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“百印调神方”治疗单纯性失眠的临床研究
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摘要
研究背景:
     失眠是指经常不能获得正常睡眠而言。轻者入睡困难,重者彻夜不能成寐,严重影响患者日常工作和身心健康。主要在睡眠时间、深度及消除疲劳作用等方面表现得令人不满意,可谓是一种持续的生理障碍,严重影响人们的生活质量。世界卫生组织2006年公布的睡眠障碍患者比例逐年上升,在中国成年人中就有三亿之多的患有失眠和睡眠过度等睡眠障碍,继头痛之后,失眠已经成为了神经科门诊的第二大疾病。失眠患者往往有情绪障碍,尤其是焦虑、抑郁、紧张及容易激动等。严重的失眠直接影响人体的免疫力,使其下降,无论是抗病能力,还是康复能力都会随其低下,不只会易感,而且使其它疾病加重,还会令原有的疾病诱发。睡眠质量与我们的生存质量是直接挂钩,密不可分的了。现在,人们的生活水平提高了,对于生存质量的要求也空前的提高,因此睡眠质量的高低已成为人们关注的重点之一。
     随着失眠发病率的日趋增高,睡眠问题引起了国际社会的广泛关注。世界卫生组织召集全球三分之二的睡眠医学和流行病专家一起讨论睡眠障碍这一世界性问题,同时制定了该问题的治疗指南。可是现代医学在目前只有教育、行为疗法和药物治疗等综合治疗较为理想。近年来,关于针灸治疗失眠的报道较多。不仅病症多样,而且治法各异,疗效也不尽相同。以“百印调神法”为主要治方,是赖新生教授长期医疗经验总结,在治疗单纯性失眠上有较好的临床效果。通过临床随机对照研究其对单纯性失眠的治疗作用,对正确认识其临床疗效及作用机制指导临床有较高的价值。研究目的
     通过随机对照临床研究评价以“百印调神方”为主的针刺方法对单纯性失眠的疗效,以期为临床治疗提供参考。研究方法
     采用随机对照的临床研究方法,将符合纳入标准的单纯性失眠患者60例为研究对象按1:1比例随机分为两组,两组皆采用“百印调神方”针刺,分为电针频率100HZ刺激组(治疗组)和电针频率10HZ刺激组(对照组),每组各30例。
     治疗组治疗:以“百印调神方”针刺百会、印堂为主穴,并根据辨证配穴,加神门、内关、足三里、三阴交、太溪、太冲。采用一次性针灸针,常规75%酒精局部消毒,采用单手快速进针法,按照患者体型而定,平刺0.5-0.8寸,行针使之得气,配韩氏电针治疗仪,选用1OOHZ的连续波,持续通电二十分钟。其余各穴位在行针得气后施以平补平泻法,刺激量以中等为宜。连续两个疗程,一周为一个疗程,一个疗程为五次。
     对照组治疗:与治疗组相同的辩证配穴,只是更改电针机的频率为10HZ。针刺百会、印堂为主穴,加神门、内关、足三里、三阴交、太溪、太冲。采用一次性针灸针,常规75%酒精局部消毒,采用单手快速进针法,按照患者体型而定,平刺0.5-0.8寸,行针使之得气,配韩氏电针治疗仪,选用1OHZ的连续波,持续刺激二十分钟。其余各穴位在行针得气后施以平补平泻法,刺激量以中等为宜。每周针灸治疗5次,1周为一疗程,2个疗程后观察疗效。
     治疗前和疗程结束后,分别观察包括匹兹堡睡眠质量指数量(PSQI)表、焦虑自评量表(SAS)和抑郁自评量表(SDS)的评分,并随时记录治疗过程中的不良反应及副作用。整理数据之后,录入spss11.0,建立数据库,然后进行数据分析和处理。基础数据采用均衡性分析,在具有可比性的基础上对试验结果所得的数据进行直观的分析。计量资料都采用x±S(均数±标准差)来表示,其中符合正态分布和方差齐性的部分采用t检验,不符合这一类的采用秆人秩和检验;分类资料根据资料性质采用x2检验、秩和检验。P为双侧检验,P<0.05为有显着性差异,P<0.01有非常显着性差异,P>0.05为无显着性差异。研究结果:
     治疗前两组患者一般情况包括年龄、病程、睡眠率、匹兹堡睡眠质量指数、焦虑自评量表(SAS)评分和抑郁自评量表(SDS)评分均具有可比性(P>0.05)。
     疗程结束:
     1、睡眠率(%)方面:治疗组组内治疗前后睡眠率比较,具有统计学意义(P<0.01);对照组组内治疗前后睡眠率比较,亦具有统计学意义(P<0.01)。治疗后两组间睡眠率比较,P>0.05,不具有统计学意义。
     2、匹兹堡睡眠质量指数(PSQI)积分方面:治疗组治疗前后比较,差异有统计学意义(P<0.01)。对照组治疗前后比较,差异亦有统计学意义(P<0.01)。而两组间治疗后差值比较,差异不具有统计学意义(P>0.05)。在各睡眠品质、入睡时间、睡眠时间、睡眠效率、睡眠障碍和日间功能评分评价中,组内差异具有统计学意义(P<0.01),组间差异不具有统计学意义(P>0.05)。
     3、在自评焦虑量表(SAS)评分方面:治疗组治疗前后比较,差异有统计学意义(P<0.01)。对照组治疗前后比较,差异亦有统计学意义(P<0.01)。而两组间治疗后差值比较,差异不具有统计学意义(P>0.05)。
     4、在自评抑郁量表(SDS)评分方面:治疗组治疗前后比较,差异有统计学意义(P<0.01)。对照组治疗前后比较,差异亦有统计学意义(P<0.01)。而两组间治疗后差值比较,差异不具有统计学意义(P>0.05)。
     结论
     本次研究结果表明,治疗组和对照组两者在治疗后数据改善程度上无明显差异;在睡眠率数据上,两者皆对单纯性失眠有较好的疗效。治疗后较治疗前睡眠率、匹兹堡睡眠质量指数(PSQI)积分、焦虑自评量表(SAS)评分及抑郁自评量表(SDS)评分都有较大的改善。
     结果提示,根据赖新生教授多年临床经验总结而得的“百印调神方”在电针何种频率的刺激下,对治疗单纯性失眠都具有较好的疗效。其疗效确切,不因电针频率的高低而影响治疗效果。其不仅对单纯性失眠患者的临床睡眠质量有较好的疗效,而且对失眠引起的抑郁、焦虑等相关症状均有较好的改善作用,值得广泛推广应用。
Research background
