摘要
中医临床研究优化是理念、过程和方法,非常必要,可在不同层次进行。中医临床研究优化要遵循一定的原则和程序,分为两部分进行。临床治疗方案的优化中,课题组需具备研究积累和吸收文献经验,可通过课题组和行业专家的论证进行完善。临床设计方案优化中,可通过同行专家讨论、反复咨询多学科专家并修改来完成,其中研究目的明确、目标人群定义准确、设计方案选择得当、样本量估算有依据、主要观察指标精当、数据管理方案系统、医学伦理和统计分析是重点。
Optimization of Traditional Chinese Medicine （TCM） clinical trials as philosophy, process and method, is extremely necessary and can be applied in different levels. Optimization of TCM clinical trials should follow some principles and procedures, and be executed in two ways. Optimization of treatment plan should be supported by the research basis and literature experience, and be perfected by research group and experts argumentation. Optimization of design plan is modified and accomplished by expert discussion and repeated consulting multi-disciplinary experts. Specific research objective, exact target population definition, proper design plan selection, valid calculation of sample size, precise and appropriate main outcome measures, data management system, medical ethics and statistical analysis are the focuses.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2010年第1期89-93,共5页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
"十一五"国家科技支撑计划重大项目资助(No.2006BAI04A21)
"重大新药制剂"科技重大专项资助(No.2009ZX09301-005)
第42批中国博士后科学基金资助项目(No.20070420505)
第1批中国博士后特别资助科学基金资助(No.200801167)
中国中医科学院自主选题资助(No.Z02119)~~
关键词
临床试验
中医
治疗方案
设计方案
优化
必要性
原则
程序
Clinical trial
TCM
Therapeutic regimen
Design proposal
Optimization
Necessity
Principle
Procedures
