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OBSTETRICS AND GYNECOLOGY

INVENTION
Patent of the Russian Federation RU2242002

METHOD OF DIAGNOSTICS OF THE STAGE OF EXTERNAL GENITAL ENDOMETRIOSIS

METHOD OF DIAGNOSTICS OF THE STAGE OF EXTERNAL GENITAL ENDOMETRIOSIS

The name of the inventor: Gerasimov AM (RU); Posiseeva L.V. (RU); Romanov V.N. (RU); Mironycheva N.A.
The name of the patent holder: GU "Ivanovo Research Institute of Maternity and Childhood named after VN Gorodkov"
Address for correspondence: 153731, Ivanovo, ul. Pobedy, 20, GU "Ivanovo Research Institute of Maternity and Childhood named after VN Gorodkov", Patent Department
Date of commencement of the patent: 2003.05.13

The invention relates to medicine, viz., Gynecology. A new method for diagnosing the stage of external genital endometriosis is suggested by the study of blood serum, which consists in determining the content of a 2 -macroglobulin in serum and at a level of 600.0 mg / dL and above diagnose stage I, at a value of 599, 0 to 480.0 mg / dL - stage II endometriosis, from 479.0 to 360.0 mg / dL - endometriosis of stage III and from 359.0 mg / dL - endometriosis of stage IV. Technical result: The proposed method allows to diagnose the stage of external genital endometriosis with an accuracy of 92.5% in women, even at early stages of the development of the process.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, viz. Gynecology, and can be used to diagnose the stage of external genital endometriosis.

The urgency of the invention is determined by the high incidence of external genital endometriosis in the population, its effect on reproduction processes (external endometriosis increases the incidence of infertility by 20 times) [7]. At present, there is only a subjective assessment of the degree of the endometrioid process, and this is possible only with highly invasive manipulations [3]. At the same time, the tactics and type of hormonal treatment of this pathology depend on the stage of the endometrioid process [2]. All this makes the search for new ways of diagnosing the stage of the endometriosis process particularly urgent.

A method for diagnosing external genital endometriosis based on the determination of the index of spontaneous HCT activity of neutrophils after incubation with a 2- microglobulin fertility (AMGF) is known, and at the values ​​of this index of 24% or more, external endometriosis is diagnosed with an accuracy of 84% [Patent No. 2164687].

Disadvantages of the method:

1. The AMGF preparation proposed for use does not have a broad industrial standardized production and is not included in the "Register of new medical devices and products approved for use by the Ministry of Health of the Russian Federation."

2. The results are read using light microscopy, which has a large share of subjectivity.

3. There is no indication of the stage of the process.

The method closest to the claimed method is the method for diagnosing external endometriosis, based on the determination of the content of autoantibodies to the endometrium in the serum of peripheral blood. The essence of the method is that external endometriosis of III-IV degree is established with increasing titer of serum autoantibodies with an accuracy of 45.5% [1]. This method was chosen by us as the closest analogue. However, it has a number of drawbacks:

1. Low accuracy - 45.5%.

2. Non-informative method at the early stages of the development of the process.

3. This method allows to diagnose only the difficult stages of the process, which are easily diagnosed clinically and, often, do not require additional diagnostic methods.

4. In view of the foregoing, the low specificity of the method.

These disadvantages are proposed to be eliminated in the claimed method. The claimed technical result is achieved by the fact that in women with suspected external genital endometriosis in the serum of venous blood, the concentration of a 2 -macroglobulin is determined. And at the values ​​of the latter above 600.0 mg / dl, external endometriosis of stage I is diagnosed, with values ​​ranging from 599.0 to 480.4 mg / dl for stage II endometriosis, at values ​​ranging from 479.0 to 360.0 mg / dl, Endometriosis III stage and at values ​​below 359.0 mg / dL - external endometriosis of the IV stage with an accuracy of 92.5%.

The novelty of the claimed method is that for the first time it is proposed to diagnose the stage of external genital endometriosis according to the level of a 2 -macroglobulin in the serum of venous blood.

