ITRM20110216A1 - VITAMIN B1 FOR USE IN THE TREATMENT OF INFLAMMATORY DISEASES - AUTOIMMUNITY. - Google Patents
VITAMIN B1 FOR USE IN THE TREATMENT OF INFLAMMATORY DISEASES - AUTOIMMUNITY. Download PDFInfo
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- ITRM20110216A1 ITRM20110216A1 IT000216A ITRM20110216A ITRM20110216A1 IT RM20110216 A1 ITRM20110216 A1 IT RM20110216A1 IT 000216 A IT000216 A IT 000216A IT RM20110216 A ITRM20110216 A IT RM20110216A IT RM20110216 A1 ITRM20110216 A1 IT RM20110216A1
- Authority
- IT
- Italy
- Prior art keywords
- vitamin
- treatment
- inflammatory
- disease
- chronic fatigue
- Prior art date
Links
- 238000011282 treatment Methods 0.000 title claims description 18
- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 title claims description 11
- 208000027866 inflammatory disease Diseases 0.000 title description 4
- 230000005784 autoimmunity Effects 0.000 title description 2
- 229960003495 thiamine Drugs 0.000 claims description 30
- 229930003451 Vitamin B1 Natural products 0.000 claims description 29
- 239000011691 vitamin B1 Substances 0.000 claims description 29
- 235000010374 vitamin B1 Nutrition 0.000 claims description 29
- 206010016256 fatigue Diseases 0.000 claims description 23
- 208000023275 Autoimmune disease Diseases 0.000 claims description 11
- 239000008194 pharmaceutical composition Substances 0.000 claims description 11
- 206010009900 Colitis ulcerative Diseases 0.000 claims description 8
- 201000006704 Ulcerative Colitis Diseases 0.000 claims description 8
- 201000006417 multiple sclerosis Diseases 0.000 claims description 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 7
- 206010043778 thyroiditis Diseases 0.000 claims description 7
- 208000011231 Crohn disease Diseases 0.000 claims description 6
- 208000001640 Fibromyalgia Diseases 0.000 claims description 6
- 206010039073 rheumatoid arthritis Diseases 0.000 claims description 6
- 208000023328 Basedow disease Diseases 0.000 claims description 5
- 208000015023 Graves' disease Diseases 0.000 claims description 5
- 201000004681 Psoriasis Diseases 0.000 claims description 5
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims description 5
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims description 5
- 239000003826 tablet Substances 0.000 claims description 5
- 239000002775 capsule Substances 0.000 claims description 4
- 238000007918 intramuscular administration Methods 0.000 claims description 4
- 239000008187 granular material Substances 0.000 claims description 3
- -1 lyophilisate Substances 0.000 claims description 3
- 239000006187 pill Substances 0.000 claims description 3
- 239000000843 powder Substances 0.000 claims description 3
- 239000000243 solution Substances 0.000 claims description 3
- 208000037979 autoimmune inflammatory disease Diseases 0.000 claims 2
- KYMBYSLLVAOCFI-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SCN1CC1=CN=C(C)N=C1N KYMBYSLLVAOCFI-UHFFFAOYSA-N 0.000 description 21
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 10
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 9
- 201000010099 disease Diseases 0.000 description 9
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 7
- 239000000203 mixture Substances 0.000 description 7
- 230000007170 pathology Effects 0.000 description 7
- 238000002560 therapeutic procedure Methods 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
- 238000009472 formulation Methods 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 3
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 description 3
- 239000002202 Polyethylene glycol Substances 0.000 description 3
- 239000001913 cellulose Substances 0.000 description 3
- 235000010980 cellulose Nutrition 0.000 description 3
- 229920002678 cellulose Polymers 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
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- 239000002904 solvent Substances 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 2
- 229920000881 Modified starch Polymers 0.000 description 2
- 240000007817 Olea europaea Species 0.000 description 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 235000010443 alginic acid Nutrition 0.000 description 2
- 229920000615 alginic acid Polymers 0.000 description 2
- SESFRYSPDFLNCH-UHFFFAOYSA-N benzyl benzoate Chemical compound C=1C=CC=CC=1C(=O)OCC1=CC=CC=C1 SESFRYSPDFLNCH-UHFFFAOYSA-N 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
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- 235000011852 gelatine desserts Nutrition 0.000 description 2
- 210000000987 immune system Anatomy 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 238000009115 maintenance therapy Methods 0.000 description 2
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- 238000011084 recovery Methods 0.000 description 2
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- 239000000725 suspension Substances 0.000 description 2
- 239000000454 talc Substances 0.000 description 2
