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INVENTION
Russian Federation Patent RU2140270

METHOD OF TREATMENT the idiopathic type of Kaposi's sarcoma

METHOD OF TREATMENT the idiopathic type of Kaposi's sarcoma

Name of the inventor: Milk VA .; Chilingirov RH .; Molochkov AV
The name of the patentee: Moscow Regional Research Clinical Institute
Address for correspondence: 129110, Moscow, ul.Schepkina, 61/2 MONICA, Patent Group
Starting date of the patent: 1998.11.26

The invention relates to medicine, namely to dermatology. It is proposed for the treatment of idiopathic type of Kaposi's sarcoma prospidina introduction of pre-amplified microcirculation in the direction of the lymphatic system. Then prospidin lymphotropic administered at a dose of 50-150 mg every other day, 10-15 injections per course of treatment. Additionally rectally administered drug recombinant interferon - "viferon" ME 500000 dose 2 times a day for 30 days. The proposed method provides a long-term remission, 6-7 times the duration of remission after treatment according to known methods.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, namely to dermatology.

A method of treating Kaposi's sarcoma introduction vinblastine (see "Treatment of Kaposi's sarcoma with vinblastine" -. Cancer, 1980, vol 45, p 427 -.. 431).

The disadvantage of this method is the presence of significant side reactions, since the cytostatic effect of the drug is combined with immunosuppressive - inhibited proliferating lymphoid tissue. The drug inhibits the lymphatic, erythromycin, and trombotsitopoez. If its application is often noted dizziness, nausea, discomfort in the digestive tract. A major shortcoming of vinblastine should consider it a small breadth of therapeutic action. Lacking epidermotropizmom, it does not provide long-term remission in Kaposi's sarcoma.

Known and method for treating Kaposi's sarcoma, comprising administering intravenously a pharmaceutical composition comprising a compound of the family of drugs that block receptors of morphine and a second compound that facilitates penetration of the first cells in the human body (endorphin and enkephalin group). (French Patent N 92/15281, IPC A 61 K 9/08, publ. 1992).

A disadvantage of the method is to block morphine receptors whole body, including the cerebral cortex, endocrine glands, hypothalamus, since action of the pharmaceutical composition does not have selectivity for a tumor. Taking into account the effect of trigger endorphin and enkephalin and their impact on the biochemical homeostasis of the organism, may cause side effects such as weakness, uncontrollable surges in blood pressure, disorders of the central and peripheral nervous system, gastrointestinal tract.

The closest to the claimed is a method of treatment of Kaposi's sarcoma including the introduction of a comprehensive treatment prospidina and other drugs, namely, vincristine and prednisolone on the developed scheme (see. Kalamkaryan AK et al. Kaposi's sarcoma. M .: Nauka, 1986, p. 95).

The disadvantage of this method is the presence of side effects, such as inhibition of leukocyte, erythrocyte and trombotsitopoeza; the appearance of general weakness, headache, nausea, low blood pressure. The presence of paresthesias, expressed in onemeneii fingers and toes, face, tip of the tongue, the occurrence of cystitis. Combination chemotherapy causes significant immunosuppression, when a sharp lifting of corticosteroids may develop "withdrawal symptoms" after treatment.

The task set by the authors, is to eliminate these disadvantages by carrying out complex pathogenetically substantiated therapy.

It is proposed for the treatment of idiopathic type of Kaposi's sarcoma, which includes a comprehensive treatment administration prospidina pre-amplified microcirculation in the direction of the lymphatic system, and prospidin enter lymphotropic at a dose of 50 - 150 mg every other day, 10 - 15 injections per course of treatment, and rectal administration of recombinant interferon drug a 2B " viferon "at a dose of 500,000 IU 2 times a day for 30 days.

In recent years, a high degree of confidence is set etiological agent involved in the development of Kaposi's sarcoma - human herpes virus type 8 (HHV-8). It is shown and a significant reduction in patients with idiopathic type of Kaposi's sarcoma Interferon production by lymphocytes and a U in response to specific inducers like in vitro, and in vivo. In the serum of patients with all types of Kaposi's sarcoma (KS) and found high levels of abnormal acid-interferon a.

These data need to be included in the complex therapy of the idiopathic type of Kaposi's sarcoma antiviral and immunostimulatory drugs. It is known that immunomodulators are interferon preparations affecting differentiation processes, recruiting, and a functional activity of effector cells of the immune system and particularly T-lymphocytes and monocytes / macrophages. Under the action of interferons, increases the efficiency of the immune antigen recognition and enhanced phagocytic and cytolytic function, aimed at the elimination of the pathogen or the antigenically altered cells.

Designed recently drug "viferon" to reduce the daily dose of interferon after a single dose and prolong its action. The composition includes viferona Membrane preparations - Antioxidants - vitamins C and E in therapeutically effective doses. This enhances the antiviral and immunomodulatory activity of the drug in 10 - 14 times compared to its predecessor - reaferonom. The dosage form of the drug - rectal suppositories and reduces adverse reactions typical for parenteral administration of interferon preparations, such as fever, flu-like symptoms; and, moreover, gives a new drug pharmacokinetic properties: compared with titers in serum IFN blood of healthy volunteers after intravenous, intramuscular and rectal administration of recombinant antioxidant It noted that when administered 1 Mill. rectally IU IFN titer in serum IFN exceed such as in intravenous or intramuscular administration of 2 Mill. IU IFN.

