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Method of conservative treatment of women in premenopause period with prolapse of genitalia

IPC classes for russian patent Method of conservative treatment of women in premenopause period with prolapse of genitalia (RU 2427369):
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FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to gynecology and can be used for conservative treatment of women in premenopause period with prolapse of genitalia. In women in premenopause period with prolapse of genitalia, undergoing substituting hormonal therapy, level of C-end telopeptides is determined, if values are lower than 0.6 ng/ml, only substituting hormonal therapy is administered. If values equal and are higher than 0.6 ng/ml, additionally to substituting hormonal therapy administered is metabolic therapy in form of ascorbic acid in dose 500 mg 3 times per day and magnerot in dose 500 mg 3 times per day for three months. Additionally determined is amount of immunoglobulin E, circulating immune complexes, C3- and C4-components of complement. If level of immunoglobulin E is higher than 150 IU/ml, circulating immune complexes more than 200 units of optic density, C3-component of complement lower and equal 83 mg/dl, C4-component of complement lower and equal 18 mg/dl, to substituting hormonal and metabolic therapy additionally administered is vobenzim in dose 3 pills 3 times per day for three months.

EFFECT: method provides specified differentiated approach to selection of treatment method and determination of specific schemes of treatment depending on connective tissue state, as well as taking into account immune status, makes it possible to normalise disturbed with connective tissue pathology collagen metabolism, prevent development of genitalia prolapse in combination with connective tissue dysplasia and 2 times reduce degree of said disease progressing.

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The invention relates to medicine, namely to the gynecologist can be used in the conservative treatment of women with genital prolapse. The method can be used in specialized gynecological care.

Important role in the development of genital prolapse play hormonal disorders, especially gipoestrogeniya. Therefore, one of the treatments is the purpose of hormone replacement therapy in women of perimenopausal period (Smetnik VP Medicine menopause. 2006; 217-274). Although this method of treatment aimed at improving the metabolism of collagen, however, did not address all etiopathogenetic processes leading to the development of genital prolapse.

Today, widespread theory of systemic connective tissue dysplasia as the leading cause of prolapse (Radzinsky VE Perineology. 2006; 14-96).

Catarineu TI proposed treatment system and follow up with hereditary connective tissue diseases. Composite elements are diet therapy, exercise therapy, massage, physiotherapy, psychotherapy, intake of vitamins, minerals and metabolites (Caurina TI Hereditary collagenoses: clinic, diagnostics, treatment, prophylactic medical examination. S.-Pb., Nevsky dialect. 2000). However, the management of patients with isolated about what areas of connective tissue dysplasia is discussed by many authors, but the uniform program management of patients with numerous manifestations of the pathology of the connective tissue there.

Also now proven the role of immune disorders in the development of connective tissue dysplasia, however, in the available literature information about the possible therapeutic effect on immune indices in the pathology of the connective tissue is not detected (Yakovlev V.M., A.V. Glotov, Berry AV Immunopathological syndromes of hereditary connective tissue dysplasia. Stavropol, 2005). It is known that in patients with genital prolapse in combination with connective tissue dysplasia, there are significant changes in some parameters of the immune status. We surveyed women with an increased breakdown of collagen. They had studied some indicators of immune status: IgG, IgA, IgM, IgE, circulating immune complexes (CIC), C3 and C4 complement components (Ilyina YOU, Dobrokhotova WE, Zhdanov M.S. connective tissue Dysplasia and possible changes in immune status in women with genital prolapse. / Vestnik RUDN. No. 5. 2009. 72-76). After careful analysis of the results we have identified indicators of immune status, which vary in the pathology of the connective tissue.

Despite modern treatment methods not found an optimal algorithm for management of patients with genital prolapse is combined with connective tissue dysplasia or without taking into account the immunological features (T.U. Smolenova Pathogenetic substantiation of choice of method of surgical correction of genital prolapse in women of reproductive age. // Abstract. Diss. Kida. the honey. Sciences - Moscow, 1999; Radzinsky VE Perineology. 2006).

We were set a task to develop a differentiated way conservative management of women with genital prolapse.

