MD1909Z - Method for the combined treatment of biliary dyskinesia - Google Patents

Abstract

The invention relates to medicine, in particular to gastroenterology and therapy and can be used for the combined treatment of biliary dyskinesia.Summary of the invention consists in alternating every 2 days the intravenous administration of ozonized 0.9% NaCl solution and major autohemotherapy, namely 200…500 mL of a 0.9% NaCl solution ozonized with an ozone-oxygen mixture, with an ozone concentration of 2…12 µg/mL, are administered, and major autohemotherapy consists in collecting 400…800 mL of venous blood from the patient, which is ozonized, with an ozone concentration of 20…35 µg/mL and transfused to the patient, for 8 weeks, then continuing with minor autohemotherapy, which consists in collecting 5 mL of venous blood, which is ozonized, with an ozone concentration of 20…35 µg/mL and administered intramuscularly to the patient, which is administered every 2 days, and the course includes 14 consecutive procedures. At the same time, ozonized drinking water, with an ozone concentration of 30…40 µg/mL is administeredper osin the morning on an empty stomach, 200…500 mLperprocedure, once a day, daily, for 30 days, and at the same time, 30 minutes before meals, daily, 10…15 mL of ozonized vegetable oil, with an ozone concentration of 20…25 µg/mL, is administeredper os, for up to 90 days. Simultaneously with oral administrations, intestinal insufflations, 150…300 mLperprocedure, of an ozone-oxygen mixture, with an ozone concentration of 20…40 µg/mL, are performed daily, for up to 21 days, after which acupuncture is performed in points F3, V17, VB34, IG4, E25, where 0.3…0.5 mL of an ozone-oxygen mixture, with an ozone concentration of 10 µg/mL, is administeredperpoint, which is administered every other day, for 6 weeks. Olive, hemp or sesame oil can be used as vegetable oil.

Description

The invention relates to medicine, in particular to gastroenterology and therapy, and can be used for the combined treatment of biliary dyskinesia.

[0002] Biliary dyskinesia is a functional disorder of the biliary system, characterized by dysfunction of the gallbladder or sphincter of Oddi, which causes an abnormal flow of bile. This pathology affects the digestion of fats and leads to symptoms such as pain in the right hypochondrium, nausea, bloating, fat intolerance. Although it does not involve organic lesions, biliary dyskinesia can significantly influence the quality of life. Biliary dyskinesia involves functional alteration of the motility of the biliary system in the absence of obvious organic lesions. The following may be involved:

[0003] - hyper- or hypotonia of the gallbladder;

[0004] - spasm or inadequate relaxation of the sphincter of Oddi;

[0005] - neurovegetative imbalances;

[0006] - hormonal imbalances (cholecystokinin, secretin);

[0007] - chronic subclinical inflammation of the bile ducts.

These changes lead to biliary stasis, changes in bile composition, local inflammation, sympathetic hyperactivity and gastrointestinal symptoms.

[0009] The motility disorder of the gallbladder is called gallbladder dyskinesia. Patients with this condition present with biliary pain and investigations do not reveal the presence of gallstones in the gallbladder. Diagnosis is made by performing a gallbladder ejection fraction, which is a radionuclide investigation. An abnormal gallbladder ejection fraction is less than 40%. Patients with an abnormal gallbladder ejection fraction should undergo treatment (James Toouli. Biliary Dyskinesia. Curr Treat Options Gastroenterol. 2002 Aug, vol. 5(4), p. 285-291. doi: 10.1007/s11938-002-0051-9). In addition, disordered motility of the biliary tract may be associated with the etiology of common biliary tract disorders, such as gallstones. In this case, treatment of gallstone disease improves symptoms in most patients. However, in up to 10% of patients, biliary motility disorders may occur in the absence of stones or in patients after cholecystectomy (J. Toouli. Biliary motility disorders. Baillieres. Clin. Gastroenterol. 1997 Dec, vol. 11(4), p. 725-740. doi: 10.1016/s0950-3528(97)90018-x).

[0010] There is no evidence that biliary dyskinesia can go away on its own. Biliary dyskinesia is generally not diagnosed until symptoms have been present for at least three months. If it does, it is likely that it was not truly a functional disorder, but a different type of motility disorder that was caused by temporary factors.