When Kaposi's sarcoma occur proliferative disorders of the lymphatic endothelial cells. For this tumor tissue characterized by increased collagenase activity which is capable of extracellular collagen cleavage, causing tumor growth and invasion. Administering to a patient in epidermotropnogo cytostatic prospidina lymphatic system creates and maintains a long time a high concentration of the drug in surrounding and distant organs, thereby suppressing the proliferation of tumor cells and inhibition of mitotic activity.

Thus, the proposed method combines the impact on the causative agent of the disease and its pathogenic mechanisms.

The method is as follows

The patient is in a horizontal position on his stomach; on the border of the lower and middle third of the leg on its dorsal surface of subcutaneously injected 32 units. lidazy dissolved in 3-4 ml of 0.25% solution of novocaine to enhance microcirculation in the direction of the lymphatic system; after 4-5 minutes without removing the needle, the other syringe prospidina solution administered in a dose of 100 mg; course of treatment consists of 15 injections every day (one at each lower leg) - prospidina course dose - 1.5 g possible and to enhance microcirculation in the direction of the lymphatic system apply a tourniquet to the area of ​​the distal third of the femur for 1.5 hour, creating a pressure of 35 - 40 mm Hg. v., followed by syringe prospidin solution administered in a dose of 100 mg.

Viferon used in rectal suppositories in the dose of 500,000 IU 2 times a day for 30 days.

Through the course of treatment carried out in patients with significantly improved interferon status, achieved long-lasting clinical remission. Treatment prevents complications and easy to carry.

Example 1. Patient J. (ist. Bol. Of N 1027), 68 years, Bole 62 years of age, when the skin of the right foot saw the appearance of red spots the size of 0.3 x 0.5 cm, accompanied by subjective sensations. During the year, the spot grows in size, joined tight swelling of the right foot, new foci in the left calf, then the process spread to the foot. Three years after the onset of the disease on the skin of the left lower leg started to appear hemispherical nodules form a red-brown color. When a common pathological process, symmetrical, represented by the red-cyanotic patches and plaques irregular shapes ranging in size from 1 x 2 to 5 x 7 cm, which were located on both lower extremities, nodules hemispherical shape with a diameter of 0.5 to 1 cm on the left shin, patches of pale red color up to 1 cm on the forearms. In the area of ​​the stop - dense edema, swelling of the skin over the area is sealed, infiltrated, brownish-black with peeling. Movement in both ankles limited due to edema. In the study of interferon status showed a reduction in virus-induced activity of the interferon alpha to 4.21% of the norm, interferon gamma - up to 8.88% of the norm. Ultrasound examination of internal organs revealed no pathology. Clinical diagnosis - idiopathic type of Kaposi's sarcoma, Stage 1.

Started on Lydasum lymphotropic administration prospidina shin at 100 mg per injection every other day - in the course of 1.5 g and the introduction of rectal suppositories 500,000 IU viferon on 2 times a day - in the course of 30 million IU.

On the 5th day from the start of treatment was decreased intensity staining lesions. On the 9th day was a decrease in swelling of feet, on the 15th day - the flattening of the nodules and plaques, recovered movement in the ankle joints. On the 30th day - spots in both feet and legs pale purple, their number has decreased; individual plaque up to 2 x 3 cm; on the left tibia much uplostivshiesya nodules. No swelling, joint motion in its entirety. In the control study of interferon activity indicators virus-induced interferon alpha status rose to 33.65% from the norm, and interferon gamma - up to 44.44% of the norm. When viewed within 12 months of exacerbation of the disease were observed.

Example 2. Patient A. (ist. Bol. Of N 3659), 27 years old. Ill about 2 years ago when I first noted discomfort in swallowing. After 1 month for no apparent reason in the left fossa mindalikovoy noticed node purple color measuring 1 x 1.5 cm. The neoplasm grew rapidly, and therefore the patient asked the oncologist, where after histological examination of the node was diagnosed Cheka. The tumor was surgically removed, but after 2 months relapse occurred - at the same place there was a painful knot purple color size of 1 x 2 cm on the subject received radiotherapy blizkofokusnuyu that gave krotkovremenny only effect is to reduce the size of the tumor. At 3 months, the tumor continued to grow. At the time of treatment (1 year after the onset of the disease), in the left mindalikovoy holes - assembly dome-shaped, purple-bluish color, tightly-elastic consistency, size 3 x 4 cm, with ulceration in the center that prevents swallowing. Clinical diagnosis - idiopathic type SK, the atypical form, step 2. In the study of interferon status - reducing virus-induced activity of the interferon alpha to 4.25% of the norm, interferon gamma - up to 8.88% of the norm.

The treatment lymphotropic on Lydasum introduction prospidina shin at 100 mg per injection every other day - in the course of 1.5 g, and the introduction of rectal suppositories 500,000 IU viferon on 2 times a day - in the course of 30 million IU. After treatment education completely regressed when control study of interferon status indicators virus-induced activity of the interferon alpha rose to 36.23% from the norm, and interferon gamma - up to 48.74% of the norm. During 10 months of follow relapses did not occur.

The proposed method provides a long-term remission, 6 - 7 times the duration of remission after treatment according to known methods.

CLAIM

A method for treating idiopathic type of Kaposi sarcoma, comprising integrated treatment introduction prospidina and medications, characterized in that, before the introduction prospidina carried increased microcirculation toward lymphatic system, thus prospidin administered lymphotropic dose of 50 - 150 mg a day, 10 - 15 injections for the course treatment, and as a drug rectally administered interferon a 2B "viferon" at a dose of 500,000 IU twice daily for 30 days.

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Publication date 01.04.2007gg