中药新药临床试验量表应用存在的问题和研究展望

量表的正确运用对中药有效性评价至关重要。本文梳理了目前临床试验存在的问题,提出使用者应该注意根据试验目的选择适合的量表。建议选用应经过检验的量表,注意避免随意更改、编制。在运用过程中应注意质量控制。建议中医界加强量表研制和验证的研究工作,以便用于支持中药新药临床有效性评价的研究。

Deficiencies in the Use of Scale in Clinical Trials on Traditional Chinese Medicines and Research Expectation

The correct use of scale is crucial to the evaluation of effectiveness of traditional Chinese medicines. This paper reviewed the current deficiencies in the use of scale in clinical trials, and suggestions were put forward that users should select an appropriate scale according to the purposes of clinical trials. It was proposed the scale to be selected should have been calibrated and readjustment at will should be avoided. In the use of scale, attention should be paid to the quality control. It is suggested that the research and development of scale and validation studies should be strengthened in the field of Chinese medicine so as to provide the support to clinical studies on the evaluation of the effectiveness of new traditional Chinese medicines.