[0011] The method of treatment of biliary dyskinesia caused by the gallbladder is known, which consists in performing cholecystectomy [1].

[0012] The disadvantages of the method are that it is an invasive method and causes postoperative complications such as biliary hemorrhage and biliary peritonitis, which require additional interventions, and at the same time up to 10% of patients present with biliary motility disorders with abdominal pain, nausea and vomiting, which can occur in the absence of gallstones or in patients after cholecystectomy (J. Toouli. Biliary motility disorders. Baillieres Clin. Gastroenterol. 1997 Dec, vol. 11(4), p. 725-740. doi: 10.1016/s0950-3528(97)90018-x).

[0013] The method of treating biliary dyskinesia with the administration of nonsteroidal anti-inflammatory and spasmolytic drugs, namely papaverine and diclofenac sodium [2], is known.

[0014] The disadvantages of the known method are that long-term administration of non-steroidal anti-inflammatory drugs causes complications in the gastrointestinal tract, with the appearance of gastropathies, gastroduodenal ulcers often complicated by upper gastrointestinal bleeding.

[0015] The problem solved by the invention consists in developing an efficient and non-invasive method, which would eliminate the disadvantages of known methods, while eliminating the patient's complaints by combining several methods with synergistic, non-toxic action and without the administration of non-steroidal anti-inflammatory drugs with the mentioned side effects.

[0016] The essence of the invention consists in alternating every 2 days the intravenous administration of ozonated 0.9% NaCl solution and major autohemotherapy, namely 200...500 mL of a 0.9% NaCl solution ozonated with an ozone-oxygen mixture, with an ozone concentration of 2...12 µg/mL, are administered, and major autohemotherapy consists in collecting 400...800 mL of venous blood from the patient, which is ozonized, with an ozone concentration of 20...35 µg/mL and transfused to the patient, for 8 weeks, then continuing with minor autohemotherapy, which consists in collecting 5 mL of venous blood, which is ozonized, with an ozone concentration of 20...35 µg/mL and administered intramuscularly to the patient, which is administered every 2 days, and the series includes 14 consecutive procedures. At the same time, ozonated drinking water with an ozone concentration of 30...40 µg/mL is administered orally in the morning on an empty stomach, 200...500 mL per procedure, once a day, daily, for 30 days, and at the same time, 30 minutes before meals, daily, 10...15 ml of ozonated vegetable oil with an ozone concentration of 20...25 µg/mL is administered orally, for up to 90 days. Simultaneously with oral administration, intestinal insufflations are performed daily, 150...300 mL per procedure, of an ozone-oxygen mixture, with an ozone concentration of 20...40 µg/mL, for up to 21 days, after which acupuncture is performed at points F3, V17, VB34, IG4, E25, where 0.3...0.5 mL per point of an ozone-oxygen mixture, with an ozone concentration of 10 µg/mL, is administered, which is administered every other day, for 6 weeks.

[0017] Olive, hemp or sesame oil can be used as vegetable oil.

[0018] The technical result of the invention consists in reducing the adverse effects of drug treatment with non-steroidal preparations, decreasing the frequency of biliary colic, prolonging the active period of patients' life, increasing their quality of life and increasing tolerance to physical exertion. The effective result of the invention is due to the synergism of treatment with the combination of several methods with the use of ozone therapy.

[0019] The advantages of the invention are:

[0020] - integration of 7 types of administrations for synergistic action;

[0021] - increased efficiency compared to conventional monotherapy;

[0022] - lack of toxicity and minimal adverse effects;

[0023] - holistic approach to functional biliary pathology;

[0024] - possibility of application as a preventive method in relapses;

[0025] - reducing the frequency of biliary colic;

[0026] - prolonging the active period of patients' lives;

[0027] - enhancing their quality of life and increasing tolerance to physical exertion.

