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脑卒中恢复期中医药临床研究设计关键要素考量

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脑卒中(stroke)致残造成严峻的社会公共卫生问题,患者恢复期是功能恢复的关键阶段,但目前尚无有效治疗药物.近年来,中医在药物研发领域表现出显著潜力.该文基于近年来国内外脑卒中恢复期诊疗指南,结合中药研发临床研究现状和潜在问题,就目前脑卒中恢复期临床研究设计的关键环节,包括临床定位、疗效指标、试验对照、疗程以及访视点等展开探讨,并以芪蛭通络胶囊临床试验为例进行说明,旨在提供客观、可操作性的方案设计要素,为中医药领域广大研究者开展高质量的临床研究提供借鉴.
Stroke recovery key elements of traditional Chinese medicine clinical study design considerations
The disability caused by stroke is a serious public health problem that causes a heavy burden to the society.The convalescence of stroke disability is the key stage of functional recovery,but there is no effective drug treatment at present.In recent years,traditional Chinese medicine(TCM)has significant potential in the field of drug research and development.Based on the guidelines for the diagnosis and treatment of stroke recovery at home and abroad in recent years,combined with the current clinical research situation and potential problems of TCM research and development,this paper discussed the key link in the process of clinical research design,including clinical positioning,efficacy indicators,clinical test control,treatment course,and visiting perspective,and takes the clinical trial of Qizhi Tongluo capsule as an example to explain,aiming to provide objective and operable design elements for the majority of researchers in the field of TCM to carry out high-quality clinical research.

stroke recoveryclinical trialscheme designtraditional Chinese medicineQizhi Tongluo capsule

王思村、李牧之、党海霞、刘骏、王忠、于亚南

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中国中医科学院中医临床基础医学研究所,北京 100700

中国中医科学院中医药发展研究中心,北京 100700

脑卒中恢复期 中药 临床试验 方案设计 芪蛭通络胶囊

2024

世界临床药物
上海医药工业研究院

世界临床药物

CSTPCD
影响因子:0.849
ISSN:1672-9188
年,卷(期):2024.45(12)