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
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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.
[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.
引文
[1]陈伟伟,高润霖,刘力生.《中国心血管病报告2017》概要[J].中国循环杂志,2018,33(1):1-8.
[2]庞稳泰,张俊华,翟静波,等.通脉养心丸治疗冠心病心绞痛随机对照试验的系统评价[J/OL].中国中药杂志.https://doi.org/10.19540/j.cnki.cjcmm.20190305.005.
[3]刘文红,薛艳艳,蒋戈利,等.冠心病的中西医结合心脏康复研究概况[J].解放军医药杂志,2017,29(2):32-35.
[4]何亚州,黄彩依,黄景伟,等.基于肠道微生态系统探讨以脾论治冠心病[J].辽宁中医药大学学报,2019,21(4):116-119.
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[7]陈婷,王天琪,张砚.基于整合药理学分析通脉养心丸治疗冠心病心绞痛及心律不齐的分子机制[J].中华中医药杂志,2018,33(12):5553-5558.
[8]杜柏,褚瑜光,宋庆桥,等.通脉养心丸对冠心病心力衰竭气阴两虚型病人心功能及RAAS激活的影响[J].中西医结合心脑血管病杂志,2018,16(12):1706-1708.
[9]中华医学会心血管病学分会,中华心血管病杂志编辑委员会.慢性稳定性心绞痛诊断与治疗指南[J].中华心血管病杂志,2007,35(3):195-206
[10]徐一兰,高杉,许慧愚,等.冠心病稳定性心绞痛痰瘀互结证多中心、小样本、精细化临床研究方案[J].天津中医药,2018,35(2):86-90.
[11]Moran A,Gu D,Zhao D,et al.Future cardiovascular disease in china:markov model and risk factor scenario projections from the coronary heart disease policy model-china[J].Circ Cardiovasc Qual Outcomes,2010,3(3):243-252.
[12]吴丽虹,陈桥,张波.通脉养心丸和复方丹参片治疗气虚血瘀证慢性稳定性心绞痛54例临床观察[J].中国实验方剂学杂志,2015,21(15):172-175.
[13]覃裕旺,朱智德,卢健棋,等.养心通脉方治疗气阴两虚挟血瘀型冠心病心绞痛临床研究[J].中医学报,2015,30(3):428-429,432.
[14]施红英,沈毅.混合模型在临床试验重复测量资料中的应用[J].中国卫生统计,2007,24(2):140-142.
[15]王瑜,谭荣,李昀生.线性混合效应模型在种植效果评价中的应用[J].统计与决策,2013,29(21):73-75.
[16]黄坤,倪宗瓒,程薇波.混合线性模型在临床试验中重复测量资料的应用[J].现代预防医学,2005,41(11):166-167.
[17]严涛.基于变参数和混合模型的医学纵向数据研究[D].南昌:南昌大学,2014.
[18]周倩,张晋昕.含缺失值的重复测量资料分析在SPSS和SAS中的实现[J].循证医学,2013,13(2):120-123,128.
[19]赵振,潘晓平,张俊辉.广义估计方程在纵向资料中的应用[J].现代预防医学,2006,42(5):707-708.
[20]罗家洪,万崇华.高级医学统计学[M].北京:科学出版社,2014.
[21]冯国双,罗凤基.医学案例统计分析及SAS应用[M].北京:北京大学医学出版社,2011.
[22]张华君,闵捷.广义估计方程与多水平模型在相关资料中的比较研究[J].中国卫生统计,2012,29(2):214-216,219.
[23]毛广运,沈恬,陈常中,等.广义估计方程在多元统计分析中的运用及检验效率评价[J].中国卫生统计,2014,31(1):123-125.
[24]柳青.中华医学统计百科全书多元统计分册[M].北京:中国统计出版社,2013.
[25]张文彤,田晓燕.基于广义估计方程的多重应答资料统计分析方法[J].中国卫生统计,2004,21(3):10-12.
[26]Shoben AB,Rudser KD,Emerson SS.More data,less information?Potential for nonmonotonic information growth using GEE[J].Journal of Biopharmaceutical Statistics,2016,27(1):135-147.
