bluuebunny/crossref_metadata_2025_split huggingface dataset:
A real-world pharmacovigilance analysis of adverse events associated with irbesartan using the FAERS and JADER databases
Authors: Liu Qian , Cui Zhiwei , Deng Chao , Yang Chao , Shi Tao 
Published: November 2024

ObjectiveHypertension is a leading global risk factor for disability and death. Irbesartan, a potent angiotensin II receptor blocker, requires continuous safety monitoring. We conducted a disproportionality analysis of irbesartan-related adverse drug events (ADEs) using the FDA’s FAERS and Japan’s JADER databases.MethodsWe extracted irbesartan-related ADE reports from FAERS (Q1 2004 to Q1 2024) and JADER (Q2 2008 to Q4 2023). We used Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) for signal detection. Sensitivity analyses were conducted to exclude comorbid medications, and subgroup analyses by age and gender were performed to explore ADE occurrence in specific populations. Th time to onset (TTO) of ADEs was assessed using Weibull distribution test and Kaplan-Meier curves.ResultsA total of 5,816 (FAERS) and 366 (JADER) reports were analyzed, with irbesartan-related preferred terms (PTs) involving 27 System Organ Classes (SOCs) in FAERS and 22 in JADER. Three SOCs met detection thresholds in both databases: “metabolism and nutrition disorders,” “cardiac disorders,” and “renal and urinary disorders.” We identified 219 positive signals in FAERS and 20 in JADER, including known signals like hyperkalemia, hypotension, and acute kidney injury. Notably, newly identified signals such as acute pancreatitis (n = 50, ROR: 7.76 [5.88–10.25]) and rhabdomyolysis (n = 50, ROR: 7.76 [5.88–10.25]) in FAERS and respiratory failure (n = 7, ROR: 6.76 [3.20–14.26]) in JADER could have significant clinical implications, as they may lead to severe outcomes if not recognized and managed promptly. Subgroup analyses revealed both similarities and differences in signal detection across gender and age groups. Sensitivity analyses, excluding concomitant medications, confirmed the persistence of key positive signals, including hyperkalemia, angioedema, acute pancreatitis, and agranulocytosis. ADEs mainly occurred within 1 month (34.14%) and after 1 year (32.32%) after dosing, with a median onset of 107 days.ConclusionThis study provides valuable real-world evidence on the safety profile of irbesartan. The identification of new safety signals underscores the necessity of updating drug labels, particularly for assessing and managing high-risk patients. Additionally, the TTO analysis emphasizes the importance of sustained vigilance for adverse events over time. In conclusion, our findings contribute to a more comprehensive understanding of irbesartan’s safety, aiding healthcare professionals in optimizing its use in clinical practice.
Evaluation of pharmacokinetics and relative bioavailability of pentoxifylline and its metabolite in beagle dogs following different formulations
Authors: Xu Yuxiang , Qie Hongxin , Zhao Haopeng , Gong Wenlin , Wang Peiyuan , Gao Xiaonan , Gao Jinglin , Feng Zhangying , Wang Mingxia 
Published: November 2024