- 229910052623 talc Inorganic materials 0.000 description 2
- 229940088594 vitamin Drugs 0.000 description 2
- 229930003231 vitamin Natural products 0.000 description 2
- 235000013343 vitamin Nutrition 0.000 description 2
- 239000011782 vitamin Substances 0.000 description 2
- 150000003722 vitamin derivatives Chemical class 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- JNYAEWCLZODPBN-JGWLITMVSA-N (2r,3r,4s)-2-[(1r)-1,2-dihydroxyethyl]oxolane-3,4-diol Chemical class OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O JNYAEWCLZODPBN-JGWLITMVSA-N 0.000 description 1
- 239000005995 Aluminium silicate Substances 0.000 description 1
- 235000017060 Arachis glabrata Nutrition 0.000 description 1
- 244000105624 Arachis hypogaea Species 0.000 description 1
- 235000010777 Arachis hypogaea Nutrition 0.000 description 1
- 235000018262 Arachis monticola Nutrition 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 206010008874 Chronic Fatigue Syndrome Diseases 0.000 description 1
- 229920000742 Cotton Polymers 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- LVGKNOAMLMIIKO-UHFFFAOYSA-N Elaidinsaeure-aethylester Natural products CCCCCCCCC=CCCCCCCCC(=O)OCC LVGKNOAMLMIIKO-UHFFFAOYSA-N 0.000 description 1
- 206010060891 General symptom Diseases 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 241000219146 Gossypium Species 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 235000004443 Ricinus communis Nutrition 0.000 description 1
- 244000000231 Sesamum indicum Species 0.000 description 1
- 235000003434 Sesamum indicum Nutrition 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- SSZBUIDZHHWXNJ-UHFFFAOYSA-N Stearinsaeure-hexadecylester Natural products CCCCCCCCCCCCCCCCCC(=O)OCCCCCCCCCCCCCCCC SSZBUIDZHHWXNJ-UHFFFAOYSA-N 0.000 description 1
- JZRWCGZRTZMZEH-UHFFFAOYSA-N Thiamine Natural products CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N JZRWCGZRTZMZEH-UHFFFAOYSA-N 0.000 description 1
- 206010043781 Thyroiditis chronic Diseases 0.000 description 1
- 235000021307 Triticum Nutrition 0.000 description 1
- 244000098338 Triticum aestivum Species 0.000 description 1
- 240000008042 Zea mays Species 0.000 description 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 1
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 239000003655 absorption accelerator Substances 0.000 description 1
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- 239000004480 active ingredient Substances 0.000 description 1
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- 235000012211 aluminium silicate Nutrition 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 239000008365 aqueous carrier Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 229960005070 ascorbic acid Drugs 0.000 description 1
- 235000010323 ascorbic acid Nutrition 0.000 description 1
- 239000011668 ascorbic acid Substances 0.000 description 1
- 230000001363 autoimmune Effects 0.000 description 1
- 229960002903 benzyl benzoate Drugs 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 235000010216 calcium carbonate Nutrition 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 229910000389 calcium phosphate Inorganic materials 0.000 description 1
- 235000011010 calcium phosphates Nutrition 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 210000003169 central nervous system Anatomy 0.000 description 1
- 229960000541 cetyl alcohol Drugs 0.000 description 1
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 1
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- 235000005822 corn Nutrition 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- UGMCXQCYOVCMTB-UHFFFAOYSA-K dihydroxy(stearato)aluminium Chemical compound CCCCCCCCCCCCCCCCCC(=O)O[Al](O)O UGMCXQCYOVCMTB-UHFFFAOYSA-K 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
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- 239000012645 endogenous antigen Substances 0.000 description 1
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- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 1
- 235000019439 ethyl acetate Nutrition 0.000 description 1
- LVGKNOAMLMIIKO-QXMHVHEDSA-N ethyl oleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC LVGKNOAMLMIIKO-QXMHVHEDSA-N 0.000 description 1
- 229940093471 ethyl oleate Drugs 0.000 description 1
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- YQEMORVAKMFKLG-UHFFFAOYSA-N glycerine monostearate Natural products CCCCCCCCCCCCCCCCCC(=O)OC(CO)CO YQEMORVAKMFKLG-UHFFFAOYSA-N 0.000 description 1
- SVUQHVRAGMNPLW-UHFFFAOYSA-N glycerol monostearate Natural products CCCCCCCCCCCCCCCCC(=O)OCC(O)CO SVUQHVRAGMNPLW-UHFFFAOYSA-N 0.000 description 1
- 208000035474 group of disease Diseases 0.000 description 1
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 1
- 239000003906 humectant Substances 0.000 description 1
- 230000028993 immune response Effects 0.000 description 1
- 239000003018 immunosuppressive agent Substances 0.000 description 1
