RS
Synagis RS RSRespiratory Syncytial Virus RSBPD CHDRS RS RS1998 7020021BPD 200510CHD 50mg100mg2012 812 RS20138 RS Respiratory Syncytial Virus RS 28 12 29 35 6 6BPD24 24CHD 24 24 28 2935 RS 12 6 RS BPD 246 CHD 24 24 24 1 4 2) RS,, 106, 9 : 1288-1292 (2002) 12 2
RS RS RS 1 RS 2 3,000RS 20122011RS 2010 3 RS ; 2010 6 2016 12 RS 2006 2012 2006 2007 2008 2009 2010 2011 2012 469 536 551 509 568 593 628 790 1,009 1,102 1,046 1,400 1,635 1,864 1,259 1,545 1,653 1,555 1,968 2,228 2,492 2011 118 2012 1 http://www.nih.go.jp/niid/ja 3
RS RSRespiratory Syncytial VirusRSV2 1502100 1, 4 3RS76.5 5 509040RS 6 RS02 7 040130210151 70390 3 02 35 6 9 1015 RS 2011,, p27 (2011) RS2004201336 % 100 80 1.6 6.2 4.7 9.8 1.2 0.1 5.9 5.7 11.6 0.5 0.1 6.1 5.7 12.5 0.4 6.1 6.2 13.0 0.2 5.0 6.1 13.8 0.2 6.3 7.0 14.5 0.2 6.7 7.9 16.0 0.2 5.5 6.6 13.9 0.1 4.9 6.6 14.1 0.2 4.3 5.3 12.7 20 1519 414 3 2 60 25.8 28.3 29.9 30.1 31.7 33.0 32.8 32.8 33.9 33.5 1 611 05 40 23.5 22.0 22.5 22.4 22.7 20.7 19.8 22.4 23.0 24.4 20 28.3 25.1 22.6 21.8 20.4 18.2 16.6 18.5 17.3 19.7 0 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 36 http://www.nih.go.jp/niid/ja 4
RS RSBPDCLD RS2530 4, 8 BPDRS60 9 CHD RS 10, 11 3335RS 12 RS11,000 R S V 140 120 06 612 CHD 12241,000100 80 60 40 20 0 CHD 28 2932 3335 1 1HIV 1989711993630Medicaid3 Boyce TG, et al : J Pediatr, 137, 6 : 865-870 (2000) RS 32 n=28 33 35 n=31 37 n=215 P 2 % 21.4 38.7 12.1 0.002 ICU % 39.3 48.4 27.9 0.101 ICU 5.8 7.7 3.8 0.021 6.8 8.4 4.1 0.0001 2 2 199541996 9RS 1 304RS Horn SD, et al : J Pediatr, 143, suppl 5 : S133-S141 (2003) 5
1 2 3 4 5 RS RSF in vitro 32 RSAB RS1 BPDCHDRS 8 3233 21 BPDIMpact-study CHDPalivizumab Cardiac-study 8 12 6 BPD 1,222 2.82.72.2 CHD 639 2.71.70.9 71 8.55.65.64.22.82.8 28 7.1 440 130570 193.3%1.4%1.2% Drug Information Drug Information 6
RSF A RSF RS A B F G RS2A BF GF G RS FA A B RS 1 S 2 mrna 4 3 3 5 RSG 1 F 2 3 4 RS1 RSF F A RS S 7
P0.001 Drug Information Ⅲ BPD The IMpact-RSV Study Group : Pediatrics, 102, 3 : 531-537 (1998) BPDRS RS53/50010.648/1,0024.8 P0.001Fisher RS % 15 10 0 10.6 5 4.8 n=500 n=1,002 Fisher BPD 356 BPD246 19961997RS RS RS ICU 1391,5021,002500 8
12.8IMpact-study 13 BPDP=0.038P0.0015kgP=0.0145kgP=0.001 32P=0.0263235P0.001RS Fisher RS 14 % 15 P=0.038 10 10.7 P0.001 8.1 7.9 P=0.014 P=0.001 10.5 P=0.0026 11.0 P0.001 9.8 5 5.2 4.5 5.8 0 1.8 2.0 BPD BPD 5kg 5kg 32 3235 Fisher BPD 15mg/kg30 5 15mg/kg 150 30 30 30 30 30 9
