RU2389499C1 - Method of treating patients with hyperbilirubinemia - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly to gastroenterology, and concerns treatments of the patients with hyperbilirubinemia. That is ensured by conventional pharmacotherapy combined with oral introduction of hepabene in a dose 1 capsule 3 times a day at mealtimes from the first day of treatment. From the next day, intravenous introductions of ozonised physiologic saline of table salt in volume 200 ml with ozone concentration 500 mcg/ml and introduction rate 8-10 ml/min is applied. The course includes 6 infusions every second day. After that preparation Hepabene is continued in a dose 1 capsule twice a day at mealtimes during 7-10 days.

EFFECT: method provides effective decrease in bilirubin with reduced treatment time.

2 ex

Description

The invention relates to medicine, mainly to gastroenterology, and can be used to treat patients with diseases of the liver and extrahepatic bile ducts, accompanied by elevated levels of blood bilirubin.

Hyperbilirubinemia - an increase in the level of bilirubin in the blood of patients, clinically manifested by jaundice. Jaundice staining of the skin and mucous membranes is detected at a blood bilirubin level of 34.2 μmol / L and higher (B.I. Shulutko. Liver diseases. Clinical symptoms and syndromes. - St. Petersburg. - Publishing House of the St. Petersburg Medical and Hygiene Medical Institute. - 1993. - P.45). Hyperbilirubinemia significantly worsens the condition of patients. Due to endogenous intoxication, it causes pronounced general weakness and apathy, and also disrupts blood coagulation and leads to encephalopathy. Therefore, the elimination of hyperbilirubinemia is one of the urgent problems in the treatment of patients with diseases of the liver or extrahepatic bile ducts and liver failure.

The search for scientific, medical and patent literature has found various methods of treating hyperbilirubinemia.

So, in the work of OA Lefterova “Intensive therapy of newborn hyperbilirubinemia”. - Abstract. dis. Cand. - Saratov. - 1997. - 24 p. A method for the treatment of hyperbilirubinemia by using antioxidant drugs such as unitiol, vitamin E, as well as hyperbaric oxygenation sessions is described. The disadvantage of this method is the limited application of this method. In particular, hyperbaric oxygenation sessions cannot be performed for diseases of the ENT organs, certain lung and heart diseases.

In the article by I.V. Maev et al. “Benign hyperbilirubinemia” (Clinical medicine. - 1999. - No. 6. - P.9-14) and the monograph by SD Podymova “Diseases of the liver” (M .: Medicine. - 1993. - P.36-39) with the treatment of Gilbert’s hyperbilirubinemia, hyperbilirubinemia with Meilengraht’s syndrome, the drug phenobarbital 0.1 g 3 times a day for 2 weeks or benzonal drug - a modification of the phenobarbital molecule (see MD Mashkovsky “Medicines”. - M .: Medicine - 1993. - S.38) 0.1 g 3 times a day for a week. The disadvantage of this method is the side effect caused by these drugs, which manifests itself in severe drowsiness, weakness, apathy (radar "Encyclopedia of drugs." - 2004. - No. 11. - P.911).

In the work of I.V. Maev et al. "Benign hyperbilirubinemia" (Clinical honey. - 1999. - No. 6. - C.12) describes a method for the treatment of hyperbilirubinemia in type Krigler-Nayyar syndrome, which consists in phototherapy with blue light with a wavelength of 430-470 nm, supplemented by plasmapheresis exchange blood transfusion. In addition, the drug phenobarbital 30-180 mg for 2-4 weeks. The disadvantage of this treatment method is its complexity, low efficiency, laboriousness, and the use of phenobarbital causes the above side effects.

A known method of treating hyperbilirubinemia by intravenous infusion of ozonized physiological saline solution. This solution is administered daily at 400 ml with an ozone concentration of 200 μg / L for 5 days. In addition, rectal infusions of this solution are possible at a rate of 8-10 ml / kg body weight with an ozone concentration of 400 μg / l (A.Yu. Yakovlev et al. "The effectiveness of ozone therapy in the treatment of acute viral hepatitis. - Inform. Collection" Resuscitation and intensive care. Anesthesiology ". - 2000. - No. 4. - Appendix. - P.81). The disadvantage of the described treatment of hyperbilirubinemia is the low effectiveness of such therapy and, therefore, the long duration of treatment.

There is a method of treating hyperbilirubinemia by restoring the outflow of bile from the liver due to external or internal drainage of extrahepatic bile ducts, supplemented with a complex of medications (Yu.V. Ivanov, S. M. Chudnykh. "Mechanical jaundice: diagnostic algorithm and treatment." - The attending physician . - 2002. - No. 7-8. - P.76-78; MD Khanevich et al. "Treatment of obstructive jaundice of non-tumor origin." - Clinical prospects of gastroenterology, hepatology. - 2003. No. 1. - P.31 -34). The disadvantage of this method is the large invasiveness, as well as the relatively slow decrease in the level of hyperbilirubinemia after surgery, especially in the first days.

