糖尿病临床试验气阴两虚证评分的中心效应分析  

Analysis on the Central Effect of Qi-Yin Deficiency Syndrome Scoring in Clinical Trials of Diabetes.

作　　者：胡镜清[1] 王静[1] 刘萍[1] 易丹辉[2] 吴喜之[2] 

机构地区：[1]中国中医科学院广安门医院,北京100053 [2]中国人民大学统计学院,北京100872

出　　处：《中药新药与临床药理》2006年第5期370-373,共4页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家高技术研究发展计划(863计划)"临床试验关键技术及平台研究"(2003AA2Z3412)

摘　　要：目的分析糖尿病临床试验气阴两虚证评分的中心效应。方法选取2个2004～2005年间完成的治疗2型糖尿病中药新药Ⅲ期临床试验数据的符合方案数据集,应用离散程度分析、回归分析方法,对中医气阴两虚证证候评分、空腹血糖和餐后2h血糖指标治疗前后差值的中心效应进行比较。结果A药和B药治疗前后证候评分差值在中心间的变异系数比空腹血糖和餐后2h血糖要小得多,前者仅为后者的1/2～1/10。同时,无论是从有显著影响的中心的个数,还是从标准回归系数的绝对值大小来看,中心对治疗前后证候差值评分的影响程度都比对空腹血糖和餐后2h血糖差值的影响程度小。结论糖尿病临床试验气阴两虚证评分的治疗前后差值存在一定的中心趋同性,其中心效应较小。Objective To analyze the central effect of Qi - Yin Deficiency Syndrome （QYDS） scoring in clinical trials of diabetes. Methods Dispensation degree analysis and multiple linear regression analysis were adopted to compare the differences of central effects among the Qi - Yin deficiency syndrome scoring , fasting plasma glucose （FPG） level and 2 - hour postprandial blood sugar （2 hPG）level before and after treatment in the suited databases from two phase Ⅲ clinical trials of type two diabetes performed in 2004 - 2005. Results The variation coefficients of QYDS scoring treated with drug A and drug B varied from one tenth to half times of those of FPG and 2 hPG levels before and after treatment . And the influence of centers on QYDS is weaker than those on blood sugar levels （FPG ＆ 2 hPG） either referring to the numbers of significant centers or referring to the absolute values of standard regression coefficients in multiple linear regression equation. Conclusion There exists a central effect in QYDS scoring before and after treatment, and the central effect of QYDS scoring is weaker than that of blood sugar levels （FPG ＆ 2 hPG） in clinical trials of diabetes.

关 键 词：糖尿病 气阴两虚证候 血糖 中心效应 

分 类 号：R285.6[医药卫生—中药学] R195.1[医药卫生—中医学]