     Insomnia is often cannot obtain the normal sleep. The light is difficult to fall asleep, or not to sleep all night, seriously affect the patient's routine work and physical and mental health. The main ways to eliminate fatigue performance is not satisfied in the sleep time, depth and, it is a continuous physiological disorder, a serious impact on people's quality of life. The proportion of patients with sleep disorder who announced in2006each year, China has about300000000adults suffer from insomnia and hypersomnia sleep disorder, insomnia has become the second major diseases in the wake of headache in neurological clinic. Insomnia patients often have emotional disorders, especially anxiety, depression, nervous and excitable. Severe insomnia directly affect the immunity of the human body, to bring it down, whether the disease-resistant ability, or rehabilitation ability will with low, not only susceptible, and cause other disease, also make the disease induced by the original. Sleep quality and our quality of life is directly linked, inextricably linked. Now, people's living standard improves, the quality of life requirements are also an unprecedented increase, so sleep quality has become one of the focus of attention.
     With the increased prevalence of insomnia, sleep problems aroused widespread concern in the international community. WHO convened a nearly2/3of sleep medicine and epidemiology expert meeting to discuss health problems with sleep disorder and the formation of the guidelines for the treatment of this aspect.[1] but the Western ideal is the comprehensive treatment involving education, behavioral therapy and drug treatment. In recent years, many reports about acupuncture treatment of insomnia. Not only the symptoms and treatment efficacy of diversity, different, is not the same."Bai Yin Regulate N Recipe" as the main treatment, long-term experience of Professor Lai Xinsheng in the treatment of medical summary, simple insomnia has better clinical effect. Randomized controlled clinical study by therapeutic effect on simple insomnia, for a correct understanding of its clinical efficacy and mechanism of action have a greater clinical value.
     Research objective
     The therapeutic effect of acupuncture method through clinical research evaluation of randomized to " Bai Yin Regulate N Recipe " based on simple insomnia, in order to provide reference for the clinical treatment of. Research methods
     A randomized control clinical study, with simple insomnia patients included60patients as the research object in the ratio of1:1were randomly divided into two groups, two groups are using "Bai Yin Regulate N Recipe" acupuncture, electroacupuncture stimulation frequency divided into100HZ group (treatment group) and frequency of electroacupuncture stimulation group (group10HZ), each group of30cases.
