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Problemy Sotsial'noi Gigieny,... Mar 2024The review considers the approach placing famous French surgeon A. Paré into more general European context of European Renaissance of XVI century and into local context...
The review considers the approach placing famous French surgeon A. Paré into more general European context of European Renaissance of XVI century and into local context of intellectual life of Paris of this period. The refutation of widespread in history of medicine opinion about strict separation of university medicine from artisan surgery in Medieval Europe is discussed.
Topics: Humans; Surgeons; Europe; Medicine; Military Medicine; France; General Surgery
PubMed: 38640228
DOI: 10.32687/0869-866X-2024-32-2-296-298 -
EJNMMI Radiopharmacy and Chemistry Apr 2024Steps have been taken by pharmaceutical companies to obtain marketing authorisation of PSMA ligands in the European Union. Since December 2022, Locametz® (PSMA-11,...
BACKGROUND
Steps have been taken by pharmaceutical companies to obtain marketing authorisation of PSMA ligands in the European Union. Since December 2022, Locametz® (PSMA-11, gozetotide) is licensed as kit for manual radiolabelling with gallium-68 and commercially available since mid-2023. The Summary of Product Characteristic (SmPC) describes manual radiolabelling with a maximum activity after radiolabelling of 1369 MBq. We aimed for radiolabelling with a higher activity to increase production efficiency, and thus, automated radiolabelling is strongly preferred over manual radiolabelling to reduce radiation exposure to personnel. The aim of this study was to develop and validate a method for automated radiolabelling of the Locametz® kit using ~ 2000 MBq of gallium-68 eluate for radiolabelling.
RESULTS
Automated radiolabelling of [Ga]Ga-PSMA-11 using the Locametz® kit provided a product which complies to the Ph. Eur., had a shelf-life of 6 h at room temperature, and theoretically reduced radiation exposure 5.7 times. Radiolabelling with one and two generator(s) resulted in a radiochemical yield of 91-102% and 96-101% after preparation, respectively. The radiochemical purity ranged from 98.0 to 99.6% for radiolabelling with one generator and ranged from 98.4 to 99.3% for radiolabelling with two generators with similar stability. The activity of the final product was much higher when using two generators, 1961-2035 MBq compared to 740-1260 MBq, which leads to ~ 1.5 times more patient syringes available per preparation.
CONCLUSION
Automated radiolabelling of [Ga]Ga-PSMA-11 using the Locametz® kit with higher gallium-68 activity than specified in the SmPC results in a product that is in compliance with the Ph. Eur. monograph and has a shelf-life of 6 h at room temperature. Radiolabelling with two generators proved possible and resulted in a product with similar quality but with much higher efficiency.
PubMed: 38632189
DOI: 10.1186/s41181-024-00260-4 -
Ecology Jun 2024The recent availability of open-access repositories of functional traits has revolutionized trait-based approaches in ecology and evolution. Nevertheless, the...
The recent availability of open-access repositories of functional traits has revolutionized trait-based approaches in ecology and evolution. Nevertheless, the underrepresentation of tropical regions and lineages remains a pervasive bias in plant functional trait databases, which constrains large-scale assessments of plant ecology, evolution, and biogeography. Here, we present MelastomaTRAITs 1.0, a comprehensive and updatable database of functional traits for the pantropical Melastomataceae, the ninth-largest angiosperm family with 177 genera and more than 5800 species. Melastomataceae encompass species with a wide diversity of growth forms (herbs, shrubs, trees, epiphytes, and woody climbers), habitats (including tropical forests, savannas, grasslands, and wetlands from sea level to montane areas above the treeline), ecological strategies (from pioneer, edge-adapted and invasive species to shade-tolerant understory species), geographic distribution (from microendemic to continental-wide distribution), reproductive, pollination, and seed dispersal systems. MelastomaTRAITs builds on 581 references, such as taxonomic monographs, ecological research, and unpublished data, and includes four whole-plant traits, six leaf traits, 11 flower traits, 18 fruit traits, and 27 seed traits for 2520 species distributed in 144 genera across all 21 tribes. Most data come from the Neotropics where the family is most species-rich. Miconieae (the largest tribe) contains the highest number of trait records (49.6%) and species (41.1%) records. The trait types with the most information in the database were whole-plant traits, flowers, and leaf traits. With the breadth of functional traits recorded, our database helps to fill a gap in information for tropical plants and will significantly improve our capacity for large-scale trait-based syntheses across levels of organization, plant-animal interactions, regeneration ecology, and thereby support conservation and restoration programs. There are no copyright restrictions on the dataset; please cite this data paper when reusing the data.
Topics: Melastomataceae; Databases, Factual; Ecosystem
PubMed: 38629131
DOI: 10.1002/ecy.4308 -
Research and Practice in Thrombosis and... Mar 2024Tranexamic acid is safe and effective for the treatment of heavy vaginal bleeding during menstruation and childbirth. It improves the quality of life, facilitates...
