RU2391977C2 - Method of acute bacterial vaginitis treatment - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention belongs to medicine, notably to gynaecology and dermatovenerology, and concerns treating of acute bacterial vaginitis. Before suppository insertion vagina must be treated with cotton or gauze pad soaked with 30-50 ml of Tantum Rosa solution. Vaginal suppository Bifilis must be inserted in the morning and midday, and suppository Syntomycin must be inserted in the evening. Course of treatment lasts 5-7 days.

EFFECT: method provides quick arresting of disease symptoms, normalises vaginal microflora without side effects of therapy, extends remission in the patients with acute vaginitis.

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Description

The invention relates to medicine, namely to dermatovenereology, obstetrics, gynecology, and can be used to treat inflammatory diseases of the vagina - nonspecific vaginitis caused by opportunistic microorganisms, including aerobic vaginitis, and may find application for the prevention of ascending uterine infection.

The occurrence of these diseases is closely associated with a violation of the microecology of the woman's vagina. Imbalance in the body-microbe balance leads to suppression of normal vaginal bacteria: lacto- and bifidobacilli, and in some cases to their complete disappearance and, accordingly, to active proliferation of opportunistic microorganisms.

Vaginal microecology is a complex relationship between the environment and the vaginal microflora, which are important in gynecology. Vaginal environment: the walls of the vagina and the vaginal part of the cervix are covered with a multilayer flat non-keratinizing epithelium that does not contain glands. The cells of the basal layer of the epithelium divide and mature in the process of their advancement to the lumen of the vagina. Vaginal secret: is a serous transudate, a secret of the glands of the mucous membrane of the cervical canal and large glands of the vestibule, leukocytes, cells of desquamated epithelium. The main chemical composition of vaginal secretions is water, inorganic salts, proteins (albumin, immunoglobulins), carbohydrates, fatty acids, urea, lysozyme. Physiological maturation of epithelial cells, their desquamation, enrichment with glycogen, and also ensuring the acidity of vaginal secretions are estrogen-dependent processes controlled by ovarian hormones.

In vaginitis, among the pathogens, representatives of enterobacteria prevail: E. coli, Klebsiella, enterobacteria. Together with them, golden staphylococcus, hemolytic group B streptococci, diphtheroids (Escherihia coli, Enterococcus, Enterobacter, Klebsiella, Staphilococcus aureus, Streptococcus b, Diphteroides) are found. The latter increase the pH of the vaginal contents, the chemical composition of the vaginal secretion changes, its immunological properties change. This, in turn, favors the predominant growth of opportunistic flora over lacto- and bifidobacilli (Kanishcheva E.Yu. Clinical, microbiological and morphological characteristics of chronic inflammatory diseases of the pelvic organs in women and their relationship with sexually transmitted infections // Abstract Ph.D. Candidate of Medical Sciences, M., 2003 - 26 p.).

There is a method of local treatment of bacterial vaginitis, carried out in two stages (Tsvelev, Kocherovets V.T., Kira E.F. // Questions of antibiotic therapy of infectious complications in a non-infectious diseases clinic. M., 1987. - pp. 189-190). However, the two-stage treatment method leads to an increase in the duration of treatment of patients, stay in the hospital. In addition, bacterial preparations in lyophilized form are used here, which significantly reduces their colony resistance and does not sufficiently contribute to the restoration of the vaginal microflora.

There is also known a method of treating vaginal infections by introducing live lactic acid bacteria on a sterile swab (RF Patent No. 2111710, IPC 6 A61B 17/42 A61K 35/74, publ. 1998.05.27). According to the authors, the method reduces treatment time. However, this method is laborious in terms of the manufacture of a medicinal product. A woman should either prepare this drug herself or be in a hospital with the aim of carrying out the procedure, which increases the bed-day, i.e. treatment costs. The disadvantages of the method are not always expressed the effectiveness of the treatment, as it does not ensure the penetration of drugs into the deeper layers of biological tissues; the complexity of the methodological execution of procedures is rather complicated, because specialized equipment is needed.

There is also a method of treating inflammatory processes of the genitals (vulva and vagina) using a solution of malavit in the form of vaginal baths and a swab moistened with it with an exposure of 2-4 hours (RF Patent No. 2144890, IPC 6 A61K 31/30, A61K 31/185, A61K 35/56, A61K 35/78, publ. 1999).

This method of treatment by introducing a chemical substance selectively affects conditionally pathogenic microflora with minimal suppression of lactobacilli, however, the use of malavite leaves open the question of the specificity of its use as a medicinal substance. Also unknown is the mechanism of how sanitation occurs with this method of treating inflammation in the vagina.

