针刺治疗缺血性中风恢复期疗效综合评价研究
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摘要
研究背景
长期以来,针刺被当做治疗缺血性中风恢复期的一种有效治疗手段。然而,从循证医学角度来说,还没有足够证据证明针刺在治疗缺血性中风恢复期中具有确切疗效,是否采用针刺疗法存在争议。Park及Sze等人分别对1999年前、2002年前针刺治疗脑卒中发表的随机对照试验进行了系统评价,均未显示针刺有确切的疗效。国内张世洪等人对2003年8月前发表14篇关于针刺治疗急性脑卒中研究(共1208例患者)进行了系统评价,结果显示：与对照组(假针刺或者不针刺)相比,针刺组随访期末病死或者残疾率降低,病死或需要住院的人数显著降低,神经功能评分显著改善；与假针刺单独比较时,两组随访期末病死率或残疾人数及全面神经功能评分无显著性差异。2010年《中国急性缺血性脑卒中诊治指南》将针刺疗法列为Ⅱ级推荐(B级证据),认为针刺疗效有待进一步证实,建议根据具体情况结合患者意愿使用。那么,针刺到底有没有疗效?作为一名医生,在众多疗法中,是否有必要选择针刺作为治疗缺血性中风恢复期的治疗手段?患者能否从针刺治疗中获益?
我们知道,临床治疗是由诸多的独立因素组成,这些独立要素对总体效果有不同的贡献,包括特异性和非特异性的,同时它们之间的联系也是错综复杂的,其效应应该包括各组分单独的和交互的作用。中医疗法一直被认为是一种复杂干预,国外就有学者把针刺作为一种复杂干预,通过采用定性研究的方法探索它的复杂干预组成要素。国内一项研究表明：中医临床实践是一种复杂的整体性干预,中医疗效的体现是中医诊疗过程中诸多因素如处方药物、医嘱、心理干预、医患关系和患者依从性等共同作用的综合结果。如何反映这一综合结果呢?回答是建立一套科学的、合理的疗效评价体系,而基于这一评价体系,选择综合效果最佳的治疗手段可以为我们临床决策提供依据,也是最能反映中医药整体调节优势。
综合评价技术可以为中医复杂干预疗效评价提供一个很好的平台。综合评价是指对被评价对象所进行的客观、公正、合理的全面评价,通过一定的数学模型将多个评价指标值“合成”为一个整体性的综合评价值,即对一个复杂系统的多个指标进行总评价的方法。通过这种方法,我们可以对若干种不同治疗方法进行优劣排序,选取最合适的方法为患者服务。
目前国内还很少有报道关于综合评价在中医药领域中应用情况,有鉴于此,本研究拟对综合评价在中医药复杂干预疗效评价中的应用进行初步探索,并就针刺治疗缺血性中风恢复期疗效做更深入的评价。
研究目的
1.在中医药领域开展综合评价研究,对可能存在的问题进行分析并提出对策,为中医药疗效评价开辟新的思路。
2.深入探讨针刺干预缺血性中风恢复期疗效评价的现状,同时结合综合评价结果提出目前的治疗建议,为临床决策提供参考。
内容与方法
本研究采用定性研究与定量研究相结合的方法,具体内容和方法包括：
1.构建针刺治疗缺血性中风恢复期综合评价模型
1.1首先,我们对近十年针刺治疗缺血性中风研究发表文献进行了分析,了解目前国内类似研究指标使用现状,同时也为下一步专家咨询备选指标条目池的建立提供基础。
1.2在专家咨询法(Delphi)和层次分析法(Analytic Hierarchy Process, AHP)基础上,初步建立针刺治疗缺血性中风恢复期疗效评价体系和综合评价模型。
2.针刺治疗缺血性中风恢复期随机对照研究。采用经典的随机对照试验(Randomized controlled trial, RCT)和综合评价模型就针刺与假针刺的疗效比较进行深入探讨,分析两种评价的优劣,同时就目前的临床治疗给出了建议。
结果
1.构建针刺治疗缺血性中风恢复期综合评价模型
1.1近十年针刺治疗缺血性中风研究发表文献分析共获得文献799篇,经过筛选纳入随机对照研究文献83篇。采用指标使用情况：
(1)神经功能测评
所有83篇研究文献中,均有相关神经功能测评量表,应用依次排在前5位的量表分别是95年第四届脑血管病会议通过的脑卒中临床神经功能缺损程度评分标准(32/83,38.5%)、86年第三次脑血管病会议通过的脑血管病疗效评价标准(14/83,15.8%)、改良barthel指数(13/83,15.6%)、Fugl—Meyer量表(8/83,9.6%)及Brunnatrom量表(6/83,7.2%)。
(2)中医证候指标总共有10篇文献(12%)对缺血性中风证候情况进行了疗效评价。
(3)生存质量在所有文献中仅有2篇(2.4%)报道了治疗期末生存质量分析。
(4)终点结局指标有17篇文献(20.5%)采用了终点结局指标进行评价,4篇文章(4.8%)报道了治疗期末的残疾发生率；有4篇(4.8%)文献研究对治疗进行了3—6个月的随访,其中3篇对随访期末神经功能缺损评分进行了比较,仅有1篇文献报道了随访期末病死率、治疗率以及复发率；有9篇(10.8%)文献报道并比较了针刺的不良反应发生率；总共有9篇(10.8%)文献描述了出现严重不良反应的标准,其中7篇报道无不良反应,2篇报道有不良反应且描述较好。
(5)替代指标
有19篇(22.9%)文献报道了治疗期末理化指标变化情况,除了观察治疗前后梗死面积、TCD变化情况外,观测较多的生物学指标分别有血流变(4/83)、丙二醛(3/83)、内皮素(2/83)、血栓素(2/83)、前列腺素(2/83)以及超氧化物岐化酶(2/83)等。
从整体而言,疗效评价指标的选取还是比较混乱,缺乏从多个维度对针刺干预缺血性中风疗效进行全面评价的研究,建立大家认可的、规范的疗效评价体系依然是摆在我们面前较为严峻的课题。
1.2基于Delphi法和AHP的针刺治疗缺血性中风恢复期综合评价模型的建立
1.2.1第一轮专家咨询
第一轮专家咨询共发出问卷15份,共收回10份,收回问卷全部问卷符合填写要求,问卷回收率66.7%,专家积极系数为66.7%,专家的权威系数为0.82。采用Kendall协调系数W检验,协调系数W为0.40,P<0.01,显示专家对各指标的评分具有一致性。
从反映指标重要性的集中系数来看,一级指标神经功能、生存质量、终点指标、中医证候、理化指标分别为4.10±0.74、4.50±0.52、4.30±0.79、3.70±0.68、2.80±0.63,理化指标没有达到筛选标准,提示专家普遍认为在针刺干预缺血性中风恢复期临床疗效评价中没有必要采用理化指标。在二级指标方面,除了理化指标下属的血流变、梗死面积变化、生化指标等均没达到筛选标准外,其他维度二级指标均令人满意。
1.2.2第二轮专家咨询
第二轮专家咨询共发出问卷15份,共收回11份,收回问卷全部问卷符合填写要求,问卷回收率73.3%,专家积极系数为73.3%,专家的权威程度0.83。Kendall协调系数W为0.83,P<0.01,提示专家评分具有很高的一致性。
集中程度方面,一级指标神经功能、生存质量、终点指标、中医证候、理化指标集中系数分别为4.46±0.52、4.73±0.47、4.55±0.52、4.18±0.41、3.09±0.70,理化指标仍然没有达到筛选标准。
经过前两轮专家咨询,同时经过领导小组讨论,初步确立了针刺治疗缺血性中风恢复期疗效评价体系。
1.2.3第三轮专家咨询
为了提高Delphi法的质量,让专家充分表达自己的想法,本轮专家咨询的主要目的是就如何对各指标进行Saaty等级评分向专家举例说明,并让专家试填,从中发现问题,并及时纠正。
在回收的11份问卷中,共有3份填写不当,satty评分正确率72.7%。主要问题表现在：(1)两两比较时评分错误,跟自己赋值矛盾；(2)另一方面是出现前后矛盾,n与1/n不对称。经及时沟通后,专家基本上掌握了具体评分流程。1.2.4第四轮专家咨询
本轮专家咨询的主要目的是对各指标进行Saaty等级评分,共发出问卷15份,共收回11份,收回问卷全部问卷符合填写要求,问卷回收率73.3%,专家积极系数为73.3%,专家的权威系数为0.83,全部指标专家赋值经Kendall检验,协调系数W为0.865,经显著性检验,P<0.01,提示专家赋值有很好的一致性。