- 229940124589 immunosuppressive drug Drugs 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 239000007951 isotonicity adjuster Substances 0.000 description 1
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
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- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 208000029766 myalgic encephalomeyelitis/chronic fatigue syndrome Diseases 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- 150000002895 organic esters Chemical class 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 235000020232 peanut Nutrition 0.000 description 1
- 229960003742 phenol Drugs 0.000 description 1
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 description 1
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 description 1
- 150000003856 quaternary ammonium compounds Chemical class 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 150000004760 silicates Chemical class 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 230000003381 solubilizing effect Effects 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 235000019157 thiamine Nutrition 0.000 description 1
- 239000011721 thiamine Substances 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
- A61K31/51—Thiamines, e.g. vitamin B1
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
"VITAMINA B1 PER USO NEL TRATTAMENTO DI MALATTIE INFIAMMATORIE - "VITAMIN B1 FOR USE IN THE TREATMENT OF INFLAMMATORY DISEASES -
AUTOIMMUNITARIE" AUTOIMMUNE "
DESCRIZIONE DESCRIPTION
La presente invenzione si riferisce all’uso della vitamina B1 e a composizioni farmaceutiche che la comprendono, nel trattamento della stanchezza cronica associata a malattie di natura infiammatoria-autoimmunitaria. In particolare la presente invenzione si riferisce alla vitamina B1 per uso nel trattamento della stanchezza cronica nelle seguenti patologie: rettocolite ulcerosa, malattia di Crohn, tiroiditi, morbo di Basedow, fibromialgia, psoriasi e artrite psoriasica, artrite reumatoide, sclerosi multipla. The present invention relates to the use of vitamin B1 and to pharmaceutical compositions including it, in the treatment of chronic fatigue associated with inflammatory-autoimmune diseases. In particular, the present invention refers to vitamin B1 for use in the treatment of chronic fatigue in the following pathologies: ulcerative colitis, Crohn's disease, thyroiditis, Graves' disease, fibromyalgia, psoriasis and psoriatic arthritis, rheumatoid arthritis, multiple sclerosis.
STATO DELLA TECNICA ANTERIORE STATE OF THE PRIOR ART
Le malattie infiammatorie-autoimmunitarie croniche sono patologie nelle quali il sistema immunitario produce autoanticorpi diretti contro un antigene endogeno con conseguente danno tissutale. Di norma un organo o apparato viene caratteristicamente colpito. Il trattamento delle malattie autoimmuni prevede in genere farmaci immunosoppressori che diminuiscono la risposta immunitaria. Nella maggior parte dei casi però questi trattamenti non sono risolutivi. Queste malattie oltre ai sintomi legati alla sofferenza degli organi specificamente interessati presentano anche sintomi generali come la stanchezza cronica che, finora, à ̈ stata considerata un ulteriore inemendabile fardello di queste patologie. La stanchezza cronica ha un’alta prevalenza,e, in molte di queste patologie à ̈ vista così intimamente legata alla malattia di base che non sono mai stati fatti studi di prevalenza. Inoltre spesso anche i pazienti che hanno la malattia di base in remissione hanno comunque una stanchezza cronica invincibile che determina una qualità di vita ridotta (assenze dal lavoro frequenti e spese mediche notevoli). Nello stato della tecnica non esiste una terapia efficace e risolutiva per il trattamento della stanchezza cronica associata a queste malattie. Chronic inflammatory-autoimmune diseases are diseases in which the immune system produces autoantibodies directed against an endogenous antigen with consequent tissue damage. Usually an organ or system is characteristically affected. Treatment of autoimmune diseases typically involves immunosuppressive drugs that decrease the immune response. In most cases, however, these treatments are not conclusive. These diseases, in addition to the symptoms related to the suffering of the specifically affected organs, also present general symptoms such as chronic fatigue which, up to now, has been considered a further inemendable burden of these pathologies. Chronic fatigue has a high prevalence, and in many of these diseases it is seen so intimately linked to the underlying disease that no prevalence studies have ever been done. Furthermore, often even patients who have the underlying disease in remission still have an invincible chronic fatigue that determines a reduced quality of life (frequent absences from work and considerable medical expenses). In the state of the art, there is no effective and decisive therapy for the treatment of chronic fatigue associated with these diseases.