A single-oral-dose, two-period cross-over study with a 5-day washout period under fed condition was conducted in six beagle dogs to explore the pharmacokinetic characteristics and relative bioavailability between sustained-release (SR) tablets and enteric-coated (EC) tablets of pentoxifylline (PTX) and its metabolite. The results showed that M5 exhibited the highest exposure level, while M1 demonstrated the lowest in both the SR and EC tablet groups. For PTX and M1, T1/2 were 0.42 and 0.55 h, with tmax of 1.83 and 1.83 h, respectively, in the SR tablet group; in the EC tablet group, T1/2 were 0.38 and 0.47 h, respectively. However, a significantly prolonged absorption process was noted, with tmax values of 5.06 and 5.78 h. In contrast, M5 exhibited distinct pharmacokinetic differences compared to PTX and M1. For the SR tablet group, T1/2 and tmax were recorded at 2.03 and 3.08 h, respectively. In the EC tablet group, T1/2 and tmax were 1.67 and 5.78 h, respectively. With regard to the geometric least squares mean (LSM) of AUC and Cmax for SR tablets and EC tablets, the ratios of SR/EC of PTX, M1 and M5 were 67.62% (90% CI, 50.49%–90.55%), 78.18% (90% CI, 54.15%–112.88%), and 119.11% (90% CI, 99.62%–142.41%), respectively, for AUC(0-t). The ratios were 67.62% (90% CI, 50.50%–90.55%), 78.36% (90% CI, 54.48%–112.72%), and 119.39% (90% CI, 100.03%–142.50%) for AUC(0−∞) and 54.36% (90% CI, 36.63%–80.67%), 58.80% (90% CI, 40.84%–84.66%), and 100.51% (90% CI, 89.50%–112.88%) for Cmax, respectively. The AUC ratio predictions of bioconversion results indicated that there was no significant difference in the bioconversion of M1 between the SR tablets and EC tablets, with conversion rates of 0.37 and 0.36, respectively. In contrast, the conversion rate of M5 demonstrated a significant difference (p &lt; 0.05) between the SR tablets and EC tablets, with the ratio of 3.09 and 1.91, respectively. Furthermore, the EC tablet group demonstrated notable inter-individual differences and irregular drug absorption, following meals. Consequently, the SR tablets appeared to provide a more stable and controllable therapeutic effect in beagle dogs.
Optimization of initial dosage of quetiapine in schizophrenic patients: effects of fluvoxamine or duloxetine coadministration
Authors: Chen Xiao , Zhang Yue , Yin Di , Jin Ying-Wei , He Su-Mei , Liu Chen-Xu , Zhang Cun , Wang Dong-Dong 
Published: November 2024

ObjectiveAlthough quetiapine has been approved for use in schizophrenic patients, its individualized dosage regimen remains unclear, especially with respect to drug–drug interactions (DDIs). Thus, we investigated the potential DDIs and optimal initial dosage of quetiapine in schizophrenic patients based on population pharmacokinetics (PPK).MethodsNinety-six schizophrenic patients treated with quetiapine were included to establish the PPK model, which also includes coadministration of multiple drugs.ResultsIt was found that the patient weights and fluvoxamine or duloxetine coadministration affected quetiapine clearance in schizophrenic patients. Without fluvoxamine or duloxetine coadministration, 16 and 12 mg/kg/day of quetiapine were recommended to schizophrenic patients whose weights were in the ranges of 40–50 and 50–120 kg, respectively. With fluvoxamine coadministration, 8 mg/kg/day of quetiapine was recommended to patients with weights in the range of 40–120 kg. With duloxetine coadministration, 8 mg/kg/day of quetiapine was recommended to patients with weights in the 40–120 kg range. With simultaneous coadministration of fluvoxamine and duloxetine, 4 mg/kg/day of quetiapine was recommended to patients with weights in the 40–120 kg range.ConclusionThe present study was a pilot effort at investigating the potential DDIs and optimal initial dosage of quetiapine in schizophrenic patients based on PPK. The initial dosages of quetiapine administered to the patients were optimized according to the coadministration of fluvoxamine or duloxetine.
Cognitive performance in ISS astronauts on 6-month low earth orbit missions
Authors: Dev Sheena I. , Khader Alaa M. , Begerowski Sydney R. , Anderson Steven R. , Clément Gilles , Bell Suzanne T. 
Published: November 2024

