RU2200599C2 - Method and intracavitary end piece for treating the patient for uterine myoma aggravated with fibrous cyst disease of the mammary glands - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves applying electromagnetic wave treatment in millimeter bandwidth with wavelength equal to 7.0-7.2 mm. Uterine cervix, vaults and the upper 1/3 of the uterus are treated beginning from 5-7 day of menstrual cycle in morning time. Intracavitary end piece is used being tube filled with dielectric substance. Tube diameter-to-end-piece ratio is equal to 1/9-1/15. Radiator at the end of the end piece has conic shape with smaller- to greater diameter ratio being equal to 1/2.5-1/3. EFFECT: enhanced effectiveness of treatment. 2 cl, 1 dwg, 1 tbl

Description

 The invention relates to medicine, namely to gynecology and physiotherapy, and can be used to treat patients with uterine fibroids in combination with fibrocystic disease of the mammary glands.

 Uterine fibroids - the most common benign tumor formation arising from smooth muscle elements with subsequent predominant fibrosis in conditions of tissue hypoxia, occurs in 20% of women over 30 years old and 40% of women over 40 years old, while 80% of gynecological operations are performed specifically for uterine fibroids.

 Fibrocystic breast disease (mastopathy) is also one of the most common diseases in women: in the population, the incidence is 30-45%, and among women suffering from dishormonal diseases of the genital organs, it reaches 97.8%. A special place among them is occupied by uterine fibroids: in patients of this category in 74.4% of cases in the mammary glands (mammary gland) severe forms of diffuse and nodular mastopathy are often proliferative in nature, accompanied by hyperplasia of the glandular component.

 Studies have shown unity in the genesis of pathological changes in target organs in hyperplastic processes. Moreover, all the mechanisms that regulate the formation of genital pathology, realize their effect in the mammary glands.

 There is a method of treating mastopathy and uterine fibroids (1), based on the patient's use of therapeutic ointments based on the Milife drug in combination with the Milife oral route, and the patient is additionally given a course of 10-35 intramuscular injections of the Galavit drug during 3-7 days daily, and then with intervals of 1-5 days, while the drug is administered in a single dose of 25-1000 mg in 1-10 ml of water for injection.

 Known tip of the apparatus of millimeter therapy Corvette-01 (2), available at the end of the remote emitter, made in the form of a metal tube filled with a dielectric; the working end of the tip has an irradiator.

 Millimeter-wave electromagnetic waves (EMW-MM) are currently used to treat many diseases, including the treatment of uterine fibroids (3) and mastopathy (4). Features of therapy with EMV-MM are: non-invasiveness, high adaptability and effectiveness of the therapeutic effect. The main therapeutic effect when exposed to EMV-MM is to increase the nonspecific resistance of the body, mobilize its reserves, and increase the immune status indicators.

 The objective of the invention is to increase the effectiveness of treatment of patients with uterine myoma and mastopathy and shortening the treatment time.

The problem is solved by exposure to electromagnetic waves of the millimeter range, a wavelength of 7.0-7.2 mm, a power flux density of 0.5-1.5 mW / cm ² on the cervix, arches and the upper third of the vagina lasting 20-25 minutes 5-7 days of the menstrual cycle in the morning from 9.00 to 12.00, for a course of 10-12 procedures.

 To implement the method, a tip made in the form of a tube and filled with a dielectric is used, with the possibility of connecting it to a therapeutic EHF emitter at one end and an irradiator at the opposite end, the ratio of the diameter of the tube to the length of the tip being 1 / 9-1 / 15, and the irradiator is made conical with the ratio of small diameter to large 1 / 2.5-1 / 3.

The method is as follows: to the apparatus "Stella-1" connect using a flexible waveguide tip for intracavitary exposure, which put on a condom. A woman who is lying on a couch with bent at the hip and knee joints and legs apart, the tip is inserted into the vagina until there is slight resistance (cervix). Frequency 7.0-7.2 mm, power 1 mW / cm ² , exposure duration 20-25 minutes, daily, for a course of 10-12 sessions. Treatment is carried out from 5-7 days of the menstrual cycle in the morning (09.00-12.00).

