WO2023184818A1 - 米托蒽醌在制备预防或治疗急性移植物抗宿主病药物中的应用 - Google Patents
米托蒽醌在制备预防或治疗急性移植物抗宿主病药物中的应用 Download PDFInfo
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- mitoxantrone
- host disease
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- 229960001156 mitoxantrone Drugs 0.000 title claims abstract description 27
- KKZJGLLVHKMTCM-UHFFFAOYSA-N mitoxantrone Chemical compound O=C1C2=C(O)C=CC(O)=C2C(=O)C2=C1C(NCCNCCO)=CC=C2NCCNCCO KKZJGLLVHKMTCM-UHFFFAOYSA-N 0.000 title claims abstract description 27
- 208000024340 acute graft versus host disease Diseases 0.000 title claims abstract description 25
- 239000003814 drug Substances 0.000 title claims abstract description 16
- 229940079593 drug Drugs 0.000 claims description 14
- 238000002347 injection Methods 0.000 claims description 12
- 239000007924 injection Substances 0.000 claims description 12
- 208000009329 Graft vs Host Disease Diseases 0.000 claims description 10
- 208000024908 graft versus host disease Diseases 0.000 claims description 10
- 239000002552 dosage form Substances 0.000 claims description 6
- 210000003958 hematopoietic stem cell Anatomy 0.000 claims description 6
- 230000004083 survival effect Effects 0.000 claims description 6
- 238000002360 preparation method Methods 0.000 claims description 5
- 210000002798 bone marrow cell Anatomy 0.000 claims description 4
- 239000006186 oral dosage form Substances 0.000 claims description 4
- 210000004989 spleen cell Anatomy 0.000 claims description 4
- 230000000919 anti-host Effects 0.000 claims description 3
- 201000010099 disease Diseases 0.000 claims description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 3
- 206010067125 Liver injury Diseases 0.000 claims description 2
- 239000004480 active ingredient Substances 0.000 claims description 2
- 239000002775 capsule Substances 0.000 claims description 2
- 239000008187 granular material Substances 0.000 claims description 2
- 231100000234 hepatic damage Toxicity 0.000 claims description 2
- 238000010255 intramuscular injection Methods 0.000 claims description 2
- 239000007927 intramuscular injection Substances 0.000 claims description 2
- 238000010253 intravenous injection Methods 0.000 claims description 2
- 230000008818 liver damage Effects 0.000 claims description 2
- 239000000843 powder Substances 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims description 2
- 238000010254 subcutaneous injection Methods 0.000 claims description 2
- 239000007929 subcutaneous injection Substances 0.000 claims description 2
- 239000003826 tablet Substances 0.000 claims description 2
- 238000011282 treatment Methods 0.000 abstract description 7
- 238000011269 treatment regimen Methods 0.000 abstract description 3
- 210000001744 T-lymphocyte Anatomy 0.000 abstract 1
- 238000002626 targeted therapy Methods 0.000 abstract 1
- 241000699670 Mus sp. Species 0.000 description 26
- 241001465754 Metazoa Species 0.000 description 5
- 241000699666 Mus <mouse, genus> Species 0.000 description 4
- 210000004185 liver Anatomy 0.000 description 4
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 3
- 230000001154 acute effect Effects 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 238000007490 hematoxylin and eosin (H&E) staining Methods 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 2
- 230000018044 dehydration Effects 0.000 description 2
- 238000006297 dehydration reaction Methods 0.000 description 2
- 239000003651 drinking water Substances 0.000 description 2
- 235000020188 drinking water Nutrition 0.000 description 2
- 230000002035 prolonged effect Effects 0.000 description 2
- NHBKXEKEPDILRR-UHFFFAOYSA-N 2,3-bis(butanoylsulfanyl)propyl butanoate Chemical compound CCCC(=O)OCC(SC(=O)CCC)CSC(=O)CCC NHBKXEKEPDILRR-UHFFFAOYSA-N 0.000 description 1
- 206010000830 Acute leukaemia Diseases 0.000 description 1
- 238000011740 C57BL/6 mouse Methods 0.000 description 1
- CEAZRRDELHUEMR-URQXQFDESA-N Gentamicin Chemical compound O1[C@H](C(C)NC)CC[C@@H](N)[C@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](NC)[C@@](C)(O)CO2)O)[C@H](N)C[C@@H]1N CEAZRRDELHUEMR-URQXQFDESA-N 0.000 description 1
- 229930182566 Gentamicin Natural products 0.000 description 1
- 102100028999 High mobility group protein HMGI-C Human genes 0.000 description 1
- 101000986379 Homo sapiens High mobility group protein HMGI-C Proteins 0.000 description 1
- 206010060862 Prostate cancer Diseases 0.000 description 1
- 208000000236 Prostatic Neoplasms Diseases 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 238000010171 animal model Methods 0.000 description 1
- PYKYMHQGRFAEBM-UHFFFAOYSA-N anthraquinone Natural products CCC(=O)c1c(O)c2C(=O)C3C(C=CC=C3O)C(=O)c2cc1CC(=O)OC PYKYMHQGRFAEBM-UHFFFAOYSA-N 0.000 description 1
- 150000004056 anthraquinones Chemical class 0.000 description 1