[2]庞稳泰,张俊华,翟静波,等.通脉养心丸治疗冠心病心绞痛随机对照试验的系统评价[J/OL].中国中药杂志.https://doi.org/10.19540/j.cnki.cjcmm.20190305.005.
[3]刘文红,薛艳艳,蒋戈利,等.冠心病的中西医结合心脏康复研究概况[J].解放军医药杂志,2017,29(2):32-35.
[4]何亚州,黄彩依,黄景伟,等.基于肠道微生态系统探讨以脾论治冠心病[J].辽宁中医药大学学报,2019,21(4):116-119.
[5]张伯礼.中医内科学[M].北京:人民卫生出版社,2012:81.
[6]张国骏.基于《伤寒论》炙甘草汤的通脉养心丸方义研究[C].北京:中华中医药学会仲景学说分会,2012:3.
[7]陈婷,王天琪,张砚.基于整合药理学分析通脉养心丸治疗冠心病心绞痛及心律不齐的分子机制[J].中华中医药杂志,2018,33(12):5553-5558.
[8]杜柏,褚瑜光,宋庆桥,等.通脉养心丸对冠心病心力衰竭气阴两虚型病人心功能及RAAS激活的影响[J].中西医结合心脑血管病杂志,2018,16(12):1706-1708.
[9]中华医学会心血管病学分会,中华心血管病杂志编辑委员会.慢性稳定性心绞痛诊断与治疗指南[J].中华心血管病杂志,2007,35(3):195-206
[10]徐一兰,高杉,许慧愚,等.冠心病稳定性心绞痛痰瘀互结证多中心、小样本、精细化临床研究方案[J].天津中医药,2018,35(2):86-90.
[11]Moran A,Gu D,Zhao D,et al.Future cardiovascular disease in china:markov model and risk factor scenario projections from the coronary heart disease policy model-china[J].Circ Cardiovasc Qual Outcomes,2010,3(3):243-252.
[12]吴丽虹,陈桥,张波.通脉养心丸和复方丹参片治疗气虚血瘀证慢性稳定性心绞痛54例临床观察[J].中国实验方剂学杂志,2015,21(15):172-175.
[13]覃裕旺,朱智德,卢健棋,等.养心通脉方治疗气阴两虚挟血瘀型冠心病心绞痛临床研究[J].中医学报,2015,30(3):428-429,432.
[14]施红英,沈毅.混合模型在临床试验重复测量资料中的应用[J].中国卫生统计,2007,24(2):140-142.
[15]王瑜,谭荣,李昀生.线性混合效应模型在种植效果评价中的应用[J].统计与决策,2013,29(21):73-75.
[16]黄坤,倪宗瓒,程薇波.混合线性模型在临床试验中重复测量资料的应用[J].现代预防医学,2005,41(11):166-167.
[17]严涛.基于变参数和混合模型的医学纵向数据研究[D].南昌:南昌大学,2014.
[18]周倩,张晋昕.含缺失值的重复测量资料分析在SPSS和SAS中的实现[J].循证医学,2013,13(2):120-123,128.
[19]赵振,潘晓平,张俊辉.广义估计方程在纵向资料中的应用[J].现代预防医学,2006,42(5):707-708.
[20]罗家洪,万崇华.高级医学统计学[M].北京:科学出版社,2014.
[21]冯国双,罗凤基.医学案例统计分析及SAS应用[M].北京:北京大学医学出版社,2011.
[22]张华君,闵捷.广义估计方程与多水平模型在相关资料中的比较研究[J].中国卫生统计,2012,29(2):214-216,219.
[23]毛广运,沈恬,陈常中,等.广义估计方程在多元统计分析中的运用及检验效率评价[J].中国卫生统计,2014,31(1):123-125.
[24]柳青.中华医学统计百科全书多元统计分册[M].北京:中国统计出版社,2013.
[25]张文彤,田晓燕.基于广义估计方程的多重应答资料统计分析方法[J].中国卫生统计,2004,21(3):10-12.
[26]Shoben AB,Rudser KD,Emerson SS.More data,less information?Potential for nonmonotonic information growth using GEE[J].Journal of Biopharmaceutical Statistics,2016,27(1):135-147.