Bmc Med
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Cell and gene therapy products (CGTPs) often receive accelerated approvals, lacking comprehensive long-term safety and efficacy data, which can raise significant safety concerns. This research aims to study the post-marketing surveillance (PMS) of CGTPs in the European Union (EU), the United States (US), Japan, South Korea, and China, to offer insights for the development of a secure and standardized post-marketing regulatory framework for CGTPs. ⋯ This study demonstrates that the regulatory policies of PMS for CGTPs in the EU, the US, Japan, and South Korea were comprehensive. The implementation of PMS for CGTPs in the EU, the US, and Japan was well developed. This knowledge holds valuable insights for China's future learning and development in this field.
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Breast cancer (BC) is a complex disease with profound genomic aberrations. However, the underlying molecular disparity influenced by age and ethnicity remains elusive. ⋯ Our findings collectively provide unprecedented insights into the significance of age and ethnicity on the molecular and clinical characteristics of BC patients.
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Although electronic alerts are being increasingly implemented in patients with acute kidney injury (AKI), their effect remains unclear. Therefore, we conducted this meta-analysis aiming at investigating their impact on the care and outcomes of AKI patients. ⋯ Electronic alerts increased the incidence of AKI and dialysis in AKI patients, which likely reflected improved recognition and early intervention. However, these changes did not improve the survival or kidney function of AKI patients. The findings warrant further research to comprehensively evaluate the impact of electronic alerts.
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Kidney transplantation is the optimal renal replacement therapy for children with end-stage renal disease; however, delayed graft function (DGF), a common post-operative complication, may negatively impact the long-term outcomes of both the graft and the pediatric recipient. However, there is limited research on DGF in pediatric kidney transplant recipients. This study aims to develop a predictive model for the risk of DGF occurrence after pediatric kidney transplantation by integrating donor and recipient characteristics and utilizing machine learning algorithms, ultimately providing guidance for clinical decision-making. ⋯ In this study, we developed a machine learning-based predictive model for DGF following pediatric kidney transplantation, termed DGF-RS, which integrates both donor and recipient characteristics. The model demonstrated excellent predictive accuracy and provides essential guidance for clinical decision-making. These findings contribute to our understanding of the pathogenesis of DGF.
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Preterm birth is a major cause of infant mortality and morbidity and accounts for 7-8% of births in the UK. It is more common in women from socially deprived areas and from minority ethnic groups, but the reasons for this disparity are poorly understood. To inform interventions to improve child survival and their quality of life, this study examined the socioeconomic and ethnic inequalities in preterm births (< 37 weeks of gestation at birth) within Health Trusts in England. ⋯ There was evidence of variation in rates of preterm birth by ethnic group, with some Trusts reporting below average rates in white ethnic groups whilst concurrently reporting well above average rates for women from Asian or black ethnic groups. The risk of preterm birth varied substantially at the intersectionality of maternal ethnicity and the level of socioeconomic deprivation of their residency. In the absence of other explanations, these findings suggest that even within the same Health Trust, maternity care may vary depending on the women's ethnicity and/or whether she lives in an area of high socioeconomic deprivation. Thus, social factors are likely key determinants of inequality in preterm birth rather than provision of maternity care alone.