, ,800U cDNA 498 C 2230 H 3357 N 633 O 718 S 50 52, ,000 Glycoprotein (molecular weightca.64,000) consi
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- ともみ たけくま
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1 審議結果報告書 平成 19 年 12 月 4 日医薬食品局審査管理課 [ 販売名 ] リコモジュリン点滴静注用 [ 一 般 名 ] トロンボモデュリンアルファ ( 遺伝子組換え ) [ 申 請 者 ] 旭化成ファーマ株式会社 [ 申請年月日 ] 平成 18 年 8 月 29 日 [ 審議結果 ] 平成 19 年 11 月 22 日に開催された医薬品第一部会において 本品目を承認して 差し支えないとされ 薬事 食品衛生審議会薬事分科会に上程することとされた なお 本品目は生物由来製品に該当し 再審査期間は 8 年とし 原体及び製剤 ともに毒薬又は劇薬に該当しないとされた
2 , ,800U cDNA 498 C 2230 H 3357 N 633 O 718 S 50 52, ,000 Glycoprotein (molecular weightca.64,000) consists of 498 amino acid residues (C 2230 H 3357 N 633 O 718 S 50 molecular weight52,124.58) produced in Chinese hamster ovary cells by expression of cdna encoding amino acid residues at position of human thrombomodulin Thrombomodulin Alfa (Genetical Recombination) 1
3 β-hydroxyl Asn(Asn 324 ) 2
4 (a) (b) (c) O 3
5 , Disseminated Intravascular CoagulationDIC DIC DIC DIC DIC DIC DIC DIC 7 DIC U/kg 30 4
6 , ,800U DICDIC U/kg Disseminated Intravascular CoagulationDIC DIC DIC Biologicals; 30, ,
7 rhtmαhtm cdna CHO 498 C 2230 H 3357 N 633 O 718 S 50 52, ,000 5 Asn 29 Asn 97 Asn 98 Asn 364 Asn 391 N 7 Ser 287 Ser 474 Ser 480 Ser 482 Ser 485 Thr 486 Thr 488 O 46 Cys rhtmα cdna cdna TMJ2 TMD123TMD123 cdna SV40 psv2tmd123 psv2tmd123 psv2dhfr DHFR DHFR CHO MTX MTX rhtmα MCBMCB WCB 2 MCBWCB in vitro CAL MCB WCB CAL MTX MTX NT MTX NT NT rhtmα NT 1 rhtmα rhtmα µg/10 6 cells/day µg/10 6 cells/day µg/10 6 cells/day DNA NT DNA kb NT kb 6
8 mrna RT-PCR cdna MCB WCB CAL kb kb NT NT NT cdna rhtmα 2-2 MCB WCB CAL NT S L NT 1 NT NT NT In vitro VeroMRC-5CHO-K1 NT In vivo NT NT NT NT NT 2 NT NT MCB CAL WCB WCB MCB 1 MCB MCB WCB MCB MCB WCB WCB in vitro in vivo 1 BT Bovine viral diarrhea virusbovine adenovirus type 3Bovine parvovirusinfectious bovine rhinotracheitis virusbovine parainfluenza virus type 3 2 PT1 Porcine parvovirus 7
9 3 WCB 2-3 cells/ml L 2-3 ± L/ cells/ml µm in vitro MRC5VeroCHO-K1 U/mL EU/mL 2-3 *) 1L ml 1L ml * Medium 4 rhtmα 1 1 ph ± 2 ph 2 mg/ml 2 2 rhtmα 3 3 mg/ml 3 3 nm 0.22µm 20±5 AEXC AFCCEXC SEC
