METHOD FOR TREATING A SIDE EFFECT CAUSED BY BCG PERFUSION THERAPY FOR BLADDER CANCER

20220062364 · 2022-03-03

    Inventors

    Cpc classification

    International classification

    Abstract

    The present invention relates to a method for treating a side effect caused by bacillus Calmette-Guérin (BCG) perfusion therapy for bladder cancer. The method includes: administering a Chinese medicine composition to a subject in need thereof; wherein the Chinese medicine composition is an extract of a first mixture comprising gentiana scabra, scutellariae Radix, gardeniae fructus, angelicae sinensis Radix, rehmanniae radix, akebiae caulis, Bupleurum chinense, plantaginis Semen, Atractylodes lancea, rhizoma alismatis, and glycyrrhiza uralensis.

    Claims

    1. A method for treating a side effect caused by bacillus Calmette-Gu{tilde over (e)}rin (BCG) perfusion therapy for bladder cancer, comprising: administering a Chinese medicine composition to a subject in need thereof; wherein, the Chinese medicine composition is an extract of a first mixture comprising gentiana scabra, scutellariae Radix, gardeniae fructus, angelicae sinensis Radix, rehmanniae radix, akebiae caulis, Bupleurum chinense, plantaginis Semen, Atractylodes lancea, rhizoma alismatis, and glycyrrhiza uralensis.

    2. The method of claim 1, wherein the Chinese medicine composition is prepared by the following steps: providing the first mixture; mixing the first mixture with water to form a second mixture; and heating the second mixture to obtain the Chinses medicine composition.

    3. The method of claim 1, wherein the first mixture comprises 1-5 parts by weight of gentiana scabra, 1-13 parts by weight of gardeniae fructus scutellariae Radix, 1-8 parts by weight of gardeniae fructus, 1-5 parts by weight of angelicae sinensis Radix, 1-5 parts by weight of rehmanniae radix, 1-5 parts by weight of akebiae caulis, 1-5 parts by weight of Bupleurum chinense, 1-5 parts by weight of plantaginis Semen, 2-6 parts by weight of Atractylodes lancea, 2-11 parts by weight of rhizoma alismatis, and 3-7 parts by weight of glycyrrhiza uralensis.

    4. The method of claim 3, wherein the first mixture comprises 2-4 parts by weight of gentiana scabra, 2-12 parts by weight of gardeniae fructus scutellariae Radix, 2-7 parts by weight of gardeniae fructus, 2-4 parts by weight of angelicae sinensis Radix, 2-4 parts by weight of rehmanniae radix, 2-4 parts by weight of akebiae caulis, 2-4 parts by weight of Bupleurum chinense, 2-4 parts by weight of plantaginis Semen, 3-5 parts by weight of Atractylodes lancea, 3-10 parts by weight of rhizoma alismatis, and 4-6 parts by weight of glycyrrhiza uralensis.

    5. The method of claim 3, wherein the part by weight is 2.5-5 gram per part.

    6. The method of claim 1, wherein the first mixture further comprises typhae pollen.

    7. The method of claim 6, wherein the first mixture further comprises 3-7 parts by weight of typhae pollen.

    8. The method of claim 6, wherein the first mixture comprises 1-5 parts by weight of gentiana scabra, 1-5 parts by weight of gardeniae fructus scutellariae Radix, 4-8 parts by weight of gardeniae fructus, 1-5 parts by weight of angelicae sinensis Radix, 1-5 parts by weight of rehmanniae radix, 1-5 parts by weight of akebiae caulis, 1-5 parts by weight of Bupleurum chinense, 1-5 parts by weight of plantaginis Semen, 2-6 parts by weight of Atractylodes lancea, 7-11 parts by weight of rhizoma alismatis, 3-7 parts by weight of glycyrrhiza uralensis, and 3-7 parts by weight of typhae pollen.

