基本药物中成药的循证文献特征研究

Research into Evidence-based Literatures on the Chinese Patent Medicines on the National Essential Medicine List

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 examine the characteristics of the evidence-based clinical literatures regarding the Chinese patent medicines on the National Essential Medicine List of China （2009 Edition） so as to lay a foundation for the establishment of an evi- dence-based pharmaceutical review system for the Chinese patent medicines oriented at treating TCM-syndromes. METHODS The evidence-based literatures on Chinese patent medicines were categorized, and their characteristics were analyzed concerning the distri- bution of the literatures according to the five levels of evidence, the concentration of the diseases under treatment, and chronological changes; in accordance with the Drug Registration Regulation, the differences among these literatures were explored. RESULTS With regard to the literatures on some Chinese patent medicines, there were a large proportion of randomized controlled trials （RCTs）, with a rapid increase in the number of the literatures in recent years and a clear focus on certain diseases. By contrast, some other Chi- nese patent medicines had a high proportion of before-after studies and empirical introductions as well as a low concentration of diseases under treatment. CONCLUSION The Chinese patent medicines can be divided into two categories, namely, the modern branch and the traditional branch. While the disease-oriented evidence-based review system can be applied to the evaluation of the literatures on some patent medicines in the modem branch, it does not fit the traditional branch. Therefore, in order to reflect the characteristics of the Chinese patent medicines, a TCM-syndrome-oriented evidence-based review system has to be established.