IntroductionCurrent and future astronauts will endure prolonged exposure to spaceflight hazards and environmental stressors that could compromise cognitive functioning, yet cognitive performance in current missions to the International Space Station remains critically under-characterized. We systematically assessed cognitive performance across 10 cognitive domains in astronauts on 6-month missions to the ISS.MethodsTwenty-five professional astronauts were administered the Cognition Battery as part of National Aeronautics and Space Administration (NASA) Human Research Program Standard Measures Cross-Cutting Project. Cognitive performance data were collected at five mission phases: pre-flight, early flight, late flight, early post-flight, and late post-flight. We calculated speed and accuracy scores, corrected for practice effects, and derived z-scores to represent deviations in cognitive performance across mission phases from the sample’s mean baseline (i.e., pre-flight) performance. Linear mixed models with random subject intercepts and pairwise comparisons examined the relationships between mission phase and cognitive performance.ResultsCognitive performance was generally stable over time with some differences observed across mission phases for specific subtests. There was slowed performance observed in early flight on tasks of processing speed, visual working memory, and sustained attention. We observed a decrease in risk-taking propensity during late flight and post-flight mission phases. Beyond examining group differences, we inspected scores that represented a significant shift from the sample’s mean baseline score, revealing that 11.8% of all flight and post-flight scores were at or below 1.5 standard deviations below the sample’s baseline mean. Finally, exploratory analyses yielded no clear pattern of associations between cognitive performance and either sleep or ratings of alertness.ConclusionThere was no evidence for a systematic decline in cognitive performance for astronauts on a 6-month missions to the ISS. Some differences were observed for specific subtests at specific mission phases, suggesting that processing speed, visual working memory, sustained attention, and risk-taking propensity may be the cognitive domains most susceptible to change in Low Earth Orbit for high performing, professional astronauts. We provide descriptive statistics of pre-flight cognitive performance from 25 astronauts, the largest published preliminary normative database of its kind to date, to help identify significant performance decrements in future samples.
Health-related fitness benefits following concurrent high-intensity interval training and resistance training in patients with type-1 diabetes or type-2 diabetes
Authors: Scoubeau Corentin , Klass Malgorzata , Celie Bert , Godefroid Chantal , Cnop Miriam , Faoro Vitalie 
Published: November 2024

IntroductionCardiorespiratory fitness (CRF), as assessed by VO2peak, along with metabolic and cardiovascular health indices, represents the strongest predictors of survival. However, it remains unclear whether concurrent high-intensity interval training (HIIT) and resistance training (RT) can similarly enhance these health markers in patients with type-1 diabetes (T1D) or type-2 diabetes (T2D) compared to healthy individuals.MethodsAdults with uncomplicated T1D or T2D and healthy normoglycemic controls matched for sex and age (HC1 and HC2) performed 3 training sessions/week of concurrent HIIT and RT for 12 weeks. Pre- and post-intervention assessments included: lipids and glycemic profile, body composition (dual-energy x-ray absorptiometry) and a cyclo-ergometric cardio-pulmonary exercise test.ResultsTraining improved VO2peak, the ventilatory threshold (VT1), maximal workload, ventilation and O2pulse, similarly in T1D in HC1 without changes in body composition or glycemic profile. In patients with T2D, training improved insulin sensitivity (HOMA-IR), lean mass, VE/VCO2 slope, VT1 and maximal O2pulse, workload and VO2peak with reduction in fat mass and visceral adipose tissue (VAT) (all, p &lt; 0.05). However, improvements in VO2peak and O2pulse were lower than in healthy controls (respectively, T2D: +9%, HC2: +18% and T2D: +6%, HC2: +19%, p &lt; 0.05).ConclusionsBoth patients with T1D and T2D benefit from combined HIIT and RT by improving CRF with specific adaptations influenced by the presence and type of diabetes. While identical magnitude of achievements were observed in T1D and HC1, T2D patients exhibited lower VO2peak and maximal O2pulse improvements but associated with notable additional health benefits regarding insulin sensitivity, body composition, visceral adipose tissue and ventilatory efficiency.
The relationships between race, employment, and self-rated health among older South Africans: exploring the mediating role of generalized anxiety
Authors: Yunus Adams , Zhou Lulin , Jamatutu Seidu Abdulai , Tackie Evelyn Agba 
Published: November 2024

ObjectiveThis study explores the impact of race and employment status on self-rated health among older adults in South Africa. It reveals new insights by examining the mediating role of generalized anxiety. The findings highlight the importance of addressing these factors to improve the wellbeing of older adults.MethodsDrawing from Wave 5 of the National Income Dynamics Study—Coronavirus Rapid Mobile Survey, a cross-sectional survey encompassing a nationally representative cohort of South African adults, this research employs a sophisticated blend of logistic regression and structural equation modeling techniques.ResultsThe study reveals that race is strongly linked to self-rated health. Individuals of Colored and White backgrounds have lower odds of favorable self-rated health. Retirement has a positive impact on self-rated health. Generalized anxiety mediates the complex relationship between race and self-rated health.ConclusionsAddressing the imperative need to mitigate racial disparities in self-rated health and advance equitable healthcare access for older adults, targeted interventions are undeniably warranted.
How significant is cost-shifting behavior under the diagnosis intervention packet payment reform? Evidence from the coronary heart disease market
Authors: Tan Huawei , Zhang Xueyu , Bi Shengxian , Chen Yingchun , Guo Dandan 
Published: November 2024