10 2-4 APC IgG ELISA IgG ELISA ELISA DNA IgG AEXC AFC CEXC SEC AFC rhtmα S L XC In vitro MRC-5VeroNIH-3T3 In vivo MAP 3 4 Bovine testiclebovine turbinatevero Rodent ParvovirusMouse parvovirusprospect Hill virus 4 Bovine respiratory syncytial virus BRSVBovine viral diarrhea virus BVDVRabies virusbluetongue virus type17reo 3Bovine parvovirus BPVBovine adenovirus BAV 9
11 rhtmα in vivo passage A rhtmα SDS-PAGESDS-PAGEpH AFC AFC 5 MCBWCB / MCBWCB / MCBWCB CAL CHO 2.12 in vitro MRC5VeroCHO-K1 ICH Q5A CHO XMuLVXenotropic murine leukemia virus PRVPseudorabies virus 3 Reo 3 MVMMinute virus of mice PRV XMuLV Reo 3 MVM / DNA/ env RNA/ env RNA/ env DNA/ env AEXC AFC CEXC ph nm
12 rhtmα 2-5 in vivo passage rhtmα in vitro MRC-5VeroNIH-3T3 MAP 6/ L CEXC A rhtmα 2 B C AC C D D L L E nm CEXC F E F mmol/l mmol/l G G G L L L H H G H G H G H 11
13 2 1 N C MALDI-TOF/MS MALDI-TOF/MS SDS-PAGEMALDI-TOF/MS SDS-PAGE RP-HPLCSECAEXC C cdna SDS-PAGE 1 SDS-PAGE MALDI-TOF/MS 64,000 N Ala Ala LC/MS Ala ± ±C 2 Gly 498 Gly LC/MS 46 Cys 23 Cys 12 -Cys 17 Cys 34 -Cys 149 Cys 78 -Cys 115 Cys 119 -Cys 140 Cys 157 -Cys 206 Cys 227 -Cys 238 Cys 234 -Cys 247 Cys 249 -Cys 262 Cys 270 -Cys 278 Cys 274 -Cys 290 Cys 292 -Cys 305 Cys 311 -Cys 322 Cys 318 -Cys 331 Cys 333 -Cys 344 Cys 351 -Cys 360 Cys 356 -Cys 370 Cys 372 -Cys 386 Cys 390 -Cys 395 Cys 399 -Cys 407 Cys 409 -Cys 421 Cys 427 -Cys 437 Cys 433 -Cys 446 Cys 448 -Cys nm SDS-PAGE pi pi rhtmα 1 rhtmα 12
14 rhtmα 1 U C S-2366L-Pyroglutamyl-L-prolyl-L-arginine-p-nitroaniline hydrochloride p-rhtmα 1 U 1 0.1µmol p-biologicals 2002; 30, 69-76rhTMα 1mg U rhtmα C C rhtmα K d 4.0nmol/LrhTMα C K m 5.1µmol/Lk cat 48min 1 N 5 O 7 N 2 O 1-1 SEC AEXC rhtmα AEXC rhtmα SDS-PAGE rhtmα SEC AEXC rhtmα SEC rhtmα Native-PAGE SEC AEXC
15 -3 DNA IgG 2 SDS-PAGE IEFpH SECAEXCDNA IgG 3 G L2 Lot No H L1 Lot No 20±5 36 5±3 6 25±2 3 20±2 2,500lx 120 lxhr ml ml ml µl 36 5±36 25±23 SECAEXC SDS-PAGE 20± mmol/l ph mmol/l rhtmα rhtmα L- 6,400U mg 14
16 2-7 G mmol/l C 2-7 A B C D 0.1mg640U 1mg6,400U 1mg6,400U 2mg12,800U 12,800U rhtmα 0.1 mg 1 mg 1 mg 2 mg 12,800 U mg mg L- 20 mg 20 mg 40 mg 40 mg D D G G G H 2 L- ph 0.22µm PVDF g± rhtmα ph SEC 4 10 / 3 Lot No. 25±260RH5RH36 15
17 40±275RH5RH6 60±23 20±22,500lx 120 lxhr SDS-PAGE 36 SEC SDS-PAGE ,000lx SDS-PAGEIEF SECAEXC 1 U mg mg ml Lot No.TS Biologocals; 30:69-76, mg/ml ml/ RP-HPLCN MALDI-TOF/MS 16
