INVENTION
Russian Federation Patent RU2144836

METHOD FOR THE TREATMENT OF CHRONIC LIVER DISEASES with carriage HBSAG low-intensity helium-neon laser irradiation of blood

METHOD FOR THE TREATMENT OF CHRONIC LIVER DISEASES with carriage HBSAG low-intensity helium-neon laser irradiation of blood

Name of the inventor: Radchenko VG .; Yermolov S. Yu .; Rusanov TV
The name of the patentee: Saint-Petersburg State Medical Academy
Address for correspondence: 195067, St. Petersburg, Piskarevskiy pr 47, St. Petersburg State Medical Academy.
Starting date of the patent: 1995.06.13

The invention relates to medicine and is intended for the treatment of patients with chronic liver diseases with the carriage of HBsAg. Previously a course glucocorticosteroid therapy daily for 9-11 days, after which the plasmapheresis is performed in an amount of 3-5 sessions with simultaneous fence 500-600 ml of plasma with an interval of 3 days. During plasmapheresis is performed in vitro irradiation of blood helium-neon laser through a disposable system for blood transfusion. The radiation power - 1.6 × 10 -3 watts. The power density of - 12,8 mW / cm 2. The exposure time - 40-45 minutes. Simultaneously with the beginning of plasmapheresis is performed outside the irradiation field of the right and left lobes of the liver, spleen, thymus, helium-neon laser for 9-11 days. Power density - 12.8 mW / cm. Irradiation power - 1.6 × 10 -3 watts. Outside laser therapy is performed on the background of the introduction of immunomodulatory drugs. The method allows to achieve greater efficiency and reduce blood NBsAg patients.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, in particular for the treatment of patients with chronic liver diseases carriage HBsAg.

A method of treating patients with chronic liver diseases HBsAg carriage c interferon, t. To. Interferon has antiviral activity by inducing the cells in a state reziotentnosti to viral infections, but also modulate the effectors of the immune system to a virus neutralization or destruction of affected cells to them. However, this drug is marked a number of significant shortcomings: unstable therapeutic effect / majority of cases relapse after adequate treatment accounted for the 4th month of the end of treatment /. This method has a number of contraindications: severe disorders of the kidneys, liver and hematopoietic system, chronic hepatitis in the background running decompensated cirrhosis, chronic hepatitis in patients treated shortly before immunosuppressive therapy, the presence of diseases of the cardiovascular system, epileptic disorder or other disorders central nervous system, increased sensitivity to interferon. Prolonged treatment / 6-9 months. /, The high commercial value of the drug. / SD Podymova Diseases of the liver. M .: Medicine, 1993, 247 c., F. Hoffman La Roche "Roferon-A in oncology and virology", 1993, Switzerland, 14 /.

A method of treating patients with chronic liver disease with HBsAg carrier state with adenine arabinoside and its derivatives / arabinoside monophosphate, acyclovir, vidarabine /. / SD Podymova Diseases of the liver. M: Medicine, 1993, 246 /. Under the influence of the drug in some patients observed reduction of viral DNA, DNA polymerases reactivity to serum, a decline of HBsAg, improvement of biochemical parameters. However, positive changes are short, unstable and after drug withdrawal process activity indices returned again to the stowed position level. When using these drugs have been a number of complications: myalgia, polyneuropathy, impaired function of the gastrointestinal tract, thrombocytopenia, which limits their use / AS Loginov largely Tsaregorodtseva TM, MM Zotin The immune system and digestive diseases. M .: Medicine, 1986, p 238 /.

A method of treating patients with chronic liver diseases with the carriage of HBsAg levamisole. In the treatment of notes, slight or moderate reaction of reduction of gamma globulin major classes of immunoglobulins, autoantibodies and circulating immune complexes. However, even if the three-year continuous treatment with levamisole saved persistence of HBsAg, although its concentration is greatly reduced. Occasional breaks in the treatment of some patients lead to a significant increase in rates of pathological process activity. and side effects, manifested neutropenia, fever, skin erythema, headache restricts the use of levamisole / Loginov AS, Tsaregorodtseva TM, MM Zotin The immune system and digestive diseases. M .: Meditsina, 1986, p. 234-235. Podymova SD Diseases of the liver. M .: Medicine, 1993, p.151 /.

A method of treating patients with chronic liver disease with HBsAg carrier state by repeated intradermal BCG vaccine has led to a significant proportion of cases to positive clinical and laboratory dynamics, and in some cases the disappearance of the persistence of the virus in the blood serum. Among the shortcomings of this method is the low efficiency of basic therapy / 36% /. / ZG Aprosina Chronic active hepatitis as a systemic disease. M .: Meditsina, 1981, p. 233 /.

