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多中心随机临床试验比较地塞米松与安慰剂在预防危重症儿童拔管后上呼吸道梗阻中的作用。

Multicenter randomized clinical trial comparing dexamethasone versus placebo in preventing upper airway obstruction after extubation in critically ill children.

机构信息

Service of Pediatric Intensive Care, Gregorio Marañón General University Hospital, Calle Doctor Castelo 47, 28009, Madrid, Spain.

Gregorio Marañón Health Research Institute, Madrid, Spain.

出版信息

Sci Rep. 2022 Mar 14;12(1):4336. doi: 10.1038/s41598-022-08178-0.

DOI:10.1038/s41598-022-08178-0
PMID:35288599
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8921236/
Abstract

To analyze the effectiveness of dexamethasone in preventing upper airway obstruction (UAO) symptoms after extubation and the need of reintubation in critically ill children. Multicenter, prospective, double-blind, randomized, phase IV clinical trial involving five pediatric intensive care units. Children between 1 month and 16 years-of-age intubated for more than 48 h were included. Patients were randomized to receive placebo or dexamethasone 0.25 mg/kg every 6 h, 6-to-12 h prior to extubation (four doses). 48 h follow-up was carried out after extubation. Severity of UAO symptoms (Taussig score, stridor) and reintubation requirement were compared. 147 patients were randomized (10 were excluded), 70 patients received dexamethasone and 67 placebo. No global differences were found in the presence of stridor or moderate-to-severe UAO symptoms (Taussig ≥ 5), but Taussig ≥ 5 was less frequent in patients less than 2 years-of-age treated with steroids (p = 0.014). Median Taussig score was lower in the dexamethasone group 1 h after extubation, p < 0.001. 27 patients required reintubation, 9 due to UAO: 3 (4.3%) in the dexamethasone group and 6 (8.9%) in the placebo group, p = 0.319. In those intubated > 5 days, reintubation due to UAO was higher in the placebo group (2.4% vs. 14.3, p = 0.052). Nebulized epinephrine and budesonide were required more frequently in the placebo group in the first 2 h (p = 0.041) and 1 h (p = 0.02) after extubation, respectively. No relevant side effects were observed. Dexamethasone prior to extubation did not significantly reduce moderate-severe UAO symptoms, except for patients under 2-years of age. Dexamethasone could decrease Taussig score and the need of rescue therapies, as well as reintubation rates in those intubated for more than 5 days.

摘要

目的

分析地塞米松预防危重症患儿拔管后上气道梗阻(UAO)症状及再插管的有效性。方法:多中心、前瞻性、双盲、随机、四期临床试验,纳入 5 个儿科重症监护病房。纳入年龄 1 个月至 16 岁、插管超过 48 h 的患儿。患者随机接受安慰剂或地塞米松 0.25 mg/kg,于拔管前 6-12 h (4 剂),拔管后 48 h 进行随访。比较 UAO 症状严重程度(Taussig 评分、喘鸣)和再插管需求。结果:共纳入 147 例患者(10 例排除),70 例接受地塞米松,67 例接受安慰剂。两组喘鸣或中重度 UAO 症状(Taussig≥5)的发生率无差异,但小于 2 岁患儿使用激素治疗时 Taussig≥5 的发生率较低(p=0.014)。拔管后 1 h 地塞米松组的 Taussig 评分中位数较低(p<0.001)。27 例患者需要再次插管,9 例由于 UAO,地塞米松组 3 例(4.3%),安慰剂组 6 例(8.9%),p=0.319。在插管超过 5 天的患者中,安慰剂组由于 UAO 再次插管的比例更高(2.4%比 14.3%,p=0.052)。拔管后 2 h 和 1 h ,安慰剂组需要更频繁使用肾上腺素和布地奈德雾化治疗(p=0.041 和 p=0.02)。未观察到相关不良反应。结论:拔管前使用地塞米松不能显著减少中重度 UAO 症状,除了 2 岁以下的患儿。地塞米松可降低 Taussig 评分,减少需要抢救治疗的需求,以及减少插管超过 5 天患者的再插管率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e6b/8921236/411141530e54/41598_2022_8178_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e6b/8921236/abc9dd639f95/41598_2022_8178_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e6b/8921236/411141530e54/41598_2022_8178_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e6b/8921236/abc9dd639f95/41598_2022_8178_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e6b/8921236/411141530e54/41598_2022_8178_Fig2_HTML.jpg

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