| 张彦红,梁伟雄,朱磊,刘云涛,张万方,温泽淮.实用性临床试验与解释性临床试验的比较[J].中国中西医结合杂志,2009,(2):161-164 |
| 实用性临床试验与解释性临床试验的比较 |
| Comparison of Pragmatic Clinical Trials and Explanatory Clinical Trials |
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| DOI： |
| 中文关键词: 实用性临床试验 解释性临床试验 |
| 英文关键词:pragmatic clinical trials explanatory clinical trials |
| 基金项目:“十一五”国家科技支撑计划课题(No.2006BAI04A213) |
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| 中文摘要: |
| 临床试验的设计实用性和分解释性两种,实用性临床试验用来衡量一种治疗方法在日常的临床实际中的效果,而解释性临床试验是用来衡量一种治疗方法在理想条件下的治疗效能。目前国内对实用性临床试验方法介绍甚少,本文对其特点和优缺点进行了介绍,并以德国一项针刺疗法治疗腰背痛的实用性临床试验为例具体说明该方法实际中的具体应用,对试验设计的关键步骤进行详细的解析,并对实用性临床试验中的常见问题如内部准确度与外部准确度的平衡、结局的评价等问题做出了合理的建议。 |
| 英文摘要: |
| Clinical trials are often designed as either pragmatic or explanatory.The pragmatic clinical trials are generally used for measuring the effectiveness of a treatment in common clinical practice,while the explanatory trial for measuring the efficacy of a treatment under ideal conditions.Since the methods concerning pragmatic clinical trials are less introduced in China,its archetypal features,advantages and limitations were introduced in this paper.And a current study of pragmatic clinical trials on using acpuncture for treatment of low back pain carried out in German was taken as an example to illustrate the practical methods concretely.The key steps of the design were presented in detail,and reasonable suggestions about the problems often encountered in the trial,as well as how to balance the internal and external validity,outcome measurement,etc.,were offered. |
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