RU2311184C2 - Method for treating ectopia of uterine cervix in female teenagers - Google Patents

Abstract

FIELD: medicine, gynecology.

SUBSTANCE: one should dissolve the ampoule of 100 mcg "Superlymph" dry substance in 4 ml 0.9% physiological solution to irrigate cervical canal and uterine cervix with the obtained solution of immunotropic preparation. Then it is important to impregnate the tampon with this preparation to guide it towards the uterus for about 4-5 h. The procedure suggested should be fulfilled daily for 5 d. The innovation suppresses the differentiation of cylindrical epithelium cells and normalizes the differentiation of reserve cells into the cells of flat multi-layer epithelium of uterine cervix and, thus, removes ectopia.

EFFECT: higher efficiency of therapy.

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Description

The present invention relates to medicine, namely to gynecology, and can be used to treat cervical ectopy in adolescent girls by using the immunotropic drug Superlim.

The relevance of the proposed method is determined by the high frequency (54.2% -90%) of cervical ectopia in the group of nulliparous women under 25 years of age. Up to 18 years old, ectopia occurs in 12.3% of girls, at the age of 18-35 years old - in 69.3% of young women [1]. This pathology belongs to the group of background processes of the cervix and is a source of development of precancerous diseases [2]. Early detection of cervical ectopia, adequate treatment of the revealed pathology are effective prevention of precancerous conditions and cervical cancer [3]. Each method of treating cervical ectopia has its own indications and contraindications, as well as characteristic complications arising from the treatment, which lead to the search for new ways to treat this pathology [4].

A known method of treating cervical ectopy with a laser-surgical method, in which carbon dioxide or a mixture of helium with neon is used as an active medium using the Camomile-23 surgical laser unit (Smetnik V.P., Tumilovich L.G. Non-operative gynecology: Guide for Doctors. - M.: Medical News Agency, 2000. - P.538-546). However, this method has several disadvantages:

1. During its implementation, complications are possible (bleeding with large ectopias; development of the “coagulated neck syndrome” after using a high-intensity laser);

2. preliminary elimination of the concomitant inflammatory process of the cervix and vagina;

3. restriction in use in the absence of a specialist trained in this technique;

4. the method is invasive;

5. you must have an expensive device.

A known method of treating ectopia of the cervix with a chemical coagulant, the drug "Solkovagin". The drug is an aqueous solution of organic acids (acetic, oxalic acid) and zinc nitrate in nitric acid. The mechanism of action is due to devitalization and intravital fixation of the ectopic cylindrical epithelium of the cervix after treatment of the affected area with Solkovagin solution twice with an interval of 2-3 minutes. If there is no effect after 42 days, it is necessary to conduct a second course of treatment (Prilepskaya VN, Rudakova EB, Kononov A.V. Ectopia and cervical erosion. - M .: MEDpress-inform, 2002. - 176 p. )

The method has several disadvantages:

1. when working with this drug, it is necessary to avoid contact with the skin, mucous membrane of the external genital organs and vagina, since the acids that make up the drug can cause burns to the above tissues;

2. the risk of not sufficiently deep penetration of the drug into the affected area with extensive ectopia;

3. preliminary elimination of the concomitant inflammatory process of the cervix and vagina;

4. The effectiveness of treatment in young nulliparous women is 74.3% [5].

The most common is a method of treating cervical ectopy with a cryosurgical method. Cryodestruction causes necrosis of the pathological focus due to the influence of low temperature using the apparatus for local cryocoagulation. As a refrigerant, liquid nitrogen or nitrous oxide is used (Polyakova V.A. Oncogynecology: A Guide for Doctors. - M.: Medical Book, 2001. - P.73-91). To treat the surface of the vaginal part of the cervix, cryoprobes of various shapes are used, depending on the size of the pathological site. It is frozen until a rim of hoarfrost appears around the tip at a distance of 2-2.5 mm (Prilepskaya V.N., Rudakova E.B., Kononov A.V. Ectopia and cervical erosion. - M .: MEDpress -inform., 2002 .-- 176 p.).

