中风病气虚血瘀证中医复杂干预研究与综合评价

发布时间：2018-06-21 13:33

本文选题：中医复杂干预 + 中风病　；参考：《中国中医科学院》2017年博士论文

【摘要】：1 研究背景复杂干预是临床实践中极为普遍的干预模式,现代医学逐渐开始关注复杂干预问题。主要围绕干预实施过程的标准化、干预起效的作用机制等问题展开,涉及行为干预、健康管理、非药物治疗等多方面内容。中医药从来不乏在复杂干预上的探索与实践。中医理论体系是建立在古代哲学的整体观基础上的,重视天人合一,讲究因人、因时、因地施治。从汤药的创制到针药并用、内外合治,乃至治未病思想的医食同源、病后调理的治养结合等思想无不体现复杂干预的思维方式,这使得中医复杂干预还具有个性化、动态化、时空观的鲜明特点。此外,近百年来中成药、中药注射液等得到了广泛的应用,运用中医治疗的同时亦不可避免的采用一些西医诊疗手段,临床实践中的复杂性可想而知。虽然中医药的复杂干预现象十分常见,但是对于惯常的干预方式却很少进行深入的剖析,或者说很难在此有所突破。从目前该领域的研究现况看,相关的内容比较少,自身研究的科学问题不够明确,基于中医复杂干预中的诸多环节,该如何建立整个研究的思路与模式?均是需要解决的重要问题。根据现有的条件与研究的难度,初期的研究更多的是针对复杂干预的具体问题进行相关的探索与尝试,从而寻求研究的立足点与突破口。2研究目的立足于当前病证结合的诊疗模式,尝试对中、西医联合的复杂干预形式进行探讨,针对复杂干预中多结局、多指标的评价问题,从中医体系自身特点出发,建立适用于中医的综合结局评价方法。3研究内容选择急性缺血性脑卒中的患者作为研究对象,研究以病证结合的模式展开,在西诊断的基础上,将中医的证候的因素融入设计中,以中医气虚血瘀证的证候评分作为分层指征,以体现中医辨证论治的思想。使用西医相关的量表与中医的证候积分量表对疗效进行测评,以研究中医辨证思想在治疗中的机制。运用统计分析的联合模型与二阶因子模型对临床研究的数据进行建模,从次要指标对主要指标的调整、潜变量的构建等角度着手进行中医中风病综合评价指标的架构。4研究方法4.1研究设计本次研究为多中心的前瞻性、分层、随机对照研究。将患者入组时的气虚、血瘀证证候量化积分作为分层的指征,分为气虚血瘀证≥7分层与气虚血瘀证7分层,再通过中央随机系统按比例进行随机分组。4.2干预方案全部患者均接受西医标准治疗,若患者气虚血瘀证≥7分,则随机接受丹红注射液+西医标准治疗、参麦注射液+西医标准治疗、丹红+参麦注射液+西医标准治疗、单纯西医标准治疗四种干预方案,随机比例是2:2:2:1;若患者气虚血瘀证7分,则按1:2的比例随机接受丹红+参麦注射液+西医标准治疗、单纯西医标准治疗两种干预方案,干预用药14天。患者可自行选择是否使用针灸、康复治疗,非干预用药期间可合并使用其它治疗。西医标准治疗遵《中国急性缺血性脑卒中诊治指南2010年》。4.3评价指标选择NIHSS量表、Brunnstrom运动功能评级、mRS评分、Barthel指数评价患者的神经功能、运动功能与日常生活能力。选用中医气虚、血瘀证证候积分量表作为证候的诊断与评价指标。4.4统计分析运用SPSS 21.0软件进行基本信息、各指标的统计描述与各组组间的差异性检验,运用MatLab R2016进行综合评价指标模型的建立,包括运用联合模型、二阶因子模型构建综合指标或对指标进行调整。5结果2013年05月-2016年04月期间,全国15家临床参研单位符合纳、排标准的急性缺血性脑卒中住院患者,共计313例。随访3月,其中脱落45例,违背方案37例。268例患者完成全部试验过程,238例患者遵循随机方案完成全部试验。从单一指标的比较看,NIHSS、Brunnstrom两项指标各干预组治疗前后的改善情况均显著,但是组间的差异不明显。从中医证候积分上看,以气虚血瘀证评分≥7分患者的证候改善的幅度更大。各组患者90天时的Barthel指数中值达到90分,mRS评分集中在0分上,说明治疗有较好的远期疗效,但组间的差异不显著。在西医标准治疗的基础上加用中医干预与单纯西医治疗人群的比较结果显示,中西医干预联用的患者在各项指标的改善上均优于单纯使用西医组,尤其是中医证候积分的改善情况组间有显著差异(P0.05)。综合评价部分,采用混合效应模型分析发现患者的年龄与合并疾病情况对治疗的结局有显著的影响。进一步通过联合模型分析,“是否为复发中风”这项因素变得更为显著。依据二阶因子模型,运用mRS、NIHSS、Brunnstrom三项指标建立综合评价指标,比较中西医干预组与单纯西医干预组的综合得分,前者的疗效显著高于后者。6结论运用联合模型和二阶因子模型是实现复杂干预综合评价的可行方法。其中联合模型中将西医指标作为中风病的主要指标,中医证候指标作为次要指标,以次要指标对主要指标进行调整,是用于不同类型指标之间综合的可行方法,能够更准确的找出影响结局的因素,较混合效应模型的估计更好。二阶因子模型通过对多指标进行综合,以构建潜变量的方式实现指标的降维,综合性强,适用范围广。以上方法切实符合复杂干预的综合结局评价的要求,较传统的单一指标评价更加全面、客观。7创新点本项目以中风病气虚血瘀证患者作为实证研究的对象,通过分层随机的设计,对中医复杂干预的干预时点进行研究,并针对中医复杂干预结局指标多样的情况,开展综合评价的方法学研究,运用联合模型能够实现不同类型的主、次指标间的调整,运用二阶因子模型能够构建综合评价体系,实现对多指标的降维,在中医复杂干预综合结局评价的方法学上具有创新性。
[Abstract]:1 the complex intervention is a very common intervention model in clinical practice. Modern medicine has gradually begun to pay attention to the complex intervention. It mainly focuses on the standardization of the intervention process, the mechanism of intervention and the action mechanism, involving behavioral intervention, health management, non drug treatment and so on. The theoretical system of traditional Chinese medicine is based on the overall view of ancient philosophy, paying attention to the unity of heaven and man, paying attention to people, in time and in the field of treatment. From the creation of the medicine to the medicine and the use, the internal and external treatment, and even the treatment of the thought of the disease without disease, the thought of the combination of treatment and nourishing after the disease is the embodiment of complex intervention. In addition, Chinese traditional medicine and traditional Chinese medicine injection have been widely used in the past hundred years. In addition, some Western medical treatment hand segments are inevitably adopted at the same time, and the complexity of clinical practice can be imagined. The complex intervention of drugs is very common, but there is little in-depth analysis of the usual intervention methods, or it is difficult