本文選題：中醫(yī)復(fù)雜干預(yù) + 中風(fēng)病�。� 參考：《中國中醫(yī)科學(xué)院》2017年博士論文

【摘要】：1 研究背景復(fù)雜干預(yù)是臨床實(shí)踐中極為普遍的干預(yù)模式,現(xiàn)代醫(yī)學(xué)逐漸開始關(guān)注復(fù)雜干預(yù)問題。主要圍繞干預(yù)實(shí)施過程的標(biāo)準(zhǔn)化、干預(yù)起效的作用機(jī)制等問題展開,涉及行為干預(yù)、健康管理、非藥物治療等多方面內(nèi)容。中醫(yī)藥從來不乏在復(fù)雜干預(yù)上的探索與實(shí)踐。中醫(yī)理論體系是建立在古代哲學(xué)的整體觀基礎(chǔ)上的,重視天人合一,講究因人、因時、因地施治。從湯藥的創(chuàng)制到針?biāo)幉⒂�、�?nèi)外合治,乃至治未病思想的醫(yī)食同源、病后調(diào)理的治養(yǎng)結(jié)合等思想無不體現(xiàn)復(fù)雜干預(yù)的思維方式,這使得中醫(yī)復(fù)雜干預(yù)還具有個性化、動態(tài)化、時空觀的鮮明特點(diǎn)。此外,近百年來中成藥、中藥注射液等得到了廣泛的應(yīng)用,運(yùn)用中醫(yī)治療的同時亦不可避免的采用一些西醫(yī)診療手段,臨床實(shí)踐中的復(fù)雜性可想而知。雖然中醫(yī)藥的復(fù)雜干預(yù)現(xiàn)象十分常見,但是對于慣常的干預(yù)方式卻很少進(jìn)行深入的剖析,或者說很難在此有所突破。從目前該領(lǐng)域的研究現(xiàn)況看,相關(guān)的內(nèi)容比較少,自身研究的科學(xué)問題不夠明確,基于中醫(yī)復(fù)雜干預(yù)中的諸多環(huán)節(jié),該如何建立整個研究的思路與模式?均是需要解決的重要問題。根據(jù)現(xiàn)有的條件與研究的難度,初期的研究更多的是針對復(fù)雜干預(yù)的具體問題進(jìn)行相關(guān)的探索與嘗試,從而尋求研究的立足點(diǎn)與突破口。2研究目的立足于當(dāng)前病證結(jié)合的診療模式,嘗試對中、西醫(yī)聯(lián)合的復(fù)雜干預(yù)形式進(jìn)行探討,針對復(fù)雜干預(yù)中多結(jié)局、多指標(biāo)的評價問題,從中醫(yī)體系自身特點(diǎn)出發(fā),建立適用于中醫(yī)的綜合結(jié)局評價方法。3研究內(nèi)容選擇急性缺血性腦卒中的患者作為研究對象,研究以病證結(jié)合的模式展開,在西診斷的基礎(chǔ)上,將中醫(yī)的證候的因素融入設(shè)計(jì)中,以中醫(yī)氣虛血瘀證的證候評分作為分層指征,以體現(xiàn)中醫(yī)辨證論治的思想。使用西醫(yī)相關(guān)的量表與中醫(yī)的證候積分量表對療效進(jìn)行測評,以研究中醫(yī)辨證思想在治療中的機(jī)制。運(yùn)用統(tǒng)計(jì)分析的聯(lián)合模型與二階因子模型對臨床研究的數(shù)據(jù)進(jìn)行建模,從次要指標(biāo)對主要指標(biāo)的調(diào)整、潛變量的構(gòu)建等角度著手進(jìn)行中醫(yī)中風(fēng)病綜合評價指標(biāo)的架構(gòu)。4研究方法4.1研究設(shè)計(jì)本次研究為多中心的前瞻性、分層、隨機(jī)對照研究。將患者入組時的氣虛、血瘀證證候量化積分作為分層的指征,分為氣虛血瘀證≥7分層與氣虛血瘀證7分層,再通過中央隨機(jī)系統(tǒng)按比例進(jìn)行隨機(jī)分組。4.2干預(yù)方案全部患者均接受西醫(yī)標(biāo)準(zhǔn)治療,若患者氣虛血瘀證≥7分,則隨機(jī)接受丹紅注射液+西醫(yī)標(biāo)準(zhǔn)治療、參麥注射液+西醫(yī)標(biāo)準(zhǔn)治療、丹紅+參麥注射液+西醫(yī)標(biāo)準(zhǔn)治療、單純西醫(yī)標(biāo)準(zhǔn)治療四種干預(yù)方案,隨機(jī)比例是2:2:2:1;若患者氣虛血瘀證7分,則按1:2的比例隨機(jī)接受丹紅+參麥注射液+西醫(yī)標(biāo)準(zhǔn)治療、單純西醫(yī)標(biāo)準(zhǔn)治療兩種干預(yù)方案,干預(yù)用藥14天。患者可自行選擇是否使用針灸、康復(fù)治療,非干預(yù)用藥期間可合并使用其它治療。西醫(yī)標(biāo)準(zhǔn)治療遵《中國急性缺血性腦卒中診治指南2010年》。