A method of treating patients with chronic liver diseases with the carriage of HBsAg using immunosuppressive drugs - prednisone. Under the influence of prednisolone happening replication of hepatitis B virus reduction B. However, under the influence of glucocorticoids is amplified DNA in the serum polymerase activity, and glokokortikosteroidy inhibit macrophage function that delays the elimination of the virus from the body / SD Podymova Diseases of the liver. M .: Meditsina, 1993, p. 247 /.

As a prototype for the closest the technical essence we selected a method of treating patients with chronic liver disease with carriage of HBsAg using a low-intensity laser irradiation of blood. Under the influence of the laser radiation, the inactivating effect on viruses / Gurzazyan GG Nigosyan DN, PG Kryukov, "The mechanism of action of the laser and the inactivating UV radiation on viruses and bacterial plasmids. Biophysics, 1981, Vol. 26, issue 4, with 659 -. 663 /, which has a positive effect on the clinical course of chronic liver disease of viral etiology, provides the normalization of liver function tests / Dzhashiashvili VI Efficiency helium-neon laser in liver cirrhosis Abstract Ph.D. diss.... , Tbilisi, 1991 /. However, the resulting changes in brief, in some cases there is the activation process in the liver, which largely restricts the use of low-intensity laser radiation in the treatment of chronic liver diseases with the carriage of HBsAg.

The object of the invention to provide a method of treatment, the effectiveness of therapy by enhancing elimination of HBsAg organism.

This object is achieved by the fact that in the known method of treatment of chronic diseases of the liver with the carriage of HBsAg low-intensity helium-neon laser irradiation of blood previously carried glucocorticosteroid therapy with prednisolone at a dose of 60 mg intravenously daily for 9-11 days, after which the plasmapheresis is performed in an amount of 3- 5 sessions with simultaneous fence 500-600 ml of plasma with an interval of 3 days. During the irradiation of blood plasmapheresis carried helium-neon laser irradiation power - 1.6 × 10 -3 W, irradiation density - 12.8 mW, exposure time - 40-45 minutes. Simultaneously with the start of irradiation of plasmapheresis is performed outside the area of ​​the right and left lobe of the liver, spleen, thymus, helium-neon laser for 20-25 seconds daily for 9-11 days, irradiation density - 12.8 mW irradiating power - 1.6 W × 10 -3, and the outer laser therapy performed during administration of immunomodulatory drugs / timalin T-activin / dose 10 mg daily intramuscularly in an amount of 9-11 days.

The present method of treatment was used in 7 patients with chronic liver disease carriage of HBsAg. As an example, are extracts from case histories.

Example 1.

Case history N 20455, Patient P., 45 years. Diagnosis: HBsAg. Micronodular cirrhosis, active, subcompensated, with signs of portal hypertension and hypersplenism, ascites. Sick for 3 years. Repeatedly treated in therapeutic hospitals, without effect. Objectively: the patient's condition is relatively satisfactory, liver protrude from under the costal arch by 4 cm, the spleen is palpated. In analyzes: total protein - 65 g / l, albumin - 38%, sulemovaya sample - 1.5 ml, ALT - 1.66 mmol / L, bilirubin- 26.5 mmol / L, erythrocyte sedimentation rate - 31.1 mm / hour CEC - 0.680. Spent treatment: Festal, Reglan, triampur. The patient within 10 days of receiving daily intravenous prednisolone 60mg, whereupon plasmapheresis carried out in an amount of 3 sessions simultaneously fence to 1 liter of blood and plasma elimination of 400-450 ml every 3 days during the irradiation of blood was carried out plasmapheresis helium-neon laser radiation power - 1.6 × 10 -3 W, irradiation density - 12.8 mW, irradiation time - 40 min, simultaneously with the beginning of the plasmapheresis external irradiation was performed right and left lobe of the liver, spleen, thymus helio- neon laser for 20 sec for 9 days exposure density - 12.8 mW emission power - 1.6 × 10 -3 Wt. Outside laser therapy was performed on background thymalin intramuscular injection at a dose of 10 mg for 9 days. After the therapy, the patient's condition has improved, decreased weakness. In analyzes: total protein - 65 g / l, 52% albuminy-, selemovaya sample - 2.0 ml, ALT - 0.25 mmol / L, bilirubin - 11 umol / L, erythrocyte sedimentation rate - 28 mm / h CEC-110. Of HBsAg, determined by ELISA, negative.

Example 2.