18 SECAEXC Lot No. Lot No. 1AFC rhtmα rhtmα 1mL A C XuMLV rhtmα AFC rhtmα XMuLV / RNA/ env A AFC CEXC ph nm AEXC AFC AEXC PRVReo3MVMXMuLV AFC Reo3MVM XMuLV 17
19 3 rhtmα rhtmα rhtmα rhtmα rhtmα rhtmα AEXC SEC rhtmα 4 N N pi 18
20 C C nmol/L 2nmol/L C 10µmol/L K d 4.0nmol/L 0.5µmol/L C C n=3 C µg/mL C C n=2 2 FVa µg/mL tissue factortf FVa 50%IC µg/mL FVa FVa 0.1µg/mL FVa 50% 2.6µg/mL FVa TF CaCl µg/mL IC µg/mL C % S % AT % C S C 27% 19
21 S 20% C S 10% 1µg/mL AT TF TF CaCl µg/mL0.0110µg/mL 0.160µg/mL IC µg/mL IC U/mL 20% 80%IC 80 /IC n=3 TF TF CaCl 2 5 CAPCAT AT ATAT µg/mLAPC TF 5 IC µg/mL0.030µg/mL0.15µg/mL 0.58µg/mL0.037U/mL 0.065IU/mL APC IC 80 /IC APC C 3 TCT TCT µg/mL U/mL TCT
22 APC TCT 2 8.2µg/mL6.7µg/mL 0.4µg/mL0.15µg/mL0.25U/mL 0.74 IU/mL IC 50 ±24±4.5nmol/L1.5±0.3µg/mL IC ±0.7 nmol/l97±20 nmol/l0.08±0.02u/ml 0.15±0.03IU/mL n= µg/mL 4DIC TFDIC1TF Sprague-Dawley 89 TF150mg/kg 1 DIC DIC TAT APTTPT FDP D- 6406,400U/kg0.1 1mg/kgTF 30300IU/kg 330mg/kg 0.33mg/kg TF 1 Control TF Normal DIC 1,900U/kg 0.3mg/kg PT 6,400U/kg1mg/kg TATFDP D- APTT 30IU/kg/hr 100IU/kg/hr TAT PT 100IU/kg/hr D-300IU/kg/hr APTT 0.3mg/kg/hr FDP D-n=56 TFDIC4TF Sprague-Dawley g TF100mg/kg 4 DIC DIC 1,900U/kg0.3mg/kg 300U/kg n=781,900u/kg0.3mg/kg 21
23 300U/kg µg/mL U/mL TFDIC1TFAT Sprague-Dawley g TF150mg/kg 1 DIC DIC AT 6406,400U/kg0.11mg/kg 30100U/kg TF 6,400U/kg 1mg/kg 100U/kg DIC n=412 Sprague-Dawley g AT 20mg/kg 1 6,400U/kg1mg/kg 100U/kg TF 90mg/kg 1 AT AT92 57% 6,400U/kg1mg/kgTF 100U/kg n=56 LPSDIC4LPS Wistar 67 LPS 055:B5 50mg/kg 4 DIC DIC APTT PT FDP GFD 1,90019,000U/kg mg/kg U/kg LPS 4 DIC FDP 6,400U/kg 1mg/kg1,900U/kg0.3mg/kg 1,900U/kg0.3mg/kg 200U/kg GFD 6,400U/kg 400U/kg n=617 TFDIC0.5TF kgTF50mg/kg 0.5 DIC DIC TAT FDP C APTT PT 6.46,400U/kg mg/kg 540U/kg TF TATFDP C APTTPT APTT TAT APTT 640U/kg0.1mg/kg 20U/kg TAT 64U/kg 0.01mg/kg 20% 70%ED 70 /ED
24 n= µg/mL 5DIC TFDIC0.5TF Sprague-Dawley 89 TF50mg/kg 0.5 DIC TF 1901,900U/kg mg/kg U/kg/hr U/kg0.1mg/kgTF U/kg/hr 300U/kg/hr n=10 6DIC LPSDIC24LPS Sprague-Dawley 7 LPS 055:B5 30mg/kg 24 DIC LPS 19,000U/kg3mg/kgLPS 1,900U/kg/hr 0.3mg/kg/hr 56%14/2592%23/25 GPT GOT C APC FVa Fa 2 1TAFI TAFI Sprague-Dawley 56nmol/L2.9µg/mLCaCl 2 TAFI TFDIC0.5TFTAFI Sprague-Dawley7TF1.9U/kg0.5 DIC6,400U/kg1mg/kg TFTAFI TATn=6 23