Technical result achieved in the implementation of the proposed method is the refinement of a differentiated approach to the choice of treatment in women with genital prolapse perimenopausal period and in the definition of specific treatment regimens depending on the condition of the connective tissue, including hormone replacement, metabolic and systemic enzyme therapy, as well as taking into account the state of the immune status by study objective indicators that accurately characterize the presence of connective tissue dysplasia and related this state of immune status. We empirically set diagnostically significant objective indicators - criteria selection of the treatment method. The scheme of complex treatment helps to normalize disturbed in the pathology of connective tissue metabolism of collagen, thereby to prevent the development of genital prolapse in combination with connective tissue dysplasia and reduce stateprescribed this disease almost in half. In addition, this scheme allows for the prevention of allergic and autoimmune diseases without the use of immunomodulatory drugs that have a strong impact on many other indicators of immunity.

The invention consists in the following.

Women postmenopausal period with genital prolapse taking hormone replacement therapy, determine the level of C-terminal telopeptides. When the indicators below 0.6 ng/ml are limited to the appointment of substitution therapy, with performance equal to and more than 0.6 ng/ml, in addition to hormone replacement therapy is prescribed metabolic therapy in the form of ascorbic acid 500 mg 3 times a day and magnerot 500 mg 3 times a day for three months. In addition, determine the amount of immunoglobulin E, circulating immune complexes, C3 and C4 components of complement. When the level of immunoglobulin E more than 150 IU/ml, circulating immune complexes more than 200 units of optical density, the C3 component of complement, less than and equal to 83 mg/DL, C4 component of complement, less than and equal to 18 mg/DL, hormone replacement therapy and metabolic appoint Wobenzym to 3 pills 3 times a day for three months.

The method is as follows.

Substitution hormone is supplemented flax therapy is administered according to the standard scheme with regard to possible contraindications.

Conduct a blood test to determine the level of C-terminal telopeptides formed during the degradation of collagen 1-St type. This study can be conducted using various diagnostic systems, such as, for example, immunoassay analyzer Stat Fax 2100.

Regulatory indicators C-terminal telopeptide (Caurina TI, Gorbunova V., Gorbunov. Connective tissue dysplasia. 2009): fertile women 0,112-0,738 ng/ml in postmenopausal women - 0,142-1,351 ng/ml.

In the study of immune status was determined by the following indicators: assessment of humoral immunity immunoglobulins (Ig) E, circulating immune complexes (CIC), C3 and C4 complement components (SS, C4C). In the study can be used in different diagnostic systems and methods, such as method of flow cytometry (flow-through cytometer Epics XL Becmn Coulter).

Regulatory indicators (Nikulin B.A. Estimation and correction of immune status. 2008):

Ig E 10-150 ME/ml,

CEC - 50-200 units of optical density,

SS - 90-180 mg/DL,

C4C is 10-40 mg/DL.

The possibility of implementing the stated purpose and achievement of the technical result is confirmed by the following data.

We were treated 68 women with genital prolapse. All patients received hormone replacement therapy. Of these, 46 (67,4%) patients with C-Ko is zevah of telopeptides was equal to or greater than 0.6 ng/ml, later they were assigned to metabolic therapy in the form of ascorbic acid 500 mg 3 times a day for three months and magnerot 500 mg 3 times a day for three months. Also these patients was determined by the following indicators: immunoglobulin E, circulating immune complexes, C3 and C4 complement components. When the level of immunoglobulin E more than 150 IU/ml, circulating immune complexes more than 200 units of optical density, the C3 component of complement, less than and equal to 83 mg/DL, C4 component of complement, less than and equal to 18 mg/DL, hormone replacement therapy and metabolic additionally appointed Wobenzym to 3 pills 3 times a day for 3 months. The above therapy was prescribed 21 patient (45,7% of women with elevated C-terminal telopeptides).

Two years of observations in 68 women who were treated, our proposed method, including the appointment of hormone replacement, and metabolic therapy, and enzyme therapy, prolapse were observed. Showed normalization of hormone levels, as well as C-terminal telopeptides that testified to the improvement of the metabolism of collagen.

In all patients with compromised immune status, which was appointed Wobenzym to 3 pills 3 times a day for 3 months, was observed normalization pokazatel the th.

Thus, long-term results of complex treatment of patients with genital prolapse in combination with connective tissue dysplasia helped to reduce the degree of progression of genital prolapse in two times.

In addition, this scheme allows for the prevention of allergic and autoimmune diseases that often accompany connective tissue dysplasia.

Examples.