SOMMARIO DELL'INVENZIONE SUMMARY OF THE INVENTION
La presente invenzione si basa sull’osservazione che somministrando la vitamina B1 (tiamina) ad alte dosi, a pazienti con stanchezza cronica associata a malattie infiammatorie-autoimmunitarie, la stanchezza cronica à ̈ completamente eliminata o fortemente ridotta. The present invention is based on the observation that by administering vitamin B1 (thiamine) in high doses, to patients with chronic fatigue associated with inflammatory-autoimmune diseases, chronic fatigue is completely eliminated or greatly reduced.
L’effetto terapeutico osservato à ̈ ancora più sorprendente considerando che tutti i pazienti trattati avevano valori di vitamina B1 nel plasma ampiamente nella norma. Questi valori quindi suggerivano che un trattamento a base di vitamina B1 non fosse necessario e che non avrebbe determinato alcun effetto terapeutico. The observed therapeutic effect is even more surprising considering that all treated patients had largely normal plasma vitamin B1 values. These values therefore suggested that a vitamin B1-based treatment was not necessary and that it would not have any therapeutic effect.
Pur non volendo legare a un meccanismo specifico la presente invenzione, si può ipotizzare che l’effetto terapeutico osservato sia il seguente: While not wanting to link the present invention to a specific mechanism, it can be hypothesized that the observed therapeutic effect is the following:
la normale concentrazione della vitamina nel plasma, associata alla presenza di sintomi di carenza della stessa, depone per un blocco dell’utilizzazione della stessa a livello periferico. In altre parole la vitamina passa con difficoltà dal sangue ai tessuti oppure c’à ̈ un qualcosa che comunque blocca la sua utilizzazione a livello dei vari organi e apparati. Le alte dosi somministrate aumentano ulteriormente la concentrazione di vitamina B1 nel sangue e ciò porta a una maggiore disponibilità che corregge i sintomi da carenza forzando il blocco periferico. the normal concentration of the vitamin in the plasma, associated with the presence of symptoms of its deficiency, leads to a block in its use at the peripheral level. In other words, the vitamin passes with difficulty from the blood to the tissues or there is something that still blocks its use at the level of the various organs and systems. The high doses administered further increase the concentration of vitamin B1 in the blood and this leads to greater availability which corrects deficiency symptoms by forcing peripheral blockage.
Forma pertanto oggetto della presente invenzione l’impiego della vitamina B1 per l’uso nel trattamento della stanchezza cronica associata a malattie infiammatorieautoimmunitarie. Therefore, the subject of the present invention is the use of vitamin B1 for use in the treatment of chronic fatigue associated with inflammatory and autoimmune diseases.
Formano anche oggetto dell’invenzione composizioni farmaceutiche comprendenti la vitamina B1 e uno o più eccipienti farmacologicamente accettabili per uso nel trattamento della stanchezza cronica associata a malattie infiammatorie e di natura autoimmune. Also object of the invention are pharmaceutical compositions comprising vitamin B1 and one or more pharmacologically acceptable excipients for use in the treatment of chronic fatigue associated with inflammatory and autoimmune diseases.
I vantaggi, caratteristiche e le modalità di impiego della presente invenzione risulteranno evidenti dalla seguente descrizione dettagliata di alcune forme di realizzazione, presentate a scopo esemplificativo e non limitativo. The advantages, characteristics and methods of use of the present invention will become evident from the following detailed description of some embodiments, presented by way of non-limiting example.