[0028] The ozone-oxygen mixture acts by:

[0029] - oxidation of unsaturated fatty acids, leading to the formation of lipid peroxides, which modulate inflammation;

[0030] - activation of the endogenous antioxidant system (superoxide dismutase, catalase, glutathione);

[0031] - improving microcirculation by increasing 2,3-DPG and decreasing blood viscosity;

[0032] - bacteriostatic, antifungal and antiviral effect in cases associated with biliary infections;

[0033] - modulation of neurovegetative tone through parasympathetic stimulation (depending on dose and method of application).

The method is carried out in the following manner.

[0035] Every 2 days, the intravenous administration of ozonated 0.9% NaCl solution and major autohemotherapy are alternated, namely 200...500 mL of a 0.9% NaCl solution ozonated with an ozone-oxygen mixture, with an ozone concentration of 2...12 µg/mL, are administered, and major autohemotherapy consists of collecting 400...800 mL of venous blood from the patient, which is ozonized, with an ozone concentration of 20...35 µg/mL and transfused to the patient, for 8 weeks, then minor autohemotherapy is continued, which consists of collecting 5 mL of venous blood, which is ozonized, with an ozone concentration of 20...35 µg/mL and administered intramuscularly to the patient, which is administered every 2 days, and the series includes 14 consecutive procedures. At the same time, ozonated drinking water with an ozone concentration of 30...40 µg/mL is administered orally in the morning on an empty stomach, 200...500 mL per procedure, once a day, daily, for 30 days, and at the same time, 30 minutes before meals, daily, 10...15 ml of ozonated vegetable oil with an ozone concentration of 20...25 µg/mL is administered orally, for up to 90 days. Simultaneously with oral administration, intestinal insufflations are performed daily, 150...300 mL per procedure, of an ozone-oxygen mixture, with an ozone concentration of 20...40 µg/mL, for up to 21 days, after which acupuncture is performed at the points F3 (liver), V17 (diaphragm), VB34 (gallbladder), IG4 (large intestine), E25 (abdomen), where 0.3...0.5 mL per point of an ozone-oxygen mixture, with an ozone concentration of 10 µg/mL, is administered, which is administered every other day, for 6 weeks.

[0036] Olive, hemp or sesame oil can be used as vegetable oil.

[0037] The effect of parenteral administration of ozonated solution and blood consists of:

[0038] - immunological modulation;

[0039] - improving liver tissue oxygenation;

[0040] - decrease in neurovegetative tension;

[0041] - adaptogenic stimulation;

[0042] - neuro-hormonal balancing;

[0043] - hepatic detoxification;

[0044] - stimulation of bile flow.

[0045] The effect of administering drinking water and ozonated oil consists of:

[0046] - detoxification of the digestive system;

- increased intestinal motility;

[0048] - slight alkalization of intestinal contents;

[0049] - hepatoprotective effect;

[0050] - regulation of intestinal peristalsis;

[0051] - anti-inflammatory action on the duodenal mucosa;

[0052] - regulation of intestinal flora;

[0053] The effect of acupuncture with the ozone-oxygen mixture consists of:

[0054] - neurovegetative regulation;

[0055] - increasing biliary motility through reflexology.

The biochemical and physiological effects for each method used in the claimed invention are presented in the table.

[0057] Table

Type

Main effect

Biochemical mechanism

Ozonated water

Detoxification, digestive stimulation

Mild alkalinization, decreased gastric pH, reduced intestinal inflammation

Ozonated oil

Anti-inflammatory, hepatoprotective

Active lipid peroxides, liver regeneration

Major autohemotherapy

Oxygenation, immunomodulation

Increase in ATP, 2,3-DPG, activation of antioxidants

Minor autohemotherapy

Adaptogen, neuro tonic

Increased IL-2, sympathetic balancing

Ozonated infusion

Systemic detox, liver stimulation

Hepatic vasodilation, hepatic modulation

Rectal insufflations

Digestive, immune regulation

Colonic mucosal oxidative stimulation

Acupoint injections, acupuncture

Reflexogenic, neuroregulation

Autonomic rebalancing, sympatho-vagal action

[0059] The method according to the invention was applied to 54 patients aged 18...65 years, after which the results of the combined treatment with several methods of administering ozonated solutions, i.e. multimodal ozonotherapy, were analyzed, and following the analysis of the results it was determined that in all patients the general condition improved, with the disappearance of complaints of pain, nausea and vomiting and they were discharged in satisfactory condition with the extension of the treatment in outpatient conditions.

