Method for the treatment and prevention of recurrence of genital human papillomavirus infection

 

(57) Abstract:

The invention relates to medicine and can be used for the treatment and prevention of recurrence of genital human papillomavirus infection (RSI). Spend photodynamic therapy (PDT) by intravenous injection in the body of the photosensitizer “Photohem” followed by laser exposure. At this dose laser irradiation is 100-150 j/cm2. The cervical canal and/or the vaginal wall perform laser irradiation through a quartz fiber with a cylindrical diffuser. On the vaginal portion of the cervix and/or vaginal vault, and/or vulva and/or perianal area carry out laser treatment using quartz fiber, provided with a microlens. The method can reduce the likelihood of recurrences of HPV infection, to extend disease-free period, to improve the prognostic factors in relation to the flow of precancer, the initial forms of cancer, to be able to cure not only the clinical manifestations of the MBC, but subclinical and latent stages of the MBC, to avoid scarring of the tissues, to reduce the duration of treatment. 2 C. p. F.-ly.

The invention relates to medicine, namely to FNI papillomaviruses infection of the mucous membranes and the skin of the anogenital area (cervix, vagina, vulva, perianal area).

Currently known about a hundred different types of human papilloma virus (hereinafter HPV), of which a selected group of mucosal HPV (over 30 types), predominantly infecting the anogenital area.

There is a method of drug therapy of HPV, including the use of cytotoxic drugs (podofillina, podophyllotoxin, 5-fluorouracil) (L. A. Kolomiets, L. N. Urazova. Genital papillomavirus infection and cervical cancer // Tomsk, 2002). A common feature for known and proposed methods of treatment of HPV is the suppression of the synthesis of cellular and viral DNA. However, when using these drugs in 50-67% of cases 3 months after treatment, there are relapses and side effects in the form of moist contact dermatitis. The reason for this phenomenon lies in the absence of systemic antiviral effects on intracellular mechanisms of virus replication.

It is also known the use of HPV immune interferon treatment, causing the formation of virus protein that blocks viral replication, resulting in the surrounding tissues become resistant to this virus (the causative agent) and thus predot is of the genitals. // A guide for physicians. M, 2003). Factor hindering the achievement of the following therapeutic results is the following. When known variant treatment HPV often relapses in places primary lesions or on adjacent areas of the skin and mucous membranes, which indicates a lack of antiviral effect. In this regard, to maintain to the last resistance of the cells and achieve full cure requires prolonged and repeated introduction of interferon.

Known also use for the treatment of HPV-destructive method that causes cell necrosis: cryotherapy with liquid nitrogen, laser, electrosurgical excision of condylomas and chemical coagulation trichloroacetic acid. (Mikhailov, I., Maksimov, S. J., Novik Century. And. and other Comparative evaluation of some methods of treatment of genital HPV infection in women with different genotypes of the virus // Matters. The oncologist.-2000.- So 46 (3). S. 340-343). This method is most applicable when treating patients with a large number or wide area large persistent lesions in the form of genital warts. The necessity of removing the primary clinically apparent defeat by destroying patol the e effects do not affect multifocal lesions, having a hidden component in the latent and subclinical forms of the disease, do not stop the expression of the virus in the surrounding tissues, do not provide selective antiviral effects, as well as the elimination of latent viral infections that, in turn, can lead to onset of disease recurrence in a short period of time after removal of the primary pathological focus. The above circumstances are the reasons that impede the achievement of the following therapeutic results. In addition, the disadvantages of this method of treatment can be attributed to the need for anesthesia, prolonged swelling of the tissues, formation of scars.

Closest to the claimed invention by way of the same purpose is a method of treatment of manifestations papillomaviruses infection on the skin and mucous membranes, including crorepati with subsequent application to the lesions ointment with interferon containing dimethyl sulfoxide, ensuring sharing of interferon to the basal and parabasal layers of the epithelium (RF patent No. 2084202, publ. 20.07.97 bull. No. 20). Adopted for the prototype.

