防治慢性心衰的中药新研发思路与技术要点分析

Analysis on new research and development ideas and technical points of traditional Chinese medicine for prevention and treatment of chronic heart failure

慢性心力衰竭(chronic heart failure,CHF)为各种心脏病的严重和终末阶段,是21世纪常见的慢性心血管病症,文献资料显示心衰住院患者5年死亡率高达50%。开发心衰治疗药物成为当今热点,中药在慢性心衰的治疗中体现了中医治疗优势。该文提出慢性心衰防治中药开发的4步考虑要点,首先以临床需求为导向,论述中成药开发、临床中药处方筛选思路和方法;其次,阐述参考中药处方已有的临床用药背景,分析处方中各味药材化学成分和药理作用特点,开展制备工艺和质量控制方法研究;进一步通过中药处方临床用药经验和未来临床定位设计药效学、毒理学等非临床评价方案和开展研究工作,并在方案实施过程中逐步调整完善;最后考虑该处方的临床用药经验、临床前研究药学、主要药效学和安全性实验结果,结合临床定位,依据中医理论设计合理的临床试验方案,形成注册申报资料进行临床试验申请(IND)。在通过IND技术审评后正式开展临床试验。以期取得预期结果,获得疗效确切的心衰治疗中成药。

Chronic heart failure(CHF),a serious and end stage of various heart diseases,is a common chronic cardiovascular disease in the 21 st century.Literature data show that the 5-year mortality rate of hospitalized patients with heart failure is as high as 50%.Nowadays,the development of drugs treating heart failure has become a hot spot,meanwhile,traditional Chinese medicine(TCM)has shown the advantages in the treatment of chronic heart failure.In this article,four stages to develop traditional Chinese medicine for chronic heart failure were proposed.Firstly,discuss and screen ideas and methods with regard to the development of TCM and its prescriptions based on clinical needs.Secondly,study the preparation process and quality control method by referring to the existing clinical background of TCM prescriptions and analyzing the chemical compositions and pharmacological action characteristics of each herb in the prescription.Then,design non-clinical evaluation programs and carry out researches on pharmacodynamics and toxicology by combining the experience of clinical use of TCM prescriptions and future clinical positioning,and gradually adjust and improve the programs during implementation.Finally,conduct clinical trial application(IND)by submitting registration application data which are base on the clinical drug experience,preclinical research pharmacy,main pharmacodynamics,safety test results of the prescription,clinical positioning,and reasonable clinical trial plan designed by the theory of TCM.After passing the IND technical review,the clinical trial study shall be officially launched to achieve the desired results and obtain effective Chinese patent medicines for heart failure treatment.