- 230000001093 anti-cancer Effects 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 229940041181 antineoplastic drug Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000010322 bone marrow transplantation Methods 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 210000000805 cytoplasm Anatomy 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 238000007598 dipping method Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 229960003276 erythromycin Drugs 0.000 description 1
- 229960002518 gentamicin Drugs 0.000 description 1
- 208000014951 hematologic disease Diseases 0.000 description 1
- 238000011134 hematopoietic stem cell transplantation Methods 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 238000001794 hormone therapy Methods 0.000 description 1
- 230000036571 hydration Effects 0.000 description 1
- 238000006703 hydration reaction Methods 0.000 description 1
- 238000007654 immersion Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 210000004969 inflammatory cell Anatomy 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 210000005228 liver tissue Anatomy 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- ZAHQPTJLOCWVPG-UHFFFAOYSA-N mitoxantrone dihydrochloride Chemical compound Cl.Cl.O=C1C2=C(O)C=CC(O)=C2C(=O)C2=C1C(NCCNCCO)=CC=C2NCCNCCO ZAHQPTJLOCWVPG-UHFFFAOYSA-N 0.000 description 1
- 229960004169 mitoxantrone hydrochloride Drugs 0.000 description 1
- 201000006417 multiple sclerosis Diseases 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 238000004393 prognosis Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
Definitions
- the invention belongs to the drug technology for anti-host disease, and specifically discloses the application of mitoxantrone in preparing drugs for preventing or treating acute graft-versus-host disease.
- graft-versus-host disease graft-versus-host disease
- mitoxantrone has broad-spectrum anti-cancer effects and low myocardial toxicity. It is currently mainly used clinically to treat acute leukemia, prostate cancer, and multiple sclerosis. treatment of acute graft-versus-host disease; there are no studies on the treatment of acute graft-versus-host disease.
- the invention discloses a new function of mitoxantrone - the effect of preventing the occurrence of acute graft-versus-host disease, and provides more effective treatment strategies and ideas for the new treatment of acute graft-versus-host disease.
- the invention discloses the application of mitoxantrone in the preparation of medicines for preventing or treating graft-versus-host disease, especially the application of mitoxantrone in the preparation of medicines for preventing or treating acute graft-versus-host disease.
- the invention discloses the application of mitoxantrone in preparing drugs for preventing or treating anti-host disease caused by hematopoietic stem cells.
- the invention discloses the application of mitoxantrone in preparing drugs for prolonging the survival time of patients with graft-versus-host disease.
- the invention discloses the application of mitoxantrone in preparing drugs for reducing liver damage in patients with graft-versus-host disease.
- a drug for preventing or treating acute graft-versus-host disease the active ingredient of which is mitoxantrone or a pharmaceutically acceptable salt thereof.
- the acute transplant is hematopoietic stem cells.
- the drug is an injection dosage form or an oral dosage form.
- the oral dosage form includes tablets, capsules, powders, and granules
- the injection dosage form includes intravenous injection, intramuscular injection, subcutaneous injection, Intradermal injection, intracavity injection.
- the present invention uses mitoxantrone to treat hematopoietic stem cell donor mice, obtains the hematopoietic stem cells of the donor mice, transplants them to recipient mice, and observes the occurrence time of acute graft-versus-host disease; confirming the new function of mitoxantrone - Prevent the occurrence of acute graft-versus-host disease and provide more effective treatment strategies for acute graft-versus-host disease in the future.
- Figure 1 is a comparison curve of the acute rejection index of recipient mice in the experimental group and the control group.
- Figure 2 is a comparison curve of survival time of recipient mice in the experimental group and the control group.
- Figure 3 shows the comparison of HE staining of liver tissue of recipient mice in the experimental group and the control group.
- mice C57BL/6 mice (H-2 b ) and BALB/C mice (H-2 d ) are both female mice, 6-8 weeks old and weighing 17-22 grams. Purchase Shanghai Slack Laboratory Animals company. The mice's drinking water, feed and bedding were sterilized. All mice were housed in SPF grade isolation cages. All animal experiments were conducted in accordance with the requirements of the Experimental and Animal Ethics Committee of Soochow University.
- mice C57 mice (donor mice) were injected with mitoxantrone diluent 1 day before bone marrow transplantation.