4.3評價指標(biāo)選擇NIHSS量表、Brunnstrom運(yùn)動功能評級、mRS評分、Barthel指數(shù)評價患者的神經(jīng)功能、運(yùn)動功能與日常生活能力。選用中醫(yī)氣虛、血瘀證證候積分量表作為證候的診斷與評價指標(biāo)。4.4統(tǒng)計(jì)分析運(yùn)用SPSS 21.0軟件進(jìn)行基本信息、各指標(biāo)的統(tǒng)計(jì)描述與各組組間的差異性檢驗(yàn),運(yùn)用MatLab R2016進(jìn)行綜合評價指標(biāo)模型的建立,包括運(yùn)用聯(lián)合模型、二階因子模型構(gòu)建綜合指標(biāo)或?qū)χ笜?biāo)進(jìn)行調(diào)整。5結(jié)果2013年05月-2016年04月期間,全國15家臨床參研單位符合納、排標(biāo)準(zhǔn)的急性缺血性腦卒中住院患者,共計(jì)313例。隨訪3月,其中脫落45例,違背方案37例。268例患者完成全部試驗(yàn)過程,238例患者遵循隨機(jī)方案完成全部試驗(yàn)。從單一指標(biāo)的比較看,NIHSS、Brunnstrom兩項(xiàng)指標(biāo)各干預(yù)組治療前后的改善情況均顯著,但是組間的差異不明顯。從中醫(yī)證候積分上看,以氣虛血瘀證評分≥7分患者的證候改善的幅度更大。各組患者90天時的Barthel指數(shù)中值達(dá)到90分,mRS評分集中在0分上,說明治療有較好的遠(yuǎn)期療效,但組間的差異不顯著。在西醫(yī)標(biāo)準(zhǔn)治療的基礎(chǔ)上加用中醫(yī)干預(yù)與單純西醫(yī)治療人群的比較結(jié)果顯示,中西醫(yī)干預(yù)聯(lián)用的患者在各項(xiàng)指標(biāo)的改善上均優(yōu)于單純使用西醫(yī)組,尤其是中醫(yī)證候積分的改善情況組間有顯著差異(P0.05)。綜合評價部分,采用混合效應(yīng)模型分析發(fā)現(xiàn)患者的年齡與合并疾病情況對治療的結(jié)局有顯著的影響。進(jìn)一步通過聯(lián)合模型分析,“是否為復(fù)發(fā)中風(fēng)”這項(xiàng)因素變得更為顯著。依據(jù)二階因子模型,運(yùn)用mRS、NIHSS、Brunnstrom三項(xiàng)指標(biāo)建立綜合評價指標(biāo),比較中西醫(yī)干預(yù)組與單純西醫(yī)干預(yù)組的綜合得分,前者的療效顯著高于后者。6結(jié)論運(yùn)用聯(lián)合模型和二階因子模型是實(shí)現(xiàn)復(fù)雜干預(yù)綜合評價的可行方法。其中聯(lián)合模型中將西醫(yī)指標(biāo)作為中風(fēng)病的主要指標(biāo),中醫(yī)證候指標(biāo)作為次要指標(biāo),以次要指標(biāo)對主要指標(biāo)進(jìn)行調(diào)整,是用于不同類型指標(biāo)之間綜合的可行方法,能夠更準(zhǔn)確的找出影響結(jié)局的因素,較混合效應(yīng)模型的估計(jì)更好。二階因子模型通過對多指標(biāo)進(jìn)行綜合,以構(gòu)建潛變量的方式實(shí)現(xiàn)指標(biāo)的降維,綜合性強(qiáng),適用范圍廣。以上方法切實(shí)符合復(fù)雜干預(yù)的綜合結(jié)局評價的要求,較傳統(tǒng)的單一指標(biāo)評價更加全面、客觀。7創(chuàng)新點(diǎn)本項(xiàng)目以中風(fēng)病氣虛血瘀證患者作為實(shí)證研究的對象,通過分層隨機(jī)的設(shè)計(jì),對中醫(yī)復(fù)雜干預(yù)的干預(yù)時點(diǎn)進(jìn)行研究,并針對中醫(yī)復(fù)雜干預(yù)結(jié)局指標(biāo)多樣的情況,開展綜合評價的方法學(xué)研究,運(yùn)用聯(lián)合模型能夠?qū)崿F(xiàn)不同類型的主、次指標(biāo)間的調(diào)整,運(yùn)用二階因子模型能夠構(gòu)建綜合評價體系,實(shí)現(xiàn)對多指標(biāo)的降維,在中醫(yī)復(fù)雜干預(yù)綜合結(jié)局評價的方法學(xué)上具有創(chuàng)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.
【學(xué)位授予單位】：中國中醫(yī)科學(xué)院
【學(xué)位級別】：博士
【學(xué)位授予年份】：2017
【分類號】：R255.2

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