دورية أكاديمية
Effect of poloxamer 188 vs placebo on painful vaso-occlusive episodes in children and adults with sickle cell disease : a randomized clinical trial
| العنوان: | Effect of poloxamer 188 vs placebo on painful vaso-occlusive episodes in children and adults with sickle cell disease : a randomized clinical trial |
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| المؤلفون: | Casella, James F., Barton, Bruce A., Kanter, Julie, Black, L. Vandy, Majumdar, Suvankar, Inati, Adlette, Wali, Yasser, Drachtman, Richard A., Abboud, Miguel R., Kilinc, Yurdanur, Fuh, Beng R., Al-Khabori, Murtadha K., Takemoto, Clifford M., Salman, Emad, Sarnaik, Sharada A., Shah, Nirmish, Morris, Claudia R., Keates-Baleeiro, Jennifer, Raj, Ashok, Alvarez, Ofelia A., Hsu, Lewis L., Thompson, Alexis A., Sisler, India Y., Pace, Betty S., Noronha, Suzie A., Lasky, Joseph L., III, de Julian, Elena Cela, Godder, Kamar, Thornburg, Courtney Dawn, Kamberos, Natalie L., Nuss, Rachelle, Marsh, Anne M., Owen, William C., Schaefer, Anne, Tebbi, Cameron K., Chantrain, Christophe F., Cohen, Debra E., Karakas, Zeynep, Piccone, Connie M., George, Alex, Fixler, Jason M., Singleton, Tammuella C., Moulton, Thomas, Quinn, Charles T., de Castro Lobo, Clarisse Lopes, Almomen, Abdulkareem M., Goyal-Khemka, Meenakshi, Maes, Philip, Emanuele, Marty, Gorney, Rebecca T., Padgett, Claire S., Parsley, Ed, Kronsberg, Shari S., Kato, Gregory J., Gladwin, Mark T. |
| المصدر: | 0098-7484 ; JAMA : the journal of the American Medical Association |
| سنة النشر: | 2021 |
| المجموعة: | IRUA - Institutional Repository van de Universiteit Antwerpen |
| مصطلحات موضوعية: | Human medicine |
| الوصف: | Key PointsQuestionCan poloxamer 188, an agent that is reported to reduce blood viscosity and cell-cell interactions, effectively reduce the duration of vaso-occlusive episodes (painful crises) in hospitalized patients with sickle cell disease? FindingsIn this randomized clinical trial that included 388 children and adults with sickle cell disease, treatment with poloxamer 188 vs placebo resulted in mean time to last dose of parenteral opioids during vaso-occlusive episodes of 81.8 vs 77.8 hours, a difference that was not statistically significant. MeaningAmong patients with sickle cell disease, poloxamer 188 did not significantly shorten the duration of painful vaso-occlusive episodes. ImportanceAlthough effective agents are available to prevent painful vaso-occlusive episodes of sickle cell disease (SCD), there are no disease-modifying therapies for ongoing painful vaso-occlusive episodes; treatment remains supportive. A previous phase 3 trial of poloxamer 188 reported shortened duration of painful vaso-occlusive episodes in SCD, particularly in children and participants treated with hydroxyurea. ObjectiveTo reassess the efficacy of poloxamer 188 for vaso-occlusive episodes. Design, Setting, and ParticipantsPhase 3, randomized, double-blind, placebo-controlled, multicenter, international trial conducted from May 2013 to February 2016 that included 66 hospitals in 12 countries and 60 cities; 388 individuals with SCD (hemoglobin SS, SC, S-beta(0) thalassemia, or S-beta(+) thalassemia disease) aged 4 to 65 years with acute moderate to severe pain typical of painful vaso-occlusive episodes requiring hospitalization were included. InterventionsA 1-hour 100-mg/kg loading dose of poloxamer 188 intravenously followed by a 12-hour to 48-hour 30-mg/kg/h continuous infusion (n=194) or placebo (n=194). Main Outcomes and MeasuresTime in hours from randomization to the last dose of parenteral opioids among all participants and among those younger than 16 years as a separate subgroup. ResultsOf 437 participants ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/isi/000642636500016 |
| الإتاحة: | https://doi.org/10.1001/JAMA.2021.3414Test https://hdl.handle.net/10067/1782400151162165141Test |
| حقوق: | info:eu-repo/semantics/closedAccess |
| رقم الانضمام: | edsbas.830FD728 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |