High-energy bio-ion instrument for hypertension & stroke disease
New breakthroughs of Physical therapeutic instrument for hypertension & stroke disease
PRODUCT
Product Name
High-energy bio-ion instrument for hypertension & stroke disease
Product Structure
Host Output line Two Physical probes
Mechanism of action
According to the conductance fundamental equilibrium principle of biological electrophysiological and biological tissue ,High-energy bio-ion instrument for coronary artery disease convert biological ion wave to bio-electric ion and re-integrate the disordered charge for diseased tissue( nerves, bloods, muscles) to restore their normal function when it effects on human body. Especially its high technology not only broke through the difficulties that traditional physical therapy factor is hard to penetrate deeply into human organs and tissues, but also according to the principle of TCM meridian, combined the therapy of acupuncture and moxibustion with the effect of biological ionizing to get excellent physiological and therapeutic effects, and achieve its effect:
a.Restore the vasomotion in resistance vessel, relieve wall fibrosis, change the status of vascular stenosis, make the vascular softened and reduce blood pressure.
b.Improve microcirculation to open microvascular, increasing brain lesion area's blood provide, improving the ischemic injury of the brain tissue..
c.Increase electric charges motion of nerve cells membrane (inside and outside);improve nerve inflammation edema, enhance the activity of neuronal cell and resurrect nerve function.
d. Make the muscles passive rhythmic contractions, speed up metabolism, reduce lactic acide stimulation,improve muscle strength and make limb function rehabilitation.
FEATURES
Clinical characteristics
a. Short-term treatment even the first treatment will significantly improve main symptoms that caused by hypertension disease(such as dizziness, headache, insomnia and neurasthenia). It also make the patients with cerebral thrombosis and cerebral infarction keep clear mind ,also enhance their memory and improve the symptoms of numbness symptoms.
b. Long-term treatment will keep blood pressure stable and gradually reduce antihypertensive medical amount until completely without using any antihypertensive drugs. Besides that, it will make the patients with stroke hemiplegic gradually recover the limb function.
c. Simply physical treatment, safety, no toxic side effect.
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, lacunar infarction and ischemic encephalopathy.
d.The sequela of apoplexy caused by hypertension and vascular disease, such as aphasia, limb dysfunction..
Exclusion criteria
a.Patients with malignant tumors, bone deformities, internal bleeding, glaucoma and other serious diseases.
b.Psychiatric patients
c.Pregnant or lactating women
d.Children and patients in critical condition
OPERATION
A．Treatment operation of hypertension
Head treatment: basic portion of hypertension treatment
Operation: Place two treatment physical probes(small or medium) in the therapy cap as 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 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 operation of stroke hemiplegia
Head treatment: basic portion of hypertension treatment
Operation: Place two treatment physical probes(small or medium) in the therapy cap as 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.
Notice
a. The product specification of high-energy bio-ion instrument for coronary artery disease must be read before operation.
b. Clean the treatment site' skin with saline before the implementation of the treatment, then directly place the physical probes on the treatment sites
c. It must strictly put attention to the change of the current, especially the head current must be within 7MA.
d. It must be explained to the patients that it is a normal phenomenon if they complain the skin is a little uncomfortable during the treatment. Reduce the stalls to relieve the irritation if the patients feel unbearable. Smear medical Vaseline at the treatment sites to reduce patients’ discomfort after the treatment if patients' skin contacted with physical probes appear to allergies. And appropriately prompt patients in order to eliminate their concerns.
e. Immediately stop treating and to take appropriate relief measure if patients occur other concurrent symptoms in the course of treatment.
Treatment arrangements
Treatment arrangement
1.The treatment for hypertension disease
Adopting the head treatment of hypertension to make the treatment for two times a day , each time for 20 minutes. Course of treatment should be increased until the major indexes have improved to achieve effective standards if the efficacies of main symptoms have improved after six times’ treatments. Then take the re-examination and follow-up the efficacy after 30 days. Give up this treatment if it failed to improve the main symptom efficacy or major indexes after the treatment accumulated to ten times.
2.The treatment for stroke disease
Adopting the head treatment of stroke to make the treatment for two times a day , each time for 20 minutes. Course of treatment should be increased until the major indexes have improved to achieve effective standards if the efficacies of main symptoms have improved after six times’ treatments. Then take the re-examination and follow-up the efficacy after 30 days. Give up this treatment if it failed to improve the main symptom efficacy or major indexes after the treatment accumulated to ten times.