Ⅲ BPD ICU RSP0.001WilcoxonP0.001Wilcoxon LRI 1 3P0.001WilcoxonICUP=0.026 Fisher RS100 0 20 40 60 80 n500 n1,002 36.4 62.6 P0.001 2 100 0 20 40 60 80 n500 n1,002 30.3 50.6 P0.001 2 LRI 1 3100 0 20 40 60 80 n500 n1,002 29.6 47.4 P0.001 2 ICU 0 5 10 n500 n1,002 3.0 15/500 1.3 13/1,002 P=0.026 3 1Lower Respiratory Infection 2Wilcoxon 3Fisher 10
IMpact-study 13 10.9 10.0 ⅢIMpact-study482/50096.4 2,737961/1,00295.95,413 1554 4 50/50010.081 109/1,00210.9159 1,002 10910.9 159 54 5.4 28 2.8 2 0.2 25 2.5 2 0.2 1 0.1 1 0.1 20 2.0 10 1.0 1 0.1 11 1.1 3 0.3 26 2.6 25 2.5 1 0.1 13 1.3 1 0.1 3 0.3 3 0.3 5 0.5 2 0.2 12 1.2 1 0.1 1 0.1 10 1.0 1 0.1 1 0.1 13) The IMpact-RSV Study Group : Pediatrics, 102, 3 : 531-537 (1998) 11
Ⅲ CHDPalivizumab Feltes TF, et al : J Pediatr, 143, 4 : 532-540 (2003) CHDRS RS63/6489.734/6395.3 P=0.003Fisher RS% 15 10 5 0 9.7 P=0.003 5.3 n=648 n=639 Fisher CHD 24CHD 199820024RS RS RSICUICU 761,287 639339300 648343305 12
Cardiac-study 15 RS7.9 5.611.85.0 15 10 RS P=0.285 7.9 11.8 P=0.003 5 5.6 5.0 0 n=343 n=339 n=305 n=300 Fisher 15mg/kg30 5 15mg/kg 150 30 30 30 30 30 13
Ⅲ CHDPalivizumab RSP0.003P=0.014Wilcoxon ICUICU RS100 n648 n639 57.4 129.0 P=0.003 1 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 100 n648 n639 27.9 101.5 P=0.014 1 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 ICU n648 n639 3.724/648 2.013/639 P=0.094 2 0 1 2 3 4 5 6 7 8 9 10% ICU100 n648 n639 15.9 71.2 P=0.080 1 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 n648 n639 2.214/648 1.38/639 P=0.282 2 0 1 2 3 4 5 6 7 8 9 10% 100 n648 n639 6.5 54.7 P=0.224 1 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 1Wilcoxon2Fisher 14
15 639 467.2 64 RS 26 1 11 17 1 1 6 1 3 1 1 8 1 5 2 4 2 2 7 1 6 4.1 0.2 1.7 2.7 0.2 0.2 0.9 0.2 0.5 0.2 0.2 1.3 0.2 0.8 0.3 0.6 0.3 0.3 1.1 0.2 0.9 7.2 6.9 ⅢPalivizumab Cardiac-study625/64896.5 4,518611/63995.64,169 45/6486.946/6397.2 409/64863.1354/63955.4 30 2721 Cardiac-study 15
Ⅲ CHD Ⅲ. RS 673 CHD 67RS34.511.5 CHDRS RS 4.53/67 1.51/67 CHD 24CHD CHD 15mg/kgRS200310200433045 15mg/kg 150 30 30 30 30 30 717167 CHD. 24CHD RSRS CHD CHDRS 15 RS 4.53/67 1 5.3 34/639 2 9.7 63/648 2 1.51/67 1 1.3 8/639 1 2.2 14/648 1 16
1338 Ⅲ7165403 133823 1211 211 C- 71 13 38 11.4 11.4 11.4 11.4 22.8 11.4 22.8 57.0 68.5 11.4 22.8 34.2 22.8 22.8 22.8 11.4 11.4 34.2 45.6 11.4 34.2 11.4 11.4 45.6 11.4 45.6 11.4 11.4 17
