Contrastive analysis on the safety of brand and generic nebivolol: a real-world pharmacovigilance study based on the FDA adverse event reporting system.

Background: The equivalence of generic drugs to their brand-name counterparts is a controversial issue. Current literature indicates disparities between the generic nebivolol (GN) and the brand nebivolol (BN). Aim: The study is designed to investigate the safety difference between GN and BN and provide reference information for clinical practice. Methods: We reviewed adverse event (AE) reports that recorded nebivolol as the primary suspect drug in the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2022, conducted a disproportional analysis to detect signals for the GN and BN respectively, and compared the AE heterogeneity between them using the Breslow-Day test. Results: A total of 2613 AE reports of nebivolol were recorded in the FAERS database from 2004 to 2022, of which 2,200 were classified as BN, 346 as GN, and 67 unclassifiable AE reports were excluded. The signals of 37 AEs distributed in cardiac, gastrointestinal, psychiatric, and nervous systems were detected in disproportional analysis. 33 out of 37 AEs were positive signals, with 21 not previously listed on the drug label, indicating an unrecognized risk with nebivolol. In the heterogeneity analysis of AE signals between GN and BN, the GN generally showed a higher AE signal value than BN, especially 15 AEs distributed in the cardiac, neurological, and psychiatric systems that showed statistically significantly higher risk by taking GN. Conclusion: Our study shows some previously overlooked adverse effects of nebivolol. It suggests that the risk of GN's adverse effects may be higher than those in BN, which deserves further attention and investigation by healthcare professionals, regulators, and others.

Holo-omics analysis reveals the influence of gut microbiota on obesity indicators in Jinhua pigs.

BACKGROUND: The mechanisms behind obesity are complex and multi-faceted, involving the interplay of both host genomics and gut microbiome. In recent years, research has largely focused on these factors separately, but rarely from the viewpoint of holo-omics, which considers the host and microbiome as an integrated entity. To address this gap in knowledge, the present study aimed to investigate the holo-omics basis of obesity in Jinhua pigs, a Chinese indigenous breed known for its high degree of fat deposition and superior meat quality. METHODS: Six pigs with extreme obesity phenotype were selected from a larger cohort of eighteen Jinhua pigs, and the contents of the jejunum, cecum, and colon regions were collected after slaughter at 240 days of age. The data obtained was processed, denoised, and annotated using QIIME2, with expression differences being analyzed using edgeR software. RESULTS: The results showed significant differences in jejunal microbial diversity and composition between the two groups, with gut transcriptomics also indicating that differentially expressed genes in the jejunum were enriched in lipid metabolism pathways. These findings provide further evidence of the influence of the gut microbiome and host gene expression on fat deposition in Jinhua pigs. CONCLUSIONS: This study provides valuable insights into the mechanisms of fat deposition in Jinhua pigs from the viewpoint of holo-omics. The integration of host transcriptomics and microbiome data helps shed light on the complex interactions between the host and gut microbiome, and highlights the importance of considering both factors in our understanding of obesity.

Integration of Selection Signatures and Protein Interactions Reveals NR6A1, PAPPA2, and PIK3C2B as the Promising Candidate Genes Underlying the Characteristics of Licha Black Pig.

Licha black (LI) pig has the specific characteristics of larger body length and appropriate fat deposition among Chinese indigenous pigs. Body length is one of the external traits that affect production performance, and fat deposition influences meat quality. However, the genetic characteristics of LI pigs have not yet been systematically uncovered. Here, the genomic information from 891 individuals of LI pigs, commercial pigs, and other Chinese indigenous pigs was used to analyze the breed characteristics of the LI pig with runs of homozygosity, haplotype, and FST selection signatures. The results showed the growth traits-related genes (i.e., NR6A1 and PAPPA2) and the fatness traits-related gene (i.e., PIK3C2B) were the promising candidate genes that closely related to the characteristics of LI pigs. In addition, the protein-protein interaction network revealed the potential interactions between the promising candidate genes and the FASN gene. The RNA expression data from FarmGTEx indicated that the RNA expression levels of NR6A1, PAPPA2, PIK3C2B, and FASN were highly correlated in the ileum. This study provides valuable molecular insights into the mechanisms that affect pig body length and fat deposition, which can be used in the further breeding process to improve meat quality and commercial profitability.