 When choosing the optimal parameters of EMV-MM therapy, we were guided by the following points.

 Exposure zones were chosen taking into account the provision that the influence of EMW-MM is carried out on biologically active points (BAP) or zones (BAS), as well as on reflexogenic zones. Until now, BAS and BAP, located on the surface of the skin, have been used. However, a person has intracavitary and intraorgan BAS and BAP along the inner course of meridians with high biological activity, in some cases exceeding the activity of surface BAS and BAP (5). Experimental and clinical data allow us to claim the presence of a cervical-pituitary reflex, the path of which passes through the upper cervical sympathetic nodes, through the hypothalamus and appendage of the brain. As shown by numerous clinical observations by S.N.

 When choosing the frequency (wavelength), we took into account that irradiation with waves of 7.0-7.2 mm in length has a depressing effect on endometrial hyperplasia and uterine fibroids in sick women, which indicates the restoration of hormonal balance in the body, in addition, In in vitro experiments on blood cells, immunostimulating activity was shown in women with the same pathology. Irradiation at a frequency of 5.6 and 8 mm causes a variable effect until the complete absence of reaction.

 The duration of the procedure is chosen on the basis that it should be sufficient for the development of adequate reactions of "training" and "activation" (defined by the L.Kh. Garkavi index) in the body, with the help of which the therapeutic effect is realized, which does not stop after the end of irradiation. To achieve a therapeutic effect, the required exposure time is 20-25 minutes, 10-12 procedures per course. The selection of the number of procedures is also based on numerous data on the effectiveness of the effects of EME-MM in the pathology of other organs and systems.

 The exposure is carried out in the first phase of the menstrual cycle, since the normalizing effect of EMV-MM on the hypothalamic-pituitary region reflexively leads to normalization of the secretion of estradiol by the ovaries and stimulation of the functional activity of the corpus luteum.

 The time of day optimally chosen for treatment helps to restore the temporal structure of the body, therefore EMV-MM therapy is recommended in the morning (in the time interval 09.00-12.00), which coincides with the transition period in the daily rhythm of the activity of the autonomic nervous system and is more adequate to the reserve capabilities of the body.

 The advantages of the proposed method are: reducing the duration of exposure, normalizing the functional activity of the hypothalamic-pituitary-ovarian system - the main pathogenetic link of combined hyperplastic diseases of the reproductive system, maximum approximation of the effect to the pathological focus (myomatous uterus), high efficiency, the possibility of an indirect effect on the second organ the target is the mammary gland.

 To implement the method, we propose a device consisting of a switching power supply unit of the Stella-1 EHF-IR therapy apparatus (state registry 96 / zi-198), an external therapeutic emitter and an intracavitary tip 12-14 cm long. The tip design is shown in figure 1. The tip is made on the basis of an aluminum tube 1, with a dielectric filling 2. A polymer material having minimal losses in the EHF range, polystyrene, is used as a filler material. The ratio of the diameter of the tube to its length is 1/9: 1/15. A therapeutic emitter 3 is attached to one end of the tip; the opposite end of which is provided with a cone-shaped irradiator 4 with a ratio of small diameter to large 1 / 2.5: 1/3, which is inserted into the cavity (into the vagina) in the immediate vicinity of the pathological focus, so that radiation from it enters the cervix, arches and the upper third of the vagina.

 The device works as follows: the operability of the Stella-1 apparatus and the emitter is checked according to the product passport. The EHF emitter is connected to the power supply unit of the device, and the radiating surface to the tip. A condom is put on the tip and inserted into the patient's vagina. The power supply unit is turned on. The moment of inclusion and the presence of radiation is determined by the indication of the apparatus. The power supply unit generates pulses of the supply voltage, which are supplied via cable to the EHF emitter. The emitter accordingly generates pulses of the EHF range, which, through the dielectric rod of the tip, arrive at its end and are re-emitted into the outer space with a conical shape of wave propagation, reaching the impact area.