Previously, a2-macroglobulin concentrations were used to diagnose inflammation acuity in combination with other acute phase parameters of the process (C-reactive protein, acid antitrypsin, sialic acids) [4, 5, 6], its use was unknown as an individual indicator [4 ]. In its essence, a 2- macroglobulin is a universal protease inhibitor [5, 6], which rises secondarily in response to the development of inflammation [4]. The concentration of α 2 -macroglobulin is determined by a standard method [4], based on the reaction between a 2 -macroglobulin and a specific antibody, the Sentinel CH sets.

The method is carried out as follows: from the ulnar vein is withdrawn according to the standard procedure of 2 ml of blood. After the formation of the clot, 0.1 ml of serum is sampled, in which the content of a 2 -macroglobulin is tested by the standard procedure [4].

Using the proposed method allows to diagnose the degree of external endometriosis with an accuracy of 92.5%.

Distinctive features of the method are:

Diagnostic criteria for the severity of external endometriosis were established for the content of a 2 -macroglobulin in serum of peripheral blood, and at a value of 600.0 mg / dL or more, endometriosis of stage I was diagnosed, ranging from 599.0 to 480.0 mg / dL - Stage II endometriosis, with values ​​from 479.0 to 360.0 mg / dL - external endometriosis of stage III and at values ​​below 359.0 mg / dL - external endometriosis of stage IV.

The essence of the claimed method is explained by the following examples.

1. The sick woman., 27 years old. In the gynecological clinic of the State Institution "IvNII Mead. VN Gorodkova "The Ministry of Health received the following diagnosis: primary infertility of unknown origin. Suspicion of external endometriosis.

According to the tests of functional diagnostics in a woman, the cycle had a two-phase character, the endometrial TSUG - secretory. The level of prolactin, testosterone in the blood and 17-CS urine is within normal limits. Postcoital test is positive. With hysterosalpingography, the lumen of the fallopian tubes is contrasted all the way, emptying into the abdominal cavity is free. According to the ultrasound study, the uterus and appendages without features. At a physical and special gynecological examination of the data for any pathology was not revealed. Given the lack of data for any causes of infertility, the patient was recommended diagnostic laparoscopy. In the preoperative period, when the biochemical blood test was performed, the patient was examined for a2-macroglobulin, which was 624.02 mg / dL, which corresponds to the claimed method of stage I of external endometriosis. When performing surgery, the woman was diagnosed with external endometriosis: single surface surface heterotopia of not more than 3 cm 2 of total area was identified. When the biopsy specimens of the peritoneum were examined, the diagnosis was confirmed.

Conclusion: The diagnosis of external endometriosis of the first stage according to the claimed method was confirmed.

2. Patient Mrs., 32 years old. In the gynecological clinic of the State Institution "IvNII Mead. VN Gorodkova "The Ministry of Health received the following diagnosis: External endometriosis. Endometrioid cyst of the left ovary. NFM by type of algodismenorea. Pain syndrome. Ineffectiveness of hormonal treatment.

Painful menstruation marks the last 5 years that arose after 3 menstrual cycles after a medical abortion at 8 weeks of pregnancy. In the last 3 years, pain has acquired a permanent character with increased intensity in the perimenstrual period. Was examined on the anti-inflammatory department of the State Institution "IvNII Mead. VN Gorodkov "Ministry of Health of the Russian Federation. An inflammatory pathology was excluded. With vaginal examination, it was found that the uterus and appendages of normal size, palpation of the sacro-uterine ligaments is painful, the uterus shifts anteriorly and painfully. On the sacro-uterine ligaments, palpation areas of seals up to 0.5 cm, painful. The patient was diagnosed with external endometriosis and was prescribed hormonal treatment in the form of a norkolut at a dose of 0.01 per day in continuous mode for 6 months. The patient developed amenorrhea during treatment, but the pain syndrome continued to persist, and after the treatment was canceled, the clinic relapsed. The patient was recommended laparoskpiya. In the course of preoperative preparation in the serum, acute phase parameters of the inflammatory reaction were studied: C-reactive protein (-) negative, sialic acids - 0.1, and 2- macroglobulin - 285.45 mg / dl. In the patient, external endometriosis of grade IV was suspected on the basis of serum a 2 -macroglobulin level within 360.0 mg / dL, which corresponds to the IV degree of external endometriosis according to the claimed method.

