Hilary Davies‐Kershaw, Kevin Tang, Dawd Gashu, Semira Mitiku Saje, Filomena Gomes, Edward J. M. Joy, E. Louise Ander, Sarah Gibson, Ziaul H. Rana, Elaine L. Ferguson
Increasing dietary calcium intakes of Ethiopian women of reproductive age (WRA) is a public health priority for reducing pre‐eclampsia in pregnancy. Using linear programming, we determined whether locally available foods consumed by WRA in nine regions (urban and rural) and two administrative cities of Ethiopia could provide 1000 mg/day of dietary calcium, and we identified food‐based recommendations (FBRs) to improve dietary calcium adequacy in each region. Results showed that diets providing 1000 mg/day of calcium were feasible in eight regions (40%) of the target populations examined. It would, however, require marked changes for most populations (90%), increasing the number of servings per week of several food groups to levels close to those of high consumers in each population. The selected calcium‐specific FBRs integrate well into the 2022 Ethiopian Dietary Guidelines, requiring additional messages to consume green leafy vegetables, milk, root crops, or teff (Eragrostis tef) or to consume a higher number of servings of vegetables than currently recommended, depending on the population. In conclusion, these analyses show that a food‐based approach can be used to achieve dietary calcium adequacy among WRA in 40% of the populations examined. For the other populations, food‐based interventions alone may be inadequate and other interventions are likely needed.
{"title":"Food‐based dietary guidelines for optimizing calcium intakes for reproductive‐aged women in Ethiopia using local foods","authors":"Hilary Davies‐Kershaw, Kevin Tang, Dawd Gashu, Semira Mitiku Saje, Filomena Gomes, Edward J. M. Joy, E. Louise Ander, Sarah Gibson, Ziaul H. Rana, Elaine L. Ferguson","doi":"10.1111/nyas.15218","DOIUrl":"https://doi.org/10.1111/nyas.15218","url":null,"abstract":"Increasing dietary calcium intakes of Ethiopian women of reproductive age (WRA) is a public health priority for reducing pre‐eclampsia in pregnancy. Using linear programming, we determined whether locally available foods consumed by WRA in nine regions (urban and rural) and two administrative cities of Ethiopia could provide 1000 mg/day of dietary calcium, and we identified food‐based recommendations (FBRs) to improve dietary calcium adequacy in each region. Results showed that diets providing 1000 mg/day of calcium were feasible in eight regions (40%) of the target populations examined. It would, however, require marked changes for most populations (90%), increasing the number of servings per week of several food groups to levels close to those of high consumers in each population. The selected calcium‐specific FBRs integrate well into the 2022 Ethiopian Dietary Guidelines, requiring additional messages to consume green leafy vegetables, milk, root crops, or teff <jats:italic>(Eragrostis tef)</jats:italic> or to consume a higher number of servings of vegetables than currently recommended, depending on the population. In conclusion, these analyses show that a food‐based approach can be used to achieve dietary calcium adequacy among WRA in 40% of the populations examined. For the other populations, food‐based interventions alone may be inadequate and other interventions are likely needed.","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":null,"pages":null},"PeriodicalIF":5.2,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142236477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The gut microbiome may be related to the prevalence of overweight and obesity, but high interindividual variability of the human microbiome complicates our understanding. Obesity often occurs concomitantly with micronutrient deficiencies that impair energy metabolism. Microbiota composition is affected by diet. Host–microbiota interactions are bidirectional. We propose three pathways whereby these interactions may modulate the gut microbiome and obesity: (1) ingested compounds or derivatives affecting small intestinal transit, endogenous secretions, digestion, absorption, microbiome balance, and gut barrier function directly affect host metabolism; (2) substrate availability affecting colonic microbial composition and contact with the gut barrier; and (3) microbial end products affecting host metabolism. The quantity/concentration, duration, and/or frequency (circadian rhythm) of changes in these pathways can alter the gut microbiome, disrupt the gut barrier, alter host immunity, and increase the risk of and progression to overweight and obesity. Host-specific characteristics (e.g., genetic variations) may further affect individual sensitivity and/or resilience to diet- and microbiome-associated perturbations in the colonic environment. In this narrative review, the effects of selected interventions, including fecal microbiota transplantation, dietary calorie restriction, dietary fibers and prebiotics, probiotics and synbiotics, vitamins, minerals, and fatty acids, on the gut microbiome, body weight, and/or adiposity are summarized to help identify mechanisms of action and research opportunities.