25 APTTPTXa µg/mLC APTT APTT2 100µg/mL1,000µg/mL Sprague-Dawley320420g13,000 51,000U/kg28mg/kg100400U/kg 1526,000U/kg4mg/kg200U/kg n=717 4DIC CLP-αTNF-α -6IL C57BL/681020% CLP19,000U/kg3mg/kgCLP 117CLP612 TNF-αIL-6CLP744% TNF-αIL-6n=483%n=18 LPSDIC3LPS-1β IL-1β Sprague-Dawley7LPS055:B5 3.75mg/kg3DIC 19,000U/kg3mg/kgLPSLPS 1,900U/kg/hr0.3mg/kg/hrLPS IL-1β770pg/mL 482pg/mL ddy5619,000u/kg3mg/kg 1Irwin open-field5 24
26 thiopental sodium 35mg/kg 5pentetrazol65125mg/kg Wistar6719,000U/kg3mg/kg 1Irwin Sprague-Dawley81,900U/kg0.3mg/kg 19,000U/kg3mg/kg190,000U/kg30mg/kg herg herg µg/mL kg19,000U/kg 3mg/kg kg19,000U/kg3mg/kg kg64,000U/kg10mg/kg 0.53pH Hartley250g10100µg/mL mol/l mol/l mol/l mol/l 24ddY5 619,000U/kg3mg/kg
27 Wistar6719,000U/kg3mg/kg 5 4 1APTT APTT13µg/mL0.168U/mL 0.11IU/mL0.1122µg/mL µg/mL 30 C Thromb Haemost; 70: J Biol Chem; 270: APC 15 Chest; 124(3 Suppl): 26S-32S U/kg 0.06mg/kg IC 50 90ng/mL TF DIC 270ng/mL DIC IC 50 90ng/mL DIC 30 C DIC DIC DIC DIC 26
28 ELISAenzyme-linked immunosorbent assay 125 I U/kg50µg/kg α β T 1/2α T 1/2β hr ,600U/kg µg/kg mL/kgCL mL/hr/kg AUC C ,600U/kg µg/kg mL/kgCL mL/hr/kg AUC C 0 320U/kg50µg/kg 2 C max AUC C max 320U/kg50µg/kg AUC C 0 T 1/2β CL 125 I- 320U/kg50µg/kg U/kg50µg/kg ,00038, ,000U/kg26 18mg/kg ,3003,800 13,000U/kg mg/kg C 5min AUC 0-24hr I- 320U/kg50µg/kg
29 125 I- 125 I 125 I I- 320U/kg50µg/kg I- 320U/kg50µg/kg 125 I- 320U/kg50µg/kg I- 320U/kg50µg/kg I I- 320U/kg50µg/kg ,600U/kg µg/kg
30 /6 320U/kg 50µg/kgT 1/2α hrT 1/2β hr T 1/2α T 1/2β hr Vd I Vd 2 Vd 1 Vd 1 Vd ,000380,000 1,200,000U/kg mg/kg 5 1,200,000U/kg 180mg/kg ,200,000U/kg180mg/kg 1 2 1,200,000U/kg180mg/kg 2 1,200,000U/kg180mg/kg
31 1 13,00038, ,000U/kg26 18mg/kg ,000U/kg ,000U/kg 1 120,000U/kg18mg/kg 2 1 GOTGPT 1 38,000U/kg/6mg/kg/ ,300 3,800U/kg mg/kg 1 1 3,800U/kg0.6mg/kg 2 3,800U/kg/0.6mg/kg/ 1 1,3003,80013,000 38,000U/kg mg/kg 1 1 1,300U/kg 3 5 1,300U/kg 1 13,000U/kg2mg/kg 1 38,000U/kg6mg/kg 2 38,000U/kg6mg/kg 2 13,000U/kg 2mg/kg 1 13,000U/kg2mg/kg 1 38,000U/kg6mg/kg 1 3,800U/kg0.6mg/kg 13,000U/kg2mg/kg 3,800U/kg0.6mg/kg ,000U/kg2mg/kg ,000U/kg6mg/kg 3 3,800U/kg0.6mg/kg GOTGPT 38,000U/kg6mg/kg 2 13,000U/kg2mg/kg 3,800U/kg0.6 mg/kg 13,000U/kg2mg/kg 1 1,300U/kg/ 0.2mg/kg/ 6 4 1,3003,800 13,000U/kg mg/kg
