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Iranian Journal of Blood and Cancer، جلد ۱۳، شماره ۲، صفحات ۳۵-۳۹
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عنوان انگلیسی A Prospective Triple-blind Randomized Trial on Safety and Efficacy of Abitant in the Prevention of Chemotherapy-Induced Nausea and Vomiting
چکیده انگلیسی مقاله Background: Oral Aprepitant, a neurokinin-1 receptor antagonist, is suggested in combination with other antiemetic agents in preventing chemotherapy-induced nausea and vomiting(CINV) associated with emetogenic chemotherapeutic regimens in adolescents, but its efficacy and safety in pediatric patients more than six months are unknown. in this study, we used abitant drug (a generic name of Aprepitant produced by Exir pharmaceutical company) for preventing CINV in children.  Methods: In this triple-blind clinical trial, patients aged between 6 months to 15 years were randomly assigned to receive 3 mg/kg (maximum of 120 mg per dose) Abitant 60 minutes before receiving moderate to highly emetogenic chemotherapy and 2 mg/kg (maximum 80 mg per dose) in days 2 and 3 or placebo plus ondansetron. The primary efficacy endpoint was the percentage of patients who obtained complete response (stated as no retching, no vomiting, and no urge for rescue medication) during 25–120 hours (delayed phase) after initiation of emetogenic chemotherapy. The secondary endpoint was the proportion of children who attained complete response throughout the acute (0–24 h) and the total phase(0-120 h). Efficacy and safety analyses were done with randomly assigned patients who received at least one study treatment dose.  Results: twelve patients of the Abitant group (66/7%) and 11 patients of the placebo group (64/7%) showed complete response (P=0.186). There was no significant adverse effect observed in both groups. Complete response on day 5 was 83.3% in the Abitant group and 86/7% in the placebo group.  Conclusion: The efficacy of a combination of abitant along with ondansetron in controlling CINV was not inferior to the ondansetron alone in our pediatric population study group.
کلیدواژه‌های انگلیسی مقاله Abitant, Antiemetic, Children, Nausea and vomiting
نویسندگان مقاله | Faatemeh Malek
Pediatric Congenital Hematologic Disorders Research Center, Research Institute for Children’s Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran


| Peyman Eshghi
Pediatric Congenital Hematologic Disorders Research Center, Research Institute for Children’s Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran


| Bahador Mirrahimi
Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran


| Samin Alavi
Pediatric Congenital Hematologic Disorders Research Center, Research Institute for Children’s Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran


| Shiva Nazari
Pediatric Congenital Hematologic Disorders Research Center, Research Institute for Children’s Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran


| Bibi Shahin Shamsian
Pediatric Congenital Hematologic Disorders Research Center, Research Institute for Children’s Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran


| Ahmad Reza Shamshiri
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran


| Parasto Molaei Tavana
Pediatric Congenital Hematologic Disorders Research Center, Research Institute for Children’s Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran
نشانی اینترنتی http://ijbc.ir/browse.php?a_code=A-10-682-1&slc_lang=en&sid=1
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کد مقاله (doi)
زبان مقاله منتشر شده en
موضوعات مقاله منتشر شده Pediatric Hematology & Oncology
نوع مقاله منتشر شده پژوهشی
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