BackgroundControlling the growth of inpatient costs presents a major challenge in China’s healthcare system. China introduced a new case-based payment method, the “Diagnosis Intervention Packet” (DIP), to address the surge in hospitalization expenses. However, the influence of DIP payment reform on cost shifting among coronary heart disease (CHD) inpatients remains unclear.MethodsThis study focused on Zunyi, a national pilot city for DIP, utilizing inpatient claim data to assess the effects of DIP payment reform. We analyzed the influence on total health expenditures (THE), individual payments excluding reimbursement (IPER), proportion of IPER, copayments for category-B, proportion of copayments for category-B, copayments for category C, and proportion of copayments for category C per case for CHD inpatient.ResultsResults indicate a significant reduction in THE per case for CHD inpatients after the DIP reform (β = −0.1272, p &lt; 0.01). Increases in cost shifting were observed in IPER (β = 0.1080, p &lt; 0.05), the proportion of IPER (β = 0.0551, p &lt; 0.01), copayments for category B (β = 0.2392, p &lt; 0.01), and the proportion of copayments for category B (β = 0.0295, p &lt; 0.01), along with the proportion of copayments for category C (β = 0.0255, p &lt; 0.01). However, the copayments for category C did not significantly change. Notable variations in the effects of cost control and shifting were observed across different hospital categories, teaching statuses, hospital grades, and ownership types.ConclusionThe DIP reform significantly reduced the THE per case for CHD inpatients, while shifting in-policy expenditures to IPER, particularly with a greater shift intensity in the proportion of Class B compared with the proportion of Class C.
Correlation between the physical activity volume and cognitive and mental capacity among older adult people in China: a cross-sectional study based on the 2020 CHARLS database
Authors: Li Shixin , Zhang Jiayi , Yang Yonghong 
Published: November 2024

BackgroundCurrently, due to the progress of the aging population in China and the government’s attention to healthy aging, there is an increasing emphasis on the cognitive function and psychological function of older adult people. Therefore, the aim of our study was to investigate the relationships between physical activity and cognitive and psychological function in order to provide recommendations for exercise guidance.MethodsThe Center for Epidemiologic Studies Depression Scale (CESD-10) was used to assess mental capacity, and cognitive function was evaluated across three domains: orientation, memory and calculation. Total physical activity data were obtained via interviews. Ability of Daily Living (ADL) and Instrumental Ability of Daily Living (IADL) scores were used to determine the presence or absence of daily physical function impairment. Finally, we conducted correlation analysis and logistic regression on participants’ physical activity volume (PAV) and their cognitive and psychological functions, respectively.ResultsA total of 5,871 participants who met the inclusion criteria were selected from the China Health and Retirement Longitudinal Study (CHARLS). The prevalence of depression was 8.1, and 31.6% of the older adult participants reported experienced depressive symptoms. Additionally, 15.6% of the older adult individuals had insufficient weekly physical activity, while 3.9% had daily physical function (DPF) impairment. Physical activity volume (PAV) was negatively correlated with the CESD-10 score, as well as with orientation, calculation, and memory.ConclusionOur study confirmed that inactive weekly physical activity was associated with an increased risk of depression, cognitive impairment, and DPF impairment among older adult individuals in China.
Unveiling the hidden threats: a review of pathogen diversity and public health risks from bats, rodents, and non-human primates in Zambia (1990–2022)
Authors: Munjita Samuel Munalula , Mubemba Benjamin , Changula Katendi , Tembo John , Hamoonga Raymond , Bates Matthew , Chitanga Simbarashe , Munsaka Sody , Simulundu Edgar 
Published: November 2024

