电针仪设计技术及其参数的相关因素研究
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摘要
市面上充斥着许多非欧盟医疗器械合格认证CE规格所出产的电针仪,这些电针仪售价低廉,但对使用者及病患来说是非常大的威胁,因为非欧盟医疗器械合格认证CE规格所出产的电针仪对于人体安全一点保障也没有,而且家庭工厂所出产的电针仪大部份都未能提供有效的刺激参数的选择,更不用说是刺激参数的显示了,这对于使用者甚至病患来说,往往不知道该给病患怎么样的治疗参数,当然在使用电针仪的过程中也会发生输出范围不一的问题了,另外,有许多市面出售的电针仪刺激参数的调整大都是以旋钮方式,缺乏定量的数据,而且亦未经过相关政府机构的认证许可,也因为如此常常造成使用者使用仪器时的困扰。
     本课题通过4部份包括电针仪机理和临床文献研究、实验研究、向医师派发问卷调查和临床测试完成,有助了解电疗和电针仪刺激参数的意义,而提高电针疗法的疗效,将现化科学和传统的中医针灸学的学术研究推向另一个高峰。
     1.文献研究
     1.1电针通过以不同频率电流通过电极作用于穴位,设置一定的作用时间,极大的节省了人力。目前国内外对电针治疗仪器的应用相当广泛,而且研制了多种形式的电针仪器。电针仪器种类繁多,其原理也不尽相同,有调频电针仪和调幅电针仪。近年来所研究开发的电针仪器随着设备的不断改进,成功率和长期疗效也不断提高。
     1.2在神经机制中,针刺信息与伤害性信息在脊髓水平、脑干水平发生相互作用,抑制伤害性信息。启动脑干下行抑制系统中的PAG. RVM和NA能神经核团,释放阿片肽、5-HT、P物质及NA;通过对间脑、边缘系统和基底神经节的痛觉的调制,产生镇痛效应。在神经化学机制中,针刺镇痛与多种中枢神经递质有关。
     在中医脏腑经络整体观的理论基础上,针刺某一腧穴或某几个腧穴,产生对经络气血运行之调节,使之通畅无阻,气血运行通畅,故其痛即止。
     1.3不同电针刺激参数对机体具有不同的效应,临床实践证明,针刺手法是决定针刺疗效的一个重要因素,而在电针镇痛中时常通过改变电针的各种参数来模拟不同的针刺手法。因此,电针刺激参数对镇痛效应的影响是一个重要的研究问题。电针参数包括波形、波幅、波宽、频率、节律和持续时间。其中波幅即强度和频率被认为是较重要的参数。
     1.4胆囊收缩素CCK-8是目前已知的作用最强的内源性抗阿片肽,长时间电针治疗后所出现的电针耐受现象,是与胆囊收缩素CCK-8的释放有关。
     1.5在整理1994-2009年近15年来以电针治疗各种膝痛临床报导和实验研究的文献中,可发现内外膝眼、血海和梁丘为电针治疗膝痛最常使用的穴位。另外通常是配合TDP照射,及以连续波电针30分钟。
     另一方面,大部份文献都没有详细注明所使用的电针仪型号,或者都以G6805名称或相近的名称制造不同规格的电针仪,令使用者混淆,致文献缺乏无可比性和科研重复性的依据。
     2实验研究
     2.1实验目的
     通过测定电针治疗仪的输出参数,如波形、频率、强度、波宽等,从而加深了解不同型号电针仪的性能,更好地掌握电针仪的正确使用方法。通过此次实验利用National Instruments USB-6009记录仪测定多款电针仪的输出参数,从参数上认识脉冲电特征及比较以上多款针灸治疗仪输出电流性质的形态特征。
     2.2实验步骤
     全部16个不同品牌,共29台电针治疗仪,测定各针灸治疗仪的输出参数。包括:
     (1)测量连续波输出频率测量(固定强度,调整频率)
     (2)连续波波幅测量(固定频率,测量幅度)
     (3)观察29台电针治疗仪主要波形(连续波)的形态
     2.3研究结果
     (1)旋钮刻度与输出频率关系
     结果显示在今次研究的29台的电针仪中有11台电针仪使用旋钮式连续波频率调整方式,包括燕山WQ-IOC2、青春之泉、华佗SDZ-II、华谊G6805-2A、长城KWD-808I、长城KWD-808II、上海G6805、上海G6805II、Relaxer.上海商业G6805和鑫升6805I,而且刻度的上数字并未反映真实的输出频率。旋钮刻度和频率的关系可分成两大类型,即线性和非线性关联。
