Clinical application scheme of tanshinone and trimetazidine compound medicament for treating hypertrophic cardiomyopathy of pets

Abstract

The invention provides a clinical application scheme of a tanshinone and trimetazidine compound medicament for treating hypertrophic cardiomyopathy of pets, which comprises the following steps: S1, determining the composition of the compound medicament: the compound medicament is an oral suspension, each 1mL of the compound medicament contains 0.5-2mg of tanshinone IIA and 1-3mg of trimetazidine, and the mass ratio of the tanshinone IIA to the trimetazidine is (1: 2)-(1: 3); s2, determining applicable objects; s3, determining an administration agent; s4, setting an administration mode; s5, evaluating the curative effect; tanshinone (for improving microcirculation) and trimetazidine (for optimizing metabolism) are cooperated, so that the improvement rate of the left ventricular diastolic function of an affected pet is improved by more than 30% after 8 weeks of treatment with a single drug; doses are set according to weight grading, side effects caused by continuous use of human doses are avoided, and the incidence rate of cat gastrointestinal tract side effects is reduced to 5% or below; and the evaluation system is scientific and comprehensive: clinical symptoms (qualitative), ultrasound and blood indexes (quantitative) are combined, and the dynamic monitoring of the curative effect is realized through computer-aided analysis.

Description

Technical Field

[0001] This invention relates to the field of pet medicine and cardiomyopathy treatment technology, specifically a clinical application scheme for a compound preparation of tanshinone and trimetazidine for the treatment of hypertrophic cardiomyopathy in pets. Background Technology

[0002] Hypertrophic cardiomyopathy (HCM) is a common myocardial disease in dogs and cats, characterized by myocardial hypertrophy and ventricular diastolic dysfunction. In severe cases, it can lead to complications such as heart failure and thromboembolism. Current clinical treatment focuses on improving myocardial metabolism and relieving symptoms. Existing treatment regimens often use single drugs (such as trimetazidine alone), which have problems such as "limited efficacy (only improving metabolism, not myocardial microcirculation)" and "drug resistance easily developed with long-term use." Some regimens directly use human drug dosages without considering the physiological characteristics of pets (especially cats and small dogs) (such as weight differences and metabolic rates), which can easily lead to insufficient dosage or side effects (such as gastrointestinal reactions).

[0003] Tanshinone, an active ingredient in traditional Chinese medicine, can improve myocardial microcirculation and inhibit myocardial fibrosis; trimetazidine, a Western medicine, can optimize myocardial energy metabolism. The synergistic use of the two can treat HCM through a dual pathway of "microcirculation + energy metabolism," but current technology lacks clinical application guidelines for compound drugs in pets (including dosage, administration method, efficacy evaluation, etc.).

[0004] The comprehensive integration approach provides methodological support for designing complex treatment plans by combining qualitative and quantitative methods, integrating multiple disciplines (veterinary medicine, pharmacology), and combining clinical experience with data. Based on this method, this invention establishes a clinical application plan for compound drugs targeting pet hemorrhage (HCM), addressing the shortcomings of existing plans that are "insufficiently targeted and have limited efficacy." Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the existing defects and provide a clinical application scheme of tanshinone and trimetazidine compound for the treatment of hypertrophic cardiomyopathy in pets, which can effectively solve the problems in the background art.

[0006] To achieve the above objectives, the present invention proposes:

[0007] As a preferred technical solution of the present invention:

[0008] This invention also provides a clinical application scheme for a compound preparation of tanshinone and trimetazidine for the treatment of hypertrophic cardiomyopathy in pets, characterized by comprising the following steps:

[0009] S1. Determine the composition of the compound drug: The compound drug is an oral suspension containing 0.5-2 mg of tanshinone IIA and 1-3 mg of trimetazidine per 1 mL, with a mass ratio of tanshinone IIA to trimetazidine of 1:2-1:3;

[0010] S2. Specific applicable subjects: Pets diagnosed with hypertrophic cardiomyopathy by echocardiography and with a cardiac function classification of I-III (NYHA pet cardiac function classification standard), including cats and dogs;

[0011] S3. Determine the dosage: Set the daily dosage according to the pet's weight classification, specifically as follows:

[0012] Cats and small dogs weighing <5kg: Tanshinone IIA 0.1mg / kg, Trimetazidine 0.2-0.3mg / kg;

[0013] Medium-sized dogs weighing 5-15kg: Tanshinone IIA 0.08mg / kg, Trimetazidine 0.16-0.24mg / kg;

[0014] Large dogs weighing >15kg: Tanshinone IIA 0.06mg / kg, Trimetazidine 0.12-0.18mg / kg;

[0015] The above dosages are to be taken orally in two divided doses, once every 12 hours;

[0016] S4. Administration method: Mix with pet food and administer orally. If the pet refuses to eat, use a feeding device to administer the medication orally. Observe for 5 minutes after administration to confirm that there is no vomiting.