BackgroundInfectious disease agents of animal origin, which can cause mild to severe illnesses in humans, are increasingly spilling over into human populations. Southern Africa, particularly Zambia as a regional transport hub, has experienced notable outbreaks of zoonotic pathogens in recent years. This context underscores the importance of research, as numerous studies over the past 33 years have reported various infectious agents with differing zoonotic potential from bats, rodents, and non-human primates (NHPs) in Zambia. However, the data remained unaggregated, hampering comprehensive and organized understanding of these threats.MethodsA review spanning January 1990 to December 2022 synthesised data from selected studies conducted in bats, rodents, and NHPs across 14 of Zambia’s 116 districts.ResultsAmong the reported pathogens, viruses predominated (62%, 31/50), followed by parasites (20%, 10/50)), and bacteria (18%, 9/50). Notable pathogens included Ebola virus, Marburg virus, Hantavirus, Zika virus, Human parainfluenza virus-3, Anaplasma phagocytophilum, Borrelia faini, Coxiella burnetii, Trypanosoma brucei rhodesiense, Calodium hepaticum, and Trichinella spiralis. Most identified infectious agents came from short term cross-sectional investigations, thus, the temporal dynamics related to abundance and likelihood of outbreaks remain unknown.ConclusionThe findings starkly illuminate significant zoonotic public health threats amidst glaring under-surveillance of zoonoses in humans in Zambia. This critical gap calls urgently for enhanced active, passive and syndromic surveillance activities to identify new diseases and provide evidence-based measures to safeguard public health from emerging infectious risks in Zambia and the Southern African sub-region, considering the country’s position as a regional transport hub.
Can public health services promote the settlement intention of migrant workers: empirical analysis from China
Authors: Lyu Tong 
Published: November 2024

IntroductionEnhancing migrant workers’ settlement intention in cities requires ensuring they have equal public health rights as urban residents. Full access to public health services can strengthen their sense of belonging and improve the well-being of this vulnerable group. Evaluating the welfare impact of public health services from the perspective of city identification offers valuable insights and informs policies aimed at improving the quality of public health service provision.MethodsThis study utilizes data from the 2017 China CMDS survey. We employed various analytical methods, including the Probit model, IV-Probit model, Propensity Score Matching, and KHB decomposition, to empirically examine the impact of public health services on the settlement intention of migrant workers. Additionally, we explored the underlying mechanisms and heterogeneity of this impact.ResultsPublic health services such as health records management and public health education significantly increase the settlement intention of migrant workers. The positive effect of public health services on the settlement intention is more pronounced among migrant workers who have moved across provinces and those who are married. Public health services indirectly enhance the settlement intention by improving urban satisfaction and sense of belonging, with the latter having a more substantial indirect effect.DiscussionThe current provision of basic public health services in China for migrant workers still needs improvement. This highlights the necessity of enhancing health record management, increasing health education and training, and tailoring services to better meet the needs of migrant workers. By improving the supply of public health services, we can effectively raise migrant workers’ urban satisfaction and sense of belonging, thereby indirectly increasing their willingness to settle in cities. The findings of this study contribute to further optimizing the implementation of public health service policies and provide meaningful guidance for improving the urban integration of migrant workers.
Descriptive analysis of adverse events following immunization with oral cholera vaccine in Lebanon
Authors: Zeitoun Abeer , Ibrahim Aya , Reda El Sayed Sarah , Hobeika Eva , Karam Rita 
Published: November 2024

BackgroundA national Oral Cholera Vaccine (OCV) Euvichol-Plus® campaign was launched in Lebanon, in response to the first outbreak in three decades, recorded in October 2022. The OCV vaccination campaign was carried out between November 2022 and February 2023. This study aims to cover adverse events reports, received at the Lebanese National Pharmacovigilance Program’s (LNPVP) passive surveillance system.MethodsCase reports were extracted from the LNPVP’s database. SPSS software was used to perform statistical analysis, with categorical variables compared using Pearson’s χ2 test. A descriptive analysis was performed based on age, gender, vaccine administered, and adverse event(s) associated with the administered vaccine.ResultsA total of 115 Adverse Events Following Immunization (AEFIs) were reported, which corresponded to 46 case reports. The top three reported AEFIs were fever (39.13%), diarrhea (30.43%), and vomiting (30.43%). Reported cases were non-serious (82.6%). The highest proportion of Individual Case Safety Reports (ICSRs) received is attributed to females (56.5%), and the age category of 2 and 11 years old (41.3%). Reporters’ age range was 1–74 years old.ConclusionMonitoring AEFIs through the cholera outbreak’s emergency campaign favors the safety profile of OCV.