There are many articles in the literature that describe bacterial preparations for the treatment of vulvovaginal diseases. The fundamental of them can be proposed as follows (O. Miroshnik // Bacterial and biological preparations for the correction of dysbiosis and their rational use // Omsk Medical Newspaper No. 8 (29), May 1997). The systematization of bacterial preparations intended for the correction of the biocenosis of the mucous membranes proposed in this publication gives the most complete scenario for the effective use of the entire arsenal of medicines in everyday practice. Moreover, in addition to such long-known drugs as bifidumbacterin, lactobacterin, colibacterin and bificol, many new tools have appeared, among which it is difficult for doctors, pharmacists and patients to navigate.

The closest solution to the claimed is a method of treating inflammatory processes of the vulva and vagina by prior drug treatment of the patient, treating the vagina with a cotton or gauze swab and subsequent local injection of the drug. Patients are vaccinated with the Solko Trichovac preparation three times a week, which is a vaccine from inactivated minus variants of acidophilus bacillus. When administered locally, the antibacterial drug Fucidin is used for 10 days, 2 times a day. After 8-12 months, the Solko Trichovac revaccination is carried out (RF patent No. 2240781 IPC ⁷ A61K 9/08 31/56 35/74 A61P 15/02 publ. 11/27/2004) - prototype.

This method provides an etiopathogenetic effect on a bacterial agent by local administration of Fucidin cream, and when vaccinated, antibodies increase in the blood, which adversely affects pathogenic microorganisms, including minus variants of lactobacilli, due to which there is an update and restoration of "normal" microflora. Unfortunately, this method of treatment did not find wide application because of its high cost and the practical inaccessibility of drugs (drugs of foreign manufacturers).

The objective of this invention is the selection of drugs, treatment regimens for acute forms of inflammatory diseases of the vagina (aerobic vaginitis), which allows to reduce the duration of therapy, reduce the number of relapses and extend the periods of remission, quickly stop the vaginal discharge syndrome.

The technical result that will be achieved from the use of this invention is to increase the effectiveness of treatment, reduce the cost of treatment (inexpensive drugs, treatment on an outpatient basis).

The technical result is achieved by the fact that in the method of treating acute forms of bacterial vaginitis by treating the vagina with a cotton or gauze swab and subsequent local administration of the drug, the vagina is pretreated with Tantum Rose in an amount of 30-50 ml. With subsequent local administration, drug treatment is carried out for 5-7 days: in the morning and in the afternoon - "Bifilis", and "Sintomycin" is administered at night.

The essence of the invention consists in the adequate and effective use of the methods and combinations of drugs that are used only locally (excluding the general effect on the macroorganism), using finished pharmaceutical forms in the form of vaginal suppositories. At the same time, a therapeutic effect is carried out in three directions: antibacterial, antilysocyme and bioremediation.

Treatment of the vagina with Tantum Rose solution provides a stable antiseptic effect with a deep penetration into inflammatory tissues.

Tantum Rosa (benzidamine) is a non-steroidal anti-inflammatory drug with analgesic and antiexudative properties. Belongs to the group of indosols. Benzidamine has anti-inflammatory, analgesic and decongestant effects. Due to its high lipophilicity when applied topically, it exhibits antibacterial activity and acts as a local antiseptic and anesthetic. Benzidamine also has histoprotective activity. The mechanism of action of the drug is associated with stabilization of cell membranes and inhibition of prostaglandin synthesis.

Intravaginal (local administration) use of Bifilisa in the morning and afternoon due to the optimal combination of bifidobacteria and lysozyme in its composition allows to enhance the therapeutic effect of each component and limit the use of antibiotics for the treatment of vaginal infections and selective decontamination.

Antilizoyim and bioremediation - suppositories "Bifilis": the therapeutic effect of the drug is due to the presence of bifidobacteria in its composition, the action of which is aimed at normalizing the lacto and bifidoflora of microflora and lysozyme as a natural factor in protecting the vaginal environment. Live bifidobacteria with high antagonistic activity against a wide range of opportunistic and enteropathogenic microorganisms displace the latter from intestinal microbiocenosis, creating favorable conditions for normalizing microflora and improving metabolic processes, preventing the formation of protracted forms of the genital tract diseases. Lysozyme has a bifidogenic, immunomodulating, anti-inflammatory effect, stimulates metabolic, reparative processes and erythropoiesis, and increases the body's anti-infection and antitoxic resistance. It has a non-specific antibacterial effect and is synergistic with many antibiotics.

Its administration twice a day in the morning and in the afternoon for 5-7 days in the form of vaginal suppositories provides the necessary and fairly stable restoration of the vaginal microflora due to bifidogenic and non-specific immunostimulating effects.

