电针结合穴位敷贴治疗缺血性脑卒中偏瘫的疗效观察
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摘要
缺血性中风具有发病率高、致残率高、死亡率高的特点,作为脑血管疾病的常见病之一,是世界范围危害极大、函待攻克的一种疾病。鉴于此,探索缺血性中风的治疗方法是基础医学和临床医学的重要课题。中医药防治缺血性中风有一定优势,其中穴位敷贴疗法通过药物刺激相应的穴位而发挥药物和穴位经络的双重治疗作用。但一直未有系统的临床疗效和实验机理的研究。本课题通过采用临床研究科学方法,客观评估电针与穴位贴敷疗法对缺血性脑卒中偏瘫的疗效,为缺血性中风的治疗提供新的思路。
目的：
本课题采用临床科研方法学,进行随机对照研究,以康复治疗作为基础治疗,以常规电针作为对照,观察电针结合穴位敷贴治疗缺血性脑卒中偏瘫肢体运动功能和日常生活活动能力的影响,观察电针结合穴位敷贴与电针治疗缺血性脑卒中偏瘫的临床疗效的差异,探讨偏瘫的治疗作用机理,为缺血性中风偏瘫治疗提供一定的临床依据。
方法：
收集2009年10月至2012年1月期间在台湾骏安中医诊所病人,脑梗死后两星期至半年遗留偏瘫的患者共72例,男40例,女32例。按1：1的比例随机分配至电针结合穴位敷贴组、电针组,其中电针结合穴位敷贴组36例,电针组36例。西医诊断标准参照中华医学会2009年编著《临床诊疗指南·神经病学分册》中所拟定的有关脑梗塞的诊断标准,中医诊断标准采用国家中医药管理局脑病急症科研协作组制订的《中风病诊断和疗效评定标准》(试行)进行诊断。所有符合纳入标准病例按设计要求观察、治疗。疗程28天。电针：每周针刺3次,共治疗4周；穴位敷贴：每日1次,共治疗4周；康复治疗：每周5次,休息2天再继续治疗,共治疗4周。疗效观察具体项目包括：《中药新药治疗中风病的临床研究指导原则》制定脑卒中病主要症状分级量化表、神经功能缺损评分、Fugl-Meyer运动功能评分法、日常生活活动能力(巴氏BI指数法)及功能综合评定(FCA)。疗效评定标准主要参考《中药新药治疗中风病的临床研究指导原则》的中医证候疗效评定标准及全国第四届脑血管病学术会议通过的《脑卒中患者临床神经功能缺损程度评分标准(1995)》。
数据分析采用统计软件SPSS17.O。计量资料用均数±标准差(x±S)表示,计数资料用构成比(%)表示；计量资料的组间比较采用t检验,自身前后比较用配对样本t检验。分类资料组间比较采用χ2检验,等级资料组间比较采用Ridit分析。
结果：
治疗前电针结合穴位敷贴组、电针组的性别、年龄、病程、中医证型、中医症状积分、神经功能缺损评分、Fugl-Meyer运动功能评分、巴氏BI指数、功能综合评定(FCA)得分经分析均无统计学上的差异,说明电针结合穴位敷贴组与电针组间的一般基线资料具有可比性。疗效观察指标、疗效评定结果如下：
一、中医症状各项评分
各中医症状积分方面,电针结合穴位敷贴组治疗前后相比较得分有所下降(P<0.05),其中在改善患者半身不遂、肢体麻木、舌强语謇、头晕头痛方面疗效显著(P<0.01)；电针组疗前后各中医症状积分相比较除心烦易怒外,其余各项中医症状积分差异均有统计学意义(P<0.05)。
二、中医症状总积分
在改善缺血性脑卒中偏瘫患者中医症状方面,电针结合穴位敷贴治疗在治疗14天后,中医症状有所改善(P<0.01),而治疗28天后中医症状改善效果尤为明显(P<0.01)；电针治疗在14天虽可改善偏瘫患者中医症状(P<0.01),但在治疗28天后疗效与治疗14天后无明显变化(P>0.05)。电针结合穴位敷贴在改善缺血性脑卒中偏瘫患者中医症状方面优于单用电针组(P<0.01)。
三、神经功能缺损评分
在降低缺血性脑卒中偏瘫患者神经功能缺损程度评分方面,电针结合穴位敷贴组在治疗14天后,神经功能缺损程度有所改善(P<0.05),而治疗28天后神经功能缺损评分改善效果尤为明显(P<0.01)；电针治疗缺血性脑卒中偏瘫患者在治疗14天后效果不明显(P>0.05),但治疗28天后神经功能缺损评分有显著下降(P<0.01)。两组对于改善缺血性脑卒中偏瘫患者神经功能缺损程度评分均有一定疗效,但以电针结合穴位敷贴治疗的效果最为显著(P<0.01)。
四、Fugl-Meyer运动功能评分
在改善缺血性脑卒中偏瘫患者的日常生活活动能力方面,电针结合穴位敷贴治疗在治疗28天后改善幅度显著(P<0.01)；治疗14天后,电针对升高缺血性脑卒中偏瘫患者巴氏BI指数评分有改善(P<0.01),但28天治疗后改善幅度进一步上升(P>0.05)。电针结合穴位敷贴治疗对于改善缺血性脑卒中偏瘫患者的日常生活活动能力效果比电针治疗效果较佳(P<0.01)。
五、日常生活活动能力评定(巴氏BI指数评分)
