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耳针配合针刺治疗非痴呆型血管性认知功能障碍的临床研究

The Clinical Research of Vascular Cognitive Impairment-No Dementia Treated with Auricular Acupuncture Cooperate with Acupuncture

【作者】 王澍欣

【导师】 庄礼兴;

【作者基本信息】 广州中医药大学 , 针灸推拿学(专业学位), 2015, 博士

【摘要】 研究背景与目的:现代医学认为非痴呆型血管性认知功能障碍是血管性痴呆的前期,也是血管性认知功能障碍这一疾病中比较常见的一个亚型,该病患者认知功能受损程度较轻,而且其病情进展具有一定的可逆性;随着我国人口老龄化进程的加速,该病的临床发病人数正以惊人的速度迅速增加,所以,积极开展和探索行之有效的预防和控制本病的治疗措施,不仅对于减轻患者自身疾病带来的痛苦,而且对于减轻患者家庭经济压力和社会医疗负担都有着重要的意义。因为该病的病因和病理机制并未阐明,也尚无确定性的辅助检查手段,现行临床也无针对性的治疗措施,除了控制原发病外,基本沿用治疗血管性痴呆的药物,且疗效有限;而该病在传统中医药中属于“神志”疾病范畴,关于这类疾病有着系统和详细的论述,临床报道采用中医中药、针灸、或针药结合等治疗措施效果显著。针刺疗法在脑血管疾病和血管性痴呆中的有效性和一定的作用机制已被临床应用和实验研究所证实;耳针作为传统的针灸疗法之一,有着操作简单、副作用小等优点,关于其临床应用于脑血管疾病多有报道,且疗效较好,但关于应用耳针治疗认知功能障碍的研究和报道较少。所以,本课题研究采用耳针联合针刺应用于非痴呆型血管性认知功能障碍的治疗,不仅对于探索简单有效且安全的治疗该病的方法,而且对于进一步挖掘耳针的临床应用价值都有着重要的意义。方法:本课题选用平行随机对照实验,为同时性前瞻性研究,该研究选择2013年3月至2014年12月就诊于广州中医药大学第一附属医院康复中心门诊及住院部符合纳入标准的100例非痴呆型血管性认知功能障碍患者。西医诊断标准参照2007年《血管性认知功能损害的专家共识》,中医诊断标准参照1990中国中医药学会年提出的《老年呆病的诊断、辨证分型及疗效评定标准》。采用随机数字表法按照1:1的比例将入组病例随机分成治疗组和对照组,每组50例,两组患者均在进行神经内科的基础治疗上分别接受不同治疗方案,其中治疗组采用耳针联合针刺治疗措施,对照组只采用针刺疗法;疗程为四周。本研究采用简易智能精神状态量表(MMSE量表)、蒙特利尔认知评估量表(MoCA量表)、社会功能问卷(FAQ)和日常生活活动能力量表(ADL量表)作为评价指标,研究过程中采用观察分析者盲法,所有入组患者均在治疗前、治疗两周后和治疗四周后进行量表评价,各项评价指标由专门的工作人员认真核对并进行详细记录,所采集数据统一进行管理建立数据库后采用SPSS17.0统计软件进行相关的统计分析,以客观准确评价耳针联合针刺的临床有效性和安全性。结果:此次研究纳入100例符合诊断标准的患者,但治疗过程中先后有3人因个人原因未能完成该项研究,最终完成的患者在治疗组49例,对照组48例。研究结果显示:入组的两组患者治疗前在年龄、性别、病程、中医辨证分型、受教育程度等方面构成的差异无统计学意义(P>0.05),提示两组患者在这些方面基本均衡,结果受上述因素影响的可能性较小;两组患者治疗前分别采用MMSE量表、MoCA量表、FAQ量表和ADL量表四个量表进行评分,结果显示两组患者在四个量表评分的总分及相应量表的子项评分差异均无统计学意义(P>0.05),提示两组患者治疗前病情基本一致,具有可比性。治疗两周后四个量表评分结果分别是:MMSE量表评分显示治疗组患者在总分和定向力、即刻记忆、注意和计算力、回忆、命名、三步指令以及绘图七个子项方面较治疗前有了一定的改善(P<0.05),对照组患者在总分及注意和计算力、回忆两个子项目方面较治疗前改善(P<0.05)。