Tranexamic acid is safe and effective for the treatment of heavy vaginal bleeding during menstruation and childbirth. It improves the quality of life, facilitates participation in school and work, and reduces the risk of death from postpartum hemorrhage. Despite its well-established benefits, individual- and structural-level barriers preclude its widespread utilization, hindering effective patient care and perpetuating health inequities in women's health. We first describe the evidence for the use of tranexamic acid in treating heavy menstrual bleeding and postpartum hemorrhage. Barriers to tranexamic acid use, including structural sexism, period poverty, misinformation in product monograph labeling, stigmatization of vaginal blood loss, and drug access, are then discussed. Finally, we summarize relevant data presented during the 2023 International Society on Thrombosis and Haemostasis Congress.
PubMed: 38623473
DOI: 10.1016/j.rpth.2024.102389 -
The Lancet. Oncology May 2024
Topics: Humans; Neoplasms; Advisory Committees; Health Priorities
PubMed: 38621402
DOI: 10.1016/S1470-2045(24)00208-0 -
Biodiversity Data Journal 2024Insects represent one of the most diverse groups in the organism world with extremely rich species and morphological diversity, playing important roles in natural and...
BACKGROUND
Insects represent one of the most diverse groups in the organism world with extremely rich species and morphological diversity, playing important roles in natural and city ecosystems. Regional compilation of insect species lists helps to clarify the richness of insect species in a region, enhances our understanding the structure and function of a local ecosystem and promotes the protection and development of insect resources. Moreover, it also serves as a valuable reference for cities with small area, large population and high urbanisation like Macao. Macao (Macau) Special Administrative Region (SAR) is situated at the Pearl River Delta on the southeast coast of mainland China. With urban development accelerating at great rate in a quite restricted area, Macao still has rich fauna, within which the insect diversity is surprisingly high.
NEW INFORMATION
In this study, we systematically sorted out major references items of manuals or handbooks, monographs, articles, dissertations, official websites and other publicly available information sources about the insects recorded in Macao and, thus, generated a checklist of 15 orders, 166 families, 868 genera, 1,339 species and 118 subspecies. During this process, the preliminarily summarised list was re-examined to eliminate synonyms and invalid species, based on many more extensive literature reviews. Besides, spelling errors of scientific names, authors and years were corrected. Meanwhile, the catalogue revealed a different composition pattern of species diversity between orders from those of the world and China. Even based on the most conservative estimates, the number of insect species in Macao should not be lower than 3,340 species, which hints at the necessity of deeper investigations with adequate collecting in the future to achieve more comprehensive recognition and understanding of Macao's insect biodiversity.
PubMed: 38617834
DOI: 10.3897/BDJ.12.e118110 -
The Annals of Pharmacotherapy Apr 2024The objective was to review the safety and efficacy of daprodustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) in the treatment of anemia of... (Review)
Review
OBJECTIVE
The objective was to review the safety and efficacy of daprodustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) in the treatment of anemia of chronic kidney disease (CKD).
DATA SOURCES
A literature search was conducted in MEDLINE, EMBASE, and ClinicalTrials.gov using the keywords "daprodustat," "GSK1278863," and "hypoxia-inducible factor-prolyl hydroxylase inhibitors" from January 2010 through November 2023.
STUDY SELECTION AND DATA EXTRACTION
Literature was included if it evaluated pharmacology, pharmacokinetics, efficacy, and/or safety of daprodustat in human subjects and was reported in English. The manufacturer's product monograph was also utilized.
DATA SYNTHESIS
Daprodustat significantly increased hemoglobin levels in CKD patients on dialysis (difference 0.18 g/dL) and not on dialysis (difference 0.08 g/dL) over 52-week treatment periods compared with erythropoiesis stimulating agents (ESA) in Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat (ASCEND)-D and ASCEND-ND, respectively. First occurrence of major adverse cardiovascular events (MACEs) was similar between daprodustat and ESAs in both trials.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON TO EXISTING DRUGS
Daprodustat can be used in patients with CKD on dialysis and already receiving an ESA for at least 6 weeks to further increase serum hemoglobin levels without increasing the risk of MACE. Adverse effects of daprodustat that may occur more than ESAs include headache, emesis, and thrombosis.
CONCLUSIONS
Daprodustat is a novel oral, non-iron therapy for treatment of anemia of CKD. It was Food and Drug Administration approved in 2023 in patients already receiving dialysis for at least 4 months but not in non-dialysis patients. Long-term data for safety and additional benefits are pending.
