一、W.Passath教授与G.Leb教授的研究
德国慕尼黑的W.Hass公众医疗检测中心199o年对电磁场治疗骨质疏松症进行了临床试验和科学研究,并同药物治疗进行了比较,据他们在Franzen大学1991年所发表的论文称:运用电磁场治疗后的骨质疏松病人比较三个月前骨密度增长为3.31%,6个月后6.06%,12个月后7.5%,个别达10%以上,而且在停止治疗一年后骨密度仍呈增长趋势。他们采用每三十次为一个疗程,每次三十五至四十五分钟,整个疗程八至十二周,他们还将电磁场疗法与常用药物进行了比较,结果显示如表三:
In 1990 W.Hass Public Assistance Medical Examination Centre,Munich made clinical experiments and sclentific study of thetreatment of osteoporosis with electromagnetic field and comparedit with medication.According to their paper published at FranzenUniversity in 1991,the bone mineral density of patients suffering osteoporosis Increased by 3.31% three months after the patientsunderwent the treatment with the electromagnetic field,by 6.06% six months late.by 7.5%twelve months later, with that of some patients increasing by over 10%.And the bone mineral density continued to show the trend of increase one year after thediscontinuance of the treatment.They adopted a period of treatment consisting of 30 times of treatment,each treatment ranging from 35 to 45 minutes, which lasted for 8 to 12 weeks They also ompared the electromagnetic field therapy with commonly used drugs, whose findings are shown in Table 3:
疗程
见效时间
调整控制
疗效
副作用
预后
电磁场治疗
8-12周30次
10-20次后即见效
易控制立即可调
一年增长
无任何副作用
疗效巩固
药物治疗
至少6个月
至少3个月后
要先做DEXA检查再人工计算药量
仅0.8%
肝功损伤
内分泌乱胃肠反应
停药反跳
表三 Table 3
他们认为运用电磁场治疗骨质疏松症有以下几个特点:
* 无任何毒副作用;
* 疗程短,仅8-12周,巩固期更短。而药物至少要6
个月而且中途不能停药;
*疗效持久巩固,无药物治疗停药后的反跳现象;
*完成治疗过程的费用低;
*治疗方法简便,计算机控制。
随后由W.Passath教授和G.Leb教授主持的、联合W.Huss公众医疗检测中心,W.Ruberg磁场医疗研究所和 H.Waller分析研究所(W.Haas Public Assistance Medical Examination Centre,Munich H.Waller Di-alysis Institute,Feldbach W.Ruberg Magnetomedies Medical Techndogy GmbH,Munich)等三家医学机构对电磁场治疗骨质疏松症又进行了深入地研究,包括对病人的选择、治疗和所有有关监护检查等。 Karl Franzen大学为此也提供了协助评估治疗原始数据和骨密度测量等辅助性工作。
W.Passath教授与G.Leb教授挑选了36名女性患者,她们的年龄在46-61岁,(平均年龄53.3岁)接受电磁场热疗(以下简称MFT患者)。治疗过程包括:每疗程30次,每次45分钟,持续8-12周。各患者骨密度在治疗前和治疗后3个月、6个月、12个月测量。
做为辅助,患者服用雌激素、钙、维生素D3。在36名患者中,骨密度在Z-Score区域中-2.74~+O.05,结束治疗后一年内,骨代谢值为5.81%(P≤ 0.0001)。另一组23名骨质疏松患者,年龄46-61(平均53.6),骨密度在Z-Score区域中-2.74~-1.04,结束治疗后一年内,骨密度增长7.5%(P<0.0001)。另一对照组35名患者,年龄37至62(平均 53.1),服用相同药物,骨密度增长 0.8%。
根据服用药物情况,MFT患者分成以下分组:
—一雌激素短于3个月;
—一雌激素超过12个月;
—一无雌激素;
—一闭经前。
They thought that the treatment of osteoporosis with electromagnetic field had the following features:
* Free from any side effect;
* Short period of treatment,only lasting for 8 to 12 weeks and a shorter period of strengthening; whereas medication takes at least 6 months and allows no discontinuance of medicine halfwny;
* Lasting and solid curative effects;
* Low cost for completion of the period of treatment;
* Simple and convement treatmnt methods and computer control.
