RU2567043C1 - Solution for peritoneal dialysis - Google Patents

Abstract

FIELD: pharmacology.

SUBSTANCE: intracorporeal detoxification preferentially conducted in a clinical setting involves using a solution containing albumin, Fraxiparine, dialysis fluid. The solution additionally contains papaverine, platyphyllin and heparine in the following proportions, wt %: albumin - 3-5%, Fraxiparine - 0.025-0.075%, papaverine - 0.3-0.6%, platyphyllin - 0.015-0.03%, heparin - 0.025-0.05%, dialysis fluid - the rest.

EFFECT: more effective dialysis process, reduced length of stay in hospital.

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Description

The invention relates to medicine and can be used for intracoporal detoxification, mainly carried out in stationary conditions.

A known pharmaceutical composition for peritoneal dialysis (RF Patent No. 21118531, IPC A61M 1/14, publ. 1998), which is intended for washing blood with temporary or prolonged renal failure. The composition is an aqueous solution containing a physiologically acceptable electrolyte and / or one or more osmotically effective substances and 1-12 wt.% Starch ester. Starch is substituted by acyl groups of mono- or dicarboxylic acids with 2-6 carbon atoms, or a mixture thereof. Osmotically effective substances are polyhydric alcohols, monosaccharides and / or amino acids.

The disadvantages of using this composition for peritoneal dialysis (PD) are: incomplete biocompatibility due to the presence of starch, leading to a reduction in the duration of treatment with peritoneal dialysis, the presence of amino acids in the solution does not imply the prolonged presence of such a solution in the abdominal cavity due to the loss of its effectiveness, which leads to increase the frequency of exchanges and increases the cost of treatment. In addition, the proposed composition does not contribute to increasing the degree of detoxification regarding the use of a standard composition, and the presence of amino acids determines the possibility of using such a composition only depending on the individual tolerance of such a solution.

Known biocompatible aqueous solution for use in continuous ambulatory peritoneal dialysis (RF Patent No. 2158593, IPC A61M 1/14, publ. 2000). The solution contains at least one osmotically active agent selected from acetylated amino sugar, deacetylated amino sugar and combinations thereof. The agent is present as a monomer or oligomer of 2-12 carbohydrate units. The solution may additionally contain electrolytes: Na, Cl, Ca, Mg lactate, malate, acetate, succinate, and combinations thereof. It has a pH of 5.0-7.4.

The use of this type involves frequent exchanges of the solution, increases the risk of dialysis peritonitis, and in addition, increases the cost of treatment due to the need to use a large volume of solution for PD and due to the need for a combination of detoxification methods using hemodialysis, hemofiltration and hemodiafiltration.

The closest is the method of detoxification of the body (RF Patent No. 325194, IPC A61M 1/28, publ. 2008), which describes the solution used for peritoneal dialysis. The solution contains albumin in a dose of 60-100 g / l and fraxiparin in a dose of 0.3-0.8 ml / l, introduced into the dialysis solution.

The disadvantage of this composition is that the solution is not biocompatible due to the presence of glucose in it, in addition, the high osmolarity of such a solution rapidly decreases, which suggests frequent exchanges, and this, in turn, increases the risk of dialysis peritonitis and a significant increase in cost treatment.

The objective of the invention is to remedy these shortcomings, increase the effectiveness of peritoneal dialysis, especially during detoxification, reduce the risk of developing dialysis peritonitis by reducing the multiplicity of exchanges of the dialysis solution, and also achieve the economic effect associated with these factors.

To solve this problem, a solution for peritoneal dialysis, containing albumin, fraxiparin, dialysis solution, the solution additionally contains papaverine, platifillin and heparin, in the following ratio, wt.%:

albumin - 3-5%;

fraxiparin - 0.025-0.075%;

papaverine - 0.3-0.6%;

platifillin - 0.015-0.03%;

heparin - 0.025-0.05%;

dialysis solution - the rest.

The albumin content in the dialysis solution at a concentration 2 times higher than that in the blood plasma provides a high clearance of medium and low molecular weight toxins. The long exposure of the presented solution in the abdominal cavity contributes to this. The content of fraxiparin in the solution allows you to maintain albumin in a dissolved state and ensures its functional viability.

The proposed solution provides the most complete biocompatibility, increases the effectiveness of treatment, by improving the filtration and convection properties of the peritoneum with this solution. The content of fraxiparin in the solution allows you to maintain albumin in a dissolved state and ensures its functional viability.

The solution is obtained by simple mixing of the proposed components or first papaverine at a concentration of 0.3-0.6%, platifillin at a concentration of 0.015-0.03% and heparin at a concentration of 0.025-0.05% are combined with each other and mixed for 7-10 minutes at room temperature, and then introduced into a standard dialysis solution (known standard dialysis solutions differ in osmolarity and the percentage of glucose and its polymer icodextrin). Then, albumin is mixed at a concentration of 3-5% with fraxiparin at a concentration of 0.025-0.075% for 3-5 minutes, followed by introduction through the infusion system into a dialysis solution, heated to 37-40 ° C.

The proposed solution is used in detoxification, in renal and hepatic insufficiency, as well as endogenous and exogenous poisoning.

The use of the solution is shown in specific clinical examples.

Example 1

Patient T., born in 1965, was admitted to the hospital with a diagnosis of acute renal damage. The patient's condition upon admission is severe. BMI - 27.

