RU2185843C2 - Method for treating diseases of liver and biliferous ducts - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves applying basic pathogenetic therapy involving administering a preparation at a dose of 15 drops per one table spoon of water at room temperature 20-30 min before taking meals during 3-4 weeks in the cases of biliferous ducts dyskinesia, cholestatic syndrome and delayed recovery of functional hepatic tests. EFFECT: enhanced effectiveness of treatment. 2 tbl

Description

 The invention relates to medicine and is intended for the treatment of internal and infectious diseases.

Therapy of liver diseases, including hepatitis, includes the following known means of pathogenetic syndromic therapy (Sorinson S. N., 1996): detoxification (5% glucose solution, saline, hemodesis), hepatoprotective (vitamins A, C, B ₁ , ₂ , ₁₂ , rutin, potassium orotate, riboxin, heptral, essential forte, carlsil), anti-inflammatory (indomethacin, antibiotics), hemostatic (vikasol, calcium preparations, ascorbic acid), immunocorrective (GCS, immunoglobulin, thymogen), antispasmodic (papaverine, but- na) and cholagogue - zhelchesoderzhaschie (allohol, liobil, holenzim) or vegetable preparations (Helichrysum flowers, corn silk, cholagogue charges flakumin, tanatsehol, holosas). Most often, highly targeted herbal preparations (cholekinetics) are included in the treatment regimen for liver diseases for the implementation of the choleretic effect.

 Given the variety of emerging pathogenetic syndromes with inflammation of the liver and biliary tract, drugs with combined action are being created in the world. So, there are known foreign means “Hepatofalk plant” (capsules for the treatment of acute and chronic liver diseases) and “Hepabene” (capsules for the treatment of biliary tract) [2], which are widely used to treat various liver diseases.

 The composition of the Hepatofalk Plant preparation includes extracts of the fruits of the Milk Thistle, grass and roots of the celandine root and rhizomes of the Tumeric Javanese (producer: Dr. Falk Pharma GmbH, Germany), the Hepabene product consists of extracts of the fruits of the Milk Thistle and the herb of the medicinal haze ( manufacturer: Merkle GmbH, Germany). However, these drugs do not have all the necessary properties for stopping various manifestations of diseases, and are also expensive drugs.

 For the prototype of the invention, we took the drug "Hepatofalk plant", which includes extracts of the fruits of the milk thistle, grass and roots of the celandine of the large and rhizomes of tumeric Javanese.

 The disadvantages of this tool include a narrow spectrum of biological activity (lack of sedative, immunocorrecting effect, insufficient severity of anti-inflammatory, antispasmodic properties). In addition, the bioavailability of tablet preparations containing substances based on the fruits of milk thistle, as a rule, does not exceed 20% compared with the liquid extract. The prototype also does not meet the requirements of pharmacoeconomics in terms of the cost of treatment for one patient (about 750 rubles).

 Given the traditionally good effect of herbal preparations on individual links in the pathogenesis of hepatitis, as well as the variety of emerging pathogenetic syndromes requiring drug correction, we previously created a new domestic complex herbal preparation Silibokhol [1] containing the following plant components and substances: milk thistle extract liquid not less than 200; yarrow grass of at least 3; chamomile flowers pharmacy not less than 5; coriander fruits not less than 2; dioica nettle leaves at least 5; knotweed grass at least 5; licorice root is not less than 10; lemon balm herb not less than 5; grass of a series of tripartite - not less than 3; calendula flowers at least 2; birch leaves at least 10; 40% ethyl alcohol up to 300.

The objective of the invention is to increase the effectiveness of the treatment of diseases of the liver and biliary tract
The problem solved by the invention is to use the drug "Silibochol" as a drug in the treatment of diseases of the liver and biliary tract.

 The cholekinetic effect of this drug is due to birch leaves, knotweed grass (avian highlander) and dioica nettle leaves. From the point of view of tactics for treating liver diseases, especially hepatitis, birch leaves and knotweed grass, containing flavonoids as the main biologically active compounds, compares favorably with other choleretic drugs (for example, Helichrysum sandwort) in that they combine pronounced cholekinetic properties and mild choleretic act. In addition, birch leaves, as well as leaves of the nettle dioica (multivitamin plant) favorably affect metabolic processes, which is important at the stage of rehabilitation of patients with hepatitis. The knotweed grass along with the above effects is shown as a medicinal raw material, the use of which is advisable against the background of various functional disorders in the digestive system that take place in the recovery period. For the anti-inflammatory effect of silibochol, such components as pharmacy chamomile flowers, yarrow grass and calendula flowers are responsible, moreover, in the first two plants the effect is caused by essential oil containing chamazulene and other terpenoids, and in the case of calendula, by a complex of biologically active compounds (carotenoids, flavonoids, saponins). Calendula flowers are also one of the most effective and mild immunocorrective components. Given the fact that in most liver diseases, including viral hepatitis, not only hepatocytes are affected, but also the immune system, the immunocorrective effect is enhanced by us using a three-part sequence herb containing a rich complex of biologically active substances (carotenoids, flavonoids, saponins, etc. .). The immunostimulating effect is also enhanced by the herb of lemon balm, which, in addition, provides a sedative and antiviral effect due to essential oil and phenylpropanoids, in particular rosmarinic acid. The antispasmodic effect of the Silibochol preparation is realized with the help of seed coriander fruits containing essential oil (linalool). Licorice roots play a special role in this composition: they provide choleretic, anti-inflammatory, immunomodulating and other properties, and also play the role of a solubilizer (due to the high content of glycyrrhizic acid) of biologically active substances of other plants.

