RU2715423C1 - Method of complex preoperative preparation and postoperative care of patients with surgical correction of genital prolapse based on application of local forms of sex hormones, lactobacilli and hyaluronic acid - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention refers to medicine, namely to obstetrics and gynecology, and can be used for pre- and postoperative therapy in gynecologic surgeries in postmenopausal women using Trioginal (0.2 mg estriol, 2 mg progesterone combined with Lactobacillus casei rhamnosus). That is ensured by prescribing Trioginal according to the schedule: before operation for 1.5-month, 2 capsules 1 time per day for 20 days, then 1 capsule per day for 25 days, in postoperative period 1 capsule every second day for 1.5 months, and 1 month after the surgical operation, a hyaluronic acid-based gel 1.0 % – 2.0 ml is introduced into the postoperative seam area.EFFECT: method provides forming a thin scar on the vaginal mucosa by improving the ability to proliferate and differentiate the vaginal epithelium with improved local blood supply.1 cl, 1 tbl, 2 ex

Description

The invention relates to medicine, namely to obstetrics and gynecology, and is a comprehensive method for preoperative preparation and postoperative care of patients with surgical correction of genital prolapse using mesh implants, based on the use of local forms of sex hormones, lactobacilli and hyaluronic acid to improve results surgical treatment.

In reconstructive plastic surgery, great importance is attached to the state of tissues in the area of the proposed surgical intervention, in connection with this, the results of a surgical operation for genital prolapse are largely determined by the state of the vaginal mucosa epithelium.

The need for special preoperative preparation is associated with the special properties of the tissues on which the operation is performed, which is why for women who are undergoing surgical treatment for genital prolapse, properties of the vaginal epithelium, such as the ability to proliferative processes, differentiation of epithelial cells, glycogen accumulation, destruction, are especially important. biofilm of conditional pathogens, as well as to improve local microcirculation and, accordingly, trophism.

1. A high indicator of the ability of the proliferative processes of the vaginal epithelium in women before surgical treatment determines the timing and quality of restoration of the integrity of the epithelium, and due to the stimulation of the proliferative activity of the cellular elements of the macrophage and fibroblastic series, the epithelization in the suture on the vaginal mucosa is accelerated.

2. Differentiation of epithelial cells with subsequent synthesis by the accumulation of glycogen in the intermediate layers of the epithelium, which is a nutrient substrate for lactobacilli, guarantees an increase in the resistance of the epithelium to infectious and inflammatory processes, and also affects the quality and quantity of vaginal secretions.

3. When analyzing the dynamics of the wound process in patients undergoing pelvic floor reconstruction with a mesh implant for genital prolapse, it is important to note the ability to quickly restore the vaginal microflora with the destruction of biofilms of conditional pathogens, their displacement from the surface of epithelial cells, the formation of protective biofilms, which ensures a reduction terms of relief of perifocal inflammation and a decrease in the exudative phase of inflammation.

4. Improving the blood supply to the vaginal mucosa and together with the intensity of glycosaminoglycan formation largely determines the speed of the healing process, and also increase the collagen content in the connective tissue of the vagina.

The accumulated experience of using local forms of estriol as a preoperative preparation in postmenopausal women suffering from genital prolapse shows the absence of complications such as erosion and incomplete healing of the vaginal mucosa in the postoperative period, as well as the leveling of such complaints in the early postoperative period as vaginal dryness, discomfort in the area vagina, in the late postoperative period - discomfort during intercourse [1, 2, 5]. The described positive effect of low-dose local estrogens is achieved due to the full restoration of the normal structure of the vaginal mucosa, improved microcirculation.

The method consists in the local administration of micronized estriol preparations of 500 mcg daily with a course before surgery for two weeks of daily use, as well as in the postoperative period in the same dose with the transition to the “two days to a third” regimen.

The disadvantages of the method are the lack of influence on the vaginal microflora, especially on the quantitative composition of the lactobacillus population, thereby there is no stimulation of the mechanisms of natural biological defense, as well as prevention of secondary infection, which may worsen the postoperative prognosis. Also, when using this method, there is a high probability of the formation of a rough scar in the suture on the vaginal mucosa due to the lack of influence on the processes of formation of glycosaminoglycans and, in particular, hyaluronic acid, which improves local microcirculation and activates the migration and proliferation of cells that participate in tissue regeneration.

