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  

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

作　　者：梁馨予 王泓午[2] 邓兵[3] 毛美娇[3] 杜廷海[4] 李彬[4] 杨宝平[5] 于研 张虹[6] 张世姝[6] 毛静远[7] 王贤良[7] 徐强[8] 张蕾 宋光明[9] 田莉 李朋 刘嘉琳 王丽[10] 高杉[2] 李琳[2] 高树明[2] 徐一兰[2] 潘晔[2] 蔡雪朦 王朔[2] 边育红[2] 李晓枫[1,2] 于春泉 LIANG Xinyu;WANG Hongwu;DENG Bing;MAO Meijiao;DU Tinghai;LI Bin;YANG Baoping;YU Yan;ZHANG Hong;ZHANG Shishu;MAO Jingyuan;WANG Xianliang;XU Qiang;ZHANG Lei;SONG Guangming;TIAN Li;LI Peng;LIU Jialin;WANG Li;GAO Shan;LI Lin;GAO Shuming;XU Yilan;PAN Ye;CAI Xuemeng;WANG Shuo;BIAN Yuhong;LI Xiaofeng;YU Chunquan(Dalian Medical University, Dalian 116044, China;Tianjin Second People Hospital, Tianjin 300192, China;Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 136300, China;Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou 730699, China;Tianjin Nankai Hospital, Tianjin 300100, China;The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China;Tianjin Wuqing Hospital of Traditional Chinese Medicine, Tianjin 301700, China)

机构地区：[1]大连医科大学,大连116044 [10]天津市第二人民医院,天津300192 [2]天津中医药大学,天津301617 [3]上海中医药大学附属龙华医院,上海200032 [4]河南中医药大学第一附属医院,郑州136300 [5]甘肃省中医院,兰州730699 [6]天津市南开医院,天津300100 [7]天津中医药大学第一附属医院,天津300193 [8]天津中医药大学第二附属医院,天津300150 [9]天津市武清区中医医院,天津301700

出　　处：《天津中医药》2019年第6期528-533,共6页Tianjin Journal of Traditional Chinese Medicine

基　　金：国家重点基础研究发展计划(973计划)项目(2014CB542902)

摘　　要：[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(P<0.05),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(P<0.05)。[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。[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.

关 键 词：冠心病稳定性心绞痛 线性混合模型 广义估计方程 SCL-90 SF-36 

分 类 号：R541.4[医药卫生—心血管疾病]