 Thus, Silibochol combines hepatoprotective properties, as well as cholekinetic, anti-inflammatory, antispasmodic, immunocorrective and mild sedative effects, which are necessary in terms of tactics and strategies for treating liver and biliary tract diseases.

 These approaches are especially relevant in the case of chronic and acute viral hepatitis in the presence of biliary dyskinesia, chronic cholecystitis, the development of cholestatic syndrome, delayed recovery of functional liver samples. In this regard, a method for treating the liver and biliary tract is proposed, which is carried out as follows: along with pathogenetic therapy, the drug Silibochol is prescribed 15 drops per tablespoon of room temperature water 20-30 minutes before meals for 3-4 weeks.

 The claimed method of treating the liver and biliary tract is illustrated by the following examples.

 Example 1. Patient I., 58 years old, and / b 9791/1366, was admitted for treatment to the clinic of infectious diseases on the 9th day of illness, 5th day jaundice with complaints of general weakness, malaise, decreased appetite, yellowness of the skin and sclera, dark color of urine.

 He gradually became ill with increasing asthenovegetative (general weakness, malaise) and dyspeptic (loss of appetite, stooling) syndromes, from the 4th day of the disease the color of urine (the color of "dark" beer) and the color of the skin and sclera (yellowness) changed.

In the epidemiological history of intravenous injection and minor surgical intervention (panaritium) within the incubation period. An objective examination of the state of moderate severity, body temperature of 36.8 ^o C. Skin, sclera - icteric (icteric) In the lungs, vesicular breathing. Heart sounds are quiet, rhythmic, 64 beats / min, blood pressure 160 and 80 mm. Hg. Art. The abdomen is soft, painless. An increase in the liver by 2 cm, a dense-elastic consistency. The spleen is the lower pole.

Blood test from 07/10/98: Hb 110 g / l, Le 4,5 • 10 ⁹ / l, ESR 10 mm / h.

 Urinalysis: yellow, turbid, acidic, protein negative, sugar (+), bile pigments (+), flat epithelium - single in the field of view, Le 2-3 in the field of view, single oxalates in the field of view.

β-липопротеиды 12 г/л, тимол 19,7 ЕД, сулемовая проба 1,48 мл,

ПТИ 48,3%, АлАТ 16,5 ммоль/ч•л, глюкоза крови 11 ммоль/л.Biochemical study of blood serum

β-lipoproteins 12 g / l, thymol 19.7 units, sublimate assay 1.48 ml,

PTI 48.3%, AlAT 16.5 mmol / h • l, blood glucose 11 mmol / l.

 Clinical diagnosis: Viral hepatitis B, acute icteric form, moderate. Diabetes mellitus - type II.

 Treatment: table 5a-9, bed rest, Acesol 400.0 solution in a vein for 10 days drip, ascorbic acid solution 5% 5.0 in a vein for 10 days, riboxin solution 2% 1.0 in a vein, solcoseryl solution 2, 0, Essential Forte 5.0 into the vein, papaverine 2% 2.0 intramuscularly at night. Inside, lipoic acid is 0.2x3 times a day, folic acid is 0.001x3 times a day, diabetes is 1 tablet x2 times a day.

 Within 2 weeks the patient's condition improved: general weakness decreased, the skin lightened, urine became lighter.

 However, on the 17th day of the disease (the 10th day of stay in the clinic) there was a tendency to exacerbate the disease: ALAT 16.5 mmol / h l -> 23.4 mmol / h l, β-lipoproteins 12.0 g / l -> 17.7 g / l, and from the 24th day of the disease there were clinical signs of poor health: itching of the skin, heaviness in the right hypochondrium, bitterness in the mouth. An ultrasound study revealed signs of chronic pancreatitis, biliary dyskinesia of the hypomotor type. Fatty hepatosis II.