两组比较,治疗组在总分和注意力、计算力、回忆、三步指令和绘图方面较对照组得分改善差异性有统计学意义(P<0.05);MoCA量表评分结果显示两组患者在总分和延迟记忆、注意、视空间与执行能力、定向能力、命名五个子项均较治疗前有所改善(P<0.05)。两组比较,在总分及延迟记忆、注意、视空间与执行能力三个子项方面差异有统计学意义(P<0.05),提示治疗组优于对照组;FAQ量表评分为治疗组在总评分及账目管理、工作能力、购物、准备饭菜、参加讨论、独自外出六个子项目方面较治疗前改善(P<0.05),对照组在总分及账目管理、购物和独自外出三个方面较治疗前改善明显(P<0.05),两组对比治疗组较对照组在FAQ总分改善明显(P<0.05),其余各子项目未见统计学差异(P>0.05);ADL量表评分结果显示两组患者在ADL总分、基本日常生活能力和工具性日常能力均较治疗前改善明显(P<0.01),治疗组在工具性日常能力和ADL总分与对照组比较改善更加明显(P<0.05)。治疗四周后统计结果显示:MMSE量表评分显示治疗组患者在治疗四周后总分及定向力、即刻记忆、注意和计算力、回忆、命名和绘图七个子项方面明显改善(P<0.01),三步指令改善(P<0.05),治疗四周后评分与治疗两周后相对比在总分及定向力、即刻记忆、注意和计算力、回忆四个子项方面改善(P<0.01)。对照组治疗四周后评分较治疗前、治疗两周后在总分及定向力、即刻记忆、注意和计算力、回忆、重复、绘图六个子项方面均有改善(P<0.01),两组患者治疗四周后MMSE评分在总分和即刻记忆、注意和计算力、回忆、绘图四个子项差异明显(P<0.05);MoCA量表评分治疗组在治疗四周后较治疗前在延迟记忆、注意、视空间与执行能力、定向能力、语言、命名、抽象七个子项及总分均明显改善(P<0.01),治疗组治疗四周较治疗两周在总分及延迟记忆、注意、视空间与执行能力、定向能力、命名、抽象六个子项方面明显改善(P<0.01),语言改善(P<0.05),对照组治疗四周后较治疗前在总分及延迟记忆、注意、视空间与执行能力、定向能力、语言、命名六个子项方面改善(P<0.01),抽象方面改善(P<0.05),对照组治疗四周后较治疗两周后在总分及延迟记忆、注意、视空间与执行能力三个方面明显改善(P<0.01),语言和抽象两个方面改善(P<0.05),两组治疗四周后在总分及延迟记忆、注意、视空间与执行能力、命名四个子项方面差异有统计学意义(P<0.05),治疗组优于对照组;FAQ量表评分显示治疗四周后与治疗两周后相比对照组在总分及账目管理、工作能力、购物、准备饭菜和独自外出等子项方面改善明显(P<0.01),而治疗组在总分及账目管理、工作能力、购物、准备饭菜、了解时事等方面明显改善(P<0.01);对照组治疗四周后与治疗前相比在总分及账目管理、工作能力、购物、准备饭菜和独自外出方面进步明显(P<0.01),而治疗组在总分及账目管理、工作能力、购物、准备饭菜、参加讨论、独自外出方面明显改善(P<0.01),还有了解时事改善(P<0.05),两组对比治疗组在账目管理这个子项目和FAQ总分较对照组差异有统计学意义(P<0.05),治疗组优于对照组,两组间其它子项目差异无统计学意义(P>0.05);ADL量表评分显示两组患者治疗四周后在总分和两个子项目方面均较治疗前和治疗两周时评分明显改善(P<0.01),治疗四周后两组间对比,治疗组较对照组在总分和子项目工具性日常生活能力方面改善更加明显(P<0.01)。在安全性方面,两组患者均未见明显与治疗相关的不良反应。结论:不管是单用针刺治疗,还是耳针联合针刺治疗非痴呆型血管性认知功能障碍,对于改善患者认知功能障碍和提高日常生活能力均有一定的效果,而且安全无明显不良反应;耳针联合针刺治疗方案较单用针刺治疗方案不仅能更快提高患者生活能力和改善认知功能,而且随着治疗时间的延长,该治疗作用更加显著,并未见明显不良反应,显示出耳针联合针刺治疗方案的临床有效性,可以作为针刺联合使用模式应用于临床治疗非痴呆型血管性认知功能障碍,其具体作用机制有待于继续深入研究。