DESCRIZIONE DETTAGLIATA DELL'INVENZIONE DETAILED DESCRIPTION OF THE INVENTION
Secondo la presente invenzione la vitamina B1 à ̈ somministrata ai pazienti affetti da stanchezza cronica associata a patologie infiammatorie-autoimmunitarie. Nella presente descrizione con il termine patologie infiammatorie-autoimmunitarie s’intende un gruppo di malattie in cui il sistema immunitario, stimolato da fattori endogeni o ambientali possa innescare una reazione infiammatoria anomala, rivolta verso strutture biologiche del medesimo organismo (autoimmunità ), con la caratteristica autoperpetuazione del fenomeno. In alcune malattie à ̈ preponderante il coinvolgimento intestinale,nelle altre à ̈ preponderante l’interessamento articolare, del sistema nervoso centrale e così via. According to the present invention, vitamin B1 is administered to patients suffering from chronic fatigue associated with inflammatory-autoimmune pathologies. In the present description, the term inflammatory-autoimmune pathologies means a group of diseases in which the immune system, stimulated by endogenous or environmental factors, can trigger an abnormal inflammatory reaction, aimed at biological structures of the same organism (autoimmunity), with the characteristic self-perpetuation of the phenomenon. In some diseases intestinal involvement is predominant, in others joint involvement, central nervous system and so on is predominant.
Ad esempio appartengono a questo gruppo di patologie la rettocolite ulcerosa, malattia di Crohn, tiroiditi, morbo di Basedow, fibromialgia, psoriasi e artrite psoriasica, artrite reumatoide, sclerosi multipla. For example, this group of pathologies includes ulcerative colitis, Crohn's disease, thyroiditis, Graves' disease, fibromyalgia, psoriasis and psoriatic arthritis, rheumatoid arthritis, multiple sclerosis.
La vitamina B1 può essere somministrata in funzione dell’età e delle condizioni generali del paziente, della natura e della gravità della patologia o disturbo e della via e tipo di somministrazione. Il dosaggio dovrà quindi tener conto, della particolare condizione da trattare, della severità della condizione da trattare, dell’età , del peso e delle condizioni fisiche generali del particolare paziente. Inoltre, à ̈ evidente che le quantità efficaci possono essere all’occorrenza abbassate o aumentate secondo le risposte del paziente trattato e/o secondo la valutazione del medico. Vitamin B1 can be administered according to the age and general conditions of the patient, the nature and severity of the pathology or disorder and the route and type of administration. The dosage must therefore take into account the particular condition to be treated, the severity of the condition to be treated, the age, weight and general physical condition of the particular patient. Furthermore, it is evident that the effective quantities can be lowered or increased if necessary according to the responses of the patient treated and / or according to the evaluation of the doctor.
La sperimentazione clinica riportata negli esempi ha evidenziato che la forte riduzione o totale eliminazione della stanchezza cronica à ̈ ottenuta con un dosaggio di vitamina B1 compreso tra 600 e 1800 mg al giorno per via orale oppure con una somministrazione intramuscolare di circa 100 mg al giorno. Preferibilmente il dosaggio per via orale à ̈ compreso tra i 600 ai 1200 mg per pazienti donne e tra 1200-1800 mg per pazienti uomini. The clinical experimentation reported in the examples has shown that the strong reduction or total elimination of chronic fatigue is obtained with a dosage of vitamin B1 between 600 and 1800 mg per day orally or with an intramuscular administration of about 100 mg per day. Preferably, the oral dosage is between 600 and 1200 mg for female patients and between 1200-1800 mg for male patients.
Sono oggetto della presente invenzione anche composizione farmaceutiche comprendenti la vitamina B1 e uno o più eccipienti farmacologicamente accettabili per uso nel trattamento della stanchezza cronica associata a malattie infiammatorioautoimmuni, in particolare per uso nel trattamento delle malattie scelte nel gruppo comprendente rettocolite ulcerosa, malattia di Crohn, tiroiditi, morbo di Basedow, fibromialgia, psoriasi e artrite psoriasica, artrite reumatoide, sclerosi multipla. Also subject of the present invention are pharmaceutical compositions comprising vitamin B1 and one or more pharmacologically acceptable excipients for use in the treatment of chronic fatigue associated with inflammatory autoimmune diseases, in particular for use in the treatment of diseases selected in the group comprising ulcerative colitis, Crohn's disease, thyroiditis, Graves' disease, fibromyalgia, psoriasis and psoriatic arthritis, rheumatoid arthritis, multiple sclerosis.