Adverse reactions
Contraindication
Clinical reports
高能生物離子治療儀治療缺血性中風的療效觀察
[
摘要] 目的：觀察高能生物離子治療儀對恢復期缺血性腦血管病的療效。方法：生物電組為杏丁注射液25ml靜滴，加高能生物離子治療儀治療；對照組為單純杏丁注射液25ml靜滴。10d為一個1個療程，共2個療程。觀察指標：神經功能缺損評分，病殘程度評定，肌力測定。結果：經過2個療程治療，治療組上肢和下肢力均顯著高于對照組。結論：高能生物離子治療儀治療缺血性中風療效是肯定的，是缺血性中風康復治療重要手段之一。
[
關鍵詞] 高能生物離子；缺血性中風
腦血管病是一種嚴重危害人們生命和健康的疾病，其發病率高，是中老年人致死、致殘的主要病因之一，腦卒中患者由于未進行及時和適當的功能鍛煉，經常會導致永久性殘疾，給家庭和社會帶來沉重的負擔。本文對腦卒中患者急性期和恢復期實施藥物結合高能生物離子治療，并與對照組比較，探討高能生物離子在腦卒中患者功能恢復及減輕殘疾方面的效果。
1 資料與方法
1．1病例選擇標準：2002年中藥新藥臨床研究指導原則《中藥新藥治療中風病的臨床研究指導原則》選擇恢復期患者43例，隨機分為兩組。治療組29例，男21例，女8例，平均年齡64（52-73）歲；對照組14例，男9例，女5例，平均年齡62（54-70）歲。合并冠心病10例，高血壓病11例，糖尿病8例。中醫辨證氣虛血瘀證23例，陰虛風動證11例，風痰瘀阻證9例。
1．2 治療方法：兩組均采用5%葡萄糖溶液或生理鹽水250ml、杏丁注射液25ml靜滴qd，為常規治療。10d為1個療程，共2個療程,療程間隔3d。治療組在常規治療的同時加用海南天光高科技開發有限公司生產的高能生物離子治療儀治療。治療方法：按照治療帽（圖6）圖示放置兩個治療物理探頭（小號或中號），將治療帽戴在頭上，治療物理探頭正確壓在頭部雙側運動區（圖7），按照上1/5是下肢，軀干運動區。中2/5是上肢運動區，下2/5是頭面部運動區交替治療，每個運動區設置治療時間為20分鐘，緩慢調節微調使治療電流增加至患者可耐受程度，最佳治療電流為5-6.5MA, 電流達不到時可加擋位，最大不得超過7.5MA. 每日兩次，每次20分鐘共2個療程。2個療程結束后進行療效評定。
1．3 觀察指標：（1）臨床神經功能缺損改善程度。（2）患者總的生活能力狀態（病殘程度0-7級）。（3）肌力改善程度。（4）中醫證侯改善情況。
1．4 療效判斷標準：
參照2002年中藥新藥臨床研究指導原則《中藥新藥治療中風病的臨床研究指導原則》。
1．4．1神經功能缺損評分改善情況。
1．4．2臨床療效評定分級標準：
基本痊愈：功能缺損評分減少90%以上，病殘程度為0級。
顯著進步：功能缺損評分減少46%-89%，病殘程度1-3級。
進 步：功能缺損評分減少18%-45%。
無變 化：功能缺損評分減少或增加在18%以內。
惡 化：功能缺損評分增加在18%以上。
1．4．3肌力改善情況。
1．5統計學處理：全部數據均采用SPSS10.0統計軟件進行統計學處理，計量資料采用t檢驗、方差分析；計數資料采用x
2檢驗；等級資料采用Ridit分析。當p>0.05時表明差異無統計學意義;當p<0.05時表明差異有統計學意義;當p<0.01時表明差異有高度統計學意義。
2 結果
2.1治療組29例和對照組14例患者治療2個療程后，按療效判斷標準判斷結果。（見表1）
表1 療效判斷結果
|
|
例數
|
基本痊愈
|
顯著進步
|
進步
|
無效
|
惡化
|
|
治療組
|
29
|
7
|
13
|
8
|
1
|
0
|
|
對照組
|
14
|
0
|
4
|
6
|
4
|
0
|
注：經Ridit分析，與對照組比較，u=2.86，p<0.01
2．2兩組患者肢體肌力恢復情況。（見表2）
表2 肌體肌力恢復情況
|
組別
|
例數
|
|
