摘要
中医临床研究根据研究目的,选用不同类型设计。中医临床探索性研究过程多选用横断面研究、叙述性研究(如病例报告、病例分析等)设计,验证性研究多选用随机对照试验设计。随机对照试验最常用于治疗性或预防性研究,方法比较成熟。随机交叉试验设计,应考虑顺序效应的影响,双盲法是最佳选择。队列研究因为不涉及随机分配患者和盲法,在中医临床研究中可用多种干预措施。病例-对照研究适应面宽,但偏倚较多。横断面研究是中医证候调查常用设计方法。叙述性研究是中医临床经验总结、中医探索性研究的常用设计方法。随机方法推荐第三方中央在线网络随机系统,可靠性高,随机化不易被破坏,注重随机隐藏。在不能采用盲法时,盲态测评也可减少测量偏倚,阳性对照必须有高级别证据的支持。安慰剂使用可提高循证证据级别。
TCM clinical research covers different design types on basis of objective of the study. For exploratory research of TCM, cross-sectional study and descriptive research （e.g. case report and case analysis） is suitable. For hypothesis- testing research, RCT design is commonly adopted. RCT is most commonly used in activity or prevention therapy research, when using randomized cross-over design, the influence of sequence effects should be considered, and double-blind method is the best choice. Cohort study includes various intervention measures, as it doesn＇t involve randomized allocation and blinding. Case-control study is widely applicable, but it may bring about bias. Cross-sectional study is much used in syndrome investigation of TCM clinical research. Descriptive research is available for summarization of TCM clinical experience and TCM exploratory research. Third party-central randomization system is recommended, as the randomization is not easy to be damaged. Randomization concealment should also be attached importance to. When blinding is impossible, blindness testing could reduce measurement bias, positive control should be supported high-level evidence. Placebo application could improve the level of evidence-based medicine.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2010年第4期556-559,共4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)
"重大新药创制"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
设计类型
优化
随机
盲法
对照
Clinical trial
TCM
Design types
Optimization
Randomize
Blinding
Control