PubMed: 38616529
DOI: 10.1177/10600280241241563 -
Environmental Pollution (Barking, Essex... Jun 2024Urbanization has numerous benefits to human society, but some aspects of urban environments, such as air pollution, can negatively affect human health. Two major air... (Meta-Analysis)
Meta-Analysis Review
Urbanization has numerous benefits to human society, but some aspects of urban environments, such as air pollution, can negatively affect human health. Two major air pollutants, particulate matter (PM) and polycyclic aromatic hydrocarbons (PAH), have been classified as carcinogens by the International Agency for Research on Cancer. Here, we answer two questions: (1) What are the carcinogenic effects of PM and PAH exposure? (2) How does carcinogenic risk vary across geographical regions? We performed a comprehensive literature search of peer-reviewed published studies examining the link between air pollution and human cancer rates. Focusing on studies published since 2014 when the last IARC monograph on air pollution was published, we converted the extracted data into relative risks and performed subgroup analyses. Exposure to PM (per 10 μg/m) resulted in an 8.5% increase in cancer incidence when all cancer types were combined, and risk for individual cancer types (i.e. lung cancer and adenocarcinoma) was also elevated. PM was also associated with 2.5% higher mortality due to cancer when all types of cancer were combined, and for individual cancer types (i.e., lung and breast cancer). Exposure to PM and PM posed the greatest risk to lung cancer incidence and mortality in Europe (PM RR 2.15; PM RR 1.26); the risk in Asia and the Americas was also elevated. Exposure to PAH and benzo[a]pyrene significantly increased the pooled risk of cancer incidence (10.8% and 8.0% respectively) at the highest percentile of exposure concentration. Our meta-analyses of studies over the past decade shows that urban air pollution in the form of PM, PM, and PAH all elevate the incidence and mortality of cancer. We discuss the possible mechanisms of carcinogenesis of PM and PAH. These results support World Health Organization's conclusion that air pollution poses among the greatest health risks to humans living in cities.
Topics: Particulate Matter; Polycyclic Aromatic Hydrocarbons; Humans; Air Pollutants; Neoplasms; Environmental Exposure; Air Pollution; Carcinogens
PubMed: 38614427
DOI: 10.1016/j.envpol.2024.123941 -
Progress in Brain Research 2024The chapter begins with a review of some of the background thinking during Hippocrates time. The brain was considered to be the location of the soul which was the... (Review)
Review
The chapter begins with a review of some of the background thinking during Hippocrates time. The brain was considered to be the location of the soul which was the essence of subjective experience. However, this was not a brain function as such but rather a location where the pneuma reacted with the soul. Hippocrates' monograph on cranial trauma begins with a description of the bones and sutures. He then systematized the classification of cranial injury. He sensibly advised accurate diagnosis into one of the types of injury he described and supported extension of any skin opening to facilitate diagnosis of the bone, the injury of which was his primary concern. His description of operative technique has rarely been surpassed, placing emphasis on care and methods for the avoidance of further injury. He also emphasized the importance of probing during trepanation to avoid damaging the dura and underlying brain. In addition, he insisted on using water to cool the trepan. All of this was positive. However, the respect in which he was held in subsequent generations meant that two albeit understandable errors were perpetuated. The first error was the use of prophylactic trepanation to permit the drainage of the pus which he believed would inevitably develop under a fissure. The second was to avoid trepanning at sutures, the reasons for which proscription are not clearly stated. In conclusion, it may be noted that what limited reporting of results is available demonstrates that Hippocrates trepanations were largely not successful.
Topics: Male; Humans; Brain; Skull
PubMed: 38609293
DOI: 10.1016/bs.pbr.2024.02.004 -
Regulatory Toxicology and Pharmacology... May 2024Although the United States Food & Drug Administration (FDA) has provided guidance on the control of drug degradants for prescription drugs, there is less guidance on how...
Although the United States Food & Drug Administration (FDA) has provided guidance on the control of drug degradants for prescription drugs, there is less guidance on how to set degradant specifications for FDA OTC monograph drugs. Given that extensive impurity testing was not part of the safety paradigm in original OTC monographs, a weight of evidence (WOE) approach to qualify OTC degradants is proposed. This approach relies on in silico tools and read-across approaches alongside standard toxicity testing to determine safety. Using several drugs marketed under 21 CFR 341 as case studies, this research demonstrates the utility of a WOE approach across data-rich and data-poor degradants. Based on degradant levels ranging from 1 to 4% of the maximum daily doses of each case study drug and 10th percentile body weight data for each patient group, children were recognized as having the highest potential exposure relative to adults per body mass. Depending on data availability and relationship to the parent API, margins of safety (MOS) or exposure margins were calculated for each degradant. The findings supported safe use, and indicated that this contemporary WOE approach could be utilized to assess OTC degradants. This approach is valuable to establish specifications for degradants in OTCs.
Topics: Nonprescription Drugs; Humans; United States; Antitussive Agents; United States Food and Drug Administration; Cough; Risk Assessment; Child; Drug Contamination; Adult; Toxicity Tests; Common Cold
PubMed: 38608922
DOI: 10.1016/j.yrtph.2024.105621