AfterwardS, directed by Professor W.Passath and Professor G.Leb,a further deeper study of the treatment of osteoporosis with electromagnetic field,including patient selection and treatment and all relevant supervision, nursing and examination, was conducted by three medical institutions, W.Haas Public Assistance Medical Examination Centre,Munich,W.Ruberg Magnetomedies Medical Technology GmbH Munich and H.Waller Analysis Institute, Feldbach, Karl Franzen University also did supplementary work for the Study,such as assisting in the appraisal of the original treatment data and bone mineral density measurement.Professor W.Passath and Professor G.Leb selected 36 female patients(hereinafter referred to as MFT patients), aged from 46 to 6呛 years old, (with an average age of 53.3 years old)to undergo the electromagnetic thermotherapy. The period of treatment ran in this way:each period consisting of 30 treatments, each treatment lasting 45 minutes,with the whole period of treatment ranging from 8 to 12 weeks.The bone mineraldensities of all patients were measured before the treatment, 3 months, 6 months and 12 months after the treatment respectively.
As the supplementary treatment, patients took estrogen, calcium and vitamin D3.Among the 36 patients, for those whose bone mineral density ranged within the Z-Score area of-274~+ 0.05 the metabolic value of their bones was 5.81%(P≤0.0001)within one year following the comPletion of their treatment.As for the other group of 23 patients suffering from osteoporosis, aged from 46 to 61 years old(with an average age of 53.6 years old), whose bone mineral density ranged within the Z-Score area of-2.74--l.04, their bone densities IncfCased by 7.5%wltlllnollC year following the completion of their treament.As for another control group of 35 patients,aged from 37 to 62 years old(with an average age of 53.1 years old), who took same drugs,their bone densities increased by 0.8%.
According to their medicine taking,MFT patients were divided into the following groups:
--taking estrogen for less than 3 months;
--taking estrogen for over 12 months;
--taking no estrogen;
--Premenopause.
W.Passath教授与G.Leb教授认为:目前采用的药物如雌激素、钙片和维生素D3,可部分级差闭经后快速的骨质衰退,但这同时亦减少了患者营养物质的吸收。
The isolated build-up of fluorides and the irreversible arrest of decay through the use of such agent as bio-phosphanates are matters on whch opinions are divided.
每天或每周三次皮下注射钙剂可以阻止骨质衰退,但治疗效果具有反跳性。长期服用钙可使骨密度提高几个百分点,并可止痛。但皮下注射钙会产生极为不适的副作用,只有非常严重的骨质疏松患者才不得不忍受这种副作用;大多数妇女也拒绝服用长达一年左右的雌激素。
W.Passath教授与G.Leb教授运用电磁场治疗骨质疏松的治疗计划与规则是建立在Basset,Brighton,Becker, Cruess, Janssen, Lengel, Rubin∫ Wallach 的临床研究基础之上的,其中 Rodemann, Bayreuther和Pfecderer于1985年开展的细胞培养研究,即人类皮肤、肺成胶原细胞对一定电磁场强度和交变密度的反应对W.Passath教授与G.Leb教授影响最大,在此项研究所获得的电磁场刺激细胞有丝分裂和成熟细胞以及有关交变电磁场密度、特性、频率等研究成果,被他们整理成一套治疗骨折、股骨头坏死和骨质疏松的治疗规则。
在这一套治疗规则下,1991年5月他们开始着手研究,其研究情况如下:
1.综述
W·Passath教授与G.Leb教授研究的电磁场治疗仪器主要治疗整修脊柱区域,这也是骨质疏松易发区。其目的是严格检查MFT的有效性,44名女性患者给予30个小时治疗过程,延续8-19周。同时,挑选了一组能自由活动的病人作为对照组,MFT组患者与对照组患者都服用雌激素、钙、维生素D作为辅助治疗。主观感觉包括副作用。
Professor w Passath and Professor G.Leb believed that currently used medicine such as estrogen, calcium and vitamin D3, can partially degrade the rapid bone decay after menopause,yet reduced a patient's absorption of nutriments at the same time.
The isolated build-up of fluorides and the irreversible arrest of decay through the use of such agent as bio-phosophanates are matters on which opinions are divided.
Hypodermic injection of calcium agent three times per day or per week can arrest the raapid bone decay. Yet the curative effects are featured by future degeneration Taking calcium over a long period can raise bone mineral density by several penentages and relieve pain;whereas hypodermic injection of calcium will produce extremely uncomfortable side effects. Only patients suffering very serous osteoporosis had to bear such side effect. And most women refuse to take estrogen for as long as about one year.
