High-energy bio-ion portable instrument (HNTG-163)

Five therapeutic mechanism to make the treatment of encephalopathy effectively.
a. Improve vasomotor state, Restore the vasomotion in resistance vessel, relieve wall fibrosis, change the status of vascular stenosis,make the vascular softened and reduce blood pressure.
b.Strengthen circulatory function, open microvascular, increase blood supply for myocardial infarction lesions, as well as improve the ischemic injury of myocardial tissue and promote nerve function to activate.
c.Relieve myocardial degeneration and the fibrillation of myocardial cell atrophy interstitial, also improve coronary atherosclerosis and the status of cardiac hypertrophy.
d.Increase the motion of electric charges of nerve cells membrane (inside and outside);Improve nerve inflammation edema, enhance the activity of neuronal cell and resurrect nerve function.
f.It is conductive to the rehabilitation of limb function by making make muscles passive shrink by rhythm, speeding up metabolism, and reducing lactic stimulation, as well as improving muscle strength.

Clincal characteristics
a. One course of treatment can make the symptoms caused by hypertension disappearing, such as dizziness, headache, insomnia and neurasthenia. 2-4 courses of treatment could basically control the blood pressure and strengthen memory. Long-term treatment can keep the blood pressure stable, and gradually reduce to use the dosage of antihypertensive drug, until completely without any antihypertensive drugs.
b. One course of treatment can make the patients with cerebral thrombosis and cerebral infarction keep clearheaded and enhance their memory, as well as improve or eliminate the symptoms of numbness in hands and feet.2-4 course can basically improve the symptom of cerebral insufficiency capital and keep energetic;  Long-term treatment can gradually recovery limb function caused by stroke hemiplegics.
C, Patients with stroke hemiplegics who take the treatment for 2-4 course will be keep clearheaded and enhance their memory, also will improve or eliminate the symptoms of numbness in hand and feet, as well as it will improve language barriers and alleviate the symptoms of choking water and food, some patients function of hemiplegic limb will be improved. Long-term treatment will achieve better results(especially the course within three months)
d.The symptoms of shortness of breath and chest tightness that the patients with coronary artery disease will be significantly relived with 2-4 courses; long-term treatment will improve regional myocardial ischemia or necrosis that are caused by coronary artery stenosis and obstruction, and it also will prevent the symptoms of angina pectoris, myocardial infarction, arrhythmias and sudden death happened.

Adaptation disease
a.Hypertension, cerebral arteriosclerosis, cerebral insufficiency, dizziness, headache, insomnia, neurasthenia.
b.Mental transition fatigue, brain function decline, headache, memory loss , and so on.
c.Cerebral thrombosis, cerebral embolism, lacunars infarction and ischemic encephalopathy.
d.The sequel of stroke disease caused by hypertension and vascular disease, such as aphasia, limb dysfunction.
e.Patients with coronary atherosclerosis and myocardial infarction.
f.Old men with prostatic hypertrophy and prostatitis which will cause the disease of regency, frequent urination and difficulty urinating caused by prostatitis.
g.The pain caused by lumbar and neck disease, as well as various soft tissue injuries.

Contraindications
a.Patients with malignant tumors, bone deformities, internal bleeding, glaucoma and other serious diseases.
b.Psychiatric patients, Pregnant or lactating women, Children and patients in critical condition
c.Patients with pacemakers and artificial limbs.

Treatment operation of hypertension
a.Head treatment: basic portion of hypertension treatment
Operation: Place two treatment physical probes(small or medium) in the therapy cap as according the Figure 1, put the therapy cap on the head with the probes correct pressing on the bilateral vasomotor of the head. Set the treatment time for 10-20 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 5-6.5 mA, plus the stalls when current is not enough, and the current should not exceed 7.5 mA


b.Treatment of upper limb buck points( mainly suitable for the treatment of higher low-voltgage)
According to the Figure 3 to make the treatment
Operation: Fasten two electrodes(medium) in the bilateral Quchi with limb bandage , setting the treatment time for 15-20 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient who can tolerant. The best treatment current is 10-12 mA, plus the stalls when current is not enough, and the current should not exceed 15mA.





c.The treatment of waist buck point(mainly suitable for the treatmen lower low-voltgage)
According to the Figure 4 to make the treatment
0peration: Fasten two electrodes(medium) in the waist hypertension point with waistband , setting the treatment time for 12-15 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient who can tolerant. The best treatment current is 12-15 mA, plus the stalls when current is not enough, and the current should not exceed 15mA.( This site is the effect acupoint for hypertension, it is very effect to make the blood pressure come down as long as make the treatment on this site when blood pressure elevated; The hypertension acupoint is a very important acupuncture point, especially for the treatment of chronic fatigue and lower limb weakness.)