在改善缺血性脑卒中偏瘫患者的日常生活活动能力方面,电针结合穴位敷贴治疗在治疗28天后改善幅度显著(P<0.01)；治疗14天后,电针对升高缺血性脑卒中偏瘫患者巴氏BI指数评分有改善(P<0.01),但28天治疗后改善幅度进一步上升(P>0.05)。电针结合穴位敷贴治疗对于改善缺血性脑卒中偏瘫患者的日常生活活动能力效果比电针治疗效果较佳(P<0.01)。
六、功能综合评定(FCA)
治疗14天后,电针结合穴位敷贴对改善缺血性脑卒中偏瘫患者功能综合评定有一定疗效(P<0.05),而电针治疗改善不明显(P>0.05),治疗28天后,电针组脑卒中偏瘫患者功能综合评定得分改善(P<0.05)。电针结合穴位敷贴治疗对于改善缺血性脑卒中偏瘫患者的功能综合评分效果比电针治疗较佳。
七、中医证候疗效
电针结合穴位敷贴组痊愈人数2人、占5.56%,显效人数19人、占52.78%,有效人数12人、占33.33%,无效人数3人,占8.33%,总有效率为91.67%；电针组痊愈人数1人、占2.78%,显效人数8人、占22.22%,有效人数21人、占58.33%,无效人数6人,占16.67%,总有效率为83.33%。经Ridit分析,Z=3.45,比较有统计学意义(P<0.01),电针结合穴位贴敷组总体疗效优于电针组。其中,电针结合穴位贴敷组显效率显著高于电针组(P<0.01)。提示：在改善缺血性脑卒中偏瘫患者的中医证侯疗效方面,电针结合穴位敷贴治疗与电针治疗相比较,临床疗效较好,能够提高患者治疗的显效率。
八、神经功能临床疗效
电针结合穴位敷贴组痊愈人数3人、占8.33%,显效人数15人、占41.67%,有效人数16人、占44.44%,无效人数2人,占5.56%,总有效率为94.44%；电针组痊愈人数0人、占0.0%,显效人数7人、占19.44%,有效人数22人、占61.11%,无效人数7人,占19.44%,总有效率为80.55%。经Ridit分析,Z=3.45,比较有统计学意义(P<0.01),电针结合穴位贴敷组总体疗效优于电针组。其中,电针结合穴位贴敷组显效率显著高于电针组(P<0.05)。提示：在改善缺血性脑卒中偏瘫患者的神经功能临床疗效方面,电针结合穴位敷贴治疗与电针治疗相比较,临床疗效较好,能够提高患者治疗的显效率。
结论：
在我国,每年死于脑血管病的人数约为150万人,其是现今人类死亡率最高的三大疾病之一,也是三大疾病中发病最快、致残最重、死亡最多的病种。很多病人常常因不能坚持而导致治疗的失败。因而寻找一种有效、作用持续久、病人依从性好的疗法,有着重要的意义。
本研究是在以往研究的基础上,立足针灸与中药疗效的结合,以缺血性中风偏瘫患者为研究对象,整合优化针灸、中西医以往的研究成果,通过严谨的流行病学／循证医学方法设计,采用随机对照的研究方法的原则,对缺血性中风偏瘫进行系统地、深入地研究,探索选穴、操作方法、疗程与疗效的关系,更能准确体现该法的有效性。
电针与穴位敷贴这两种疗法的有机结合,能够更好的促进患者神经功能缺损的改善,提高缺血性中风偏瘫患者的生活质量,与单独使用电针疗法比较均有统计学差异,说明电针结合穴位敷贴疗法在治疗缺血性卒中偏瘫方面能够相互促进,相得益彰。电针结合穴位敷贴疗法无需服药,患者痛苦少,疗效显著,患者容易接受,是一种有效、快捷、经济、疗效持久、无毒副作用的治疗方法。
Ischemic stroke is the main type of stroke, its high incidence, high mortality, and thigh morbidity, making it to be a disease which has done great harm in the world-wide and difficult to be overcome. Thereby, the study and treatment of ischemic stroke is an important issue of basic medicine and clinical medicine. The prevention of ischemic stroke by Chinese medicine has certain advantages and acupoint application through specific drugs stimulating specific acupoint, it plays a dual therapeutic effect. However, there never been having a systematic clinical and experimental researchs about it. This study aimed at an objective assessment of acupoint application therapy for ischemic stroke hemiplegia, clinical efficacy, and experimental methods and mechanisms.