to make a breakthrough. From the current status of the research in this field, the related content is less, the scientific problems of their own research are not clear enough, and how to establish the whole process based on the complex intervention of traditional Chinese medicine should be established. The ideas and patterns of the research are all important problems to be solved. According to the existing conditions and the difficulty of the research, the initial research is more to explore and try the specific problems of the complex intervention, so as to seek the foothold of the research and the breakthrough point.2 research purpose based on the diagnosis and treatment mode combined with the current disease and syndrome. The complex intervention forms of the combination of Western medicine and Chinese medicine are discussed. In view of the multiple outcomes in the complex intervention and the evaluation of multiple indexes, from the characteristics of the traditional Chinese medicine system, the comprehensive outcome evaluation method suitable for traditional Chinese medicine (.3) is established to select the patients with acute ischemic stroke as the research object, and the model of the combination of disease and syndrome is studied. On the basis of the Western diagnosis, the factors of TCM syndrome are integrated into the design, the syndrome score of qi deficiency and blood stasis syndrome is taken as the stratified indication, and the idea of TCM syndrome differentiation is reflected. The therapeutic mechanism of TCM syndrome differentiation in the treatment is evaluated by using the related scale of Western medicine and the TCM syndrome score scale. The combined model of statistical analysis and the two order factor model were used to model the data of clinical research. From the angle of secondary indexes to the adjustment of main indexes and the construction of latent variables, the.4 research method of the comprehensive evaluation index of TCM apoplexy was carried out 4.1 research and design. This study was a multi center prospective, stratified and randomized controlled study. The Qi deficiency of the patients and the quantitative integral of blood stasis syndrome as stratified indications were divided into 7 layers of qi deficiency and blood stasis syndrome more than 7 stratification and Qi deficiency and blood stasis syndrome, and all patients were randomly divided into.4.2 intervention programs by the central random system to receive western medicine standard treatment. If the syndrome of qi deficiency and blood stasis was more than 7, then Dan red was accepted randomly. The injection + western medicine standard treatment, Shenmai injection + western medicine standard treatment, Danhong + Shenmai injection + western medicine standard treatment, the pure western medicine standard treatment four intervention programs, the random proportion is 2:2:2:1; if the patient Qi deficiency and blood stasis syndrome 7 points, then randomly accept Dan Hong + Shenmai injection + western medicine standard treatment, simple western medicine standard treatment Two intervention programs, intervention medication for 14 days. Patients can choose whether or not to use acupuncture, rehabilitation, and non intervention medication in combination with other treatments. Western medicine standard treatment follows the 2010 >.4.3 evaluation index of Chinese acute ischemic stroke NIHSS, Brunnstrom exercise function rating, mRS score, and Barthel index To evaluate the neurological function, motor function and daily living ability of the patients, the integral scale of TCM Qi deficiency and blood stasis syndrome was selected