RU2175564C2 - Combined method for treating malignant tumors - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves administering combined double action to patients at the beginning of special-purpose anti-tumor therapy daily during two weeks and then every second day between 9 and 11 o'clock. The first treatment involves head magnetization in the center of the head back at the level of imaginary line connecting acoustic orifices by means of extremely low frequency magnetic field of 7.9 Hz with 5 mTesla units magnetic density which value is continuously exponentially reduced in the 5 - 3.5 - 2.5 - 1.8 - 0.6 mTesla units sequence. The sequence is repeated to the end of treatment. Exposure time is 3 min increasing by 1 min concurrently with lowering density. The second treatment involves individually selected controlled skin treatment in the areas topographically related to systems of organs and tissues with pain syndrome and other disorders using SCENAR-therapy in frequency range of 15-350 Hz ± 5% with 30-120 Hz ± 5% modulation under general treatment duration of 15-20 min during 20-30 days. EFFECT: enhanced effectiveness of combined treatment of malignant tumors. 1 tbl

Description

 The invention relates to medicine, more specifically to oncology, based on the development of the discovery of the USSR, diploma N 158 of 05.23.75, and can be used in the combined treatment (chemoradiation and surgical) of cancer of advanced stages of the development of major localizations, including the breast.

 It is known that the aggressive nature of the growth of malignant tumors creates critical conditions for maintaining homeostasis, blocks the mechanisms of protective-compensatory reactions. The use of medicinal, radiation, and surgical methods of treating cancer that are effective in suppressing tumor growth exacerbates the resulting disturbances. The integral expression of the body's adaptation to the damaging effects of the tumor and specific antitumor effects is the development of tumor stress.

 Based on the discovery of the patterns of development of common non-specific adaptive reactions, a strategy and tactics for overcoming stress by developing anti-stress training and activation reactions that differ in the state of the central nervous system and other systems, the level of energy consumption and the nature of increasing antitumor resistance have been developed (L.Kh. Garkavi et al., 1977 , 1979, 1990, 1998).

 The conditions for the formation of anti-stress reactions consist in presenting to the body in a stressful state effects that are initially small in magnitude but of high informative value. Such effects include electromagnetic effects of low frequency and low intensity (V.P.Kaznacheev, L.P. Mikhailova, 1985; A.A. Putilov, 1987). The role of such actions in adaptation functions is associated with the possibility of a reciprocal restructuring of the central regulatory mechanisms (Yu.A. Kholodov, 1982, Yu.A. Kholodov, N.N. Lebedeva, 1992), reversible adaptation (A.S. Presman, 1997), and is defined as coordinating and system-forming.

 At present, the development of modern wave technologies has led to the use of electromagnetic radiation (optical, super- and extremely high-frequency ranges) in oncology in combination with both chemo-radiation and surgical treatment of cancer (V.V.Sokolov, R.K. Kabisov , B.K. Poddubny, A.S. Barchuk. "New physical methods in the treatment of malignant tumors of the main localizations." Russian Oncological Journal, N 3, 1996, p. 35-41).

 The authors were able to show the effectiveness of such methods of exposure, using a laser, EHF, microwave radiation, vortex and constant magnetic fields on the area of postoperative radiation damage to tissues associated with the anatomical and topographic localization of tumor foci. Although these approaches allow us to determine the important role of local reactions, the formation of a systemic response - the general reaction of the body under the influence of different modality and high frequency is not taken into account. It does not take into account the fact that in the body, as a complex oscillatory system, fluctuations endogenously occur with frequency parameters many orders of magnitude lower (for example, brain frequency rhythms) than suggested. Therefore, the developed methods for using physical factors are not designed to involve the wave properties of the brain, as the main regulatory system, in the processes of synchronization and integrative activity of the body.

 A known method of treating cancer of various localizations, we have chosen as a prototype, including irradiation, chemotherapy, surgical treatment and the use of the effects of an ultra-low-frequency magnetic field (VLF MP) on the brain (patent examination dated 06/19/98 on application for invention No. 94038764/14 , with a priority of 10/12/94 on the "Method for the treatment of cancer" in the name of Garkavi L.Kh., Kvakina EB, Shikhlyarova A.I., Korobeynikova E.P., Rubtsova V.R., Orlovskaya L.A. , Sarieva E.A., Varvantsa Yu.V. and Maslova A.I.). Its main difference from the known methods is to correct the desynchronization of the brain by using the VLF MP according to a special program of frequencies that are adequate to the rhythms of the brain based on the study of the electroencephalogram (EEG).

