[关键词]
[摘要]
目的 探讨重复测量方法用于中医药临床疗效评价的作用与效果。方法 在中药胃炎颗粒治疗慢性浅表性胃炎的临床研究中,研究设计采用重复测量设计(Repeated Measures Design),对疗效指标采用多个时点测量,数据结果分别采用重复测量设计的分析法和常规t检验分析法。结果 重复测量分析和t检验结果均显示治疗后组间比较没有差异;重复测量轮廓分析折线图显示,中医证候积分随观测时点推移显著减少,在4周之前减少较快,之后减少较慢。结论 重复测量设计可以客观地反映疾病随着治疗时间推移动态变化的过程,在时间维度上对临床疗效做出更合理、客观的综合评价。
[Key word]
[Abstract]
Objective To investigate the role and effect of the repeated measures for evaluating clinical efficacy of Chinese medicine. Methods In the clinical study of traditional Chinese medicine Weiyan granula in treating chronic superficial gastritis,repeated measures were used as the study design,efficacy evaluation factors at multiple time points were monitored,and the data were managed by repeated measures design analysis and conventional T-test analysis. Results The repeated measure analysis and T-test results showed that there was no difference between the two groups after treatment. The repeated measures contour analysis line chart showed that TCM syndrome score significantly decreased with the prolongation of observation time,the score decreased rapidly in the first four weeks and then slowed down in the next week. Conclusion Repeated measurement design can reflect the dynamic changing process of disease with treatment time,and will help making a reasonable,objective and comprehensive evaluation of clinical efficiency in the dimension of time.
[中图分类号]
R285.6
[基金项目]
“十一五”国家科技支撑计划(2007BAI20B094)。