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注射促红细胞生成素预防急性高原病的预防效果:一项开放标签随机对照试验。

Prophylactic effect of erythropoietin injection to prevent acute mountain sickness: an open-label randomized controlled trial.

作者信息

Heo Kyoung, Kang Joong Koo, Choi Chang Min, Lee Moo Song, Noh Kyoung Woo, Kim Soon Bae

机构信息

Department of Neurology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.

Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

出版信息

J Korean Med Sci. 2014 Mar;29(3):416-22. doi: 10.3346/jkms.2014.29.3.416. Epub 2014 Feb 27.

Abstract

This study was performed to evaluate whether increasing hemoglobin before ascent by prophylactic erythropoietin injections prevents acute mountain sickness (AMS). This open-label, randomized, controlled trial involved 39 healthy volunteers with hemoglobin ≤ 15.5 g/dL who were divided randomly into erythropoietin (n=20) and control (n=19) groups. Epoetin alpha 10,000 IU injections were given weekly for four consecutive weeks. On day 1, and 7 days after the last injection (day 29), oxygen saturation (SaO2), and hemoglobin were measured. The subjects departed Seoul on day 30 and arrived at Annapurna base camp (ABC, 4,130 m) on day 34. AMS was diagnosed when headache and Lake Louise score (LLS) of ≥ 3 were present. Immediate descent criteria followed US Army recommendations. Two groups differ in hemoglobin levels on day 29 (15.4 ± 1.1 vs 14.2 ± 1.0 g/dL, P=0.001). At ABC, erythropoietin group had a significantly lower mean LLS, AMS incidence, and number of subjects who met immediate descent criteria. Multiple logistic regression analysis showed that SaO2<87% and control group, but not hemoglobin<15.0 g/dL, independently predicted satisfaction of immediate descent criteria. Erythropoietin-related adverse effects were not observed. In conclusion, erythropoietin may be an effective prophylaxis for AMS.(Clinical Trial Registry Number; NCT 01665781).

摘要

本研究旨在评估通过预防性注射促红细胞生成素在登高前提高血红蛋白水平是否能预防急性高原病(AMS)。这项开放标签、随机、对照试验纳入了39名血红蛋白≤15.5 g/dL的健康志愿者,他们被随机分为促红细胞生成素组(n = 20)和对照组(n = 19)。连续四周每周注射10,000 IU的α - 促红细胞生成素。在第1天以及最后一次注射后7天(第29天),测量血氧饱和度(SaO2)和血红蛋白。受试者在第30天离开首尔,并于第34天抵达安娜普尔纳大本营(ABC,海拔4,130米)。当出现头痛且路易斯湖评分(LLS)≥3分时诊断为AMS。立即下山标准遵循美国陆军的建议。两组在第29天的血红蛋白水平存在差异(15.4±1.1与14.2±1.0 g/dL,P = 0.001)。在ABC,促红细胞生成素组的平均LLS、AMS发病率以及符合立即下山标准的受试者数量均显著更低。多因素logistic回归分析显示,SaO2<87%和对照组,而非血红蛋白<15.0 g/dL,可独立预测符合立即下山标准。未观察到促红细胞生成素相关的不良反应。总之,促红细胞生成素可能是预防AMS的一种有效措施。(临床试验注册号:NCT 01665781)

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