Ethanol-induced symptoms in patients receiving gemcitabine diluted from a concentrate for solution for infusion containing ethanol
| العنوان: | Ethanol-induced symptoms in patients receiving gemcitabine diluted from a concentrate for solution for infusion containing ethanol |
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| المؤلفون: | José Miguel Martín Martínez, Teresa Molina-Garcia, Laura López-Esteban, Rocío Vázquez-Sánchez, Miguel Soria-Tristán, Laura Díaz-Paniagua, Ana Sanchez-Pena, Raúl Diez-Fernández, Santos Enrech-Frances |
| المصدر: | Journal of Oncology Pharmacy Practice. 24:511-516 |
| بيانات النشر: | SAGE Publications, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Male, Excipient, Pharmacology, Deoxycytidine, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, medicine, Humans, Pharmacology (medical), In patient, Solubility, Aged, Cross-Over Studies, Ethanol, business.industry, Incidence, 030208 emergency & critical care medicine, Middle Aged, Gemcitabine, Pharmaceutical Solutions, Breath Tests, Oncology, chemistry, Anesthesia, Toxicity, Blood Alcohol Content, Female, business, 030217 neurology & neurosurgery, medicine.drug |
| الوصف: | Purpose Ethanol as an excipient is used to enhance the solubility of gemcitabine, but, sometimes, the dose of ethanol a patient may be given is much higher than the dose considered to be toxic. We aimed to assess ethanol-related symptoms and signs in patients receiving two formulations of gemcitabine, with and without ethanol. Methods A randomized double blind cross-over study was conducted. All patients being treated with gemcitabine received two consecutive doses of the drug, one diluted from a concentrate for solution for infusion (CSI) containing ethanol and the other from a lyophilized powder, without ethanol, which was used as control group. After each administration, patients were surveyed in order to assess the appearance of any alcohol consumption symptoms (dizziness, difficulty speaking, unsteady walking, impaired balance, mood swings and slower reactions). Widmark formula and the amount of alcohol measured on the breath (breathalyzer) were used to estimate blood alcohol concentration. Results Twenty-four patients received both formulations and were included in the analysis. Mean administered ethanol dose when prepared from CSI was 15.81 ± 2.25 g (mean ± SD). When using CSI gemcitabine, estimated blood ethanol concentration was 0.033 g/dl according to Widmark formula and 0.02 g/dl according to breathalyzer results. Although overall incidence of symptoms was higher in the study group, the difference was not statistically significant (33% vs. 25%; p = 0.53). Conclusions These findings prove there is no difference in the onset of ethanol related symptoms when using CSI instead of lyophilized powder on the reconstitution of gemcitabine. |
| تدمد: | 1477-092X 1078-1552 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::24d6d40815898ae2db26751fb9f00738 https://doi.org/10.1177/1078155217715790 |
| حقوق: | CLOSED |
| رقم الأكسشن: | edsair.doi.dedup.....24d6d40815898ae2db26751fb9f00738 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1477092X 10781552 |
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