 Clinical testing of the device was carried out on a group of patients (60 people) suffering from uterine myoma in combination with fibrocystic breast disease, which was treated in accordance with the claimed method. In the control group there were 20 people who received a placebo procedure.

 Almost all women after treatment reported an improvement in menstrual function, a decrease in blood loss, the absence of clots, the regularity of the cycle, and a decrease or disappearance of pain. Objectively, the size of the uterus decreased from 6.05 ± 0.2 weeks to 5.85 ± 0.3 weeks. According to sonography, the sizes of the uterus and myomatous nodes before and after treatment are presented in the table.

 On the part of the mammary glands, a decrease in soreness, engorgement and palpation of breast tissue was noted.

 The treatment efficiency was 96%.

To better understand the essence of the method, we offer a specific example of its implementation:
1. Patient M.N.P., 49 years old, was in the gynecological department of the TNIIKiF from January 4, 2000 to January 22, 2000. Diagnosis upon admission: uterine fibroids, fibrocystic mastopathy.

 From the anamnesis it was found that in childhood the patient suffered measles, scarlet fever, chicken pox, and mumps. Family history is burdened with diabetes and gastric cancer (relatives of the II degree of kinship). Of somatic diseases, chronic cholecystitis, arthroso-arthritis, and osteochondrosis are noted. Gynecological history: menarche from 14 years old, regularly, the duration of menstruation up to 7 days, after 28 days, painless, moderate intensity. Married since 28 years, childbirth - 1 (twins) without complications, abortions - 1, no miscarriages. During the reproductive period I used an IUD for contraception (three times taking into account the recommendations on the duration of use, the last IUD was removed in 1990), after that I used a condom, I have not used contraception for the last 3 years. In recent years, there has been a decrease in libido and an orgasm rate. Of the transferred gynecological diseases - chronic adnexitis and cervical erosion, for which diathermocoagulation was performed.

 Uterine fibroids were first discovered in 1990 up to 6 weeks in size. The course of the disease is asymptomatic with slow growth. Diagnostic curettage was not carried out. I did not receive treatment. Mastopathy (diffuse fibrocystic) was also discovered in 1990, for which she received therapy with vitamins A, E, undevit and clamin for 2 months with a temporary improvement.

 Upon admission, she complained of pains of a pulling nature in the lower abdomen, radiating to the lower back, increased urination, constipation, rapid fatigability, frequent headaches, sleep disturbance, sweating, diffuse breast pains that appear 7-10 days before the next menstruation.

 Objectively: an overweight woman, height 160 cm, weight 90 kg (excess body weight - 50%), blood pressure 120/80, pulse - 72 beats. per minute, respiratory rate - 12. Consultation of a neurologist: osteochondrosis of the cervical spine, vertebrogenic cervicobrachialgia, remission period. Auscultatory: vesicular respiration in the lungs, no wheezing; heart - tones are clear, rhythmic, no noise.

 The mammary glands are slightly asymmetric (D> S), the skin is not changed, the nipples are without features. On palpation, the presence of unevenly compacted areas without clear contours is noted, there are no discharge from the nipples, lymph nodes are not palpated.

 Status genitalis: the external genitalia are formed correctly, female-type hair growth, the vagina of the woman giving birth, the cervix is not changed, the uterus is increased in volume, respectively, 6-7 weeks of gestation, its mobility is limited, palpation is painless. Appendages without features.

The results of additional research methods:
general blood test: Нb - 126, eri - 4.2, z - 4.6, ESR - 8, n - 2%, s - 65%, l - 24%, m - 3%, e - 6%;
biochemical analysis of blood: total protein - 78.2; total bilirubin - 11.5, direct - 1.7; cholesterol - 5.33; sugar 6.0 (N-5.5); ALT - 0.01; ACT 0.37; thymol sample 1.3; z-amylase - 12.3; GTP - 1.42 (N to 1.1);
immunological blood test: T - 37%, B - 14%, Tx -17%, Tc - 20%, AgC - 12.8, AgA - 2.3, AgM - 1.4, HCT spontaneous - 20, stimulus. - 20, CEC - 110 p.u.