     (2)旋钮刻度和频率的线性关联
     燕山WQ-IOC2、青春之泉、华佗SDZ-II、达佳DJ6805AII和华谊G6805-2A电针机的旋钮刻度与频率之间呈为线性关联。
     (3)旋钮刻度和频率的非线性关联
     有7台的电针仪旋钮刻度和频率呈非线性关联,包括长城KWD-808I、长城KWD-808II、上海66805、上海G6805II、上海商业G6805I、鑫升6805I(1)和Relaxer。
     (4)9台鑫升6805I电针仪刻度与脉冲真实频率统计比较
     结果显示9台鑫升电针仪在刻度与真实频率的个别比较在统计学上没有分别;另外,以频率平均数所作的回归分析亦说明9台鑫升的频率输出和刻度的关系无明显的个体差异。
     (5)按钮刻度与输出频率关系
     结果说明4台电针仪使用按钮式LCD显示频率调整呈线性关联,包括上海AWQ-10D、华谊G6805-2B、华佗SDZ-V和ITO ES160。
     (6)5台ITO ES160电针仪LCD显示与真正频率统计比较
     5台ITO ES160电针机在脉冲LCD显示对真正频率(Hz)没有非常显着差异。
     (7)输出电压强度(伏特)特征
     除上海66805和长城KWD-808II外,发现具他12款电针仪在旋钮在1时,均未有电压的输出,这样患者能从小至大感受到电冲动的感觉,减少触电的机会;13款电针仪的最高输出电压,当中有10款包括上海66805、华谊66805-2A、华谊66805-2B、长城KWD-808I、长城KWD-808II、达佳6805AII、华佗SDZ-II、华佗SDZ-V、燕山WQ-IOC2、上海商业G6805I、上海G6805II输出最大电压强度皆超越75伏特。而Ito、上海AWQ和鑫升6805I这4款都限制最高电压强度在40伏特以内。
     (8)十款电针仪旋钮刻度与电压输出特征
     只有长城KWD-808II和ITO ES-160两部电针仪的旋钮刻度和电压输出呈线性关系。其余8台在调整电压输出时波幅较大。这10台电针仪的电压输出都是以旋钮碳膜式可变电阻分压器(CVR)控制,当出现碳膜剥离的现象,便出现输出电压出现极大波幅改变。
     (9)波形正负向脉冲幅度的比较
     电脉冲作用于机体时,刺激(兴奋)首先在负极产生,即电流流出的电极。一般的电针仪输出的为非对称性双向脉冲波(NSBP),易出现电极的极化现象(Polarization)影响疗效。
     而对称性相向脉冲波(SBP),脉冲正负双向对称,两个电刺激(穴位)的刺激强度相同,效果一致,解决了电极化的问题,即避免电针期间出现的“适应现象”
     所以电针仪所输出的正负向脉冲幅度尤为重要,在29台电针仪中波形正负向脉冲幅度的比较的关系可分成参3类型:
     大(X>1.6)—患者容易发生电针电解作用,产生不良性过早的适应。
     小(1.3>X<1.5)—燕正负幅度比率在1.3-1.5之间
     相等(X≦1.1)—其正负向脉冲幅度呈相等的比率,即在不同的强度下均呈现对称性,其差异率极小。对称性正负向脉冲可完成抵消电针的电解作用,减少电针对患者产生过早的适应。
     (10)9台鑫升电针电压刻度和正负波幅比较
     9台鑫升电针仪在刻度与正负向脉冲幅度的比率个别比较在统计学上没有分别。
     (11)5台ITO ES-160电针电压刻度和正负波幅比较
     5台ITO ES-160电针仪在刻度与正负向脉冲幅度的比率个别比较在统计学上没有分别。
     (12)回零安全制
     新款的设计均有回零安全制,开启仪器前所有输出必需关闭,否则蜂呜器长呜且没有电压输出,可以防止因上一次使用后忘却重设输出电压至零点,突然间有过大的电压加诸于患者,产生触电的可怕经历。
     2.4研究分析
     (1)22台电针仪的正负向脉冲幅度为非对称双方向脉冲波(NSBP),其中最大差异率达到198%,患者容易发生电针电解作用,产生过早的适应。只有ITO采用对称双方向脉冲波Symmetic bi-phase rectangular pluse (SBP),这种设计渐被新开发的生产商所采用,这设计使红黑两色的正负电极意义完全消失。
