New breakthroughs of Physical therapeutic instrument for coronary Artery disease
Product Name
High-energy Bio-ion Instrument for Coronary Artery Disease
Product Structure
Host Output line Two Physical probe
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, increase myocardialinfarction lesion area's blood provide, 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, 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.
Clinical characteristics
a. Short-term treatment will significantly improve the main symptoms of angina and shortness of breath.
b. Long-term treatment will improve the blood supply of coronary, repair the organization of myocardial infarction, delay the progress of disease, and make patients to full recovery. No any treated patient is happened depends on heart surgery or cardiac interventional treatment due to the protracted illness.
c. It has been proved by case-by –case that the methods for rescuing patients with acute myocardial infarction are more effective than regular methods.
d. Simply physical treatment, safety, no toxic side effect.
Adaptation disease
a.Initial onset angina pectoris: patients with angina pectoris within one month.
b.Stable angina pectoris: patients with angina pectoris more than one month
c.Progressive angina pectoris: chest pain that induced by the same degree of fatigue is happen frequency, the severity and duration is also suddently increasing.
d.It has been tested and confirmed as the treatment of patients with acute myocardial infarction in acute and convalescent stages.
Exclusion criteria
a. Angina pectoris at test
b. The chest pain caused by other heart disease, severe neurosis, menopausal syndrome, cervical spondylosis, gallbladder and the reflux of stomach and esophageal.
Contraindication
a. Patients who had cardiac surgery or interventional cardiology treatment.
b. Patients with severe primary disease, including severe hypertension, severe cardiopulmonary dysfunction, severe arrhythmia, as well as the severe primary disease caused by liver, kidney, and hematopoietic system.
c. Patients with malignant tumors, bone deformities, internal bleeding, glaucoma and other serious diseases.
d. Psychiatric patients
e. Pregnant or lactating women
f. Children under 12 years old.
Methods of operation
Patients with posterior wall myocardial infarction are proposal method A; patients with anterior wall myocardial infarction are proposal method B.
Method A: Place two physical probes in parallel to patients’ back [figure 1]
Let the patient supine to press the physical probes, setting 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 10-20 mA, plus the stalls when current is not enough, and the current should not exceed 30 mA.
1.The treatment for Initial onset angina pectoris
Twice a day, each time 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 three times’ treatments. Then take the re-examination and follow-up the efficacy after 30 days.Give up this treatment method if it failed to improve the main symptom efficacy or major indexes after the treatment accumulated to five times.
2.The treatment for stable angina pectoris:
Twice a day, each time 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 five times’treatments. Then take the re-examination and follow-up the efficacy after 20 days. Give up this treatment method if it failed to improve the main symptom efficacy or major indexes after the treatment accumulated to ten times.
3.Treatment for Progressive angina pectoris
Twice a day, each time 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 five times’ treatments. Then take the re-examination and follow-up the efficacy after 20 days. Give up this treatment method if it failed to improve the main symptom efficacy or major indexes after the treatment accumulated to twenty times for ten days.
4.Treatment for rescuing the patients with acute myocardial infarction.
Reference Method1,Method2 or Method3
5.The convalescent treatment for the patients with acute myocardial infarction
Reference Method 1, Method 2 or Method 3.
Adverse reactions
Contraindication
[摘要]:目的 探討高能生物離子治療穩定型和不穩定型心絞痛患者的療效。方法選擇冠心病心絞痛患者，給予常規抗心絞痛治療（抗心肌缺血藥物+抗血小板藥物、抗凝藥），分成兩組進行觀察。
?、僦委熃M：在以上常規治療基礎上，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進行治療，每次30分鐘，10次為一個療程。
?、趯φ战M：僅給予常規治療。觀察指標為心絞痛癥狀緩解率、心電圖改善程度。結果 治療后不穩定型心絞痛癥狀緩解有效率為90%，穩定型心絞痛癥狀緩解有效率為96.15%；心電圖缺血改善有效率為86.27%，治療后的24h動態心電圖ST段總壓低時間縮短以及ST段最大壓低深度減少情況，與治療前比較有明顯改善，P<0.05。
結論 高能生物離子對心絞痛癥狀的近期改善有著肯定的療效，值得臨床進一步觀察和推廣。
[關鍵詞]：高能生物離子 心絞痛
Clinical Analysis of Therapeutic Efectiveness on the patients of Angina Pectoris of Coronary Artery Disease with High-energy Bio-ion YAO Zhen,Chen Jing, Kong Yueqiong, Zheng Hailong, Rong Congwen, Liu Chan
Abstract Objectives To observe the therapeutic effectiveness of high-energy bio-ion in treatment of patients with angina pectoris of coronary artery disease. Methods 56 caese of coronary heart disease were divided into two groups: unstable angina pectoris (UAP) and stable angina pectoris (SAP). All of them weregiven with antimyocardial ischemia drugs. Some of them were also treated with high-energy bio-ion equipment (therapy group), which was manufactured by Hainan Tianguang Hi-technology Development Corporation and treated in 40 minutes per session, 10 sessions per course. Some of them were given only with antimyocardial ischemia drugs (control group). Rsults After therapy, the effective rate of symptom im provement in UAP group was 90% and in SAP was 96.15%. The effective rate of ECG improvement of ischemia in all patients was improved greatly. Conclusion The high-energy bio-ion is much effective for the recent action in angina pectoris.
[Key words]：high-energy bio-ion angina pectoris
冠心病是臨床常見多發病，其以反復、病情危重為特點，日益威脅著廣大患者的健康。本研究以高能生物離子治療儀并采用單盲、自身對照方法對冠心病穩定型心絞痛和不穩定型心絞痛患者進行治療，取得了較好的近期療效，現將結果報道如下。
材料與方法
1.1 病例選擇：
按國際心臟病學會和協會以及世界衛生組織（ISFC/WHO）臨床命名聯合標準化聯合專題組1979年的《缺血型心臟病的命與診斷標準》，選擇冠心病不穩定型心絞痛（UAP）患者30例，其中男性11例，女性19例，平均年齡66±12（52~71）歲；穩定型心絞痛（SAP）患者26例，其中男性9例，女性17例，平均年齡62±15（43~72）歲。伴發疾病中，在不穩定型心絞痛患者中，有高血壓病者17例，Ⅱ型糖尿病者6例；穩定型心絞痛患者有高血壓病者15例，Ⅱ型糖尿病者2例。
若3個月內患過腦血管意外、嚴重心腎功能不全者、新近心肌梗死者、未控制的糖尿病患者均排除在入選病例中。
1.2．治療方法和觀察指標：
所有病例入院后均常規應用硝酸酯類藥物，部分用美托洛爾12.5mg~25mg，每日2次；靜息狀態下發生心絞痛者用地爾硫30mg，每日2~3次。經以上治療效果不佳者方進入本研究。給予高能生物離子治療儀治療，治療儀器采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，輸出電壓50~100V，電流強度15~20mA，正弦波?；颊呷⊙雠P位，將兩個物理探頭平行放置在患者背部，讓患者平臥使背部壓緊物理探頭。設置治療時間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10-20mA，電流達不到時可加檔位，最大不得超過30mA。每次治療時間20分鐘，共10天為一療程。
接受高能生物離子治療儀的治療前后均常規檢查血糖、血脂、心肌酶（CK-MB、TnT）,以及纖維蛋白原（FN）、心電圖和動態心電圖等檢查，每次治療前后均觀測心率、血壓變化。
1.3．療效判定：
參照1974年全國高血壓冠心病普查預防座談會制定的《冠心病心絞痛與心電圖療效評定標準》進行評定。
1.3.1．臨床療效
顯效：心絞痛基本消失或減少80%以上，硝酸酯類耗量減少80%以上；
有效：心絞痛減少發作50%以上，硝酸酯類耗量減少50%~80%；
無效：心絞痛減少發作50%或硝酸酯類耗量未達到顯效與有效的標準。
1.3.2．心電圖判定標準
心肌缺血的心電圖診斷：R波頂點垂線與ST段交叉≥90°，ST段呈水平型、下斜型下移≥0.05mv，以NST與∑ST表示心肌缺血的范圍與程度，NST表示常規12導聯中ST段壓低的導聯數，∑ST表示12導聯ST段壓低值的總和。療效判定標準:
顯效：休息時心電圖恢復至正?；虼笾抡?；
改善：壓低的ST段治療后回升≥0.05mv，但未達到正常水平。主要導聯倒置T波變淺達20%以上或T波由低平變為直立；
無效：靜息時心電圖與治療前相同。
1.3.3．動態心電圖判定標準
采用Brewood動態心電圖儀檢測24小時心電圖，在R波為主的檢測導聯中，ST段在J點后0.08秒呈水平型或下斜型壓低0.1mv，持續1分鐘以上，作為心肌缺血的診斷標準。
1.3.4．統計方法
所有計量資料結果以均數±標準差（X±S）表示，兩組均值比較用非配對t檢驗判定。P<0.05為有統計學上的意義。
結 果
2.1．心絞痛緩解情況：
30例UAP患者中，顯效16例，占53.33%；有效11例，占36.67%；無效3例，占10%；總有效率為90%；26例SAP患者中，顯效17例，占65.38%；有效8例，占30.77%；無效1例，占3.85%；總有效率為96.15%。見表一。
| 各組患者的心絞痛緩解情況 |
| 顯效 有效 無效 合計 |
| UAP組 16 11 3 30 SAP組 17 8 1 26 合計 33 19 4 56 |
30例UAP患者治療前心絞痛發作次數總計為1564次，治療后心絞痛發作次數總計為218次；治療前消心痛治療片劑為1260片/周，治療后為630片/周。26例UAP患者治療前心絞痛發作次數總計為782次，治療后心絞痛發作次數總計為96次；治療前消心痛治療片劑為952片/周，治療后為420片/周。治療前后對比，在心絞痛發作次數、消心痛應用方面均有明顯減少，P<0.01。
2.2． 心電圖恢復情況：
56例心絞痛患者中有靜息或動態心電圖ST-T變化者51例，其中16例顯效（31.37%），28例有效（54.9%），總有效率為86.27%；用藥前后NST與∑ST比較見表二。
| 表二 治療前后靜息心電圖NST與∑ST比較(X±S) |
| 治療前 治療后 |
| NST 2.8±1.2 2.2±1.2 ∑ST 3.2±1.7 2.3±1.1 |
△與治療前相比，P<0.05；△△與治療前相比，P<0.01。
| 表三 治療前后靜息心電圖NST與∑ST比較(X±S) |
| 治療前 治療后 |
| ST段總壓低時間(min) 504±40.2 546±51.2 ST段最大壓低深度(mm) 3.6±1.5 2.5±1.2 |
△與治療前相比，P<0.05。
| 表四 治療前后血液流變學情況 |
| UAP組 SAP組 |
| 前 后 前 后 |
| TC(mmol/L) 5.85±0.82 5.12±0.94 5.67±0.73 5.03±0.81 Tg(mmol/L) 2.07±0.46 1.87±0.47 2.13±0.32 1.98±0.53 SOD(ng/L) 786±71.8 812±85.6 759±82.8 794±91.2 F(ng/L) 4.6±2.1 3.1±1.6 4.3±1.8 3.0±1.2 FDP(mg/L) 1.6±0.7 1.2±0.2 1.7±0.5 1.3±0.3 血液低切變速率 8.73±0.97 7.65±0.89 7.97±0.88 7.21±0.63 (10s-1mpa.s) 血液高切變速率 6.57±0.74 6.11±0.38 5.63±0.59 4.89±0.42 (10s-1mpa.s) 血漿粘度 1.43±0.31 1.06±0.23 1.52±0.27 1.02±0.24 PAG(M)% 76.19±12.78 70.12±8.43 77.67±9.24 70.89±8.97 |
△與治療前相比，P<0.05。
討 論
不穩定型心絞痛的發作多由于冠狀動脈粥樣斑塊病灶不穩定、血小板聚集、血栓形成所致；有時與冠狀動脈痙攣有關。因此，臨床治療的觀點主要針對性應用硝酸酯類藥物、鈣拮抗劑、抗血小板藥（阿司匹林、氯比格雷等）和抗凝藥（肝素、低分子肝素等），但也有一定的應用限制。探索更加有效、安全的治療措施，實屬必要。
高能生物離子治療儀運用生物電生理和生物組織電傳導基本均衡的原理，將對人體組織有良好生理效應的50HZ正弦波電流經施治醫生人體調理后產生高能生物離子經交變電場達到人體深層組織，而作用于心血管系統。其之所以可以治療心絞痛，主要是通過調整血管平滑肌的舒縮，改善血管壁的運動，從而解除了血管壁的緊張狀態，提高了冠狀動脈的血液循環功能，增加了病變區域的血供；另方面針對心肌細胞，可使到細胞膜內外離子運動增加，新陳代謝加強，改善了細胞的微環境，促進組織再生和修復，故而起到改善心肌缺血的作用。
本組穩定型和不穩定型心絞痛患者經過治療后，心絞痛癥狀發作情況明顯減少、依賴硝酸酯類藥物治療也減少；心電圖心肌缺血也有明顯改善，主要表現為24h動態心電圖ST段總壓低時間明顯縮短以及ST段最大壓低深度顯著減輕。目前臨床上對于心絞痛頻繁發作，有研究已顯示出凝血系統功能亢進和纖溶功能低下造成的血液高凝狀態是發生的主要原因之一。本組心絞痛患者在高能生物離子治療后的纖維蛋白原明顯下降，說明了這種治療有一定的抗纖維蛋白原作用；另外，本組病例血FDR水平在治療后無升高，也說明了并非纖溶系統活性增加，促使纖維蛋白原的消耗，而推測是作用在纖維蛋白原水平，使之下降。無論是穩定型或不穩定型心絞痛，其血小板最大聚集率PAG（M）%，經過一療程治療后，有顯著下降，也提示了高能生物離子治療具有的抗血小板聚集作用，從而穩定了病情，防止了冠狀動脈的進一步減少和心肌缺血的加重。這些均是高能生物離子治療心絞痛的可能機制。
高能生物離子治療儀作為近年來出現的治療新技術。其無創傷性、副反應小、適應面廣正在引進臨床重視。但是，其在臨床上應用治療心血管疾病患者的確切機制，尚有待于進一步研究；對于治療冠心病患者遠期療效評價，尚需大樣本量的更長時間的臨床觀察。