以各种专家赋值的中位数作为指标的最终赋值,建立判断矩阵,计算初始权重和归一化权重系数,最后确定各指标组合权重,得出针刺干预缺血性中风恢复期疗效综合评价初步线性模型为：
其中：Y表示综合评价得分；
X1,X2,X3,X4分别表示4个一级指标的评价得分；
X11,X122分别表示第一个一级指标X1下2个二级指标的单项得分；
X31,X32,X33,分别表示第三个一级指标X3下3个二级指标的单项得分；
X41,X42分别表示第四个一级指标X4下2个二级指标的单项得分。
2.针刺治疗缺血性中风恢复期随机对照研究
2.1 RCT结果
2.1.1基线比较
两组患者入院时年龄、性别比例以及治疗前中医证型比例、Barthel指数、MRS评分、SS-QOL评分、NIHSS评分、中医证候评分、中医健康量表评分等经检验无统计学差异,提示两组基线均衡。
2.1.2两组治疗前后NIHSS评分比较
经重复测量方差分析,两组在改善NIHSS评分方面较前均有统计学差异,但是与对照组相比,治疗组在改善NIHSS评分方面未见优势。
2.1.3两组治疗前后SS-QOL评分比较
经重复测量方差分析,随着时间的变化不同处理组之间SS-QOL评分变化无统计学意义,与对照组相比,治疗组在增加SS-QOL评分方面未见统计学差异。
2.1.4两组治疗前后中医证候评分评分比较
经重复测量方差分析,两组在改善中医证候评分方面较前均有统计学差异,但是与对照组相比,治疗组在改善中医证候评分方面未见优势。
2.1.5两组治疗前后中医健康量表评分比较
经重复测量方差分析,随着时间的改变不同组中医健康评分变化无统计学意义,治疗组与对照组相比,在减少中医健康评分方面无统计学差异。
2.1.6两组治疗前后Barthel指数比较
按照国际惯例将Barthel指数进行二分类变量(≤60分为依赖,>60分为独立)分析,经卡方检验,与对照组相比,治疗组在改善Barthel评分方面无统计学差异(P>0.05)。
2.1.7终点指标比较
(1)随访期末病死率及残疾率
出院3个月后进行电话随访,两组均没有出现死亡病例；以MRS≥3为残疾,治疗组41例患者中有17例残疾(41.7%),对照组42例中有21例残疾(50%)。经卡方检验无统计学差异(P>0.05)。
(2)复发率
出院后3个月随访,治疗组41例患者中复发4人(9.8%),对照组42例患者复发5人(11.9%),经比较无统计学差异(P>0.05)。
(3)不良反应发生率
治疗组45例中有3人(6.7%)出现不可耐受的疼痛,对照组所有45例患者均无严重不良反应。
2.1.8依从性分析
治疗组中有2人因为不可耐受的疼痛(不良反应)退出,有1人因为并发症停止针刺及其他康复治疗中途退出,1人因为患者家属要求主动退出；对照组有2人因为并发症停止针刺及其他康复治疗而退出试验,1人主动退出。
2.2综合评价结果
将两组各指标数值经转换后得到归一化矩阵值,最后经过归一化处理分别代入综合评价方程,得出两组综合评价值：治疗组=0.48,对照组=0.42,治疗组>对照组,显示在治疗方案选择时候,治疗组方案应被优选。
结论
1.通过对近十年针刺治疗缺血性中风研究发表文献进行分析,发现针刺治疗缺血性中风临床研究评价指标的选取较为随意、混乱,很多评价指标选取还停留在过去的生物医学模式上面,不能反映研究目的,应该建立一套科学的、合理的疗效评价体系；
2.基于Delphi法和层次分析法,初步构建了针刺干预缺血性中风恢复期疗效评价体系,同时建立了综合评价模型,发现生存质量、日常生活能力、终点指标等是针刺干预缺血性中风恢复期疗效评价体系中最值得关注的评价指标；
3.与对照组(假针刺结合现代康复)相比,治疗组(醒脑开窍针刺法结合现代康复)在改善缺血性中风恢复期患者神经功能缺损评分、中医健康评分及中医证候评分,提高日常生活能力及生存质量方面,均没有显示出统计学优势；在终点指标方面,治疗组在降低死亡率、残疾率及复发率方面与对照组相比也没有显示出统计学优势,同时,针刺较假针刺不良反应有增加的趋势,应该注意监测在针刺过程中患者可能出现的不良反应。
4.采用综合评价模型,根据综合评价值,治疗组(针刺结合现代康复)整体疗效优于对照组(假针刺结合现代康复),建议在缺血性中风恢复期临床实践中采用；
5.基于中医复杂干预的特点,综合评价模式有助于从整体上揭示其优势,适合不同干预方案的优选,值得进一步推广。
Background
Acupuncture has been used as an effective treatment of the patients post-stroke for a long time. However, from the perspective of evidence-based medicine; there hasn't enough evidence of the exact effect of acupuncture's treatment for ischemic stroke's rehabilitation. Park an Sze had wrote systematic review about randomized-controlled trials published before 1990 and 2000, but got useful information barely. Domestic Zhang Shihong etc systematically reviewed 14 published-articles about acupuncture treatment in acute stroke (1208 patients in total) before August 2003,and the results showed that the control group (sham-acupuncture or non-acupunctured) compared with acupuncture group, the follow-up of the latter reduced final illness or needed-hospitalization significantly, the number of neurobehavioral scores improved significantly. When compared with fake acupuncture alone, two groups of follow-up final mortality or disabled toll and comprehensive neurobehavioral scores have no significant differences. China Guidelines of treatment on acute ischemic stroke 2010 ranked acupuncture as LevelⅡrecommendation (Class B Evidence), considered that curative effect from acupuncture needed further information, and suggested that therapists pick it out in conjunction with the patients'wish. So, does acupuncture exactly have effect? As a doctor, among numerous therapies, is it necessary that we choose acupuncture for ischemic stroke recovery as the treatments? Can patients benefit from the acupuncture treatment?