{"title":"Understanding the role of the human gut microbiome in overweight and obesity","authors":"Michael I. McBurney, Clara E. Cho","doi":"10.1111/nyas.15215","DOIUrl":"https://doi.org/10.1111/nyas.15215","url":null,"abstract":"The gut microbiome may be related to the prevalence of overweight and obesity, but high interindividual variability of the human microbiome complicates our understanding. Obesity often occurs concomitantly with micronutrient deficiencies that impair energy metabolism. Microbiota composition is affected by diet. Host–microbiota interactions are bidirectional. We propose three pathways whereby these interactions may modulate the gut microbiome and obesity: (1) ingested compounds or derivatives affecting small intestinal transit, endogenous secretions, digestion, absorption, microbiome balance, and gut barrier function directly affect host metabolism; (2) substrate availability affecting colonic microbial composition and contact with the gut barrier; and (3) microbial end products affecting host metabolism. The quantity/concentration, duration, and/or frequency (circadian rhythm) of changes in these pathways can alter the gut microbiome, disrupt the gut barrier, alter host immunity, and increase the risk of and progression to overweight and obesity. Host-specific characteristics (e.g., genetic variations) may further affect individual sensitivity and/or resilience to diet- and microbiome-associated perturbations in the colonic environment. In this narrative review, the effects of selected interventions, including fecal microbiota transplantation, dietary calorie restriction, dietary fibers and prebiotics, probiotics and synbiotics, vitamins, minerals, and fatty acids, on the gut microbiome, body weight, and/or adiposity are summarized to help identify mechanisms of action and research opportunities.","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":null,"pages":null},"PeriodicalIF":5.2,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142273611","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lilia Bliznashka, Dalia Elsabbagh, Sikandra Kurdi, Olivier Ecker, Aulo Gelli
School feeding programs can support children's nutrition, health, and education in emergencies. This study assessed the feasibility, trade‐offs, cost efficiency, and perceived benefits of school feeding modalities operating in urban Yemen. It draws on primary data from a qualitative evaluation with 21 school feeding implementers and 88 beneficiaries conducted in Feb–Mar 2023, and secondary data from a desk review of published and program literature on school feeding operations. Results showed that school feeding provided students with on average 18%, 40%, and 66% of daily energy, protein, and micronutrient requirements, respectively. Models including fortified snacks were 3–11 times more cost‐efficient in terms of nutrient delivery. The most prominent strength of the models examined were the perceived benefits on child, family, and financial outcomes. Among the main weaknesses was the poor nutritional quality of the meal, which in turn emerged as a primary opportunity to improve school feeding through hybrid models providing a combination of fortified snacks and healthy meals. Other weaknesses such as poor water, sanitation, and hygiene infrastructure, and desired improvements such as the school kitchen and canteen, require considerable investments. Hybrid models are cost‐efficient, acceptable, and feasible in Yemen and can serve the diet and nutrition needs of school‐aged children.
