Feinstein Institute for Medical Research, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, New York.
Department of Emergency Medicine, Northwell Health, New York, New York.
JAMA Netw Open. 2019 Nov 1;2(11):e1914988. doi: 10.1001/jamanetworkopen.2019.14988.
Vomiting resulting from acute gastroenteritis is commonly treated with intravenous antiemetics in acute care settings. If oral treatment were beneficial, patients might not need intravenous administered hydration or medication. Furthermore, a long-acting treatment could provide sustained relief from nausea and vomiting.
To determine whether an experimental long-acting bimodal release ondansetron tablet decreases gastroenteritis-related vomiting and eliminates the need for intravenous therapy for 24 hours after administration.
DESIGN, SETTING, AND PARTICIPANTS: This placebo-controlled, double-blind, randomized clinical trial included patients from 19 emergency departments and 2 urgent care centers in the United States from December 8, 2014, to February 17, 2017. Patients 12 years and older with at least 2 vomiting episodes from presumed gastroenteritis in the previous 4 hours and symptoms with less than 36 hours' duration were randomized using a 3:2 active to placebo ratio. Analyses were performed on an intent-to-treat basis and conducted from June 1, 2017, to November 1, 2017.
Bimodal release ondansetron tablet containing 6 mg of immediate release ondansetron and 18 mg of a 24-hour release matrix for a total of 24 mg of ondansetron.
Treatment success was defined as no further vomiting, no need for rescue medication, and no intravenous hydration for 24 hours after bimodal release ondansetron administration.
Analysis included 321 patients (mean [SD] age, 29.0 [11.1] years; 195 [60.7%] women), with 192 patients in the bimodal release ondansetron group and 129 patients in the placebo group. Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), with an 11.4% (95% CI, 0.3%-22.4%) absolute probability difference. The proportion of treatment success was 21% higher among patients who received bimodal release ondansetron compared with those who received a placebo (relative risk, 1.21; 95% CI, 1.00-1.46; P = .04). In an analysis including only patients with a discharge diagnosis of acute gastroenteritis and no major protocol violations, there were 123 treatment successes (69.5%) in the bimodal release ondansetron group compared with 67 treatment successes (54.9%) in the placebo group (relative risk, 1.27; 95% CI, 1.05-1.53; P = .01). Adverse effects were infrequent and similar to the known safety profile of ondansetron.
This randomized clinical trial found that a long-acting bimodal release oral ondansetron tablet was an effective antiemetic among adolescents and adults with moderate to severe vomiting from acute gastroenteritis. The drug benefits extended to 24 hours after administration. Bimodal release ondansetron may decrease the need for intravenous access and emergency department care to manage acute gastroenteritis.
ClinicalTrials.gov identifier: NCT02246439.
急性肠胃炎引起的呕吐通常在急性护理环境中使用静脉止吐药进行治疗。如果口服治疗有效，患者可能不需要静脉补液或药物治疗。此外，长效治疗可以提供持续缓解恶心和呕吐。
确定一种实验性长效双相释放昂丹司琼片是否能减少肠胃炎相关的呕吐，并在给药后 24 小时内消除对静脉治疗的需求。
设计、地点和参与者：这是一项安慰剂对照、双盲、随机临床试验，纳入了来自美国 19 个急诊科和 2 个紧急护理中心的患者，纳入时间为 2014 年 12 月 8 日至 2017 年 2 月 17 日。年龄在 12 岁及以上，在过去 4 小时内至少有 2 次因疑似肠胃炎引起的呕吐，且症状持续时间不到 36 小时的患者，按 3:2 的比例随机分配至活性药物组或安慰剂组。分析采用意向治疗方法，于 2017 年 6 月 1 日至 2017 年 11 月 1 日进行。
双相释放昂丹司琼片，含有 6 毫克即刻释放昂丹司琼和 18 毫克 24 小时释放基质，总剂量为 24 毫克昂丹司琼。
治疗成功定义为双相释放昂丹司琼给药后 24 小时内无进一步呕吐、无需抢救药物且无需静脉补液。
分析纳入了 321 名患者（平均[标准差]年龄 29.0[11.1]岁；195[60.7%]名女性），其中 192 名患者接受双相释放昂丹司琼治疗，129 名患者接受安慰剂治疗。在双相释放昂丹司琼组，126 名患者（65.6%）治疗成功，安慰剂组 70 名患者（54.3%）治疗成功，绝对概率差异为 11.4%（95%CI，0.3%-22.4%）。与安慰剂组相比，接受双相释放昂丹司琼治疗的患者中，治疗成功率提高了 21%（相对风险，1.21；95%CI，1.00-1.46；P=0.04）。在仅包括急性肠胃炎出院诊断且无主要方案违规的患者分析中，双相释放昂丹司琼组 123 名患者（69.5%）治疗成功，安慰剂组 67 名患者（54.9%）治疗成功（相对风险，1.27；95%CI，1.05-1.53；P=0.01）。不良反应罕见且与昂丹司琼已知的安全性特征相似。
这项随机临床试验发现，一种长效双相释放口服昂丹司琼片在患有中度至重度肠胃炎引起呕吐的青少年和成年人中是一种有效的止吐药。药物的益处可延长至给药后 24 小时。双相释放昂丹司琼可能减少对静脉通路和急诊科护理的需求，以管理急性肠胃炎。
ClinicalTrials.gov 标识符：NCT02246439。