 However, this treatment method has drawbacks, namely, taking into account only endogenous frequency rhythms of the brain and modeling the integral antistress response with central (on the head) exposure, the frequency characteristics of other hierarchical levels are not taken into account. In this connection, it is of particular interest to model the conditions for the combination of central (on the head) and local (on organs and tissues) regulation and correction of homeostasis disorders during tumor growth based on the commensurability of the frequencies of endo- and exogenous nature according to the principle of resonance-field relationships. For this, it is advisable to apply physical factors not only of one, but of different modality and frequency, in order to address the effects to different hierarchical levels of the body to obtain a more pronounced synchronizing effect. A prerequisite for using a combination of physical factors is also a number of general patterns in the reactions of regulatory systems (Lebedeva NI, 1995), which create the basis for the directed regulation of homeostasis.

 The aim of the invention is to increase the effectiveness of treatment: improving the immediate results of cancer treatment, normalizing disorders of the neuro-adaptation processes by the central nervous system, general ergization of the body, reducing toxicity, normalizing blood counts (lymphocytes, white blood cells), achieving an analgesic effect.

 This goal is achieved by the fact that at the beginning of any special antitumor therapy, patients additionally receive a combined double effect for 2 weeks daily, and then every other day, between 9 and 11 hours: the first effect is magnetization of the head in the center of the head at the level of an imaginary line between auditory openings with an ultra-low-frequency magnetic field (ELF) of 7.9 Hz, an induction of 5 mT, the value of which is gradually reduced exponentially in the mode of 5-3.5-2.5-1.8-1.2-0.8-0, 6 mT with repetition of the sequence until the end of treatment, and exposure of 3 minutes with an increase of one minute as the induction decreases; the second effect is an individually dosed treatment of the skin integument topographically associated with organ and tissue systems with pain and other disorders, weak electrical impulses from the electrode (SCENAR-97.1 device) with a frequency in the range of 15-350 Hz ± 5% with 30- modulation 120 Hz ± 5% and amplitude with a duration of a series of pulses (1, 2, 3, 4, 5) ± 0.5 seconds and pauses of 1 ± 0.5 seconds with a total duration of exposure of 15-20 minutes for 20-30 days.

 The invention "A method for the combined treatment of malignant tumors" is new, as it is unknown from the level of medical technology in the field of complex treatment (chemo-radiation and surgical) of malignant tumors.

 The novelty is confirmed not only by comparing the proposed solution with known methods, but also by the presence of significant differences with the prototype. This difference lies in the correction of the functional state of the body by synchronizing influences not only centrally on the central nervous system, but also locally, on other peripheral subsystems.

 The parameters of the used ELF MP also make a significant difference: an exponential intensity mode in the range of 5-0.6 mT is used with increasing exposure (from 3 to 8 minutes) with a monotonic frequency of 7.9 Hz. The choice of frequency is based on the presence of a similar band of resonant frequencies for the hippocampus, normalizing circadian rhythms (Schumann waves) disturbed in cancer patients. An important difference is the time sequence of actions of various modality.

 The influence of VLF MP is aimed at correcting the desynchronization of brain processes, i.e., correction of central regulatory processes, and SCENAR-therapy determines the possibility of including peripheral parts of neuroadaptive regulation and is addressed to organs and tissues with pronounced metabolic disturbances. Such a combined synchronizing general and local effect has a general regulatory and strengthening effect due to the mechanism of development of antistress reactions of the body.

 The invention "A method for the combined treatment of malignant tumors" has an inventive step, since for a specialist oncologist it does not explicitly follow from the level of medicine in this field of oncology that is limited by the use of chemoradiation and surgical treatment methods without the use of special correction of desynchronization of various physiological systems, primarily the central nervous system . At the same time, desynchronization that develops with tumor disease prevents the increase of antitumor resistance and improves the quality of life of cancer patients. The proposed combination of factors (VLF MP and SCENAR) using frequencies that are organically inherent in the body and therefore easily assimilated prevents the dominance of the stress syndrome by addressing the central and peripheral mechanisms of homeostasis regulation with an adequate functional load.

 The proposed method is industrially applicable, as it can be used in special oncological medical institutions and in hospitals of the general medical network. Due to the dominance of a non-specific link in the mechanism of used physical factors (VLF MP, SCENAR), the proposed method can be used for various cancer localization, severity and duration of oncopathology, starting from precancerous proliferative processes accompanied by neuroendocrine disorders, up to deeply involved processes that are not subject to special antitumor treatment. Compact and reliable technical equipment makes it possible to work with large groups of patients.