     Treatment:" Bai Yin Regulate N Recipe " Acupuncture of Baihui, Yintang main points, and according to the dialectical combination of acupoints, plus Shenmen, Neiguan, Zusanli, Sanyinjiao, Taixi, taichong. The disposable acupuncture needle, the conventional75%alcohol local disinfection, with single hand fast needling, decide according to patient body habitus, flat spines0.5-0.8inch needle, to get gas, and Han's acupuncture instrument, continuous wave, the frequency of100HZ, strength in patients with tolerance, power20min, the needle for30minutes, the rest of the acupoint in the needle after the gas with the reinforcing-reducing method, stimulating amount appropriate medium. Acupuncture treatment5times a week,1weeks for a course of treatment, observation of therapeutic effect after2courses of treatment.
     Treatment of control group and treatment group with the same:dialectical point, just change the electric machine frequency is10HZ. Acupuncture Baihui, Yintang mainly points, plus Shenmen, Neiguan, Zusanli, Sanyinjiao, Taixi, taichong. The disposable acupuncture needle, the conventional75%alcohol local disinfection, with single hand fast needling, decide according to patient size,0.5-0.8inch flat thorn, needle to get gas, and Han's acupuncture instrument, continuous wave, the frequency of10HZ, strength in patients with tolerance, power20min, the needle for30minutes, the rest each point in the needle after the·gas with the reinforcing-reducing method, stimulating amount appropriate medium. Acupuncture treatment5times a week,1weeks for a course of treatment, observation of therapeutic effect after2courses of treatment.
     Before and after treatment, including the Pittsburgh sleep quality index (PSQI) were observed in scale, Self-rating Anxiety Scale (SAS) and self-rating depression scale (SDS) score, and to keep a record of adverse reactions in the course of treatment and side effects. After finishing all data entry SPSS11.0, establish the database, analysis and processing. Equilibrium analysis of basic data, on a comparable basis the results are intuitive analysis. All measurement data are used x±S (mean±standard deviation) said, the measurement data with the normality and homoscedasticity using t test, does not conform to the rank sum test; classification data according to the data using2χ test, rank sum test. P is a two-sided test, P<0.05was significantly, P<0.01there was a significant difference, P>0.05as no significant difference.
     The research results
     The general situation of two groups of patients before treatment including age, course of disease, sleep rate, Pittsburgh sleep quality index, Self-rating Anxiety Scale (SAS) score and self-rating depression scale (SDS) scores were comparable (P>0.05).
     The end of the treatment period
     1, sleep rate (%):the treatment group before and after treatment of sleep rate, with statistical significance (P<0.01); the control group before and after the treatment of sleep rate, also has statistical significance (P<0.01). Between two groups after treatment compared sleep rate, P>0.05, was not statistically significant.
     2, the Pittsburgh sleep quality index (PSQI) score:comparison of therapeutic group before and after treatment, the difference was statistically significant (P<0.01). Comparison between the groups before and after treatment, the difference had statistical significance (P<0.01). And between the two groups after treatment of difference, the difference was not statistically significant (P>0.05). The quality of sleep, sleep time, sleep time, sleep efficiency, sleep disorders and daytime function evaluation, group differences were statistically significant (P<0.01), the difference between groups was not statistically significant (P>0.05).
     3, in the Self-rating Anxiety Scale (SAS) score:comparison of therapeutic group before and after treatment, the difference was statistically significant (P<0.01). Comparison between the groups before and after treatment, the difference had statistical significance (P<0.01). And between the two groups after treatment of difference, the difference was not statistically significant (P>0.05).
     4, in the Self-rating Depression Scale (SDS) score:comparison of therapeutic group before and after treatment, the difference was statistically significant (P<0.01). Comparison between the groups before and after treatment, the difference had statistical significance (P<0.01). And. between the two groups after treatment of difference, the difference was not statistically significant (P>0.05).
     Conclusion
     The results of this study showed that, the treatment group and the control group in improving both data after treatment had no significant difference in degree; in the sleep rate data, both had a good therapeutic effect on simple insomnia. Sleep rate than before treatment, after treatment with Pittsburgh sleep quality index (PSQI) score, Self-rating Anxiety Scale (SAS) score and self-rating depression scale (SDS) score had improved greatly.
     The results suggest that, according to Professor Lai Xinsheng for many years of clinical experience and the " Bai Yin Regulate N Recipe " in which frequency electroacupuncture stimulation, has a better therapeutic effect on simple insomnia. Its efficacy, not because of EA frequency effect on treatment. It not only clinical sleep quality on simple insomnia patients have better curative effect on insomnia, and associated symptoms of depression and anxiety, and have good effect, worthy of extensive promotion and application.
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