Tipicamente dette composizioni possono contenere una quantità di vitamina B1 compresa tra 100 mg e 500 mg per unità di dosaggio. Preferibilmente l’unità di dosaggio per somministrazione orale à ̈ compresa tra 250-500 mg, per somministrazione intramuscolare tra 50-150 mg, preferibilmente 100 mg. Typically, said compositions can contain a quantity of vitamin B1 ranging from 100 mg to 500 mg per dosage unit. Preferably the dosage unit for oral administration is between 250-500 mg, for intramuscular administration between 50-150 mg, preferably 100 mg.
Con il termine unità di dosaggio s’intende nella presente descrizione la formulazione unitaria per una singola somministrazione, ad esempio una compressa, capsula ecc. Per dosaggio unitario s’intende nella presente descrizione la quantità di principio attivo per una singola somministrazione. In the present description, the term dosage unit means the unitary formulation for a single administration, for example a tablet, capsule, etc. By unit dosage is meant in the present description the quantity of active principle for a single administration.
Le composizioni farmaceutiche secondo la presente invenzione possono essere formulate in una varietà di modi che dipendono dalla via di somministrazione prescelta. Secondo una specifica forma di realizzazione dell’invenzione, la composizione farmaceutica à ̈ idonea alla somministrazione orale di forme solide e può includere forme quali capsule, compresse, pillole, polveri e granuli. In queste forme solide la vitamina B1 può essere miscelata con uno o più eccipienti inerti, farmaceuticamente accettabili. Tali eccipienti possono essere scelti fra quelli normalmente noti nello stato dell’arte e includono, ma non sono ad essi limitati : a) carrier, quali citrato di sodio e calcio fosfato, b) filler quali amido, lattosio, cellulosa microcristallina, saccarosio, glucosio, mannitolo e silice colloidale, c) umettanti, quali il glicerolo, d) agenti disintegranti, quali alginati, carbonato di calcio, amidi, derivati dell’amido, della cellulosa e del polivinilpirrolidone, silicati e carbonato di sodio e) leganti quali carbossimetilcellulosa, alginati, gelatina, polivinilpirrolidone, saccarosio, derivati polimerici della cellulosa, derivati dell’amido f) agenti ritardanti quali paraffina, polimeri della cellulosa, esteri degli acidi grassi g) accelleratori dell’assorbimento, quali composti di ammonio quaternario, h) agenti bagnanti e tensioattivi quali alcool cetilico e glicerolo monostearato, i) adsorbenti, quali argille bentoniche e caolino, k) lubrificanti quali talco, stearato di calcio, stearato di magnesio, glicol polietilenico, sodio lauril solfato, sodio stearilfumarato j) glidanti quali talco, silice colloidale. The pharmaceutical compositions according to the present invention can be formulated in a variety of ways which depend on the chosen route of administration. According to a specific embodiment of the invention, the pharmaceutical composition is suitable for oral administration of solid forms and can include forms such as capsules, tablets, pills, powders and granules. In these solid forms, vitamin B1 can be mixed with one or more inert, pharmaceutically acceptable excipients. These excipients can be selected from those normally known in the state of the art and include, but are not limited to: a) carriers, such as sodium citrate and calcium phosphate, b) fillers such as starch, lactose, microcrystalline cellulose, sucrose, glucose, mannitol and colloidal silica, c) humectants, such as glycerol, d) disintegrating agents, such as alginates, calcium carbonate, starches, starch derivatives, cellulose and polyvinylpyrrolidone, silicates and sodium carbonate e) binders such as carboxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, sucrose, cellulose polymeric derivatives, starch derivatives f) retardants such as paraffin, cellulose polymers, fatty acid esters g) absorption accelerators, such as quaternary ammonium compounds, h ) wetting agents and surfactants such as cetyl alcohol and glycerol monostearate, i) adsorbents, such as benthic clays and kaolin, k) lubricants such as talc, calc stearate io, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, sodium stearyl fumarate j) glidants such as talc, colloidal silica.