 The method of combined treatment of malignant tumors is used as follows. The first part of the combined treatment is carried out using the magnetotherapy apparatus "Spectrum-2" with microprocessor control. For treatment, an MP with a frequency of 7.9 Hz and magnetic induction of 5 mT is used, the initial value of which daily decreases exponentially: 5 mT; 3.5 mT; 2.5 mT; 1.8 mT; 1.2 mT; 0.8 mT; 0.6 MT After this, the procedure is repeated in the same sequence, starting with a lower value of 2.5, then 1.8 mT, etc. As induction decreases, the exposure every day increases by one minute, starting from 3 minutes (exposure to 5 mT) and up to 8 minutes (exposure to 0.8 and 0.6 mT). Thus, at a constant frequency of 7.9 Hz, the magnitude of induction decreases daily, and exposure increases. This mode of magnetic exposure is used at the beginning of the course daily for 2 weeks, and then continue until the end of the course of special treatment - every other day. The course of magnetotherapy is 20-30 procedures.

 The second part of the combined treatment is carried out 5-10 minutes after exposure to the VLF MP. It is an electrical stimulation using the SCENAR-97.1 apparatus (GOST R50444, class B according to RD 50-707) of human skin integrally with pulses with a frequency adjustable within 15-350 Hz ± 5% and amplitude (pulse packs) - with a duration of series pulses (1, 2, 3, 4, 5) ± 0.5 sec and pauses 1 ± 0.5 sec. The signal parameters are set automatically due to the action of the biological feedback of the device - the patient.

 To provide a general regulatory effect, first the skin is exposed to the back along the spine for 3-5 minutes, then the adjacent areas (humerus, sacral region, buttocks) are sore and prone to pressure sores. If necessary, areas of lymphostasis, suture scars, pain, gastro-duodenal zone are treated.

 Before starting, in the process, as well as at the end of the course of combined treatment of UHF MP and SCENAR, the dynamics of the body's reactions are taken into account: the dominant type of the general adaptive reaction is determined by the Schilling leukogram; assessment of the electrical activity of the brain using computer analysis of the background and reactive EEG; the energetics and symmetry of the nervous, endocrine, lymphatic and other channels are assessed according to the acupuncture measurement of skin resistance according to R. Voll, a questionnaire determination of well-being is carried out with an indication of the observed types of toxicity.

 Examples of specific performance of the "Method of combined treatment of malignant tumors."

1. Chernobil N.A., 48 years old, and.b. N 15418 / x, diagnosis: generalization of cancer of the left breast with metastases in the pelvic bone, St-III, column 3, condition after mastectomy. On admission, pain in the right hip joint in the metastasis zone was noted. In the analysis of blood leukopenia (2.6 • 10 ⁹ ). Simultaneously with chemotherapy conducted according to the MF-Mtx regimen - 30 mg IM, 5 FU - 1250 mg IV for 6 hours drip 3 weeks in a row, received VLF MP centrally (per head) and SCENAR-therapy for the pain zone . The impact of the VLF MP was carried out in the frequency mode of 7.9 Hz with induction on the first day - 5 mTl - 3 min; in the second - 3.5 mTl - 4 min; in the third - 2.5 mTl - 5 min; in the fourth - 1.8 mTl - 6 min; in the fifth - 1.2 mTl - 7 min; in the sixth, 0.8 mTl - 8 min; in the seventh, 0.6 mT - 8 min, and on subsequent days with a series of repeating, starting from 3.5 mT - 4 min, etc., a total of 13 procedures. Every day, 5-10 minutes after the VLF MP session, SCENAR-therapy was applied to general control zones and the pain area. The number of leukocytes increased to 5.0 • 10 ⁹ and Le-singing was not observed in any of the subsequent courses. The immediate result of treatment is a significant> 50% decrease in lymph nodes, a complete restoration of joint mobility, the disappearance of pain, and improvement of well-being.

