rt-PA（アルテプラーゼ）静注療法 適正治療指針 第版

1 Rt-PA .. 2012 10 . 2016 9 .. rt-PA . rt-PA . 2016 9 .. * .. * . rt-PA . 2012 10 . 2012 10 . rt-PA .. MRI .. 2016 9 ---------- 1. 2012 10 ---------- 2. ---------- 3. 1. ---------- 6. 2. ---------- 7. 3. ---------- 9. 4. ---------- 13. 5. ---------- 14. 6. ---------- 14. 7. ---------- 18. 8. ---------- 22. 9. ---------- 25. 10. ---------- 27. ---------- 30. ---------- 38. 2016 9 ---------- 39. ---------- 40. 2016 9 . 2012 10 rt-PA 4 . 2005 10 10 . 5% . 2015 . 2015 2014 . 2015 2015 4 . 2 rt-PA .. 2012 .. 2 .. 2012.

2 3 .. -1- 2012 10 .. recombinant tissue-type plasminogen activator: rt-PA alteplase . National Institute of Neurological Disorders and Stroke NINDS . NINDS rt-PA Stroke Study [1] 1996 .. Japan Alteplase Clinical Trial: J-ACT [2] . 2005 . rt-PA . 2005 10 [3] . 7 . 2012 8 .. rt-PA .. 2005 .. mg/kg . 10 1 .. -2- .. 1. Ia, A .. 2. 3 . 3 10 5 20% Ia . 3. mg/kg IIa, A .. 4.. Ia, A . 5.. 1 . Ia, A . 6. IV, A .. 7.. Ia, A .. 8. Ia . CT MRI III .. D .. 9.. IIa, C1 . 10. IIb .. 11.. 1) CT MRI . 2) . 3) . Ia, A .. 12.

3 IIa, B . 13.. III, B . -3- . 14. IV, A . 15. NIHSS IV, A . 16. IV, A .. 17. CT MRI . Ia, A . 18.. Ia, C2 . 19.. IIa, C1 . 20. IV, A .. 21.. IV, . B .. 22. IV, B .. 23. mg/kg 10 1 IIa, A . 24. 24 SCU Ia, B . 25. 24 . III, B .. 26.. IIa, C2 .. 27. 6 . Ia, B . 28.. 2 2015 4 . Ia, A .. 2009 [4]. 1 . -4- 1 4 . Ia randomized controlled trial: RCT . Ib RCT. IIa . IIb . III . IV . A . B . C1 . C2 . D . -5- 1.. 1. Ia, . A .. 2. 3 . 3 10 5 20% Ia . 3. mg/kg IIa, A . 1.. NINDS rt-PA Stroke Study [1] 3 . 3 modified Rankin scale mRS 0 1 39% 26%) 36.

4 6. mg/kg . European Cooperative Acute Stroke Study ECASS [5] . 3 30 .. mg/kg . ECASS II[6] mRS 0 1 . mRS 0 2 . 3 3 6 Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke ATLANTIS [7] NINDS . 3 5 6 . 2 . NINDS rt-PA Stroke Study . mg/kg [12-15] . 5 20% 3 10 . [16-18] . 2.. 3 mRS 0-1 .. (h) (mg/kg) (%)*. NINDS (1995)1 624 3 39% 26% ECASS (1995)5 620 6 ECASS-II (1998)6 800 6 ATLANTIS (1999)7 579 3 5 J-ACT (2006)2 103 3 - DEFUSE (2006)8 74 3 6 42% - ECASS-III (2008)9 821 3 EPITHET (2008)10 100 3 6 35% 24% IST-3 (2012)11 rt-PA 3035 6 24% 21% 7.

5 * : NINDS, IST-3 NIHSS 1 ECASS (PH1,2) . ATLANTIS DEFUSE NIHSS 2 NIHSS 4. 6 3 NIHSS 8 mRS Oxford Handicap Score . -6- 2.. J-ACT[2] 3 103 mg/kg NINDS rt-PA Stroke Study [1] . mg/kg 20 MU 60 kg . 3 mRS 0 1 37% 36 NINDS. rt-PA Stroke Study J-ACT . 2005 mg/kg 3 . Japan Alteplase Clinical Trial II: J-ACT II [19] Japan post-Marketing Alteplase Registration Study: J-MARS . [20] Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI) rt-PA Registry[21] J-ACT II . MR MR angiography: MRA 58.

