RU2585165C1 - Method of treating patients with complicated mechanical jaundice - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Bile is collected along external percutaenous drainage catheter. In a drying chamber “SNOL 58/350”, method includes sorbing, inactivation of infection in bile for 60-80 minutes at temperature +70-80 °C. Dry residue of bile is obtained by convective drying at temperature +50-55 °C for 7-8 hours. Dry residue is subjected to ultraviolet radiation for 30-60 s. Dry residue is then placed in gelatine capsules.

EFFECT: method provides return autobile to patients with biliary unit by oral administration of capsules, reduces drying bile simultaneous return bile can be used in respect to several patients in need of compensation of losses of bile and having contraindications.

1 cl, 2 ex

Description

The invention relates to medicine, namely to methods for treating patients with diseases complicated by obstructive jaundice and requiring minimally invasive endobiliary interventions in which there is a loss of bile outward with a complete block of biliary tract, and can be used to return bile to a patient. The invention can also be used to eliminate the phenomena of acholia, to ensure the enterohepatic circulation of bile acids, in case of digestion disorders in diseases of the biliary tract complicated by obstructive jaundice.

A.F. Grejev et al. (1976) proposes to compensate for the loss of bile by taking it through the mouth. Advantages: minimum cost of resources and labor to ensure the return of bile. Disadvantages: it is contraindicated in inflammatory changes in the mucous membranes of the upper gastrointestinal tract, as it independently leads to irritation of the mucous membrane of the stomach and esophagus. Change in the conditions of proteolysis in the stomach. Unpleasant sensations of the patient.

A known method for the return of bile to patients with diseases complicated by obstructive jaundice. The method consists in introducing a T-shaped tube into the common bile duct, in which the distal transverse branch is cut off. A thin catheter is inserted into the same bile duct opening, passing through the Oddi sphincter after dissection or stretching. This allows you to collect bile, freely flowing through a T-shaped tube, and enter through a catheter into the duodenum or after filtering, give the patient drink with beer 2-3 times a day after meals. A.N. Numez (1959). Advantage of the method: the creation of an outflow path simultaneously during surgery for choledocholithiasis. Disadvantage: Applicability only in the treatment of choledocholithiasis.

In 1971, E.G. Mnushkin describes a method for producing sterile bovine bile. Filtration of native bile through ceramic bacterial filters. Bacterial growth was observed in bile only before filtration. Physico-chemical analysis of bile before and after filtering it through ceramic filters shows its immutability. Advantage: the introduction of unchanged bile. Disadvantage: to ensure a long return of bile - the need for keeping bulls.

Kuznetsov V.A. et al. suggested bilio-digestive bypass surgery. The method consists in the fact that the patient simultaneously with external drainage of the biliary tract or with an existing external biliary fistula performs external drainage of the duodenum through microgastrostomy. The outer ends of the drains are connected with a tee, one of the holes of which serves for control studies, and a Morra clamp is applied to the duodenal drainage to regulate the lumen of the shunt. During the operation, a purse string suture is placed on the front wall of the antrum of the stomach, in the center of which an incision is made no more than 5 mm long, through which a tube is inserted into the lumen of the stomach and duodenum. The purse string suture is tightened. A tight channel 2-2.5 cm long is formed around the tube. The proximal part of the tube is led out through a separate puncture of the anterior abdominal wall at the beginning of the attachment of a round liver ligament to it. The drainage area between the stomach and the anterior abdominal wall is peritonized with a round ligament without dissecting its leaves. Then drain the biliary tract in one of the known ways. On the 4th – 5th day, the bile duct drainages and duodenum are connected with a glass tee [Kuznetsov V.A., Khasanov P.M., Knubovets S.Ya. Surgery. - 1982. - 6: 99-101]. The advantages of the method are that there is no need for the patient to drink bile, a direct return of bile to the duodenum is carried out. Disadvantages: the need for surgical intervention, the patient has another stoma, a possible infection of the biliary tract due to reflux. Inlay of the tube with duodenostomy bile salts and the need for its replacement and at intervals of 2-3 months.

V.G. Dudenas et al. (1987) proposed a spray drying method for bird bile in a Nitro Atomizer. The resulting product, a fine crystalline yellow powder, is tabletted, spherical tablets with a diameter of 8 mm, weighing 0.2 g, the patient takes orally. Advantages: the absence of a negative attitude of the patient to taking the drug. Disadvantages: the need for a large amount of bile and carcasses of chicken for processing bile [Dudenas V.G., Savitskas A.B., Bernatnis D.A. Tabletting of bird bile obtained by spray drying. Abstracts 4th Congress of Pharmacists of the Lithuanian SSR. Vilnius 1987, 70-71, USSR patent SU 1537256 A1].