Objective
The subject used the clinical epidemiology, clinical research methodology and statistical analysis of mathematical methods, and randomized controlled study. The electric acupuncture is control group, and rehabilitation is a basis of treatment. Through the observation of the clinical effect of electroacupuncture combined with acupoints application on treating hemiplegia due to ischemic stroke, to investigate the differences among electroacupuncture combined with acupoints application, electric acupuncture, and their curative mechanisms, so as to provide a clinical basis for treating hemiplegia due to ischemic stroke.
Methods
The patients were selected from clinic and hospital during October2009to January2012.72patients who suffered cerebral infarction after two weeks to six months left over from hemiplegia were collected, the ration of l:lwere randomly allocated to the electroacupuncture combined with acupoints application, electric acupuncture groups, which included36patients in electroacupuncture combined with acupoints application group,36patients in electric acupuncture group. Western diagnostic criteria issued referred to the ischemic cerebravascular disease diagnostic criteria in Neurology Volume of the clincal practice guideline which agreed by Chinese Medical Associationin2009. TCM diagnostic criteria referred to the stroke diagnosis and evaluation standard which agreed by the State Administration of Traditional Chinese Medicine encephalopathy acute collaborative research group. All patients met the inclusion criteria according to design requirements observation and treatment. Treatment for a course of28days, electroacupunture:3times a week,4weeks a course; acupoint application: once a day,4weeks a course; rehabilition:5times a week, continue the treatmen after2d rest,4weeks a course. Efficacy of specific items include: the main symptoms of stroke disease classification quantization table established by the guiding principles of Traditional Chinese Drug treatment of stroke clinical research, neurological deficit score, the score of the Fugl-Meyer motor function, activities of daily living(BI index) and functional comprehensive assessment (FCA). Efficacy evaluation standars referred to TCM syndrome efficacy criteria in the guiding principles of Traditional Chinese Drug treatment of stroke clinical research and the clinical neurologic impairment score in the4th National Cerebravascular Disease Conference (1995).
Data analysis used SPSS17.0software for statistical analysis. Measurement data used in forming the mean±standard deviation (χ±S), and the count data used in forming ration (%); Measurement data groups were compared using t test, before and after their use paired t test or Wilcoxon paired rank sum test. Segment information is used to compare groups χ~2test, ranked data was used to compare between the two groups Kruskal-Wallis H rank sum test.
Results
1. Chinese medicine symptoms of the score
The Chinese medicine symptoms of the score of electroacupuncture combined with acupoint application group was statistically significant compared to treatment before(P<0.05), especially in improving hemiplegia, limbs numbness, aphasia, dizziness and headache. Ecept for irritability, the chinese medicine symptoms of the score of electroacupuncture group was statistically significant compared to treatment before (P<0.05)
2. TCM symptoms total score
After14days treatment, the TCM symptoms total score of electroacupuncture combined with acupoint appl ication group was significantly reduced compared with before treatment (P<0.05). EA group compared with before treatment was also statistically significant (P<0.05). But the TCM symptoms total score of the rehabilitation group didn't reduce so much (P>0.05).After14days treatment, the TCM symptoms total score of electroacupuncture combined with acupoint application group was obviously reduced compared with before treatment (P<0.01). It suggested that after14days treatment, the electroacupuncture combined with acupoint application can lower the TCM symptoms total score of hemiplagia patients due to ischemic stroke. After28days treatment, the therapeutic effect of electroacupuncture combined with acupoint application got better. Eletric acupuncture treatment can ameliorate hemiplagia patients'TCM symptoms after14days treatment, but after28days treatment there was not prominent changes.
3. Neurological deficit score
For decreasing the neurological deficit score of hemiplagia patient by ischemic stroke, the neurological deficit degree was improved in electroacupuncture combined with acupoint application group after14days treatment, and it was more statistically significant after28days treatment. The neurological deficit score of electroacupuncture group and rehabilitation group was not statistically significant after14days treatment, but it was significant reduced after28days treatment.
