Synagis RS RSRespiratory Syncytial Virus RSBPD CHDRS RS RS BPD CHD 50mg100mg RS20138 RS Respiratory Syncytial Virus RS

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1 RS

2 Synagis RS RSRespiratory Syncytial Virus RSBPD CHDRS RS RS BPD CHD 50mg100mg RS20138 RS Respiratory Syncytial Virus RS BPD24 24CHD RS 12 6 RS BPD 246 CHD ) RS,, 106, 9 : (2002) 12 2

3 RS RS RS 1 RS 2 3,000RS RS RS ; RS ,009 1,102 1,046 1,400 1,635 1,864 1,259 1,545 1,653 1,555 1,968 2,228 2,

4 RS RSRespiratory Syncytial VirusRSV , 4 3RS RS 6 RS RS 2011,, p27 (2011) RS %

5 RS RSBPDCLD RS2530 4, 8 BPDRS60 9 CHD RS 10, RS 12 RS11,000 R S V CHD 12241, CHD HIV Medicaid3 Boyce TG, et al : J Pediatr, 137, 6 : (2000) RS 32 n= n=31 37 n=215 P 2 % ICU % ICU RS 1 304RS Horn SD, et al : J Pediatr, 143, suppl 5 : S133-S141 (2003) 5

6 RS RSF in vitro 32 RSAB RS1 BPDCHDRS BPDIMpact-study CHDPalivizumab Cardiac-study BPD 1, CHD %1.4%1.2% Drug Information Drug Information 6

7 RSF A RSF RS A B F G RS2A BF GF G RS FA A B RS 1 S 2 mrna RSG 1 F RS1 RSF F A RS S 7

8 P0.001 Drug Information Ⅲ BPD The IMpact-RSV Study Group : Pediatrics, 102, 3 : (1998) BPDRS RS53/ /1, P0.001Fisher RS % n=500 n=1,002 Fisher BPD 356 BPD RS RS RS ICU 1391,5021,

9 12.8IMpact-study 13 BPDP=0.038P0.0015kgP=0.0145kgP= P= P0.001RS Fisher RS 14 % 15 P= P P=0.014 P= P= P BPD BPD 5kg 5kg Fisher BPD 15mg/kg mg/kg

10 Ⅲ BPD ICU RSP0.001WilcoxonP0.001Wilcoxon LRI 1 3P0.001WilcoxonICUP=0.026 Fisher RS n500 n1, P n500 n1, P LRI n500 n1, P ICU n500 n1, / /1,002 P= Lower Respiratory Infection 2Wilcoxon 3Fisher 10

11 IMpact-study ⅢIMpact-study482/ ,737961/1, , / /1, , ) The IMpact-RSV Study Group : Pediatrics, 102, 3 : (1998) 11

12 Ⅲ CHDPalivizumab Feltes TF, et al : J Pediatr, 143, 4 : (2003) CHDRS RS63/ / P=0.003Fisher RS% P= n=648 n=639 Fisher CHD 24CHD RS RS RSICUICU 761,

13 Cardiac-study 15 RS RS P= P= n=343 n=339 n=305 n=300 Fisher 15mg/kg mg/kg

14 Ⅲ CHDPalivizumab RSP0.003P=0.014Wilcoxon ICUICU RS100 n648 n P= n648 n P= ICU n648 n / /639 P= % ICU100 n648 n P= n648 n / /639 P= % 100 n648 n P= Wilcoxon2Fisher 14

15 RS ⅢPalivizumab Cardiac-study625/ ,518611/ ,169 45/ / / / Cardiac-study 15

16 Ⅲ CHD Ⅲ. RS 673 CHD 67RS CHDRS RS 4.53/ /67 CHD 24CHD CHD 15mg/kgRS mg/kg CHD. 24CHD RSRS CHD CHDRS 15 RS 4.53/ / / / / /

17 1338 Ⅲ C

18 P= g/mL41.433g/mLS.D.58P= g/ml S.D n= g/mL 30g/mL 58% n= g/mL 15 30g/mL 16 RS :, 108, 12 : (2004) 1 18

19 CHD BPD 2424 Ⅲ1 15mg/kg g/mL g/mL S.D.CHD BPD RS 15mg/kg CHD BPD S.D. CHD BPD g/mL n=28 NA g/mL n=26 NA g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n=37 NA 15mg/kg mg/kg/ S.D g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= g/mL n= /28 19

20 mlkg15mg/kg100mg/ml kg 1mL mg 50mg Drug Information

21 2 1mL 3 RS1 RS 15mg/kg 1 1 RS 1kg15mgRS1 1mL 1mL kg 15mg/kg 100mg/mL RSRS 1 21

22 50mg100mg BPD / CHD / %

23 主なコンテンツ 製品基本情報 RS ウイルスについて シナジス R 筋注液の基本的な製品情報を掲載しています 投与対象 RS ウイルスに関する基礎知識や関連情報サイトをご紹介しています FAQ シナジス R の効能 効果 用法 用量についてご確認いただけます 製品に関するよくある質問に対しての回答がまとめてあります サポートツールのご案内 ビデオライブラリ RS ウイルスとシナジスの疑問にお答えする医療従事者のための WEB サイト RS ウイルス感染症とシナジス R に関する保護者向けサポートツールをダウンロードいただけます RS ウイルス感染症の発症 臨床症状のメカニズムについて CG を使った動画でご覧いただけます 1Glezen WP, et al : Am J Dis Child, 140, 6 : (1986) 2 :, 25, 1 : 6-12 (1997) 3 ( 4Hall CB : Contemporary Pediatrics, 10 : (1993) (November). 5Saijo M, et al : Acta Paediatr Jpn, 36, 4 : (1994) 6Hall CB, et al : Principle and Practice of Infection Disease(4ed), New York Churchill Livingstone : p.1501 (1999) 72011,, p (2011) 8Cunningham CK, et al : Pediatrics, 88, 3 : (1991) 9Groothuis JR, et al : Pediatrics, 82, 2 : (1988) 10McDonald NE, et al : N Eng J Med, 307, 7 : (1982) 11 :, 86, 12 : p.2076 (1982) 12Horn SD, et al : J Pediatr, 143, suppl 5 : S133-S141 (2003) 13The IMpact-RSV Study Group : Pediatrics, 102, 3 : (1998) 14Committee on Infectious Diseases and Committee on Fetus and Newborn : Pediatrics, 102, 5 : (1998) 15Feltes TF, et al : J Pediatr, 143, 4 : (2003) 16Johnson S, et al : J Infect Dis, 176, 5 : (1997) 17 CHDBPD 23

24 20173 PP--JP

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