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Drug evaluation in children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
A poorly designed study will fail to attract investigators, obtain ethical approval and recruit children. The study design is therefore crucial. Investigators need to ask the following questions: Which paediatric age group is most likely to benefit from the medicine?How many patients are needed?Is more than one centre needed to recruit all the patients?Should a placebo be included in the trial design? (Placebo is appropriate if there is no existing treatment for the condition. If however, effective therapy is available, then the use of a placebo is neither appropriate nor ethical).How will the pharmacodynamic effect be studied in the particular age group of the study?Which pharmacokinetic parameters, if any, need to be determined?What is the likelihood of significant drug toxicity?
Basic Principles of Antifungal Treatment
Published in Firza Alexander Gronthoud, Practical Clinical Microbiology and Infectious Diseases, 2020
Monitor signs of drug toxicity All antifungal drugs can cause hepatotoxicity, lowest risk seen with echinocandins.Azoles: Prolonged QT interval. Visual disturbances and encephalopathy can be seen with voriconazole. IV voriconazole can result in renal toxicity.Echinocandins: Low toxicity profile. Infusion-related reaction is a rare side effect.Amphotericin B: Infusion-related reaction (lower with liposomal amphotericin B), renal toxicity, hypokalaemia, hepatotoxicity.
The Patient with Refractory Seizures
Published in Stanley R. Resor, Henn Kutt, The Medical Treatment of Epilepsy, 2020
In a study of 40 consecutive patients, Sutula et al. (18) performed CCTV-EEG for 6 hours on admission and before discharge, with additional recordings as needed, for seizure classification and assessment of the effects of therapy. Serum AED levels were carefully monitored and seizures were recorded by nurses trained in the recognition, observation, and classification of epileptic seizures. Eight-five percent of patients were receiving at least two AEDs, 55% three or more drugs, and 15% four or more drugs. Overt signs of drug toxicity were present in 20%. Major social and adjustment problems occurred in 82%.
Novel amides of mycophenolic acid and some heterocyclic derivatives as immunosuppressive agents
Published in Journal of Enzyme Inhibition and Medicinal Chemistry, 2022
Juliusz Maksymilian Walczak, Dorota Iwaszkiewicz-Grześ, Michalina Ziomkowska, Magdalena Śliwka-Kaszyńska, Mateusz Daśko, Piotr Trzonkowski, Grzegorz Cholewiński
Drug toxicity that affects the cells can cause a variety of serious side effects, including uncontrolled suppression of the immune system. In order to check the cytotoxicity of the tested compounds, the XTT test was performed, the results of which are presented in Table 2. All tested compounds were characterised by lower cytotoxicity than native MPA. Unfortunately, several compounds (marked with ↓) were partially insoluble in culture despite surfactant addition. They were investigated too, but one could not use them as an immunosuppressive drug in their current form. Taking into account the EC50 values obtained in the proliferation tests (VPD540 staining, Table 3), the compound A2 was selected as the one with the highest immunosuppressive potential and the possibility of its later use in therapy, and is presented in the graphs (Figures 2–4).
Genotoxic, biochemical and histopathological studies to assessment the topiramate hepatorenal toxicity in mice
Published in Drug and Chemical Toxicology, 2022
Aida I. El Makawy, Dalia M. Mabrouk, Faten M. Ibrahim, Kawkab A. Ahmed
Liver and kidney are vulnerable to drug toxicity due to their role as primary organs of drug excretion and its successive exposure to potential toxins. Many usually prescribe medications including virtually all of the major antiepileptic drugs (AEDs) can cause liver and kidney dysfunction (Asconape, 2014, Poorrostami et al. 2014). The antiepileptic drug hepatotoxicity can cause liver failure and arise as creation of reactive toxic metabolite or initiation of immunoallergic reactions. Hepatotoxicity is a familiar adverse effect of first generation antiepileptic, while, the second-generation antiepileptic have a milder side effect profile (George et al. 2016). Many studies have confirmation for the harmful effect of some AEDs on the kidney, Topiramate found to provoke renal tubular acidosis (Hamed 2017).
The reporting of observational studies of drug effectiveness and safety: recommendations to extend existing guidelines
Published in Expert Opinion on Drug Safety, 2021
Jacquelyn J. Cragg, Laurent Azoulay, Gary Collins, Mary A. De Vera, Mahyar Etminan, Fawziah Lalji, Andrea S. Gershon, Gordon Guyatt, Mark Harrison, Catherine Jutzeler, Rosemin Kassam, Tetyana Kendzerska, Larry Lynd, Mohammad Ali Mansournia, Mohsen Sadatsafavi, Bobo Tong, Freda M. Warner, Helen Tremlett
Several funding bodies, including the European Commission (Horizon 2020), the USA’s National Institutes of Health (NIH) and the Canadian Institutes of Health Research (CIHR) require research designs that incorporate sex- (biological) and/or gender-based (socio-cultural) differences [32–34]. The rationale for these recommendations includes the recognition that aggregating sexes may mask differences and produce spurious results. Drug toxicity and drug safety profiles in particular can differ between sexes [35]. Table 1 (e.g. 2.7) shows two examples from published literature: one of antivirals in HIV-infected individuals, and the other examining the association between NSAIDs and the risk of gastrointestinal bleeds [36,37]. While the current STROBE statement includes an item to ‘describe any methods used to examine subgroups and interactions’ (under methods) and ‘report other analyses done-eg analyses of subgroups and interactions’ (under results), sex and gender-based analyses are not explicitly stated in the checklist. In reporting checklists, the methods and results section should include a description of sex- and gender-based considerations, including analyses and results (under subgroup effects).