【Abstract】 Objective:Modern medicine thinks vascular cognitive impairment-no dementia as the early stage of vascular dementia, is a subtype of vascular cognitive impairment in this disease more common, the disease in patients with impaired cognitive function to a lesser degree, and the progress of the disease was reversible to some extent; along with the acceleration of China’s population aging process, clinical incidence of the disease is increasing rapidly, at an alarming rate so, actively develop and explore effective treatment measures of prevention and control of the disease, not only for the patients to relieve the pain of their disease, but also to reduce patient family economic pressure and social burden of medical care are of great significance.Because the etiology and pathological mechanism of the disease is still unclearly, auxiliary examination means no deterministic, current clinical no targeted treatment measures, in addition to control the primary disease, the basic use of the drug in the treatment of vascular dementia, and limited efficacy; and this disease belongs to "consciousness" the scope of the disease in traditional Chinese medicine, on the this kind of disease has a systematic and detailed exposition, the clinical effect of traditional Chinese medicine, acupuncture and moxibustion by, or combination of acupuncture and medicine and other treatment measures significantly.Clinical application and experimental study of acupuncture has been confirmed in cerebrovascular disease and vascular dementia in effectiveness and the mechanism of action of a certain; As one of the classic traditional therapy, auricular needle has the advantages of simple operation, little side effects, reports of its clinical application in cerebrovascular diseases have more, and the curative effect is good, but the investigations and reports about the application of auricular acupuncture for treatment of less cognitive impairment is too little.Therefore, this research adopts combined auricular acupuncture with Jin’s three needle acupuncture therapy applied in vascular cognitive impairment-no dementia, not only to explore the treatment method is simple and effective and safe for the disease, but also to further explore the clinical application values of auricular acupuncture has important significance.Methods:The topics chosen small sample parallel randomized controlled trials, as a prospective study at the same time, the study chose 2013 March to 2014 December visit to the rehabilitation center of the First Affiliated Hospital of Guangzhou University of Chinese Medicine of outpatient and inpatient department of 100 patients with vascular cognitive impairment-no dementia in patients with the inclusion criteria. The diagnosis of western medicine with 《expert consensus of vascular cognitive impairment》 in 2007, the diagnosis of TCM with 1990 years of Chinese society of Chinese medicine of《the elderly stay disease diagnosis, and curative effect evaluation standard));and using the method of random number table according to the ratio of 1:1 to the patients were randomly divided into treatment group and control group,50 cases in each group; Two groups of patients in the basic treatment of neural Department of internal medicine respectively receive different treatments, the treatment group treated by Acupuncture of auricular acupuncture combined with acupuncture, while the control group only with acupuncture, four weeks as a period of treatment; this study adopts MMSE scale, MoCA scale, FAQ scale and ADL scale as the evaluation index, the study used in the process of observation of analysts blind method, all the patients were performed before treatment, at the end of the two week and 4 weeks after treatment evaluation scale, evaluation indicators by specialized personnel carefully check and detailed records, data collected by the unified management to establish a database using SPSS17.0 statistical software for analysis of relevant statistics, to the clinical efficacy and safety of the objective and accurate evaluation of auricular acupuncture combined with acupuncture.Results:The study enrolled 100 patients who accorded with the diagnostic standard, but there are three people in the process of treatment for personal reasons failed to complete the study, patients with final 49 cases in the treatment group, control group of 48 cases. Results show:the two group patients before treatment of traditional Chinese medicine in age, gender, duration, type, level of education and other aspects of difference has no statistical significance (P > 0.05), suggesting that two groups of patients in these aspects of the fundamental equilibrium, the smaller possibility of results by the above factors; Two groups of patients before treatment respectively using MMSE scale, MoCA scale, FAQ rating scale and ADL scale four scale, the results show two groups of patients in the four rating scale total score and corresponding scale sub item scores were no statistically significant differences, suggesting that two groups of patients before treatment basic consistent and comparable.Treatment for two weeks when the four rating scale results:MMSE scale scores show that the treatment group patients in the total score and the directional force, immediate memory, attention, and computing power, memory, naming, three-step instruction and drawing has a certain improvement before the treatment (P<0.05), the control group patients in the total score and the two aspects of attention and computing power, memory improvement before the treatment (P<0.05); After two weeks of treatment compared with pre-treatment score difference was found after two weeks of treatment, the treatment group in total score and attention and calculation, memory, three-step instructions and graphics aspects score improvement than the control group difference was statistically