The treatment plan and rules of Professor W.Passath and Professor G.Leb regarding the treatment of osteoporosis with electromagnetic field were built on the clinical studies of Basset, Brighton, Becker, Cruess, Janssen, Lengel, Rubin and Wallach, among which the cell cultivation study made by Rodermann, Bayreuther and Pfederer in 1985,that is the reaction of human skin and pulmonary collagen cells to certain electromagnetic field intensity and alternating density, exerted the biggest influence on Professor W.Passath and Professor G.Leb. They organized findings obtained in the study, such as the stimulation of cell mitosis and ripe cells by electromagnetic field, densities, features and frequencies of relevant alternating electromagnetic fields, into a set of treatment rules for treating fracture, thigh-bone necrosis and osteoporosis.
They started to study in May 1991 under this set of treatment rules. Their study ran as follows:
1.Summary
The electromagnetic field treatment instrument studied by Professor W.Passath and Professor G.Leb mainly treats and repairs spine area, which is also the area susceptible to osteoporosis.The purPose of the instrument was to strictly examine the effectiveness of MFT. 44 female patients were granted a 30-hour period of treatment lasting for 8 to 19 weeks.Meanwhile a group of patients who could move were chosen as the control group. Patients of the MFT group and patients of the control group all took estrogen,calcium and vitamin D3 as supplementary treatment. Subjective feelings included side effects.
2.治疗过程
为取得满意效果,W.Passath教授与G.Leb教授安排患者进行30次治疗,每次持续45分钟。两次不治疗相隔0-2天,整个治疗周期延续8-12周。治疗选在上午或下午,专业劳动患者也包括在内。每天询问患者疗效、不适,并做记录,督促并确定辅助药物服用情况,定量体力活动情况。
3.患者选择
W.Passath教授与G.Leb教授选择的患者均为女性,在1991年5月前都已确诊为骨质疏松,骨密度降低,需要治疗。其选择原则如下:
—一年龄30-60岁;
—一闭经前、闭经后自发的骨质疏松或Secondary Osteporosis
雌激素、钙和维生素D可以服用,但不是必须的。所有患者的治疗计划已经开始后都未曾变更。47名年龄35-61岁的女性患者都表述自愿参加MFT计划,其中两位分别于第10、15次次治疗后终止治疗,另一名患者因治疗记录不全,不在统计之列。44名患者完成注治疗计划,并参加所有对比检查项目。
4.骨密度仪
MFT患者的骨密度在MFT治疗前、治疗后3个月、6个月、12个月检查,使用的是 DPA设备( Sophos),检测精度通过使用一块平坦金属板(metal phantom)以及W.A.Klender提出的ESP 046 phantom来控制。
骨密度测量在每个患者腰椎1-4进行,有几例仅在腰椎2—4进行。
其给出的评估是基于单个腰椎比较基础上的;也就是说,不同腰椎的测量结果相互比较。这样保证了最高统计可靠性和推导结果的正确性。
2. Period of Treatment
In order to achieve satisfactory effects, Professor W.Passath and Professor G.Leb arranged patients to undergo 30 treatments, each treatment lasting for 45 minutes. Interval of dual non-treatments, each treatment lasting for 45 minutes. Interval of dual non-treatments ranged from 0 to 2 days. The whole period of treatment lasted for 8 to 12 weeks. The treatment was chosen either in the morning or in the afternoon, including professional labor patients. They inquired the patients on the curative effects and uncomfortable reaction, recorded them, supervised, urged and made sure of the patients’taking of supplementary medicine as well as their set amount of physical labor.
3. Selection of Patients
All patients selected by Professor W.Passath and Professor G.Leb were female and had been diagnosed as suffering osteoporosis, having reduced bone mineral density and needing to be treated. Their principle of selection ran as follows:
* Aged from 30 to 60 years old;
* Spontaneous osteoporosis or secondary osteoporosis before or after menopause.
Estrogen, calcium and vitamin D3 may be taken but are not necessary. The treatment plan of all patients did not change from the beginning. 47 patients aged from 35 to 61 years old expressed their willingness to join the MFT plan, among which two ended their treatment after the 10th treatment and the 15th treatment respectively and another patient was not included in the statistics because of incomplete treatment record. 44 patients completed the treatment plan and joined all contrast examination items.
4. Bone mineral density Instrument
Bone densities of MFT patients were measured before the treatment, 3 months, 6 months and 12 months after the treatment respectively, using DPA equipment (Sophos). The examination precision was controlled by one flat metal phantom and Esp 046 phantom put forward by W.A.Klender.
The measurement of bone mineral density was made on lumbar vertebra 1-4 of each patient, with only several measurements on lumbar vertebra 2-4.
The given appraisal was based on the comparison basis of single lumbar vertebra, that is to say, comparison of the measured findings of different lumbar vertebra, in this way guaranteeing the reliability of maximum statistics and the correctness of derived findings.
