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Background Hyperkalemia is a frequent life-threatening condition in hemodialysis (HD) patients. Data comparing the usage of various K + binders in HD patients is still scarce. This study aimed to compare the efficacy and safety of Sodium zirconium cyclosilicate (SZC) and sodium polystyrene sulfonate (SPS) for treatment of hyperkalemia in HD patients. Methods This prospective, double-blinded, randomized multicenter clinical trial enrolled 120 HD patients with predialysis serum potassium > 5 mmol/L. Patients were randomized to receive SZC (5 g, 3 times/wk on non-dialysis days, 15 gm/wk) or SPS (15 g, 3 times/wk on non-dialysis days, 45 gm/wk) for 8 weeks. The change in serum potassium through the 8 weeks of the study was our primary outcome. Results Serum potassium significantly decreased in both groups compared to baseline values from the first week till the end of the study with p value of < 0.001 and < 0.001 respectively. Serum K levels in the SZC group were significantly lower (achieved normokalemia after 2 weeks) than K levels in the SPS group (achieved normokalemia after 6 weeks) through the study period ( p  < 0.001). Rescue therapy for hyperkalemia was less frequent in the SZC group (3.3%) than the SPS group (6.6%) ( p  = 0.678). Gastrointestinal side effects were non significantly fewer with SZC (5%) compared to SPS (11.6%). However, SPS was less palatable ( p  < 0.001). Conclusions When compared to SPS treatment, SZC was associated with a more rapid and efficacious resolution of hyperkalemia with potentially a better safety profile and palatability among HD patients. Clinical trials registration ClinicalTrials.gov Identifier: NCT06029179. First registration date: 9/01/2023.

Background & objectives: For improved male contraception, a new polymeric drug molecule - Reversible Inhibition of Sperm under Guidance (RISUG) has been synthesized and has been found to be effective, safe and reversible in various animal species. Phase-I and phase-II clinical trials have confirmed its safety and contraceptive efficacy. The present study was undertaken as a multicentric-limited phase-III clinical trial to test the efficacy and safety of RISUG in human volunteers. Methods: One hundred and thirty nine young males each having at least two children and living with wife were given 120 μl of RISUG as bilateral vas intraluminal injection. After the single-dose administration, the individuals were followed in respect of general health and semen parameters. Their wives were also followed particularly to determine onset of pregnancy. Results: During the six month follow up, the health of male volunteers and their wives was normal with no significant adverse effects. Temporary scrotal enlargement and mild scrotal and inguinal region pain were manifested in most individuals and resolved within one month without any routine activity impairment. In six individuals, there was injection procedure failure and azoospermia was not achieved. The other 133 individuals had either severe oligozoospermia or azoospermia at the first semen examination one month following RISUG injection; 82.7 per cent individuals had continued azoospermia in the month following first semen examination onwards and the rest 17.3 per cent manifested azoospermia within three to six months. Interpretation & conclusions: RISUG intravasal injection appears to be a safe clinical procedure with no significant adverse effects and has high sustained contraceptive efficacy. The localized intervention and continued contraceptive action on single-dose administration were significant features of the RISUG technology.

Due to its increasing production, durability and multiple applications, plastic is a material we encounter every day. Small plastic particles from the μm to the mm range are classified as microplastics and produced for cosmetic and medical products, but are also a result of natural erosion and decomposition of macroplastics. Although being omnipresent in our environment and already detected in various organisms, less is known about the effects of microplastics on humans in general, or on vascular biology in particular. Here we investigated the effects of carboxylated polystyrene microplastic particles (PS, 1 μm) on murine endothelial and immune cells, which are both crucially involved in vascular inflammation, using in vitro and in vivo approaches. In vitro , PS induced adhesion molecule expression in endothelial cells with subsequent adhesion of leukocytes both under static and flow conditions. In monocytic cells, PS enhanced pro-inflammatory cytokine expression and release. Accordingly, administering mice with PS led to enhanced aortic expression of cytokines and adhesion molecules. Furthermore, we identified neutrophils as the PS-clearing blood leukocyte population. The findings from this study for the first time indicate polystyrene microplastic as a new environmental risk factor for endothelial inflammation.

