昂丹司琼治疗可减轻轮状病毒症状——一项随机双盲安慰剂对照试验
Ondansetron treatment reduces rotavirus symptoms-A randomized double-blinded placebo-controlled trial.
作者信息
Hagbom Marie, Novak Daniel, Ekström Malin, Khalid Younis, Andersson Maria, Lindh Magnus, Nordgren Johan, Svensson Lennart
机构信息
Department of Clinical and Experimental Medicine, Division of Molecular Virology, Medical Faculty, Linköping University, Linköping, Sweden.
Sahlgrenska University Hospital, The Queen Silvia Children's Hospital, The Emergency Department, Gothenburg, Sweden.
出版信息
PLoS One. 2017 Oct 27;12(10):e0186824. doi: 10.1371/journal.pone.0186824. eCollection 2017.
BACKGROUND
Rotavirus and norovirus cause acute gastroenteritis with severe diarrhoea and vomiting, symptoms that may lead to severe dehydration and death. The objective of this randomized double-blinded placebo-controlled study was to investigate whether ondansetron, a serotonin receptor antagonist could attenuate rotavirus- and norovirus-induced vomiting and diarrhoea, which would facilitate oral rehydration and possibly accelerate recovery and reduce need for hospitalization.
METHODS
Children with acute gastroenteritis, aged 6 months to 16 years where enrolled (n = 104) and randomized to one single oral dose (0.15mg/kg) of ondansetron (n = 52) or placebo (n = 52). The number of diarrhoea and vomiting episodes during the 24 hours following treatment was reported as well as the number of days with symptoms. Pathogens in faeces were diagnosed by real-time PCR. Outcome parameters were analyzed for rotavirus- and norovirus-positive children.
RESULTS
One dose of oral ondansetron reduced duration of rotavirus clinical symptoms (p = 0.014), with a median of two days. Furthermore, ondansetron reduced diarrhea episodes, most pronounced in children that had been sick for more than 3 days before treatment (p = 0.028).
CONCLUSION
Ondansetron may be a beneficial treatment for children with rotavirus gastroenteritis.
TRIAL REGISTRATION
European Clinical Trial Database EudraCT 2011-005700-15.
背景
轮状病毒和诺如病毒可引发伴有严重腹泻和呕吐的急性肠胃炎，这些症状可能导致严重脱水甚至死亡。这项随机双盲安慰剂对照研究的目的是调查5-羟色胺受体拮抗剂昂丹司琼是否能减轻轮状病毒和诺如病毒引起的呕吐和腹泻，从而有助于口服补液，并可能加速康复以及减少住院需求。
方法
纳入104名年龄在6个月至16岁的急性肠胃炎儿童，随机分为两组，一组单次口服剂量为0.15mg/kg的昂丹司琼（n = 52），另一组口服安慰剂（n = 52）。记录治疗后24小时内的腹泻和呕吐发作次数以及症状持续天数。通过实时PCR诊断粪便中的病原体。对轮状病毒和诺如病毒检测呈阳性的儿童的结果参数进行分析。
结果
单次口服昂丹司琼可缩短轮状病毒临床症状的持续时间（p = 0.014），中位数为两天。此外，昂丹司琼减少了腹泻发作次数，在治疗前患病超过3天的儿童中最为明显（p = 0.028）。
结论
昂丹司琼可能是治疗轮状病毒肠胃炎患儿的有效药物。
试验注册
欧洲临床试验数据库EudraCT 2011-005700-15 。
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