The treatment operation for Stroke (Ischemic cerebrovascular disease)
a.Vasodilator therapy
Operation: Make the terrier race site that the patients diagnosis by CT as electrode placement sites, which will make the lesions establish collateral circulation as soon as possible. setting the treatment time for 10-12 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient who can tolerant. The best treatment current is 5-6.5 mA, plus the stalls when current is not enough, and the current should not exceed 15mA.(First treatment must be carried out under the guidance of professions)
b. The treatment for the expansion of blood volume
According to the Figure 5 to make the treatment
Operation: Place the electrodes next to mastoid that according to the figure 5, setting the treatment time for 15-20 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient who can tolerant. The best treatment current is 6-7.5 mA, plus the stalls when current is not enough, and the current should not exceed 8.5mA




The treatment operation for stroke hemiplegia
a.Head treatment: basic portion of hypertension treatment
Operation: Place two treatment physical probes(small or medium) in the therapy cap as according the Figure 6, put the therapy cap on the head( as Figure 7) with the probes correct pressing on the bilateral motor areas of the head to make alternative treatment，upper 1/5 is the torso movement area of the lower extremity; Middle 2/5 is motor area of the upper extremity, under 2/5 is motor area of head and face. Set the treatment time for 20 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 5-6.5 mA, plus the stalls when current is not enough, and the current should not exceed 7.5 mA.





b. limb treatment
Operation: Fasten two treatment electrodes(medium) in the hemiplegic limb treated acupuncture points with limb bandages, making alternate treatment with two points for each time. Each side setting the treatment for 10 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 10-15 mA, plus the stalls when current is not enough, and the current should not exceed 18mA.
c.Treatment operation for Prostate disease（This treatment is the attached treatment）
Supine to press the electrode placed in the patient’s sacrum, compress the other electrode placed at the bottom of small abdominal with bags. Setting the treatment for 30 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 8-10 mA, plus the stalls when current is not enough, and the current should not exceed 15mA.
d.The treatment for lumbar muscle strain（This treatment is the attached treatment）
Fasten two electrode pads placed at the waist ache with belt, Setting the treatment for 30 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 10-15 mA, plus the stalls when current is not enough, and the current should not exceed 20mA.
 
Notice
a.The product specification must be red before operation.
b.It must be skilled learning to master the operation method of high-energy bio-ion instrument.
c.It must strictly put attention to the change of the current, especially the head current must be within 7MA.
d.Therapy electrodes must be soaked in warm water before starting to make the treatment, and make sure they have soaked enough to stimulate the patients in course of the treatment

Everyday  for 1-2 times, each time for 30-45minutes, 10 days for a treatment. course.

受海南天光高科技开发有限公司（法人代表：任道常）委托，由山东省千佛山医院中医科具体实施，于2005年1月至２005年7月对该公司生产的“高能生物离子治疗仪”治疗缺血性中风进行了系统严谨的临床观察，现将结果报告如下。
　　摘要 目的：观察高能生物离子治疗仪对恢复期缺血性脑血管病的疗效。方

法： 生物电组为杏丁注射液25ml静滴，加高能生物离子治疗仪治疗；对照组为单纯杏丁注射液25ml静滴。10d为一个1个疗程，共2个疗程。观察指标：神经 功能缺损评分，病残程度评定，肌力测定。结果：经过2个疗程的治疗，治疗组上肢和下肢肌力均显著高于对照组。结论：高能生物离子治疗仪治疗缺血性中风疗效 是肯定的，是缺血性中风康复治疗的重要手段之一。
　　关键词 高能生物离子；缺血性中风
　　脑血管病是一种严重危害人们生命和健康的疾 病，其发病率高，是中老年人致死、致残的主要病因之一，脑卒中患者由于未进行及时和适当的功能锻炼，经常会导致永久性残疾，给家庭和社会带来沉重的负担。 本文对脑卒中患者急性期和恢复期实施药物结合高能生物离子治疗，并与对照组比较，探讨高能生物离子在脑卒中患者功能恢复及减轻残疾方面的效果。

　　1 资料与方法
　 　1.1病例选择标准：2002年中药新药临床研究指导原则《中药新药治疗中风病的临床研究指导原则》选择恢复期患者43例，随机分为两组。治疗组29 例，男21例，女8例，平均年龄64（52-73）岁；对照组14例，男9例，女5例，平均年龄62（54-70) 岁。合并冠心病10例，高血压病11例，糖尿病8例。中医辨证气虚血瘀证23例，阴虚风动证11例，风痰瘀阻证9例。
　　1.2治疗方法：两组均 采用5% 葡萄糖溶液或生理盐水250ml、杏丁注射液25ml静滴qd，为常规治疗。10d为1个疗程，共2个疗程,疗程间隔3d。治疗组在常规治疗的同时加用海 南天光高科技开发有限公司生产的高能生物离子治疗仪治疗。治疗方法：患者取仰卧位，机器一处电极置于颈项部4-7椎体处，另一处手持电极由治疗师左手掌 握，治疗师右手则放在患者前额部，微调调幅在最小值，然后开机治疗，10分钟后再将右手先后放在左、右两侧额颞部各治疗5分钟，然后再在患侧肢体治疗10 分钟。电流强度：6-10mA。治疗过程中，患者头部应有舒适的麻震感，或视觉闪烁感。治疗时间共30分钟，每日一次，共2 个疗程。治疗过程中，结合中医八纲辩证，按揉点穴等手法以提高疗效。2个疗程结束后进行疗效评定。

