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Kayla Ann Andrews Joel S. Owen James McCarthy David Wesche Nathalie Gobeau Thaddeus H. Grasela Jrg J. Mhrle 《CTS Clinical and Translational Science》2021,14(2):712
Volunteer infection studies using the induced blood stage malaria (IBSM) model have been shown to facilitate antimalarial drug development. Such studies have traditionally been undertaken in single‐dose cohorts, as many as necessary to obtain the dose‐response relationship. To enhance ethical and logistic aspects of such studies, and to reduce the number of cohorts needed to establish the dose‐response relationship, we undertook a retrospective in silico analysis of previously accrued data to improve study design. A pharmacokinetic (PK)/pharmacodynamic (PD) model was developed from initial fictive‐cohort data for OZ439 (mixing the data of the three single‐dose cohorts as: n = 2 on 100 mg, 2 on 200 mg, and 4 on 500 mg). A three‐compartment model described OZ439 PKs. Net growth of parasites was modeled using a Gompertz function and drug‐induced parasite death using a Hill function. Parameter estimates for the PK and PD models were comparable for the multidose single‐cohort vs. the pooled analysis of all cohorts. Simulations based on the multidose single‐cohort design described the complete data from the original IBSM study. The novel design allows for the ascertainment of the PK/PD relationship early in the study, providing a basis for rational dose selection for subsequent cohorts and studies. Study Highlights
- WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?
- WHAT QUESTION DID THIS STUDY ADDRESS?
- WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?
- HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?
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Torture victims often show symptoms of dental anxiety when receiving dental care, but little systematic research is available. The purpose of this study was to explore torture experiences, symptoms of post‐traumatic stress disorder (PTSD), and dental anxiety in refugees in Norway and to test the hypothesis that refugees with torture experiences are more prone to dental anxiety than refugees with no such experiences. A total of 173 refugees were interviewed shortly after an oral examination. The Modified Dental Anxiety Scale (MDAS) and the Harvard Trauma Questionnaire‐PTSS16 were administered verbally through attending interpreters. Among torture victims (47%, n = 81), the prevalence of torture experiences involving mouth or teeth was 35% and 23%, respectively. Harvard Trauma Questionnaire mean sum scores were statistically significantly higher in torture victims (34.3 vs. 24.8). Torture survivors report a larger number of symptoms of PTSD, and dental anxiety shows a higher prevalence in refugees reporting PTSD symptoms than in refugees who do not report such symptoms. When analysed using logistic regression models, the data showed the odds of high levels of dental anxiety being 6.1 times higher in refugees with torture experiences compared with other refugees and 9.3 times higher in torture victims with PTSD symptoms. Oral health professionals should be aware of these associations when providing dental care to refugees. The hypothesis that tortured refugees are more prone to dental anxiety is supported. 相似文献
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Susan C. Fox Jane A. May Natalia Dovlatova Jackie R. Glenn Andrew Johnson Ann E. White 《Platelets》2019,30(3):290-295
Measurement of P-selectin on activated platelets as a means of measuring platelet function utilizing the technology described here has the advantage of not requiring immediate access to specialist equipment and expertise. Blood samples are activated, fixed, stored, and transported to a central laboratory for flow cytometric analysis. Here we have compared P-selectin with other more traditional approaches to measuring platelet function in blood and/or platelet-rich plasma (PRP) from patients with acute coronary syndromes on treatment for at least 1 month with either aspirin and clopidogrel or aspirin with prasugrel. The comparators were light transmission aggregometry (LTA), VerifyNow and Multiplate aggregometry (for determining the effects of aspirin) and LTA, VerifyNow and Multiplate together with the BioCytex VASP phosphorylation assay (for the P2Y12 antagonists). The P-selectin Aspirin Test revealed substantial inhibition of platelet function in all but three of 96 patients receiving aspirin with clopidogrel and in none of 51 patients receiving aspirin and prasugrel. The results were very similar to those obtained using LTA. There was only one patient with high residual platelet aggregation and low P-selectin expression. The same patients identified as “non-responders” to aspirin also presented with the highest residual platelet activity as measured using the VerifyNow system, although not quite as well separated from the other values. With the Multiplate test only one of these patients clearly stood out from the others. The results obtained using the P-selectin P2Y12 Test in 102 patients taking aspirin and clopidogrel were similar to the more traditional approaches in that a wide scatter of results was obtained. Generally, high values seen with the P-selectin P2Y12 Test were also high with the LTA, VerifyNow, Multiplate, and BioCytex VASP P2Y12 Tests. Similarly, low residual platelet function using the P2Y12 test was seen irrespective of the testing procedure used. However, there were differences in some patients. Prasugrel was always more effective than clopidogrel in inhibiting platelet function with none of 56 patients (P-selectin and VerifyNow), only 2 of 56 patients (Multiplate) and only 3 of 56 patients (Biocytex VASP) demonstrating high on-treatment residual platelet reactivity (HRPR) defined using previously published cut-off values. The exception was LTA where there were 11 of 56 patients with HRPR. It remains to be seen which experimental approach provides the most useful information regarding outcomes after adjusting therapies in treated patients. 相似文献