Design Method of Master Protocol of Clinical Study on Diseases of Same Syndrome Type in Chinese Medicine

ZHAO Chen; ZHANG Xiaoyu; HU Jiayuan; JIN Yinghui; SI Jinhua; LI Ge; ZHAI Jingbo; BIAN Zhaoxiang; SHANG Hongcai

doi:10.13288/j.11-2166/r.2018.02.006

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Design Method of Master Protocol of Clinical Study on Diseases of Same Syndrome Type in Chinese Medicine

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- Design Method of Master Protocol of Clinical Study on Diseases of Same Syndrome Type in Chinese Medicine
- Journal of Traditional Chinese Medicine Vol. 59, Issue 2, Pages: 111-115(2018)
- 作者机构：
  
  1. 香港浸会大学中医药学院
  2. 北京中医药大学东直门医院
  3. 武汉大学中南医院
  4. 天津中医药大学
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2018.02.006
  CLC： R24
- Published：2018
- 稿件说明：
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[1]赵晨,张晓雨,胡嘉元,靳英辉,思金华,李戈,翟静波,卞兆祥,商洪才.中医同证候系疾病临床研究母方案设计方法[J].中医杂志,2018,59(02):111-115.

ZHAO Chen, ZHANG Xiaoyu, HU Jiayuan, et al. Design Method of Master Protocol of Clinical Study on Diseases of Same Syndrome Type in Chinese Medicine[J]. Journal of Traditional Chinese Medicine2018, 59(2): 111-115.
[1]赵晨,张晓雨,胡嘉元,靳英辉,思金华,李戈,翟静波,卞兆祥,商洪才.中医同证候系疾病临床研究母方案设计方法[J].中医杂志,2018,59(02):111-115. DOI： 10.13288/j.11-2166/r.2018.02.006.

ZHAO Chen, ZHANG Xiaoyu, HU Jiayuan, et al. Design Method of Master Protocol of Clinical Study on Diseases of Same Syndrome Type in Chinese Medicine[J]. Journal of Traditional Chinese Medicine2018, 59(2): 111-115. DOI： 10.13288/j.11-2166/r.2018.02.006.

摘要

病证结合是中医临床试验设计中体现中医学特色的主要方式。在目前以病统证为主的研究对象认知体系下

中医临床研究的思路和规模一定程度上受到限制

难以反映真实世界中医诊疗和疾病演进情况

影响了中医临床证据的有效应用。基于同证候系疾病病机的相通性

引入新式母方案临床研究设计方法

在研究多种干预治疗多个同证候系疾病的同时

评价各疾病间可能存在的演进情况

有望在保留中医真实世界诊疗特征的基础上

为证候评价提供可行性思路。

Abstract

The combination of disease and syndrome is the main way to reflect the characteristics of Chinese medicine in the design of clinical trials in Chinese medicine. Under the current cognition system of research subjects based on the disease-based syndromes

the thought and scale of Chinese medicine clinical research are limited to some extent

and it is difficult to reflect the diagnosis and treatment of diseases and the evolution of diseases in the real world

which has affected the effective application of clinical evidence in Chinese medicine. Based on the connection of the pathogeneses of the diseases of the same syndrome

the introduction of the new design method for master protocol of clinical research could evaluate the potential evolution of the diseases during the study of a variety of interventions in treating diseases of the same syndrome

which is expected to retain the real-world characteristics of diagnosis and treatment in Chinese medicine and provide feasible ideas for the evaluation of syndromes.

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