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地塞米松预防接受表面活性剂治疗婴儿支气管肺发育不良的对照试验。

A controlled trial of dexamethasone to prevent bronchopulmonary dysplasia in surfactant-treated infants.

作者信息

Rastogi A, Akintorin S M, Bez M L, Morales P, Pildes R S

机构信息

Department of Pediatrics, University of Illinois, Chicago, USA.

出版信息

Pediatrics. 1996 Aug;98(2 Pt 1):204-10.

PMID:8692619
Abstract

BACKGROUND

Surfactant therapy now has a well-established role in the treatment of neonates with respiratory distress syndrome but has failed to reduce the incidence of bronchopulmonary dysplasia (BPD). We conducted a double-blind, placebo-controlled trial to test the hypothesis that dexamethasone therapy given during the first 12 days of life to very low birth weight infants would be synergistic to surfactant in preventing BPD.

METHODS

Seventy surfactant-pretreated infants (700-1500 g) who had severe respiratory distress syndrome (a/A ratio, 0.18 +/- 0.10; mean airway pressure, 11.1 +/- 1.9 cm H2O; fraction of inspired oxygen, 0.81 +/- 0.22) were enrolled to receive a 12-day course of dexamethasone (n = 36) or saline placebo (n = 34) starting within the first 12 hours after birth. The starting dose of dexamethasone was 0.5 mg/kg per day, and it was tapered progressively.

RESULTS

Ventilator variables at 5 to 14 days were significantly improved in those infants who received dexamethasone compared with those who received the placebo. The effect seem to be more marked in infants weighting less than 1250 g at birth. Significantly more infants could be extubated by 14 days of age in the dexamethasone group (26 of 32 vs 14 of 32). Dexamethasone therapy reduced the incidence of BPD at 28 days (odds ratio, 0.1; 95% confidence interval, 0.03 to 0.3) and eliminated BPD at 36 weeks' postconceptional age. Dexamethasone-treated infants had greater weight loss at 14 days (12.9 +/- 6.4% vs 3.7 +/- 8.6%, respectively) and higher blood pressures from days 3 to 10. However, no differences were seen in time to regain birth weight, hypertension (1 infant in each group), or incidence of intraventricular hemorrhage.

CONCLUSIONS

We found an additive effect between dexamethasone and surfactant in improving pulmonary status and reducing the incidence of BPD. Compared with the placebo, dexamethasone therapy was more effective in reducing the incidence of BPD in surfactant-pretreated very low birth weight infants.

摘要

背景

表面活性剂疗法在治疗新生儿呼吸窘迫综合征方面已确立了明确的作用,但未能降低支气管肺发育不良(BPD)的发生率。我们进行了一项双盲、安慰剂对照试验,以检验以下假设:在出生后前12天给予极低出生体重儿地塞米松治疗,与表面活性剂联合使用对预防BPD具有协同作用。

方法

70例接受过表面活性剂治疗的婴儿(体重700 - 1500克),患有严重呼吸窘迫综合征(a/A比值为0.18±0.10;平均气道压为11.1±1.9厘米水柱;吸入氧分数为0.81±0.22),在出生后12小时内入组,接受为期12天的地塞米松治疗(n = 36)或生理盐水安慰剂治疗(n = 34)。地塞米松起始剂量为每天0.5毫克/千克,并逐渐减量。

结果

与接受安慰剂的婴儿相比,接受地塞米松治疗的婴儿在5至14天时的通气变量有显著改善。这种效果在出生体重低于1250克的婴儿中似乎更为明显。地塞米松组在14日龄时更多婴儿能够拔管(32例中有26例,而安慰剂组32例中有14例)。地塞米松治疗降低了28天时BPD的发生率(优势比为0.1;95%置信区间为0.03至0.3),并在孕龄36周时消除了BPD。接受地塞米松治疗的婴儿在14天时体重减轻更多(分别为12.9±6.4%和3.7±8.6%),且在第3至10天血压更高。然而,在恢复出生体重的时间、高血压(每组各1例)或脑室内出血发生率方面未发现差异。

结论

我们发现地塞米松与表面活性剂在改善肺部状况和降低BPD发生率方面具有相加作用。与安慰剂相比,地塞米松治疗在降低接受过表面活性剂治疗的极低出生体重儿BPD发生率方面更有效。

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