　　1.3观察指标:（1）临床神经功能缺损改善程度。（2）患者总的生活能力状态（病残程度0-7级）。（3）肌力改善程度。（4 ）中医证侯改善情况。
　　1.4疗效判断标准：参照2002年中药新药临床研究指导原则《中药新药治疗中风病的临床研究指导原则》。
　　1.4.1 神经功能缺损评分改善情况。
　　1.4.2 临床疗效评定分级标准：

　　基本痊愈：功能缺损评分减少90%以上，病残程度为0级。
　　显著进步：功能缺损评分减少46%-89%，病残程度1-3级。
　　进步：功能缺损评分减少18%-45% 。
　　无变化：功能缺损评分减少或增加在18%以内。
　　恶化：功能缺损评分增加在18%以上。
　　1.4.3 肌力改善情况。
　 　1.5 统计学处理：全部数据均采用SPSS10.0统计软件进行统计学处理，计量资料采用t检验、方差分析；计数资料采用x2检验；等级资料采用Ridit分 析。当p>0.05时表明差异无统计学意义;当p<0.05时表明差异有统计学意义;当p<0.01时表明差异有高度统计学意义。

 2 结果
 2.1 治疗组29例和对照组14例患者治疗2个疗程后，按疗效判断标准判断结果。（见表1）
                            表1疗 效判断结果

  注：经Ridit分析，与对照组比较，u=2.86 ，p<0.01
  2.2 两组患者肢体肌力恢复情况。（见表2）
                            表2 肢体肌力恢复情况

注：治疗组上肢、下肢肌力分级治疗后比治疗前均显著提高（X²=17.78，p<0.01;X²=15.44,p<0.01）；对照组治疗2个疗程后，上肢、下肢肌力分级比较无显著统计学意义（X²=4.6 0,p>0.05;X²=2.34,p>0.05）。

  2.3 两组患者神经功能缺损情况。（见表3）
                       表3 神经功能缺损情况

 注：**表示治疗组治疗前与治疗组后相比P<0.01；☆表示治疗组治疗前后差值与对照组治疗前后差值相比P<0.05。
 2.4 两组患者中医证侯分级量化改善情况。（见表4）
                       表4 症状分级量化表

注：**表示治疗组治疗前与治疗后相比P<0.01；△表示对照组治疗前与治疗后相比P<0.05；☆☆表示治疗组治疗前后差值与对照组治疗前后差值相比P<0.01。

3 讨论：
　 　近年来用物理手段辅助治疗缺血性中风病已越来越引起关注，并在临床治疗脑血管病方面逐渐普及。高能生物离子治疗仪所产生的生物离子流通过治疗师传到患者 的治疗部位，并形成一个回路。临床观察证明高能生物离子治疗仪,在治疗脑血管病时,对患者的神经功能缺损及患肢肌力改善等疗效肯定，无明显副作用。目前高 能生物离子治疗仪的确切治疗机理尚未研究清楚，初步认为本疗法可能有如下作用：（1）治疗仪输出的正弦波信号与人类自身产生的自然电信号相类似，并通过治 疗师传导，使患者产生相应的生物反应以控制和替代患者的生物机能，从而使患者的神经、肌肉通过被动刺激，而保持其活跃程度。对于急性期患者能维持神经元正 常兴奋性，降低致残率；对于恢复期患者能促进神经功能的恢复与轴突再生，从而形成新的传导通路，有良好促进神经功能强化重组作用。（2）在人体生物离子作 用下，起到稳定细胞膜电位环境，抑制自由基的产生，防止脑细胞进一步损伤和发生水肿的作用。（3）电场作用下，改变血液流变学性质，降低血粘度及血小板聚 集能力，增加红细胞变形能力；通过电刺激小脑顶核使局部血流量增加。共同改善损伤区脑组织的供血，促进缺血区脑组织功能的恢复。（4）电刺激对于神经肌肉 的刺激作用，使痪肌群被动的有规律舒缩，并产生小范围的伸指、伸肘、屈膝等关节运动 , 有利于防止肌萎缩，促

进肌力的恢复。
　　4 结语：
　　高能生物离子治疗仪对缺血性脑血管病的疗效确切，能使患者神经功能缺损明显好转，促进患者瘫痪肢体肌力的恢复，明显改善患者的临床症状，有助于减少脑血管病的致残率和致残程度，值得在临床进一步观察研究和推广。