中药上市后证候临床再评价四诊信息量表研制的探讨

Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs

中药上市后证候再评价是最能够体现中药特色,也是最容易被忽略的临床再评价内容。这种认识和重视程度的不足,直接表现在有关证候评价及上市后再评价临床方案设计方法探讨缺如,不利于提高中药有效性和安全性。因此,必须就证候再评价的临床试验方法、统计分析方法,尤其是中医四诊信息采集量表的研制进行重点阐述,以提升证候再评价在中药上市后临床再评价中的地位。

Post-marketing re-evaluation of chinese herbs can well reflect Chinese medicine characteristics,which is the most easily overlooked the clinical re-evaluation content.Since little attention has been paid to this,study on the clinical trial design method was lost.It is difficult to improving the effectiveness and safety of traditional Chinese medicine.Therefore,more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design,the study of Chinese medical information collection scale and statistical analysis methods,so as to improve the clinical trial design method study about tcm syndrome of chinese herbs postmarketing re-evalutation status.