{"title":"School feeding for improving child nutrition in conflict‐affected settings: Feasibility and cost efficiency of alternative models in Yemen","authors":"Lilia Bliznashka, Dalia Elsabbagh, Sikandra Kurdi, Olivier Ecker, Aulo Gelli","doi":"10.1111/nyas.15222","DOIUrl":"https://doi.org/10.1111/nyas.15222","url":null,"abstract":"School feeding programs can support children's nutrition, health, and education in emergencies. This study assessed the feasibility, trade‐offs, cost efficiency, and perceived benefits of school feeding modalities operating in urban Yemen. It draws on primary data from a qualitative evaluation with 21 school feeding implementers and 88 beneficiaries conducted in Feb–Mar 2023, and secondary data from a desk review of published and program literature on school feeding operations. Results showed that school feeding provided students with on average 18%, 40%, and 66% of daily energy, protein, and micronutrient requirements, respectively. Models including fortified snacks were 3–11 times more cost‐efficient in terms of nutrient delivery. The most prominent strength of the models examined were the perceived benefits on child, family, and financial outcomes. Among the main weaknesses was the poor nutritional quality of the meal, which in turn emerged as a primary opportunity to improve school feeding through hybrid models providing a combination of fortified snacks and healthy meals. Other weaknesses such as poor water, sanitation, and hygiene infrastructure, and desired improvements such as the school kitchen and canteen, require considerable investments. Hybrid models are cost‐efficient, acceptable, and feasible in Yemen and can serve the diet and nutrition needs of school‐aged children.","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":null,"pages":null},"PeriodicalIF":5.2,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142236481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Karen L. Kadamani, Reyhaneh Rahnamaie‐Tajadod, Liam Eaton, John Bengtsson, Mohammad Ojaghi, Hang Cheng, Matthew E. Pamenter
Ameliorating the deleterious impact of systemic or tissue‐level hypoxia or ischemia is key to preventing or treating many human diseases and pathologies. Usefully, environmental hypoxia is also a common challenge in many natural habitats; animals that are native to such hypoxic niches often exhibit strategies that enable them to thrive with limited O2 availability. Studying how such species have evolved to tolerate systemic hypoxia offers a promising avenue of discovery for novel strategies to mitigate the deleterious effects of hypoxia in human diseases and pathologies. Of particular interest are naked mole‐rats, which are among the most hypoxia‐tolerant mammals. Naked mole‐rats that tolerate severe hypoxia in a laboratory setting are also protected against clinically relevant mimics of heart attack and stroke. The mechanisms that support this tolerance are currently being elucidated but results to date suggest that metabolic rate suppression, reprogramming of metabolic pathways, and mechanisms that defend against deleterious perturbations of cellular signaling pathways all provide layers of protection. Herein, we synthesize and discuss what is known regarding adaptations to hypoxia in the naked mole‐rat cardiopulmonary system and brain, as these systems comprise both the primary means of delivering O2 to tissues and the most hypoxia‐sensitive organs in mammals.
{"title":"What can naked mole‐rats teach us about ameliorating hypoxia‐related human diseases?","authors":"Karen L. Kadamani, Reyhaneh Rahnamaie‐Tajadod, Liam Eaton, John Bengtsson, Mohammad Ojaghi, Hang Cheng, Matthew E. Pamenter","doi":"10.1111/nyas.15219","DOIUrl":"https://doi.org/10.1111/nyas.15219","url":null,"abstract":"Ameliorating the deleterious impact of systemic or tissue‐level hypoxia or ischemia is key to preventing or treating many human diseases and pathologies. Usefully, environmental hypoxia is also a common challenge in many natural habitats; animals that are native to such hypoxic niches often exhibit strategies that enable them to thrive with limited O<jats:sub>2</jats:sub> availability. Studying how such species have evolved to tolerate systemic hypoxia offers a promising avenue of discovery for novel strategies to mitigate the deleterious effects of hypoxia in human diseases and pathologies. Of particular interest are naked mole‐rats, which are among the most hypoxia‐tolerant mammals. Naked mole‐rats that tolerate severe hypoxia in a laboratory setting are also protected against clinically relevant mimics of heart attack and stroke. The mechanisms that support this tolerance are currently being elucidated but results to date suggest that metabolic rate suppression, reprogramming of metabolic pathways, and mechanisms that defend against deleterious perturbations of cellular signaling pathways all provide layers of protection. Herein, we synthesize and discuss what is known regarding adaptations to hypoxia in the naked mole‐rat cardiopulmonary system and brain, as these systems comprise both the primary means of delivering O<jats:sub>2</jats:sub> to tissues and the most hypoxia‐sensitive organs in mammals.","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":null,"pages":null},"PeriodicalIF":5.2,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142231648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Previous studies have implicated epithelial–mesenchymal transition (EMT) in salamander limb regeneration. In this review, we describe putative roles for EMT during each stage of limb regeneration in axolotls and other salamanders. We hypothesize that EMT and EMT‐like gene expression programs may regulate three main cellular processes during limb regeneration: (1) keratinocyte migration during wound closure; (2) transient invasion of the stump by epithelial cells undergoing EMT; and (3) use of EMT‐like programs by non‐epithelial blastemal progenitor cells to escape the confines of their niches. Finally, we propose nontraditional roles for EMT during limb regeneration that warrant further investigation, including alternative EMT regulators, stem cell activation, and fibrosis induced by aberrant EMT.
