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肠外与肠内液体疗法治疗毛细支气管炎住院患儿。

Parenteral versus enteral fluid therapy for children hospitalised with bronchiolitis.

机构信息

Pediatric Outcomes Research Team, Division of Pediatric Medicine, Department of Pediatrics, The Hospital for Sick Children, Toronto, Canada.

Department of Pediatrics, Faculty of Medicine, University of Toronto, Toronto, Canada.

出版信息

Cochrane Database Syst Rev. 2021 Dec 1;12(12):CD013552. doi: 10.1002/14651858.CD013552.pub2.

Abstract

BACKGROUND

The main focus of treatment for children hospitalised with bronchiolitis is supportive, including oxygen supplementation, respiratory support, and fluid therapy. Up to half of infants hospitalised with bronchiolitis require non-oral fluid therapy due to dehydration or concerns related to the safety of oral feeding. The two main modalities used for non-oral fluid therapy are parenteral (intravenous (IV)) and enteral tube (nasogastric (NG) or orogastric (OG)). However, it is not known which mode is optimal in young children.

OBJECTIVES

To systematically review randomised clinical trials (RCTs) of the effectiveness and safety of parenteral and enteral tube fluid therapy for children under two years of age hospitalised with bronchiolitis.

SEARCH METHODS

We conducted a search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, Web of Science, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 8 March 2021. We handsearched conference proceedings, conducted forward and backward searching of citation lists of relevant articles, and contacted experts.

SELECTION CRITERIA

We included RCTs and quasi-RCTs of children aged up to two years admitted to hospital with a clinical diagnosis of bronchiolitis who required fluid therapy. The trials compared enteral tube fluid therapy with parenteral fluid therapy. The primary outcome was difference in length of hospital stay in hours after each non-oral fluid therapy modality. As actual time of discharge can be impacted by various factors, we also assessed theoretical length of stay (i.e. time when a patient is safe for discharge). We assessed several secondary outcomes.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures expected by Cochrane.  MAIN RESULTS: The searches yielded 615 unique records, of which four articles underwent full-text screening. We included two trials (810 children). Oakley 2013 was an open, non-blinded RCT of infants aged two to 12 months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons. The trial enrolled 759 children, of which 381 were randomised to NG tube therapy and 378 to IV therapy. Risk of bias was low in most domains. Kugelman 2013 was an open, non-blinded RCT that enrolled infants aged less than six months with a clinical diagnosis of "moderate bronchiolitis" at a single hospital in Israel. The study enrolled 51 infants, of which 31 were assigned to NG or OG tube therapy and 20 to IV therapy. Risk of bias was unclear in most domains. The application of enteral tube fluid therapy compared to IV fluid therapy probably makes little to no difference for actual length of hospital stay (mean difference (MD) 6.8 hours, 95% confidence interval (CI) -4.7 to 18.4 hours; 2 studies, 810 children, moderate certainty evidence). There was also little to no difference for theoretical length of stay (MD 4.4 hours, 95% CI -3.6 to 12.4 hours; 2 studies, 810 children, moderate certainty evidence). For the secondary outcomes, enteral tube fluid therapy probably makes little to no difference for time to resume full oral feeding compared to IV fluid therapy (MD 2.8 hours, 95% CI -3.6 to 9.2 hours; 2 studies, 810 children, moderate certainty evidence). The use of enteral tube for fluid therapy probably results in a large increase in the success of insertion of fluid modality at first attempt (risk ratio (RR) 1.52, 95% CI 1.36 to 1.69; 1 study, 617 children, moderate certainty evidence), and probably largely reduces the chances of change in fluid therapy modality (RR 0.52, 95% CI 0.38 to 0.71; 1 study, 759 children, moderate certainty evidence) compared to IV fluid.  Oakley 2013 reported 47 local complication events after discharge in the IV fluid group compared to 30 events in the NG tube group. They also evaluated parental satisfaction, which was high with both modalities. Enteral tube fluid therapy makes little to no difference to the duration of oxygen supplementation (MD 2.2 hours, 95% CI -5.0 to 9.5 hours; 2 studies, 810 children, moderate certainty evidence). Compared with the IV fluid therapy group, there was a 17% relative reduction in the number of intensive care unit admissions (RR 0.83, 95% CI 0.47 to 1.46; 1 study, 759 children, moderate certainty evidence) and a 19% relative reduction in number of readmissions to hospital (RR 0.81, 95% CI 0.33 to 2.04; 1 study, 678 children, moderate certainty evidence) in the enteral tube fluid therapy group. Adverse events were uncommon in both trials, with likely little to no differences between groups.

AUTHORS' CONCLUSIONS: Based on two RCTs, enteral tube feeding likely results in little to no difference in length of hospital stay compared with the IV fluid group. However, enteral tube fluid therapy likely results in a large increase in the success of insertion of fluid modality at first attempt, and a large reduction in change in modality of fluid therapy. It also probably reduces local complications compared to the IV fluid group. Despite bronchiolitis being one of the most prevalent childhood conditions, we identified only two studies with under 1000 participants in total, which highlights the need for multicentre trials. Future studies should explore type of fluid administered, parent-reported outcomes and preferences, and the role of shared decision-making.