The disadvantages of this method is that impede the achievement of the following medical resub therapeutic effects on lesions;

- the need for for a long time several therapeutic sessions;

the inefficiency of the application in subclinical and latent forms of the disease;

- the impossibility of selective antiviral effect;

- possible side effects of immunomodulators when they overdose.

The claimed invention is directed to solving the problem of treatment and prevention of recurrence of HPV female genital organs in the various forms of genital human papillomavirus infection (clinical, subclinical and latent), identified in the course of cytological and/or histological control extended colposcopy, molecular-biological methods.

Use in clinical practice, the proposed method allows to reach several medical and economic results:

- significant reduction in the likelihood of recurrence of human papillomavirus (HPV);

- prolonged survival period;

- improvement of prognostic factors in relation to the flow of precancer, primary cancers of the cervix, vagina and vulva, perianal area, associated with HPV high risk

- possibility of cure not only klovach changes of tissues, what gives in the subsequent possibility of procreation vaginal delivery;

- reduced the duration of treatment;

- availability and low cost medications.

These therapeutic results by carrying out the invention are achieved due to the fact that just as in the known method, the treatment of genital human papillomavirus infection is carried out by removal of tumors. A feature of the invention is that removal of tumors is performed with the use of photodynamic therapy by intravenous injection into the body of a photosensitizer (hereafter FS) and subsequent diffuse laser action on areas of tumors. For the treatment of cervical and/or vaginal walls perform laser irradiation through a quartz fiber with a cylindrical diffuser, and treatment of the vaginal portion of the cervix and fornix of the vagina, vulva and perianal areas provide laser action using quartz fiber, provided with a microlens.

The invention consists in the following.

Intravenous FS is its selective accumulation in the cells, interweaving portion of the cervix, vagina, vulva and perianal skin area provides a uniform dose distribution to all cells affected by the virus. When this takes place directly phototoxic destructive, antiviral effect, leading to the destruction of HPV lesions, localized in all layers of cylindrical and stratified squamous epithelium to the basal and parabasal cell layers. The inventive method of treatment makes it possible impacts on multifocal lesions due to selective antiviral effect.

This circumstance makes it possible to use the proposed method in clinical, subclinical and latent HPV in recurrent human papillomavirus infection after previous treatment other therapies, as well as preventive measures for cancer of the cervix. At the same time in the body has the effect of activating the stimulation of immunocompetent cells without the use of immunomodulators. PDT, as pathogenetic treatment can significantly reduce the rate of recurrence and increase survival period, to avoid scarring of the tissue, provides the opportunity to implement a full generative function laser radiation with a capacity of 100-150 j/cm is optimal to avoid phototoxic damage unchanged mucosa and the skin, and as a consequence development of cicatricial changes. The method is effective in all cases of papilloma viral infection, regardless of the type of virus and the square of the mucous of the cervix, vagina, vulva and perianal skin area. The greatest efficacy in the treatment of HPV consider localization showed FS Photohem.

Specific to PDT HPV anogenital area drug “Photohem” is a laser with a wavelength of 630 nm.

The method is as follows.

When the Cytology of the cells with perinuclear enlightenment cytoplasm (koilocytes), the expanded colposcopy characteristic endoscopic pictures (fields atypical epithelium, atypical vessels, yadegarynia zone of proliferating leukoplakia, acutally epithelium), different types of HPV by PCR (polymerase chain reaction) provide therapeutic course of PDT. In darkened conditions intravenous “Photohem in the dose of 1.5-3.0 mg/kg of body weight. After 48 hours, which corresponds to a period of selective accumulation of the drug in the affected cells, hold the session of PDT. In the cervical canal of the cervix place a quartz fiber with a cylindrical distal end of a length of 3 cm and conduct a session l is vetoed length 1 see In this case, perform poleposition irradiation with the movement of the fiber in sequence, from the inner to the outer fix. Upon irradiation of the vaginal portion of the cervix and fornix of the vagina, vulva and perianal area session of laser irradiation is conducted quartz fiber, provided with a microlens, a few positions diameter of the light spot from 1.0 to 2.0 cm, depending on the area affected and the size of the body. The influence of the laser radiation is performed on the diseased areas and the surrounding unmodified tissue.