{"title":"Putative epithelial–mesenchymal transitions during salamander limb regeneration: Current perspectives and future investigations","authors":"Ryan T. Kim, Jessica L. Whited","doi":"10.1111/nyas.15210","DOIUrl":"https://doi.org/10.1111/nyas.15210","url":null,"abstract":"Previous studies have implicated epithelial–mesenchymal transition (EMT) in salamander limb regeneration. In this review, we describe putative roles for EMT during each stage of limb regeneration in axolotls and other salamanders. We hypothesize that EMT and EMT‐like gene expression programs may regulate three main cellular processes during limb regeneration: (1) keratinocyte migration during wound closure; (2) transient invasion of the stump by epithelial cells undergoing EMT; and (3) use of EMT‐like programs by non‐epithelial blastemal progenitor cells to escape the confines of their niches. Finally, we propose nontraditional roles for EMT during limb regeneration that warrant further investigation, including alternative EMT regulators, stem cell activation, and fibrosis induced by aberrant EMT.","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":null,"pages":null},"PeriodicalIF":5.2,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142231647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Edouard G. Mills, Ali Abbara, Waljit S. Dhillo, Alexander N. Comninos
The neuropeptide kisspeptin and its cognate receptor have been extensively studied in reproductive physiology, with diverse and well-established functions, including as an upstream regulator of pubertal onset, reproductive hormone secretion, and sexual behavior. Besides classical reproduction, both kisspeptin and its receptor are extensively expressed in bone-resorbing osteoclasts and bone-forming osteoblasts, which putatively permits direct bone effects. Accordingly, this sets the scene for recent compelling findings derived from in vitro experiments through to in vivo and clinical studies revealing prominent regulatory interactions for kisspeptin signaling in bone metabolism, as well as certain oncological aspects of bone metabolism. Herein, we comprehensively examine the experimental evidence obtained to date supporting the interaction between kisspeptin and bone. A comprehensive understanding of this emerging facet of kisspeptin biology is fundamental to exploiting the future therapeutic potential of kisspeptin-based medicines as a novel strategy for treating bone-related disorders.
{"title":"Interactions between kisspeptin and bone: Cellular mechanisms, clinical evidence, and future potential","authors":"Edouard G. Mills, Ali Abbara, Waljit S. Dhillo, Alexander N. Comninos","doi":"10.1111/nyas.15213","DOIUrl":"https://doi.org/10.1111/nyas.15213","url":null,"abstract":"The neuropeptide kisspeptin and its cognate receptor have been extensively studied in reproductive physiology, with diverse and well-established functions, including as an upstream regulator of pubertal onset, reproductive hormone secretion, and sexual behavior. Besides classical reproduction, both kisspeptin and its receptor are extensively expressed in bone-resorbing osteoclasts and bone-forming osteoblasts, which putatively permits direct bone effects. Accordingly, this sets the scene for recent compelling findings derived from in vitro experiments through to in vivo and clinical studies revealing prominent regulatory interactions for kisspeptin signaling in bone metabolism, as well as certain oncological aspects of bone metabolism. Herein, we comprehensively examine the experimental evidence obtained to date supporting the interaction between kisspeptin and bone. A comprehensive understanding of this emerging facet of kisspeptin biology is fundamental to exploiting the future therapeutic potential of kisspeptin-based medicines as a novel strategy for treating bone-related disorders.","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":null,"pages":null},"PeriodicalIF":5.2,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142198035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katherine P. Adams, Stephen A. Vosti, Emily Becher, Faith Ishaya, Reina Engle-Stone
Bouillon is a widely consumed condiment in many West African countries, including Nigeria. Although Nigeria has mandatory fortification standards for multiple food vehicles, bouillon fortification could help address remaining gaps in micronutrient intake. Using household food consumption data, we used the nutrient density method to model the additional contribution of bouillon fortified with vitamin A (40–250 µg/g bouillon), folic acid (20–120 µg/g), vitamin B12 (0.2–2 µg/g), iron (0.6–5 mg/g), and zinc (0.6–5 mg/g) for meeting micronutrient requirements of women of reproductive age (WRA) and children aged 6–59 months. Accounting for existing fortification programs, our results showed that, except for iron, the prevalence of inadequacy was substantially higher among WRA and children living in poorer and rural households. Given the ubiquity of bouillon consumption, bouillon fortification has the potential to virtually eliminate vitamin A, folate, and vitamin B12 inadequacy, reduce the prevalence of zinc inadequacy by over 20 percentage points, and improve equity in the micronutrient adequacy of diets across socioeconomic strata and urban and rural residence. Our results also suggested that designing a bouillon fortification program would require careful planning to balance reductions in inadequacy with the risk of high intakes. This evidence provides important input into decisions around bouillon fortification in Nigeria.