     (2)只有华佗SDZ-II型、华佗SDZ-V型和ITO ES-160贴上欧洲合格认证CE标志,其它没有电器安全检定的电针仪在使用上是带有危险性的,容易发生触电的意外。
     3电针仪使用情况问卷调查
     3.1问卷调查目的
     电针仪是现今医师作针灸治疗时常用的仪器,但在针炙学教学课程内容一直都缺乏电针仪使用的详细步骤、解释和禁忌,致使医师们对此各持不同的见解或谬误,不能充份利用电针仪的优点。
     透过此问卷调查,除了可以了解医师对使用电针仪的认识,也可以知道现医师在使用日常的电针仪有什么不足之处,此有助选择适合的电针机及提升电针仪的规格。
     3.2方法
     设计问卷并向50位中医师发出电针仪使用情况调查问卷,收回后再作统计。3.3电针仪使用情况问卷结果
     发现日常有为病人作针灸治疗的中医师全部都曾使用电针仪,可见针灸医师使用电针仪极为普遍。
     有75.2%的问卷回复日常使用的电针仪型号为G6805,但大部份都未能提供其所属品牌的名称。而23.3%的受访者不知道自己日常使用的电针仪的品牌和型号。受访者中88.4%认为适当的电针仪输出参数是可提高疗效,但78.4%不清楚应用那种刺激参数达到最佳的镇痛效果。
     所有问卷回复曾经在调控电针仪输出时出现患者触电的情况,也曾经在为患者使用电针仪治疗时出现“适应现象”,即在治疗期间患者对电针的感觉减弱或消失,但只有11.6%略知道这跟电极极化有关。
     4临床测试
     4.1测试目的
     近年有很多对电针仪刺激参数的研究,研究的题目大部份都是波频、波形、波型和强度,鲜有波宽对电针镇痛的疗效研究,以最主要的原因相信是因为市面上仅有一部电针仪能提供调校波宽的功能,故是次的临床测试是希望从而了解窄波(50μs)和宽波(400μs)在镇痛疗效上的差别。
     4.2测试方法
     在临床测试方面,取20位愿意接受临床实验的膝关节疼痛患者接受ITO ES-160电针刺激实验。其中共计女15位,男5位,平均年龄为56.5岁。4.3临床测试步骤
     20位受测者随机分为2组,每组10人,分2天分别接受2组不同刺激参数的电针刺激,实验场所的室温在11~15℃,实验时间控制在下午一时至六时。实验分为2组:2Hz 400μs电针刺激组和2Hz 50μs电针刺激组4.4 VAS值实验结果
     从老年膝痛患者在接受两种不同模式电针刺激后VAS值的变化,结果显示,患者在接受两组电针刺激后VAS值都有不同程度的下降,尤其接受2Hz 400 u s的电针刺激组的VAS值呈现有意义的下降(p<0.001),说明电针仪参数2Hz 400μs时的确可以舒缓患者的疼痛程度。
     结论
     ITO ES-160的性能最佳,也最安全,其频率、电压输出和电针仪上显示的度数呈线性关系,使用者容易调控输出的频率和电压的强弱大细,在调控中途不致出现突然的变大和变细,致患者不适和害怕,也便于科研资料的采集。
     另外,ITO ES-160设有回零安全装置,这可防止使用者因在前一次使用时忘记把电压输出调回零位而突然有过大电压输出,致患者触电。
     ITO ES-160亦附有CE和UL电器安全检定,而且其输出电压限制在40伏特以内,这亦可减轻触电情况出现。
     在疗效上,因其输出的为对称方向脉冲波(SBP),所以在治疗时可避免出现电极极化而产生“适应现象”影响疗效。
     从电针仪使用情况调查问卷结果可得知,大部份电针仪的使用者都曾试过在治疗时出现患者不同情度的触电情况,但大家又对此像是无可避免的,其实只要在使用和购买电针仪时注要以下几点,是可避免患者出现触电的痛苦和危险。
     (1)选购按键式电压输出的电针仪
     (2)购买时测试电压输出是否呈线性关联
     (3)回零安全装置
     (4)电器安全检定
     (5)最高输出电压
     (6)注意使用步骤
     在电针仪使用情况调查问卷结果亦可得知大部份使用者都曾经遇过“适应现象”,但只有少数使用者知道当中原因是跟电针仪输出的脉冲波是否对称有关,在是次研究发现只有华佗SDZ-II、华佗SDZ-V、达佳6805AII和Ito ES-160输出的脉冲波为对称方向脉冲波,故大部份使用者都不能避免“适应现象”。
