Randomised controlled trial of oxygen therapy and high-flow nasal therapy in African children with pneumonia.
Randomised controlled trial of oxygen therapy and high-flow nasal therapy in African children with pneumonia.
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DOI：
10.1007/s00134-021-06385-3
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发表时间：
2021-05
影响因子：
38.9
通讯作者：
COAST trial group
中科院分区：
文献类型：
--
作者：
Maitland K;Kiguli S;Olupot-Olupot P;Hamaluba M;Thomas K;Alaroker F;Opoka RO;Tagoola A;Bandika V;Mpoya A;Mnjella H;Nabawanuka E;Okiror W;Nakuya M;Aromut D;Engoru C;Oguda E;Williams TN;Fraser JF;Harrison DA;Rowan K;COAST trial group
氧疗对非洲重症肺炎儿童的救命作用尚未确立。这项开放标签的部分因素海岸试验随机选择了符合条件的乌干达和肯尼亚儿童，年龄28天的 >； 患有严重肺炎和严重低氧血症(SpO2 <； 80%)，接受高流量鼻腔治疗(HFNT)或低流量氧气(LFO：标准护理)和低氧血症(SpO2 80-91%)与HFNT或LFO(自由策略)或允许性低氧血症(比例1：1：2)。患有青紫型心脏病、慢性肺病或 >； 3小时吸氧的儿童被排除在外。主要终点是48小时死亡率；次要终点包括28天的死亡率或神经认知后遗症。在招募了1,852/4,200名儿童后，试验提前停止，其中388名在严重低氧血症组(中位数7个月；SpO2中位数75%)，随机分为HFNT(n = 194)或LFO(n = 194)，以及1454名低氧血症组(中位数9个月；中位数SpO2 88%)，随机分为HFNT(n = 363)、LFO(n = 364)和允许性低氧血症(n = 727)。根据方案，允许性低氧血症组有15%的患者接受氧气治疗(当SpO2 <； 为80%时)。在重度低氧血症组，HFNT组48小时死亡率为9.3%，而LFO组为13.4%。在低氧血症组，HFNT组48小时死亡率为1.1%，而2.5%LFO组为1.4%，容许性低氧血症组为1.4%。在低氧血症组，自由与许可比较中48小时死亡率的调整优势比为1.16(0.49-2.74；p = 为0.73)；高血压素与低氧血症比较的调整后优势比为0.60(0.33-1.06；p = 为0.08)。各阶层28d死亡率分别为18.6、23.4和3.3、4.1、3.9%。神经认知后遗症很少见。HFNT的呼吸支持显示出潜在的益处，应该会促使进一步的试验。网上版载有补充材料，可在10.1007/s00134021-06385-3查阅。
The life-saving role of oxygen therapy in African children with severe pneumonia is not yet established. The open-label fractional-factorial COAST trial randomised eligible Ugandan and Kenyan children aged > 28 days with severe pneumonia and severe hypoxaemia stratum (SpO2 < 80%) to high-flow nasal therapy (HFNT) or low-flow oxygen (LFO: standard care) and hypoxaemia stratum (SpO2 80–91%) to HFNT or LFO (liberal strategies) or permissive hypoxaemia (ratio 1:1:2). Children with cyanotic heart disease, chronic lung disease or > 3 h receipt of oxygen were excluded. The primary endpoint was 48 h mortality; secondary endpoints included mortality or neurocognitive sequelae at 28 days. The trial was stopped early after enrolling 1852/4200 children, including 388 in the severe hypoxaemia stratum (median 7 months; median SpO2 75%) randomised to HFNT (n = 194) or LFO (n = 194) and 1454 in the hypoxaemia stratum (median 9 months; median SpO2 88%) randomised to HFNT (n = 363) vs LFO (n = 364) vs permissive hypoxaemia (n = 727). Per-protocol 15% of patients in the permissive hypoxaemia group received oxygen (when SpO2 < 80%). In the severe hypoxaemia stratum, 48-h mortality was 9.3% for HFNT vs. 13.4% for LFO groups. In the hypoxaemia stratum, 48-h mortality was 1.1% for HFNT vs. 2.5% LFO and 1.4% for permissive hypoxaemia. In the hypoxaemia stratum, adjusted odds ratio for 48-h mortality in liberal vs permissive comparison was 1.16 (0.49–2.74; p = 0.73); HFNT vs LFO comparison was 0.60 (0.33–1.06; p = 0.08). Strata-specific 28 day mortality rates were, respectively: 18.6, 23.4 and 3.3, 4.1, 3.9%. Neurocognitive sequelae were rare. Respiratory support with HFNT showing potential benefit should prompt further trials. The online version contains supplementary material available at 10.1007/s00134-021-06385-3.
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