{"title":"Bouillon fortification as a strategy to address inequities in micronutrient adequacy of diets in Nigeria","authors":"Katherine P. Adams, Stephen A. Vosti, Emily Becher, Faith Ishaya, Reina Engle-Stone","doi":"10.1111/nyas.15207","DOIUrl":"https://doi.org/10.1111/nyas.15207","url":null,"abstract":"Bouillon is a widely consumed condiment in many West African countries, including Nigeria. Although Nigeria has mandatory fortification standards for multiple food vehicles, bouillon fortification could help address remaining gaps in micronutrient intake. Using household food consumption data, we used the nutrient density method to model the additional contribution of bouillon fortified with vitamin A (40–250 µg/g bouillon), folic acid (20–120 µg/g), vitamin B12 (0.2–2 µg/g), iron (0.6–5 mg/g), and zinc (0.6–5 mg/g) for meeting micronutrient requirements of women of reproductive age (WRA) and children aged 6–59 months. Accounting for existing fortification programs, our results showed that, except for iron, the prevalence of inadequacy was substantially higher among WRA and children living in poorer and rural households. Given the ubiquity of bouillon consumption, bouillon fortification has the potential to virtually eliminate vitamin A, folate, and vitamin B12 inadequacy, reduce the prevalence of zinc inadequacy by over 20 percentage points, and improve equity in the micronutrient adequacy of diets across socioeconomic strata and urban and rural residence. Our results also suggested that designing a bouillon fortification program would require careful planning to balance reductions in inadequacy with the risk of high intakes. This evidence provides important input into decisions around bouillon fortification in Nigeria.","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":null,"pages":null},"PeriodicalIF":5.2,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142161090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hye‐Na Kang, Meenu Wadhwa, Ivana Knezevic, Chris Burns, Elwyn Griffiths
Technological advances in analytics, as well as scientific and regulatory knowledge and experience gained from biosimilar development/approvals over the last decade, enabled the World Health Organization (WHO) in 2022 to revise its guidelines on the evaluation of biosimilars. Among the revisions, there is more reliance on analytical and functional aspects to prove similarity (and likely fewer clinical requirements). WHO international reference standards for biosimilars provide additional confidence to regulators looking for evidence‐ and data‐based regulatory convergence in scientific and technical measures of quality attributes. These standards serve as a benchmark for harmonizing the bioactivity or potency of biosimilars, ensuring their future sustainability. This article discusses the availability and role of WHO international reference standards throughout the product life cycle of biosimilars.
{"title":"The importance of World Health Organization international reference standards in the product life cycle of biosimilars","authors":"Hye‐Na Kang, Meenu Wadhwa, Ivana Knezevic, Chris Burns, Elwyn Griffiths","doi":"10.1111/nyas.15217","DOIUrl":"https://doi.org/10.1111/nyas.15217","url":null,"abstract":"Technological advances in analytics, as well as scientific and regulatory knowledge and experience gained from biosimilar development/approvals over the last decade, enabled the World Health Organization (WHO) in 2022 to revise its guidelines on the evaluation of biosimilars. Among the revisions, there is more reliance on analytical and functional aspects to prove similarity (and likely fewer clinical requirements). WHO international reference standards for biosimilars provide additional confidence to regulators looking for evidence‐ and data‐based regulatory convergence in scientific and technical measures of quality attributes. These standards serve as a benchmark for harmonizing the bioactivity or potency of biosimilars, ensuring their future sustainability. This article discusses the availability and role of WHO international reference standards throughout the product life cycle of biosimilars.","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":null,"pages":null},"PeriodicalIF":5.2,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142166425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nipun Lakshitha de Silva, Bonnie Grant, Suks Minhas, Channa N Jayasena
This review assesses the evidence of the physiological effects of testosterone on cardiovascular health, the association between male hypogonadism and cardiovascular health, and the effects of testosterone therapy on cardiovascular health in male hypogonadism. Preclinical studies suggest complex effects of testosterone on cardiovascular risk by acting on skeletal muscle, cardiomyocytes, vasculature, adipocytes, insulin action, and erythropoiesis. Furthermore, low testosterone has a bi-directional association with cardiometabolic risk. Observational studies have reported worse metabolic profiles in men with organic hypogonadism. However, a consistent association between major cardiovascular events and male hypogonadism has not been established. Hematocrit increases with testosterone therapy; however, most studies do not report an increase in venous thromboembolism risk. Although some observational studies and a small randomized controlled study reported an increased risk of cardiovascular disease, recent data confirm the medium-term cardiovascular safety of testosterone therapy in middle-aged and older men with low testosterone.