The disadvantages of the method:

1. possible adverse reactions in the form of vegetative-vascular reactions (hot flush, lowering blood pressure), pain in the lower abdomen;

2. after cryocoagulation, severe swelling of the cervix and copious watery discharge occur;

3. the possibility of complications after cryogenic intervention in the form of a coagulated mucosa;

4. the risk of insufficient freezing of the tissue, because of which the death of all altered cells is not ensured and a relapse of the disease is possible;

5. preliminary elimination of the concomitant inflammatory process of the vagina and cervix;

6. the method is invasive;

7. The effectiveness of cryotherapy is 54-96%, according to various authors [6, 7].

A known method of treating pseudo-erosion of the cervix using locoregional cytokine therapy by summing up a patient swab for 3-4 hours daily for 10-15 days with a complex of autologous endogenous cytokines obtained by stimulating patient mononuclear cells with interleukin 2, with the presence of concomitant cicatricial deformations and hypertrophy, the patient is preliminarily undergoing diathematectomy of the cervix [2, 8].

However, this method has several disadvantages:

1. The positive effect of this method is based on the anti-inflammatory and stimulating regeneration processes of the complex of autologous endogenous cytokines (KAEC), which are the consequences of the inflammatory process, and not the normalization of proliferation and differentiation of cervical epithelial cells, which can contribute to the relapse of the disease.

2. The method uses a non-standardized preparation obtained by culturing a patient's cells with interleukin-2. The authors do not indicate which cytokines and in what quantity are present in the culture medium. However, it is known that the synthesis of cytokines may be impaired [9]. For example, the presence of pseudo-erosion of the cervix is often combined with an active viral and bacterial infection. In these cases, the patient’s cells are initially in an activated state and spontaneously produce the corresponding Th1 or Th2 complex of cytokines, while additional stimulation may not be effective. In addition, very often their own cells are not able to produce cytokines or produce an inadequate complex of cytokines. In the inflammatory response, Th1 type cytokines are produced more often, which have a cytotoxic effect and can contribute to worsening the course of the inflammatory process.

3. This method has limitations in use in the treatment of cervical pseudoerosion in adolescents, since the cytokine status of adolescents with an ectopia of the cervix has significant differences from the cytokine status of women of childbearing age with an ectopia of the cervix [10]. Thus, it should be expected that mononuclear cells of adolescents stimulated by IL-2 will produce a complex of cytokines other than cells of women of childbearing age, with other regenerating and anti-inflammatory effects.

4. In addition, to perform this method, an additional procedure is required to obtain an autologous complex of cytokines, which is a rather laborious and lengthy process that requires preliminary patient blood sampling, the use of expensive culture media, equipment and special sterile culturing conditions, as well as the involvement of specialists, carrying out the cultivation of cells.

This method is selected as the closest analogue, the disadvantages are proposed to eliminate the claimed method.

The technical solution of the proposed method is the creation of an effective method for the treatment of cervical ectopia in adolescent girls with the Superlimf immunotropic drug by topical application of a solution of this drug in the form of irrigation of the cervical canal and cervix with a 2 ml solution and the subsequent introduction of a tampon to the cervix with 2 ml of the drug for 4-5 hours daily for 5 days with an efficiency of 90%. The therapeutic effect of the method is based on the local effect of the Superlimf preparation on the mucous membrane of the cervix with the manifestation of the immunostimulating effect of the drug on the normalization of proliferation and differentiation of reserve epithelial cells in the direction of stratified squamous epithelium, increased proliferative activity of fibroblasts, that is, the effect on the cause of the disease, and not on its consequences.

The novelty of the method lies in the fact that for the first time it is proposed to treat cervical ectopia with the Superlimf immunotropic drug.

Earlier, Superlimf was used in urology for the treatment of patients with herpes virus infection and prostatitis; in surgical practice for the treatment of purulent wounds, trophic ulcers, burns; in ophthalmology for the treatment of patients with penetrating eye injuries, corneal burns, viral keratitis; in otorhinolaryngology for the treatment of acute and chronic rhinosinusitis, pharyngitis, tonsillitis and otitis media; in dentistry for the treatment of periodontitis and gingivitis, in cosmetology for the treatment of skin defects in plastic surgery; in oncology during surgical interventions, after radiation and chemotherapy and in gynecology for the treatment of patients with cervical lesions with human papillomavirus, cytomegalovirus, herpes virus, for the treatment of patients with vaginosis, chronic endocervicosis, salpingo-oophoritis, as well as for the prevention and treatment of suppurative septic complications after cesarean section, after operations on the perineum [11]. In order to treat cervical ectopy, the method is used for the first time.

Distinctive features of the method are: an ampoule containing 100 μg of dry matter, diluted in 4 ml of 0.9% physiological saline and a solution of Superlimf irrigate the cervical canal and cervix, followed by a tampon to the cervix for 4-5 hours daily 5 days.