32 3,800U/kg 0.6mg/kg 1 13,000U/kg2mg/kg ,000U/kg 2mg/kg ,000U/kg2mg/kg ,800U/kg 0.6mg/kg 1 13,000U/kg2mg/kg 2 Fe 3,800U/kg0.6mg/kg 1 13,000U/kg2mg/kg 2 3,800U/kg0.6mg/kg 3,800U/kg 0.6mg/kg 13,000U/kg2mg/kg 1 13,000U/kg2mg/kg 1 1, ,800U/kg0.6mg/kg 27 13,000U/kg 2mg/kg 1 C 5min AUC 0-24hr 1,300U/kg/0.2mg/kg/ Don D-6 in vitro ,000U/kg18mg/kg ,000U/kg18mg/kg 13,00038, ,000U/kg26 18mg/kg ,000U/kg 6mg/kg ,000U/kg 31
33 18mg/kg ,000U/kg6mg/kg 38,000U/kg6mg/kg 7 120,000U/kg18mg/kg 13,000U/kg/2mg/kg/ 38,000U/kg/6mg/kg/ 13,000U/kg/2mg/kg/ 13,000U/kg2mg/kg ,00038, ,000U/kg26 18mg/kg ,000U/kg6mg/kg 2 120,000U/kg18mg/kg 22 38,000U/kg 6mg/kg 1 120,000U/kg18mg/kg ,000U/kg18mg/kg 38,000U/kg6 mg/kg 13,000 38,000U/kg2 6mg/kg 120,000U/kg18mg/kg120,000U/kg18mg/kg 120,000U/kg18mg/kg 13,000U/kg2mg/kg 3,800 13,000U/kg0.6 2mg/kg ,000U/kg2mg/kg 2 38,000U/kg6mg/kg 3,80013,000 32
34 38,000U/kg0.62 6mg/kg ,000U/kg6mg/kg ,000U/kg6 mg/kg4/ 1 38,000U/kg(6mg/kg) 13,000U/kg/2mg/kg/ 3,800U/kg/0.6mg/kg/ 38,000U/kg/6mg/kg/ ,700 U/kg1.2mg/kg 1/3 7,700U/kg1.2 mg/kg 1,300 3,800 7,700U/kg mg/kg ,700 U/kg 1.2mg/kg 3 2 7,700 U/kg1.2mg/kg ,800U/kg/0.6mg/kg/ ,000U/kg6mg/kg 3,80013,000U/kg 38,000U/kg0.62 6mg/kg ml/kg ,000 U/kg6mg/kg ,000U/kg2mg/kg ,000U/kg6mg/kg ,000U/kg 2mg/kg 5 38,000 U/kg6 mg/kg 33
35 3,800U/kg/0.6mg/kg/ 3,800U/kg/0.6mg/kg/ 13,000U/kg/ 2mg/kg/ ,900 19,000U/mL mg/mL 0.05mL/ ()3mg/mL ASA ASA PCA ASA mg/14 1mg/ PCA 12 ASA mg/ ASA PCA PCA mg/ 24 1mg/ 64,000 DNA in vitro 34
36 DIC ELISA ,900U/ mg/ 2 C max 190U/ ,900U/ 48 C max ± 10.15± ± ±5.16ng/mL AUC AUC inf ± ±31.731,074.72± ,030.89± nghr/ml T 1/2α hrt 1/2β hr CL ml/hr/kg ,900U/0.3mg/ 1 C ±5.43 ng /ml±auc inf ±
37 nghr/mlt 1/2α 3.37±2.27 hrt 1/2β 19.82±2.10 hrcl 1.49±0.24 ml/hr/kg ± ±10.3% C ,300U/0.2mg/ C max AUC inf 93.29±4.62ng/mL 2,143.09±204.43nghr/mL T 1/2α 3.94±1.83hrT 1/2β 18.73±4.25hrCL 1.40±0.31mL/hr/kg DIC U/kg mg/kg ± ± ±237.9ng/mL ± ± ,730.7±445.1ng/mL ± ± ±313.7ng/L 10.6± ± ±6.8ng/mL 4 7 DIC DIC ng/mL ng/mL 500ng/mL ng/mL 70% 380U/kg0.06mg/kg6 36
38 PPK kg3190kg 1.14 mg/dl mg/dl NONMEM 79 / GOT GPT CV Vd 34.4%CL 31.3% Vd WT 1.43 HT CL WT AGE HT1 or 0 AGE1 or 0 WTkg PPK CL 16% 43% 1 DIC 30 I DIC 30 37