 In this regard, the drug "Silibokhol" was included in the destination list 15 drops x 3 times a day before meals. Over the next 2 weeks, without prescribing antibacterial and hepatoprotective therapy, the patient's condition improved: the pain syndrome disappeared, the color of the skin and urine normalized, he improved, general well-being, the size of the liver decreased, and along with clinical improvement, there was a good dynamics of biochemical parameters (Table 1 )

 Example 2. Patient R., 24 years old, and / b 13506/1992, was admitted for treatment to the clinic of infectious diseases with a preliminary diagnosis of acute viral hepatitis on the 3rd day of illness with complaints of jaundice of the skin and sclera, dark urine, light stool .

 Objectively expressed jaundice of the skin and sclera were observed. On the skin of the breast there are single vascular "stars", palmar erythema. In the lungs - vesicular breathing, no wheezing, heart sounds are loud, the rhythm is correct.

 The abdomen is soft, painless. The liver is palpated 2.0 cm below the edge of the costal arch, a dense consistency. The spleen is the lower pole.

Blood test from 09.30.99 g: Нb 138 g / l, Le 5.4 • 10 ⁹ / l, ESR 7 mm / h.

наличие синдрома цитолиза: АлАТ 22,5 ммоль/ч•л, незначительного холестаза (β-липопротеиды 4,8 г/л) и мезхенхимального воспаления (тимоловая проба 4,8 ЕД).In the study of functional liver samples revealed a violation of pigment metabolism:

the presence of cytolysis syndrome: AlAT 22.5 mmol / h • l, minor cholestasis (β-lipoproteins 4.8 g / l) and mesenchymal inflammation (thymol test 4.8 IU).

 Urinalysis: 1.015, protein traces, epithelium 1-2 in the field of view, Le-15-19-21 in the field of view.

 The absence of a disease cycle, the absence of an infectious-toxic syndrome, as well as the recording of objective examination data: a tight liver texture, biliary signs, a history of blood transfusion (4 years ago), the presence of antibodies to HCV in the blood (total) (ELISA) made it possible to diagnose : chronic viral hepatitis C (antiHCV +) with a moderate degree of activity of the process. Concomitant disease: gastric ulcer, remission. Chronic cholangitis, cholecystitis, remission. Chronic pyelonephritis, exacerbation. Confirmation of the diagnosis was reflected during an additional examination: according to ultrasound, the structure of the parenchyma is heterogeneous, unevenly compacted, echogenicity is increased, the gall bladder with thickened walls, parietal sediment. The spleen is enlarged. When scintigraphy marked diffuse changes in the liver, blood flow with a tendency to decrease.

 The patient was prescribed basic therapy: glucose solution 5% 400.0 in a vein drip, solution of ascorbic acid 5% 5.0 in a vein, physiological solution 400.0 in a vein drip, benzylpenicillin sodium (due to exacerbation of pyelonephritis).

 The improvement of pigment metabolism occurred quite quickly, but in terms of mesenchymal inflammation and cholestatic syndrome, the tendency to increase continued. By the end of the second week, Silibochol was added to the basic therapy 15 drops x3 times a day before meals. After 2 weeks, the color of the skin and urine returned to normal, the size of the liver decreased, and all functional liver tests became close to normal (Table 2). The patient was discharged in satisfactory condition.

 The claimed method using the Silibochol drug treated 16 people, and in the case of the control group, the therapy was carried out using the Hepatofalk Plant agent. The following results were noted: the use of Silibochol with the use of Hepatofalk Plant means helps to reduce the period of jaundice, more quickly reduce the size of the liver and restore its functional tests, especially against the background of cholestatic syndrome.

Thus, clinical trials of Silibochol showed:
1. The use of Silibochol, which has a wide spectrum of biological activity (hepatoprotective, cholekinetic, anti-inflammatory, antispasmodic, immunocorrective and mild sedative), for the treatment of inflammatory diseases of the liver and biliary tract increases the effectiveness of treatment due to the combined effect on various pathogenesis links.

 2. Silibochol is indicated in the treatment of diseases of the liver and biliary tract, including acute viral and chronic hepatitis, especially in the presence of biliary dyskinesia, chronic cholecystitis, the development of cholestatic syndrome, slow recovery of liver function tests.

 3. Economic calculations show that the cost of a course of treatment using Silibochol is about 10 rubles, which is significantly (75 times) cheaper than the similar indicator for the comparison drug - the foreign drug Hepatofalk Plant (750 rubles).

Sources of information
1. RF patent 2139722, 1999

 2. Reference Vidal. Medicines in Russia. - M .: Astra Farm Service, 1998.

Claims (1)

 A method of treating diseases of the liver and biliary tract, including acute viral and chronic hepatitis, including basic pathogenetic therapy, characterized in that in the presence of biliary dyskinesia, the development of cholestatic syndrome, delayed recovery of functional liver samples, Silibochol is prescribed to take 15 drops on a tablespoon of water at room temperature for 20-30 minutes before meals for 3-4 weeks.

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