     在VAS值结果知道在相同频率不同波宽的电针参数输出,可出现不同的疗效,如在此次的临床研究发现接受2Hz 400μs电针刺激组的VAS值较2Hz 50μs有明显下降,则宽波宽的镇痛较果较佳。
     基于资源所限,是次研究只能对16个不同品牌,共29台电针治疗仪作出测定。透过今次的电针仪测定为不同电针仪使用者,提供选购和使用电针仪的客观依据,进而为各电针仪开发商提供规格的标准参考,提升电针仪的认受性、安全性和使用接口。
     长远来说,政府单位和科研单位应制定一个电针仪的生产标准,如外国的IS0认证,使电针仪在功能和安全程度上得到保证,有助于开发商、医师和病人的利益。
Market is filled with many electroacpuncture device (EAD) without CE compliance of EU which are sold in low prices, but it is threatening to both the users and patients,because this EAD cannot provide safety assurance and adjustable effective parameter. The parameter input of these EAD are mostly knobbing button which are not able to subtle parameter calibrations.
     This study is comprised of four parts, including literature review, experimental trial, questionnaires to the physicians and clinical testing, which help to understand the definition of EAD stimulation parameters and to improve the efficacy and modernization of acupuncture therapy. 1 Literature review
     1.1 The apply of electro-acupuncture electrode on the acupoints with different frequency can safe a lot of manpower. Nowadays, the apply of EAD is very common in the world. In recent years, the research and development of electro-acupuncture device are with continuous improvement, and so the success rate and long-term effects are.
     1.2 In the neural mechanisms, acupuncture can inhibit the harfaml by the interaction between the spinal cord and brain stem level. The PAG, RVM and NA brainstem of descending inhibitory system in nerve nuclei release the opioid peptides 5-HT, P substance and NA. Through regulating pain modulation of the diencephalon, limbic system and basal ganglia, it results analgesia effect. Neurochemical mechanisms in acupuncture analgesia is related to the various central neurotransmitter.