    9. The method of claim 8, wherein the first mixture comprises 2-4 parts by weight of gentiana scabra, 2-4 parts by weight of gardeniae fructus scutellariae Radix, 5-7 parts by weight of gardeniae fructus, 2-4 parts by weight of angelicae sinensis Radix, 2-4 parts by weight of rehmanniae radix, 2-4 parts by weight of akebiae caulis, 2-4 parts by weight of Bupleurum chinense, 2-4 parts by weight of plantaginis Semen, 3-5 parts by weight of Atractylodes lancea, 8-10 parts by weight of rhizoma alismatis, 4-6 parts by weight of glycyrrhiza uralensis, and 4-6 parts by weight of typhae pollen.

    10. The method of claim 1, wherein the first mixture further comprises Moutan cortex, puerariae lobatae radix, and optionally rhei Radix et rhizoma.

    11. The method of claim 10, wherein the first mixture comprises 6-10 parts by weight of Moutan cortex, 6-10 parts by weight of puerariae lobatae radix, and 0-3 parts by weight of rhei Radix et rhizoma.

    12. The method of claim 10, wherein the first mixture comprises 1-5 parts by weight of gentiana scabra, 9-13 parts by weight of gardeniae fructus scutellariae Radix, 1-5 parts by weight of gardeniae fructus, 1-5 parts by weight of angelicae sinensis Radix, 1-5 parts by weight of rehmanniae radix, 1-5 parts by weight of akebiae caulis, 1-5 parts by weight of Bupleurum chinense, 1-5 parts by weight of plantaginis Semen, 2-6 parts by weight of Atractylodes lancea, 2-6 parts by weight of rhizoma alismatis, 3-7 parts by weight of glycyrrhiza uralensis, 6-10 parts by weight of Moutan cortex, 6-10 parts by weight of puerariae lobatae radix, and 0-3 parts by weight of rhei Radix et rhizoma.

    13. The method of claim 12, wherein the first mixture comprises 2-4 parts by weight of gentiana scabra, 10-12 parts by weight of gardeniae fructus scutellariae Radix, 2-4 parts by weight of gardeniae fructus, 2-4 parts by weight of angelicae sinensis Radix, 2-4 parts by weight of rehmanniae radix, 2-4 parts by weight of akebiae caulis, 2-4 parts by weight of Bupleurum chinense, 2-4 parts by weight of plantaginis Semen, 3-5 parts by weight of Atractylodes lancea, 3-5 parts by weight of rhizoma alismatis, 4-6 parts by weight of glycyrrhiza uralensis, 7-9 parts by weight of Moutan cortex, 7-9 parts by weight of puerariae lobatae radix, and 0-2 parts by weight of rhei Radix et rhizoma.

    14. The method of claim 1, wherein the first mixture further comprise fructus crataegi and galli Gigerii Endothelium Coreneum.

    15. The method of claim 14, wherein the first mixture comprises 2-6 parts by weight of fructus crataegi and 2-6 parts by weight of galli Gigerii Endothelium Coreneum.

    16. The method of claim 10, wherein the first mixture further comprises fructus crataegi and galli Gigerii Endothelium Coreneum.

    17. The method of claim 16, wherein the first mixture comprises 1-5 parts by weight of gentiana scabra, 9-13 parts by weight of gardeniae fructus scutellariae Radix, 1-5 parts by weight of gardeniae fructus, 1-5 parts by weight of angelicae sinensis Radix, 1-5 parts by weight of rehmanniae radix, 1-5 parts by weight of akebiae caulis, 1-5 parts by weight of Bupleurum chinense, 1-5 parts by weight of plantaginis Semen, 2-6 parts by weight of Atractylodes lancea, 2-6 parts by weight of rhizoma alismatis, 3-7 parts by weight of glycyrrhiza uralensis, 6-10 parts by weight of Moutan cortex, 6-10 parts by weight of puerariae lobatae radix, 0-3 parts by weight of rhei Radix et rhizoma, 2-6 parts by weight of fructus crataegi and 2-6 parts by weight of galli Gigerii Endothelium Coreneum.