A known method of preventing the formation of postoperative scars, adhesions and keloids in connection with surgical intervention, comprising a biologically active peptide containing the amino acid sequence of SEQ ID NO: 56, where the peptide is present in a concentration of from 0.1 mg / ml to 100 mg / ml; and high molecular weight hyaluronic acid or a pharmaceutically acceptable high molecular weight hyaluronic acid salt, where the high molecular weight hyaluronic acid has an average molecular weight of over 300,000 Da and where the hyaluronic acid is present in a concentration of from 0.1 to 10% (w / mass.) (patent for the invention No. 2501566 dated 12/20/2013).

Also known is a method of preventing adhesions in the peritoneal cavity during obstetric and gynecological operations through the use of a composition that is applied by layer-by-layer suturing of the surgical wound into the preperitoneal and subcutaneous tissue of the anterior abdominal wall, the composition being a sponge from 60 × 100 × 4 mm to 240 × 180 × 4 mm, which contains 2% collagen acetate, 2% chitosan ascorbate with a deacetylation degree of more than 95%, molecular weight from 100 to 700 kDa, ascorbic acid - 1.8 g / g dry chitosan, chondroitinsern acid - 5-100 mg / g dry chitosan, hyaluronic acid - 10-100 mg / g dry chitosan, heparin - 2.5-5 mg / g dry chitosan and serum growth factor cattle "Adgelon" - 11-220 μg / g dry chitosan (Patent for the invention No. 2386441 dated 04/20/2010). The method increases the effectiveness of prevention of the formation of adhesions in the pelvis in women in the postoperative period, prevents the development of exudative processes in the tissues of the postoperative wound and accelerates the healing time.

The effect of drugs based on high molecular weight native hyaluronic acid as part of a biorevitalizing drug is based on the fact that, after the hyaluronidase enzyme is introduced into the tissue, shialuronic acid is destroyed with the formation of oligosaccharides and low molecular weight fragments that have biological activity. Active metabolites, interacting with the CD44 receptor, purposefully stimulate fibroblasts to synthesize their own hyaluronic acid and collagen.

The disadvantages of these methods are the impossibility of influencing the ability to differentiate epithelial cells, the accumulation of glycogen, as well as the destruction of biofilms of conditional pathogens.

As the closest analogue (prototype) of the invention, we have chosen a method of pre- and postoperative therapy in gynecological operations in postmenopausal women using local forms of micronized estriol 0.2 mg, micronized progesterone 2 mg in combination with lactobacilli (Lactobacillus casei rhamnosus 10 ⁷ CFU) . The method consists in prescribing capsules that are applied intravaginally in the regimen: 2 capsules 1 time per day for 2 weeks before surgery and for 2 weeks after surgery (Chushkov Yu.V., Kuznetsova I.V., Ishenko A.I. The role of local use of estriol in optimizing the outcome of surgical treatment of genital prolapse in patients with peri- and postmenopausal women. Effective pharmacotherapy. 19/2015, p. 24-28c.).

It is known that suture healing on the vaginal mucosa occurs through inflammation, in which the regeneration process slows down sharply, coarse scar tissue forms and the risk of developing implant-associated complications such as erosion of the vaginal mucosa, protrusion of the mesh implant is increased. The speed of the healing process is largely determined by the intensity of the formation of glycosaminoglycans and, in particular, hyaluronic acid, which improves local microcirculation and activates the migration and proliferation of cells that are involved in tissue regeneration. Given the above, the disadvantage of this method is the impossibility of influencing the speed and pace of healing, with the subsequent lack of prevention of implant-associated complications.

The task of the invention is to develop a method for the comprehensive preoperative preparation and postoperative care of patients with surgical correction of genital prolapse based on the use of local forms of sex hormones, lactobacilli and hyaluronic acid.

EFFECT: improved condition of vaginal tissues in the form of good ability to proliferate and differentiate vaginal epithelium, improved local blood supply, which ensures the formation of a thin scar on the vaginal mucosa, complete epithelization in the area of mesh implant placement.

The method also allows for the displacement of conditional pathogens from the surface of epithelial cells with the formation of protective biofilms, which is an important property, since under the conditions of operational stress, blood loss and mechanical trauma to tissues in the presence of genital tract dysbiosis, the risk of development of purulent-inflammatory complications in the postoperative period sharply increases before surgery period.