Introduction at night of antibacterial suppositories "Syntomycin" (a drug - chloramphenicol) provides a detrimental, antibacterial effect on the pathogenic spectrum of bacteria, which are the etiological factor in the development of the disease. Synthomycin is a broad-spectrum antibiotic. The mechanism of antimicrobial action is associated with a violation of the synthesis of proteins of microorganisms. It has a bacteriostatic effect. Active against gram-positive bacteria: Staphylococcus spp., Streptococcus spp .; gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Haemophilus influenzae, Salmonella spp., Shigella spp., Klebsiella spp., Serratia spp., Yersinia spp., Proteus spp., Rickettsia spp .; active against Spirochaetaceae, some large viruses. Chloramphenicol is active against strains resistant to penicillin, streptomycin, sulfonamides. The resistance of microorganisms to chloramphenicol develops relatively slowly. It is prescribed in the form of vaginal suppositories once a day at night for 5-7 days, which is enough until complete cure.

From an analysis of the scientific, technical and patent literature of the claimed combination of features that contribute to the destruction of pathogenic bacteria that cause vaginitis (aerobic vaginitis) using a sufficient dose of the active ingredient (medication) and at the same time ensure the restoration and preservation of the vaginal microbiota, we have not identified, which allows us to conclude compliance of the proposed solutions to the criteria of "novelty" and "inventive step".

In practice, the method is as follows. Treatment is prescribed after establishing a clinical diagnosis of acute nonspecific bacterial vaginitis (aerobic vaginitis).

The procedure for local therapy is as follows. Before the introduction of directly solid dosage forms, the vagina is treated with douching with a Tantum Rose solution in an amount of 30-50 ml, then a Bifilis candle is inserted deep into the vagina, this procedure is performed twice a day in the morning and evening. At night, use candles "Synthomycin." These actions are carried out for at least five, but no more than seven days. The best option is a seven-day course of therapy.

The cure is controlled two weeks after the end of the therapy, which consists in establishing clinical symptoms and laboratory tests that correspond to the normal state with the dominant position of lactic acid bacteria (lacto-, bifido-) in the vaginal biotope.

To confirm the effectiveness of the proposed method of therapy, a comparative treatment of acute vaginitis of aerobic etiology was performed in 83 patients with outpatient treatment at the Federal State Medical Research Institute of Rosmedical Technologies and Medical Technologies. The group of the proposed method of treatment was 42 patients, and the comparison group was 41 patients. A persistent effect of treatment in the group of the proposed method was achieved in 98% of the cured, in the comparison group - in 91% (p <0.05). Selection of lactate-producing microflora is confirmed in 100% of cases in patients of the proposed method of treatment and in 95% of cases in the comparison group (p <0.05).

Example 1

Patient U. Over the past week, the appearance of soreness in the genital area, distressing from the genital tract, itching. On clinical examination, there is hyperemia of the vaginal mucosa, detachable gray-yellow, odorless; microscopy shows an increased number of leukocytes, a diverse bacterial and coccal flora; bacteriological examination revealed the presence of Staphylococcus aureus (10 ⁹ CFU / ml). Diagnosed with acute bacterial vaginal infection (aerobic vaginitis). A five-day course of the above complex of drugs (Tantum Rose, candles Bifilis and Synthomycin) has been prescribed. After the course of therapy, improvement was noted during the first day, the complete disappearance of symptoms on the third day. In a control study, complete restoration of vaginal microflora was noted. For six months, the patient with similar symptoms did not seek medical help.

Example 2

A young woman G., 20 years old, complained of moderate discharge from the genital tract, burning sensation, pain during sexual intercourse, consulted a dermatovenerologist. These symptoms are disturbing for two weeks. After a clinical and laboratory study, a diagnosis of acute vaginal infection (aerobic vaginitis) is made. A course of seven-day therapy with the Tantum Rose vaginal douching method was carried out twice a day, then by intravaginal administration of Bifilis suppositories twice a day and at night by Syntomycin suppositories. The patient notes an almost complete recovery on day 4-5 of the treatment. A follow-up examination showed: the absence of any signs of inflammation, microscopically - 1-2 leukocytes in the field of view, rods, the bacteriological culture revealed a sufficient amount of lacto- and bifidoflora, at least 10 ⁵ CFU / ml. Conclusion: the state of convalescence has been reached.

Thus, the use of the proposed method of combining antibacterial and biological product for local sanitation of the vulva and vagina allows, in comparison with the prototype method, to prolong the period of remission in patients with acute vaginitis, to prevent relapse, to quickly stop unpleasant symptoms of the disease, including pain, to normalize the flora the vagina. In addition, the proposed method for the treatment of acute forms of bacterial vaginitis, in contrast to oral and intramuscular administration of the same drugs, does not cause many side effects of nausea, headache, anorexia, etc.

Claims (1)

A method of treating acute forms of bacterial vaginitis by pretreatment of the vagina and subsequent local administration of the drug substance, characterized in that the vagina is treated with Tantum Rose solution in an amount of 30-50 ml before each subsequent local drug administration of the drug substance, and the drug treatment is carried out for 5- 7 days: in the morning and in the afternoon candles “Bifilis” are administered, and at night - “Synthomycin” candles.