The “Method for the treatment of neuronal hyperbilirubinemia” has been published (application for invention No. 2002101159, publ. Bulletin No. 26, 2003), providing for the use of basic drug therapy and additional exposure of the child’s liver region with continuous infrared laser radiation in combination with a constant magnetic field with energy density of radiation per 1 session D = 0.66 J / cm ² and 0.99 J / cm ² . The course of treatment consists of 5 sessions of 60 seconds for premature babies and 90 seconds for full-term babies. The disadvantage of this method is its low efficiency, since under the influence of this irradiation bilirubin isomers not associated with glucuronic acid are formed (I.V. Maev et al. "Benign hyperbilirubinemia". - Clinical honey. - 1999. - No. 6. - P. 12 )

The well-known "Method for the prevention of liver failure in patients with obstructive jaundice in the postoperative period" (application for invention No. 2004107707, publ. Bull. No. 25, 2005). The essence of the method is that they carry out drug treatment and additionally carry out intravenous infusion of physiological saline solution saturated with ozone to a concentration of 270 μg / L. The disadvantage of this method is its low efficiency and, as a consequence, the long duration of treatment.

A “Method for the treatment of hyperbilirubinemia in patients with calculous cholecystitis without impairing the outflow of bile through the common bile duct” is described (RF patent No. 2252715, publ. Bull. No. 15, 2005), for the implementation of which external drainage of the common bile duct through the cystic duct stump is performed. The disadvantage of this method is its great invasiveness and the duration of treatment of hyperbilirubinemia.

The closest technical solution, taken as a prototype of the claimed invention, is a method for the treatment of hyperbilirubinemia described in the work of V.N. Katyukhin et al. “The use of medical ozone in the complex treatment of chronic parenchymal liver diseases” (Nizhny Novgorod medical journal - 2003. - Appendix. - P.88). The essence of the method, taken as a prototype, is that for the treatment of hyperbilirubinemia, patients are prescribed conventional medication and intravenous administration of ozonized physiological saline solution. Conventional drug therapy includes the appointment of hepatoprotectors, detoxification and metabolic agents, vitamin C, B vitamins, as well as antioxidant drugs. Intravenous administration of 400 ml of ozonized physiological saline solution, with an ozone concentration of 800 μg / l, is carried out daily for the first 5 days, and then every other day. The course of treatment is 10-12 intravenous infusions. In this case, a decrease in the total bilirubin content to 50-60.0 μmol / L occurs in 19.0 ± 2.0 days. The disadvantage of this method is the lack of effectiveness of such treatment and, therefore, the long duration of treatment.

The aim of the present invention is to reduce the treatment time for patients with hyperbilirubinemia. This goal is achieved in that patients from the first day of treatment, in addition to conventional drug therapy, are prescribed oral administration of the hepatene preparation 1 capsule 3 times a day with meals. From the next day of treatment, every other day, intravenous injections of 200 ml ozonized physiological saline are started with a zone concentration of 500 μg / l and an injection rate of 8-10 ml / min in an amount of 6 infusions. After the end of intravenous administration of an ozonized solution of sodium chloride, ingestion of the hepabene preparation is continued for 7-10 days, 1 capsule 2 times a day with meals.

Hepabene (registration number: P N 012369/01) has a normalizing effect on bile secretion, eliminates spasm of the bile ducts, facilitates the flow of bile into the intestines, binds free radicals in the liver tissue, has an antioxidant and stabilizing membrane effect, restores the structure of liver cells, and improves the synthesis of proteins in them (Vidal Handbook, 2003. - M .: AstraFarmService. - 2003. - S. B-335-336). It is important that, along with the normalizing effect on hepatocytes, this drug improves the outflow of bile into the intestine, so necessary to reduce the severity of hyperbilirubinemia, since only in this way is bilirubin excreted from the body.

Detailed description of the proposed method

Patients with hyperbilirubinemia from the first day of treatment, in addition to conventional medication, are prescribed hepabene 1 capsule 3 times daily with meals. From the next day of treatment, every other day, intravenous administration of ozonized physiological solution of sodium chloride is carried out. This solution is prepared immediately before intravenous infusion using an ozonizer, for example, the UOTA-60-01 Medozon unit by connecting to it a bottle containing 200 ml of sterile physiological saline solution. During ozonation of this solution, the level of its saturation with ozone is periodically monitored using an analyzer available in the ozonizer. While this solution is saturated with ozone, an infusion system, such as KDM, is prepared for intravenous administration. A saline solution saturated with ozone up to a concentration of 500 μg / l is injected intravenously every other day, at a rate of 8-10 ml / min, in a volume of 200 ml. For treatment, 6 similar intravenous infusions are used. At the end of the intravenous infusion of the ozonized sodium chloride solution, the oral administration of the hepabene preparation is continued 1 capsule 2 times a day with meals for 7-10 days. The practical implementation of the proposed method is illustrated by the following examples.