Case history N 10557. Patient G., 58 years old. Diagnosis: HBsAg. Chronic active hepatitis. If you receive complaints about the weakness, decreased performance, pain in the joints and the right upper quadrant. Bohlen about 2 years, repeatedly treated in therapeutic hospitals, without effect. Objectively: the state of moderate severity, icteric skin, bloating, liver protrude from under the costal arch to 3 cm thick on palpation. In assays: HBsAg / + / blood immunosorbent assay, total protein 80 g / l, albumin - 26% gamma globulin - 35%, ALT - 1.56 mmol / L, bilirubin - 82 umol / l, sulemovaya - 1 0 ml ESR - 40 mm / hour, 0,900-CEC. The patient was treated mezim forte, Reglan, vitamin B, for 11 days, the patient received in / tively prednisolone 60 mg, followed by plasmapheresis of 5 sessions with an interval of 3 days with simultaneous fence to 1 liter of blood and elimination 500-550 ml of plasma, during the irradiation of blood plasmapheresis carried helium-neon laser, radiation power - 1.6 × 10 -3 W, the radiation density - 12.8 mW, exposure time - 45 minutes. Simultaneously with the beginning of plasmapheresis conducted external irradiation of the right and the left lobe of the liver, spleen, thymus, helium-neon laser for 25 seconds for 11 days, radiation density - 12.8 mW output power - 1,6 × 10 -3 W, external laser therapy was performed in the background as / thymalin muscle injection at a dose of 10 mg for 11 days. After the therapy, the patient's condition has improved, has passed weakness, decreased pain in the right upper quadrant. The analysis: HBsAg, determined by ELISA, negative. Total protein - 80 g / l, albumin - 34% sulemovaya Sample - 1.2 ml, ALT - 1.0 mmol / L, bilirubin - 50 umol / l, ESR 35 mm / h, CRC 0.135.

Test Case

Case history N 199. Patient L., 45 years old. Diagnosis: HBsAg. Mikronodullyarny cirrhosis, active, subkompensipovanny, with signs of portal hypertension and hypersplenism. When you receive complaints: weakness, pain in the right upper quadrant, swelling in the legs. Bohlen 2 years, was treated in a variety of therapeutic hospitals. Objectively: the patient's condition is satisfactory, bloating, liver protruded from the costal arch to 3 cm thick on palpation, spleen palpable, says pastoznost lower extremities. In analyzes: total protein - 72 g / l, albumin - 35% gamma globulin - 37%, sulemovaya sample - 0.9 ml, bilirubin - 12 umol / L, ALT - 1.44 mmol / L, erythrocyte sedimentation rate - 20 mm / h. CEC 0.390. Spent treatment: triampur, vitamins B and the C, mezim forte, gomodez. Patients underwent intravenous blood irradiation of helium-neon laser, radiation power - 1.6 × 10 -3 W, irradiation time - 6 minutes, the number of sessions - 10, daily. Against the background of the therapy went weakness, pain in the right upper quadrant. The analysis: HBsAg, determined by ELISA, stayed positive, total protein - 72 g / l, albumin - 42% gamma globulin - 32%, ALT - 0.36 mmol / L, bilirubin - 8 mmol / L, erythrocyte sedimentation rate - 10 mm / h, the CEC - 0.198.

These extracts from case histories have shown that by using the proposed method can be more efficient in comparison with the prior art to treat patients with chronic liver disease with HBsAg carrier state of HBsAg clearance by the body.

In the inventive process, presented in Table 2, revealed the absence of HBsAg carrier state after the course of treatment, while in the prototype method after the course of therapy HBsAg carrier state, determined by enzyme immunoassay, is maintained. This prior art method is presented in Table 1.

CLAIM

A method of treatment of chronic liver diseases with carriage HBs Ag nizkointensivnym helium-neon laser irradiation of blood, characterized in that the pre carried course glucocorticosteroid therapy for 9 - 11 days after which carried plasmapheresis in an amount of 3 - 5 sessions at intervals of 3 days, during blood is irradiated with helium-neon laser irradiation power - 1.6 × 10 -3 Watt power density - 12.8 mW / cm2, irradiation time - 40 - 45 min, simultaneously with the start of irradiation plasmapheresis carried outside the right and left lobe of the liver, spleen, thymus, helium-neon laser for 20 - 25 daily for 9 - 11 days, the power density - 12.8 mW / cm 2, the irradiation power of - 1.6 × 10 -3 W, with outer laserotherapy carried out against the background of the introduction of immunomodulatory drugs.

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Publication date 28.03.2007gg