As we known that clinical treatment is composed by many of the independent factors, which have different contribution to the totality, including specific and non-specific ones, and the relations among which is intricate. Its effects should include various components of the single and interactive functions. Chinese medicine has been regarded as a kind of complex interventions. There were foreign scholars deeming acupuncture as a complex intervention, with the qualitative research through the method of exploring its elements of complex interventions. A domestic study shows that domestic TCM clinical practice is a complex intervention as a whole. The effect of TCM medicine diagnosis is now the integrated elements from such as drugs, doctor's advice, psychological intervention, the relationship between doctors and patients interaction of adherence etc. And how to reflect the comprehensive results? The answer is to establish a set of evaluation system scientifically and reasonably. Based on this evaluation system, choosing a comprehensive effect of treatments can provide us with evidence for clinical decision, which is also the best way of demonstrating overall adjustment advantage of TCM.
Comprehensive evaluation technology can offer a excellent platform for assessment of evaluation of TCM invention. Comprehensive evaluation refers to the assessed object with objective, fair and reasonable comprehensive evaluation, through some mathematical model will be a number of evaluation index "synthesis" as a integration, namely, the comprehensive evaluation value of a complex system of indexes of the total evaluation method. In this way, we can put several different treatments in order and choose the most appropriate method for patients.
At present relevant areas have rare reports about comprehensive evaluation applications in the field in traditional Chinese medicine. In view of this, this research focuses on comprehensive evaluation of traditional Chinese medicine about complex effect assessment in the application intervention, and the further evaluation of preliminary exploration of acupuncture treatment of ischemic stroke recovery.
Objectives
1. In the field of comprehensive evaluation of Chinese medicine research, We put up with some tactics accord to the existing problems for a new way of evaluation of TCM.
2. We probed the status quo of ischemic stroke recovery efficacy in-depth study. Meanwhile combining with the current assessment of comprehensive evaluation, I got the present medical advice and offered reference for clinical decision-making.
Methods
This study used the method of combining the qualitative research and quantitative research, specific contents and was as follow:
1. Constructing a comprehensive evaluation model of acupuncture treatment of ischemic stroke recovery
1.1 Firstly, we analyzed studies of published literature in acupuncture treatment of ischemic stroke of recent 10years, got the main understanding of domestic similar index in status quo, and offered the advice of expert advice pool for the next step.
1.2 Between Delphi method (Delphi) and AHP (Analytic Hierarchy Process, the AHP), we established recovery efficacy evaluation system and comprehensive evaluation model of acupuncture treatment of ischemic stroke at the first step.
2. Randomized study of acupuncture treatment of ischemic stroke recovery
We took a deep discussion of comparing of using classical Randomized controlled Randomized controlled trials (RCT) and comprehensive evaluation model, analyzed the two kinds of evaluations'superiority, and gave useful advice for clinical treatment.
Result
1. Constructing a comprehensive evaluation model of acupuncture treatment of ischemic stroke recovery
1.1 Analysis of published literature of acupuncture treatment of ischemic stroke study for recent 10years
We obtained 799 articles from which we selected 83 into randomized study. Situation of using the standards:
(1)The neural function evaluation
All 83 study documents, have related neural function assessment scale, applied in the top four were the scoring standards of the 4th cerebrovascular disease meeting of stroke by 1995 (32/83,38.5%), the assessment standard of the 3nd cerebrovascular disease by 1986 (14/83,15.8%), the improved barthel index (13/83,15.6%) and Fugl-Meyer scale (8/83,9.6%).
(2)Syndromes index of TCM
There are 10 articles (12%) in all evaluating the syndromes effect assessment of ischemic stroke.
(3)Quality of life(QL)
There only 2 articles (2.4%) in all the documents reporting a final survival quality analysis of treatment.
(4)Destination end index
17 articles (20.5%) adopted ending index to evaluate, four articles (4.8%) reported a final disability incidence treatment; four papers (4.8%) for treatment of literature research kept 3-6 months of follow-up, including 3 articles reported the comparison of follow-up of the final neural function defect scale.Only 1 article reported follow-up of final mortality, dots and recurrence rate; nine articles (10.8%) reported the literature and compared the incidence of adverse acupuncture; there are 9 (10.8%) documents describing the standard that serious adverse reactions appeared, including 7 reports having no adverse reactions,2 reports having adverse reactions but better description.
(5)Substitution index
19 articles (22.9%) reported the changes of final physicochemical indexes, except for the observation of infarction area before and after treatments, TCD changes. More biological index observed, have hemorheology (4/83), malondialdehyde (3/83), endothelin (2/83), thrombosis, grain (2/83), prostaglandins (2/83) and super oxide of enzyme (2/guhya 83), etc.
On the whole, the selection of evaluation standards is in chaos and lack of acupuncture intervention from multiple dimensions of ischemic strokes curative effect. However, it is a serious work to build up a regular and acceptable evaluation.
1.2 The establishment of comprehensive evaluation model of acupuncture treatment of ischemic stroke recovery based on the Delphi method and the AHP
1.2.1 The first round of expert advice
The first round of expert advice were issued 15 questionnaires, ten copies of all questionnaire returned. And we withdraw all the questionnaires with complete requirements, whose recovery is 66.7%, experts actively coefficient is 66.7%, the expert's authority coefficient is 0.82. Using coordinate coefficient W inspection, Kendall coordinate coefficient W weigh.40, P< 0.01, show that the index rating with consistency by experts.
From the concentration standpoint coefficient reflecting importance's index, one class index of neural function, quality of life, the destination index, syndromes, physical and chemical index were 4.10±0.74、4.50±0.52、4.30±0.79、3.70±0.68、2.80±0.63. The physicochemical index hasn't reached screening standards, showing that experts generally agreed that it was not necessary to adopt it in acupuncture interventions in ischemic stroke recovery in the evaluation. In the secondary indexes, besides affiliate hemorrheology of physiochemical index and infarction area of changes, biochemical indicators are not reach screening standards, other dimensions secondary indexes all with satisfactory.