- Mitoxantrone hydrochloride was purchased from SIGMA Company, diluted in PBS, and injected subcutaneously into the abdomen of mice at a dose of 5.2 mg/kg. test group. No injection of mitoxantrone served as a control group.
- livers of the mice in the experimental group had only a small amount of degeneration, with loose and lightly stained cytoplasm (white arrow), while the livers of the recipient mice in the control group showed obvious necrosis (black arrow) and inflammatory cell infiltration (black arrow). See Figure 3.
- mitoxantrone can slow down the occurrence of aGvHD through in vivo animal experiments, which provides valuable theoretical support for subsequent clinical research.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Transplantation (AREA)
- Gastroenterology & Hepatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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- Epidemiology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
本发明公开了米托蒽醌在制备预防或治疗急性移植物抗宿主病药物中的应用。如何预防以及治疗aGvHD是困扰血液界的一大难题，供体T细胞的数量及患者的年龄等均是导致aGvHD产生的重要因素，aGvHD的治疗方法多种，且目前尚未有药物能够彻底治愈它，因此迫切需要寻找新的针对aGvHD的靶向药物来解决这一难题。本发明公开了米托蒽醌新的功能-预防急性移植物抗宿主病发生的作用，为急性移植物抗宿主病新的治疗提供更有效的治疗策略提及思路。
Description
本发明属于抗宿主病药物技术，具体公开了米托蒽醌在制备预防或治疗急性移植物抗宿主病药物中的应用。
造血干细胞移植是当今根治恶性血液病的方式，但随之而来的移植物抗宿主病（GVHD），严重影响此类病人的预后和存活。虽然移植物抗宿主病的临床治疗取得了一些进展，但仍有大量病例对现有以激素治疗为基础的治疗方法无效或激素依赖。因此，寻找新的药物已经成为非常棘手的问题。米托蒽醌 (mitoxantrone)作为蒽醌类抗肿瘤药物，具有广谱抗癌效应及较低的心肌毒性的特点，目前在临床上主要将其用于治疗急性白血病、前列腺癌，以及多发性硬化病的治疗；未见治疗急性移植物抗宿主病的研究。
本发明公开了米托蒽醌新的功能-预防急性移植物抗宿主病发生的作用，为急性移植物抗宿主病新的治疗提供更有效的治疗策略提及思路。
本发明公开了米托蒽醌在制备预防或治疗移植物抗宿主病药物中的应用，尤其是米托蒽醌在制备预防或治疗急性移植物抗宿主病药物中的应用。
本发明公开了米托蒽醌在制备预防或治疗造血干细胞导致的抗宿主病药物中的应用。
本发明公开了米托蒽醌在制备延长移植物抗宿主病患者生存时间药物中的应用。
本发明公开了米托蒽醌在制备减轻移植物抗宿主病患者肝脏损伤药物中的应用。
一种预防或治疗急性移植物抗宿主病药物，其活性成分为米托蒽醌或其药学上可接受的盐，优选的，急性移植物为造血干细胞。
本发明中，药物为注射给药剂型或者口服给药剂型，进一步的，口服给药剂型包括片剂、胶囊剂、散剂、颗粒剂，注射给药剂型包括静脉注射、肌内注射、皮下注射、皮内注射、腔内注射。
本发明用米托蒽醌处理造血干细胞供体小鼠，获取供体鼠的造血干细胞，移植给受体小鼠，观察急性移植物抗宿主病的发生时间；证实米托蒽醌新的功能-预防急性移植物抗宿主病发生，为今后急性移植物抗宿主病提供更有效的治疗策略提及思路。
图1为实验组与对照组受体小鼠急性排异指数对比曲线。
图2为实验组与对照组受体小鼠生存时间对比曲线。
图3为实验组与对照组受体小鼠肝脏组织HE染色对比。
本发明具体建模方法以及实验操作都为本领域常规方法。C57BL/6小鼠(H-2
b)和BALB/C小鼠(H-2
d)均为雌性小鼠，周龄为6-8周，体重为17-22 克，购买上海斯莱克实验动物公司。小鼠的饮用水、饲料和垫料均经过灭菌处理。所有小鼠均饲养于SPF级别的隔离笼内。所有动物实验均按照苏州大学实验与动物伦理委员要求操作。
动物实验：1. Babl/c小鼠（受体鼠）移植通过饮水喂庆大霉素和红霉素一周。
2. C57小鼠(供体鼠)骨髓移植前1天注射米托蒽醌稀释液，盐酸米托蒽醌购自SIGMA公司，PBS稀释，小鼠腹部皮下注射，注射剂量5.2mg/kg，作为实验组。不注射米托蒽醌作为对照组。