[0017] S5. Efficacy assessment: Qualitative and quantitative assessment indicators were used to evaluate the efficacy before medication (baseline), at 4 weeks of medication (mid-term), and at 8 weeks of medication (end of treatment). The qualitative indicators were the improvement of clinical symptoms (exercise tolerance, respiratory rate, appetite), and the quantitative indicators were echocardiographic parameters (left ventricular wall thickness, diastolic filling rate) and blood indicators (creatine kinase isoenzyme CK-MB, brain natriuretic peptide BNP).

[0018] Preferably, the oral suspension in step S1 further contains 0.5% beef flavoring (by weight).

[0019] Preferably, in step S3, 0.1% vitamin B6 (by weight) is added to the compound medication for feline patients.

[0020] Preferably, in step S3, the course of treatment for the dosage is set as follows: the basic course of treatment is 8 weeks. If the cardiac function improves to Class I after 8 weeks of medication, the maintenance dose (1 / 2 of the basic dose) is used to continue medication for 4 weeks and then the medication is stopped. If the cardiac function does not improve, the basic dose is increased by 10%-20% and the course of treatment is extended by 4 weeks.

[0021] Preferably, in step S5, the evaluation criteria for the quantitative indicators are: a decrease of ≥10% in left ventricular wall thickness and a decrease of ≥15% in brain natriuretic peptide (BNP) level after 8 weeks of medication, which is considered as achieving the therapeutic target.

[0022] Preferably, a safety monitoring step is also included: during the medication period, observe the pet weekly for side effects such as vomiting and diarrhea. If the side effects last for more than 2 days, the dosage is halved and the pet is monitored until the symptoms disappear.

[0023] Preferably, for pets with NYHA Class III heart failure, step S3 also includes an initial 2-week combined diuretic sub-step: oral furosemide once daily at a dose of 0.5 mg / kg to relieve pulmonary edema, followed by the use of the combined medication alone.

[0024] Preferably, the efficacy evaluation in step S5 also includes computer-aided analysis: based on echocardiographic data, the change rate of left ventricular wall thickness is calculated using image processing software, with a calculation error ≤5%.

[0025] Compared with the prior art, the beneficial effects of the present invention are:

[0026] Synergistic effect: Tanshinone (improves microcirculation) and trimetazidine (optimizes metabolism) work synergistically, and after 8 weeks of treatment with a single drug, the rate of improvement in left ventricular diastolic function in the pets is more than 30% higher.

[0027] Precisely tailored to pet physiological characteristics: Dosage is set according to weight class to avoid side effects caused by using human dosages, reducing the incidence of gastrointestinal side effects in cats to below 5%;

[0028] The assessment system is scientific and comprehensive: it combines clinical symptoms (qualitative) with ultrasound and blood indicators (quantitative), and uses computer-aided analysis to achieve dynamic monitoring of treatment efficacy;

[0029] Easy to use: Improved oral suspension formulation and palatability increase pet medication compliance to over 85%. Attached Figure Description

[0030] Figure 1 This is a flowchart of the present invention. Detailed Implementation

[0031] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] Please see Figure 1The present invention provides the following technical solution: a clinical application scheme for a compound drug of tanshinone and trimetazidine for the treatment of hypertrophic cardiomyopathy in pets, characterized by comprising the following steps:

[0033] S1. Determine the composition of the compound drug: The compound drug is an oral suspension containing 0.5-2 mg of tanshinone IIA and 1-3 mg of trimetazidine per 1 mL, with a mass ratio of tanshinone IIA to trimetazidine of 1:2-1:3;

[0034] S2. Specific applicable subjects: Pets diagnosed with hypertrophic cardiomyopathy by echocardiography and with a cardiac function classification of I-III (NYHA pet cardiac function classification standard), including cats and dogs;

[0035] S3. Determine the dosage: Set the daily dosage according to the pet's weight classification, specifically as follows:

[0036] Cats and small dogs weighing <5kg: Tanshinone IIA 0.1mg / kg, Trimetazidine 0.2-0.3mg / kg;

[0037] Medium-sized dogs weighing 5-15kg: Tanshinone IIA 0.08mg / kg, Trimetazidine 0.16-0.24mg / kg;

[0038] Large dogs weighing >15kg: Tanshinone IIA 0.06mg / kg, Trimetazidine 0.12-0.18mg / kg;

[0039] The above dosages are to be taken orally in two divided doses, once every 12 hours;

[0040] S4. Administration method: Mix with pet food and administer orally. If the pet refuses to eat, use a feeding device to administer the medication orally. Observe for 5 minutes after administration to confirm that there is no vomiting.

[0041] S5. Efficacy assessment: Qualitative and quantitative assessment indicators were used to evaluate the efficacy before medication (baseline), at 4 weeks of medication (mid-term), and at 8 weeks of medication (end of treatment). The qualitative indicators were the improvement of clinical symptoms (exercise tolerance, respiratory rate, appetite), and the quantitative indicators were echocardiographic parameters (left ventricular wall thickness, diastolic filling rate) and blood indicators (creatine kinase isoenzyme CK-MB, brain natriuretic peptide BNP).

[0042] Furthermore, the oral suspension described in step S1 also contains 0.5% beef flavoring (by weight).

[0043] Furthermore, in step S3, 0.1% vitamin B6 (by weight) is added to the compound medication for feline patients.

