朱泉,郭新峰,赖世隆.临床试验效应值的分析和解释[J].,2005,(8):677-681 |
临床试验效应值的分析和解释 |
How to Analyze and Interpret the Effective Values in Clinical Trials |
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DOI: |
中文关键词: 临床试验 效应值 中医药 疗效评价 |
英文关键词:clinical trial effective value traditional Chinese medicine outcome assessment |
基金项目:广东省科技厅资助的循证医学方法研究(No.2KM05801s) |
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中文摘要: |
临床试验效应值的分析应包括效应值大小和精度两个方面,而对试验效应的解释应遵循准确、清晰和定量的原则。对于主要临床结局,可使用相对危险度、比数比、相对危险度降低率、绝对危险度降低率、减少1例重大临床事件需要治疗的人数等指标;而替代指标和中间指标的解释方法仍需要加强研究。国内中医药研究中的试验效应表达尚有很多问题有待解决。 |
英文摘要: |
The analysis of the effective value obtained in clinical trails should take account of both sides of its size and precision, for its interpretation, the general principles of: accuracy, explicitness and quantification should be complied. Criteria such as relative risk (RR), relative risk reducing rate (RRR), absolute risk reducing rate (ARR) and number needed to treat (NNT) an important clinical event, etc. are commonly used in the primary outcomes interpretation, while the methods to express the effective size and precision of surrogate outcomes and intermediary outcomes are needed to be further studied. Many problems for give expression to the outcome of TCM clinical trail still remain to be solved. |
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