Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine

LAI Jiaqi; HUANG Qian; CHEN Xueyin; LIU Shaonan; YANG Lihong; Mimazhuoga; Dawa; LI Zhijian; Tuerxun Wufuer; GUO Xinfeng

doi:10.13288/j.11-2166/r.2026.13.018

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Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine

更新时间：2026-06-29

- Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
- Journal of Traditional Chinese Medicine Vol. 67, Issue 13, Pages: 1461-1464(2026)
- 作者机构：
  
  1.广东省中医院/广州中医药大学第二附属医院，广东省广州市越秀区大德路111号，510120
  2.西藏自治区藏医院/西藏自治区藏医药研究院
  3.新疆维吾尔自治区维吾尔医医院/新疆维吾尔自治区第二人民医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2026.13.018
  CLC：
- Received：08 July 2025，
  
  Revised：2026-05-06，
  
  Accepted：26 April 2026，
  
  Published：02 July 2026
- 稿件说明：
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赖佳琪,黄仟,陈雪吟等.中医药临床试验目标值制定的现状与优化策略[J].中医杂志,2026,67(13):1461-1464.

LAI Jiaqi,HUANG Qian,CHEN Xueyin,et al.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine[J].Journal of Traditional Chinese Medicine,2026,67(13):1461-1464.
赖佳琪,黄仟,陈雪吟等.中医药临床试验目标值制定的现状与优化策略[J].中医杂志,2026,67(13):1461-1464. DOI： 10.13288/j.11-2166/r.2026.13.018.

LAI Jiaqi,HUANG Qian,CHEN Xueyin,et al.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine[J].Journal of Traditional Chinese Medicine,2026,67(13):1461-1464. DOI： 10.13288/j.11-2166/r.2026.13.018.

摘要

当前中医药领域在目标值制定中存在报告质量低、方法欠规范、人群可比性不足及少数民族群体遗传与环境特殊性被忽视等问题。据此提出针对中医药，尤其是少数民族医药的目标值制定优化策略，即完善方法学技术与统计描述，确保Meta分析及数据源报告透明；规范点估计与置信区间计算，并结合多领域专家共识进行取值裁定；引入当地同期真实世界数据，尤其是队列研究，以弥补高质量随机对照试验数据不足。通过流程透明化与动态更新，提升目标值法的公信力，为该领域循证能力建设提供方法学支撑。

Abstract

Current formulation of objective performance criteria （OPC） in traditional Chinese medicine （TCM） faces methodological challenges， including poor reporting quality， insufficient standardization of methods， limited comparability of study populations， and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues， this paper proposes optimization strategies for setting OPC in TCM， with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions， ensuring transparency in meta-analyses and data sources； standardizing the estimation of point estimates and confidence intervals， and incorporating multidisciplinary expert consensus for value determination； introducing local real-world data from the same period， especially cohort study evidence， to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms， the credibility of OPC method can be enhanced， thereby providing methodological support for strengthening evidence-based research capacity in this field.

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references

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