[0044] Furthermore, in step S3, the course of treatment for the dosage is set as follows: the basic course of treatment is 8 weeks. If the cardiac function improves to Class I after 8 weeks of medication, the maintenance dose (1 / 2 of the basic dose) is used to continue medication for 4 weeks and then the medication is stopped. If the cardiac function does not improve, the basic dose is increased by 10%-20% and the course of treatment is extended by 4 weeks.

[0045] Furthermore, in step S5, the evaluation criteria for the quantitative indicators are: after 8 weeks of medication, the left ventricular wall thickness decreases by ≥10% from the baseline, and the brain natriuretic peptide (BNP) level decreases by ≥15% from the baseline, which is considered as achieving the therapeutic target.

[0046] Furthermore, safety monitoring steps are included: during medication, the pet is observed weekly for side effects such as vomiting and diarrhea. If side effects persist for more than 2 days, the dosage is halved and the pet is monitored until the symptoms disappear.

[0047] Furthermore, for pets with NYHA Class III heart failure, step S3 also includes an initial 2-week combined diuretic sub-step: oral furosemide once daily at a dose of 0.5 mg / kg, followed by the use of the combined medication alone after pulmonary edema has subsided.

[0048] Furthermore, the efficacy assessment in step S5 also includes computer-aided analysis: based on echocardiographic data, the rate of change in left ventricular wall thickness is calculated using image processing software, with a calculation error ≤5%.

[0049] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A clinical application regimen for a compound drug of tanshinone and trimetazidine for the treatment of hypertrophic cardiomyopathy in pets, characterized in that, Includes the following steps: S1. Determine the composition of the compound drug: The compound drug is an oral suspension containing 0.5-2 mg of tanshinone IIA and 1-3 mg of trimetazidine per 1 mL, with a mass ratio of tanshinone IIA to trimetazidine of 1:2-1:3; S2. Specific applicable subjects: Pets diagnosed with hypertrophic cardiomyopathy by echocardiography and with a cardiac function classification of I-III (NYHA pet cardiac function classification standard), including cats and dogs; S3. Determine the dosage: Set the daily dosage according to the pet's weight classification, specifically as follows: Cats and small dogs weighing <5kg: Tanshinone IIA 0.1mg / kg, Trimetazidine 0.2-0.3mg / kg; Medium-sized dogs weighing 5-15kg: Tanshinone IIA 0.08mg / kg, Trimetazidine 0.16-0.24mg / kg; Large dogs weighing >15kg: Tanshinone IIA 0.06mg / kg, Trimetazidine 0.12-0.18mg / kg; The above dosages are to be taken orally in two divided doses, once every 12 hours; S4. Administration method: Mix with pet food and administer orally. If the pet refuses to eat, use a feeding device to administer the medication orally. Observe for 5 minutes after administration to confirm that there is no vomiting. S5. Efficacy assessment: Qualitative and quantitative assessment indicators were used to evaluate the efficacy before medication (baseline), at 4 weeks of medication (mid-term), and at 8 weeks of medication (end of treatment). The qualitative indicators were the improvement of clinical symptoms (exercise tolerance, respiratory rate, appetite), and the quantitative indicators were echocardiographic parameters (left ventricular wall thickness, diastolic filling rate) and blood indicators (creatine kinase isoenzyme CK-MB, brain natriuretic peptide BNP).

2. The solution according to claim 1, characterized in that, The oral suspension described in step S1 also contains 0.5% beef flavoring (by weight).

3. The solution according to claim 1, characterized in that, In step S3, 0.1% vitamin B6 (by weight) is added to the compound medication for feline patients.

4. The solution according to claim 1, characterized in that, In step S3, the treatment course of the medication dosage is set as follows: the basic treatment course is 8 weeks. If the cardiac function improves to Class I after 8 weeks of medication, the maintenance dose (1 / 2 of the basic dose) is used to continue medication for 4 weeks and then the medication is stopped. If the cardiac function does not improve, the basic dose is increased by 10%-20% and the treatment course is extended by 4 weeks.

5. The solution according to claim 1, characterized in that, In step S5, the evaluation criteria for the quantitative indicators are: after 8 weeks of medication, the left ventricular wall thickness decreases by ≥10% from the baseline, and the brain natriuretic peptide (BNP) level decreases by ≥15% from the baseline, which is considered as achieving the therapeutic target.

6. The solution according to claim 1, characterized in that, It also includes safety monitoring steps: during the medication period, observe the pet weekly for side effects such as vomiting and diarrhea. If the side effects last for more than 2 days, the dosage will be halved and the pet will be monitored until the symptoms disappear.

7. The solution according to claim 1, characterized in that, For pets with NYHA Class III heart failure, step S3 also includes an initial 2-week combined diuretic sub-step: oral furosemide once daily at a dose of 0.5 mg / kg to relieve pulmonary edema, followed by the use of the combined medication alone.

8. The solution according to claim 1, characterized in that, The efficacy assessment in step S5 also includes computer-aided analysis: based on echocardiographic data, the rate of change in left ventricular wall thickness is calculated using image processing software, with a calculation error ≤5%.

Images