Exploration of the health needs of patients with poorly controlled type 2 diabetes using a user-centred co-production approach in the area of mHealth: an exploratory sequential mixed-method protocol.

INTRODUCTION: Research on the needs and preferences of patients with poorly controlled type 2 diabetes mellitus (T2DM) with mobile health (mHealth) service is limited. With the principles of co-production, this study aims to address this research gap by exploring the health needs of Chinese patients with poorly controlled T2DM. METHODS AND ANALYSIS: This study uses a three-phase, exploratory sequential mixed-method design. Phase 1 aims to assess the health needs of patients with poorly controlled T2DM by conducting semi-structured interviews with patients, doctors and nurses. Participants will be recruited by purposive sampling with maximum variation. Content analysis will be employed. Phase 2 will form item generation and develop the mHealth need scale. The scale will be subject to pilot testing and psychometric evaluation, including content validity, construct validity, discriminant validity, internal validity and test-retest reliability. Phase 3 will explore the priority of health needs perceived by patients with poorly controlled T2DM through a cross-sectional study. The measurement tools include an mHealth needs scale, the Summary of Diabetes Self-care Activities Questionnaire, the Diabetes Empowerment Scale-Short Form, the Diabetes Health Literacy Scale and the eHealth Literacy Scale. Multiple regression techniques with a hierarchical block design will be used for the model building to identify the factors contributing to the heterogeneity of the perceived mHealth needs. The findings of phase 1 and phase 3 will be integrated using data correlation, comparison and consolidation. ETHICS AND DISSEMINATION: The Ethics Committee of the School of Nursing, Sun Yat-sen University, has approved this study (No. 2021ZSLYEC). The results of this study will be disseminated through conference presentations and peer-reviewed publications.

Humanistic caring ability of midwifery students in China and its associated factors: A multi-centre cross-sectional study.

BACKGROUND: Research regarding humanistic caring has proliferated to enable person-centred and holistic care. Empirical evidence investigating the humanistic caring ability is largely derived from studies recruiting general nursing students. Midwifery students, however, remain underrepresented. OBJECTIVES: To assess the humanistic caring ability of midwifery students in China and investigate its associated factors. DESIGN: A multi-centre cross-sectional descriptive study. SETTINGS: Five medical colleges spreading across Eastern, Central and Southern China. PARTICIPANTS: Secondary vocational, higher vocational and undergraduate midwifery students (N = 303). METHODS: The Caring Ability Inventory (CAI), the Jefferson Scale of Physician Empathy for Nursing Students (JSPE-NS), the Connor-Davidson Resilience Scale (CD-RISC) and the Professional Identity Scale for Nursing Students (PISNS) were used to measure humanistic caring ability, empathy, resilience and professional identity, respectively. Stepwise multiple linear regression was used to explore associated factors. RESULTS: The midwifery students' total mean CAI score was 184.63 ± 19.88. In the multiple linear regression analysis, empathy (ß = 0.394, p < 0.001), resilience (ß = 0.233, p < 0.001) and professional identity (ß = 0.161, p = 0.002) were positively associated with the humanistic caring ability of midwifery students. The humanistic caring ability was also influenced by educationl level, perceived concern from peers and recognition of caring ability as a prerequisite for midwifery profession. CONCLUSIONS: Midwifery students in China have poor humanistic caring ability, which needs to be further improved. Interventions that cultivate the empathy, resilience and professional identity have the potential to advance the humanistic caring ability of midwifery students. Promoting a supportive and caring atmosphere among peers is also important.

Effectiveness of smartphone application-based self-management interventions in patients with type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.