2. Trofimova L. N., 45 years old, and. N 2999 / e, diagnosis: generalization of cancer of the left breast with metastases in the head of the left humerus, supraclavicular lymph nodes on the left, St-IV, gr. 4. Condition after mastectomy and local radiation therapy. All previous courses of adequate chemotherapy, as well as radiation therapy were accompanied by persistent prolonged leukopenia (Le - 2.0 • 10 ⁹ ) and poor health. The first course of CT MF-Mtx - 30 mg, 5FU - 1250 mg iv was carried out for 3 weeks in combination with VLF MP and SCENAR-therapy. At a frequency of 7.9 Hz, induction and exposure were on the first day — 5 mT — 3 min; in the second - 3.5 mT - 4 min, etc. exponentially up to 0.6 mT - 8 min. In subsequent courses of chemotherapy, the effects of VLF MP and SCENAR were repeated: a total of 25 sessions were conducted, allowing 3 chemotherapy courses in full without leukopenia (Le - 4.8 • 10 ⁹ ; 4.1 • 10 ⁹ ; 3.9 • 10 ⁹ ) the number of lymphocytes is up to 23%. The immediate result of treatment is a decrease in the tumor node by more than 50%, a decrease in supraclavicular lymph nodes, an increase in joint mobility, and the disappearance of bone pain. At the moment - a complete clinical and radiological remission, good general condition.

3. Hvorostova L. V., 48 years old, and. N 6051 / f, diagnosis: edematous-infiltrative form of cancer of the left breast with metastases to the axillary lymph nodes on the left, T4 N2 M0, St-III, column 2. Before the start of special training, the number of leukocytes is 2.0 • 10 ⁹ . The patient immediately began to receive VLF MP and SCENAR-therapy and a week later Le = 5.0 • 10 ⁹ . In the future, 2 courses of PCT CMFV + doxirubicin, radiation therapy, radical mastectomy were carried out against the background of continued exposure to VLF MP and SCENAR. Leukopenia was not noted, signs of intoxication were also not detected. The course of ELF MP and SCENAR-therapy consisted of 20 sessions: on the first day - 5 mTl - 3 min; in the second - 3.5 mT - 4 min, etc. up to 0.6 mT - 8 min. Repeating the exponent for the induction values twice starting from 3.5 mT - 4 min, SCENAR-therapy was applied daily to the zones of general regulation (along the spine, shoulder and lumbar regions, gastroduodenal zone). Leukopenia was noted once at the end of a course of radiation therapy. Pain sensations, manifestations of toxicity were not noted. The number of Le is 4.2 • 10 ⁹ , lymphocytes up to 36%. The immediate result of treatment is a decrease in the tumor by more than 50%, improvement of well-being.

4. Fomchenko L.A., 64 years old, and.b. N 2937 / f, diagnosis: generalized cancer of the left breast with metastases to the lymph nodes and bones, T2 N2 M1, St-IV, gr. 4.1. The course of PCT - CMFV was accompanied by persistent deep leukopenia - up to 2.0 • 10 ⁹ . The next stage was the start of radiation therapy on the mammary gland and all groups of lymph nodes of diabetes 40 Gy in combination with the effects of VLF MP and SCENAR-therapy. The patient received 14 procedures VLF MP frequency of 7.9 Hz with induction on the first day - 5 MT - 3 min; the second day - 3.5 mTl - 4 min; the third - 2.5 mTl - 5 min; etc. exponentially decreasing daily to 0.6 mT - 8 min. Repeated exposure to VLF MP was carried out starting from induction of 3.5 mTl - 3 min, then 2.5 mTl - 4 min; and so on to the end. SCENAR-therapy was carried out in general control zones 5-10 minutes after VLF MP. At present, the patient has a state of developing remission without complications and leukopenia (Le - 4.3 • 10 ⁹ ), lymphocytes - over 20%. No manifestations of toxicity were detected. The immediate result of treatment is a complete clinical remission in the bones, a decrease in lymph nodes.

 The proposed method was carried out treatment of 40 patients with a common malignant process.

 Control (treatment according to the usual tactics without the use of VLF MP and SCENAR-therapy).

1. Varycheva R. N., 36 years old, and. N 7614 / f, diagnosis: cancer of the right breast, exophytic form T4 N2 M0; St-III, column 2. The course of PCT with doxorubicin. At the end of treatment, deep leukopenia (Le - 2.2 • 10 ⁹ ) with agranulocytosis, severe hematotoxicity, nausea, pain in the gastroduodenal zone. The antitumor effect was 30%.