Example 1

Patient I., 58 years old, came with complaints of dropped uterus, dragging pain in the lower abdomen, discomfort in the crotch area, leakage of urine when coughing, sneezing, exercise. Within 10 years bother dragging pain in the lower abdomen, feeling of a foreign body in the vagina. The first episode of incontinence said about 5 years ago. History of 4 pregnancies, two births, the first was complicated by rupture of the perineum and cervix. Menopause 4 years. Comorbidities: umbilical hernia, scoliosis, myopia, chronic bronchitis, varicose veins of the lower extremities. When viewed draws attention to hypermodernity joints. At vaginal examination sexual slit gaping, legs levatores are widely. Outside of the genital slit without natureline is the cervix, is determined cystocele, elongation of the cervix, when the cough is determined by the leakage of urine (cough what Rob positive).

Conducted clinical laboratory tests: estradiol - 73 pmol/l, C - terminal telopeptide - 1,21 ng/ml, Ig E - 164,5 IU/ml, CEC - 211 units of optical density, CS - 80 mg/DL, C4C - 15 mg/DL.

When performing an ultrasound of the pelvic organs was obtained conclusion: Partial prolapse of the cervix of the uterus, prolapse of the anterior wall of the vagina, cystocele, the defect of the pelvic fascia, the failure of the pelvic floor muscles.

Comprehensive urodynamic study. Conclusion: during cystometry in the supine position, average speed filling 49 ml/min, normal bladder sensation, the first urge to urinate when the volume 173 ml, normal urge at 217 ml, a strong urge in 262 ml Maximum sistematicheskaya capacity of more than 265 ml. of Signs detrusor hyperactivity no. When stressprime be the pressure when the volume of 270 ml signs of leakage of urine. Urodynamic signs of stress urinary incontinence.

Thus, on the basis of complaints, anamnesis and gynecological examination diagnosed a partial prolapse of the uterus and vaginal walls, cystocele, elongation of the cervix, the failure of the pelvic floor muscles, stress incontinence, connective tissue dysplasia.

From surgical treatment the woman refused. Were assigned to the treatment: livial scheme for 6 months, metabolic scheme, including Sarbinowo acid 500 mg 3 times a day, magnerot 500 mg 3 times a day, just 3 months; Wobenzym to 3 pills 3 times a day for 3 months.

After 3 months the level of estradiol was equal to 86 pmol/l, C-terminal telopeptide - of 1.03 ng/ml after 6 months respectively - 186 pmol/l and 0.78 ng/ml, in the year 194 pmol/l and 0.74 ng/ml, after 2 years of 198 ng/ml and 0.68 ng/ml, Ig E - 142,3 IU/ml, CEC - 182 units of optical density, SS - 95 mg/DL, C4C - 33 mg/DL.

Gynecological examination data still, the progression of genital prolapse is missing.

Thus, a therapy aimed at improving processes collagenopathy and consisting of drugs that normalize the levels of estradiol and C-terminal telopeptides, helps to prevent further progression of genital process. In addition, the background treatment is normalization of immune status, which is the prevention of allergic and autoimmune processes.

Recommended to continue hormone therapy under close gynecological control, monitoring of lipid profile, coagulation, to control the level of C-terminal telopeptides, indicators of immune status.

Example 2

Patient B., 60 years old, was admitted with complaints of discomfort in the lower abdomen, discomfort in the crotch area, frequent urination, feeling of incomplete is about emptying of the bladder, involuntary loss of urine when coughing, sneezing. Within 15 years of concern the above complaints. History of 8 pregnancies, two births, the first complicated by rupture of the perineum. Comorbidities: chronic pyelonephritis, peptic ulcer. When analyzing the bladder diary: the amount of urination during the day 12-14 times at night - 2 times the volume of allocated urine approximately 50-100 ml, notes involuntary loss of urine without direct dependence on physical activity 5-6 times daily. At vaginal examination sexual slit gaping, legs levatores are widely. Outside of the genital slit without natureline is the cervix, is determined cystocele, rectocele.

When conducting clinical and laboratory examination revealed the following results: estradiol 36 pmol/l, C-terminal telopeptide is 0.33 ng/ml.

When conducting a comprehensive urodynamic studies: during cystometry in standing position filling speed of 50 ml/min, hypersensitivity of the bladder, the first urge to urinate occurred when the filling volume of 68 ml, feeling the usual urge arose when a volume of 100 ml, feeling a strong urge for a volume 201 ml, maximum sistematicheskaya capacity 215 ml, identified involuntary contractions of the detrusor when the volume of 68 ml, the maximum amplitude of 25 cm water is. Art. When stressprime be pressure, the volume filling of the bladder 220 ml, signs of leakage of urine. Conclusion: the increased sensitivity of the bladder, tetrasomy hyperactivity, urodynamic symptoms of stress incontinence, the patient recorded involuntary bladder contraction.