AIMS: To synthesize evidences on smartphone application-based intervention and determine its effectiveness on glycaemic control, self-management behaviours, psychological well-being, quality of life and cardiometabolic risk factors. DESIGN: A systematic review and meta-analysis of randomized controlled trials (RCTs). DATA SOURCES: Major English and Chinese electronic databases were searched from January 2008 to January 2021, including PubMed, Web of Science, Embase, Cochrane Central Register of Controlled Trials, Google Scholar, China National Knowledge Infrastructure (CNKI), Wanfang and Sinomed. REVIEW METHODS: RCTs were screened and selected if they used smartphone applications to support patients in the self-management of diabetes. Data extraction and methodological assessment were performed by two reviewers independently. Meta-analysis was performed to pool the intervention effect on outcomes of interest using RevMan 5.3. RESULTS: Across 19 included trials involving 2585 participants, smartphone application-based interventions were associated with a clinically and statistically significant reduction of glycated haemoglobin (HbA1c). Beneficial effects were also observed in participants' behavioural performance, especially in medication adherence. Intervention effects on psychological status, quality of life and cardiometabolic risk factors were nonsignificant. Subgroup analysis showed interactive approach with medium frequency or flexible facilitator-patient interaction induced a larger effect on HbA1c reduction. Besides, patients with baseline HbA1c ≥9% benefited more than those with HbA1c <9% from the use of smartphone applications. CONCLUSIONS: Smartphone application-based diabetes self-management intervention could optimize patients' glycaemic control and enhance participants' self-management performance. Further endeavour is required to examine the long-term effects and cost-effectiveness of smartphone application-based intervention before promoting the adoption and dissemination of such intervention. IMPACT: This review supports the potential of smartphone application-based intervention as effective approach to optimize glycaemic control and promote self-management engagement among patients with type 2 diabetes. Suggestions for future research and practice are provided and discussed.

Analysis of SI-Related BoGAPDH Family Genes and Response of BoGAPC to SI Signal in Brassica oleracea L.

Glyceraldehyde 3-phosphate dehydrogenase (GAPDH) is not only involved in carbohydrate metabolism, but also plays an important role in stress resistance. However, it has not been reported in Brassica oleracea. In this study, we performed a genome-wide identification of BoGAPDH in B. oleracea and performed cloning and expression analysis of one of the differentially expressed genes, BoGAPC. A total of 16 members of the BoGAPDH family were identified in B. oleracea, which were conserved, distributed unevenly on chromosomes and had tandem repeat genes. Most of the genes were down-regulated during self-pollination, and the highest expression was found in stigmas and sepals. Different transcriptome data showed that BoGAPDH genes were differentially expressed under stress, which was consistent with the results of qRT-PCR. We cloned and analyzed the differentially expressed gene BoGAPC and found that it was in the down-regulated mode 1 h after self-pollination, and the expression was the highest in the stigma, which was consistent with the result of GUS staining. The promoter region of the gene not only has stress response elements and plant hormone response elements, but also has a variety of specific elements for regulating floral organ development. Subcellular localization indicates that the BoGAPC protein is located in the cytoplasm and belongs to the active protein in the cytoplasm. The results of prokaryotic expression showed that the size of the BoGAPC protein was about 37 kDa, which was consistent with the expected results, indicating that the protein was induced in prokaryotic cells. The results of yeast two-hybrid and GST pull-down showed that the SRK kinase domain interacted with the BoGAPC protein. The above results suggest that the BoGAPDH family of B. oleracea plays an important role in the process of plant stress resistance, and the BoGAPC gene may be involved in the process of self-incompatibility in B. oleracea, which may respond to SI by encoding proteins directly interacting with SRK.

Prevalence of periodontitis in people clinically diagnosed with diabetes mellitus: a meta-analysis of epidemiologic studies.

AIMS: The relationship between diabetes mellitus and periodontitis has long been discussed, but the conclusion of this relationship was controversial. We conducted this meta-analysis to explore the association between diabetes mellitus and the prevalence of periodontitis. METHODS: PubMed, Embase, Web of Science, and the Cochrane Library were searched for studies reporting associations of periodontitis with diabetes. Gray literature was integrated from the Open-Gray database. Prevalence estimates and odds ratios were extracted by two independent reviewers and synthesized through meta-analyses. RESULTS: Twenty-seven papers met the inclusion criteria involving 3092 diabetic patients and 23,494 controls. Overall prevalence of periodontitis was 67.8% in diabetics (combined types) and 35.5% in patients without diabetes (OR, 1.85; 95%CI, 1.61-2.11). Probing depth (MD 0.23; 95% CI, 0.17-0.29; I2 = 25%) and plaque index (MD, 0.20; 95% CI, 0.18-0.23; P = 0.59; I2 = 0%) severity scores were significantly greater among the diabetic group. CONCLUSIONS: The prevalence and severity of periodontitis are greater in patients with diabetes than in non-diabetic populations.

Optimal Nutrition Formulas for Patients Undergoing Surgery for Colorectal Cancer: A Bayesian Network Analysis.