上肢
|
下肢
|
|
0
|
Ⅰ
|
Ⅱ
|
Ⅲ
|
Ⅳ
|
Ⅴ
|
0
|
Ⅰ
|
Ⅱ
|
Ⅲ
|
Ⅳ
|
Ⅴ
|
|
|
治療組
|
29
|
治療前
|
1
|
3
|
8
|
14
|
3
|
0
|
1
|
1
|
10
|
11
|
6
|
0
|
|
|
治療后
|
0
|
0
|
3
|
7
|
15
|
4
|
0
|
0
|
2
|
6
|
15
|
6
|
|
|
對照組
|
14
|
治療前
|
0
|
1
|
6
|
5
|
2
|
0
|
0
|
1
|
4
|
6
|
3
|
0
|
|
|
治療后
|
0
|
0
|
4
|
5
|
5
|
0
|
0
|
0
|
3
|
7
|
4
|
0
|
|
注：治療組上肢、下肢肌力分級治療后比治療前均顯著提高（x
2=17.78，p<0.01; x
2=15.44,p<0.01）；對照組治療2個療程后，上肢、下肢肌力分級比較無顯著統計學意義（x
2=4.60,p>0.05;x
2=2.34,p>0.05）。
2．3兩組患者神經功能缺損情況。（見表3）
表3 神經功能缺損情況（x±s）
|
|
例數
|
治療前
|
治療后
|
差值
|
|
治療組
|
29
|
6.11±3.14
|
2.98±2.61**
|
3.13±2.87
|
|
對照組
|
14
|
6.98±3.02
|
5.48±2.87
|
1.50±2.96☆
|
注：**表示治療組治療前與治療組后相比P<0.01, ☆表示治療組治療前后差值與對照組治療前后差值相比p<0.05。
2．4兩組患者中醫證侯分級量化改善情況。（見表4）
表4 癥狀分級量化表（x±s）
|
|
例數
|
治療前
|
治療后
|
差值
|
|
治療前
|
29
|
31.7±63.84
|
22.66±3.14**
|
9.10±3.95
|
|
對照組
|
14
|
31.14±3.78
|
28.07±2.97△
|
3.07±2.09☆☆
|
注： **表示治療組治療前與治療后相比p<0.01 ；△表示對照組治療前與治療后相比p<0.05；☆☆表示治療組治療前后差值與對照組治療前后差值相比p<0.01。
3討論：近年來用物理手段輔助治療缺血性中風病已越來越引起關注，并在臨床治療腦血管病方面逐漸普及。高能生物離子治療儀所產生的正弦波，通過具有調理高能生物離子的治療師，傳到患者的治療部位，并串聯成一個回路。臨床觀察證明高能生物離子治療儀治療腦血管病，對患者神經功能缺損及患肢肌力改善等療效肯定，無明顯副作用。目前高能生物離子治療儀的確切治療機理尚未研究清楚，初步認為本療法可能有如下作用：（1）治療儀輸出的正弦波信號與人類身體產生的自然電信號相類似，并通過治療師傳導，使患者產生相應生物反應以控制和替代患者生物機能，從而使患者神經、肌肉通過被動刺激，而保持其活躍程度。對于急性期患者能維持神經元正常興奮性，降低致殘率；對于恢復期患者能促進神經功能恢復與軸突再生，形成新的傳導通路，有良好促進神經功能強化重組作用。（2）類似人體生物離子作用下，起到穩定細胞膜電位環境，抑制自由基的產生，防止腦細胞進一步損傷和發生水腫。（3）電場作用下，改變血液流變學性質，降低血粘度及血小板聚集能力，增加紅細胞變形能力；通過電刺激小腦頂核使局部血流量增加。共同改善損失區腦組織的供血，促進缺血區腦組織功能的恢復。（4）電刺激對于神經肌肉的刺激作用，使癱瘓肌群被動的有規律舒縮，并產生小范圍的伸指、伸肘、屈膝等關節運動,有利于防止和恢復廢用性肌萎縮，有利于肌力的恢復。
4結語：高能生物離子治療儀對缺血性腦血管病的療效確切，能使患者神經功能缺損明顯好轉，促進患者癱瘓肢體肌力的恢復，明顯改善患者的臨床癥狀，有助于減少腦血管病的致殘率和致殘程度，值得在臨床進一步觀察研究和推廣。
高能生離子治療儀臨床觀察參加人員
負責人（簽字）：李長生
參加人員（簽字）：李長生 程廣清 姚雷
