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目的研究我国2009年版《国家基本药物目录》中成药临床循证文献特征,为构建中成药针对证的循证药学评价方法奠定基础。方法通过中成药循证文献类别划分,分析13个中成药循证文献分布结构、治疗疾病集中度和时间变化特点,结合药品注册管理办法,探讨中成药循证文献的差异。结果部分中成药循证文献的组间对照试验比例较高,近年数量增加较快,治疗疾病的集中度较高,另一部分中成药循证文献的前后对照试验和经验介绍比例较高,治疗疾病集中度较分散。结论中成药可以分为两类,现代中成药可部分按以病为导向的循证评价方法评价,传统中成药的循证文献不宜用以病为导向的循证评价方法评价。为体现中成药的特点,必须建立以中医的证为导向的循证评价方法。
Objective To study the clinical evidence-based document characteristics of proprietary Chinese medicines in the 2009 edition of National Essential Drug List, which lays the foundation for the construction of evidence-based pharmacoeconomic evaluation methods for proprietary Chinese medicines. Methods According to the classification of evidence-based Chinese patent literature, the paper analyzed the distribution structure of 13 evidence-based Chinese medicine evidence-based documents, treated the characteristics of disease concentration and time variation, and discussed the differences of evidence-based Chinese patent literature with drug registration management. Results Some of the evidence-based literature of traditional Chinese medicine has a high proportion of inter-group control trials, the number of which has increased rapidly in recent years, the concentration of the disease is high, and that of the other part of the evidence- Concentration is more scattered. Conclusion Chinese patent medicine can be divided into two categories. Modern Chinese patent medicine can be evaluated in part by disease-oriented evidence-based evaluation. Evidence-based literature of traditional Chinese medicine should not be evaluated by disease-oriented evidence-based evaluation. In order to reflect the characteristics of proprietary Chinese medicines, we must establish an evidence-based evaluation method based on the evidence of Chinese medicine.