For the period 2002-2003 were treated 30 patients with clinical manifestations of human papillomavirus infection (HPV, cervical dysplasia and primary form of cervical cancer). All patients according to molecular-biological methods (PCR) diagnosed with genital HPV types is “low” (6, 11) and “high” (16, 18) cancer risk. Patients received PDT and the developed technique. As a result, dynamic observation periods ranging from 1 to 6 months according to cytological, histological studies, the expanded colposcopy, PCR in 92% of patients registered persistent absence of CSF. therapeutic effect of PDT HPV b research the expanded colposcopy, methods of molecular analysis (PCR).

Clinical examples

1. Patient A., 28 years. Clinical diagnosis of dysplasia severe cervical. HPV 16-18 type. In March 2002, during a routine inspection when testing on Papanicolaou (PAP-test) smear with Exo-endocervical revealed typical cytomorphological sign of human papillomavirus infection - koilocytes that gave rise to the further examination. When the expanded colposcopy of the cervix visualized acetic-white epithelium with the structure of gentle and rough mosaic in the form of plots of polygonal shape, demarcated reddish and bright red continuous lines, punctaria - reddish dots of different diameters located at unequal distances, and a single open gland with keratinization. When processing Lugol solution characterized by its uneven absorption. HPV testing onkotrone types by PCR HPV 16/18. Histological examination of the scraping of the cervical canal and biopsy of the vaginal portion of the cervix detected focal koilocytes, pockets of severe dysplasia with increased mitotic activity. Conducted a session of PDT cervical che the channel was performed using a quartz fiber with a cylindrical distal end of a length of 3 cm (1 position) the vaginal portion of the cervix using quartz fiber, provided with a microlens, and the diameter of the light spot of 1.5 cm (5 positions): the first position is Central due to exposure to the external OS, the rest is peripheral, in the clockwise direction. In both cases, the light dose was 150 j/cm2. Through 1-3-6-9 months installed cure HPV 16/18 types based on negative data cytological, histological studies, the expanded colposcopy, molecular analysis (PCR). The observed increase in immunological status of the patient, and lack of cicatricial changes of the cervical canal and the vaginal portion of the cervix.

2. Patient K., 48 years old. Clinical diagnosis: genital warts of the vulva. In April 2002, addressed to the gynecologist in occasion of itching of the vulva, pain during intercourse. When viewed at the entrance of the vagina revealed a single warty elevations grayish-white color and different size aisyastickney surface with a soft and free basis, not adherent to the surrounding tissues. When testing on Papanicolaou (PAP-test) revealed a typical cytomorphological sign of human papillomavirus infection - koilocytes. When g is CR revealed the presence of HPV low cancer risk - 6/11. Held photodynamic therapy of vulvar 48 h after intravenous injection of the photosensitizer “Photohem” in terms of polystannanes premises. Photodynamic therapy of vulvar were performed using quartz fiber, provided with a microlens, and a diameter of the light spot 2.0 cm (1 position), the light dose was 150 j/cm2. Through 1-3-6 months no condylomatosis rash at the entrance of the vagina, scarring of the vulva, the negative data Cytology, molecular analysis (PCR). In the study of the immunological status of the patient showed improvement.

Thus, the claimed method for the treatment and prevention of recurrence of genital human papillomavirus infection has significant advantages compared with the known compounds of the same purpose and meets the criteria of patentability.

1. Method for the treatment and prevention of recurrence of genital human papillomavirus infection, including photodynamic therapy (PDT), characterized in that the PDT is carried out by intravenous injection into the body of the photosensitizer “Photohem” followed by laser exposure, and the dose of laser irradiation is Li vaginal wall is carried out using a quartz fiber with a cylindrical diffuser.

3. The method according to p. 1, characterized in that the laser effect on the vaginal portion of the cervix, and/or the vault of the vagina and/or vulva, and/or perianal area is carried out using quartz fiber, provided with a microlens.

 

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