A method for producing sterile lyophilized native bile in glutoid capsules was proposed by A.N. Popov and coauthors in 2004. Bile flowing from the fistula is collected in a glass dish, perfused through cellulose acetate membranes for microbiological analysis, located in the column for filtration in a certain order as pores decrease. In the first layer, two membranes with a pore size of 0.91-1.05 μm, in the second layer two membranes with a pore size of 0.551-0.65 μm, in the third layer two membranes with a pore size of 0.251-0.35 μm in order to remove bile decay products from the walls of the fistula. Filtered bile is collected in a sterile dish, poured into 0.5 ml glass vials and freeze-dried in an EDVARS type apparatus. Then bile is packaged in glutoid capsules immediately before use and orally given to patients with an external bile fistula. Advantages: no need for the patient to drink his bile. Disadvantages: the high cost and inability to use clinics dealing with this issue in routine practice.

For the closest technical nature as a prototype, we have chosen a method for the treatment of liver failure in patients with obstructive jaundice [Patent RU 2132194, 1999]. The method consists in the removal of bile from the patient by external drainage of the biliary tract, its sorption and return to the patient their bile. For return, along with their own bile, donor bile is also used, which after sorption is further lyophilized, packaged in hard gelatin capsules, and bile is taken orally. Lyophilization of bile is carried out after inactivation of the infection in a dry oven at t = + 56 ° C for 30 minutes by repeating this system five times. The process of lyophilization of bile consists of two stages: Stage 1 - freezing at t = -30 ° C - lasts 48 hours. The 2nd stage - lyophilization proper - consists of two periods: 1 period - lyophilization at t = -22 ° C and a vacuum of 0.03 mm Hg. Art. within 14 hours, 2 period - heating of bile for 12 hours and under vacuum 0.03 mm RT. Art. up to t = + 22 ° C. After lyophilization of bile, it is placed in hard gelatin capsules and oral bile is returned to the patient 6-10 capsules per day in 3-4 doses 10 minutes before meals for 3-13 days.

The method chosen by us as a prototype allows the return of bile lost by external bile drainage catheters into the lumen of the gastrointestinal tract, without significant harm to the esophagus and stomach, and to ensure an acceptable quality of life for the patient due to the absence of the need to install a nasoduodenal probe, and also the need for patient oral administration of bile.

The disadvantages of the prototype, according to the authors of the proposed method, are:

- the need to use for obtaining dry bile residue expensive equipment for freeze drying;

- the duration of the method is not less than 48 hours;

- use along with their own bile of donor bile, which is a risk of viral infection of the patient;

- the inability to return bile at once to more than one patient.

The technical result of the invention is:

- cheaper process drying bile;

- reducing the time from the moment of collection of bile to its return to the patient, as well as the return of bile to several patients simultaneously, which will greatly simplify the method;

- the exclusion of the use of donor bile, which will increase the safety of the method by eliminating viral infection.

The technical result is achieved by the fact that a method of treating patients with diseases complicated by obstructive jaundice consists in collecting the patient’s bile lost through the external percutaneous drainage catheter, its sorption, inactivation of infection in bile for 60-80 minutes at a temperature of + 70-80 ° C, drying bile by convective drying at a temperature of + 50-55 ° C for 7-8 hours. Inactivation of infection in bile and convective drying is carried out using an oven SNOL 58/350. The dry residue is subjected to ultraviolet radiation for 30-60 seconds, then put it in hard gelatin capsules and return their bile to the patient orally.

The method is as follows.

A sample of the bile of patients lost through the external percutaneous drainage catheter of the biliary tract is taken. Bile from individual bile collection bags obtained from each patient is collected in sealed, sterile 500 ml vials each, labeled for each patient with his name, medical history number and date of bile collection. Next, alternate sorption of bile obtained from each patient is carried out. For this, standard columns with a sorbent — activated carbon of the AP-3 grade — are used, and a separate column is used for bile of each patient. After sorption of bile, it is placed in trays, each of which is 250 ml in volume and marked for each patient with his last name, medical history number and date of bile collection. Then inactivation of the infection in bile is carried out for 60-80 minutes at a temperature of + 70-80 ° C SNOL (SNOL) 58/350. Next, the temperature in the drying cabinet is reduced to + 50-55 ° C and the bile is dried in a convective way. The drying time is 7-8 hours. After drying, labeled trays with a dry residue of bile are placed for 30-60 seconds in an ultraviolet sterilizer. After that, the dry substance is taken out one by one from the marked trays, crushed and packaged in individual 1000 mg hard gelatin capsules.

Dried bile in capsules is given to patients orally, 16 capsules per day for 4 doses: 2 capsules 10 minutes before meals, washed down with 300 ml of warm liquid, 2 capsules during meals.

The duration of bile intake by the patient is the entire period of bile loss through the external transhepatic drainage catheter.

The essential distinguishing features of the invention and the causal relationship between them and the achieved result:

- Inactivation of infection in bile is carried out at a temperature of + 65-70 ° C in an oven "SNOL 58/35".

