Introduction: Because of the activities and effects they induce, hormones are prohibited for use for anabolic purposes in farm animals intended for slaughter, which is regulated in the European Union by relevant legal provisions. Therefore, there is an obligation to monitor residues of hormones in animals and food of animal origin to ensure consumer safety. A hormone banned but used formerly for fattening cattle, stanozolol, and its metabolite 16β-OH-stanozolol are synthetic compounds that belong to a large group of steroid hormones. This study investigates residues of these compounds in animal urine.
Material and methods: From 2006-2022, 2,995 livestock urine samples were tested for stanozolol residues in Poland as part of the National Residue Monitoring Programme. A liquid chromatography-tandem mass spectrometry method to determine stanozolol and 16β-OH-stanozolol in animal urine was developed and validated according to the required criteria. Urine sample analysis was based on enzymatic hydrolysis of hormones potentially present in it to the free form, extraction of them from the sample with a mixture of n-hexane and butyl alcohol, purification of an extract on an NH2 amine column and finally, instrumental detection.
Results: The apparent recovery and precision parameters of the developed method were in line with the established criteria, while its decision limits CCα and detection capabilities CCβ were lower than the recommended concentration for analytical purposes set at 2 μg L-1 (valid until December 15, 2022; currently set as 0.5 μg L-1).
Conclusion: All examined samples were compliant with the evaluation criteria.
Introduction: Iron deficiency is a common condition, especially among patients with kidney and heart failure and inflammatory bowel disease. Intravenous iron is the preferred method of treatment in these patients, but it usually requires prolonged iron polymaltose infusions or multiple administrations of alternative preparations. The aim of the study was to confirm the safety and patient acceptance of ultrarapid iron polymaltose infusions as an alternative to slower treatments and ferric carboxymaltose.
Method: An open-label, phase 4 safety study was conducted at a tertiary hospital, with consenting participants diagnosed with iron deficiency and requiring iron polymaltose up to 1,500 mg receiving the infusion over 15 min. The acute adverse event (AE) rates and their severities were compared to historical controls of 1- and 4-h iron polymaltose infusions from a retrospective study of 648 patients from the same study site. Delayed AEs as well as participant infusion acceptability were also studied.
Results: Three hundred participants over a 2-year period received ultrarapid infusions of iron polymaltose with an acute AE rate of 18.7% and severe AE rate of 1.0%. The total and mild infusion AE rates were higher compared to those of slower infusions (p < 0.001), but comparable for moderate and severe AEs. Delayed reactions occurred in 12.5% of participants, with over 95% of them preferring repeat ultrarapid infusions if required again.
Conclusion: Iron polymaltose can be safely infused at ultrarapid rates when compared to slower infusions, with similar safety to ferric carboxymaltose, offering greater convenience for patients and reduced healthcare costs.