The method is carried out using the drug "Superlim", developed at the Department of Immunology at the Russian State Medical University, registration certificate P No. 000516 / 01-2001. After an explanatory conversation with the patient, examination of the cervix, the cervical canal and cervix are irrigated with a 2 ml solution of Superlimf from a sterile syringe, then a tampon is inserted into the cervix, soaked in 2 ml of the solution of this drug, which the patient independently extracts after 4-5 hours by sipping. Previously, one ampoule containing 100 μg of the dry matter of the drug is diluted in 4 ml of 0.9% saline. The procedure is carried out daily for 5 days.

The essence of the proposed method is illustrated by the following examples.

Example 1. Patient L., 17 years old, applied for a routine examination. A history of menstruation from 12 years old was established immediately, now regular after 30 days. Menstruation lasts 8-10 days, profuse painless. Beginning of sexual activity from the age of 12; the number of sexual partners - 2. There were no pregnancies. Gynecological diseases: in 09.2003 was undergoing treatment in a hospital with a diagnosis of acute endometritis, hr. salpingoophoritis. Bad habits: smokes.

On vaginal examination: the cervix with the phenomenon of ectopia in diameter of 0.6 cm, the body of the uterus is normal in size, dense, limited in mobility, painless on palpation. Appendages are determined on both sides, painless. Discharge mucous.

Clinical diagnosis: Cervical ectopy. Chronic salpingoophoritis.

The diagnosis is confirmed:

- colposcopy: ectopia with a normal transformation zone;

- histologically: glandular pseudo-erosion.

A smear on the flora: white blood cells - 2-4-6 in the field of view, trichomonas vaginalis, gonococcus - not found.

The result of a virological study: cytomegalovirus, herpes simplex virus, human papilloma virus - the result is negative.

At the request of the teenager, ectopia of the cervix was treated with Superlimf in the form of irrigation of the cervical canal and cervix and tampons to the cervix daily for 5 days. When viewed after 2 months of the cervix using mirrors and colposcopy: the cervix without defects in the mucosa.

Example 2. Patient G., 15 years old. Appealed for a routine inspection. Menstruation from 12 years old was established immediately lasting 4-5 days after 30 days. Menstruation is moderate, painless. Beginning of sexual activity: from the age of 14, sexual partner - 1. There were no pregnancies, gynecological diseases. Bad habits: denies.

On vaginal examination: the cervix with the phenomenon of ectopia in diameter of 0.8 cm, the body of the uterus is normal in size, dense, mobile, painless. Appendages on both sides without features. Discharges are mucous, plentiful.

Clinical diagnosis: cervical ectopia.

The diagnosis is confirmed:

- colposcopy: ectopia with a normal transformation zone;

- histologically: glandular pseudo-erosion.

A smear on the flora: white blood cells - 15-20-25 in the field of view, trichomonas vaginalis, gonococcus - not found.

The result of a virological study: cytomegalovirus, herpes simplex virus, human papilloma virus - the result is negative.

At the request of the teenager, ectopia of the cervix was treated with Superlimf in the form of irrigation of the cervical canal and cervix and tampons to the cervix daily for 5 days.

When examining the cervix 2 months after treatment with mirrors and colposcopy: active ectopy epithelization, ectopia diameter decreased to 0.5 cm; after 3 months, the cervix is defective.

Example 3. Patient K., 16 years old. Appealed for a routine inspection. A history of menstruation from 11 years of age was established immediately lasting 4-5 days after 28 days. Menstruation is moderate, painless. Beginning of sexual activity: from 13 years old, sexual partner -1. Pregnancy - 1, in 2003, ended with interruption (medical abortion in the period of 5-6 weeks, without complications). Gynecological diseases: vulvovaginitis. Bad habits: denies.

On vaginal examination: the cervix with the phenomenon of ectopia in diameter of 0.8 cm, the body of the uterus is normal in size, dense, mobile, painless. Appendages on both sides without features. Discharge mucous.

Clinical diagnosis: cervical ectopia. Chronic salpingoophoritis.

The diagnosis is confirmed:

- colposcopy: ectopia with a normal transformation zone;

- histologically: glandular pseudo-erosion.

A smear on the flora: White blood cells -0-1-4 in the field of view, trichomonas vaginalis, gonococcus - not found.

The result of a virological study: cytomegalovirus, herpes simplex virus, human papilloma virus - the result is negative.

At the request of the teenager, ectopia of the cervix was treated with Superlimf in the form of irrigation of the cervical canal and cervix and tampons to the cervix daily for 5 days. When examining the cervix after 2 weeks using mirrors and colposcopy: the cervix without defects in the mucosa.