Example 1

[0061] Patient R., 53 years old, was hospitalized with complaints of general weakness, nausea, pain under the right costal margin, loss of appetite. Diagnosis of biliary dyskinesia. Chronic calculous cholecystitis.

[0062] Objective: general condition of average severity, pale pink skin and mucous membranes, vesicular breathing in the lungs, clear, rhythmic heart sounds, Ps 82permin, TA 130/95 mmHg. Moist tongue, soft abdomen, painful on palpation under the right costal margin. The liver exceeds the right costal margin by 1 cm. The presence of multiple stones with a size of 3...6 mm was determined during the USG examination.

[0063] Regime 2, diet 5, multivitamins, 5% glucose solution, 500 ml with 10% ascorbic acid solution, 5 ml, sol was indicated. 0.9% NaCl, 500 ml with 2% riboxin solution, 10 ml and the treatment according to the invention, every 2 days the intravenous administration of ozonated 0.9% NaCl solution and major autohemotherapy were alternated, namely 500 mL of a 0.9% NaCl solution ozonated with an ozone-oxygen mixture, with an ozone concentration of 12 µg/mL, was administered, and the major autohemotherapy consisted of collecting 400 mL of venous blood from the patient, which was ozonated with an ozone-oxygen mixture, with an ozone concentration of 35 µg/mL and transfused to the patient, for 8 weeks, then minor autohemotherapy continued, which consisted of collecting 5 mL of venous blood, which was ozonated, with an ozone concentration of 20 µg/mL and administered intramuscularly to the patient, which was administered every 2 days, and the series included 14 consecutive procedures. At the same time, ozonated drinking water with an ozone concentration of 40 µg/mL was administered orally in the morning on an empty stomach, which was administered 500 mL per procedure, once a day, daily, for 30 days, and at the same time, 30 minutes before meals, daily, 10 mL of ozonated olive vegetable oil with an ozone concentration of 25 µg/mL was administered orally for 90 days. Simultaneously with the internal administrations, intestinal insufflations were performed daily, 200 mL per procedure, of an ozone-oxygen mixture, with an ozone concentration of 40 µg/mL, for 21 days, after which ozone acupuncture was performed at the points F3 (liver), V17 (diaphragm), VB34 (gallbladder), IG4 (large intestine), E25 (abdomen), where 0.3 mL per point of an ozone-oxygen mixture, with an ozone concentration of 10 µg/mL, was administered, which was administered every other day, for 6 weeks.

[0064] After the treatment, the dynamics of clinical and paraclinical indices were evaluated: general weakness, nausea, pain and heaviness under the right costal margin disappeared, loss of appetite, the liver is at the level of the right costal margin. Total bilirubin 25.4 µmol/l, 17.3 µmol/l and 8.1 µmol/l, ALAT - 2.6 mmol/h/l, thymol test - 3.8 un. The patient was discharged in satisfactory condition with the extension of outpatient treatment.

Example 2

[0066] Patient D., 63 years old, was admitted with complaints of general weakness, nausea, pain under the right costal margin, loss of appetite. Diagnosis of biliary dyskinesia. Chronic acalculous cholecystitis.

[0067] Objective: general condition of average severity, pale pink skin and mucous membranes, vesicular breathing in the lungs, clear, rhythmic heart sounds, Ps 78permin, TA 140/95 mmHg. Moist tongue, soft abdomen, painful on palpation under the right costal margin. The liver does not exceed the right costal margin. The USG examination determined the absence of stones in the gallbladder, but the presence of an inflammatory process of the gallbladder was determined.

