WO2017124213A1 - 他汀类与肾上腺皮质激素类药物在治疗慢性硬膜下血肿中的联合应用 - Google Patents
他汀类与肾上腺皮质激素类药物在治疗慢性硬膜下血肿中的联合应用 Download PDFInfo
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- WO2017124213A1 WO2017124213A1 PCT/CN2016/000720 CN2016000720W WO2017124213A1 WO 2017124213 A1 WO2017124213 A1 WO 2017124213A1 CN 2016000720 W CN2016000720 W CN 2016000720W WO 2017124213 A1 WO2017124213 A1 WO 2017124213A1
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- dexamethasone
- atorvastatin
- hematoma
- statin
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
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- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- 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
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
Definitions
- Figure 4 is a graph showing the effect of different doses of atorvastatin on the expression of Ang-1 factor in the hematoma capsule of rats;
- the rate of subdural hematoma absorption is not only related to the number of neovascularization of the hematoma envelope, but also closely related to the formation of mature and stable blood vessels in the capsule; small doses of atorvastatin inhibit local inflammation of the hematoma cavity. It promotes mature and stable angiogenesis, which accelerates the absorption of hematoma.
- statin combined with low-dose dexamethasone in the treatment of chronic subdural hematoma
- the patient with serial number 9 in Table 1 had a head trauma for more than 1 month. After 2 days of adverse limb activity, a subdural hematoma was found. The hematoma volume was about 117 ml, and the midline was shifted to the right (see Figure 11). After atorvastatin After combined treatment with low-dose dexamethasone, the hematoma was gradually absorbed and surgery was avoided.
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Abstract
Description
序号 | 年龄 | 入组前血肿量(ml) | 4周时血肿量(ml) | 4周时减少量(ml) |
1 | 79 | 80 | 40 | 40 |
2 | 60 | 27 | 6 | 21 |
3 | 75 | 60 | 15 | 45 |
4 | 83 | 67.5 | 30 | 37.5 |
5 | 75 | 50 | 20 | 30 |
6 | 67 | 40 | 0 | 40 |
7 | 70 | 30 | 20 | 10 |
8 | 25 | 15 | 0 | 15 |
9 | 81 | 70.4 | 30 | 40.4 |
10 | 46 | 57.5 | 0 | 57.5 |
11 | 68 | 60 | 30 | 30 |
12 | 79 | 45 | 0 | 45 |
13 | 81 | 49.5 | 27 | 22.5 |
14 | 66 | 23.75 | 17.5 | 6.25 |
15 | 69 | 59.85 | 20.5 | 39.35 |
16 | 63 | 35 | 0 | 35 |
17 | 68 | 48 | 0 | 48 |
18 | 74 | 16 | 4 | 12 |
19 | 59 | 72 | 48 | 24 |
20 | 37 | 29.7 | 10.6 | 19.1 |
21 | 80 | 46.2 | 23.4 | 22.8 |
22 | 79 | 89 | 24 | 65 |
23 | 79 | 89 | 手术 | 手术 |
24 | 70 | 107.90 | 146.85 | 手术 |
25 | 68 | 177.45 | 138.60 | 38.85 |
26 | 58 | 52.50 | 15.00 | 37.5 |
27 | 74 | 66.00 | 29.25 | 36.75 |
28 | 66 | 73.13 | 81.90 | -8.775 |
29 | 68 | 47.25 | 38.00 | 9.25 |
30 | 83 | 123.75 | 30.00 | 93.75 |
31 | 70 | 83.16 | 36.00 | 47.16 |
32 | 79 | 131.04 | 效果不佳加用激素治疗 | 效果不佳加用激素治疗 |
33 | 66 | 73.13 | 35.00 | 38.125 |
34 | 58 | 55.00 | 40.00 | 15 |
35 | 56 | 45.00 | 30.00 | 15 |
36 | 50 | 33.00 | 25.00 | 8 |
37 | 59 | 42.35 | 26.00 | 16.35 |
38 | 66 | 55.00 | 40.00 | 15 |
39 | 62 | 40.00 | 38.00 | 2 |
40 | 64 | 65.00 | 45.00 | 20 |
41 | 68 | 35.00 | 30.00 | 效果不佳加用激素治疗 |
42 | 56 | 30.00 | 5.00 | 25 |
43 | 58 | 40.00 | 18.00 | 22 |
44 | 75 | 42.00 | 25.00 | 17 |
45 | 72 | 35.00 | 10.00 | 25 |
46 | 68 | 35.00 | 5.00 | 30 |
47 | 78 | 68.00 | 手术 | 手术 |
48 | 75 | 78.00 | 手术 | 手术 |
49 | 69 | 42.00 | 35.00 | 7 |
50 | 50 | 26.00 | 0.00 | 26 |
51 | 45 | 29.00 | 41.00 | -12 |