     1.3. Electrical stimulation of different parameters have different effects on the body, clinical practice shows that manipulative acupuncture technique is to determine the efficacy of acupuncture as an important factor, often in acupuncture analgesia by altering various parameters of electro-acupuncture in order to simulate different traditional manipulative acupuncture technique. Therefore, the effect of electrical stimulation parameters to the analgesic effect is an important research issue. EAD parameters, including waveform, amplitude, pulse width, frequency, rhythm and duration, of which amplitude and frequency of EAD stimulation output are considered as the most important parameters.
     1.4 Cholecystokinin CCK-8 is the most potent known endogenous anti-opioid peptides, the release of which is relating to tolerance phenomenon of the prolonged acupuncture treatment.
     1.5 In reviewing the literature of 1994 to 2009 in recent 15 years if the electro-acupuncture treatment of knee-pain syndrome, it can be found that the acupoints of Xi Yan, Xue Hai and Liang Qiu are most commonly used acupuncture points for the treatment of knee pain. It is often with TDP radiation, continuous waveform and 30 minutes treatment duration.
     On the other hand, most of the studies did not specify in detail the model used of EAD, or just mention G6805 or other names similar of it without detailed manufacturing specifications, therefore users are always confused and result to the lack of comparability and repetitive basis of the literature.
     2 Experimental study
     2.1 The purpose of the experiment By measuring the output parameters of electro-acupuncture device, such as waveform, frequency, intensity, pulse width, the performance of different types of electro-acupuncture device can be more easily understood and so do the proper use of electro-acupuncture device. In this experiment, National Instruments USB-6009 is used to record the output parameters of the DEA, by which we can understand the pulse power characteristics and the morphological features of the output current
     2.2 Experimental procedure
     All 16 different brands, a total of 29 electro-acupuncture device are measured the output parameters. The parameters of EAD are recorded by National InstrumentsTM USB-6009. Two sets of software based on LabVIEWTM 7. lversion from National InstrumentsTM had been designed to record and display the data.
     2.3 Results
     (1) By comparing the electric parameters of difference brand/model of EAD, such as wave form, frequency, intensity and wave duty width, we can learn more about the performance of the EAD and can utlilise them more efficiently. The result are as follows:
     (2) 4 brands included five sophisticated EADs using digital display have linear regression relation (R2=1, y=x+b) between display value and actual pulse frequency. Other 7 sets show exponential equation relation and finally 4 sets show nearly linear.
     (3) Pulse output voltage:output zero reset function found in 6 sets. It protects sudden electric shock applied on patient due to last forgetting reset to zero output.
     (4) There were non symmetric of positive and negative waves found in 22 sets. The difference found as high as±198%. It seems to be cause electrolysis and make early adaptation. Only ITO adopted Symmetric bi-phase rectangular pulse design in production of its ES-160. It makes the red/black polarity plug to be meaningless.
     (5) Only华陀SDZ-Ⅱ,华陀-V and ITO ES-160 are comply with the electric safety standard of European Union CE. Using the electric device without electric security label is dangerous and easily cause electric shock.
     (6) More than 400 sets of data have been tested from 16 brands EAD (totally 29 sets) being collected.1. Pulse frequency:4 brands included five sophisticated EADs using digital display have linear regression relation (R2=1, y=x+b) between display value and actual pulse frequency. Other 7 sets show exponential equation relation and finally 4 sets show nearly linear.2. Pulse output voltage:output zero reset function found in 5 sets. It protects sudden electric shock applied on patient due to last forgetting reset to zero output.3. There were non symmetric of positive and negative waves found in 18 sets. The difference found as high as±198%. It seems to be cause electrolysis and make early adaptation. Only ITO adopted Symmetric bi-phase rectangular pulse design in production of its ES-160. It makes the red/black polarity plug to be meaningless.4. Electric security label only found in two models i. e. sdz-II and ITO ES-160. Others operated in AC would cause danger and easy to make accidents. It is strongly recommended that new generation LCD EAD with electric security approved should be used by Chinese medicine practitioner.
