长春中医药大学学报Issue(1)：183-186,4.DOI:10.13463/j.cnki.cczyy.2016.01.065
中风病中药新药临床试验方案设计要点
Changes of main point about designment of stroke’s new TCM drugs
摘要
Abstract
Objective To findchanges and features of key point about the designment of stroke’s new TCM drugs Clinical Trial program,investigate the differences and the new features which presented. Methods Collect and organize clinical trials of stroke medicine project since January 1997 has been carried out,Establish a database to Excel and count key points designment of stroke’s new TCM drugs Clinical Trial program,such as dosage form,the choice of diagnostic criteria,treatment and evaluation point setting,control drug selection and so on. Results In the of choice of diagnostic criteria,by national expert consensus guidelines for the gradual introduction of the latest domestic or clinical guidelines;Set aspect of treatment and evaluation of test point,the emergence of apoplexy(recovery)for 8 weeks,12 weeks and showed an increasing trend,and gradually extend the evaluation point;Using multiple rating scale comprehensive evalua-tion;the control design also appeared in placebo-controlled and placebo,while positive drug control(three-arm test)and showed an increasing trend. Conclusion With the further improvement of drug evaluation system,at the same time,con-stantly updated and in-depth study of methods of clinical research of stroke,the designment of stroke TCM drug program also presents new features,promote stroke clinical trials more scientific,actual operational stronger.关键词
中风病/中药新药/药物临床试验/试验方案Key words
stroke/new TCM drug/clinical drug trial/clinicaltrial program分类
医药卫生引用本文复制引用
徐鹏,吕志国,崔英子,杨薇,王健,杨海淼..中风病中药新药临床试验方案设计要点[J].长春中医药大学学报,2016,(1):183-186,4.基金项目
“重大新药创制”科技重大专项“中药新药临床评价研究技术平台建设”（2012JX09303017-002）；吉林省中医药重点研究室“中医药临床评价重点研究室”项目。 （）
