Application of compound treotide injection in treatment of ascites due to cirrhosis

Abstract

The invention belongs to the field of medicines, and particularly relates to application of a compound treotide injection in treatment of ascites due to cirrhosis. Clinical treatment on patients with ascites due to cirrhosis discovers that the symptoms of ascites due to cirrhosis can be improved or relieved by combined use of the compound treotide injection on the basis that the patients are subjected to diuresis, human serum albumin supplementation and / or portal vein pressure reduction treatment.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of medicine, and particularly relates to application of compound troxerutin injection in treatment of ascites due to cirrhosis. BACKGROUND

[0002] Cirrhosis is a chronic progressive liver disease, which is characterized by diffuse necrosis of hepatocytes, nodular regeneration, pseudolobular formation and intrahepatic and extrahepatic vascular proliferation. Ascites due to cirrhosis is one of the late symptoms of cirrhosis, which is related to portal hypertension, hypoproteinemia, excessive lymph production and other factors, and seriously affects the quality of life of patients and threatens their lives. At present, the treatment of ascites due to cirrhosis mainly includes diuretics, abdominal puncture and drainage, transjugular intrahepatic portosystemic shunt and other methods.

[0003] Compound troxerutin injection is a compound preparation for treating cerebrovascular diseases and nerve damage, and its main components include troxerutin, active polypeptide, various amino acids and gangliosides. According to the clinical efficacy data, it is found that the patients with ascites due to cirrhosis can improve or relieve the symptoms of ascites due to cirrhosis by using compound troxerutin injection on the basis of diuresis, human albumin supplementation and / or portal pressure reduction treatment. SUMMARY

[0004] The application provides application of compound troxerutin injection in treatment and / or improvement of ascites due to cirrhosis.

[0005] Another embodiment of the application provides application of compound troxerutin injection in treatment and / or improvement of ascites due to cirrhosis, characterized in that the patients use the compound troxerutin injection on the basis of diuresis, human albumin supplementation and / or portal pressure reduction treatment.

[0006] Another embodiment of the application provides application of compound troxerutin injection in treatment and / or improvement of ascites due to cirrhosis, characterized in that the diuresis refers to using diuretics, preferably using one or a combination of furosemide and spironolactone. The administration mode of the human albumin is preferably intravenous drip. The specification of the compound troxerutin injection is selected from 2ml, 5ml or 10ml, the administration mode is preferably intravenous drip, and the dosage is preferably 10ml each time, once a day.

[0007] Another embodiment of the application provides application of compound troxerutin injection as a drug for treating and / or improving ascites due to cirrhosis.

[0008] The compound troxipide injection described in the application is a marketed drug produced by Jilin Tiancheng Pharmaceutical Co., Ltd., and its specifications include 2ml (troxipide 80mg + total nitrogen 1.0mg + monosialotetrahexosyl ganglioside (GM1) 0.6mg), 5ml (troxipide 200mg + total nitrogen 2.5mg + monosialotetrahexosyl ganglioside (GM1) 1.5mg), and 10ml (troxipide 400mg + total nitrogen 5.0mg + monosialotetrahexosyl ganglioside (GM1) 3.0mg).

[0009] Compared with the prior art, the application has the advantages that the application expands the clinical use of the compound troxipide injection, and the compound troxipide injection shows good clinical effects in improving and / or treating cirrhotic ascites. DETAILED DESCRIPTION

[0010] In order to facilitate a further understanding of the application, the following examples are provided to make a more detailed description. However, these examples are only for better understanding of the application and do not limit the scope or implementation principles of the application, and the embodiments of the application are not limited to the following.

[0011] Example 1 Clinical pathological study

[0012] 1.1 Research object

[0013] Inclusion criteria: ① age 18-80 years old; ② patients with cirrhotic ascites, with or without liver cancer;

[0014] Exclusion criteria: ① patients with hepatic encephalopathy and hepatopulmonary syndrome; ② ascites caused by non-cirrhosis; ③ cancerous ascites; ④ mental or intellectual disorders; ⑤ <18 years old or >80 years old; ⑥ incomplete data affecting efficacy

[0015] 1.2 Research method

[0016] Select 2023 June to 2024 December in our hospital 60 cases of cirrhosis of the liver ascites patients with or without liver cancer. Will be randomly divided into two groups (30 cases each), the experimental group in the acceptance of furosemide tablets (specification: 20mg / tablet, oral, 2 tablets / time, once a day) + spironolactone tablets (specification: 20mg / tablet, oral, 5 tablets / time, once a day), supplemented with human albumin (Anboling, specification: 10g / bottle (20%, 50ml), intravenous infusion, 2 bottles / time, once a day) treatment combined with compound peptide injection (Jilin Tiancheng, specification: 2ml, intravenous drip, 10ml / time, once a day), the control group only receives furosemide tablets (specification: 20mg / tablet, oral, 2 tablets / time, once a day) + spironolactone tablets (specification: 20mg / tablet, oral, 5 tablets / time, once a day), supplemented with human albumin (Anboling, specification: 10g / bottle (20%, 50ml), intravenous infusion, 2 bottles / time, once a day) treatment. Through the evaluation of two groups of patients after 2 weeks of treatment, the change of body weight, abdominal circumference, ascites volume (ascites depth), daily urine volume before and after treatment to evaluate the efficacy of the experimental group.