1.2.2 Second round of expert advice
The second round of expert-consulting has sent questionnaires, with 11 copies back of all 15. And the withdrawal questionnaires were all come up with complete requirements, questionnaire survey 73.3%, experts actively coefficient 73.3%, authority for 73.3%, Kendall coordinate coefficient W for 0.83, P< 0.01, pointed out t experts' grading with high consistency. The centralization, one class index of neural function, quality of life, the destination index, syndromes and physiochemical index concentration coefficient are respectively 4.46±0.52、4.73±0.47、4.55±0.52、4.18±0.41、3.09±0.70, physical and chemical index still hasn't reached screening standards.
After two previous rounds of expert consultation, meanwhile, after discussions from leading groups, we initially have established acupuncture treatment of ischemic stroke recovery efficacy evaluation system.
1.2.3 Third round of expert consultation
In order to improve the quality of Delphi method, letting experts fully express their ideas, this expert consultation's main purpose is to how to rate Saaty amd make explanations to experts with examples, and let experts try to fill the blanks, and notice problems, and correct them in time.
11 questionnaires in recovery, there were 3 copies finished inappropriately, compared with 72.7% accuracy of satty score. And the main problems are:(1) the performance in the binary compared with their mistakes, when rating assignment contradictions; (2) on the other hand they were appeared inconsistent, n and 1/n asymmetry. After the prompt communications, experts basically mastered specific rating process. 1.2.4 The fourth round of expert consultation
The main purpose of this experts'consultation of each index is Saaty. And ratings were issued, recovered 11 questionnaires which were all with complete requirements, that questionnaire survey was73.3%, experts actively coefficient was 73.3%, and the experts authority coefficient for 0.83, all indexes of Kendall inspection by expert assignment, coordinate coefficient for the 0.865, w. significant test, P< 0.01, presentation that expert assignment have very good consistency.
The final assignment is set by various medians defined by experts, establishing judgment matrix, calculating the initial weights and normalizing the weight coefficient, and the final determination. All that is concluded the preliminary linear model of comprehensive evaluation of acupuncture intervention ischemic stroke recovery are as follow: Among them:Y meant synthetic evaluation scores;
Clamps its X1 X2 X3, X4, respectively, said four primary index evaluation score;
X11, respectively X122 said the first primary index next 2 clamps its XI two-level index single score;
X31 X33 X32, respectively, said the third one class index next three X3 two-level index single score;
X42 X41, respectively for the first four primary index X4 said the two secondary indexes under single score.
2. Randomized study of acupuncture treatment of ischemic stroke recovery
2.1 Results of RCT
2.1.1 Baseline comparison
Age on admission gender proportion, and syndromes of TCM before treatment Barthel index, proportion, MRS score, SS-QOL NIHSS scores, TCM syndromes score, health rating scale of two groups of patients was not statistically significant by inspection, suggesting that the two groups of baseline have equilibrium.
2.1.2 Two groups NIHSS scores compared before and after treatment
After repeated measurement analysis of variance, the time between the two treatment groups have statistically significant changes to cope with different NIHSS scores. The treatment group was not better than control group in NIHSS scores reduction.
2.1.3 Comparisons of two groups before and after the treatment SS-QOL scores
After repeated measurement of anova, different treatment group changes between SS-QOL score are not statistically significant as the change of time. Compared with the control one, the treatment group have no statistical difference in increasing SS-QOL scoring.
2.1.4 Comparisons of TCM syndrome score of two groups before and after the treatment
After repeated measurement of anova, different treatment group of TCM syndrome scores'change have a statistically significant as the change of time. The treatment group in reducing syndromes scoring is not better than the control.
2.1.5 Comparisons of Two groups' traditional Chinese medicine health scale score before and after the treatment
After repeated measurement of anova, in the different group, TCM health scores'change was statistically significant along with time of change. The treatment group, compared with the control, was not statistically significant in reducing Chinese medicine health scoring.
2.1.6 Comparisons of two groups'Barthel index before and after treatment
Barthel index according to our state practices will have two classification variables (more than 60> divided into dependence, while<=60 independent) analysis, via a chi-square test, as compared with control, the treatment group Barthel scoring in improving was not statistically significant (P>0.05).
2.1.7 Comparisons of outcome events
(1)Mortality and morbidity at the end of follow-up
After 3-month telephone interview, two groups all did not appear deaths; MRS for disabled by over three, the treatment group 41 patients had 17 cases of disability (41.7%), the control group in 42 cases has 21 of disability (50%), which after a chi-square test was not statistically significant (P> 0.05).
(2)Recurrence
Three months later we have follow-up after discharge. The treatment group of 41 patients relapsing four (9.8%),42 patients relapsing 5 (11.9%), was not statistically significant (P> 0.05) by comparison.
(3)Adverse reaction rate
45 cases in treatment group having 2 persons (4.4 percent) appear no tolerance of pain and the control of 45 patients were all no serious adverse reactions.
2.1.8 Compliance analysis
Two people in the treatment group quit because of no tolerance of pain (adverse reaction), one person exits because of complications and stop acupuncturing and other rehabilitation treatment midway.1 person because patients'families want to exit; The control group has 2 because of complications and stop acupuncturing and of other rehabilitation therapy to exit test, and 1 person exits initiatively. 2.2 Results of Comprehensive evaluation
Two groups of each index numeric via after converting get normalized matrix value, finally going into the comprehensive evaluation equations respectively after normalized generation. It is concluded that the comprehensive evaluation value:the control group 0.48, the treatment group 0.42, treatments>controls, when displaying on the treatment scheme selection, the treatment group should be optimization.
Conclusion
1. Through the analysis of acupuncture treatment of ischemic stroke study published literature in recent 10 years, we find that acupuncture treatment of ischemic stroke in clinical research before with evaluation index selection are very casual, chaos. A lot of evaluation index selection have nothing in order and cannot reflect relevant research purpose. We should establish a set of scientific and reasonable efficacy evaluation system.
2. Based on the Delphi method and analytic hierarchy process, we constructed acupuncture intervention in ischemic stroke recovery efficacy evaluation system, and established the comprehensive evaluation model, finding that daily living skills, quality of life, the destination indicators acupuncture intervention ischemic stroke recovery is the most important effect assessment of evaluation index.
3. Through randomized study, we found that, compared with fake acupuncture, acupuncture can not improve patients'ischemic stroke neurologic deficits ratings and rating syndromes, at the same time, compared with a sham, acupuncture's serious adverse reactions have an increasing trend; In the closest of evaluation indicators with patients such as mortality, follow-up, daily living skills and living quality, acupuncture, show no advantage that we should discover more in the future.
4. Based on comprehensive evaluation value, we adopt comprehensive evaluation models:the treatment group (acupuncture combined with modern rehabilitation)have efficacy overall than in control group (sham acupuncture combined with modern rehabilitation), and suggest choosing it in ischemic stroke recovery during clinical practice;
5. Based on the characteristics of TCM complex intervention, the comprehensive evaluation model takes advantages of revealing them, and is suitable for different intervention scenario selections which deserves further promotion.
