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单次与多次静脉注射昂丹司琼预防儿童化疗所致恶心呕吐的比较:一项随机、双盲、对照临床试验。

Single daily dosing versus divided dosing intravenous ondansetron to prevent chemotherapy-induced nausea and vomiting among children: A comparative randomized double-blind controlled trial.

机构信息

Department of Pediatrics, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.

Division of Hematology-Oncology, Department of Pediatrics, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.

出版信息

Pediatr Blood Cancer. 2021 Jun;68(6):e29002. doi: 10.1002/pbc.29002. Epub 2021 Mar 23.

Abstract

BACKGROUND

Chemotherapy-induced nausea and vomiting (CINV) is a common complication in cancer treatment. Ondansetron is an effective antiemetic drug widely used to prevent CINV; however, the effective administrative dosing strategies among pediatrics remain unclear. The study aimed to investigate clinical effectiveness of single daily dosing versus divided dosing ondansetron.

METHODS

In all, 194 children undergoing chemotherapy were randomized to receive either single daily dosing (0.3 mg/kg/dose) or divided dosing (0.15 mg/kg/dose every 8 hours) intravenous ondansetron for 24 hours. Clinical parameters including number of emesis episodes, nausea scores, appetite levels, parent's satisfaction, and adverse effects within 24 hours were analyzed.

RESULTS

No significant differences were found between the two dosing strategies concerning number of emesis episodes and parent's satisfaction. However, nonleukemic hematologic malignancies and concurrent administration of intrathecal methotrexate-hydrocortisone-cytarabine (IT-MHA) were associated with increased risk of acute-phase vomiting. Interestingly, none of the patients aged under 7 years, receiving divided dosing ondansetron, presented nausea symptoms compared with those receiving single daily dosing (p-value .034). No significant differences regarding headache were observed between the two dosing strategies and none of the patients experienced QTc prolongation.

CONCLUSION

Ondansetron administered as divided dosing should be considered among children aged under 7 years to prevent chemotherapy-induced nausea and among patients receiving low emetogenic chemotherapy to maintain their appetite. Both administrative dosing strategies were well tolerated with no significant adverse effects.

摘要

背景

化疗引起的恶心和呕吐(CINV)是癌症治疗中的常见并发症。昂丹司琼是一种广泛用于预防 CINV 的有效止吐药物;然而,儿科患者的有效给药策略仍不清楚。本研究旨在探讨昂丹司琼单剂量与分剂量给药的临床效果。

方法

共有 194 名接受化疗的儿童随机分为两组,分别接受单剂量(0.3mg/kg/剂量)或分剂量(0.15mg/kg/剂量,每 8 小时一次)静脉内昂丹司琼治疗 24 小时。分析了 24 小时内的临床参数,包括呕吐发作次数、恶心评分、食欲水平、家长满意度和不良反应。

结果

两种给药策略在呕吐发作次数和家长满意度方面无显著差异。然而,非白血病性血液系统恶性肿瘤和同时给予鞘内甲氨蝶呤-氢化可的松-阿糖胞苷(IT-MHA)与急性期呕吐的风险增加相关。有趣的是,年龄在 7 岁以下、接受分剂量昂丹司琼治疗的患者无一例出现恶心症状,而接受单剂量昂丹司琼治疗的患者无一例出现恶心症状(p 值<.034)。两种给药策略之间头痛发生率无显著差异,且无患者发生 QTc 延长。

结论

对于 7 岁以下儿童,为预防化疗引起的恶心,以及对于接受低致吐性化疗的患者,应考虑给予昂丹司琼分剂量给药。两种给药策略均耐受良好,无明显不良反应。

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