39 I 2 2 C max 30 C max C max PPK PPK PPK 1 I 2 PPK AUC CL AUC 3509 nghr/ml α AUC 436 nghr/ml 12β AUC 3,073 nghr/ml 88% 1- PPK 1- PPK 38
40 2- α 1-2 PPK PPK 0.25 Tukey P-value 0.05 / 1.2 mg/dl Cockcroft and Gault 40mL/min 20mL/min CL PPK U/kg 0.06mg/kg 4mg/dL 1mg/dL C max 1.2 PK
41 kg kg15 48kg 4mg/dL mg/dL PPK PPK CL 15% 1 130U/kg 130U/kg DIC PPK 25 4mg/dL PPK PPK 40
42 ng/mL 1,000ng/mL 100ng/mL 1000ng/mL 100ng/mL APC IC 50 90ng/mL IC I I DIC * mg/0.2mg/ mg/1 DIC DIC mg0.61.2mg1.22.0mg mg/ : 0; ; ; ; 83.3 DIC DIC DIC mg0.02mg0.06mg/kg mg/kg U/kg/hr 6 24 DIC * 50kg 1,90019,000U/0.33.0mg/38380U/kg mg/kg : 0.006mg/kg mg/kg mg/kg 67.6% DIC Woolson-Bean 66 1 vs ,900U/ mg/ 2431,300U/0.2mg/
43 30.1mg10.3mg mg 20.3mg120.2mg ,900U/0.3mg/ ±45.3± ± ±14.6% (%) (hr) 42
44 DIC DICDIC mg// 0.6mg// ,900U/0.3mg/ 3,800U/0.6mg/ 13,800U/ 0.6mg/ 7,700U/1.2mg/ 27,700 U/1.2 mg/ 13,000U/2.0mg/ 313,000U/2.0mg/ 19,000U/3.0mg/ DIC DIC %1/1 16.7%1/6 0%0/2 100%5/5 43
45 100%3/3 16.7%1/6 60.0%3/5 66.7%2/3 100%3/3 11.1%1/9 42.9%3/7 66.7%2/3 75.0%3/4 50.0%5/ %5/9 83.3%10/12 DIC 50.0%2/4 30.0%3/ %3/9 75.0%9/ %3/4 40.0%4/ %5/9 83.3%10/ %1/4 30.0%3/ %3/9 50.0%6/ /4 0/13 1/9 1/ DIC DICDIC 92 38U/kg0.006mg/kg 1,900U/0.3mg/130U/kg 0.02mg/kg 6,400U/ 1.0mg/380U/kg0.06mg/kg19,000U/3.0mg/ FDP 4 FDP FDP mg/kg mg/kg 33/ %0.02mg/kg 31/ %0.06mg/kg 39/ % 0.006mg/kg mg/kg mg/kg 0 44
46 mg/kg mg/kg 39.3%11/ mg/kg 60.7%17/ mg/kg 67.6%23/34 Cochran-Armitage p= mg/kg 0.02 mg/kg 0.06 mg/kg % 14.30% 28.60% 21.40% 10.70% 39.30% % 17.90% 21.40% 10.70% 7.10% 60.70% % 20.60% 8.80% 8.80% 14.70% 67.60% % 17.80% 18.90% 13.30% 11.10% 56.70% DIC mg/kg 0.02 mg/kg 0.06 mg/kg / / / / / / / / / / / /90 DIC / / / /94 DIC 5 2 DIC DIC DIC DIC mg/kg mg/kg mg/kg
47 mg/kg mg/kg mg/kg mg/kg 14/ %20/ / ALP GOT GPT mg/kg 15/ / / mg/kg mg/kg mg/kg DIC 0.06mg/kg/ DIC DICDIC DIC DICDIC mg/kg/
48 8U/kg/hr DIC DIC Full Analysis SetFAS FAS Per Protocol SetPPS %PPS PPS % % DIC FAS DIC 224 DIC DIC DIC FAS DIC DIC DIC DIC 5 2 DIC DIC DIC FAS DIC 100 DIC Woolson-Bean DIC FAS -%- 95% 95%
49 7 7 FAS % 95% Mantel-Haenszel χ P FAS 95% 95% Mantel-Haenszel χ :1 P FAS 95% 95% FDPµg/mL PICµg/mL ^4/µL D-µg/mL ^4/µL α2pi% mg/dl C% PT PAI-1ng/mL APTT µg/ml TATng/mL AT% % 70.7%82/ /116 48
