依据循证医学观点,分析药物临床试验质量

According to the viewpoint of evidence-based medicine to analyse the quality of clinical pharmaceutical trial

目的:依据循证医学观点,分析药物临床试验的质量。方法:统计某药学杂志1996～2000年有关药物临床试验论文110篇,从诊断标准、研究对象、试验方法、观察指标和统计学处理等方面分析存在的问题。结果;存在问题的临床试验文献44篇,占入选文献的40％。在诊断标准方面存在的主要问题是未交代诊断标准、无诊断标准来源,或诊断标准不完整。在研究对象方面存在的主要问题是无对照组或未随机分组。在试验方法方面存在的主要问题是试验药和对照药未用双盲或未交代合并治疗。在观察指标方面存在的主要问题是观察远期指标和经济指标的文献较少。在统计学处理方面存在的主要问题是统计方法与统计资料不相称。结论:目前药物临床试验中存在着一些问题,临床试验的质量有待进一步提高。

Aim:To analyse the quality of clinical pharmaceutical trials according to the viewpoint of evidence-based medicine. Methods: One hundred and ten theses concerned clinical pharmaceuticals trials, which were published in a journal during AD 1996-2000 were analysed about the problems such as the diagnosis standards, objects of research, trial method, observation parameters and statistic methods. Results: There were 44 theses existed one or more problems, occupying 40% of the selected documents. The major problems were as follows: no diagnosis standards or no source of the standard, or in complete starndard; no control group or not grouping randomly; not adopting double blind method; very few theses with economic or forward parameters; the inappropriate statistics methods. Conclusion: In the clinical pharmaceutical trials some problems are existed at present.