Example 1. Tv, 61 years old, suffers from Gelbert's disease from adolescence. In connection with family circumstances, there was a pronounced psycho-emotional stress, a restriction in nutrition. He turned to the city polyclinic №1 of the city of Rostov-on-Don with complaints of severe weakness, fatigue, icteric staining of the skin. Examined by an infectious disease doctor - infectious hepatitis is excluded. Blood tests were taken for bilirubin, aminotransferase and alkaline phosphatase. Total bilirubin 56.8 μmol / L (normal 8.35-20.6 μmol / L), alanine aminotransferase (ALT) 0.24 μmol / L / h (normal 0.1-0.6 μmol / L / h) Aspartate aminotransferase (ACT) 0.28 μmol / L / h (normal 0.1-0.6 μmol / L / h), alkaline phosphatase 124 units / L (normal 98-279 units / L). The patient, according to the claimed method, was prescribed conventional medication: vitamin C (ascorbic acid) 5.0 ml of 5% solution once a day intramuscularly, the drug compliments 1 capsule daily after meals, livolin 1 capsule 3 times daily during meals, no-shpa, 0.04 g 3 times a day before meals. In addition, from the first day of treatment, the patient was prescribed hepatabine 1 capsule 3 times a day with meals. From the second day of treatment, intravenous infusions of 200 ml of ozonized physiological saline solution with an ozone concentration of 500 μg / l and an infusion rate of 8-10 ml / min were started. These infusions were carried out every other day. After 6 intravenous injections of ozonized physiological solution of sodium chloride, the patient continued to take hepabene, 1 capsule 2 times a day, during meals for 7 days. By this time, hyperbilirubinemia was eliminated: the total bilirubin level in the patient's blood decreased to 18.2 μmol / L. From the first days of the treatment, the patient felt cheerfulness, a surge of strength. Jaundice staining of the skin gradually decreased. By the end of treatment, i.e. after 19 days from the start of treatment, the phenomena of general weakness and fatigue, as well as icteric coloration of the skin and sclera of the eyes have passed. The patient was discharged to work.

Example 2. B-naya B-a, 65 years old (IB No. 13202/825) was operated on for acute phlegmonous cholecystitis, choledolithiasis, obstructive jaundice. After surgery, the phenomenon of hyperbilirubinemia increased. Total blood bilirubin by the 4th day of the postoperative period increased to 70.24 μmol / L. Given this increase in the severity of hyperbilirubinemia, the patient from 5 days after surgery was prescribed treatment according to the proposed method. Common treatments included Mexidol 2.0 ml 2 times a day intramuscularly, Essential Forte 5.0 ml intravenously once a day, Vitamin C (ascorbic acid) 5.0 ml 5% solution once a day intramuscularly, Vitamin B1 (thiamine bromate 6% 1.0 ml) 1 time per day intramuscularly, vitamin B6 (pyridoxine hydrochloride 5% 1.0 ml) 1 time per day subcutaneously, burden 2.0 ml subcutaneously 2 times per day, intravenous administration 10.0% glucose 800.0 ml with insulin. Simultaneously with this therapy, on the 5th day after surgery, the patient began to take hepabene 1 capsule 3 times a day with meals. From the next day, intravenous administration of ozonized physiological saline solution was started according to the proposed scheme. At the end of 6 intravenous infusions of ozonized physiological saline, the patient continued oral administration of the hepabene preparation 1 capsule 2 times a day for 10 days. By the 22nd day, there was no treatment for jaundice of the skin and mucous membranes, the total blood bilirubin decreased to 20.25 μmol / L.

The developed treatment method was applied in 6 patients. The average duration of treatment of patients until the elimination of hyperbilirubinemia was 20.50 ± 2.60 days. While in the treatment according to the method of the prototype for 19 ± 2.0 days, a decrease in the level of total bilirubin occurred to 50-60 μmol / L. Thus, the proposed technical solution leads to a faster decrease in the level of hyperbilirubinemia and reduces the treatment time for these patients.

Claims (1)

A method for the treatment of patients with hyperbilirubinemia, including conventional drug therapy and intravenous administration of an ozonized physiological solution of sodium chloride, characterized in that patients are additionally prescribed 1 capsule 3 times daily with food from the first day of treatment with food, from the next day of treatment, intravenous administration of ozonized physiological saline solution in a volume of 200 ml with an ozone concentration of 500 μg / ml and an injection rate of 8-10 ml / min every other day amount of 6 infusions, after this, the hepabene preparation is continued 1 capsule 2 times a day with meals for 7-10 days.