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(別添様式) - mhlw.go.jp

;II-105 1 1 2 2 (dimethyl sulfoxide, DMSO) 50% Rimso-50 Bioniche Pharma 50% 50mL 15.

Oct 27, 2010 · 要望番号;Ⅱ-105 1 (別添様式) 未承認薬・適応外薬の要望. 1.要望内容に関連する事項. 要 望 者 (該当する

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Transcription of (別添様式) - mhlw.go.jp

1 ;II-105 1 1 2 2 (dimethyl sulfoxide, DMSO) 50% Rimso-50 Bioniche Pharma 50% 50mL 15.

2 II-105 2 1) 2) 1 60 130 100 2) 1 20 3) 1995 10 6 8 1) 2002 10 450 1) 2005 10 300 10 680 43,500 217,500 1)

3 NIHS(National Institute of Health Sciences ) 10 500 10 865 4) NHANESIII(National Health and Nutrition Examination ) 10 60 10 850 8 3 120 4) ;II-105 3 1998 10 2 1) 2002 10 5) 1) 2 19 9 1 22 6, 7) 3 50 6 8) 1) 4 DMSO DMSO 1)

4 DMSO AUA 4) DMSO 9) DMSO DMSO 13% 18% 10) 11) LD50 >5000mg/kg( ) LD50 >3300mg/kg( ) >3700mg/kg( ) 12) DMSO 9, 13, 14) 14) 14) DMSO DMSO LD50 ;II-105 4 >606mg/kg( ) >14500mg/kg( ) 14) 1) 50 DMSO50mL 10 20 1) 1 DMSO 1 2 15) 1) 52 60 16) 15) 50~80% 15, 17)

5 DMSO 5 DMSO 1) 1) NIDDK(National Institute of Diabates and Digestive and Kidney Diseases) 2) (Interstitial Cystitis Data Base;ICDB)18) ICDB NIDDK NIDDK 1) 50%DMSO BCG 16).

6 II-105 5 2 6 6 Rimso-50(Bioniche Pharma), Dimethyl Sulfoxide(Bioniche Pharma)19) Rimso(Research Industries)20) 50mL asepto syringe 15 21, 22) Rimso-50(Bioniche Pharma 19)) 23) Dimethyl Sulfoxide( ) Rimso(Britannia Pharmaceuticals)20) 50mL asepto syringe 15 24) Rimso-50(Bioniche Pharma), Dimethyl Sulfoxide Irrigation USP(Sabdoz Canada)25) Rimso(Shire)20) 50mL asepto syringe 15 24).

7 II-105 6 6 6 6 ;II-105 7 3 PubMed( ) dimethyl sulphoxide [MeSH] AND interstitial cystitis[MeSH] 1 Limits Meta-Analysis, Randomized Controlled Trial 5 2 JDreamII( ) ( ) AND 71 3 ( ) ( ) AND 67 3 3.

8 2 Peer-reviewed journal (T. E. Jamison, Intravesical treatments for painful bladder syndrome/ interstitial cystitis, Cochrane Database Syst Rev, CD006113 (2007).)26) Cochrane Incontinence Group Specialised Trials Register QOL 9 (n=616) DMSO 1 DMSO ;II-105 8 1 R.

9 Perez-Marrero. et al., A controlled study of dimethyl sulfoxide in interstitial cystitis, J Urol, 140, 36-39 (1988).17) 1) n=33 48 3 / 30 5 b. 50%DMSO 50mL 15 4 a. minimal response 13% min:13% mod:33% marked:53% moderate response 47% maeked response 40% b. minimal response 41% min:33% mod:20% marked:47% moderate response 41% maeked response 18% a. 93% 86% b. 35% 67% RR 95%CI DMSO 23/28 22/28 (SE) RR 95%CI 17mL( ) (2) (1) (1) (1).

10 II-105 9 27) DMSO chlorpactin 5% 200928)( , ) 50%DMSO50mL 10 ( 1 8 ) 201129)( , ) DMSO 200830) ( , ) DMSO (American Urological Association) 4) DMSO DMSO C C B DMSO 15 20 DMSO B B C B.


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