After14days treatment, the differences among three groups were not tatistically significant (P>0.05). However, the differences among three groups were tatistically significant (P<0.05). It illustrated that after28days treatment, two groups all had the therapeutic effect on reduce the neurological deficit score of hemiplagia patient by ischemic stroke, and the effect of electroacupuncture combined with acupoint application was the best.
4. The score of the Fugl-Meyer motor function
For increasing the score of the Fugl-Meyer motor function of hemiplagia patient by ischemic stroke, electroacupuncture combined with acupoint application group got the obvious therapeutic effect after14days treatment, and it was more statistically significant after28days treatment. The electric acupuncture can ameliorate limbs motor function after14days treatment. However, for the observation of long-term efficacy, the degree of limb motor function improvement is not obvious.
After14days treatment, the score difference of the Fugl-Meyer motor function among two groups was not statistically significant (P>0.05). After28days treatment, compared to electric acupuncture group, the score of the electroacupuncture combined with acupoint application group was statistically significant (P<0.05). It suggested that for the observation of long-term efficacy, compared to electric acupuncture group, the electroacupuncture combined with acupoint application can get the better effect than simple electroacupuncture treatment for improving limbs motor function.
5. Activities of daily living (BI index)
For improving the activities of daily living of hemiplegia patients due to ischemic stroke, the electroacupuncture combined with acupoint application group was statistically significant after28days treatment. After14days treatment, electroacupuncture treatment can increase BI index of hemiplegia patients due to ischemic stroke (P<0.05), and was obviously significant after28days treatment.
After14days treatment, activities score of daily living (BI index) among electroacupuncture combined with acupoint application, electroacupuncture was not statistically significant (P>0.05). After28days treatment, compared to electroacupuncture group, electroacupuncture combined with acupoint application group can improve activities score of daily living better (P<0.05). It suggested that after28days treatment, electroacupuncture combined with acupoint application group can improve activities score of daily living better.
6. Functional comprehensive assessment (FCA)
For improving functional comprehensive assessment (FCA), electroacupuncture combined with acupoint application got certain therapeutic effect after14days treatment, electroacupuncture was not statistically significant(P>0.05). After28days treatment, electroacupuncture can improve functional comprehensive assessment (FCA) better(P<0.05).It suggested that electroacupuncture combined with acupoint application group electroacupuncture combined with acupoint application group can can improve functional comprehensive assessment (FCA) better than electroacupuncture.
7. TCM syndrome
Two groups by Kruskal-Wallis H rank sum test,H=14.31, P=0.026, was statistically significant (P<0.05), in which the number of the electroacupuncture combined with acupoint application group cured2people,8.3%, recovered9people,37.5%,50.0%(12people) improvement in the number, invalid number of4.2%(1people). The total effective rate was95.8%. The number of the EA group cured1people,4.2%, recovered12.5%(3people),45.8%(11people) improvement in the number, invalid number of37.5%(9people). The total effective rate was62.5%. It demonstrated that compared to the electric acupuncture, the electroacupuncture combined with acupoint application was better therapy for improving the TCM syndrome of hemiplagia due to ischemic stroke.
8. Two groups by Radit analysis, Z=3.45, was statistically significant (P <0.05), in which the number of The ectroacuputure combined with acupoint application group cured3people,8.33%, recovered15people,44.4%(16people) improvement in the number, invalid number of8.3%(2people). The total effective rate was94.4%. The number of the EA group cured1people,0.0%, recovered19.44%(7people),61.11%(23people) improvement in the number, invalid number of19.44%(7people). The total effective rate was80.55%. It demonstrated that compared to the electricacupuncture treatment, the electroacupuncture combined with acupoint application was better therapy for improving the nerve function of clinical efficacy of hemiplagia due to ischemic stroke.
Conclusion
Stroke is a common disease, frequently-occurring disease, is today one of the highest of the three diseases in human mortality, but also the fastest three disease incidence, recovery of the slowest, deathmost disabling the heaviest disease. Many patients often can not insist as a result of treatment failure. Therefore looking for an effective and sustained for a long time, the role of patient compliance and good therapy, has an important significance.
This study is based on acupuncture and traditional Chinese medicines on the basis of previous studies, the combination of ischemic stroke patients with hemiplegia, integration and optimization of acupuncture, Chinese and Western previous researche results, through rigorous epidemiology/evidence-based medicine methodsdesign, using the principles of the randomized controlled study of ischemic stroke hemiplegia system and in-depth study, to explore the relationship of point selection, methods of operation, treatmen efficacy more accurately reflect the effectiveness of the law.