The method of pre- and postoperative therapy for gynecological operations in postmenopausal women using local forms of estriol 0.2 mg, progesterone 2 mg in combination with lactobacilli Lactobacillus casei rhamnosus 108 CFU, characterized in that they prescribe estriol 0.2 mg, 2 mg progesterone and lactobacillus Lactobacillus casei rhamnosus Doderleini 108 CFU according to the scheme: before surgery 1.5 months, 2 capsules 1 time per day for 20 days, then 1 capsule per day for 25 days, in the postoperative period 1 capsule every 1 day for 1.5 months, and 1 month after chi of a rurgic operation, a gel based on hyaluronic acid of 1.0% -2.0 ml is introduced into the area of the postoperative suture.

Hyaluronic acid, entering the scar region, provides the function of active regeneration, tissue hydration and trophic improvement, while trehalose is able to stabilize cell membranes, by enveloping and making glycosidases difficult to approach, it has the ability to neutralize free radicals, which are abundant in conditions cell stress.

It is this method, based on an integrated approach, that guarantees an increase in microcirculation in all layers of the vaginal wall, accelerates the vascularization of the epithelium and connective tissue, and also provides an active antioxidant effect, promotes the displacement of conditional pathogens from the surface of epithelial cells with the formation of protective biofilms, which is an important property, since under conditions of operational stress, blood loss and mechanical trauma to tissues in the presence of genital tract dysbiosis before surgery and sharply increases the risk of developing purulent-inflammatory complications in the postoperative period.

Time / Condition dose Performance indicator
(lack of implant associated complications) Performance indicator
(increase in lactobacillary flora, decrease in aerobic and anaerobic flora) prototype within 2 weeks before surgery and within 2 weeks after surgery. 2 caps. 1 time / day In 8% of cases, complication Triozhinal + hyaluronic acid within 2 weeks before surgery and within 2 weeks after surgery
+ 1 month after surgery, a gel based on hyaluronic acid 2 caps. 1 time / day
hyaluronic acid 1.0% -2.0 ml In 5% of cases, complication In 60% of cases Proposed method Before surgery 1.5 months and after surgery 1.5 months
1 month after surgery, a gel based on hyaluronic acid Before the operation, 1.5 months, 2 capsules 1 time per day for 20 days, then 1 capsule per day for 25 days in the postoperative period, 1 capsule every 1 day for 1.5 months + hyaluronic acid 1.0% -2.0 ml In 0% of cases, complication In 100% of cases

Clinical examples of the implementation of the method.

Example 1

Patient A., 61, complained of a foreign body sensation in the vagina for 3 years. The patient has a history of two urgent deliveries through the natural birth canal, while the maximum weight of the baby at birth is 4200 g, with episiorrafia.

Suffers from genital prolapse for 5 years, when she first noted discomfort in the vagina, a foreign body sensation when performing physical exertion. I did not receive medical and surgical treatment. In 2016, she noted a constant sensation of a foreign body in the vagina, respectively, a decrease in the level of quality of life. She was consulted, diagnosed with Cystocele III degree POP-Q, apical prolapse III degree POP-Q, planned surgical treatment. In 2018, the vaginal wall was prepared using local forms of sex hormones and lactobacilli before surgery 1.5 months, 2 capsules 1 time per day for 20 days, then 1 capsule per day for 25 days, followed by surgical treatment in the amount of reconstruction of the pelvic floor using a mediocre technique with the installation of a mesh implant CalistarS. In the postoperative period, 1 capsule after 1 day for 1.5 months. The postoperative period is smooth, the temperature reaction is normal, and was discharged in satisfactory condition on the fifth day after the operation under the supervision of a female doctor. 1.5 months after the operation, a gel was introduced based on 1.0% hyaluronic acid 2.0 ml into the suture area on the anterior wall of the vaginal mucosa. Two months after the operation, an outpatient consultation took place to examine the patient. No complications of the postoperative period were observed. The patient had no complaints, her condition was satisfactory, data from a gynecological examination without deviation from the norm. On vaginal examination, the scar on the vaginal mucosa is thin.

Example 2

Patient B., 58 years old, complained of dryness in the vagina, a foreign body sensation in the vagina for 7 years. The patient has a history of 3 urgent deliveries through the natural birth canal, with a maximum birth weight of 3700 g, 2 m / a.

