GEE与LMM模型在通脉养心丸治疗冠心病临床效果研究中的作用

[目的]本研究运用线性混合模型和广义估计方程探讨了通脉养心丸在治疗冠心病稳定性心绞痛气阴两虚证患者临床效果研究中的作用,对比研究不同模型假设下效应估计值及其变异程度的差异,探讨以上方法在临床领域重复测量数据中的适用性。[方法]通过多中心、精细化临床研究,共纳入7家临床单位83例受试者,因未完成访视脱失4例,最终纳入受试者79例,其中冠心病气阴两虚证患者39例,在西医常规治疗的基础上加服中药通脉养心丸治疗,健康人40例不予干预。比较不同时点不同组别及组内前后症状自评量表(SCL-90量表)、健康调查简表(SF-36量表)的评分情况,冠心病患者检测第0、4、8、12周水平,健康人检测第0周水平。[结果]本研究中气阴两虚组在线性混合模型中SCL-90量表的总分分别与SF-36量表的总分、时间和性别相关(P0.05),在广义估计方程中SCL-90量表的总分分别和SF-36量表的总分、性别和舒张压相关(P0.05)。[结论]通脉养心丸显示出其疗效,SCL-90、SF-36量表为防治冠心病稳定性心绞痛气阴两虚证提供依据。但是在该研究数据中,采用广义估计方程分析资料能取得较为满意的结果。

Effects of the GEE and LMM models in clinical treatments of coronary heart disease by Tongmai Yangxin Pill

[Objective] This study aimed to evaluate the effects of Tongmai Yangxin Pills in the treatment of qi and yin deficiency syndrome by comparing the linear mixed model and generalized estimating equation. The effects of different models,the degree of variation,and the applicability of models were examined by using clinical repeated measurement data.[Methods] This study was a multi-center,finess interventional study. A total of 83 individuals were enrolled from 7 clinical units. Four individuals were lost due to incomplete visiting and 79 individuals were finally included in this study. Among those individuals,39 were qi and yin deficiency syndrome of coronovy heart disease,receiving conventional Western medicine treatment,and traditional Chinese medicine Tongmai Yangxin Pills;and 40 were healthy people without any intervention. The scores of SCL-90 scale and SF-36 scale in different groups were compared at each time points. Coronary heart disease patients were measured in week 0,4,8 and 12 respectively;and the healthy people were considered on the level of 0 week.[Results] In this study,the total scores of the SCL-90 scale in the linear mixed model were correlated with the total score,time and gender of the SF-36 scale (P<0.05). The total scores of the SCL-90 scale in the generalized estimating equation were respectively the total score,gender and DBP of the SF-36 scale were correlated (P<0.05).[Conclusion] Tongmai Yangxin Pills showed its efficacy. The scale of SCL-90 and SF-36 provided the evidence for the clinical diagnosis and treatment of stable angina pectoris of coronary heart disease. The data in this study obtained precise results by the generalized estimation equation analysis.