In this way, 20 adolescents with an ectopia of the cervix were treated. Of these, 18 girls showed complete epithelialization of ectopia, and 2 adolescents showed incomplete epithelization of the focus. No complications were observed. The research results are shown in table No. 1.

Table 1.
A comparative assessment of the effectiveness of the application of the claimed method and the prototype method (according to the literature [8]). Method used Number of observations Positive effect (complete epithelization) Lack of effect (incomplete epithelization) The claimed method twenty 18 (90%) 2 (10%) Prototype method twenty 14 (70%) 6 (30%)

The advantages of method 1.

High efficiency - 90%.

2. The possibility of applying the method in the treatment of ectopia of the cervix in adolescent girls.

3. The restoration of the proliferative and differentiating activity of reserve cells in the direction of stratified squamous epithelium, that is, the effect on the cause of the disease, and not on its consequences.

4. The use of a drug that includes a standardized complex of cytokines.

5. No need to use expensive cell culture methods.

6. Availability of use in wide gynecological practice, because no need for the involvement of laboratory specialists.

7. A shorter course of treatment (10-15 in the prototype method and 5 days in the present method).

8. Treatment with Superlimf is painless, while patients do not feel discomfort.

9. Good tolerance to the drug.

10. The absence of complications.

11. The ability to perform the procedure by nursing staff: midwife, nurse.

Thus, a new highly effective method for the treatment of cervical ectopia in adolescent girls is proposed, which increases the effectiveness of treatment to 90%. The method can be used on an outpatient and inpatient basis. There are no contraindications to this method.

Information sources

1. Prilepskaya VN, Rudakova EB, Kononov A.V. Ectopia and erosion of the cervix. - M .: MEDpress-inform, 2002 .-- 176 p.

2. Vishnyakova S. V., Pekarev O. G., Efremov A. V., Shirinsky B. C., Chernykh E. R. Opportunities for optimizing the treatment of cervical pathology // Akush. and gin. - 2003. - No. 3. - S.115-117.

3. Nikiforovsky N. K., Ivanova A. A., Ignatova N. B., Melnikova A. B. The experience of using drugs that accelerate regeneration in the complex treatment of patients with cervical pseudo-erosion // Akush. and gin. - 2001. - No. 6.- P.224-227.

4. Minkina G.N., Manukhin I.B., Frank G.A. Cervical precancer. - M.: Airbrush Media, 2001. - 112 p.

5. Diseases of the cervix, vagina and vulva: (Clinical lectures) / Under. ed. prof. Prilepsky V.N. - M.: MEDpress-inform, 2003. - P.66-75.

6. Polyakova V.A. Oncogynecology: A Guide for Physicians. - M.: Medical book, 2001. - P.73-91.

7. Kaukhova E.N., Lugueva A.Yu., Mishieva O.I., Solomatina A.A., Boginskaya L.N. Modern methods of treating ectopia of the cervix in young nulliparous women // Journal of the Russian Association of Obstetricians and Gynecologists. - 2002. - No. 3. - S.25-26.

8. Vishnyakova S. V., Pekarev O .. G., Efremov A.V. et al. Optimization of treatment of complicated cervical pseudo-erosion // Materials of the IV Russian Forum “Mother and Child”. - M., 2002 .-- P.78 - 79.

9. Kovalchuk L.V., Gankovskaya L.V., Rubakova E.I. The cytokine system. - M., 1999 .-- P.74.

10. Sokolova E.A., Bogatova I.K., Astraukh N.V. Changes in immunological parameters in adolescent girls with an ectopia of the cervix // Materials of the VII Russian forum "Mother and Child". - M., 2005 .-- S.507-508.

11. Superlimf in the complex treatment of diseases of the urogenital tract / Ed. Academician of the Russian Academy of Natural Sciences prof. Kovalchuk L.V., prof. Gankovskoy L.V., prof. Yudina S.M., Ph.D. Dolgina E.N. - M., 2003 .-- 42 p.

Claims (1)

A method of treating cervical ectopy in adolescent girls by bringing a tampon with an immunotropic drug to the cervix, characterized in that “Superlimf” is used as such a drug, while an ampoule containing 100 μg of dry substance “Superlimf” is diluted in 4 ml 0, 9% saline and pre-irrigate them with the cervical canal and cervix, followed by summing the swab to the cervix for 4-5 hours daily for 5 days.