血脂康胶囊上市后证候临床再评价症状条目的筛选  

Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang

作　　者：何伟[1] 谢雁鸣[2] 王永炎[2] 

机构地区：[1]中国中医科学院博士后流动站,北京100700 [2]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2011年第20期2898-2900,共3页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030);中国博士后科学基金面上项目(20100470512);中国中医科学院自主选题研究项目(Z0145);国家中医药管理局青年基金项目(06-07JQ11)

摘　　要：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 post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine（TCM） symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the aecoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

关 键 词：中药 证候临床再评价 血脂康 症状条目 

分 类 号：R286[医药卫生—中药学]