P=0.0001 15 139 98.052g/mL41.433g/mLS.D.58P=0.0001 g/ml 150 140 S.D. 130 120 110 100 90 80 70 60 50 40 30 20 10 0 n=139 98.052g/mL 30g/mL 58% n=139 41.433g/mL 15 30g/mL 16 RS :, 108, 12 : 1548-1551 (2004) 1 18
CHD BPD 2424 Ⅲ1 15mg/kg 4 7 4 30 59.012.9g/mL91.8 40.6g/mL S.D.CHD BPD RS 15mg/kg 30 17 CHD BPD 30 2 30 4 30 S.D. CHD BPD 59.012.9g/mL n=28 NA 91.840.6g/mL n=26 NA 57.211.7g/mL n=67 55.519.5g/mL n=456 90.223.7g/mL n=67 90.835.4g/mL n=559 50.517.5g/mL n=31 49.222.7g/mL n=39 76.817.6g/mL n=31 69.425.8g/mL n=37 NA 15mg/kg 30 0.5 mg/kg/ S.D. 30 53.6 16.8g/mL n=4 69.3 9.70g/mL n=5 48.0 6.82g/mL n=8 58.7 17.4g/mL n=4 61.6 7.95g/mL n=5 62.0 8.03g/mL n=6 51.2 9.85g/mL n=11 4 30 82.4 38.2g/mL n=4 77.5 34.3g/mL n=4 64.9 30.2g/mL n=7 117 46.2g/mL n=4 107 36.8g/mL n=5 122 28.2g/mL n=5 73.7 30.2g/mL n=10 2827 96.4 7 7.12/28 19
20 1 1 mlkg15mg/kg100mg/ml kg 1mL 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5 13.0 13.5 14.0 14.5 15.0 0.30 0.38 0.45 0.53 0.60 0.68 0.75 0.83 0.90 0.98 100mg 50mg 0.30 0.38 0.45 0.53 0.60 0.68 0.75 0.83 0.90 0.98 1.05 1.13 1.20 1.28 1.35 1.43 1.50 1.58 1.65 1.73 1.80 1.88 1.95 2.03 2.10 2.18 2.25 0.05 0.13 0.20 0.28 0.35 0.43 0.50 0.58 0.65 0.73 0.80 0.88 0.95 0.03 0.10 0.18 0.25 1 Drug Information
2 1mL 3 RS1 RS 15mg/kg 1 1 RS 1kg15mgRS1 1mL 1mL kg 15mg/kg 100mg/mL RSRS 1 21
50mg100mg 22 1 2312 BPD 14 8 1710 6 1 440 1.828/440 6 1 21 26 1 1 2010 6 201111 CHD 1711 19 10 130 8.4611/130 570 193.3% 28 3 22
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 : 543-546 (1986) 2 :, 25, 1 : 6-12 (1997) 3 (http://www.nih.go.jp/niid/ja) 4Hall CB : Contemporary Pediatrics, 10 : 92-110 (1993) (November). 5Saijo M, et al : Acta Paediatr Jpn, 36, 4 : 371-374 (1994) 6Hall CB, et al : Principle and Practice of Infection Disease(4ed), New York Churchill Livingstone : p.1501 (1999) 72011,, p. 26-28 (2011) 8Cunningham CK, et al : Pediatrics, 88, 3 : 527-532 (1991) 9Groothuis JR, et al : Pediatrics, 82, 2 : 199-203 (1988) 10McDonald NE, et al : N Eng J Med, 307, 7 : 397-400 (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 : 531-537 (1998) 14Committee on Infectious Diseases and Committee on Fetus and Newborn : Pediatrics, 102, 5 : 1211-1216 (1998) 15Feltes TF, et al : J Pediatr, 143, 4 : 532-540 (2003) 16Johnson S, et al : J Infect Dis, 176, 5 : 1215-1224 (1997) 17 CHDBPD 23
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