    18. The method of claim 17, wherein the first mixture comprise 2-4 parts by weight of gentiana scabra, 10-12 parts by weight of gardeniae fructus scutellariae Radix, 2-4 parts by weight of gardeniae fructus, 2-4 parts by weight of angelicae sinensis Radix, 2-4 parts by weight of rehmanniae radix, 2-4 parts by weight of akebiae caulis, 2-4 parts by weight of Bupleurum chinense, 2-4 parts by weight of plantaginis Semen, 3-5 parts by weight of Atractylodes lancea, 3-5 parts by weight of rhizoma alismatis, 4-6 parts by weight of glycyrrhiza uralensis, 7-9 parts by weight of Moutan cortex, 7-9 parts by weight of puerariae lobatae radix, 0-2 parts by weight of rhei Radix et rhizoma, 3-5 parts by weight of fructus crataegi and 3-5 parts by weight of galli Gigerii Endothelium Coreneum.

    19. The method of claim 1, wherein the bladder cancer comprises urothelial carcinoma, squamous cell carcinoma, adenocarcinoma, sarcoma, or small cell carcinoma.

    20. The method of claim 1, wherein the side effect comprises red and swollen bladder lining, pollakiuria, hematuria, dysuria, poor appetite, frigophobia or pain.

    Description

    DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

    [0025] The following embodiments are meant to explain the implementation of the present invention, they should be construed as descriptive merely, and should not restrict the remaining part of the present invention. The person having ordinary skills in the art can easily understand other advantages and effects of the present invention. The present invention may also be implemented or applied by other different embodiments, and various details in this specification may also be modified and changed according to different viewpoints and applications without departing from the spirit of the invention.

    [0026] In addition, ordinal numbers such as “first”, “second” and the like used in the specification and claim for modifying elements of the claim do not mean and represent the claimed elements have any antecedent ordinal number, nor do they represent the order (or order of production) between a claimed element and another claimed element. The ordinal numbers are only used to clearly distinguish certain claimed elements having the same name.

    [0027] The preparation of the Chinese medicine composition of the present invention is described below, wherein the materials used in the present invention are commercially available and easy to obtain. In addition, the part by weight by weight is 3.75 gram per part.

    Preparation Example 1: Preparation of Chinese Medicine Composition-1

    [0028] Provide 3 parts by weight of gentiana scabra, 3 parts by weight of gardeniae fructus scutellariae Radix, 6 parts by weight of gardeniae fructus, 3 parts by weight of angelicae sinensis Radix, 3 parts by weight of rehmanniae radix, 3 parts by weight of akebiae caulis, 3 parts by weight of Bupleurum chinense, 3 parts by weight of plantaginis Semen, 4 parts by weight of Atractylodes lancea, 9 parts by weight of rhizoma alismatis, 5 parts by weight of glycyrrhiza uralensis, and 5 parts by weight of typhae pollen to form a first mixture-1; mix the first mixture-1 with about 267 parts by weight of water to form a second mixture-1; heat the second mixture-1 for about 1 hour; filter the crude extract to remove a residue and obtain a Chinese medicine composition-1.

    Preparation Example 2: Preparation of Chinese Medicine Composition-2

    [0029] Provide 3 parts by weight of gentiana scabra, 11 parts by weight of gardeniae fructus scutellariae Radix, 6 parts by weight of gardeniae fructus, 3 parts by weight of angelicae sinensis Radix, 3 parts by weight of rehmanniae radix, 3 parts by weight of akebiae caulis, 3 parts by weight of Bupleurum chinense, 3 parts by weight of plantaginis Semen, 4 parts by weight of Atractylodes lancea, 4 parts by weight of rhizoma alismatis, 5 parts by weight of glycyrrhiza uralensis, 8 parts by weight of Moutan cortex, 8 parts by weight of puerariae lobatae radix, and 0.5 parts by weight of rhei Radix et rhizoma to form a first mixture-2; mix the first mixture-2 with about 267 parts by weight of water to form a second mixture-2; heat the second mixture-2 to form about 120 parts by weight of a crude extract; filter the crude extract to remove a residue and obtain a Chinese medicine composition-2.

