Fischer R, Lang S M, Steiner U, Toepfer M, Hautmann H, Pongratz H, Huber R M
Dept of Medicine, Klinikum Innenstadt, University of Munich, Germany.
Eur Respir J. 2000 Jan;15(1):123-7. doi: 10.1183/09031936.00.15112300.
A randomized two-part study was conducted in order to determine the efficacy of theophylline in the treatment of acute mountain sickness during fast ascent to altitudes >2,500 m. Fourteen healthy male subjects participated in a randomized single-blind placebo-controlled crossover study carried out in a decompression chamber (simulated altitude 4,500 m). A second randomized single-blind, placebo-controlled study was conducted at a high-altitude research laboratory (3,454 m) and included 21 healthy male subjects. The study medication was either 375 mg oral slow-release theophylline (250 mg if <70 kg) or a matched placebo tablet taken twice daily. The acute mountain sickness score (AMSS) was assessed three times a day, beginning 18 h prior to altitude exposure and continuing for 18 h after altitude exposure. In addition, measurements of respiratory frequency, pulse rate, oxygen saturation and arterial blood gas levels were performed. Acute mountain sickness was significantly reduced by theophylline during the decompression chamber study (mean+/-SD 1.2+/-0.9) with placebo versus 3.6+/-0.8 with theophylline; p=0.03). During the high-altitude study, subjects with theophylline showed a significantly lower AMSS on arrival and after 18 h at altitude (0.6 versus 2.3, p=0.03). Oxygenation was improved in both parts of the study. In conclusion, oral slow-release theophylline improves acute mountain sickness.
为确定茶碱在快速攀登至海拔>2500米时治疗急性高原病的疗效,开展了一项随机两部分研究。14名健康男性受试者参与了在减压舱(模拟海拔4500米)进行的随机单盲安慰剂对照交叉研究。第二项随机单盲、安慰剂对照研究在高海拔研究实验室(3454米)进行,纳入了21名健康男性受试者。研究药物为375毫克口服缓释茶碱(体重<70千克者为250毫克)或匹配的安慰剂片剂,每日服用两次。从海拔暴露前18小时开始,每天评估三次急性高原病评分(AMSS),并在海拔暴露后持续18小时。此外,还进行了呼吸频率、脉搏率、血氧饱和度和动脉血气水平的测量。在减压舱研究中,茶碱显著降低了急性高原病的发病率(安慰剂组平均±标准差为1.2±0.9,茶碱组为3.6±0.8;p=0.03)。在高海拔研究中,服用茶碱的受试者到达时和在海拔停留18小时后的AMSS显著较低(分别为0.6和2.3,p=0.03)。两项研究中氧合均得到改善。总之,口服缓释茶碱可改善急性高原病。