Examination revealed hyperazotemia with an increase in creatinine and urea levels to 831 μmol / L and 25.4 mmol / L, respectively.

In order to correct the level of azotemia, reduce the intensity of endogenous intoxication, peritoneal catheter implantation was performed and peritoneal dialysis was treated using the proposed solution.

After pre-mixing in 2 l of a standard dialysis solution with a glucose concentration of 3.86%: albumin - 4%, fraxiparin - 0.025%, papaverine - 0.3%, platifillin - 0.03%, heparin - 0.04%.

The exposure of the solution in the abdominal cavity was up to 8 hours. There were 18 exchanges of the solution over 6 days. A dynamic decrease in the level of azotemia with a parallel recovery of diuresis was noted.

The peritoneal catheter was removed on the 10th day, the patient was discharged in satisfactory condition.

Example 2

Patient U., born in 1945, was admitted to the department with a diagnosis of acute exogenous poisoning. Acute liver failure. Acute renal damage.

The patient was urgently implanted with a peritoneal catheter. The peritoneal dialysis program was carried out using the proposed solution for peritoneal dialysis, and the basis was standard dialysis solutions with glucose concentrations of 2.27% and 3.86%, which were alternated. Moreover, the composition contained albumin - 5%, fraxiparine - 0.05%, papaverine - 0.5%, platifillin - 0.02%, heparin - 0.03%. 28 exchange sessions were carried out with an exposure of 5-7 hours.

It was possible to achieve an acceptable level of azotemia after 7 days of using this treatment, and euvolemia by the 4th day of treatment.

In a laboratory study in the blood plasma before the dialysis solution exchange procedure, the total bilirubin content was 110.7 mmol / L, ACT - 71.4 units / L, ALT - 72.3 units / L. Normalization of indicators was noted by the 10th day of treatment. The catheter was removed, the patient was discharged for outpatient monitoring, the patient's condition is satisfactory.

Example 3

A patient B., born in 1973, suffering from chronic kidney disease with a terminal stage of chronic renal failure with a body mass index of 32 showed a clinically significant decrease in the effectiveness of treatment with peritoneal dialysis 3 months after the start of treatment with peritoneal dialysis due to violations of the prescribed regimen.

In order to achieve euvolemia and correct the level of azotemia in an inpatient setting, it was decided to carry out, in addition to the main daily treatment program for peritoneal dialysis, exchanges of 2 l of a standard dialysis solution containing 7.5% icodextrin with albumin - 5%, fraxiparin - 0.075%, papaverine - 0 , 6%, platyphyllin - 0.03%, heparin - 0.05%.

There were 6 exchange sessions with exposure of the solution for 12-14 hours. It was possible to achieve an acceptable level of azotemia after 4 days of using the solution obtained by the above method, and euvolemia by the 3rd day of treatment.

Subsequently, the patient is assigned a standard treatment program.

Example 4

Patient Yu., Born in 1964, was admitted to the intensive care unit with a diagnosis of chronic renal failure, terminal stage. Permanent ambulatory peritoneal dialysis. Dialysis peritonitis.

Against the background of the development of dialysis peritonitis, a decrease in the effectiveness of peritoneal dialysis was noted, which was manifested by an increase in the intensity of intoxication symptoms, an increase in the level of azotemia, and hyperhydration.

In order to detoxify, dehydrate, complex therapy was carried out, including peritoneal dialysis using solutions containing standard dialysis solutions with a glucose concentration of 2.27% and the second with icodextrin content of 7.5% (alternating them), into which, after preliminary The following components were added to the mixing: albumin - 3%, fraxiparin - 0.05%, papaverine - 0.4%, platifillin - 0.03%, heparin - 0.05%.

It was possible to achieve effective treatment with peritoneal dialysis on the 5th day, after which the use of the standard program of peritoneal dialysis was returned.

Example 5

Patient O., born in 1955, was admitted to the department with a diagnosis of chronic renal failure, terminal stage. Arterial hypertension. Anemia. Obesity 1 tbsp.

To carry out renal replacement therapy, a peritoneal catheter was implanted, peritoneal dialysis was automatically performed using a high-dose tidal PD using a standard dialysis solution with a glucose concentration of 1.36%, after the preliminary mixing in 5 l of which the following components were added: albumin - 5 %, fraxiparin - 0.075%, papaverine - 0.4%, platifillin - 0.02%, heparin - 0.05%.

Achieving adequate treatment with peritoneal dialysis was achieved on the 3rd day. The patient was discharged for outpatient treatment using a standard program of peritoneal dialysis.

Thus, the use of the proposed composition provides a high clearance of medium and low molecular weight toxins, dehydration. The possibility of prolonged exposure of the presented solution in the abdominal cavity also contributes to this.

We have not noted the development of adverse events in connection with the use of the described solution composition for peritoneal dialysis, and also not a single episode of the development of dialysis peritonitis has been noted.

The use of the described composition increases the efficiency of dialysis, reduces bed days, i.e. the patient’s stay in the hospital reduces the cost of treatment.

Claims (1)

A peritoneal dialysis solution containing albumin, fraxiparin, a dialysis solution, characterized in that the solution additionally contains papaverine, platifillin and heparin, in the following ratio, wt.%:
albumin - 3-5%;
fraxiparin - 0.025-0.075%;
papaverine - 0.3-0.6%;
platifillin - 0.015-0.03%;
heparin - 0.025-0.05%;
dialysis solution - the rest.