中药0期临床药效学试验探索  

Exploratory on Phase 0 Clinical Pharmacodynamics Trial in Chinese Materia Medica

作　　者：梁丽喆 李国信[1] 于雪峰[1] 

机构地区：[1]辽宁中医药大学附属第二医院,沈阳110034

出　　处：《世界科学技术-中医药现代化》2017年第5期851-857,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科学技术部国家"十二五"重大新药创制项目(2012ZX09303-017):中药新药临床评价研究技术平台;负责人:李国信;辽宁省科学技术计划项目(2015225015):肺系重大疾病中医转化医学规范化研究;负责人:李国信

摘　　要：目的:以舒血宁注射液为研究对象,探索中药开展0期临床药效学试验的可行性。方法:确立适合中药0期(早期)临床评价的关键技术标准。按照所建立的研究方法,进行健康受试者低剂量舒血宁注射液体内给药,收集给药前和给药后血清,进行人主动脉内皮细胞模型损伤的体外实验,并以临床给药剂量的血液样本为对照,验证低剂量用药与临床剂量用药的药效学趋势一致性。结果:在过氧化氢诱导的内皮细胞损伤实验中,低剂量舒血宁注射液含药血清能够影响细胞增殖,保护细胞形态,减少细胞损伤所导致的离子释放以及细胞上清分泌,转录组差异表达具有药效学趋势。结论:与临床给药组相比,低剂量给药具有大致相同的药理活性趋势,中药0期临床药效学试验具有可行性。Shu-Xue-Ning（SXN） injection was used as study subject in order to explore the feasibility of pharmacodynamics experiment of Phase 0 clinical trial in Chinese materia medica（CMM）. This paper tried to establish key-technique standards which fit to the evaluation on CMM phase 0（early） clinical evaluations. According to the established research methods, this research selected volunteers and assured low dose SXN injection inside their body. And then, serum before and after medication were collected for the HAEC in vitro experiment. Blood sample of the clinical dosage was used as control to verify the tendency consistency of pharmacodynamics in low dose and clinical dose. The results showed that in the H_2O_2 inducing HAEC damage experiment, low dose SXN injection can affect the cell proliferation, protect the shape of cells, reduce the release of ion owing to cell damages and influence the secretion in cells. Complete-sequence RNA gave differential multiterm expression before and after the low dose. It was concluded that compared with the clinical group, low dose medication had similar metabolic tendency. The pharmacodynamics experiment of phase 0 CMM clinical trial is feasible.

关 键 词：中药 0期临床试验 药效学 舒血宁注射液 

分 类 号：R969[医药卫生—药理学]