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中药上市后证候临床再评价的目的是明确中药临床实践中的治疗适应证,而中医症状条目设计的科学性及合理性是影响证候临床再评价结果的关键问题之一。该文以“血脂康胶囊上市后证候再评价中医症状条目筛选”为实践范例,通过综合参考血脂异常临床研究指导原则、博士学位论文、血脂康说明书、临床专家实践经验,经症状名称规范化处理后,筛选了41个血脂异常常见症状。并就症状条目筛选过程中的依据及注意事项等关键环节进行了探讨,为中药上市后临床再评价证候量表的研制提供研究思路。
The purpose of clinical re-evaluation of TCM syndromes after listing is to clarify the therapeutic indications in clinical practice of Chinese medicine. The scientific and rational design of TCM symptom items is one of the key issues that affect the clinical re-evaluation results of syndromes. In this paper, “Xuezhikang capsules listed after the syndrome re-evaluation of symptoms of TCM screening” as a practical example, by reference to the guidelines for clinical study of dyslipidemia, doctoral dissertation, Xuezhikan instructions, clinical experts and practical experience, by the name of the symptoms After standardized treatment, 41 common dyslipidemia symptoms were screened. And discussed the key points in the process of screening the symptom items and the precautions, which provided the research ideas for the development of clinical re-evaluation syndrome scale after the listing of TCM.