【摘要】 中医药是我国各族人民上千年的巨大宝库，在预防及治疗急性高原反应方面药用品种丰富、功效确切且毒副作用小，且“多成分、多靶点、多途径”的作用机制与急性高原反应病理机制的复杂性相契合。然而，许多中药因缺乏大规模、高质量的临床试验，临床证据等级较低。本文围绕中药预防急性高原反应的临床试验方案设计，主要从急性高原反应的中医临床定位、疾病诊断标准、研究人群选择、对照组设计、疗效评价、试验周期、试验现场、质量管理八方面来进行探讨，为中药预防急性高原反应临床试验方案设计提供方法学参考，促进中药预防急性高原反应临床研究质量的提高。更多还原

【Abstract】 Traditional Chinese medicine has been a huge treasure trove of people of all ethnic groups in China for thousands of years.In the prevention and treatment of acute mountain sickness,it has rich medicinal varieties,accurate efficacy and few toxic side effects and the mechanism of action of "multi-component,multi-target and multi-pathway" is in line with the complexity of the pathological mechanism of acute mountain sickness.However,many traditional Chinese medicines cannot be further promoted due to the lack of large-scale and high-quality clinical trial and clinical evidence.This article focuses on the clinical trial scheme design of traditional Chinese medicine to prevent acute mountain sickness.It mainly discusses the clinical positioning of acute mountain sickness in traditional Chinese medicine,disease diagnosis standards,researcher selection,control group design,efficacy evaluation,test cycle,test site and quality management,so as to prevent acute mountain sickness in traditional Chinese medicine.The clinical trial scheme should be designed to provide methodological reference to promote the improvement of the clinical research quality of traditional Chinese medicine to prevent acute mountain sickness.更多还原