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 ;II-105 2 1) 2) 1 60 130 100 2) 1 20 3) 1995 10 6 8 1)
2 2002 10 450 1) 2005 10 300 10 680 43,500 217,500 1) 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) DMSO AUA 4) DMSO 9) DMSO DMSO 13% 18% 10) 11)
3 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) DMSO 5 DMSO 1) 1) NIDDK(National Institute of Diabates and Digestive and Kidney Diseases) 2)
4 (Interstitial Cystitis Data Base;ICDB)18) ICDB NIDDK NIDDK 1) 50%DMSO BCG 16) ;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)
5 ;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.
6 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. 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.
7 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) ;II-105 9 27) DMSO chlorpactin 5% 200928)( , ) 50%DMSO50mL 10 ( 1 8 ) 201129)( , ) DMSO 200830) ( , ) DMSO (American Urological Association) 4)
8 DMSO DMSO C C B DMSO 15 20 DMSO B B C B ;II-105 10 (National Kidney and Urologic Diseases Information Cleaninghouse(NKUDIC))2) FDA DMSO DMSO 15 1996 FDA ( )1) A 2 I B 1 I C II D III E IV V a b c d DMSO b C b E d E E d E d C d E C BCG d C C c C b E.
9 II-105 11 b c b b E E E E c E C b C c E c C d C c E d E C b C b E c E D c E c D C b E c E 2010( )8) 50%DMSO 80cmH2O 1 ;II-105 12 (2002)5) 262 / ( ) 135/10 ( ) =1 =1 8 9 50 60 20 30 10 ( ) ( )DMSO (2007)31) 3 282 ( ) = (60 ) (1-360 ) 295( ) 186(62%) 125( ) (50-200mL) 58 19 208( ) 197( ) 77( ) DMSO 69(23%) 50%DMSO.
10 II-105 13 50% 50mL 15 ( ) DMSO DMSO DMSO DMSO DMSO 4 100 DMSO 32) 5 6 1 , , 1 , , , 2008, 2 National Kidney and Urologic Diseases Information Cleaninghouse(NKUDIC), Interstitial Cystitis/Painful Bladder Syndrome, , ( ).