Thus, the diagnosis of partial prolapse of the uterus and vaginal walls, cystocele, rectocele, the failure of the pelvic floor muscles, mixed urinary incontinence.

From surgical treatment, the patient refused. Was assigned to the following treatment: livial by the scheme. The whole treatment lasted 2 years.

After 3 months of treatment, the level of estradiol was 42 pmol/l, C-terminal telopeptide - 0.3 ng/ml after 6 months respectively - 86 pmol/l and 0.28 ng/ml, a year - 97 pmol/l and 0.26 ng/ml, across 2 years - 102 pmol/l and 0.28 ng/ml.

Gynecological examination data still, the progression of genital prolapse were observed.

Thus, in patients with normal metabolism of collagen, as evidenced by the low level of C-terminal telopeptides, a hormone replacement therapy because they have a low probability of disease progression.

Example 3

Patient S., 49 years old, turning complained of nagging pains in the lower abdomen, discomfort the perineum, loss of urine when coughing. These symptoms are troubling in the last 3 years. History 3 pregnancies, one delivery, complicated by rupture of the perineum. Menopause 2 years. Comorbidities: scoliosis, myopia, varicose veins of the pelvis. At vaginal examination sexual slit gaping, legs levatores are widely. Outside of the genital slit without natureline is the cervix, is determined cystocele, elongation of the cervix, when the cough is determined by the leakage of urine (cough test positive).

Conducted clinical laboratory tests: estradiol - 96 pmol/l, C - terminal telopeptide to 0.9 ng/ml, Ig E - 132,1 IU/ml, CEC - 186 units of optical density, SS - 92 mg/DL, C4C - 28 mg/DL.

When performing an ultrasound of the pelvic organs was obtained conclusion: Partial prolapse of the cervix of the uterus, prolapse of the anterior wall of the vagina, cystocele, the defect of the pelvic fascia, the failure of the pelvic floor muscles.

Comprehensive urodynamic study. Conclusion: during cystometry in the supine position, the average rate of filling of 47 ml/min, normal bladder sensation, the first urge to urinate when the volume of 190 ml, normal urge in 225 ml, a strong urge at 272 ml Maximum sistematicheskaya capacity of more than 250 ml. of Signs detrusor hyperactivity no. When stressprime be pressure the ri volume of 230 ml signs of leakage of urine. Urodynamic signs of stress urinary incontinence.

Thus, on the basis of complaints, anamnesis and gynecological examination diagnosed a partial prolapse of the uterus and vaginal walls, cystocele, elongation of the cervix, the failure of the pelvic floor muscles, stress urinary incontinence.

From surgical treatment the woman refused. Were assigned to the treatment: femoston 1/10 scheme, ascorbic acid 500 mg 3 times a day, magnerot 500 mg 3 times a day, just 3 months.

After 3 months the level of estradiol was equal to 115 pmol/l, C-terminal telopeptide to 0.75 ng/ml after 6 months respectively - 186 pmol/l and 0.68 ng/ml, in the year 194 pmol/l and 0.62 ng/ml, after 2 years of 198 ng/ml and 0.63 ng/ml, Ig E - 142,3 IU/ml, CEC - 182 units of optical density, SS - 95 mg/DL, C4C - 33 mg/DL.

Data gynecological examination still, the progression of genital prolapse no.

Thus, assigned the scheme of conservative treatment helps to normalize disturbed in the pathology of connective tissue metabolism of collagen, thereby to prevent the development of genital prolapse and reduce the progression of this disease.

Method of conservative treatment of women in the perimenopausal period with genital prolapse, including hormone replacement therapy, wherein the patient determine wavenis-terminal telopeptides, when the indicators below 0.6 ng/ml are limited to the purpose of hormone replacement therapy, with performance equal to and more than 0.6 ng/ml in addition to hormone replacement therapy is prescribed metabolic therapy in the form of ascorbic acid 500 mg 3 times a day and magnerot 500 mg 3 times a day for three months and additionally determine the amount of immunoglobulin E, circulating immune complexes, C3 and C4 components of complement; when the level of immunoglobulin E more than 150 IU/ml, circulating immune complexes more than 200 units of optical density, the C3 component of the complement is less than and equal to 83 mg/DL, C4 component of complement is less than and equal to 18 mg/DL to hormone replacement, and metabolic therapy appoint Wobenzym to 3 pills 3 times a day for three months.

 

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