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预防急性高原反应中药临床试验设计的关键问题讨论

范璐 张文 曾洁萍

中药与临床2025,Vol.16Issue(6):32-38,7.
中药与临床2025,Vol.16Issue(6):32-38,7.

预防急性高原反应中药临床试验设计的关键问题讨论

Discussion on key issues in the clinical trial design of traditional Chinese medicine to prevent acute mountain sickness

范璐 1张文 1曾洁萍2

作者信息

  • 1. 成都中医药大学临床医学院,四川 成都 610075
  • 2. 成都中医药大学临床医学院,四川 成都 610075||成都中医药大学附属医院 GCP临床试验中心,四川 成都 610032
  • 折叠

摘要

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 re-search quality of traditional Chinese medicine to prevent acute mountain sickness.

关键词

急性高原反应/中药/临床试验/方案设计/质量管理

Key words

Acute mountain sickness/traditional Chinese Medicine/clinical trials/scheme design/quality management

分类

医药卫生

引用本文复制引用

范璐,张文,曾洁萍..预防急性高原反应中药临床试验设计的关键问题讨论[J].中药与临床,2025,16(6):32-38,7.

基金项目

西藏自治区科技创新基地自主研究项目(XZ2021JR0004G) (XZ2021JR0004G)

中药与临床

1674-926X

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