本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(23)02502-3

摘要内容如下：

背景

低收入和中等收入国家（LMIC）的卫生设施并不总是提供补充氧气。太阳能供电的氧气输送可以克服氧气获取的缺口，产生独立于电网电力的氧气。我们假设在乌干达农村医院的儿科病房安装太阳能供氧系统可以降低低氧血症儿童的死亡率。

方法

在这项实用的、全国性的、阶梯式楔形的、集群随机对照试验中，在乌干达的20个农村卫生设施中依次安装了太阳能氧气系统（即光伏电池、电池组和氧气浓缩器）。根据以下标准选择纳入地点：提供儿科住院服务的地区医院或四级保健中心；儿科病房的补充氧气不可用或不可靠；以及足够的空间来安装太阳能电池板、电池组和电线。在安装前2周内实现了站点的分配隐藏，但该研究总体上未被掩盖。包括因低氧血症和呼吸体征而入院的5岁以下儿童。主要转归是检测到低氧血症后48小时内的死亡率。统计分析使用线性混合效应逻辑回归模型，将集群视为随机效应，将日历时间视为固定效应。该试验在ClinicalTrials.gov，NCT03851783上注册。

调查结果

在2019年6月28日至2021年11月30日期间，在20家医院招募了2409名儿童，在排除后，对2405名儿童进行了分析。964名儿童在地点随机化前入组，1441名儿童在地点随机化后入组（意向治疗）。有104例死亡，其中91例发生在检测到低氧血症的48小时内。随机分组前，964名儿童中有49名（5.1%）在48 H内死亡，随机分组后，1440名儿童中有42名（2.9%）在48 H内死亡（1名儿童在48 H内无生命状态记录）（调整后的比值比为0.50，95%CI为0.27-0.91，P=0.02 3）。结果对长期趋势的替代参数敏感。相对风险降低了48.7%（95%CI 8.5-71.5），需要使用太阳能氧气治疗的人数为45（95%CI 28-230），才能挽救一条生命。随机分组前，964名儿童中有484名（50.2%）使用氧气，随机分组后，1441名儿童中有1424名（98.8%）使用氧气（P<0.0001）。随机分组前后的不良事件相似，且被认为与干预无关。估计的成本效益为每残疾调整生命年节省25美元（6-505）。

解释

这项阶梯式楔形、集群随机对照试验显示了使用太阳能氧气改善氧气获取对死亡率的益处。这项研究可以作为扩大太阳能供电氧气的模型，作为LMIC中氧气不安全的一种解决方案。

英文原文如下：

Abstracts

BACKGROUND  Supplemental O2 is not always available at health facilities in low-income and middle-income countries (LMICs). Solar-powered O2 delivery can overcome gaps in O2 access, generating O2 independent of grid electricity. We hypothesized that installation of solar-powered O2 systems on the paediatrics ward of rural Ugandan hospitals would lead to a reduction in mortality among hypoxaemic children.

METHODS  In this pragmatic, country-wide, stepped-wedge, cluster randomised controlled trial, solar-powered O2 systems (ie, photovoltaic cells, battery bank, and O2 concentrator) were sequentially installed at 20 rural health facilities in Uganda. Sites were selected for inclusion based on the following criteria: District Hospital or Health Centre IV with paediatric inpatient services; supplemental O2 on the paediatric ward was not available or was unreliable; and adequate space to install solar panels, a battery bank, and electrical wiring. Allocation concealment was achieved for sites up to 2 weeks before installation, but the study was not masked overall. Children younger than 5 years admitted to hospital with hypoxaemia and respiratory signs were included. The primary outcome was mortality within 48 h of detection of hypoxaemia. The statistical analysis used a linear mixed effects logistic regression model accounting for cluster as random effect and calendar time as fixed effect. The trial is registered at ClinicalTrials.gov, NCT03851783.

FINDINGS  Between June 28, 2019, and Nov 30, 2021, 2409 children were enrolled across 20 hospitals and, after exclusions, 2405 children were analysed. 964 children were enrolled before site randomisation and 1441 children were enrolled after site randomisation (intention to treat). There were 104 deaths, 91 of which occurred within 48 h of detection of hypoxaemia. The 48 h mortality was 49 (5·1%) of 964 children before randomisation and 42 (2·9%) of 1440 (one individual did not have vital status documented at 48 h) after randomisation (adjusted odds ratio 0·50, 95% CI 0·27-0·91, p=0·023). Results were sensitive to alternative parameterisations of the secular trend. There was a relative risk reduction of 48·7% (95% CI 8·5-71·5), and a number needed to treat with solar-powered O2 of 45 (95% CI 28-230) to save one life. Use of O2 increased from 484 (50·2%) of 964 children before randomisation to 1424 (98·8%) of 1441 children after randomisation (p<0·0001). Adverse events were similar before and after randomisation and were not considered to be related to the intervention. The estimated cost-effectiveness was US$25 (6-505) per disability-adjusted life-year saved.

INTERPRETATION  This stepped-wedge, cluster randomised controlled trial shows the mortality benefit of improving O2 access with solar-powered O2. This study could serve as a model for scale-up of solar-powered O2 as one solution to O2 insecurity in LMICs.

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