Le forme di dosaggio solido, quali compresse, capsule, pillole e granuli, possono essere rivestite con rivestimenti enterici, gastrici o di altro tipo ben noto nello stato dell’arte. Esse possono contenere agenti opacizzanti e possono essere del tipo da permettere il rilascio degli ingredienti attivi soltanto o preferibilmente in un certo tratto dell’intestino, eventualmente, in modo ritardato. Sostanze che possono permettere tale uso ritardato includono, ma non sono ad esse limitate, polimeri e cere. Solid dosage forms, such as tablets, capsules, pills and granules, can be coated with enteric, gastric or other coatings well known in the state of the art. They may contain opacifying agents and may be of the type to allow the release of the active ingredients only or preferably in a certain tract of the intestine, possibly in a delayed manner. Substances which may permit such delayed use include, but are not limited to, polymers and waxes.
Forme liquide adatte ad una somministrazione orale sono emulsioni, soluzioni, sospensioni preparate o estemporanee, sciroppi e elisir. Eccipienti adatti alle formulazioni secondo la presente invenzione in forme liquide ad uso orale includono, ma non sono ad essi limitati, diluenti comunemente usati nell’arte, quali acqua o altri solventi, agenti solubilizzanti e emulsificanti scelti fra alcool etilico, polialcoli, glicol propilenico, glicerolo, polietilenglicol e sorbitan esteri. Queste formulazioni possono anche contenere dolcificanti e aromi scelti fra quelli ben noti nello stato dell’arte. Liquid forms suitable for oral administration are emulsions, solutions, prepared or extemporaneous suspensions, syrups and elixirs. Excipients suitable for the formulations according to the present invention in liquid forms for oral use include, but are not limited to, diluents commonly used in the art, such as water or other solvents, solubilizing and emulsifying agents selected from ethyl alcohol, polyalcohols, propylene glycol , glycerol, polyethylene glycol and sorbitan esters. These formulations may also contain sweeteners and flavorings selected from those well known in the state of the art.
Composizioni adatte per iniezioni parenterali (preferibilmente intramuscolari) farmaceuticamente accettabili possono comprendere soluzioni acquose sterili, dispersioni, sospensioni o emulsioni o polveri sterili per una ricostituzione in soluzioni o dispersioni iniettabili; esempi di eccipienti adatti a queste includono, ma non sono ad essi limitati, carrier acquosi o non acquosi, diluenti, solventi o veicoli scelti fra: acqua, etanolo, polioli (glicol propilenico o polietilenico, glicerolo e simili), polialcoli, alcool isopropilico, etil acetato, benzil alcool, benzoato di benzile, glicol propilenico, glicol 1.3-butilenico, dimetilformammide, olii vegetali (in particolare di oliva, cotone, arachide, mais, germe di grano, oliva, ricino, sesamo), esteri organici quali etile oleato o simili. Queste composizioni possono anche contenere dei conservanti del tipo antibatterico o antifungino, scelti, ma non esclusivamente, tra: parabenzoato, clorbutanolo, fenolo, acido ascorbico e simili. Può essere anche utile includere un agente isotonico, per esempio, uno zucchero, cloruro di sodio o simili. Inoltre si possono ottenere delle forme farmaceutiche ad assorbimento ritardato con agenti quali, per esempio, ma non esclusivamente, alluminio monostearato e gelatina. Compositions suitable for pharmaceutically acceptable parenteral (preferably intramuscular) injections may comprise sterile aqueous solutions, dispersions, suspensions or emulsions or sterile powders for reconstitution into injectable solutions or dispersions; Examples of excipients suitable for these include, but are not limited to, aqueous or non-aqueous carriers, diluents, solvents or vehicles selected from: water, ethanol, polyols (propylene or polyethylene glycol, glycerol and the like), polyalcohols, isopropyl alcohol, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1.3-butylene glycol, dimethylformamide, vegetable oils (especially olive, cotton, peanut, corn, wheat germ, olive, castor, sesame), organic esters such as ethyl oleate or similar. These compositions can also contain preservatives of the antibacterial or antifungal type, selected, but not exclusively, from: parabenzoate, chlorbutanol, phenol, ascorbic acid and the like. It may also be helpful to include an isotonic agent, for example, a sugar, sodium chloride or the like. Furthermore, it is possible to obtain pharmaceutical forms with delayed absorption with agents such as, for example, but not exclusively, aluminum monostearate and gelatin.
