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单组试验目标值法在中医临床研究中的应用

季聪华 曹毅 陈健

中国中西医结合杂志2012,Vol.32Issue(12):1589-1591,3.
中国中西医结合杂志2012,Vol.32Issue(12):1589-1591,3.

单组试验目标值法在中医临床研究中的应用

The Application of Single-arm Clinical Trials with Objective Performance Criteria in Clinical Research of Traditional Chinese Medicine

季聪华 1曹毅 1陈健1

作者信息

  • 1. 浙江省中医院国家中医临床研究基地,杭州,310006
  • 折叠

摘要

Abstract

Clinical research of Chinese medicine, due to its own features, is not suitable to be studied by randomized controlled trial methods in some cases. The single-arm clinical trials with objective performance criteria could be taken as a more ideal alternative method. In this paper the basic principles of single-arm clinical trials with objective performance criteria was introduced. Correlated problems of the selection of therapeutic efficacy index, the target identification, case standards, sample size calculation, statistical inference, and interpretation of results were also addressed. This method was scientific and feasible. It can partially solve some problems in the clinical research of Chinese medicine. It has better application prospect.

关键词

单组试验/目标值法/中医临床研究

Key words

single-arm clinical trial/ objective performance criteria/ clinical research of Chinese medicine

引用本文复制引用

季聪华,曹毅,陈健..单组试验目标值法在中医临床研究中的应用[J].中国中西医结合杂志,2012,32(12):1589-1591,3.

中国中西医结合杂志

OA北大核心CSCDCSTPCDMEDLINE

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