Electroacupuncture combined with acupoint application the organic combination of the two treatmens, after the accumulation of a certain amount of time to treatment, better able to promote the improvement of neurologic impairment, improve the quality of life in patients with EA alone or rehabilitation statistically significant, indicated that electroacupuncture combined with acupoint application in the treatment of ischemic stroke hemiplegia can promote each other and complement each other. Electroacupuncture combined with acupoint application without medication, less pain, a significant effect in patients with easy to accept, is an effective, efficient, economic, lasting effect, non-toxicside effects of treatment.
目的：
本课题采用临床科研方法学,进行随机对照研究,以康复治疗作为基础治疗,以常规电针作为对照,观察电针结合穴位敷贴治疗缺血性脑卒中偏瘫肢体运动功能和日常生活活动能力的影响,观察电针结合穴位敷贴与电针治疗缺血性脑卒中偏瘫的临床疗效的差异,探讨偏瘫的治疗作用机理,为缺血性中风偏瘫治疗提供一定的临床依据。
方法：
收集2009年10月至2012年1月期间在台湾骏安中医诊所病人,脑梗死后两星期至半年遗留偏瘫的患者共72例,男40例,女32例。按1：1的比例随机分配至电针结合穴位敷贴组、电针组,其中电针结合穴位敷贴组36例,电针组36例。西医诊断标准参照中华医学会2009年编著《临床诊疗指南·神经病学分册》中所拟定的有关脑梗塞的诊断标准,中医诊断标准采用国家中医药管理局脑病急症科研协作组制订的《中风病诊断和疗效评定标准》(试行)进行诊断。所有符合纳入标准病例按设计要求观察、治疗。疗程28天。电针：每周针刺3次,共治疗4周；穴位敷贴：每日1次,共治疗4周；康复治疗：每周5次,休息2天再继续治疗,共治疗4周。疗效观察具体项目包括：《中药新药治疗中风病的临床研究指导原则》制定脑卒中病主要症状分级量化表、神经功能缺损评分、Fugl-Meyer运动功能评分法、日常生活活动能力(巴氏BI指数法)及功能综合评定(FCA)。疗效评定标准主要参考《中药新药治疗中风病的临床研究指导原则》的中医证候疗效评定标准及全国第四届脑血管病学术会议通过的《脑卒中患者临床神经功能缺损程度评分标准(1995)》。
数据分析采用统计软件SPSS17.O。计量资料用均数±标准差(x±S)表示,计数资料用构成比(%)表示；计量资料的组间比较采用t检验,自身前后比较用配对样本t检验。分类资料组间比较采用χ2检验,等级资料组间比较采用Ridit分析。
结果：
治疗前电针结合穴位敷贴组、电针组的性别、年龄、病程、中医证型、中医症状积分、神经功能缺损评分、Fugl-Meyer运动功能评分、巴氏BI指数、功能综合评定(FCA)得分经分析均无统计学上的差异,说明电针结合穴位敷贴组与电针组间的一般基线资料具有可比性。疗效观察指标、疗效评定结果如下：
一、中医症状各项评分
各中医症状积分方面,电针结合穴位敷贴组治疗前后相比较得分有所下降(P<0.05),其中在改善患者半身不遂、肢体麻木、舌强语謇、头晕头痛方面疗效显著(P<0.01)；电针组疗前后各中医症状积分相比较除心烦易怒外,其余各项中医症状积分差异均有统计学意义(P<0.05)。
二、中医症状总积分
在改善缺血性脑卒中偏瘫患者中医症状方面,电针结合穴位敷贴治疗在治疗14天后,中医症状有所改善(P<0.01),而治疗28天后中医症状改善效果尤为明显(P<0.01)；电针治疗在14天虽可改善偏瘫患者中医症状(P<0.01),但在治疗28天后疗效与治疗14天后无明显变化(P>0.05)。电针结合穴位敷贴在改善缺血性脑卒中偏瘫患者中医症状方面优于单用电针组(P<0.01)。
三、神经功能缺损评分
在降低缺血性脑卒中偏瘫患者神经功能缺损程度评分方面,电针结合穴位敷贴组在治疗14天后,神经功能缺损程度有所改善(P<0.05),而治疗28天后神经功能缺损评分改善效果尤为明显(P<0.01)；电针治疗缺血性脑卒中偏瘫患者在治疗14天后效果不明显(P>0.05),但治疗28天后神经功能缺损评分有显著下降(P<0.01)。两组对于改善缺血性脑卒中偏瘫患者神经功能缺损程度评分均有一定疗效,但以电针结合穴位敷贴治疗的效果最为显著(P<0.01)。
四、Fugl-Meyer运动功能评分