During surgery, the patient was found to have been obliterated by the endometrioid process, the left appendages as a single conglomerate, the ovary increased to 5 cm in diameter due to a cyst with endometrioid content. The patient was diagnosed with external genital endometriosis of the IV stage, which was subsequently confirmed by histological examination of ovarian and peritoneal biopsy specimens.

Conclusion: The diagnosis of external endometriosis IV stage according to the claimed method was confirmed

3. Patient L-va, 35 years old. Received operative treatment in the department of endoscopic surgery of the State Institution "IvNII Mead. VN Gorodkova "MH RF with the diagnosis: Endometrioid cyst of the right ovary. Pain syndrome. Algodismenorea.

It has been sick for the last three years, when menstruation has become painful. She received non-specific anti-inflammatory therapy, without much effect. At the control examination at the gynecologist (two months prior to hospitalization), an increase in the right ovary to 6 cm in diameter was found. With palpation, education had limited mobility and soreness. In the ultrasound examination of the pelvic organs, the diagnosis: a cyst of the right ovary was confirmed. With a dynamic observation for 2 months, the cystic formation did not tend to regress. Given the limited mobility of painful formation, painful menstruation and ineffectiveness of nonspecific anti-inflammatory treatment, the patient suspected external genital endometriosis of the third degree (endometrioid ovarian cyst) and recommended laparoscopy.

In preoperative examination, the patient was examined for a 2- macroglobulin level, which was 398.05 mg / dL, which corresponds to the third stage of external genital endometriosis according to the claimed method. C-reactive protein - (++) positive, sialic acids - 0.4. However, with surgical intervention in the pelvic cavity, an adhesion process was identified involving right appendages and the formation of a peritoneal cyst.

Conclusion: the diagnosis of external genital endometriosis was not confirmed by the claimed method. An increase in α 2 -macroglobulin to the figures characteristic of external genital endometriosis is caused by chronic inflammatory changes in the peritoneum (adhesion process, peritoneal cyst), which is indicated by an increase in other acute-phase indices - C-reactive protein and sialic acids.

In this way 120 women were examined, a true positive result was obtained in 111 women, negative - in 9. The accuracy of the method is 92.5%. Verification of the diagnosis of "external genital endometriosis" was made histologically by laparoscopic examination. The data of the study are given in the table.

Advantages of the claimed method:

1. The ability to conduct a differential diagnosis of the severity of external endometriosis with high reliability.

2. Small amount of blood used for research.

3. Automatic research, excluding subjective evaluation.

4. Technical Simplicity.

5. Use of industrially produced test systems and thus simple reproduction of the method.

INFORMATION SOURCES

1. Ionov ID, Volkov NI, Sukhikh GT, Pshenichnikova T.Ya. Method of diagnosis of external genital endometriosis. // Discoveries of invention. - 1990. - №1. - p.180. A.S. №1534397

2. Reproductive endocrinology. In 2 volumes. Volume 1: Trans. With the English. Ed. SSYyena, RBJaffe. - M .: Medicine. - 1998. - 704 p .: ill.

3. Guide to endocrine gynecology. /Under. Ed. EMVikhlyaeva. -M .: Medical information agency. - 1997. - 768 p .: ill.

4. Encyclopedia of clinical laboratory tests. Ed. Titza N. // Per. With the English. Ed. V.V. Menshikova. - M .: Publishing house "Labinform". -1997. -960 sec.

5. Anchez-Margalet V., Cubero J., Cruz-Femandez JM, Goberna R. // Clin. Chem. Lab. Med. - 2002. - Vol. 7, No. 8. - p.7-9.

6. Baker AH, Edwards DR, Murphy G. // J. Cell.Sci. - 2002. - Vol.19, No.10. -p.3719-27.

7. Ory SJ // Obstet. Gynecol. Clin.J.Amer. - 1987. - Vol.14, №4. - p.999-1014.

CLAIM

A method for diagnosing an external genital endometriosis stage by examining a blood serum, characterized in that the content of a 2 -macroglobulin is determined, and at a level of 600.0 mg / dL and above, stage I is diagnosed, ranging from 599.0 to 480.0 mg / DL is stage II endometriosis, from 479.0 to 360.0 mg / dL is endometriosis of stage III and from 359.0 mg / dL is endometriosis of stage IV.

print version
Date of publication 27.03.2007gg