Optimal nutrition formulas for colorectal cancer patients underwent surgery remains uncertainty. We constructed an indirect comparison study to assess comparative efficacy of different immunonutrition formulas and standard nutrition in colorectal cancer patients underwent surgery. PubMed, the Cochrane Library, EMBASE, ClinicalTrials.gov and Web of Science databases were searched to identify RCTs that compared immunonutrition with standard nutrition or different immunonutrition formulas. Data on length of hospital stays (LOS), infectious complications (IC), noninfectious complications (NIC) and anastomotic leakage (AL) were extracted from the included RCTs for Bayesian network analysis using a random-effect model. Twelve articles that included 1032 individuals were incorporated into this study. The indirect comparison confirmed the potential improvement of arginine-based immunonutrition on IC (odds ratios [OR] = 0.43, 95%confidence interval [CI]: 0.17 to 0.95), glutamine on NIC (OR = 0.07 CI: 0.00 to 0.78) and LOS (MD=-3.91 CI: -6.33 to -1.69) and omega-3 polyunsaturated fatty acids on LOS (OR=-3.49 CI: -5.46 to -1.00). Results indicated that glutamine had the highest probability of reducing complications and hospital stays. As for colorectal cancer patients underwent surgery, this indirect comparison suggested some superiority of glutamine. Future more RCTs with larger scale are required to provide evidence for the optimal immunonutrition formulas.

Effects of art therapy in cancer care: A systematic review and meta-analysis.

OBJECTIVE: To evaluate the effect of art therapy on cancer patients' quality of life and physical and psychological symptoms. METHODS: The databases PubMed, Embase, Web of Science, The Cochrane Library, Clinical Trial.gov, the China National Knowledge Infrastructure (CNKI), Wanfang and the Chinese Biomedical Literature Database (CBM) were searched from their inception up to 20 August 2019. Trials examining the effects of art therapy on physical and psychological symptoms and quality of life versus a control group were included. The methodological quality of the included randomised controlled trials was assessed using the risk of bias tool of Cochrane Handbook. Meanwhile, the Newcastle-Ottawa Quality Assessment Scale (NOS) was used to evaluate the methodological quality of the non-randomised studies. RESULTS: Twelve studies involving 587 cancer patients were included. The results revealed that art therapy significantly reduced anxiety symptoms (standard mean difference [SMD] = -0.46, 95% confidence interval [CI] [-0.90, 0.02], p = .04), depression symptoms (SMD = -0.47, 95% CI [-0.72, 0.21], p < .01), and fatigue (SMD = -0.38, 95% CI [-0.68, -0.09], p = .01) in cancer patients. Art therapy also significantly improved the quality of life of cancer patients (SMD = 0.43, 95% CI [0.18, 0.68], p < .01). CONCLUSIONS: Art therapy had a positive effect on quality of life and symptoms in cancer patients and can be used as a complementary treatment for cancer patients.

Genome-Wide Distribution, Expression and Function Analysis of the U-Box Gene Family in Brassica oleracea L.

The plant U-box (PUB) protein family plays an important role in plant growth and development. The U-box gene family has been well studied in Arabidopsis thaliana, Brassica rapa, rice, etc., but there have been no systematic studies in Brassica oleracea. In this study, we performed genome-wide identification and evolutionary analysis of the U-box protein family of B. oleracea. Firstly, based on the Brassica database (BRAD) and the Bolbase database, 99 Brassicaoleracea PUB genes were identified and divided into seven groups (I-VII). The BoPUB genes are unevenly distributed on the nine chromosomes of B. oleracea, and there are tandem repeat genes, leading to family expansion from the A. thaliana genome to the B. oleracea genome. The protein interaction network, GO annotation, and KEGG pathway enrichment analysis indicated that the biological processes and specific functions of the BoPUB genes may mainly involve abiotic stress. RNA-seq transcriptome data of different pollination times revealed spatiotemporal expression specificity of the BoPUB genes. The differential expression profile was consistent with the results of RT-qPCR analysis. Additionally, a large number of pollen-specific cis-acting elements were found in promoters of differentially expressed genes (DEG), which verified that these significantly differentially expressed genes after self-pollination (SP) were likely to participate in the self-incompatibility (SI) process, including gene encoding ARC1, a well-known downstream protein of SI in B. oleracea. Our study provides valuable information indicating that the BoPUB genes participates not only in the abiotic stress response, but are also involved in pollination.