在改善缺血性脑卒中偏瘫患者的日常生活活动能力方面,电针结合穴位敷贴治疗在治疗28天后改善幅度显著(P<0.01)；治疗14天后,电针对升高缺血性脑卒中偏瘫患者巴氏BI指数评分有改善(P<0.01),但28天治疗后改善幅度进一步上升(P>0.05)。电针结合穴位敷贴治疗对于改善缺血性脑卒中偏瘫患者的日常生活活动能力效果比电针治疗效果较佳(P<0.01)。
五、日常生活活动能力评定(巴氏BI指数评分)
在改善缺血性脑卒中偏瘫患者的日常生活活动能力方面,电针结合穴位敷贴治疗在治疗28天后改善幅度显著(P<0.01)；治疗14天后,电针对升高缺血性脑卒中偏瘫患者巴氏BI指数评分有改善(P<0.01),但28天治疗后改善幅度进一步上升(P>0.05)。电针结合穴位敷贴治疗对于改善缺血性脑卒中偏瘫患者的日常生活活动能力效果比电针治疗效果较佳(P<0.01)。
六、功能综合评定(FCA)
治疗14天后,电针结合穴位敷贴对改善缺血性脑卒中偏瘫患者功能综合评定有一定疗效(P<0.05),而电针治疗改善不明显(P>0.05),治疗28天后,电针组脑卒中偏瘫患者功能综合评定得分改善(P<0.05)。电针结合穴位敷贴治疗对于改善缺血性脑卒中偏瘫患者的功能综合评分效果比电针治疗较佳。
七、中医证候疗效
电针结合穴位敷贴组痊愈人数2人、占5.56%,显效人数19人、占52.78%,有效人数12人、占33.33%,无效人数3人,占8.33%,总有效率为91.67%；电针组痊愈人数1人、占2.78%,显效人数8人、占22.22%,有效人数21人、占58.33%,无效人数6人,占16.67%,总有效率为83.33%。经Ridit分析,Z=3.45,比较有统计学意义(P<0.01),电针结合穴位贴敷组总体疗效优于电针组。其中,电针结合穴位贴敷组显效率显著高于电针组(P<0.01)。提示：在改善缺血性脑卒中偏瘫患者的中医证侯疗效方面,电针结合穴位敷贴治疗与电针治疗相比较,临床疗效较好,能够提高患者治疗的显效率。
八、神经功能临床疗效
电针结合穴位敷贴组痊愈人数3人、占8.33%,显效人数15人、占41.67%,有效人数16人、占44.44%,无效人数2人,占5.56%,总有效率为94.44%；电针组痊愈人数0人、占0.0%,显效人数7人、占19.44%,有效人数22人、占61.11%,无效人数7人,占19.44%,总有效率为80.55%。经Ridit分析,Z=3.45,比较有统计学意义(P<0.01),电针结合穴位贴敷组总体疗效优于电针组。其中,电针结合穴位贴敷组显效率显著高于电针组(P<0.05)。提示：在改善缺血性脑卒中偏瘫患者的神经功能临床疗效方面,电针结合穴位敷贴治疗与电针治疗相比较,临床疗效较好,能够提高患者治疗的显效率。
结论：
在我国,每年死于脑血管病的人数约为150万人,其是现今人类死亡率最高的三大疾病之一,也是三大疾病中发病最快、致残最重、死亡最多的病种。很多病人常常因不能坚持而导致治疗的失败。因而寻找一种有效、作用持续久、病人依从性好的疗法,有着重要的意义。
本研究是在以往研究的基础上,立足针灸与中药疗效的结合,以缺血性中风偏瘫患者为研究对象,整合优化针灸、中西医以往的研究成果,通过严谨的流行病学／循证医学方法设计,采用随机对照的研究方法的原则,对缺血性中风偏瘫进行系统地、深入地研究,探索选穴、操作方法、疗程与疗效的关系,更能准确体现该法的有效性。
电针与穴位敷贴这两种疗法的有机结合,能够更好的促进患者神经功能缺损的改善,提高缺血性中风偏瘫患者的生活质量,与单独使用电针疗法比较均有统计学差异,说明电针结合穴位敷贴疗法在治疗缺血性卒中偏瘫方面能够相互促进,相得益彰。电针结合穴位敷贴疗法无需服药,患者痛苦少,疗效显著,患者容易接受,是一种有效、快捷、经济、疗效持久、无毒副作用的治疗方法。
Ischemic stroke is the main type of stroke, its high incidence, high mortality, and thigh morbidity, making it to be a disease which has done great harm in the world-wide and difficult to be overcome. Thereby, the study and treatment of ischemic stroke is an important issue of basic medicine and clinical medicine. The prevention of ischemic stroke by Chinese medicine has certain advantages and acupoint application through specific drugs stimulating specific acupoint, it plays a dual therapeutic effect. However, there never been having a systematic clinical and experimental researchs about it. This study aimed at an objective assessment of acupoint application therapy for ischemic stroke hemiplegia, clinical efficacy, and experimental methods and mechanisms.
