Zheng Cheng-Rong, Chen Guo-Zhu, Yu Jie, Qin Jun, Song Pan, Bian Shi-Zhu, Xu Bai-Da, Tang Xu-Gang, Huang Yong-Tao, Liang Xiao, Yang Jie, Huang Lan
Institute of Cardiovascular Science, Xinqiao Hospital, Third Military Medical University, Chongqing, China.
Institute of Cardiovascular Science, Xinqiao Hospital, Third Military Medical University, Chongqing, China; PLA Institute of Cardiovascular Disease, Chongqing, China.
Am J Med. 2014 Oct;127(10):1001-1009.e2. doi: 10.1016/j.amjmed.2014.04.012. Epub 2014 Apr 29.
This double-blind, randomized controlled trial aimed to investigate inhaled budesonide and oral dexamethasone compared with placebo for their prophylactic efficacy against acute mountain sickness after acute high-altitude exposure.
There were 138 healthy young male lowland residents recruited and randomly assigned to receive inhaled budesonide (200 μg, twice a day [bid]), oral dexamethasone (4 mg, bid), or placebo (46 in each group). They traveled to 3900 m altitude from 400 m by car. Medication started 1 day before high-altitude exposure and continued until the third day of exposure. Primary outcome measure was the incidence of acute mountain sickness after exposure.
One hundred twenty-four subjects completed the study (42, 39, and 43 in the budesonide, dexamethasone, and placebo groups, respectively). Demographic characteristics were comparable among the 3 groups. After high-altitude exposure, significantly fewer participants in the budesonide (23.81%) and dexamethasone (30.77%) groups developed acute mountain sickness compared with participants receiving placebo (60.46%) (P = .0006 and P = .0071, respectively). Both the budesonide and dexamethasone groups had lower heart rate and higher pulse oxygen saturation (SpO2) than the placebo group at altitude. Only the budesonide group demonstrated less deterioration in forced vital capacity and sleep quality than the placebo group. Four subjects in the dexamethasone group reported adverse reactions.
Both inhaled budesonide (200 μg, bid) and oral dexamethasone (4 mg, bid) were effective for the prevention of acute mountain sickness, especially its severe form, compared with placebo. Budesonide caused fewer adverse reactions than dexamethasone.
这项双盲、随机对照试验旨在研究吸入布地奈德和口服地塞米松与安慰剂相比,对急性高原暴露后急性高原病的预防效果。
招募了138名健康的年轻男性低地居民,随机分配接受吸入布地奈德(200μg,每日两次)、口服地塞米松(4mg,每日两次)或安慰剂(每组46人)。他们乘车从400米海拔处前往3900米海拔处。在高原暴露前1天开始用药,并持续至暴露的第三天。主要结局指标是暴露后急性高原病的发病率。
124名受试者完成了研究(布地奈德组、地塞米松组和安慰剂组分别为42人、39人和43人)。三组的人口统计学特征具有可比性。高原暴露后,与接受安慰剂的参与者相比,布地奈德组(23.81%)和地塞米松组(30.77%)发生急性高原病的参与者明显更少(P分别为0.0006和0.0071)。在高原地区,布地奈德组和地塞米松组的心率均低于安慰剂组,脉搏血氧饱和度(SpO2)均高于安慰剂组。只有布地奈德组的用力肺活量和睡眠质量恶化程度低于安慰剂组。地塞米松组有4名受试者报告了不良反应。
与安慰剂相比,吸入布地奈德(200μg,每日两次)和口服地塞米松(4mg,每日两次)对预防急性高原病尤其是严重形式均有效。布地奈德引起的不良反应比地塞米松少。