[0068] The regimen 2, diet 5, multivitamins, 5% glucose solution, 500 ml with 10% ascorbic acid solution, 5 ml, 0.9% NaCl solution, 500 ml with 2% riboxin solution, 10 ml and the treatment according to the invention was indicated, every 2 days the intravenous administration of ozonated NaCl solution of 0.9% and major autohemotherapy was alternated, namely 500 mL of a 0.9% NaCl solution ozonated with an ozone-oxygen mixture, with an ozone concentration of 10 µg/mL, was administered, and the major autohemotherapy consisted in collecting 500 mL of venous blood from the patient, which was ozonated with an ozone-oxygen mixture, with an ozone concentration of 30 µg/mL and transfused to the patient, for 8 weeks, then the autohemotherapy was continued minor, which consists in the fact that 5 mL of venous blood was collected, which was ozonated, with an ozone concentration of 20 µg/mL and administered intramuscularly to the patient, which was administered every 2 days, and the series included 14 consecutive procedures. At the same time, ozonated drinking water was administered orally, in the morning on an empty stomach, with an ozone concentration of 30 µg/mL, which was administered 500 mL per procedure, once a day, daily, for 30 days, and at the same time, 30 minutes before meals, daily, 15 mL of ozonated olive vegetable oil was administered orally, with an ozone concentration of 20 µg/mL, for 60 days. Simultaneously with the internal administrations, intestinal insufflations were performed, daily, 300 mL per procedure, of an ozone-oxygen mixture, with an ozone concentration of 30 µg/mL, for 18 days, after which ozone acupuncture was performed at the points F3 (liver), V17 (diaphragm), VB34 (gallbladder), IG4 (large intestine), E25 (abdomen), where 0.3 mL per point of an ozone-oxygen mixture, with an ozone concentration of 10 µg/mL, was administered, which was administered every other day, for 6 weeks.

[0069] After the treatment, the dynamics of clinical and paraclinical indices were evaluated: general weakness, nausea, pain and heaviness under the right costal margin disappeared, loss of appetite, the liver is at the level of the right costal margin. Total bilirubin 24.4 µmol/l, 16.3 µmol/l and 8.1 µmol/l, ALAT - 2.4 mmol/h/l, thymol test - 3.4 un. The patient was discharged in satisfactory condition with the extension of outpatient treatment.

[0070] 1. Bryan K. Richmond. Biliary Dyskinesia-Controversies, Diagnosis, and Management: A Review. JAMA Surg. 2024 Sep 1, vol 159(9), p.1079-1084. two: 10.1001/jamasurg.2024.0818

2. G. Goldman, P.J. Kahn, R. Alon, T. Wiznitzer. Biliary colic treatment and acute cholecystitis prevention by prostaglandin inhibitor. Dam. Dis. Sci. 1989 Jun, vol 34(6), pp 809-811. two: 10.1007/BF01540262

Claims (2)

1. Combined treatment method for biliary dyskinesia, which consists in alternating every 2 days the intravenous administration of ozonated 0.9% NaCl solution and major autohemotherapy, namely administering 200...500 mL of a 0.9% NaCl solution ozonated with an ozone-oxygen mixture, with an ozone concentration of 2...12 µg/mL, and major autohemotherapy consists in collecting 400...800 mL of venous blood from the patient, which is ozonized, with an ozone concentration of 20...35 µg/mL and transfused to the patient, for 8 weeks, then continuing with minor autohemotherapy, which consists in collecting 5 mL of venous blood, which is ozonized, with an ozone concentration of 20...35 µg/mL and administered intramuscularly to the patient, which is administered every 2 days, and the series includes 14 consecutive procedures; simultaneously, in the morning on an empty stomach, ozonated drinking water with an ozone concentration of 30...40 µg/mL is administered orally, 200...500 mL per procedure, once a day, daily, for 30 days, and at the same time, 30 minutes before meals, daily, 10...15 ml of ozonated vegetable oil with an ozone concentration of 20...25 µg/mL is administered orally, for up to 90 days; Simultaneously with oral administrations, intestinal insufflations are performed daily, 150...300 mL per procedure, of an ozone-oxygen mixture, with an ozone concentration of 20...40 µg/mL, for up to 21 days, after which acupuncture is performed at points F3, V17, VB34, IG4, E25, where 0.3...0.5 mL per point of an ozone-oxygen mixture, with an ozone concentration of 10 µg/mL, is administered, which is administered every other day, for 6 weeks. 2. Method according to claim 1, wherein olive, hemp or sesame oil is used as vegetable oil.