3. Babl/c小鼠（受体鼠）接受3.5+3.5GY剂量照射（中间间隔1h）。
4. 取C57小鼠(供体鼠)骨髓细胞及脾脏细胞；骨髓细胞1×10
7/只、脾脏细胞5×10
6/只，使用小鼠固定器将小鼠固定，尾静脉将骨髓细胞和脾脏细胞全部注射于受体BABL/c小鼠体内。观察急性移植物抗宿主病（aGVHD）的发生并进行评分。评分标准参照表1，引自Blood,Vol8, No 8 (October
15), 1996: Pp 3230-3239。
。
5. 注射米托蒽醌组，小鼠急性移植物抗宿主病明显减轻，存活明显延长，急性排异指数下降，参见图1、图2；取移植14d后小鼠肝脏于4%中性甲醛，固定48h。按照以下方法操作：脱水-媒浸（透明）-浸蜡与包埋-切片-贴片-切片脱蜡及水化-染色（苏木精和伊红染色法，简称HE染色）-切片脱水-观察。实验组小鼠肝脏仅有少量的变性，胞质疏松淡染（白色箭头），而对照组的受体鼠肝脏可见明显的坏死（黑色箭头），炎症细胞浸润（黑色箭头）。参见图3。
通过研究发现给供体小鼠注射适当剂量的米托蒽醌后，受体小鼠的生存期会延长，且aGvHD的靶器官组织（肝脏）损伤也会减轻，这表明米托蒽醌可减缓aGvHD的发生，本发明通过动物体内实验，公开了米托蒽醌可以减慢aGvHD的发生，这为后续临床研究提供了宝贵的理论支持。
Claims (10)
- 米托蒽醌在制备预防或治疗移植物抗宿主病药物中的应用。
- 根据权利要求1所述的应用，其特征在于，米托蒽醌制备为注射给药剂型或者口服给药剂型。
- 根据权利要求2所述的应用，其特征在于，口服给药剂型包括片剂、胶囊剂、散剂、颗粒剂；注射给药剂型包括静脉注射、肌内注射、皮下注射、皮内注射、腔内注射。
- 根据权利要求1所述的应用，其特征在于，移植物抗宿主病为急性移植物抗宿主病。
- 米托蒽醌在制备预防或治疗造血干细胞导致的抗宿主病药物中的应用。
- 根据权利要求5所述的应用，其特征在于，米托蒽醌制备为注射给药剂型或者口服给药剂型。
- 根据权利要求5所述的应用，其特征在于，造血干细胞包括骨髓细胞、脾脏细胞。
- 一种预防或治疗急性移植物抗宿主病药物，其活性成分为米托蒽醌或其药学上可接受的盐。
- 米托蒽醌在制备延长移植物抗宿主病患者生存时间药物中的应用。
- 米托蒽醌在制备减轻移植物抗宿主病患者肝脏损伤药物中的应用。
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| CN115337295B (zh) * | 2022-09-21 | 2023-04-21 | 中南大学 | 米托蒽醌在制备地中海贫血治疗药物中的应用 |
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| CN114732807A (zh) * | 2022-03-27 | 2022-07-12 | 苏州大学 | 米托蒽醌在制备预防或治疗急性移植物抗宿主病药物中的应用 |
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| EP1671648A4 (en) * | 2003-10-02 | 2009-07-08 | Eisai R&D Man Co Ltd | PREVENTION AND TREATMENT OF GVHD |
| US20070110728A1 (en) * | 2003-11-28 | 2007-05-17 | Develogen Aktiengesellschaft | Method for preventing and treating diabetes using dg119 |
| PL2717887T3 (pl) * | 2011-06-09 | 2018-06-29 | University Of Florida Research Foundation, Inc. | Sposoby leczenia lub zapobiegania chorobie przeszczep przeciw gospodarzowi |
| ES2788744T3 (es) * | 2013-05-02 | 2020-10-22 | Mor Research Applic Ltd | Cannabidiol para la prevención y el tratamiento de la enfermedad de injerto contra huésped |
| CN105030749B (zh) * | 2015-07-09 | 2017-10-17 | 上海交通大学医学院附属瑞金医院 | 丙戊酸钠在制备预防和治疗移植物抗宿主病药物中的应用 |
| EP3740233A4 (en) * | 2018-01-18 | 2021-11-24 | Magenta Therapeutics, Inc. | COMPOSITIONS AND METHODS FOR DEPLOYING CD134 + CELLS |
| CN111265664B (zh) * | 2019-11-27 | 2021-09-21 | 华东医院 | 用于预防和治疗急性移植物抗宿主病的组合物 |
| CN114191544A (zh) * | 2022-01-13 | 2022-03-18 | 苏州大学 | 去泛素化酶在制备预防或治疗急性移植物抗宿主病和移植物抗白血病药物中的应用 |
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