as the diagnostic and evaluation index of syndrome.4.4. The basic information was carried out by SPSS 21 software, the statistical description of each index and the difference test between each group, and the use of MatLab R2016 for comprehensive evaluation. The establishment of the standard model, including the use of the joint model, the two order factor model construction of comprehensive indicators or the adjustment of the index.5 results in 2013 05 months -2016 04 months, the national 15 clinical research units of acute ischemic stroke hospitalized patients, a total of 313 cases, followed up in March, 45 cases, 37 cases of.268 violation of the program. The patients completed all the test process, 238 patients followed the random program to complete the whole test. From the comparison of single index, the improvement of the two indexes of NIHSS and Brunnstrom before and after treatment were all significant, but the difference between the groups was not obvious. The median of the Barthel index was 90 points at 90 days and the mRS score was concentrated on the 0 points, indicating that the treatment had a good long-term effect, but the difference between the groups was not significant. The improvement of the index was better than that of the only western medicine group, especially the improvement of TCM syndrome scores (P0.05). The comprehensive evaluation part, the mixed effect model analysis found that the patient's age and the condition of the combined disease had a significant influence on the outcome of the treatment. The factor of stroke "is more significant. Based on the two order factor model, the comprehensive evaluation index is established by using the three indexes of mRS, NIHSS and Brunnstrom. The comprehensive score of the western medicine intervention group and the simple western medicine intervention group is compared. The former is significantly higher than the latter.6 conclusion using the combination model and the two order factor model to realize the complex intervention synthesis. In the combined model, the western medicine index is the main index of stroke, the TCM syndrome index is a secondary index, and the secondary index is used to adjust the main indexes. It is a feasible method for the synthesis of different types of indicators. It can find out the factors that affect the outcome more accurately than the mixed effect model. The two order factor model is integrated with multiple indexes to build the latent variable to reduce the dimension of the index. It is comprehensive and widely applicable. The above method conforms to the requirements of the comprehensive outcome evaluation of complex intervention, more comprehensive than the traditional single index evaluation, and the objective.7 innovation point is the stroke disease Qi deficiency blood. As the object of the empirical study, the patients with blood stasis syndrome are designed by stratified random design to study the intervention time points of the complex intervention of traditional Chinese medicine. In view of the diversity of the complex intervention outcome indicators of traditional Chinese medicine, the methodological study of comprehensive evaluation is carried out. The combined model can be used to realize the adjustment of different types of main, secondary indexes and the use of the two order factors. The model can build a comprehensive evaluation system and achieve multi dimensional dimensionality reduction. It is innovative in the methodology of comprehensive evaluation of TCM complex intervention.
【学位授予单位】：中国中医科学院
【学位级别】：博士
【学位授予年份】：2017
【分类号】：R255.2

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