Browsing by Subject "Adverse effects"

Now showing 1 - 3 of 3
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    Gastrointestinal side effects and adequacy of enteral intake in hematopoietic stem cell transplant patients
    (Wiley, 2015-04) Walrath, Maegan; Bacon, Cheryl; Foley, Sharon; Fung, Henry C.; Medicine, School of Medicine
    BACKGROUND: Patients undergoing hematopoietic stem cell transplant (HSCT) can experience gastrointestinal (GI) side effects as a complication of the treatment. Limited research exists describing how the duration and severity of GI side effects influence the consumption of adequate calorie intake in this population. The purpose of this study was to assess differences in GI side effects between patients who consumed adequate calories compared with those who did not. METHODS: The MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI) tool was used to record daily GI side effects of 72 HSCT patients. Daily calorie intake was determined via calorie counts. Data were collected from day of transplant until engraftment. RESULTS: Median percentage of caloric needs consumed for all patients was 49.2% (interquartile range, 35.1-66.6). Calorie intake decreased from baseline to transplant day 8 as severity of GI symptoms increased. An inverse relationship between percentage of caloric needs met and MDASI-GI component score, MDASI-GI symptom score, and lack of appetite score was observed. The only significant difference in MDASI-GI symptom scores between those who consumed adequate calories and those who consumed inadequate calories was for diarrhea; subjects who consumed >60% of caloric needs had significantly lower median diarrhea scores. CONCLUSION: Most patients consumed <60% of their caloric needs from time of transplant to time of engraftment. More research is needed to provide insight into strategies to increase intake and to describe the implications of prolonged inadequate intake in HSCT patients.
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    Medication history-wide association studies for pharmacovigilance of pregnant patients
    (Springer Nature, 2022-09-16) Challa, Anup P.; Niu, Xinnan; Garrison, Etoi A.; Van Driest, Sara L.; Bastarache, Lisa M.; Lippmann, Ethan S.; Lavieri, Robert R.; Goldstein, Jeffery A.; Aronoff, David M.; Medicine, School of Medicine
    Background: Systematic exclusion of pregnant people from interventional clinical trials has created a public health emergency for millions of patients through a dearth of robust safety data for common drugs. Methods: We harnessed an enterprise collection of 2.8 M electronic health records (EHRs) from routine care, leveraging data linkages between mothers and their babies to detect drug safety signals in this population at full scale. Our mixed-methods signal detection approach stimulates new hypotheses for post-marketing surveillance agnostically of both drugs and diseases-by identifying 1,054 drugs historically prescribed to pregnant patients; developing a quantitative, medication history-wide association study; and integrating a qualitative evidence synthesis platform using expert clinician review for integration of biomedical specificity-to test the effects of maternal exposure to diverse drugs on the incidence of neurodevelopmental defects in their children. Results: We replicated known teratogenic risks and existing knowledge on drug structure-related teratogenicity; we also highlight 5 common drug classes for which we believe this work warrants updated assessment of their safety. Conclusion: Here, we present roots of an agile framework to guide enhanced medication regulations, as well as the ontological and analytical limitations that currently restrict the integration of real-world data into drug safety management during pregnancy. This research is not a replacement for inclusion of pregnant people in prospective clinical studies, but it presents a tractable team science approach to evaluating the utility of EHRs for new regulatory review programs-towards improving the delicate equipoise of accuracy and ethics in assessing drug safety in pregnancy.
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    A Metabolomics Approach for Early Prediction of Vincristine-Induced Peripheral Neuropathy
    (Springer, 2020-04-15) Verma, Parul; Devaraj, Jayachandran; Skiles, Jodi L.; Sajdyk, Tammy; Ho, Richard H.; Hutchinson, Raymond; Wells, Elizabeth; Li, Lang; Renbarger, Jamie; Cooper, Bruce; Ramkrishna, Doraiswami; Pediatrics, School of Medicine
    Vincristine is a core chemotherapeutic drug administered to pediatric acute lymphoblastic leukemia patients. Despite its efficacy in treating leukemia, it can lead to severe peripheral neuropathy in a subgroup of the patients. Peripheral neuropathy is a debilitating and painful side-effect that can severely impact an individual’s quality of life. Currently, there are no established predictors of peripheral neuropathy incidence during the early stage of chemotherapeutic treatment. As a result, patients who are not susceptible to peripheral neuropathy may receive sub-therapeutic treatment due to an empirical upper cap on the dose, while others may experience severe neuropathy at the same dose. Contrary to previous genomics based approaches, we employed a metabolomics approach to identify small sets of metabolites that can be used to predict a patient’s susceptibility to peripheral neuropathy at different time points during the treatment. Using those identified metabolites, we developed a novel strategy to predict peripheral neuropathy and subsequently adjust the vincristine dose accordingly. In accordance with this novel strategy, we created a free user-friendly tool, VIPNp, for physicians to easily implement our prediction strategy. Our results showed that focusing on metabolites, which encompasses both genotypic and phenotypic variations, can enable early prediction of peripheral neuropathy in pediatric leukemia patients.