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資料 4 3 - mhlw.go.jp

1 305 1 40 mg 125 mg 500mg 1000mg 500 1000mg 3-5 2 1) Multiple Sclerosis MS MS 1 60 30 MS 2 2) MS 4 3 2 305 MS 3 4

1 要望番号;305 医療上の必要性の高い未承認薬・適応外薬検討会議 公知申請への該当性に係る報告書(案)

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Transcription of 資料 4 3 - mhlw.go.jp

1 1 305 1 40 mg 125 mg 500mg 1000mg 500 1000mg 3-5 2 1) Multiple Sclerosis MS MS 1 60 30 MS 2 2)

2 MS 4 3 2 305 MS 3 4 4 SOLU-MEDROL Pharmacia & Upjohn Company 3 Diamond-Blackfan 3 305

3 10 30 mg/kg 30 48 4 6 48 72 10 40 mg 4 305 Act-O-Vial 5% 5% mg/kg/ 3 4 48 mg/m2bsa/ 24 mg/kg 2 X 5 305 X 1

4 160 mg 1 1 64 mg Solu-Medrol 40 mg: 1959 4 Solu-Medrol 125 mg : 1965 4 Solu-Medrol 500 mg : 1970 12 Solu-Medrol 1 g : 1970 12 Solu-Medrol 2 g : 1985 2 Summary of Product Characteristics 4 1. 2. 3. 4. 5. 6. 6 305 30 250 mg 5 10 500 mg 1 g/ 500 mg 1 g 48 72 30 mg/kg/ 1 g/ 3 10 20 mg/kg/ 3 1 g/

5 1 4 mg/kg/ 1 3 1 1 g 3 30 Solu-Medrol 40 mg: 1972 1 Solu-Medrol 125 mg : 1972 1 7 305 Solu-Medrol 500 mg : 1972 1 Solu-Medrol 1 g : 1974 1 SOLUMEDROL 500 mg, poudre pour solution injectable Summary of Product Characteristics (PFIZER HOLDING FRANCE) 5, 6 - - - - - - - - - - 1 500 mg 1 g 8 305 - 20 30 - 3 5 SOLUMEDROL 500 mg, poudre pour solution injectable.

6 1976 7 SOLUMEDROL 1 g, poudre et solvant pour solution injectable: 1999 5 4 MS MS 14 MS 21 MP adrenocorticotropic hormone ACTH 1984 2 1986 3 7 Schumacher criteria MS MP 1000 mg 2 1 1 5 ACTH 40 2 1 1 5 The Kurtke Scale The Disability Scale of the International Federation of Multiple Sclerosis 3 6 12 MP ACTH 80 40 2 5

7 MEDLINE PubMed MeSH term: multiple sclerosis, methylprednisolone, humans 141 24 3 15 1 141 98 MS MP 3 2 MS 1 MS 9 305 Durelli L, Cocito D, Riccio A, et al. High-dose intravenous methylpredonisolone in the treatment of multiple sclerosis: Clinical-immunologic correlations. Neurology 1986; 36 :238-43. 8 MS 23 MP CNS IgG MP MP 13 MP 15 mg/kg 1 3 10 mg/kg 4 6 5 mg/kg 7 9 mg/kg 10 12 1 mg/kg 13 15 10 15 100 mg/ 120 Kurtzke s expanded disability status scale EDSS Kurtzke s functional system scale FS 5 10 15 20 25 30 60 5 15 30 60 EDSS MP 3 6 15 EDSS 1 MP P < MP CNS IgG

8 IgG CNS IgG MP 23 5 12 10 Milligan NM, Newcombe R, Compston DA, et al. A double-blind controlled trial of high dose methylpredonisolone in patients with multiple sclerosis: 1. Clinical effects. J Neurol Neurosurg Psychiatry 1987; 50 MS 50 22 28 MP MP MP 500 mg 5 EDSS MS MP 1 4 p < MS MP 4 p < MP 10 305 Beck RW, Cleary PA, Anderson MM, et al.

9 A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. N Engl J Med 1992; 326 :581-8. 10 MS 457 MP MP MP MP 1 g/ 3 1 mg/kg/ 11 14 1 mg/kg/ 14 The Farnsworth-Munsell 100-hue color-vision testoy Visual acuity Contrast sensitivity Visual field MP p = 4 15 6 MP p = p = p = p = Relative Risk.

10 95 % MP MP 2 1 1 MP P < 2 MS 2004 1 ; 2. MP 1 1250 mg 1 20 30 mg 1 60 120 mg 1 2 mg/kg


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