The increasing presence of micro- and nanoplastics (MNPLs) in the environment, and their consequent accumulation in trophic niches, could pose a potential health threat to humans, especially due to their chronic ingestion. In vitro studies using human cells are considered pertinent approaches to determine potential health risks to humans. Nevertheless, most of such studies have been conducted using short exposure times and high concentrations. Since human exposure to MNPLs is supposed to be chronic, there is a lack of information regarding the potential in vitro MNPLs effects under chronic exposure conditions. To this aim, we assessed the accumulation and potential outcomes of polystyrene nanoparticles (PSNPs), as a model of MNPLs, in undifferentiated Caco-2 cells (as models of cell target in ingestion exposures) under a relevant long-term exposure scenario, consisting of eight weeks of exposure to sub-toxic PSNPs concentrations. In such exposure conditions, culture-media was changed every 2–3 days to maintain constant exposure. The different analyzed endpoints were cytotoxicity, dysregulation of stress-related genes, genotoxicity, oxidative DNA damage, and intracellular ROS levels. These are endpoints that showed to be sensitive enough in different studies. The obtained results attest that PSNPs accumulate in the cells through time, inducing changes at the ultrastructural and molecular levels. Nevertheless, minor changes in the different evaluated genotoxicity-related biomarkers were observed. This would indicate that no DNA damage or oxidative stress is observed in the human intestinal Caco-2 cells after long-term exposure to PSNPs. This is the first study dealing with the long-term effects of PSNPs on human cultured cells.

Nano- and microplastics (NMPs) have become a serious global environmental threat that causes damage to mammalian organs. In this work, we investigated the potential molecular mechanism underlying the development of liver fibrosis induced by long-term exposure to three different sized polystyrene (PS)-NMPs (80 nm, 0.5 µm and 5 µm) in mice. Liver fibrosis levels were evaluated in mice after chronic exposure to PS-NMPs. Liver inflammation was mainly increased in chronic exposure to 80 nm and 0.5 µm PS-NMPs. Liver lipid deposition was significantly enhanced after PS-NMPs exposure. However, oxidative stress was not changed under PS-NMPs exposure. GO enrichment and KEGG pathway analyses revealed that the DEGs and shared DEGs were mainly enriched in the metabolism of lipids. The mRNA expression levels of genes related to fatty acid oxidation, synthesis and transport were dramatically induced by PS-NMPs exposure. Four hub genes, Acot3 , Abcc3 , Nr1i3 and Fmo2 , were identified by CytoHubba analysis of shared DEGs. The mRNA expression levels of three hub genes, Acot3 , Abcc3 and Nr1i3 , were significantly augmented under chronic PS-NMPs exposure. Our results suggest that Acot3 , Abcc3 and Nr1i3 are potential molecules involved in the development of liver fibrosis under chronic exposure to PS-NMPs.

Objectives: Microplastics have been detected in the atmosphere, raising concerns about their impact on the lungs. There have been reports on the effects of surface functional groups in evaluating the physicochemical properties of microplastics, but no reports have evaluated their chronic effects. We performed intratracheal instillation in rats to evaluate the acute and chronic effects on the lungs of microplastics with different surface functional groups.Methods: Unmodified, NH2-modified, and COOH-modified polystyrene particles with a particle size of 1 μm were intratracheally instilled into the lungs of rats. Rats were dissected at 3 days, 1 week, 1 month, 3 months, and 6 months after exposure to analyze inflammatory cells and lung injury factors in bronchoalveolar lavage fluid (BALF) and to observe histopathological findings in the lungs.Results: A significant increase in the number of inflammatory cells in BALF was observed up to 1 week after exposure to the NH2-based modified polystyrene compared with the negative control group. A significant increase was observed 3 days after exposure, and histopathological findings in the lungs also showed an influx of inflammatory cells into the alveolar space in the acute phase, but not in the chronic phase. In in vitro studies using RAW cell lines, NH2-based modified polystyrene also induced the highest oxidative stress compared with unmodified and COOH-based modified polystyrene.Conclusions: These results suggest that these polystyrenes do not have high pulmonary toxicity, although there are differences in toxicity due to differences in surface functional groups only in the acute phase.

Plastics pollution is a critical global environmental issue, with growing concern over the increasing presence of nanoplastic particles. Plastics are major environmental pollutants that adversely affect human health, particularly when plastics from food sources enter the body and pose potential risks to reproductive health. Echinacea purpurea is an immunologically active medicinal plant containing phenolic acids and alkylamides. Nanoparticles present a promising approach to enhance the effectiveness, stability, and bioavailability of Echinacea purpurea ethanol extract (EE) active components. This study aimed to determine the protective effects of chitosan-silica-Echinacea purpurea nanoparticles (CSE) against reproductive injury induced by polystyrene nanoplastics (PS-NPs) in male rats. The results showed that CSE dose-dependently reduced oxidative damage and protected intestinal and reproductive health. Furthermore, CSE improved gut microbiota dysbiosis, preserved barrier integrity, and attenuated PS-NPs-induced inflammation in the colon, brain, and gonads. Inflammatory factors released from the gut can enter the bloodstream, cross the blood–brain barrier, and potentially modulate the hypothalamic–pituitary–gonadal (HPG) axis. CSE has also been shown to elevate neurotransmitter levels in the colon and brain, thereby repairing HPG axis dysregulation caused by PS-NPs through gut–brain communication and improving reproductive dysfunction. This study enhances our understanding of CSE in modulating the gut–brain and HPG axes under PS-NPs-induced damage. CSE demonstrates the capacity to provide protection and facilitate recovery by mitigating oxidative stress and inflammation, restoring gut microbiota balance, and preserving hormone levels in the context of PS-NPs-induced injury.