2. Nosivtsova L. F., 61 years old, and. N 6974 / f, diagnosis: nodular form of cancer of the left breast with metastases to the axillary lymph nodes T3 N2 M0, St-III, gr. 2. A course of PCT CMFV was carried out with an effect of 40%, but against the background of deep leukopenia (Le - 2-2.5 • 10 ⁹ ) and lymphopenia - 10-12% LF, nephro- and hematotoxicity, nausea and pain in the stomach.

 3. Bykadorova LI, 49 years old, and. N 10261 / e, diagnosis: generalization of cancer of both mammary glands with multiple metastases to soft tissues and lymph nodes. St-IV, column 4. CT was carried out with ultra-high doses of methotrexate with leukovarin protection 3 courses without effect. No leukopenia was noted, the number of lymphocytes in the blood was 8.5-9.5%. Unsatisfactory state of health, weakness, nausea, epigastric pain.

 The treatment results are shown in the table.

 Analysis of the functional indicators of the psychosomatic status of cancer patients of the 3-4 clinical group revealed the corrective and synchronizing effect of the combination of physical factors used (VLF MP and SCENAR) in combination with chemoradiotherapy. The data obtained help to make the following conclusion.

 1. The proposed method can significantly improve the immediate results of treatment, as evidenced by a decrease of more than 50% in the volume of the tumor and lymph nodes, restoration of mobility of metastatically damaged joints, the disappearance of pain in bones or other tissues and organs.

 2. There is a normalization of indicators of integrative activity - an increase in antistress reactions, recorded by an increase in the number of lymphocytes in the peripheral blood, reduces the likelihood of developing leukopenia.

 3. The indicators of systemic ergization are improved, while in the control group, against the background of increased ergization of the hypothalamus (the controlling center of the endocrine system), the cyclic activity of the endocrine system is smoothed. In the study group, against the background of normal ergization of the control centers, there is a clear cyclical activity of the endocrine system inherent in a healthy body.

 4. The dynamics of EEG indices is normalized: the transition of amplitude indices and Δ-waves index to the region of normal values is noted against the background of a decrease in the overestimated values of the average amplitude of the main rhythm (α-rhythm). The level of personal and reactive anxiety is reduced according to the blank Spilberger-Khanin method.

 5. Controlled effects on the central nervous system using VLF MP and projection zones of pathological foci (joints, liver, epigastric region, stomach, spleen, heart) with SCENAR helped to significantly reduce pain, reduce hemato-, hepato-, nephro- and gastrotoxicity, i.e., improved tolerance to systemic chemotherapy and radiation. Patients noted normalization of sleep, improved mood, which indicated an increase in the quality of life in the process of antitumor treatment. The antitumor effect did not decrease, and in some cases, significant regression of the tumors was noted.

Technical and economic efficiency lies in the fact that the use of the proposed method for the combined treatment of malignant tumors is provided in comparison with existing methods with such advantages as:
1. Correction of desynchronization of the central and peripheral links of neuro-adaptive processes with a therapeutic non-invasive individually dosed combined effect, which has an antistress general regulatory effect on all subsystems of the body.

 2. Conducting specific antitumor treatment with a satisfactory condition of patients: the absence or decrease in the depth of side damaging effects in the form of a decrease in hemato-, gastro-, nephro-, hepatotoxicity.

 3. Elimination of the need for special treatment of persistent leukopenia with the help of blood transfusion, analgesic therapy and treatment of concomitant inflammatory and degenerative processes.

 4. Cheaper treatment due to the possibility of canceling drugs that correct the activity of various subsystems of the body, analgesics, donated blood.

Claims (1)

 A method for the combined treatment of malignant tumors, including chemoradiotherapy and surgical treatment, characterized in that at the beginning of any special antitumor therapy, patients additionally receive a combined double exposure for two weeks daily, and then every other day, between 9 and 11 hours: the first exposure is head magnetization in the center of the nape at the level of an imaginary line between the auditory openings with an ultra-low-frequency magnetic field (VLF MP) of 7.9 Hz by 5 mT induction, the value of which is gradually reduced t exponentially in the regime of 5 - 3.5 - 2.5 - 1.8 - 1.2 - 0.8 - 0.6 mT, with the sequence repeating until the end of treatment, and an exposure of 3 min with an increase of 1 min as it decreases induction, the second effect is individually dosed treatment of areas of the skin that are topographically associated with systems of organs and tissues with pain and other disorders of SCENAR - therapy with a frequency in the range of 15 - 350 Hz ± 5% with a modulation of 30 - 120 Hz ± 5% with a total exposure duration of 15 to 20 minutes for 20 to 30 days.

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