病证结合多目标优化提高防治冠心病新药研究水平

Promoting development of new traditional Chinese medicine by combination disease-syndrome and multi-objective optimization research in prevention and treatment of cardiovascular disease

由于中医药在理论基础、应用方式和疗效评价标准上与现代医药学的差异,中药的安全性、有效性在某种程度上受到质疑,阻碍了中医药的发展和国际化进程。作者针对近年中药新药研究中常见的适应证定位不明确、工艺选择不合理、临床前药效学研究结果对拟定适应症的有效性支持力度不足、临床疗效中医特色和优势不突出等问题,结合防治冠心病中药新药研发体会,指出现代病证结合理论渗透在中药新药研发的各个阶段,为中药新药研发提供全方位指导。从现代病证结合理论促进防治冠心病中药新药适应症精确定位,为制剂工艺优化和质量控制提供目标导向,赋予临床前药效评价中医药特色,通过多目标优化提高临床疗效等几个方面阐释现代病证结合理论在研发现代中药新药过程中的应用价值,并结合相关学科的发展对今后中药新药研发方向进行了客观分析。

Differences in theories,application forms and evaluation standards about curative effect between traditional Chinese medicine and modern medicine lead to not only question safty and effectiveness but also hinder development and internationalization of traditional Chinese medicine. Combination of common problems in traditional Chinese new drug registration with experiences in research on traditional Chinese new drugs of prevention and treatment of coronary heart disease elucidate application value about theory of diseasesyndrome combination and multi-objective optimization in several ways such as the indications positioning,preparation process optimization,preclinical efficacy evaluating and clinical assessmenting of efficacy and analysis development prospect.