[0017] 1.3 efficacy evaluation criteria

[0018] According to the improvement of clinical symptoms of patients after treatment, the clinical efficacy criteria are formulated according to the Guideline for Diagnosis and Treatment of Ascites and Related Complications of Liver Cirrhosis (2017). Invalid: no improvement of edema, no reduction of ascites, abdominal circumference and body weight, even increase; Effective: improvement of edema, B-ultrasound shows that ascites is reduced by less than 50%, abdominal circumference is reduced by 3-5cm, body weight is reduced by less than 2kg, daily urine volume is less than 1000ml; Marked effect: obvious regression of edema, B-ultrasound shows that ascites is reduced by more than 50%, abdominal circumference is reduced by more than 5cm, body weight is reduced by more than 2kg, 1000ml≤daily urine volume<1200ml; Clinical remission: complete regression of edema, B-ultrasound shows no ascites, abdominal circumference and body weight are reduced to the level before ascites, daily urine volume is more than 1200ml. Total effective rate = (clinical remission + marked effect + effective) / total number of cases x 100%.

[0019] 1.4 clinical trial results as follows

[0020]

[0021] Note: compared with the control group after treatment * P<0.05, compared with the same group before treatment # P<0.05.

[0022] Group Clinical remission (cases) Markedly effective (cases) Effective (cases) Ineffective (cases) Total effective rate (%) Control group 0 6 17 7 76.7% Experimental group 7 15 6 2 93.3%

[0023] Example 2 animal experiment

[0024] After one week of acclimatization, rats were randomly divided into a normal group and a model group, with 20 rats in each group. In the first week, rats in the model group were given 35% phenobarbital CMC-NA suspension and intraperitoneally injected with 2 mL / kg of 10% CCL4 (Sinopharm Chemical Reagent Co., Ltd.) olive oil solution, twice a week for 12 consecutive weeks to establish a liver cirrhosis ascites model. Ten successfully modeled rats were given Compound Triptide Injection (Jilin Tiancheng) 2.0 ml / kg intraperitoneally, once a day for 2 consecutive weeks (treatment group). Blood was collected from the aorta of rats (normal group, model group, and treatment group) under routine ether anesthesia, centrifuged, and serum was collected. ALT, AST activities, and ALB levels were detected using an automated biochemical analyzer. Ascites and liver tissue were collected after abdominal rupture, and liver pathological changes were observed by HE staining. The results are shown in the table below.

[0025] ALT, AST activity and ALB level statistics table

[0026] Group ALT (U / L) AST (U / L) ALB (g / L) Normal group 72.18±8.05 56.23±28.95 42.52±5.34 Model group 197.61±13.25 485.63±145.58 12.23±2.89 Drug administration group 80.58 ± 9.62 * ]] 75.52 ± 31.25 * ]] 35.78 ± 4.78 * ]]

[0027] Note: Comparison with model group * P<0.05

[0028] Ascites volume statistics table

[0029] Group Ascites volume (mL) Normal group 0 Model group 5.85±0.32 Drug administration group 0.90 ± 0.25 * ]]

[0030] Note: Comparison with model group * P<0.05

[0031] Macroscopic observation of rat liver tissue morphology: In the normal group, the liver had good texture, bright red color, smooth surface, sharp edges, and moderate size; in the model group, the liver was brittle, brown in color, with an uneven surface, nodules of varying sizes, blunt edges, and smaller volume; in the drug-treated group, the liver was enlarged, dark red in color, with a relatively smooth surface but with fine granular areas and sharp edges.

Claims

1. The use of compound trichoteptide injection as a drug for the treatment and / or improvement of ascites in cirrhosis.

2. Application of Compound Triptyl Peptide Injection in the treatment and / or improvement of ascites in cirrhosis.

3. The application according to any one of claims 1-2, characterized in that... The patient was given compound trichopeptide injection in addition to diuretic therapy, human serum albumin supplementation and / or portal vein pressure reduction therapy.

4. The application according to claim 3, characterized in that... The term "diuresis" refers to the use of diuretic drugs.

5. The application according to claim 4, characterized in that... Diuretics are selected from one or a combination of two of furosemide and spironolactone.

6. The application according to claim 5, characterized in that... The diuretic is selected from a combination of furosemide and spironolactone.

7. The application according to any one of claims 1-6, characterized in that... The specifications of the compound triceptide injection are selected from 2ml, 5mL or 10ml.

8. The application according to claim 7, characterized in that... The dosage and administration of the compound trichotillomania injection are selected from intravenous drip, 10 mL each time, once a day.

9. Application of Compound Triptyl Peptide Injection in the preparation of drugs for treating and / or improving ascites in cirrhosis.

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