Objective
The subject used the clinical epidemiology, clinical research methodology and statistical analysis of mathematical methods, and randomized controlled study. The electric acupuncture is control group, and rehabilitation is a basis of treatment. Through the observation of the clinical effect of electroacupuncture combined with acupoints application on treating hemiplegia due to ischemic stroke, to investigate the differences among electroacupuncture combined with acupoints application, electric acupuncture, and their curative mechanisms, so as to provide a clinical basis for treating hemiplegia due to ischemic stroke.
Methods
The patients were selected from clinic and hospital during October2009to January2012.72patients who suffered cerebral infarction after two weeks to six months left over from hemiplegia were collected, the ration of l:lwere randomly allocated to the electroacupuncture combined with acupoints application, electric acupuncture groups, which included36patients in electroacupuncture combined with acupoints application group,36patients in electric acupuncture group. Western diagnostic criteria issued referred to the ischemic cerebravascular disease diagnostic criteria in Neurology Volume of the clincal practice guideline which agreed by Chinese Medical Associationin2009. TCM diagnostic criteria referred to the stroke diagnosis and evaluation standard which agreed by the State Administration of Traditional Chinese Medicine encephalopathy acute collaborative research group. All patients met the inclusion criteria according to design requirements observation and treatment. Treatment for a course of28days, electroacupunture:3times a week,4weeks a course; acupoint application: once a day,4weeks a course; rehabilition:5times a week, continue the treatmen after2d rest,4weeks a course. Efficacy of specific items include: the main symptoms of stroke disease classification quantization table established by the guiding principles of Traditional Chinese Drug treatment of stroke clinical research, neurological deficit score, the score of the Fugl-Meyer motor function, activities of daily living(BI index) and functional comprehensive assessment (FCA). Efficacy evaluation standars referred to TCM syndrome efficacy criteria in the guiding principles of Traditional Chinese Drug treatment of stroke clinical research and the clinical neurologic impairment score in the4th National Cerebravascular Disease Conference (1995).
Data analysis used SPSS17.0software for statistical analysis. Measurement data used in forming the mean±standard deviation (χ±S), and the count data used in forming ration (%); Measurement data groups were compared using t test, before and after their use paired t test or Wilcoxon paired rank sum test. Segment information is used to compare groups χ~2test, ranked data was used to compare between the two groups Kruskal-Wallis H rank sum test.
Results
1. Chinese medicine symptoms of the score
The Chinese medicine symptoms of the score of electroacupuncture combined with acupoint application group was statistically significant compared to treatment before(P<0.05), especially in improving hemiplegia, limbs numbness, aphasia, dizziness and headache. Ecept for irritability, the chinese medicine symptoms of the score of electroacupuncture group was statistically significant compared to treatment before (P<0.05)
2. TCM symptoms total score
After14days treatment, the TCM symptoms total score of electroacupuncture combined with acupoint appl ication group was significantly reduced compared with before treatment (P<0.05). EA group compared with before treatment was also statistically significant (P<0.05). But the TCM symptoms total score of the rehabilitation group didn't reduce so much (P>0.05).After14days treatment, the TCM symptoms total score of electroacupuncture combined with acupoint application group was obviously reduced compared with before treatment (P<0.01). It suggested that after14days treatment, the electroacupuncture combined with acupoint application can lower the TCM symptoms total score of hemiplagia patients due to ischemic stroke. After28days treatment, the therapeutic effect of electroacupuncture combined with acupoint application got better. Eletric acupuncture treatment can ameliorate hemiplagia patients'TCM symptoms after14days treatment, but after28days treatment there was not prominent changes.
3. Neurological deficit score
For decreasing the neurological deficit score of hemiplagia patient by ischemic stroke, the neurological deficit degree was improved in electroacupuncture combined with acupoint application group after14days treatment, and it was more statistically significant after28days treatment. The neurological deficit score of electroacupuncture group and rehabilitation group was not statistically significant after14days treatment, but it was significant reduced after28days treatment.
After14days treatment, the differences among three groups were not tatistically significant (P>0.05). However, the differences among three groups were tatistically significant (P<0.05). It illustrated that after28days treatment, two groups all had the therapeutic effect on reduce the neurological deficit score of hemiplagia patient by ischemic stroke, and the effect of electroacupuncture combined with acupoint application was the best.
