance of food waste (β – 0.261, p < 0.001), animal welfare (β – 0.174, p < 0.001), and fat intake (β – 0.181, p < 0.001). In conclusion, food insecurity negatively affects healthy and balanced diet behaviors, interest in regional and organic food products, seasonal food products consumption and avoidance of food waste, consumption of low-fat food products, and the choice of products such as free-range chicken eggs, and sustainable fisheries.

PMID:37204579 | DOI:10.1007/s11356-023-27694-8

Environ Sci Pollut Res Int. 2023 May 19. doi: 10.1007/s11356-023-27616-8. Online ahead of print.

ABSTRACT

Bioretention is a typical low impact development (LID) practice that helps reduce peak urban stormwater runoff and runoff pollutant concentrations (e.g., heavy metals, suspended solids, organic pollutants), which has become an important part of urban stormwater management over the past 15 years. To understand the research hotspots and frontiers in the field of bioretention facility research and provide a reference for research into bioretention facilities, we conduct a statistical analysis of global bioretention literature published during 2007-2021 using the Web of Science core database and the data visualization and analysis software VOSviewer and HistCite. The number of published articles related to bioretention facilities shows a rising trend over the study period, with research from China contributing greatly to global research on bioretention facilities. However, the influence of articles needs to be increased. Recent studies mainly focus on the hydrologic effect and water purification effect of bioretention facilities and on the removal of nitrogen and phosphorus nutrients from runoff rainwater. Further studies should focus on the interaction of fillers, microorganisms, and plants in bioretention facilities and its impact on the migration, transformation, and concentrations of nitrogen and phosphorus; the purification effect and mechanism of specific emerging contaminants in runoff; the selection and configuration optimization of filler materials and plant species; and the optimization of the design parameters of the model for bioretention systems.

PMID:37204577 | DOI:10.1007/s11356-023-27616-8

Ir J Med Sci. 2023 May 19. doi: 10.1007/s11845-023-03385-8. Online ahead of print.

ABSTRACT

OBJECTIVE: The study investigates the diagnostic and prognostic value of C-reactive protein (CRP) and procalcitonin (PCT) in patients with sepsis and septic shock.

BACKGROUND: Limited data regarding the prognostic value of CRP and PCT during the course of sepsis or septic shock is available.

METHODS: Consecutive patients with sepsis and septic shock from 2019 to 2021 were included monocentrically. Blood samples were retrieved from the day of disease onset (day 1), day 2, 3, 5, 7, and 10. Firstly, the diagnostic value of CRP and PCT for the diagnosis of a septic shock, as well as for the discrimination of positive blood cultures, was tested. Secondly, the prognostic value of the CRP and PCT was tested for 30-day all-cause mortality. Statistical analyses included univariable t-tests, Spearman’s correlations, C-statistics, and Kaplan-Meier analyses.

RESULTS: A total of 349 patients were included, of which 56% had a sepsis and 44% a septic shock on day 1. The overall rate of all-cause mortality at 30 days was 52%. With an area under the curve (AUC) of 0.861 on day 7 and 0.833 on day 10, the PCT revealed a superior AUC than the CRP (AUC 0.440-0.652) with regard to the discrimination between patients with sepsis and septic shock. In contrast, the prognostic AUCs for 30-day all-cause mortality were poor. Both higher CRP (HR = 0.999; 95% CI 0.998-1.001; p = 0.203) and PCT levels (HR = 0.998; 95% CI 0.993-1.003; p = 0.500) were not associated with the risk of 30-day all-cause mortality. During the first 10 days of ICU treatment, both CRP and PCT declined irrespective of clinical improvement or impairment.

CONCLUSION: PCT was a reliable diagnostic tool for the diagnosis of septic shock compared to CRP. Both CRP and PCT were shown to have poor predictive value with regard to 30-day all-cause mortality and were not associated with the risk of all-cause mortality in patients admitted with sepsis or septic shock.

PMID:37204560 | DOI:10.1007/s11845-023-03385-8

J Mater Sci Mater Med. 2023 May 19;34(6):27. doi: 10.1007/s10856-023-06731-5.

ABSTRACT

The present study aimed to evaluate osteogenic potential and biocompatibility of combining biphasic calcium phosphate with zirconia nanoparticles (4Zr TCP/HA) compared to biphasic calcium phosphate (TCP/HA) for reconstruction of induced mandibular defects in dog model. TCP/HA and 4Zr TCP/HA scaffolds were prepared. Morphological, physicochemical, antibacterial, cytocompatibility characterization were tested. In vivo application was performed in 12 dogs where three critical-sized mandibular defects were created in each dog. Bone defects were randomly allocated into: control, TCP/HA, and 4Zr TCP/HA groups. Bone density and bone area percentage were evaluated at 12 weeks using cone-beam computed tomographic, histopathologic, histomorphometric examination. Bone area density was statistically increased (p < 0.001) in TCP/HA and 4Zr TCP/HA groups compared to control group both in sagittal and coronal views. Comparing TCP/HA and 4Zr TCP/HA groups, the increase in bone area density was statistically significant in coronal view (p = 0.002) and sagittal view (p = 0.05). Histopathologic sections of TCP/HA group demonstrated incomplete filling of the defect with osteoid tissue. Doping with zirconia (4Zr TCP/HA group), resulted in statistically significant increase (p < 0.001) in bone formation (as indicated by bone area percentage) and maturation (as confirmed by Masson trichrome staining) compared to TCP/HA group. The newly formed bone was mature and organized with more trabecular thickness and less trabecular space in between. Physicochemical, morphological and bactericidal properties of combining zirconia and TCP/HA were improved. Combining zirconia and TCP/HA resulted in synergistic action with effective osteoinduction, osteoconduction and osteointegration suggesting its suitability to restore damaged bone in clinical practice.

PMID:37204535 | DOI:10.1007/s10856-023-06731-5

Acta Neurochir (Wien). 2023 May 18. doi: 10.1007/s00701-023-05627-1. Online ahead of print.

ABSTRACT

PURPOSE: Large (> 3 cm) vestibular schwannomas pose complexity in surgical management because of narrow working corridors and proximity to the cranial nerves, brainstem, and inner ear structures. With current vestibular schwannoma classifications limited in information regarding cerebellopontine edema, our retrospective series examined this radiographic feature relative to clinical outcomes and its possible role in preoperative scoring.

METHODS: Of 230 patients who underwent surgical resection of vestibular schwannoma (2014-2020), we identified 107 patients with Koos grades 3 or 4 tumors for radiographic assessment of edema in the middle cerebellar peduncle (MCP), brainstem, or both. Radiographic images were graded and patients grouped into Koos grades 3 or 4 or our proposed grade 5 with edema. Tumor volumes, radiographic features, clinical presentations, and clinical outcomes were evaluated.

RESULTS: The 107 patients included 22 patients with grade 3 tumors, 39 with grade 4, and 46 with grade 5. No statistical differences were noted among groups for demographic data or complication rates. Unlike grades 3 and 4 patients, grade 5 patients presented with worse hearing (p < 0.001), larger tumors (p < 0.001), lower rates of gross total resection (GTR), longer hospital stays, and higher rates of balance dysfunction.

CONCLUSION: With edema detected in 43% of this cohort, special considerations are warranted for grade 5 vestibular schwannomas given the preoperative findings of worse hearing, lower GTR rates, longer hospital stays, and 96% who pursued postoperative balance therapy. We propose that grade 5 with edema offers a more nuanced interpretation of a radiographic feature that holds relevance to treatment selection and patient outcomes.

PMID:37204532 | DOI:10.1007/s00701-023-05627-1