 A smear for purity: white blood cells in large quantities, streptococcus, mycelium of yeast in large quantities, gn and tr were not found.

 A smear for rare infections: chlamydia and mycoplasma - negative, ureaplasma is detected.

 Cytology: cells of the intermediate layer of the epithelium without features.

 Coloscopy: the main mucosa, Schiller's test is positive, the staining is weak, even.

 Blood test for hormones: PRL - 149.7, FSH - 9.70 MMU / ml.

 Ultrasound examination of the uterus: the uterus is usually located, its structure is heterogeneous with the presence of multiple subserous nodes with a diameter of 12-25 mm and a node with a diameter of 21 mm, located interstitially. The size of the uterus is 75 x 56 x 76 mm. The median M-echo is 17 mm in size (width), heterogeneous in structure. The cervix is enlarged, measuring 51 x 45 mm. The left ovary is not visible, the size of the right is 29 x 23 x 25 mm, its structure is typical. Pipes are not visualized. There is no fluid in the rear arch.

 Mammography: severe coarse deformity and fibrosis of stromal elements with multiple cystic cavities. The contours of the glandular triangle are scalloped due to sclerosing of Cooper's ligaments.

 The histological conclusion of endometrial scraping: glandular cystic hyperplasia.

 ECG: sinus rhythm, horizontal position of the electrical axis of the heart. Diffuse changes in the myocardium of the left ventricle.

 Cardiointervalography: initial autonomic tone - hypersympathicotonia, autonomic reactivity - sympathicotonic, autonomic activity - insufficient, type of reaction to orthostatic load - asthenic, recovery period is prolonged (fatigue reaction).

 Clinical diagnosis: multiple uterine fibroids, slow growth, low-symptom course, endometrial hyperplasia, premenopausal period, autonomic vascular dysfunction (hypersympathicotonia), vaginal candidiasis, ureaplasmosis, fibrocystic mastopathy, stage III obesity, chronic hyperglycemia, cholesterol cholesteitis, hyperglycemia of the cholestea, remission.

The patient’s treatment was carried out in accordance with the claimed method, namely, the EMV-MM exposure procedures were carried out from the Stella-1 apparatus using an intracavitary tip on the cervix, with a wavelength of 7.1 mm, a power flux density of 1 mW / cm ² , lasting 20 minutes, daily, in the morning (at 10.30-10.50), in the first phase of the menstrual cycle (from 6 to 15 days), 11 treatments per course.

 As a result of the treatment, the following dynamics were revealed: no complaints of pain in the lower abdomen and lower back. The function of the bladder and intestines was normalized, health was improved, sleep was normalized, fatigue, headaches and sweating disappeared. Pain in the mammary glands stopped, a slight feeling of tension 3-4 days before the next menstruation.

 Objective indicators were assessed using a double blind method: ultrasound scanning was performed using a transvaginal probe, a Toshiba device (Japan) by employees of the Department of Radiation Diagnostic Methods of the Siberian State Medical University, and mammary glands were examined and palpated by employees of the Regional Mammological Center at the Cancer Research Center of the Siberian Branch of the Russian Academy of Medical Sciences.

 Objectively: the skin of the mammary glands is not changed, slight asymmetry persists, gland tissue is soft by palpation, there are no discharge from the nipples. (Control mammography will be performed one year after treatment).

 Status genitalis: the uterus has decreased in size up to 5 weeks, its texture is dense, the appendages and pelvic fiber are unremarkable, the cervix is clean, the discharge is mucous, and transparent.

