Inhaled nitric oxide in preterm infants: a systematic review and individual patient data meta-analysis.

Inhaled nitric oxide in preterm infants: a systematic review and individual patient data meta-analysis.
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DOI:
10.1186/1471-2431-10-15
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发表时间:
2010-03-23
期刊:
影响因子:
2.4
通讯作者:
Meta-Analysis of Preterm Patients on inhaled Nitric Oxide (MAPPiNO) Collaboration
Meta-Analysis of Preterm Patients on inhaled Nitric Oxide (MAPPiNO) Collaboration
中科院分区:
医学3区
文献类型:
--
作者:
Askie LM;Ballard RA;Cutter G;Dani C;Elbourne D;Field D;Hascoet JM;Hibbs AM;Kinsella JP;Mercier JC;Rich W;Schreiber MD;Srisuparp P;Subhedar NV;Van Meurs KP;Voysey M;Barrington K;Ehrenkranz RA;Finer N;Meta-Analysis of Preterm Patients on inhaled Nitric Oxide (MAPPiNO) Collaboration

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需要辅助通气的早产儿面临肺和脑损伤的显着风险。吸入一氧化氮是治疗足月婴儿肺动脉高压和缺氧性呼吸衰竭的有效疗法,也在早产儿中进行了研究。最近的 Cochrane 早产儿综述包括 11 项研究和 3,370 名参与者。结果显示,在两项对插管早产儿常规使用 iNO 的研究中,死亡或慢性肺病 (CLD) 的综合结果在统计学上显着降低。然而,不确定性仍然存在,因为一项更大规模的研究(Kinsella 2006)表明 iNO 对于这一综合结果没有显着益处。此外,包括病情严重的婴儿在内的试验并未显示出显着的益处。一项在产后年龄较大时进行 iNO 治疗的试验报告称,CLD 的发病率有所下降。该个体患者荟萃分析的目的是确认或反驳这些潜在相互矛盾的结果,并确定患者或治疗特征可以在多大程度上解释结果和/或可以预测早产儿吸入一氧化氮的益处。早产儿吸入一氧化氮 (MAPPiNO) 协作的荟萃分析将进行个体患者数据荟萃分析,以回答这些重要的临床问题。如果接受辅助通气的早产儿被随机分配接受吸入一氧化氮或对照组,则将纳入研究。合作者提供的个体患者数据将尽可能在意向治疗的基础上进行分析。二元结果将使用对数二项式回归模型进行分析,连续结果将使用线性固定效应模型进行分析。将通过在模型规范中包含试验变量来调整试验差异。共有 3567 名婴儿参与的十三 (13) 项试验有资格纳入 MAPPiNO 系统评价。迄今为止,已有 11 项试验(n = 3298,92% 的可用患者)同意参与。 Ikaria Inc. 已成功以无限制拨款形式提供资金。 2006 年成立了一个合作小组,并于 2007 年开始收集数据。预计数据分析将于 2009 年底开始,结果将于 2010 年公开。
Preterm infants requiring assisted ventilation are at significant risk of both pulmonary and cerebral injury. Inhaled Nitric Oxide, an effective therapy for pulmonary hypertension and hypoxic respiratory failure in the full term infant, has also been studied in preterm infants. The most recent Cochrane review of preterm infants includes 11 studies and 3,370 participants. The results show a statistically significant reduction in the combined outcome of death or chronic lung disease (CLD) in two studies with routine use of iNO in intubated preterm infants. However, uncertainty remains as a larger study (Kinsella 2006) showed no significant benefit for iNO for this combined outcome. Also, trials that included very ill infants do not demonstrate significant benefit. One trial of iNO treatment at a later postnatal age reported a decrease in the incidence of CLD. The aim of this individual patient meta-analysis is to confirm or refute these potentially conflicting results and to determine the extent to which patient or treatment characteristics may explain the results and/or may predict benefit from inhaled Nitric Oxide in preterm infants. The Meta-Analysis of Preterm Patients on inhaled Nitric Oxide (MAPPiNO) Collaboration will perform an individual patient data meta-analysis to answer these important clinical questions. Studies will be included if preterm infants receiving assisted ventilation are randomized to receive inhaled Nitric Oxide or to a control group. The individual patient data provided by the Collaborators will be analyzed on an intention-to-treat basis where possible. Binary outcomes will be analyzed using log-binomial regression models and continuous outcomes will be analyzed using linear fixed effects models. Adjustments for trial differences will be made by including the trial variable in the model specification. Thirteen (13) trials, with a total of 3567 infants are eligible for inclusion in the MAPPiNO systematic review. To date 11 trials (n = 3298, 92% of available patients) have agreed to participate. Funding was successfully granted from Ikaria Inc as an unrestricted grant. A collaborative group was formed in 2006 with data collection commencing in 2007. It is anticipated that data analysis will commence in late 2009 with results being publicly available in 2010.
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