    Preparation Example 3: Preparation of Chinese Medicine Composition-3

    [0030] Provide 3 parts by weight of gentiana scabra, 11 parts by weight of gardeniae fructus scutellariae Radix, 6 parts by weight of gardeniae fructus, 3 parts by weight of angelicae sinensis Radix, 3 parts by weight of rehmanniae radix, 3 parts by weight of akebiae caulis, 3 parts by weight of Bupleurum chinense, 3 parts by weight of plantaginis Semen, 4 parts by weight of Atractylodes lancea, 4 parts by weight of rhizoma alismatis, 5 parts by weight of glycyrrhiza uralensis, 8 parts by weight of Moutan cortex, 8 parts by weight of puerariae lobatae radix, 0.5 parts by weight of rhei Radix et rhizoma, 4 parts by weight of fructus crataegi and 4 parts by weight of galli Gigerii Endothelium Coreneum to form a first mixture-3; mix the first mixture-3 with about 267 parts by weight of water to form a second mixture-3; heat the second mixture-3 to form about 120 parts by weight of a crude extract; filter the crude extract to remove a residue and obtain a Chinese medicine composition-3.

    Embodiment 1

    [0031] Due to bladder cancer, a 32-year-old male patient of Example 1 was performed with tumor curettage followed by BCG perfusion therapy. After two months of the BCG perfusion therapy, red and swollen bladder lining was observed in the patient by cystoscopic examination, and the patient had conditions of pollakiuria and dysuria.

    [0032] A treatment of the present invention applied to the patient of Example 1 was described below. A daily dose of the Chinese medicine composition-1 was administered to the patient every day, wherein the daily dose of the Chinese medicine composition-1 was divided into aliquots for ter in die administration. After taking the Chinese medicine composition-1 for a month, the conditions of pollakiuria and dysuria were no longer observed. In addition, after follow-up for more than 20 years, no recurrence of dysuria or bladder cancer was found, and the tumor metastasis to the ureter or kidney was not found.

    Embodiment 2

    [0033] Due to bladder cancer, a male patient of Example 2 was performed with tumor curettage, and had conditions of hematuria, losing control of urination, and frigophobia. Later, BCG perfusion therapy was performed on the patient.

    [0034] A treatment of the present invention applied to the patient of Example 2 was described below. After the tumor curettage was performed, a daily dose of the Chinese medicine composition-2 was administered to the patient every day, wherein the daily dose of the Chinese medicine composition-2 was divided into aliquots for ter in die administration. After taking the Chinese medicine composition-2 for three weeks, the conditions including frigophobia were no longer observed. In addition, the patient of Example 2 not only took the Chinese medicine composition-2 before receiving the BCG perfusion therapy, but also daily took the Chinese medicine composition-2 during the course of BCG perfusion therapy. Therefore, the patient had no uncomfortable reaction during the course BCG perfusion therapy.

    Embodiment 3

    [0035] In the Embodiment 3, an 82-year-old male patient had four tumors with a total size of 6.5 cm in the bladder, and the tumors were scraped by endoscope. Later, BCG perfusion therapy was performed. During the course of the treatment above, the patient had conditions of hematuria, pain and poor appetite.

    [0036] A treatment of the present invention applied to the patient of Example 3 was described below. After the tumor curettage was performed, a daily dose of the Chinese medicine composition-2 was administered to the patient every day, wherein the daily dose of the Chinese medicine composition-2 was divided into aliquots for ter in die administration. After taking the Chinese medicine composition-2 for three months, the patient still had conditions of pain and poor appetite. Then, the Chinese medicine composition-3 was administered to the patient every day instead, wherein the daily dose of the Chinese medicine composition-3 was divided into aliquots for ter in die administration. After about 3 months, bladder endoscopy was performed, no new tumor was found, and the side effects were significantly improved. After 9 years of follow-up, the bladder tumor did not recur or metastasized.

    [0037] Although the present invention has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the invention as hereinafter claimed.