Polystyrene nanoplastics (PS-NPs) are result from the degradation of plastic and have diameters ranging from 1 nm to 100 nm. The objective of this study is to provide information on the adverse effects of PS-NPs with in vitro and in vivo analyses of liver injury. An in vitro study was conducted using confocal microscopy, flow cytometry, and MTT test analysis. An in vivo study was conducted to determine apoptosis levels, glucose metabolism gene expressions, liver enzymes, and liver histology. Data were analyzed using GraphPad Prism software 10.2.1. The in vitro study showed the absorption of PS-NPs in the cell cytoplasm, the percentage of apoptosis, 3t3, and the WiDr cell lines’ viability. The in vivo analysis showed that PS-NPs can stimulate liver injuries, such as inducing the elevation of liver enzymes, necrosis, edema, inflammation, and the dilatation of the portal vein diameter. High levels of caspase-3, caspase-9, and Bax were detected, as well as the expression of several genes including PI3K, AKT, PEPCK, GLUT2, and PK. In conclusion, the in vitro analysis showed the detrimental effects of PS-NPs on cells, such as high levels of apoptosis and low cell viability, while the in vivo studies displayed the impairment of liver tissue and disturbances in glucose metabolism regulation.

The use of plastic products has increased, leading to higher levels of plastic pollution, and it is becoming a major public health concern. Health risks—especially those related to reproductive system dysfunction caused by polystyrene microplastics (PS-MPs)—are emerging issues that require urgent attention. This study aimed to investigate the effects of erinacine A-enriched Hericium erinaceus mycelium (HE) on high-fat-diet- and PS-MP-induced reproductive system dysfunction in male rats. Reproductive dysfunction was induced by administering a high-fat diet followed by exposure to PS-MPs for six weeks. The results showed that HE treatment significantly reduced nitric oxide levels and enhanced glutathione peroxidase activity. Furthermore, HE supplementation significantly downregulated pro-inflammatory cytokines such as interleukin (IL)-6 and IL-1β. Additionally, HE treatment significantly increased Kiss1 concentration, upregulated follicle-stimulating hormone and testosterone levels, reduced the area of the seminiferous tubule lumen, and prevented a reduction in epithelial thickness. HE treatment also significantly increased sperm count and reduced sperm abnormalities. Based on these findings, HE supplementation helps prevent reproductive system dysfunction by reducing oxidative stress and pro-inflammatory cytokines. Therefore, erinacine A-enriched H. erinaceus mycelium could be considered a potential food supplement or functional food ingredient for the treatment of reproductive or testicular dysfunction.

Surface topography is increasingly being recognized as an important factor to control the response of cells and tissues to biomaterials. In the current study, the aim was to obtain deeper understanding of the effect of microgrooves on shape and orientation of osteoblast-like cells and to relate this effect to their proliferation and osteogenic differentiation. To this end, two microgrooved polystyrene (PS) substrates, differing in the width of the grooves (about 2 μm and 4 μm) and distance between individual grooves (about 6 μm and 11 μm, respectively) were fabricated using a combination of photolithography and hot embossing. MG-63 human osteosarcoma cells were cultured on these microgrooved surfaces, with unpatterned hot-embossed PS substrate as a control. Scanning electron- and fluorescence microscopy analyses showed that on patterned surfaces, the cells aligned along the microgrooves. The cells cultured on 4 μm-grooves / 11 μm-ridges surface showed a more pronounced alignment and a somewhat smaller cell area and cell perimeter as compared to cells cultured on surface with 2 μm-grooves / 6 μm-ridges or unpatterned PS. PrestoBlue analysis and quantification of DNA amounts suggested that microgrooves used in this experiment did not have a strong effect on cell metabolic activity or proliferation. However, cell differentiation towards the osteogenic lineage was significantly enhanced when MG-63 cells were cultured on the 2/6 substrate, as compared to the 4/11 substrate or unpatterned PS. This effect on osteogenic differentiation may be related to differences in cell spreading between the substrates.