Suffers from genital prolapse for 7 years, when she first noticed discomfort in the vagina, a foreign body sensation when performing physical exertion. From 2015 to 2018, genital prolapse was corrected using a pessary. I did not receive medical and surgical treatment. In 2018, she noted the lack of correction by the pessary, the sensation of a foreign body in the vagina at rest and during physical exertion, which negatively reduced the level of quality of life. Was consulted, diagnosed with Cystocele IV degree POP-Q, planned surgical treatment. In 2018, the vaginal wall was prepared using local forms of sex hormones and lactobacilli. Before the operation, 1.5 months, 2 capsules 1 time per day for 20 days, then 1 capsule per day for 25 days. Subsequently, surgical treatment was performed in the amount of reconstruction of the pelvic floor using a mesh implant Pelviks Front. In the postoperative period, a woman intravaginally received 1 capsule after 1 day for 1.5 months. The course of the postoperative period is smooth, the temperature reaction is normal, and was discharged in satisfactory condition on the fourth day after the operation under the supervision of a doctor of antenatal clinics. 1 month after the operation, a gel was introduced based on 1.0% hyaluronic acid 2.0 ml into the suture area on the anterior wall of the vaginal mucosa. Three months after the operation, the patient was examined on an outpatient consultative appointment. No complications of the postoperative period were observed. The patient has no complaints, the condition is satisfactory, data from a gynecological examination without deviation from the norm. On vaginal examination, the scar on the vaginal mucosa is thin, the implant - associated complications are absent.

The invention ensures the achievement of a synergistic effect, as well as potentiation of the effect in relation to the leveling of dystrophic and infectious processes in the vaginal mucosa.

As a result of using this method, improvement of the condition of vaginal tissues in the form of good proliferation and differentiation of the vaginal epithelium, improvement of local blood supply, which ensures the formation of a thin scar on the vaginal mucosa, complete epithelization in the area of mesh implant installation, is achieved.

LIST OF REFERENCES:

1. Apresyan S.V., Dimitrova V.I., Slyusareva O.A. Prevention of the development of estrogen-dependent complications in the preoperative preparation of women with genital prolapse, stress urinary incontinence // MS. 2016. No2. URL: https://cyberleninka.ru/article/n/profilaktika-razvitiya-estrogenzavisimyh-oslozhneniy-v-predoperatsionnoy-podgotovke-zhenschin-s-prolapsom-genitaliy-stressovym (accessed: 11/05/2018).
2. Eliseev D.E., Kholodova J.L., Abakumov R.S., Filyaeva Yu.A. Preoperative preparation in patients with pelvic organ prolapse and genital fistulas // Breast cancer. 2018. No. 5 (I). S. 41–44.

3. Marchenko T. B. The immediate and long-term results of the surgical treatment of genital prolapse in elderly and senile women. The dissertation for the degree of candidate of medical sciences, 2015, 135 pp.

4. Nechaykin A.S., Peshev L.P., Abramova S.V., Islamova M.N. The experience of using low-intensity laser radiation in the treatment of pelvic organ prolapse // Vestnik RUDN. Series: Medicine. 2011. No1. URL: https://cyberleninka.ru/article/n/opyt-primeneniya-nizkointensivnogo-lazernogo-izlucheniya-v-kompleksnoy-terapii-prolapsa-tazovyh-organov (accessed 04.11.2018).

5. Chushkov Yu.V., Kuznetsova IV, Ischenko A.I. The role of local use of estriol in optimizing the outcomes of surgical treatment of genital prolapse in patients in peri- and postmenopausal women. Effective pharmacotherapy. 19/2015, p. 24-28.

Claims (1)

       A method of pre- and postoperative therapy for gynecological operations in postmenopausal women using Triozhinal (estriol 0.2 mg, progesterone 2 mg in combination with lactobacilli Lactobacillus casei rhamnosus), characterized in that Triozhinal is prescribed according to the scheme: before surgery 1.5 months 2 capsules 1 time per day for 20 days, then 1 capsule per day for 25 days, in the postoperative period, 1 capsule every 1 day for 1.5 months, and 1 month after surgery is introduced into the postoperative area hyalur-based seam gel new acid 1.0% - 2.0 ml.