Si possono anche preparare formulazioni a lento rilascio mediante le tecniche ed i prodotti ben noti nello stato dell’arte. Slow release formulations can also be prepared by techniques and products well known in the state of the art.
ESEMPI EXAMPLES
Sperimentazione Experimentation
Di seguito à ̈ riportata la sperimentazione clinica che dimostra l'attività della vitamina B1 secondo l'invenzione. The clinical trial which demonstrates the activity of vitamin B1 according to the invention is reported below.
Tutti i pazienti sottoposti alla terapia accusavano stanchezza cronica sin dall’inizio dell’insorgenza della malattia, a varia intensità . L’effetto terapeutico ottenuto con la somministrazione della vitamina B1 à ̈ stato valutato mediante il test standard della scala CFS (Chronic fatigue sindrome) e della scala FSS (fatigue severità scale). Prima della terapia i punteggi delle scale davano come risultato una stanchezza di grado severo nel 30% dei casi, di grado medio nel restante 70%. All the patients undergoing the therapy complained of chronic fatigue from the beginning of the onset of the disease, at varying intensity. The therapeutic effect obtained with the administration of vitamin B1 was evaluated by means of the standard test of the CFS scale (Chronic fatigue syndrome) and of the FSS scale (fatigue severity scale). Before therapy, the scores on the scales resulted in severe fatigue in 30% of cases, medium in the remaining 70%.
Tutte le pazienti donne affette da rettocolite ulcerosa e morbo di crohn (12 in tutto) hanno assunto una terapia per bocca variabile da 600 a 900 mg die per 20 g con guarigione dalla stanchezza in circa 5 g., seguita da una terapia di mantenimento con 600 mg die. I due pazienti uomini trattati con rettocolite ulcerosa hanno avuto lo stesso risultato con 1500 mg die per somministrazione orale che hanno assunto anche nella terapia di mantenimento. All female patients with ulcerative colitis and Crohn's disease (12 in all) received oral therapy ranging from 600 to 900 mg / day for 20 g with recovery from fatigue in about 5 g, followed by maintenance therapy with 600 mg per day. The two male patients treated with ulcerative colitis had the same result with 1500 mg / day by oral administration that they also took in maintenance therapy.
Con la stessa terapia sono state trattate 10 pazienti donne affette da tiroidite cronica e stanchezza cronica. 10 female patients with chronic thyroiditis and chronic fatigue were treated with the same therapy.
La somministrazione di vitamina B1 orale con dosi da 600 a 1200 mg ha portato alla completa guarigione in circa 3-5 giorni di tutte le pazienti affette da tiroiditi. Administration of oral vitamin B1 with doses of 600 to 1200 mg resulted in complete recovery in approximately 3-5 days of all patients with thyroiditis.
Sono stati trattati 4 pazienti maschi affetti sclerosi multipla. Il trattamento à ̈ stato effettuato per via intramuscolare con un dosaggio di 100 mg al giorno per due giorni successivi e 100 mg sempre per via intramuscolare ogni 15 giorni. La stanchezza à ̈ regredita completamente nell’arco di 6-7 ore. Tutti i pazienti delle restanti patologie del seguente gruppo descritto sopra Chron, rettocolite ulcerosa, fibromialgia, artrite reumatoide, sclerosi multipla, tiroidite, m. di Basedow sono stati trattati con la stessa terapia ottenendo gli stessi risultati. Four male patients with multiple sclerosis were treated. The treatment was carried out intramuscularly with a dosage of 100 mg per day for two subsequent days and 100 mg always intramuscularly every 15 days. Fatigue completely regressed within 6-7 hours. All patients of the remaining pathologies of the following group described above Chron, ulcerative colitis, fibromyalgia, rheumatoid arthritis, multiple sclerosis, thyroiditis, m. of Basedow were treated with the same therapy obtaining the same results.
Determinazione della concentrazione di vitamina B1 nel plasma Determination of the concentration of vitamin B1 in plasma
Tutti i pazienti prima del trattamento mostravano valori di vitamina B1 nel plasma ampiamente nella norma suggerendo che non fosse necessario una somministrazione di vitamina B1. All patients prior to treatment showed plasma vitamin B1 values well within normal range suggesting that no vitamin B1 administration was necessary.
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