4. The score of the Fugl-Meyer motor function
For increasing the score of the Fugl-Meyer motor function of hemiplagia patient by ischemic stroke, electroacupuncture combined with acupoint application group got the obvious therapeutic effect after14days treatment, and it was more statistically significant after28days treatment. The electric acupuncture can ameliorate limbs motor function after14days treatment. However, for the observation of long-term efficacy, the degree of limb motor function improvement is not obvious.
After14days treatment, the score difference of the Fugl-Meyer motor function among two groups was not statistically significant (P>0.05). After28days treatment, compared to electric acupuncture group, the score of the electroacupuncture combined with acupoint application group was statistically significant (P<0.05). It suggested that for the observation of long-term efficacy, compared to electric acupuncture group, the electroacupuncture combined with acupoint application can get the better effect than simple electroacupuncture treatment for improving limbs motor function.
5. Activities of daily living (BI index)
For improving the activities of daily living of hemiplegia patients due to ischemic stroke, the electroacupuncture combined with acupoint application group was statistically significant after28days treatment. After14days treatment, electroacupuncture treatment can increase BI index of hemiplegia patients due to ischemic stroke (P<0.05), and was obviously significant after28days treatment.
After14days treatment, activities score of daily living (BI index) among electroacupuncture combined with acupoint application, electroacupuncture was not statistically significant (P>0.05). After28days treatment, compared to electroacupuncture group, electroacupuncture combined with acupoint application group can improve activities score of daily living better (P<0.05). It suggested that after28days treatment, electroacupuncture combined with acupoint application group can improve activities score of daily living better.
6. Functional comprehensive assessment (FCA)
For improving functional comprehensive assessment (FCA), electroacupuncture combined with acupoint application got certain therapeutic effect after14days treatment, electroacupuncture was not statistically significant(P>0.05). After28days treatment, electroacupuncture can improve functional comprehensive assessment (FCA) better(P<0.05).It suggested that electroacupuncture combined with acupoint application group electroacupuncture combined with acupoint application group can can improve functional comprehensive assessment (FCA) better than electroacupuncture.
7. TCM syndrome
Two groups by Kruskal-Wallis H rank sum test,H=14.31, P=0.026, was statistically significant (P<0.05), in which the number of the electroacupuncture combined with acupoint application group cured2people,8.3%, recovered9people,37.5%,50.0%(12people) improvement in the number, invalid number of4.2%(1people). The total effective rate was95.8%. The number of the EA group cured1people,4.2%, recovered12.5%(3people),45.8%(11people) improvement in the number, invalid number of37.5%(9people). The total effective rate was62.5%. It demonstrated that compared to the electric acupuncture, the electroacupuncture combined with acupoint application was better therapy for improving the TCM syndrome of hemiplagia due to ischemic stroke.
8. Two groups by Radit analysis, Z=3.45, was statistically significant (P <0.05), in which the number of The ectroacuputure combined with acupoint application group cured3people,8.33%, recovered15people,44.4%(16people) improvement in the number, invalid number of8.3%(2people). The total effective rate was94.4%. The number of the EA group cured1people,0.0%, recovered19.44%(7people),61.11%(23people) improvement in the number, invalid number of19.44%(7people). The total effective rate was80.55%. It demonstrated that compared to the electricacupuncture treatment, the electroacupuncture combined with acupoint application was better therapy for improving the nerve function of clinical efficacy of hemiplagia due to ischemic stroke.
Conclusion
Stroke is a common disease, frequently-occurring disease, is today one of the highest of the three diseases in human mortality, but also the fastest three disease incidence, recovery of the slowest, deathmost disabling the heaviest disease. Many patients often can not insist as a result of treatment failure. Therefore looking for an effective and sustained for a long time, the role of patient compliance and good therapy, has an important significance.
This study is based on acupuncture and traditional Chinese medicines on the basis of previous studies, the combination of ischemic stroke patients with hemiplegia, integration and optimization of acupuncture, Chinese and Western previous researche results, through rigorous epidemiology/evidence-based medicine methodsdesign, using the principles of the randomized controlled study of ischemic stroke hemiplegia system and in-depth study, to explore the relationship of point selection, methods of operation, treatmen efficacy more accurately reflect the effectiveness of the law.
Electroacupuncture combined with acupoint application the organic combination of the two treatmens, after the accumulation of a certain amount of time to treatment, better able to promote the improvement of neurologic impairment, improve the quality of life in patients with EA alone or rehabilitation statistically significant, indicated that electroacupuncture combined with acupoint application in the treatment of ischemic stroke hemiplegia can promote each other and complement each other. Electroacupuncture combined with acupoint application without medication, less pain, a significant effect in patients with easy to accept, is an effective, efficient, economic, lasting effect, non-toxicside effects of treatment.
引文
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