益气化痰开窍法合电刺激对卒中后吞咽障碍的临床研究
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摘要
研究背景
     脑卒中的发病率、致残率很高,严重危害着人类的健康生活。脑卒中急性期吞咽障碍的发生率为41%,慢性期为16%,脑干卒中吞咽障碍发生率为51%,存活的脑卒中患者中71%有吞咽困难。而吞咽障碍常导致多种严重并发症,如吸人性肺炎、脱水、营养不良、支气管痉挛、气道阻塞以及出现社会隔绝、抑郁等负性社会心理,从而严重影响病人的身心健康。尽管其发病率很高,但很少的患者得到吞咽障碍的正规诊断,其中很多患者发生严重的并发症,且医疗费用惊人。如何在临床上建立一种或几种治疗方案针对脑卒中后吞咽障碍患者进行确实有效的治疗,尤其是中西医结合治疗,使患者能够正常进食,并且运用标准化检查进行评价,有利于临床推广,将对我国国民经济和人民健康起到十分积极的影响。
     研究目的
     通过观察益气化痰开窍法合电刺激疗法对卒中后吞咽障碍的影响,以建立一种行之有效的中西医结合治疗方案。
     研究方法
     采用分层随机分组设计法,将符合纳入标准的患者按分期(口腔期为主、咽期为主)进行分层,再将各层内患者按随机法分为治疗组和对照组。每组按方案进行治疗,治疗前及治疗3周后分别进行洼田吞咽能力评定及VFSS检查进行评分,根据洼田吞咽能力评定及吞咽障碍的程度评分(根据VFSS评估)综合判断临床疗效。另外,两组于治疗前后皆接受心电图及胸片检查,记录治疗过程的不良反应,以对两种治疗方法的安全性进行评价。治疗疗程结束后,将收集的资料以双人双输形式输入计算机,用软件包SPSS13.0进行管理和统计分析。统计方法采用秩和检验。
     研究结果
     一、共纳入病例46例,治疗组23例,对照组23例。无脱落及死亡病例。两组洼田吞咽能力评定、吞咽障碍程度评分口腔期评分、咽期评分、总分评价治疗前后数据比较存在显著差异,P<0.01(表10),表明两组治疗方案在改善卒中后吞咽功能障碍上均有疗效。
     二、两组疗效比较,根据洼田吞咽能力评定疗效评价标准,治疗组治愈率为:13.0%,显效率为:44.5%,好转率为:30.5%,无效率为:13.0%,总有效率为:86.9%;对照组治愈率为:0%,显效率为:21.7%,好转率为:60.9%,无效率为:17.4%,总有效率为:82.6%。经秩和检验处理,两组疗效差异的比较有统计学意义,P<0.05(表8),表明两组对于脑卒中后吞咽障碍的治疗效果比较有差异,治疗组优于对照组。经秩和检验分析,治疗组和对照组治疗后的洼田吞咽能力分级组间存在差异,P<0.05(表11),说明对于提高洼田吞咽能力等级方面,治疗组优于对照组。
     根据吞咽障碍程度评分疗效评价标准,治疗组治愈率为:13.0%,显效率为:0%,好转率为:74.0%,无效率为:13.0%,总有效率为:86.9%;对照组治愈率为:0%,显效率为:0%,好转率为:78.3%,无效率为:21.7%,总有效率为:78.3%。经秩和检验处理,两组疗效差异的比较有统计学意义,P<0.05(表9),表明两组对于脑卒中后吞咽障碍的治疗效果比较有差异,治疗组优于对照组。而治疗组和对照组治疗前后吞咽障碍程度评分的口腔期评分、咽期评分、总分评价分别经秩和检验分析,治疗组与对照组组间无差异,P>0.05(表11),说明对于吞咽障碍程度评分的改善作用治疗组和对照组基本一致。两组治疗后的吞咽障碍程度评分虽未达统计学意义,但从图2、图3、图4所见,两组均有疗效,且治疗组经治疗后总分评分上升的幅度比对照组大,可认为两组组间疗效是有差异的趋势。
     三、治疗过程未见不良反应。
     结论
     益气化痰开窍法合电刺激疗法对卒中后吞咽障碍的疗效确切,且疗效比单纯电刺激的较好。研究过程未见不良反应,安全性较高,为脑卒中后吞咽障碍提供了一种安全有效的中西医结合治疗方案。
Background
     The incidence of stroke, high morbidity, seriously endangering the health of human life. Dysphagia's incidence rate appearing after acute stroke is 41%, within stroke chronic period is 16%, after brainstem stroke is 51%, About 71% of all stroke patients have dysphagia. dysphagia often leads to a variety of serious complications, such as human aspiration pneumonia, dehydration, malnutrition, bronchial spasm, airway obstruction and the emergence of social isolation, depression, And other negative social psychology, thus seriously affecting the patient's physical and mental health. Despite its high incidence rate, but few patients received the formal diagnosis of dysphagia, many of them with serious complications, and the staggering medical expenses. How the clinical treatment of the establishment of one or more of the programme for post-stroke patients with dysphagia really effective treatment, particularly in combining traditional Chinese and western medicine treatment, so that patients can eat normally, and use of standardized examination to evaluate and is conducive to the promotion of, China's national economy and on people's health, played a very positive impact.