The temperature regime selected experimentally suppresses the development of microorganisms by which bile is seeded. The volume of the SNOL 58/35 drying cabinet allows bile received from several patients to be placed in it, which makes it possible to return bile to several patients simultaneously.

- Next, the temperature in the drying cabinet is reduced to + 50-55 ° C and the bile is dried in a convective way at a temperature of + 50-55 ° C for 7-8 hours.

Experimentally selected temperature and time conditions (+ 50-55 ° C and 7-8 hours) allow you to effectively dry bile in a convective way without significant loss of physiological properties of dried bile, which reduces the time from the moment of bile withdrawal to its return, as well as much cheaper Compared to the prototype.

- After drying, marked trays with a dry residue of bile are placed for 30-60 seconds in an ultraviolet sterilizer. Ultraviolet irradiation of the dry residue of bile is a method of suppressing the growth and elimination of pathogenic microflora contained in bile. The time interval of ultraviolet irradiation of the dry residue of bile in 30-60 seconds allows you to maintain its physiological properties, with an increase in the time interval, changes in the structure of its components are possible, and with a decrease in the bactericidal effect of ultraviolet radiation, it will not be enough.

- In contrast to the prototype method, in which donor bile is used, the claimed method uses only the patient’s own bile, which is undoubtedly safer and more physiological.

The set of distinctive essential features is new and allows, in contrast to the prototype method:

- reduce the cost of the drying process of bile;

- reduce the time from the moment of collection of bile to its return to the patient, as well as return bile to several patients at the same time, which greatly simplifies the method;

- to exclude the use of donor bile, which increases the safety of the method by eliminating viral infection.

We give examples from clinical practice.

Example 1. Patient S. 74 years old, a pensioner. Hospitalized in a clinic with symptoms of obstructive jaundice. According to computed tomography - cancer of the gallbladder with germination in the common bile duct and liver. Percutaneous external transhepatic drainage of the common hepatic duct was performed. Attempts to perform external-internal drainage - without effect. Loss of bile through external bile drainage - up to 700 ml of bile. The patient categorically refused to place a nasoduodenal probe and drink bile. The claimed method is applied. In dynamics, according to the coprogram, 10 days after the start of encapsulated bile intake, the following was noted: the appearance of stool coloration, a decrease in the amount of fatty acids in the stool; according to biochemical analysis of blood: an increase in the level of total protein and albumin in the blood.

Example 2. Patient S. 52 years old, Deputy General Director. Hospitalized in a clinic with symptoms of obstructive jaundice. According to the results of MSCT - a pancreatic head tumor with germination in the common bile duct and in the portal vein. Percutaneous external transhepatic drainage of the common bile duct was performed. Attempts to perform external-internal drainage without success. The volume of bile by external bile drainage is 500 ml per day. Pronounced emetic reflex in the presence of a nasoduodenal probe in the nasopharynx, according to FEGDS, erosive gastritis against the background of the underlying disease is a contraindication to oral administration of bile. The claimed method is applied. In dynamics, according to the coprogram, 7 days after the start of taking encapsulated bile, the color is light yellow, the absence of fatty acids in the feces; according to biochemical analysis of blood: normalization of the level of total protein and albumin in the blood.

The claimed method was tested in 20 patients with obstructive jaundice, which was performed external bile duct. According to the biochemical analysis of blood - the positive dynamics in terms of restoration of liver function - corresponds to the results obtained using other methods of returning bile - taking bile orally and introducing bile into a nasoduodenal probe. According to the coprograms, the amount of fatty acids in the feces decreased, and a light yellow color appeared. There were no significant differences in the results between the indicated methods.

The cost of the cheapest freeze dryer of acceptable sizes in a complete set is 15,000 euros. The cost of the drying oven "SNOL 58/350" is 26,000 rubles. The cost of an ultraviolet camera in which you can perform ultraviolet irradiation is 20,000 rubles.

The simplification of the method is achieved due to the return of bile to the patient 10 hours after its collection in comparison with 48 hours by the prototype method.

Thus, the claimed method allows, in contrast to the prototype method:

- reduce the cost of the drying process of bile;

- reduce the time from the moment of collection of bile to its return to the patient, as well as return bile to several patients at the same time, which greatly simplifies the method;

- to exclude the use of donor bile, which increases the safety of the method by eliminating viral infection.

Claims (1)

A method of treating patients with diseases complicated by obstructive jaundice, which consists in collecting the bile of the patient lost through the external percutaneous drainage catheter, its sorption, inactivation of the infection in bile, drying of bile, and then returning the bile to the patient orally in the form of a dry residue placed in hard gelatin capsules, characterized in that the inactivation of infection in bile is carried out for 60-80 minutes at a temperature of + 70-80 ° C, after which bile is dried by convective drying at a temperature of + 50-55 ° C for 7-8 hours, moreover, both inactivation of infection in bile and convective drying are carried out using an SNOL 58/350 oven, after which the dry residue is subjected to ultraviolet radiation for 30-60 s.