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经鼻胃管补液与静脉补液治疗毛细支气管炎婴儿的随机试验。

Nasogastric hydration versus intravenous hydration for infants with bronchiolitis: a randomised trial.

机构信息

Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Emergency Medicine, Monash Medical Centre, Melbourne, VIC, Australia; Southern Clinical School Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.

Department of Emergency Medicine, Princess Margaret Hospital, Perth, WA, Australia; School of Paediatrics and Child Health and School of Primary, Rural and Aboriginal Health, University of Western Australia, Perth, WA, Australia.

出版信息

Lancet Respir Med. 2013 Apr;1(2):113-20. doi: 10.1016/S2213-2600(12)70053-X. Epub 2012 Dec 21.

Abstract

BACKGROUND

Bronchiolitis is the most common lower respiratory tract infection in infants and the leading cause of hospital admission. Hydration is a mainstay of treatment, but insufficient evidence exists to guide clinical practice. We aimed to assess whether intravenous hydration or nasogastric hydration is better for treatment of infants.

METHODS

In this multicentre, open, randomised trial, we enrolled infants aged 2-12 months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons (April 1-Oct 31, in 2009, 2010, and 2011). We randomly allocated infants to nasogastric hydration or intravenous hydration by use of a computer-generated sequence and opaque sealed envelopes, with three randomly assigned block sizes and stratified by hospital site and age group (2-<6 months vs 6-12 months). The primary outcome was length of hospital stay, assessed in all randomly assigned infants. Secondary outcomes included rates of intensive-care unit admission, adverse events, and success of insertion. This trial is registered with the Australian and New Zealand clinical trials registry, ACTRN12605000033640.

FINDINGS

Mean length of stay for 381 infants assigned nasogastric hydration was 86·6 h (SD 58·9) compared with 82·2 h (58·8) for 378 infants assigned intravenous hydration (absolute difference 4·5 h [95% CI -3·9 to 12·9]; p=0·30). Rates of admission to intensive-care units, need for ventilatory support, and adverse events did not differ between groups. At randomisation, seven infants assigned nasogastric hydration were switched to intravenous hydration and 56 infants assigned intravenous hydration were switched to nasogastric hydration because the study-assigned method was unable to be inserted. For those infants who had data available for successful insertion, 275 (85%) of 323 infants in the nasogastric hydration group and 165 (56%) of 294 infants in the intravenous hydration group required only one attempt for successful insertion.

INTERPRETATION

Intravenous hydration and nasogastric hydration are appropriate means to hydrate infants with bronchiolitis. Nasogastric insertion might require fewer attempts and have a higher success rate of insertion than intravenous hydration.

FUNDING

Australian National Health and Medical Research Council, Samuel Nissen Charitable Foundation (Perpetual), Murdoch Children's Research Institute, Victorian Government.

摘要

背景

毛细支气管炎是婴儿中最常见的下呼吸道感染,也是导致住院的主要原因。补液是治疗的基础,但目前尚无足够的证据来指导临床实践。我们旨在评估静脉补液和鼻胃管补液对婴儿的治疗效果哪个更好。

方法

在这项多中心、开放、随机试验中,我们招募了澳大利亚和新西兰三家医院在三个毛细支气管炎季节(2009 年、2010 年和 2011 年 4 月 1 日至 10 月 31 日)期间因毛细支气管炎住院的 2-12 个月大的婴儿。我们使用计算机生成的序列和不透明密封信封,通过随机分配将婴儿分为鼻胃管补液组或静脉补液组,有三个随机分配的块大小,并按医院地点和年龄组(2-<6 个月与 6-12 个月)分层。主要结局是所有随机分配婴儿的住院时间,这是通过所有随机分配婴儿的住院时间来评估的。次要结局包括入住重症监护病房的比例、不良事件和插入成功率。该试验在澳大利亚和新西兰临床试验注册处注册,ACTRN12605000033640。

结果

381 名接受鼻胃管补液的婴儿的平均住院时间为 86.6 小时(SD 58.9),而 378 名接受静脉补液的婴儿的平均住院时间为 82.2 小时(58.8)(绝对差异 4.5 小时[95%CI -3.9 至 12.9];p=0.30)。两组入住重症监护病房的比例、需要通气支持的比例和不良事件的比例没有差异。在随机分组时,7 名接受鼻胃管补液的婴儿被改为静脉补液,56 名接受静脉补液的婴儿被改为鼻胃管补液,因为研究分配的方法无法插入。对于那些数据可用于成功插入的婴儿,在鼻胃管补液组的 323 名婴儿中,有 275 名(85%)和在静脉补液组的 294 名婴儿中,有 165 名(56%)仅需一次尝试即可成功插入。

解释

静脉补液和鼻胃管补液都是治疗毛细支气管炎婴儿的合适方法。鼻胃管插入可能需要较少的尝试,并且插入成功率高于静脉补液。

资金

澳大利亚国家卫生和医学研究委员会、塞缪尔·尼森慈善基金会(永续)、默多克儿童研究所、维多利亚州政府。

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