长期以来,针刺被当做治疗缺血性中风恢复期的一种有效治疗手段。然而,从循证医学角度来说,还没有足够证据证明针刺在治疗缺血性中风恢复期中具有确切疗效,是否采用针刺疗法存在争议。Park及Sze等人分别对1999年前、2002年前针刺治疗脑卒中发表的随机对照试验进行了系统评价,均未显示针刺有确切的疗效。国内张世洪等人对2003年8月前发表14篇关于针刺治疗急性脑卒中研究(共1208例患者)进行了系统评价,结果显示：与对照组(假针刺或者不针刺)相比,针刺组随访期末病死或者残疾率降低,病死或需要住院的人数显著降低,神经功能评分显著改善；与假针刺单独比较时,两组随访期末病死率或残疾人数及全面神经功能评分无显著性差异。2010年《中国急性缺血性脑卒中诊治指南》将针刺疗法列为Ⅱ级推荐(B级证据),认为针刺疗效有待进一步证实,建议根据具体情况结合患者意愿使用。那么,针刺到底有没有疗效?作为一名医生,在众多疗法中,是否有必要选择针刺作为治疗缺血性中风恢复期的治疗手段?患者能否从针刺治疗中获益?
我们知道,临床治疗是由诸多的独立因素组成,这些独立要素对总体效果有不同的贡献,包括特异性和非特异性的,同时它们之间的联系也是错综复杂的,其效应应该包括各组分单独的和交互的作用。中医疗法一直被认为是一种复杂干预,国外就有学者把针刺作为一种复杂干预,通过采用定性研究的方法探索它的复杂干预组成要素。国内一项研究表明：中医临床实践是一种复杂的整体性干预,中医疗效的体现是中医诊疗过程中诸多因素如处方药物、医嘱、心理干预、医患关系和患者依从性等共同作用的综合结果。如何反映这一综合结果呢?回答是建立一套科学的、合理的疗效评价体系,而基于这一评价体系,选择综合效果最佳的治疗手段可以为我们临床决策提供依据,也是最能反映中医药整体调节优势。
综合评价技术可以为中医复杂干预疗效评价提供一个很好的平台。综合评价是指对被评价对象所进行的客观、公正、合理的全面评价,通过一定的数学模型将多个评价指标值“合成”为一个整体性的综合评价值,即对一个复杂系统的多个指标进行总评价的方法。通过这种方法,我们可以对若干种不同治疗方法进行优劣排序,选取最合适的方法为患者服务。
目前国内还很少有报道关于综合评价在中医药领域中应用情况,有鉴于此,本研究拟对综合评价在中医药复杂干预疗效评价中的应用进行初步探索,并就针刺治疗缺血性中风恢复期疗效做更深入的评价。
研究目的
1.在中医药领域开展综合评价研究,对可能存在的问题进行分析并提出对策,为中医药疗效评价开辟新的思路。
2.深入探讨针刺干预缺血性中风恢复期疗效评价的现状,同时结合综合评价结果提出目前的治疗建议,为临床决策提供参考。
内容与方法
本研究采用定性研究与定量研究相结合的方法,具体内容和方法包括：
1.构建针刺治疗缺血性中风恢复期综合评价模型
1.1首先,我们对近十年针刺治疗缺血性中风研究发表文献进行了分析,了解目前国内类似研究指标使用现状,同时也为下一步专家咨询备选指标条目池的建立提供基础。
1.2在专家咨询法(Delphi)和层次分析法(Analytic Hierarchy Process, AHP)基础上,初步建立针刺治疗缺血性中风恢复期疗效评价体系和综合评价模型。
2.针刺治疗缺血性中风恢复期随机对照研究。采用经典的随机对照试验(Randomized controlled trial, RCT)和综合评价模型就针刺与假针刺的疗效比较进行深入探讨,分析两种评价的优劣,同时就目前的临床治疗给出了建议。
结果
1.构建针刺治疗缺血性中风恢复期综合评价模型
1.1近十年针刺治疗缺血性中风研究发表文献分析共获得文献799篇,经过筛选纳入随机对照研究文献83篇。采用指标使用情况：
(1)神经功能测评
所有83篇研究文献中,均有相关神经功能测评量表,应用依次排在前5位的量表分别是95年第四届脑血管病会议通过的脑卒中临床神经功能缺损程度评分标准(32/83,38.5%)、86年第三次脑血管病会议通过的脑血管病疗效评价标准(14/83,15.8%)、改良barthel指数(13/83,15.6%)、Fugl—Meyer量表(8/83,9.6%)及Brunnatrom量表(6/83,7.2%)。
(2)中医证候指标总共有10篇文献(12%)对缺血性中风证候情况进行了疗效评价。
(3)生存质量在所有文献中仅有2篇(2.4%)报道了治疗期末生存质量分析。
(4)终点结局指标有17篇文献(20.5%)采用了终点结局指标进行评价,4篇文章(4.8%)报道了治疗期末的残疾发生率；有4篇(4.8%)文献研究对治疗进行了3—6个月的随访,其中3篇对随访期末神经功能缺损评分进行了比较,仅有1篇文献报道了随访期末病死率、治疗率以及复发率；有9篇(10.8%)文献报道并比较了针刺的不良反应发生率；总共有9篇(10.8%)文献描述了出现严重不良反应的标准,其中7篇报道无不良反应,2篇报道有不良反应且描述较好。
(5)替代指标
有19篇(22.9%)文献报道了治疗期末理化指标变化情况,除了观察治疗前后梗死面积、TCD变化情况外,观测较多的生物学指标分别有血流变(4/83)、丙二醛(3/83)、内皮素(2/83)、血栓素(2/83)、前列腺素(2/83)以及超氧化物岐化酶(2/83)等。
从整体而言,疗效评价指标的选取还是比较混乱,缺乏从多个维度对针刺干预缺血性中风疗效进行全面评价的研究,建立大家认可的、规范的疗效评价体系依然是摆在我们面前较为严峻的课题。
1.2基于Delphi法和AHP的针刺治疗缺血性中风恢复期综合评价模型的建立
1.2.1第一轮专家咨询
第一轮专家咨询共发出问卷15份,共收回10份,收回问卷全部问卷符合填写要求,问卷回收率66.7%,专家积极系数为66.7%,专家的权威系数为0.82。采用Kendall协调系数W检验,协调系数W为0.40,P<0.01,显示专家对各指标的评分具有一致性。
从反映指标重要性的集中系数来看,一级指标神经功能、生存质量、终点指标、中医证候、理化指标分别为4.10±0.74、4.50±0.52、4.30±0.79、3.70±0.68、2.80±0.63,理化指标没有达到筛选标准,提示专家普遍认为在针刺干预缺血性中风恢复期临床疗效评价中没有必要采用理化指标。在二级指标方面,除了理化指标下属的血流变、梗死面积变化、生化指标等均没达到筛选标准外,其他维度二级指标均令人满意。
1.2.2第二轮专家咨询
第二轮专家咨询共发出问卷15份,共收回11份,收回问卷全部问卷符合填写要求,问卷回收率73.3%,专家积极系数为73.3%,专家的权威程度0.83。Kendall协调系数W为0.83,P<0.01,提示专家评分具有很高的一致性。
集中程度方面,一级指标神经功能、生存质量、终点指标、中医证候、理化指标集中系数分别为4.46±0.52、4.73±0.47、4.55±0.52、4.18±0.41、3.09±0.70,理化指标仍然没有达到筛选标准。
经过前两轮专家咨询,同时经过领导小组讨论,初步确立了针刺治疗缺血性中风恢复期疗效评价体系。
1.2.3第三轮专家咨询
为了提高Delphi法的质量,让专家充分表达自己的想法,本轮专家咨询的主要目的是就如何对各指标进行Saaty等级评分向专家举例说明,并让专家试填,从中发现问题,并及时纠正。
在回收的11份问卷中,共有3份填写不当,satty评分正确率72.7%。主要问题表现在：(1)两两比较时评分错误,跟自己赋值矛盾；(2)另一方面是出现前后矛盾,n与1/n不对称。经及时沟通后,专家基本上掌握了具体评分流程。1.2.4第四轮专家咨询
本轮专家咨询的主要目的是对各指标进行Saaty等级评分,共发出问卷15份,共收回11份,收回问卷全部问卷符合填写要求,问卷回收率73.3%,专家积极系数为73.3%,专家的权威系数为0.83,全部指标专家赋值经Kendall检验,协调系数W为0.865,经显著性检验,P<0.01,提示专家赋值有很好的一致性。