 Ultrasound of the pelvic organs: the uterus is usually located, its structure is heterogeneous, dimensions 60 x 49 x 50 mm, nodes located subserosally, with a diameter of 14-17 mm, interstitial node - with a diameter of 17 mm. The median M-echo is 7 mm wide (corresponds to the phase of the menstrual cycle). Cervix 50 x 45 mm. Both ovaries are of a typical structure, the left is 24 x 20 x 22 mm, the right is 26 x 25 x 24 mm. There is no fluid in the rear arch.

 Histological examination of endometrial scraping: gland epithelium is not changed, corresponds to the early secretory phase of the menstrual cycle.

In the general analysis of blood: Нb - 134, eri - 4.4 • 10 ¹² / l, z - 4.7 • 10 ¹² / l, ESR - 5 mm / hour, n - 2%, s - 60%, l - 30%, m - 4%, s - 4%;
biochemical blood test: total protein - 72.8; total bilirubin - 6.2, direct - 0.0; cholesterol - 5.64; sugar - 5.6; ALT - 0.22; ACT 0.33; thymol test 1.5; GTR - 0.83;
immunological blood test: T - 50%, B - 27%, Tx - 34%, Tc - 16%, AgC - 16.0, AgA - 3.1, AgM - 1.44, CEC - 110 ye

 In a smear for purity: leukocytes - up to 10 in the field of view, a small amount of streptobacillary flora, gn, tr - no; smear on ureaplasma is negative.

 Cardiointervalography: initial vegetative tone and autonomic reactivity without dynamics, autonomic activity is sufficient.

 Thus, as a result of treatment, the patient achieved: a decrease in the size of the uterus and myomatous nodes by 25% of the initial value, normalization of the endometrium, improvement of subjective and objective data from the mammary glands, elimination of the genital tract infection, improvement of the general blood count (increase in HB, decrease in ESR), biochemical parameters (reduction of sugar and GTP to normal), normalization of immunological status and improvement of the state of the autonomic nervous system.

 Thus, the proposed method of treatment and intracavitary tip for its implementation can improve the effectiveness of treatment of patients with uterine fibroids in combination with fibrocystic breast disease, reduce the duration of treatment.

LITERATURE
1. Patent 2132189 from 1999.06.27. A method for the treatment of mastopathy and uterine fibroids. Abitov M.T., Vashtanenko A.F., Kukaeva N.M. and etc.

 2. Patent 2066556 from 1996.09.20. The apparatus of millimeter therapy "Corvette-01". Kovalenko V.N., Pelikanov Yu.V., Ryabov B.A. and etc.

 3. Guidelines for the use of MM-therapy with various nosological forms. - M .: 1992.- P.57-64 (ed. V.N.Zaporozhan, S.A. Gelenin, O.V. Khait and others).

 4. Dolgushina A. F. Application of millimeter therapy in the treatment of benign breast diseases // Millimeter waves in medicine and biology. 11th Russian Symposium with international participation. April 21-24, 1997, Moscow: Coll. - 1997. - P.14-15.

 5. Luvsan G. Traditional and modern aspects of oriental reflexology. - 2nd ed., Revised. - M.: - Science, 1990, - 576 p.

Claims (2)

1. A method for the treatment of patients with uterine fibroids in combination with fibrocystic breast disease, including exposure, characterized in that the exposure is carried out by electromagnetic waves of the millimeter range, wavelength 7.0-7.2 mm, power flux density 0.5-1 , 5 mW / cm ² for the cervix, arches and the upper third of the vagina lasting 20-25 minutes from the 5-7th day of the menstrual cycle in the morning from 9.00-12.00, for a course of 10-12 procedures.  2. Intracavitary tip for the treatment of uterine fibroids in combination with fibrocystic breast disease, made in the form of a tube filled with a dielectric, with the possibility of connecting it to a therapeutic EHF emitter at one end and an irradiator - at the opposite end, characterized in that the diameter ratio the tube to the length of the tip is 1 / 9-1 / 15, and the irradiator is conical with a ratio of small diameter to large 1 / 2.5-1 / 3.

Images