     3 The questionnaire of the electro-acupuncture device usage to the physicians
     3.1 Through this survey, in addition to physicians can learn to use knowledge of acupuncture instrument can also be aware of the use daily are physicians what EA instrument deficiencies, this will help select the appropriate machine and upgrade the electric needle acupuncture device specifications.
     3.2 The questionnaire result shows that electro-acupuncture devices are commonly used in daily acupuncture treatment amongst the physicians, but most of the physicians have misunderstanding of the electro-acupuncture device and this lead to they cannot fully utilise the advantages of it.
     3.3 The result also shows that "adaptation phenomenon" and "electric shock" are very common during the electro-acupuncture treatment, but only a little somewhat aware of this with the polarization of the electrodes and the depreciation of CVR, the carbon electric resistor.
     3.4 By studying 50 pieces of questionnaire filled by the EAD users,88.4% believe that appropriate output parameters of EAD can incrase the curative effect, but they do not show any knowledge about the relationship between the early adaption and NSBP.
     4 Clinical trials
     4.1 The purpose of the test in recent years, many of the acupuncture stimulation parameters of the instrument to study the subject of most of them are wave frequency, wave, wave type and intensity, few pulse width on the efficacy of acupuncture analgesia to the main I believe the only reason is because the market can provide an acupuncture instrument features adjustable pulse width, it is time for clinical trials is to narrow to understand wave (50μs) and wide wave (400μs) in the analgesic effect of the differences.
     4.4 The results of the research showed that the paients with knee pain syndrome all felt the soothingness after either 2Hz 400μs or 2Hz 50μs consective electroacupuncture pluse simulation. The VAS values of the former were decreased significantly (p<0.01). This demonstrated that the clinical effectiveness of 2Hz 400μs is much greater than 2Hz 50μs.
     Conclusion
     The performance of ITO ES-160 is the best and most safe, and it shows a linear relationship between frequency and voltage with what it shown on the device.
     The user can be easy to control the output frequency and voltage, and this result to the less opportunity of patient discomfort and fear, but also facilitate the research data collection.
     In addition, the zero output reset function of ITO ES-160 can prevent the electrical shock due to the lack of manual zero reset in previous use.
     ITO ES-160 is also with CE and UL electrical safety test assurance and with the limitation of the output voltage not more than 40 volts, which can reduce the electric shock situation.
     In effect, because the output of ITO ES-160 is the symmetric pulse (SBP), "adaptation phenomenon" during treatment can be avoided.
     From the result of questionnaire, we know that "electric shock" is not uncommon in the treatment. And most of the user think this is inevitable.
     However, this dangerous and terrible situation can be avoided if the following points are cautioned.
     (1) Push button input of EAD (2) the linear relationship of the voltage output (3) zero reset safety function (4) Electrical safety compliance (5) Maximum output voltage (6) Be caution of using step
     From the result of questionnaire, most of the users have been "electric shock" during the treatment but the little know this phenomenon is relating to its non-symmetric bi-phase rectangular pulse (NSBP) output. The study shows that the output of华陀SDZ-II,华陀SDZ-V,达佳6805AII and Ito ES-160 are symmetric bi-phase rectangular pulse (NSBP), therefore most users of other EADs cannot avoid the "adaptation phenomenon. "
     Different pulse width of EAD output can result different treatment effect, as we know from the results of the VAS value test, which shows the VAS value of 2Hz 400μs EAD treatment group drops more significantly than 2Hz 50μs group. It implies that wide pulse width is with better analgesic effect.
     Due to limited resources in the study, only 16 different brands, a total of 29 electrocacupuncture device (EAD) can be put into this study. Objective views of purchase and usage of EAD can be projected to the users, according to this study, as well as the acceptance and safety can be increased.
     In long term, government agencies and research institutes should develop a standard of EAD production, such as the ISO certification, therefore the function and safety of EAD can be assured, and this also is for the sake of developers, physicians and patients.
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