摘要
目的分析糖尿病患者气阴两虚证评分与血糖水平的相关性及其中心效应。方法选取某治疗糖尿病中药新药Ⅲ期临床试验数据的符合方案数据集,应用相关分析、一致性信度分析和区分度分析等方法,对基线、治疗后和治疗前后差值的中医气阴两虚证评分与空腹血糖、餐后2h血糖水平的相关性进行分析。结果无论是基线、治疗后,还是治疗前后差值,空腹血糖和餐后2h血糖各分中心的相关性都较大且表现一致,其相关系数的变异度较小(变异系数为0.100～0.258)。而气阴两虚证评分与空腹血糖和餐后2h血糖之间的相关性在各中心之间变化则较大。其中,气阴两虚证评分与空腹血糖之间的相关系数波动在-0.096～0.611之间,与餐后2h血糖之间的相关系数波动在-0.150～0.537之间。如果用变异系数衡量其变异度,气阴两虚证评分与空腹血糖和餐后2h血糖之间相关系数的变异度是空腹血糖与餐后2h血糖相关系数变异度的5～10倍。结论气阴两虚证的证候评分与空腹血糖和餐后2h血糖水平之间的相关性呈现明显的中心效应。
Objective To analyze the center effect in correlation between the scores of Qi -Yin deficiency syndrome （SQYD） and blood sugar level in diabetes. Methods Correlation, consistency reliability and distinguish ability analysis were used to evaluate the correlation of the scores of Qi - Yin deficiency syndrome and blood sugar level according to the data from a clinical trial in phase m on the diabetes. Results There was a significant correlation between fasting blood sugar （FPG） level and 2 -hour blood sugar （2 hPG） level at baseline, treatment end point and difference before and after treatment, and the variation of this correlation was slight （CV = 0. 1 - 0. 258）. But there was a insignificant correlation among SQYD and FPG or 2hPG, and the variation of this correlation was obvious （CV = 0. 560 - 2.559）. The correlation coefficient among SQYD and FPG fluctuated in the range of - 0. 096 - 0. 611, and that among SQYD and 2hPG in the range of - 0. 150 - G. 537. Roughly the variation of correlation among SQYD and FPG or 2hPG was 5 - 10 times greater than that of between FPG and 2hPG. Conclusion There exists an obvious center effect in correlation between the scores of Qi - Yin deficiency syndrome and blood sugar level in diabetes.
出处
《中药新药与临床药理》
CAS
CSCD
2006年第2期150-154,共5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)
关键词
糖尿病
气阴两虚证
血糖
相关性
中心效应
Diabetes
Qi- Yin deficiency syndrome
Blood sugar
Correlation
Center effect