摘要

背景

患有毛细支气管炎而住院的儿童的主要治疗重点是支持性治疗,包括氧补充、呼吸支持和液体疗法。多达一半因脱水或口服喂养安全性问题而住院的毛细支气管炎婴儿需要非口服液体疗法。非口服液体疗法的两种主要方式是肠外(静脉内(IV))和肠内管(鼻胃管(NG)或口胃管(OG))。然而,目前尚不清楚哪种方式对幼儿最有效。

目的

系统评价随机临床试验(RCT),评估肠内管和肠外管液体疗法对患有毛细支气管炎并住院的 2 岁以下儿童的有效性和安全性。

检索方法

我们于 2021 年 3 月 8 日在 Cochrane 对照试验中心注册库(CENTRAL)、MEDLINE、Embase、CINAHL、Web of Science、ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台上进行了检索。我们还进行了会议论文集的检索、引用列表的前向和后向检索,并联系了专家。

入选标准

我们纳入了年龄在 2 岁以下、临床诊断为毛细支气管炎且需要液体疗法的儿童的 RCT 和准 RCT。试验比较了肠内管液体疗法和肠外管液体疗法。主要结局是两种非口服液体疗法模式后住院时间的差异(以每小时计算)。由于实际出院时间可能受到各种因素的影响,我们还评估了理论住院时间(即患者安全出院的时间)。我们评估了几个次要结局。

数据收集和分析

我们使用了 Cochrane 预期的标准方法程序。

主要结果

检索结果产生了 615 条独特的记录,其中 4 篇文章进行了全文筛选。我们纳入了 2 项试验(810 名儿童)。Oakley 2013 是一项在澳大利亚和新西兰进行的开放性、非盲 RCT,纳入了 2 至 12 个月大、在三个毛细支气管炎季节期间被临床诊断为毛细支气管炎的婴儿。该试验共纳入了 759 名儿童,其中 381 名被随机分配到 NG 管治疗组,378 名被随机分配到 IV 治疗组。大多数领域的偏倚风险较低。Kugelman 2013 是一项在以色列的一家医院进行的开放性、非盲 RCT,纳入了临床诊断为“中度毛细支气管炎”、年龄小于 6 个月的婴儿。该研究共纳入了 51 名婴儿,其中 31 名被分配到 NG 或 OG 管治疗组,20 名被分配到 IV 治疗组。大多数领域的偏倚风险不明确。与 IV 液体疗法相比,肠内管液体疗法的应用可能对实际住院时间(平均差(MD)6.8 小时,95%置信区间(CI)-4.7 至 18.4 小时;2 项研究,810 名儿童,中等确定性证据)和理论住院时间(MD 4.4 小时,95% CI-3.6 至 12.4 小时;2 项研究,810 名儿童,中等确定性证据)几乎没有差异。对于次要结局,与 IV 液体疗法相比,肠内管液体疗法对恢复完全口服喂养的时间可能几乎没有差异(MD 2.8 小时,95% CI-3.6 至 9.2 小时;2 项研究,810 名儿童,中等确定性证据)。与 IV 液体疗法相比,肠内管用于液体疗法可能大大增加首次尝试时插入液体模式的成功率(风险比(RR)1.52,95% CI 1.36 至 1.69;1 项研究,617 名儿童,中等确定性证据),并且可能大大降低改变液体疗法模式的可能性(RR 0.52,95% CI 0.38 至 0.71;1 项研究,759 名儿童,中等确定性证据)。Oakley 2013 报告了 IV 液体组 47 例出院后局部并发症事件,NG 管组 30 例。他们还评估了父母满意度,两种模式都很高。肠内管液体疗法对吸氧时间的长短几乎没有影响(MD 2.2 小时,95% CI-5.0 至 9.5 小时;2 项研究,810 名儿童,中等确定性证据)。与 IV 液体治疗组相比,肠内管液体治疗组的 ICU 入院率相对降低了 17%(RR 0.83,95% CI 0.47 至 1.46;1 项研究,759 名儿童,中等确定性证据),再入院率相对降低了 19%(RR 0.81,95% CI 0.33 至 2.04;1 项研究,678 名儿童,中等确定性证据)。在两项试验中,不良事件都不常见,两组之间可能几乎没有差异。

作者结论

基于两项 RCT,与 IV 液体组相比,肠内管喂养可能对住院时间的长短几乎没有影响。然而,肠内管液体疗法可能大大增加首次尝试时插入液体模式的成功率,并且大大降低改变模式的可能性。与 IV 液体组相比,它还可能降低局部并发症的发生率。尽管毛细支气管炎是最常见的儿童疾病之一,但我们仅确定了两项总共不到 1000 名参与者的研究,这突出表明需要进行多中心试验。未来的研究应探讨给予的液体类型、父母报告的结果和偏好,以及共享决策的作用。

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