6 6 52 24 69% J-MARS . 2 8313 9 7492 3 mRS0 1 . 36 SAMURAI rt-PA Registry 600 . J-MARS .. 3.. [22] . rt-PA . 1 . [23,24] 20MU 30MU 30MU . [25] .. [26 27] rt-PA .. 2.. 4.. Ia, A . 5.. 1 . Ia, A . 6.. IV, A . 1.. NINDS rt-PA Stroke Study [1] . 3 NINDS rt-PA. Stroke Study ECASS[5] ECASS II[6] ATLANTIS[7] . -7- [28] Cochrane review . 6 3 6 mRS 3 6 . [29] Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Registry SITS-ISTR [30] 3 . 664 3 11865 3 . mRS 3 . ECASS [9] 3 mRS 0 1 .. 4 ECASS.

7 Echoplanar Imaging Thrombolysis Evaluation Trial EPITHET [10] . 3 3 mRS 0 1 . [31] 6 3035 Third International Stroke Trial (IST-3) [11] 7 . 7 1 11% 7% 6 27 . Oxford Handicap Score [OHS] 0 2 37% 35% OHS 0 1. 24% 21%: OR , 95% CI IST-3 . 6 3 mRS 0 2 . [32] . ECASS 2009 . [33] 2011 11 15 . 3 2009 [14,34] 2010 . 3 [15] 2010 8 . 3 . 2009 . 3 2012 8 .. 3 rt-PA . [35] .. 2.. [28,31] . 10 . 45 1 . [36] 20 30 . [37] . 3.. 2 . -8- 3.. 7.. Ia, A . 8. Ia . CT MRI III .. D . 9.. IIa, C1 . 10.. IIb . 1.. 3 .. 33 50% 24.

8 [16,38] . [39] . 2005 . [3] .. 2.. 185/110 mmHg .. [40-42] . (1) . 3. [1,2] . 1980 CT Okada -9- 3.. ( ) [ : ] [ : ].. 1 . 3 . 21 . 14 .. ( ) .. 185mmHg . 110mmHg .. 50mg/dl 400mg/dl . 100,000/mm3 .. PT-INR . aPTT [ 40 ] . CT/MR .. 81 .. 10 . 10 . 1 . 3 .. NIHSS 26 .. Xa .. 1 . 2 .. 3 4 3 .. - 10 - [43] 41 68 10 . 1 MRI diffusion-weighted image: DWI . parenchymal hematoma [PH] 1,2 10% 11% . [44] . 1 1 . CT . 1 . 1 .. (2) . 1 . 10 . [45] . X . CT .. (3) .. X Xa .. prothrombin time: PT Xa activated partial thromboplastin time: aPTT.

9 PT international normalized ratio: INR . aPTT 40 .. (4) CT/MRI . CT MRI . MRI 3 3 . 7 .. 3.. (1) : . [21,46] NINDS rt-PA Stroke Study . 75 [47] 75 . 81 . [13,34] 81 SITS-ISTR Virtual International Stroke Trials Archive (VISTA) 81 . [48] 81 IST-3 [11] IST-3 . - 11 - [32] 2010 . 81 [49] . 81 80 . SAMURAI rt-PA Registry . [50,51] 75 80 81 .. (2) 3 : [12] . De Silva [52] 5 .. 7 . 6 [53] 3.. (3) : National Institutes of Health stroke scale (NIHSS) . [21, 46] . NIHSS 25 [13,34] . NIHSS 25 [11,51,54] NIHSS 26 25.

10 Japan Coma Scale III-100 . [55] NIHSS .. NIHSS 4 NIHSS 4 .. [28,54,56] . 3 32 . [57-60] .. stroke mimics 56 . [61] .. (4) : 1995. 2006 [62] Edwards [63]. 22 . MRA .. 5720 6697 Unruptured Cerebral Aneurysm Study of Japan (UCAS Japan) [64] 7 .. [65,66] . 2005 .. [67] .. (5) . - 12 - Xa .. PT-INR aPTT . 1 4 [68] PT-INR aPTT .. 12 .. (6) 3 . 3 . [28,31] 3 . rt-PA . 81 NIHSS 26 .. [35] . ECASS [9] . 2010 . [49] SAMURAI rt-PARegistry 3. [51] 3 .. 4.. 11.. 1) CT MRI .. 2) . 3) . Ia, A .. CT MRI .. [69] . 24 .. telestroke.