significance; MoCA rating scale results show two groups of patients in the total score and the delayed memory, attention, visual space and execution ability, orientation ability, named five items were improved than before treatment (P<0.05), the treatment group compared with control group in the total score and delayed memory, attention, visual space and execution ability three aspects difference obvious (P< 0.05),it means the effect of the treatment group super to the contro group; FAQ scale score of treatment group in account management, ability to work, shopping, prepare the meals, serve them to participate in the discussion, six child go out alone, projects to improve before the treatment (P<0.05), the control group in account the total score and management, shopping, and three aspects to go out alone before the treatment improved significantly (P<0.05), compared the two groups treatment group than the control group in the FAQ scores improved significantly (P<0.05), the others each subproject no statistical difference (P> 0.05); ADL scale score results show two groups of patients in the basic ability of daily life and instrumental daily was to improve the significantly (P<0.01), the treatment group compared with controls in instrumental daily ability and ADL scores improved more significantly (P<0.05).Treatment of four weeks after statistical results show that the MMSE scale score in treatment group patients was in the rating scale according to the patients in treatment group orientation, immediate memory, attention and calculation of forces, memories, naming, drawing and the total score on improved (P< 0.01), the three-step instruction (P<0.05), four weeks after scoring two weeks when the relative treatment than in orientation, immediate memory, attention and calculation of forces, recall three aspects to improve (P<0.01), the control group after treatment around scores compared with before treatment and two weeks later in the total score and the directional force, immediate memory, attention, and computing power, memory, repetition, drawing on improved (P< 0.01), two groups of patients four weeks after the MMSE score in the total score and immediate memory, attention, and computing power, memory, graphics four children differ significantly(P< 0.05); MoCA rating scale before treatment group in the treatment of four weeks after the treatment in delayed memory, attention, visual space and execution ability, orientation ability, language, naming, abstract seven sub item and total score were significantly improved (P < 0.01), treatment group around the treatment in two weeks delay memory, attention, visual space and execution ability, orientation ability, naming, abstract aspect to improve (P<0.05), language to improve the control treatment of four weeks after than before treatment in the total score and delayed memory, attention, visual space and execution ability, orientation ability, language, named improved (P< 0.01), abstract aspect to improve (P<0.05), the control group treatment around the treatment in two weeks the total score and delay memory, attention, visual space and executive ability improved (P<0.01), the two aspects of language and abstract improve (P<0.05), in the two groups after treatment around delay memory, attention, visual space and execution ability, naming significant difference (P<0.05); FAQ rating scale compared with the control group after treatment around two weeks treatment in account management, ability to work, shopping, prepare meals and being alone much better, while the treatment group in account management, ability to work, shopping, prepare the meals and keep track of current events and the total score improved more significantly; FAQ rating scale compared with the control group after treatment around before treatment in account management, ability to work, shopping, prepare meals, being alone and the total score much better (P<0.01), while the treatment group in account the total score and management, ability to work, shopping, prepare the meals, serve them to participate in the discussion, to go out alone on improved (P< 0.01), and keep track of current events (P< 0.05), compared the two groups treatment group in this subproject accounts management and FAQ scores than the control group significant difference (P< 0.05), the sub-project of the other differences between the two groups have no obvious statistical significance (P> 0.05); ADL rating scale according to four weeks after treatment in both groups in the total score and two components was obviously improved compared with the two weeks and before treatment (P< 0.01), all round the contrast between the two groups after treatment the treatment group than the control group improved more significantly in the total score and the aspect of IADL (P<0.01).In terms of security, adverse reactions of the two groups of patients were not found obvious associated with treatment.Conclusion:Whether treatment with acupuncture alone, or combined auricular acupuncture with acupuncture of vascular cognitive impairment-no dementia, to improve patients cognitive dysfunction and certain effect of daily life ability were safe, and no obvious adverse reaction; auricular acupuncture combined with Jin’s three needle treatment program than single use acupuncture treatment scheme can quickly improve the ability of daily living and cognitive function in patients with along with the extension, and the therapeutic effect of the treatment time is more significant, and no significant adverse reactions, showing the effectiveness of auricular acupuncture combined with acupuncture treatment program for clinical, acupuncture combined with usage patterns used in clinical treatment of vascular cognitive impairment-no dementia, its specific mechanism remains to be further research.

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