50 53.462/ %83/ % 69/ / / / GOT 6.07/ /116 GPT 5.26/ / / / / / / / /115 LDH 3.54/115 GOT 3.54/115 GPT 3.54/ / / /116 29/ /116 9/ %1/112 vs. 5.5%6/ %1/112 vs. 5.5%6/ %1/112 vs. 5.5%6/110 AL-P 1.0%1/103 vs. 4.9%5/102 LDH 0 0/109 vs. 3.8%4/106 GOT 6.5%7/107 vs. 3.8%4/ %5/89 vs. 1.2%1/84 4.3%4/92 vs. 1.1%1/90 3.2%3/93 vs. 0.0%0/ / / / / %6/ %6/ / / / / / / /116 49
51 1.74 7/ DIC DIC DIC DIC DIC DIC DIC DIC DIC 1983;38: DIC 1520% 5% 4.11 DIC DIC DIC DIC DIC Principles of Internal Medicine 16 th ed.mcgraw Hill DIC DIC DIC
52 4.12DIC DIC DIC 1 DIC U/Levi M, et al. N Engl J Med 1999; 341: DIC U/kg/ 21 pp DIC ,000U J.Pediatr; 91: JAMA; 286: C PROWESS 15,000U/N. Engl. J. Med; 344: DIC 7 10U/kg/hr; 23: C DIC 8U/kg/hrInt. J. Hematol; 75: DIC 10U/kg/hrThromb. Res; 72: DIC 8U/kg/hr 8,64012,480 U// DIC 10,000U// DIC. 1. : ; p DIC Blood; 75: U/kg/hr DIC AT AT AT 50 2DIC DIC DIC
53 , 54 : , 62 : DIC Clin Appl Thromb Hemost; 11: DIC Crit Care Med; 34: ISTH DIC overt-dic DICCrit Care Med; 32: ISTH overt-dic DIC 1988 overt-dic DIC ISTH overt-dic DIC DIC ; 31: DIC 1 DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC FDP 3 PT 2 DIC DIC DIC DIC DIC DIC 52
54 DIC DIC FDP 3 FDP DIC DIC FDP ; 18: FDP ;pp DIC DIC FDP DIC FDP CT DIC DIC DIC DIC DIC DIC DIC ISTH overt-dic Am. J. Hematol; 4: DIC DIC DIC 7 DIC DIC DIC DIC DIC 53
55 3 DIC DIC 28 1 DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC 7 DIC 28 DIC DIC 10.0%6/ %23/39 DIC DIC 8.6%6/ %16/55 7 DIC 28 DIC 3.1%1/ %11/16 DIC 7.1%3/ %8/22 DIC DIC DIC DIC 7 DIC DIC DIC DIC DIC DIC 7 3 FDP515.5µg/mLD µg/mL ATTAT ng/mLα2 54
56 PIC µg/mLSFMC µg/mL DIC DIC DIC TAT DIC DIC TAT 4 DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC Woolson-Bean DIC 95% % 95 5% DIC DIC DIC DIC N Engl J Med; 341: DIC DIC DIC 55
57 DIC FAS DIC DIC FAS 60/ / / / % 5/ % 0/ / / / / / / % 23/ / / / / / DIC DIC DIC -1 FAS DIC DIC FAS DIC 95 DIC FDP 7 7 DIC LOCF FDP DIC FAS DIC DIC 95()()
58 -3 DIC DIC DIC ; 16: DIC DIC DIC FAS D- FDP D-/FDP FDP DIC DIC 7 DIC 2 3 DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC 2 DIC DIC DIC 95()()) U/kg0.06mg/kg DIC DIC 60%3/5 DIC 4 DIC DIC 2 SIRS DIC DIC 85 SIRS 3 1 ; 16: SIRS 3 DIC 2 DIC DIC 7 DIC 3 4 DIC DIC 2 3 DIC DIC 3 DIC DIC 57