52 | 32 | 18.00 | 效果不佳加用激素治疗 | 效果不佳加用激素治疗 |
均值 | 65.9 | 55.94ml | 28.29ml | 49%(血肿吸收率) |
Claims (19)
- 他汀类药物与肾上腺皮质激素类药物联合用于制备治疗慢性硬膜下血肿药物中的用途。
- 根据权利要求1所述的用途,其特征在于:所述他汀类药物为阿托伐他汀、辛伐他汀或瑞舒伐他汀中的一种或其组合。
- 根据权利要求1所述的用途,其特征在于:所述肾上腺皮质激素类药物为地塞米松、泼尼松、甲强龙或氢化可的松中的一种或其组合。
- 根据权利要求1所述的用途,其特征在于:所述肾上腺皮质激素类药物为地塞米松或泼尼松。
- 根据权利要求1所述的用途,其特征在于:所述他汀类药物与肾上腺皮质激素类药物的等效剂量的质量比为40∶3。
- 根据权利要求5所述的用途,其特征在于:所述他汀类药物选自阿托伐他汀,所述肾上腺皮质激素类药物选自地塞米松,其中阿托伐他汀与地塞米松的质量比为40∶3。
- 根据权利要求6所述的用途,其特征在于,单位给药方案中,阿托伐他汀的含量为10mg,地塞米松的含量为0.75mg;或阿托伐他汀的含量为20mg,地塞米松的含量为1.5mg;或阿托伐他汀的含量为30mg,地塞米松的含量为2.25mg。
- 根据权利要求5-7任意一项所述的用途,其特征在于,所述他汀类药物与肾上腺皮质激素类药物的给药剂量为:30mg/天、2.25mg/天;或20mg/天、1.5mg/天;或10mg/天、0.75mg/天;所述给药剂量可以为每日1次给药或每日分2-3次给药。
- 根据权利要求5-7任意一项所述的用途,其特征在于,所述他汀类药物与肾上腺皮质激素类药物的给药剂量为:用药1周为:30mg/天、2.25mg/天;用药2-3周为:20mg/天、1.5mg/天;用药4周为:10mg/天、0.75mg/天。
- 根据权利要求9所述的用途,其特征在于,所述他汀类药物与肾上腺皮质激素类药物的给药方案为:第1周:阿托伐他汀10mg+地塞米松0.75mg,每日3次;第2-3周:阿托伐他汀10mg+地塞米松0.75mg,每日2次;第4周:阿托伐他汀10mg+地塞米松0.75mg,每日1次。
- 一种药物组合物,其特征在于:该组合物包括治疗有效量的第一活性成分,所述第一活性成分为他汀类药物;以及治疗有效量的第二活性 成分,所述第二活性成分为肾上腺皮质激素类药物。
- 根据权利要求11所述的药物组合物,其特征在于:所述他汀类药物为阿托伐他汀、辛伐他汀或瑞舒伐他汀中的一种或其组合。
- 根据权利要求11所述的药物组合物,其特征在于:所述肾上腺皮质激素类药物为地塞米松、泼尼松、甲强龙或氢化可的松中的一种或其组合。
- 根据权利要求11所述的药物组合物,其特征在于:所述药物组合物中第一活性成分与第二活性成分的等效剂量的质量比为40∶3。
- 根据权利要求11所述的药物组合物,其特征在于:所述药物组合物中第一活性成分选自阿托伐他汀,第二活性成分选自地塞米松。
- 根据权利要求15所述的药物组合物,其特征在于:所述组合物单位剂量中,阿托伐他汀的含量为10mg,地塞米松的含量为0.75mg;或阿托伐他汀的含量为20mg,地塞米松的含量为1.5mg;或阿托伐他汀的含量为30mg,地塞米松的含量为2.25mg。
- 根据权利要求11所述的药物组合物,其特征在于,所述他汀类药物与肾上腺皮质激素类药物的给药剂量为:30mg/天、2.25mg/天;或20mg/天、1.5mg/天;或10mg/天、0.75mg/天;所述给药剂量可以为每日1次给药或每日分2-3次给药。
- 权利要求15所述的药物组合物,其特征在于:所述药物组合物中阿托伐他汀与地塞米松的给药剂量应当满足下列条件:用药1周为:30mg/天、2.25mg/天;用药2-3周为:20mg/天、1.5mg/天;用药4周为:10mg/天、0.75mg/天。
- 权利要求15所述的药物组合物,其特征在于:所述阿托伐他汀与地塞米松的给药方案为:第1周:阿托伐他汀10mg+地塞米松0.75mg,每日3次;第2-3周:阿托伐他汀10mg+地塞米松0.75mg,每日2次;第4周:阿托伐他汀10mg+地塞米松0.75mg,每日1次。
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AU2016387192A AU2016387192B2 (en) | 2016-01-20 | 2016-12-29 | Joint application of statin and adrenocortical hormone for treating chronic subdural hematoma |
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EP16885486.7A EP3406245B1 (en) | 2016-01-20 | 2016-12-29 | Joint application of statin and glucocorticoid for treating chronic subdural hematoma |
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CN103203020A (zh) * | 2012-01-17 | 2013-07-17 | 天津医科大学总医院 | 他汀类药物在制备治疗慢性硬膜下血肿药物的用途 |
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Non-Patent Citations (5)
Title |
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HE, YUNWEN ET AL.: "Observation on Clinical Curative Effect of Dexamethasone in Treatment of Chronic Subdural Hematoma", JOURNAL OF NORTH PHARMACY, vol. 12, 1 August 2015 (2015-08-01), pages 42 - 43, XP9512475, ISSN: 1672-8351 * |
JAMEEL, A. ET AL.: "Statin Modulation of Human T- Cell Proliferation, IL -1beta and IL -17 Production, and IFN- y T Cell Expression: Synergy with Conventional Immunosuppressive Agents", INTERNATIONAL JOURNAL OF INFLAMMATION, vol. 2013, 1 January 2013 (2013-01-01), pages 1 - 11, XP055558756, ISSN: 2090-8040, DOI: 10.1155/2013/434586 * |
JAMEEL, A. ET AL.: "Statin Modulation of Human T- Cell Proliferation, IL -1beta and IL -17 Production, and IFN- y T Cell Expression: Synergy with Conventional Immunosuppressive Agents", INTERNATIONAL JOURNAL OF INFLAMMATION, vol. 2013, 1 January 2013 (2013-01-01), pages 1 - 12, XP055558756, ISSN: 2090-8040, DOI: 10.1155/2013/434586 * |
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