     Objective
     By observing tonify qi and resolve phlegm to open the orifices combinding electrical stimulation treatment on the impact of dysphagia after stroke in order to establish an effective program of Integrative Medicine.
     Methods
     A stratified randomized controlled study method is used. The patients meeting the standards are devided into groups according to the disease phases (oral phase, pharyngeal phase), then within each layer are divided by random finto the treatment and control groups. By programme for each treatment, patients before treatment and after treatment three weeks are respectively given the assessment of swallowing ability and VFSS inspection, according to the assessment of swallowing ability and the extent of dysphagia which according to VFSS assessment for Clinical judgement. In addition, we could record the adverse reactions in the treatment of the two groups and evaluate the safety of the two treatment methods. After the end of the treatment course, two men will enter the collected information into the computer, using software packages SPSS13.0 management and statistical analysis. The statistical methods are used Wilcoxon rank test.
     The results
     1. Cases included a total of 46 cases, that the treatment group of 23 cases and 23 cases of the control group. No cases of loss and death. In two groups before and after the treatment of the assessment of swallowing ability, oral contrast period score, pharynx period score, and score of the extent of dysphagia there were significant differences,P<0.01 (Table 10), and this study shows that the two regimens in improving swallowing dysfunction after stroke effect on both.
     2. Comparison of the two groups, according to the assessment of swallowing ability, the treatment group for the cure rate:13.0%, significant efficiency: 44.5%, efficiency:30.5%, non-efficiency:13.0%, and the total efficiency: 86.9%; control group cure rate:0%, significant efficiency:21.7%, efficiency: 60.9%, non-efficiency:17.4%, the total efficiency:82.6%. The Wilcoxon rank test shows P< 0.05 (Table 8)of the effect of the two groups, and this study shows that the effect of the two groups for post-stroke dysphagia treatment is difference, treatment group than the control group. The Wilcoxon rank test shows that the treatment group and control group which is after certain treatment were graded with the assessment of swallowing ability indicates differences between, P<0.05 (Table 11), simultaneously shows that the treatment group is more effective raising swallowing ability than the control group
     According to the extent of dysphagia, the treatment group for the cure rate:13.0%, significant efficiency:0%, efficiency:74.0%, non-efficiency: 13.0%, and the total efficiency:86.9%; control group cure rate:0%, significant efficiency:0%, efficiency:78.3%, non-efficiency:21.7%, the total efficiency:78.3%. Wilcoxon rank test shows P< 0.05 (Table 9)of the effect of the two groups, and this study shows that the effect of the two groups for post-stroke dysphagia treatment is different, treatment group than the control group. The dysphagia scores of treatment group and control group before and after treatment (Including oral phase score, pharyngeal phase score, and the total phase score) are analysed by rank sum test. The result shows no difference between scores of treatment and control groups, P>0.05 (Table 11), indicating those two groups'dysphagia severity score cannot represent any difference between. Although the improving part scores of two groups showed no statistic significance, in Figure 2, Figure 3 and Figure 4 can introduce that both of the two groups are effectively treated and the treatment group summed score reaches higher, which indicating these two groups have the trend to differ.
     3. In the treatment process group only one case of a pinhole subcutaneous bleeding and hemorrhage occurred in electro-acupuncture group, without finding such as adverse reactions and so on in other patients.
     Conclusion
     Tonify qi and resolve phlegm to open the orifices combinding electrical stimulation treatment on dysphagia after stroke is proven effectively, and better than the electrical stimulation. Course of the study shows safty and no adverse reactions, provides a safe and effective treatment of Integrative Medicine.
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