以各种专家赋值的中位数作为指标的最终赋值,建立判断矩阵,计算初始权重和归一化权重系数,最后确定各指标组合权重,得出针刺干预缺血性中风恢复期疗效综合评价初步线性模型为：
其中：Y表示综合评价得分；
X1,X2,X3,X4分别表示4个一级指标的评价得分；
X11,X122分别表示第一个一级指标X1下2个二级指标的单项得分；
X31,X32,X33,分别表示第三个一级指标X3下3个二级指标的单项得分；
X41,X42分别表示第四个一级指标X4下2个二级指标的单项得分。
2.针刺治疗缺血性中风恢复期随机对照研究
2.1 RCT结果
2.1.1基线比较
两组患者入院时年龄、性别比例以及治疗前中医证型比例、Barthel指数、MRS评分、SS-QOL评分、NIHSS评分、中医证候评分、中医健康量表评分等经检验无统计学差异,提示两组基线均衡。
2.1.2两组治疗前后NIHSS评分比较
经重复测量方差分析,两组在改善NIHSS评分方面较前均有统计学差异,但是与对照组相比,治疗组在改善NIHSS评分方面未见优势。
2.1.3两组治疗前后SS-QOL评分比较
经重复测量方差分析,随着时间的变化不同处理组之间SS-QOL评分变化无统计学意义,与对照组相比,治疗组在增加SS-QOL评分方面未见统计学差异。
2.1.4两组治疗前后中医证候评分评分比较
经重复测量方差分析,两组在改善中医证候评分方面较前均有统计学差异,但是与对照组相比,治疗组在改善中医证候评分方面未见优势。
2.1.5两组治疗前后中医健康量表评分比较
经重复测量方差分析,随着时间的改变不同组中医健康评分变化无统计学意义,治疗组与对照组相比,在减少中医健康评分方面无统计学差异。
2.1.6两组治疗前后Barthel指数比较
按照国际惯例将Barthel指数进行二分类变量(≤60分为依赖,>60分为独立)分析,经卡方检验,与对照组相比,治疗组在改善Barthel评分方面无统计学差异(P>0.05)。
2.1.7终点指标比较
(1)随访期末病死率及残疾率
出院3个月后进行电话随访,两组均没有出现死亡病例；以MRS≥3为残疾,治疗组41例患者中有17例残疾(41.7%),对照组42例中有21例残疾(50%)。经卡方检验无统计学差异(P>0.05)。
(2)复发率
出院后3个月随访,治疗组41例患者中复发4人(9.8%),对照组42例患者复发5人(11.9%),经比较无统计学差异(P>0.05)。
(3)不良反应发生率
治疗组45例中有3人(6.7%)出现不可耐受的疼痛,对照组所有45例患者均无严重不良反应。
2.1.8依从性分析
治疗组中有2人因为不可耐受的疼痛(不良反应)退出,有1人因为并发症停止针刺及其他康复治疗中途退出,1人因为患者家属要求主动退出；对照组有2人因为并发症停止针刺及其他康复治疗而退出试验,1人主动退出。
2.2综合评价结果
将两组各指标数值经转换后得到归一化矩阵值,最后经过归一化处理分别代入综合评价方程,得出两组综合评价值：治疗组=0.48,对照组=0.42,治疗组>对照组,显示在治疗方案选择时候,治疗组方案应被优选。
结论
1.通过对近十年针刺治疗缺血性中风研究发表文献进行分析,发现针刺治疗缺血性中风临床研究评价指标的选取较为随意、混乱,很多评价指标选取还停留在过去的生物医学模式上面,不能反映研究目的,应该建立一套科学的、合理的疗效评价体系；
2.基于Delphi法和层次分析法,初步构建了针刺干预缺血性中风恢复期疗效评价体系,同时建立了综合评价模型,发现生存质量、日常生活能力、终点指标等是针刺干预缺血性中风恢复期疗效评价体系中最值得关注的评价指标；
3.与对照组(假针刺结合现代康复)相比,治疗组(醒脑开窍针刺法结合现代康复)在改善缺血性中风恢复期患者神经功能缺损评分、中医健康评分及中医证候评分,提高日常生活能力及生存质量方面,均没有显示出统计学优势；在终点指标方面,治疗组在降低死亡率、残疾率及复发率方面与对照组相比也没有显示出统计学优势,同时,针刺较假针刺不良反应有增加的趋势,应该注意监测在针刺过程中患者可能出现的不良反应。
4.采用综合评价模型,根据综合评价值,治疗组(针刺结合现代康复)整体疗效优于对照组(假针刺结合现代康复),建议在缺血性中风恢复期临床实践中采用；
5.基于中医复杂干预的特点,综合评价模式有助于从整体上揭示其优势,适合不同干预方案的优选,值得进一步推广。
Background
Acupuncture has been used as an effective treatment of the patients post-stroke for a long time. However, from the perspective of evidence-based medicine; there hasn't enough evidence of the exact effect of acupuncture's treatment for ischemic stroke's rehabilitation. Park an Sze had wrote systematic review about randomized-controlled trials published before 1990 and 2000, but got useful information barely. Domestic Zhang Shihong etc systematically reviewed 14 published-articles about acupuncture treatment in acute stroke (1208 patients in total) before August 2003,and the results showed that the control group (sham-acupuncture or non-acupunctured) compared with acupuncture group, the follow-up of the latter reduced final illness or needed-hospitalization significantly, the number of neurobehavioral scores improved significantly. When compared with fake acupuncture alone, two groups of follow-up final mortality or disabled toll and comprehensive neurobehavioral scores have no significant differences. China Guidelines of treatment on acute ischemic stroke 2010 ranked acupuncture as LevelⅡrecommendation (Class B Evidence), considered that curative effect from acupuncture needed further information, and suggested that therapists pick it out in conjunction with the patients'wish. So, does acupuncture exactly have effect? As a doctor, among numerous therapies, is it necessary that we choose acupuncture for ischemic stroke recovery as the treatments? Can patients benefit from the acupuncture treatment?
