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低剂量地塞米松有助于长期依赖呼吸机的婴儿脱机:一项多中心、国际、随机、对照试验。

Low-dose dexamethasone facilitates extubation among chronically ventilator-dependent infants: a multicenter, international, randomized, controlled trial.

作者信息

Doyle Lex W, Davis Peter G, Morley Colin J, McPhee Andy, Carlin John B

机构信息

Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia.

出版信息

Pediatrics. 2006 Jan;117(1):75-83. doi: 10.1542/peds.2004-2843.

Abstract

OBJECTIVE

Postnatal corticosteroid therapy is controversial. The aim of this study was to determine the short-term effects of low-dose dexamethasone treatment among chronically ventilator-dependent neonates.

METHODS

Very preterm (gestational age: <28 weeks) or extremely low birth weight (birth weight: <1000 g) infants who were ventilator dependent after the first 1 week of life were eligible and were assigned randomly to receive masked dexamethasone (0.89 mg/kg over 10 days) or saline placebo. Data on ventilator and oxygen requirements and deaths were recorded.

RESULTS

Seventy infants were recruited from 11 centers, at a median age of 23 days. More infants were extubated successfully by 10 days of treatment in the dexamethasone group (60%, 21 of 35 patients) than in the control group (12%, 4 of 34 patients) (odds ratio [OR]: 11.2; 95% confidence interval [CI]: 3.2-39.0). Ventilator and oxygen requirements improved substantially, and the duration of intubation was shorter. There was little evidence for a reduction in either the mortality rate (dexamethasone group: 11%; control group: 20%; OR: 0.52; 95% CI: 0.14-1.95) or the rate of oxygen dependence at 36 weeks (dexamethasone group: 85%; control group: 91%; OR: 0.58; 95% CI: 0.13-2.66). There were no obvious effects of low-dose dexamethasone on blood glucose concentrations, blood pressure, or other complications. No infant experienced intestinal perforation.

CONCLUSIONS

Low-dose dexamethasone treatment after the first 1 week of life clearly facilitates extubation and shortens the duration of intubation among ventilator-dependent, very preterm/extremely low birth weight infants, without any obvious short-term complications. Combined with recent evidence that infants at very high risk of bronchopulmonary dysplasia may benefit in the long term, our study reopens debate regarding the role of low-dose, late postnatal, corticosteroid therapy.

摘要

目的

产后使用皮质类固醇疗法存在争议。本研究的目的是确定低剂量地塞米松治疗对长期依赖呼吸机的新生儿的短期影响。

方法

出生后第一周后仍依赖呼吸机的极早产儿(胎龄:<28周)或极低出生体重儿(出生体重:<1000g)符合条件,并被随机分配接受盲法地塞米松治疗(10天内0.89mg/kg)或生理盐水安慰剂。记录呼吸机使用情况、氧气需求及死亡数据。

结果

从11个中心招募了70名婴儿,中位年龄为23天。地塞米松治疗组在治疗10天时成功拔管的婴儿比对照组更多(60%,35例中的21例对比12%,34例中的4例)(优势比[OR]:11.2;95%置信区间[CI]:3.2 - 39.0)。呼吸机使用和氧气需求显著改善,插管持续时间缩短。几乎没有证据表明死亡率(地塞米松组:11%;对照组:20%;OR:0.52;95%CI:0.14 - 1.95)或36周时的氧气依赖率(地塞米松组:85%;对照组:91%;OR:0.58;95%CI:0.13 - 2.66)有所降低。低剂量地塞米松对血糖浓度、血压或其他并发症无明显影响。没有婴儿发生肠穿孔。

结论

出生后第一周后进行低剂量地塞米松治疗明显有助于依赖呼吸机的极早产/极低出生体重儿拔管并缩短插管持续时间,且无任何明显短期并发症。结合近期证据表明支气管肺发育不良极高风险的婴儿可能长期受益,我们的研究重新引发了关于低剂量、产后晚期皮质类固醇疗法作用的争论。

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