{"title":"Cardiovascular disease and testosterone therapy in male hypogonadism.","authors":"Nipun Lakshitha de Silva, Bonnie Grant, Suks Minhas, Channa N Jayasena","doi":"10.1111/nyas.15211","DOIUrl":"https://doi.org/10.1111/nyas.15211","url":null,"abstract":"<p><p>This review assesses the evidence of the physiological effects of testosterone on cardiovascular health, the association between male hypogonadism and cardiovascular health, and the effects of testosterone therapy on cardiovascular health in male hypogonadism. Preclinical studies suggest complex effects of testosterone on cardiovascular risk by acting on skeletal muscle, cardiomyocytes, vasculature, adipocytes, insulin action, and erythropoiesis. Furthermore, low testosterone has a bi-directional association with cardiometabolic risk. Observational studies have reported worse metabolic profiles in men with organic hypogonadism. However, a consistent association between major cardiovascular events and male hypogonadism has not been established. Hematocrit increases with testosterone therapy; however, most studies do not report an increase in venous thromboembolism risk. Although some observational studies and a small randomized controlled study reported an increased risk of cardiovascular disease, recent data confirm the medium-term cardiovascular safety of testosterone therapy in middle-aged and older men with low testosterone.</p>","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joshua Jeong, Juliet K. McCann, Alina Bhojani, Yuri Kim, Malia Uyehara, Zane Maguet, Wilson Ochuka, Michael Ochieng
The Moments that Matter® parenting program aims to promote nurturing care and healthy early childhood development (ECD) through monthly home visits and monthly community group meetings that are delivered by ECD promoters and coordinated with faith leaders in rural Western Kenya. We designed a process evaluation in August 2023 during the first quarter of program implementation. We conducted in‐depth interviews and focus group discussions with caregivers, ECD promoters, faith leaders, and program staff to capture their program experiences, assess program quality, and explore the implementation barriers and facilitators during this early stage of program roll‐out. Although ECD promoters delivered the program with fidelity, the roles and responsibilities of faith leaders were relatively weaker and inconsistent. Key facilitators of quality implementation included visual aids of key messages and supportive supervision. Barriers included a lack of clarity about faith leaders’ roles and relatively long group session duration. We highlight several key recommendations for improving fidelity, quality, and eventual program effects with respect to enhancing nurturing care and early child development. Overall, our study showcases how a process evaluation conducted during the early phase of program implementation can reveal practical insights that can be used to inform program adaptations and quality improvement.
Moments that Matter® 育儿计划旨在通过每月家访和每月社区小组会议，由儿童早期发展促进者提供服务，并与肯尼亚西部农村地区的宗教领袖协调，促进养育关怀和健康的儿童早期发展（ECD）。我们计划在 2023 年 8 月计划实施的第一季度进行一次过程评估。我们对保育员、幼儿发展促进者、宗教领袖和项目工作人员进行了深入访谈和焦点小组讨论，以了解他们的项目经验、评估项目质量，并探讨项目推广初期的实施障碍和促进因素。虽然幼儿发展促进者忠实地执行了计划，但宗教领袖的角色和责任相对较弱，且不一致。高质量实施的主要促进因素包括关键信息的视觉辅助工具和支持性监督。障碍包括宗教领袖的角色不明确以及小组活动时间相对较长。我们强调了几项关键建议，以提高计划的忠实度、质量和最终效果，从而加强培育护理和儿童早期发展。总之，我们的研究展示了在项目实施的早期阶段进行的过程评估如何揭示出实用的见解，这些见解可用于项目调整和质量改进。
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