As we known that clinical treatment is composed by many of the independent factors, which have different contribution to the totality, including specific and non-specific ones, and the relations among which is intricate. Its effects should include various components of the single and interactive functions. Chinese medicine has been regarded as a kind of complex interventions. There were foreign scholars deeming acupuncture as a complex intervention, with the qualitative research through the method of exploring its elements of complex interventions. A domestic study shows that domestic TCM clinical practice is a complex intervention as a whole. The effect of TCM medicine diagnosis is now the integrated elements from such as drugs, doctor's advice, psychological intervention, the relationship between doctors and patients interaction of adherence etc. And how to reflect the comprehensive results? The answer is to establish a set of evaluation system scientifically and reasonably. Based on this evaluation system, choosing a comprehensive effect of treatments can provide us with evidence for clinical decision, which is also the best way of demonstrating overall adjustment advantage of TCM.
Comprehensive evaluation technology can offer a excellent platform for assessment of evaluation of TCM invention. Comprehensive evaluation refers to the assessed object with objective, fair and reasonable comprehensive evaluation, through some mathematical model will be a number of evaluation index "synthesis" as a integration, namely, the comprehensive evaluation value of a complex system of indexes of the total evaluation method. In this way, we can put several different treatments in order and choose the most appropriate method for patients.
At present relevant areas have rare reports about comprehensive evaluation applications in the field in traditional Chinese medicine. In view of this, this research focuses on comprehensive evaluation of traditional Chinese medicine about complex effect assessment in the application intervention, and the further evaluation of preliminary exploration of acupuncture treatment of ischemic stroke recovery.
Objectives
1. In the field of comprehensive evaluation of Chinese medicine research, We put up with some tactics accord to the existing problems for a new way of evaluation of TCM.
2. We probed the status quo of ischemic stroke recovery efficacy in-depth study. Meanwhile combining with the current assessment of comprehensive evaluation, I got the present medical advice and offered reference for clinical decision-making.
Methods
This study used the method of combining the qualitative research and quantitative research, specific contents and was as follow:
1. Constructing a comprehensive evaluation model of acupuncture treatment of ischemic stroke recovery
1.1 Firstly, we analyzed studies of published literature in acupuncture treatment of ischemic stroke of recent 10years, got the main understanding of domestic similar index in status quo, and offered the advice of expert advice pool for the next step.
1.2 Between Delphi method (Delphi) and AHP (Analytic Hierarchy Process, the AHP), we established recovery efficacy evaluation system and comprehensive evaluation model of acupuncture treatment of ischemic stroke at the first step.
2. Randomized study of acupuncture treatment of ischemic stroke recovery
We took a deep discussion of comparing of using classical Randomized controlled Randomized controlled trials (RCT) and comprehensive evaluation model, analyzed the two kinds of evaluations'superiority, and gave useful advice for clinical treatment.
Result
1. Constructing a comprehensive evaluation model of acupuncture treatment of ischemic stroke recovery
1.1 Analysis of published literature of acupuncture treatment of ischemic stroke study for recent 10years
We obtained 799 articles from which we selected 83 into randomized study. Situation of using the standards:
(1)The neural function evaluation
All 83 study documents, have related neural function assessment scale, applied in the top four were the scoring standards of the 4th cerebrovascular disease meeting of stroke by 1995 (32/83,38.5%), the assessment standard of the 3nd cerebrovascular disease by 1986 (14/83,15.8%), the improved barthel index (13/83,15.6%) and Fugl-Meyer scale (8/83,9.6%).
(2)Syndromes index of TCM
There are 10 articles (12%) in all evaluating the syndromes effect assessment of ischemic stroke.
(3)Quality of life(QL)
There only 2 articles (2.4%) in all the documents reporting a final survival quality analysis of treatment.
(4)Destination end index
17 articles (20.5%) adopted ending index to evaluate, four articles (4.8%) reported a final disability incidence treatment; four papers (4.8%) for treatment of literature research kept 3-6 months of follow-up, including 3 articles reported the comparison of follow-up of the final neural function defect scale.Only 1 article reported follow-up of final mortality, dots and recurrence rate; nine articles (10.8%) reported the literature and compared the incidence of adverse acupuncture; there are 9 (10.8%) documents describing the standard that serious adverse reactions appeared, including 7 reports having no adverse reactions,2 reports having adverse reactions but better description.
(5)Substitution index
19 articles (22.9%) reported the changes of final physicochemical indexes, except for the observation of infarction area before and after treatments, TCD changes. More biological index observed, have hemorheology (4/83), malondialdehyde (3/83), endothelin (2/83), thrombosis, grain (2/83), prostaglandins (2/83) and super oxide of enzyme (2/guhya 83), etc.
On the whole, the selection of evaluation standards is in chaos and lack of acupuncture intervention from multiple dimensions of ischemic strokes curative effect. However, it is a serious work to build up a regular and acceptable evaluation.
1.2 The establishment of comprehensive evaluation model of acupuncture treatment of ischemic stroke recovery based on the Delphi method and the AHP
1.2.1 The first round of expert advice
The first round of expert advice were issued 15 questionnaires, ten copies of all questionnaire returned. And we withdraw all the questionnaires with complete requirements, whose recovery is 66.7%, experts actively coefficient is 66.7%, the expert's authority coefficient is 0.82. Using coordinate coefficient W inspection, Kendall coordinate coefficient W weigh.40, P< 0.01, show that the index rating with consistency by experts.
From the concentration standpoint coefficient reflecting importance's index, one class index of neural function, quality of life, the destination index, syndromes, physical and chemical index were 4.10±0.74、4.50±0.52、4.30±0.79、3.70±0.68、2.80±0.63. The physicochemical index hasn't reached screening standards, showing that experts generally agreed that it was not necessary to adopt it in acupuncture interventions in ischemic stroke recovery in the evaluation. In the secondary indexes, besides affiliate hemorrheology of physiochemical index and infarction area of changes, biochemical indicators are not reach screening standards, other dimensions secondary indexes all with satisfactory.