59 U/kg0.06mg/kg DIC 60.0%3/5 DIC -4 overt-dic ISTH overt-dic Crit Care Med; 32: DIC FAS 227 overt-dic DIC 7 DIC 4 5 overt-dic overt-dic DIC overt-dic Fibrin-related marker overt-dic Fibrin-related markerd- 0 1µg/mL1µg/mL 2 10µg/mL10µg/mL 3 PT overt-dic DIC Overt-DIC DIC DIC Overt-DIC 95% U/kg0.06mg/kg 35 overt-dic DIC 68.8% 11/ %4/4 42.9%3/7 50.0%1/2 ) -5 LOCFlast observation carried forward DIC
60 8 LOCF DIC 38U/kg0.006mg/kg 35.3%12/34 130U/kg 0.02mg/kg 45.2%14/31 380U/kg0.06mg/kg 54.3%19/35-6 FFP DIC FFP C S 17 9 DIC FFP FFP FFP DIC FFP DIC FAS FFP 10U 10U 95 DIC 37/ / / / / / ( ) DIC 26/ / / / / / PPS FDP FDPµg/mL /µl mg/dl PT TATng/mL
61 PICµg/mL D-µg/mL α2pi% C% PAI1ng/mL SFMCµg/mL AT% TAT 4 13 TAT TAT FAS 5 ART-123 ART-123 DIC 186 ART ART-123 DIC ART
62 ART DIC % vs % % vs % %vs % %vs % DIC DIC DIC DIC DIC %50/ %65/115 61
63 p=0.0487fisher %64/ %75/115 p= %2/ %7/ DIC / N=116 N= AMLM3 62
64 α 2 PI DIC α 2 PI ART ART ART ART
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66 6 6.6 vs ATJAMA; 286: AT38.9 vs CAPC DIC Int. J. Hematol; 75: APC20.4 vs APC N. Engl. J. Med; 344: APC24.7 vs DIC DIC ATJAMA; 286: AT44.9 vs DIC DIC DIC 2001 ISTH SSCDIC DIC Thromb. Haemost; 86: DIC DIC DIC DIC 2 Harrison s Principles of Internal Medicine 16 th ed.mcgraw Hill DIC DIC DIC DIC DIC DIC DIC DIC AT Blood; 75: ; 8: ; 23: ; 124: ; 65: DIC 65
67 AT 4 1 DIC DIC DIC DICDIC DIC 4 DIC DIC DIC DIC DIC DIC DIC TF Levi M, et al. N Engl J Med; 341: DIC DIC DIC DIC ; 8: ; 65: DIC DIC DIC DIC DIC DIC DIC DIC DIC TAT DIC DIC DIC 28 DIC DIC 25.01/4 vs. 66
68 DIC 53.8%7/13 DIC DIC DIC DIC 11, pp DIC 54 DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC DIC 67
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72 0.06mg/kg 380U/kg 0.06mg/kg 67.6% 38U/kg 0.006mg/kg130U/kg0.02mg/kg380U/kg0.06mg/kg 3 130U/kg0.02mg/kg 380U/kg0.06mg/kg DIC DIC 380U/kg0.06mg/kg in vitro in vivo 380U/kg0.06g/kg mg/kg mg/kg DIC DIC 38130U/kg mg/kg U/kg mg/kg %0/4 15.4%2/13 0%0/8 20.0%2/ mg/kg 15.4%4/ %3/ %10/ mg/kg 380U/kg0.06mg/kg 2 71
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81 3,000 1 C 10% DIC DIC DIC DIC DIC DIC DIC DIC DIC 80
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