1.2.2 Second round of expert advice
The second round of expert-consulting has sent questionnaires, with 11 copies back of all 15. And the withdrawal questionnaires were all come up with complete requirements, questionnaire survey 73.3%, experts actively coefficient 73.3%, authority for 73.3%, Kendall coordinate coefficient W for 0.83, P< 0.01, pointed out t experts' grading with high consistency. The centralization, one class index of neural function, quality of life, the destination index, syndromes and physiochemical index concentration coefficient are respectively 4.46±0.52、4.73±0.47、4.55±0.52、4.18±0.41、3.09±0.70, physical and chemical index still hasn't reached screening standards.
After two previous rounds of expert consultation, meanwhile, after discussions from leading groups, we initially have established acupuncture treatment of ischemic stroke recovery efficacy evaluation system.
1.2.3 Third round of expert consultation
In order to improve the quality of Delphi method, letting experts fully express their ideas, this expert consultation's main purpose is to how to rate Saaty amd make explanations to experts with examples, and let experts try to fill the blanks, and notice problems, and correct them in time.
11 questionnaires in recovery, there were 3 copies finished inappropriately, compared with 72.7% accuracy of satty score. And the main problems are:(1) the performance in the binary compared with their mistakes, when rating assignment contradictions; (2) on the other hand they were appeared inconsistent, n and 1/n asymmetry. After the prompt communications, experts basically mastered specific rating process. 1.2.4 The fourth round of expert consultation
The main purpose of this experts'consultation of each index is Saaty. And ratings were issued, recovered 11 questionnaires which were all with complete requirements, that questionnaire survey was73.3%, experts actively coefficient was 73.3%, and the experts authority coefficient for 0.83, all indexes of Kendall inspection by expert assignment, coordinate coefficient for the 0.865, w. significant test, P< 0.01, presentation that expert assignment have very good consistency.
The final assignment is set by various medians defined by experts, establishing judgment matrix, calculating the initial weights and normalizing the weight coefficient, and the final determination. All that is concluded the preliminary linear model of comprehensive evaluation of acupuncture intervention ischemic stroke recovery are as follow: Among them:Y meant synthetic evaluation scores;
Clamps its X1 X2 X3, X4, respectively, said four primary index evaluation score;
X11, respectively X122 said the first primary index next 2 clamps its XI two-level index single score;
X31 X33 X32, respectively, said the third one class index next three X3 two-level index single score;
X42 X41, respectively for the first four primary index X4 said the two secondary indexes under single score.
2. Randomized study of acupuncture treatment of ischemic stroke recovery
2.1 Results of RCT
2.1.1 Baseline comparison
Age on admission gender proportion, and syndromes of TCM before treatment Barthel index, proportion, MRS score, SS-QOL NIHSS scores, TCM syndromes score, health rating scale of two groups of patients was not statistically significant by inspection, suggesting that the two groups of baseline have equilibrium.
2.1.2 Two groups NIHSS scores compared before and after treatment
After repeated measurement analysis of variance, the time between the two treatment groups have statistically significant changes to cope with different NIHSS scores. The treatment group was not better than control group in NIHSS scores reduction.
2.1.3 Comparisons of two groups before and after the treatment SS-QOL scores
After repeated measurement of anova, different treatment group changes between SS-QOL score are not statistically significant as the change of time. Compared with the control one, the treatment group have no statistical difference in increasing SS-QOL scoring.
2.1.4 Comparisons of TCM syndrome score of two groups before and after the treatment
After repeated measurement of anova, different treatment group of TCM syndrome scores'change have a statistically significant as the change of time. The treatment group in reducing syndromes scoring is not better than the control.
2.1.5 Comparisons of Two groups' traditional Chinese medicine health scale score before and after the treatment
After repeated measurement of anova, in the different group, TCM health scores'change was statistically significant along with time of change. The treatment group, compared with the control, was not statistically significant in reducing Chinese medicine health scoring.
2.1.6 Comparisons of two groups'Barthel index before and after treatment
Barthel index according to our state practices will have two classification variables (more than 60> divided into dependence, while<=60 independent) analysis, via a chi-square test, as compared with control, the treatment group Barthel scoring in improving was not statistically significant (P>0.05).
2.1.7 Comparisons of outcome events
(1)Mortality and morbidity at the end of follow-up
After 3-month telephone interview, two groups all did not appear deaths; MRS for disabled by over three, the treatment group 41 patients had 17 cases of disability (41.7%), the control group in 42 cases has 21 of disability (50%), which after a chi-square test was not statistically significant (P> 0.05).
(2)Recurrence
Three months later we have follow-up after discharge. The treatment group of 41 patients relapsing four (9.8%),42 patients relapsing 5 (11.9%), was not statistically significant (P> 0.05) by comparison.
(3)Adverse reaction rate
45 cases in treatment group having 2 persons (4.4 percent) appear no tolerance of pain and the control of 45 patients were all no serious adverse reactions.
2.1.8 Compliance analysis
Two people in the treatment group quit because of no tolerance of pain (adverse reaction), one person exits because of complications and stop acupuncturing and other rehabilitation treatment midway.1 person because patients'families want to exit; The control group has 2 because of complications and stop acupuncturing and of other rehabilitation therapy to exit test, and 1 person exits initiatively. 2.2 Results of Comprehensive evaluation
Two groups of each index numeric via after converting get normalized matrix value, finally going into the comprehensive evaluation equations respectively after normalized generation. It is concluded that the comprehensive evaluation value:the control group 0.48, the treatment group 0.42, treatments>controls, when displaying on the treatment scheme selection, the treatment group should be optimization.
Conclusion
1. Through the analysis of acupuncture treatment of ischemic stroke study published literature in recent 10 years, we find that acupuncture treatment of ischemic stroke in clinical research before with evaluation index selection are very casual, chaos. A lot of evaluation index selection have nothing in order and cannot reflect relevant research purpose. We should establish a set of scientific and reasonable efficacy evaluation system.
2. Based on the Delphi method and analytic hierarchy process, we constructed acupuncture intervention in ischemic stroke recovery efficacy evaluation system, and established the comprehensive evaluation model, finding that daily living skills, quality of life, the destination indicators acupuncture intervention ischemic stroke recovery is the most important effect assessment of evaluation index.
3. Through randomized study, we found that, compared with fake acupuncture, acupuncture can not improve patients'ischemic stroke neurologic deficits ratings and rating syndromes, at the same time, compared with a sham, acupuncture's serious adverse reactions have an increasing trend; In the closest of evaluation indicators with patients such as mortality, follow-up, daily living skills and living quality, acupuncture, show no advantage that we should discover more in the future.
4. Based on comprehensive evaluation value, we adopt comprehensive evaluation models:the treatment group (acupuncture combined with modern rehabilitation)have efficacy overall than in control group (sham acupuncture combined with modern rehabilitation), and suggest choosing it in ischemic stroke recovery during clinical practice;
5. Based on the characteristics of TCM complex intervention, the comprehensive evaluation model takes advantages of revealing them, and is suitable for different intervention scenario selections which deserves further promotion.
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