アクテムラインタビューフォーム
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- かずまさ いなくら
- 9 years ago
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1 IF FAX 80mg 1 4mL 80mg 200mg 1 10mL200mg 400mg 1 20mL400mg JAN TocilizumabGenetical RecombinationJAN 200mg 80400mg
2 IF 1 MR 63 IF 10 IF 2IF IF IF 3IF 4 9 IF IF IF 11 1 IF IF 4IF IF MR IF IF MR Drug Safety Update IF
3 CAS
4
5 IgG1 6IL-6 CDR IL-6 IgG1 CHO IL B 1986 IL-6 IL IL-6 IL C 2 1 IL-6 2RA MTX 24 ACR %29.5% DAS 28ESR % 1ACR %50%70% VASVAS VASHAQ CRP ~ 5 3 2DASdisease activity score CRPVAS 28 DAS28 1
6 DMARDs % ACR X sJIA JIA % 4JIA JIA JIA 30%50%70% %50%70%30% 1 30% VAS/VASCHAQ ESR 4pJIA JIA % 5 C CRP ESR % %LDL % %ALT(GPT) % 2
7 80mg 200 mg 400 mg ACTEMRA 80 mg for Intravenous Infusion ACTEMRA 200 mg for Intravenous Infusion ACTEMRA 400 mg for Intravenous Infusion acteffective JAN TocilizumabGenetical RecombinationJAN tocilizumabr-inn C1033H1606N278O337S6 C2181H3398N582O672S15 148, C1033H1606N278O337S623, C2181H3398N582O672S1549, ,000 MRA
8 ph luxhr 5 200Whr/m 2 (1) SDS- (2) 4
9 1 80mg80mg 200 mg200mg 400 mg400mg ph mg 200mg 400mg 4 ml 10 ml 20 ml 80 mg 200 mg 400 mg mg 2 mg 500 mg 5 mg 1000 mg 10 mg ) 25kg 50mL25kg mL 20mg/mL 25kg 50mL25kg mL 5
10 (kg) 8 (mg/kg) (ml) = 20 (mg/ml) 1) [ ] 2) 80mg200mg400mg luxhr 5 200Whr/m 2 200mg 0.1 mg/ml 8 mg/ml 24 6
11 SDS- 7
12 C MASMAS MAS MAS MAS pjia 1. sjia IL-6 sjia 2.sJIA MAS MAS IL-6 TNF-IFN-IL-1IL-8 MAS MAS MAS 8
13 MAS MAS MAS MAS NSAIDs ) MAS PLT FDP-ED-dimer 2- AST/LDH/CK ) : 2007 :, 111(8), 1103, mg/kg 4 1 8mg/kg (1) sjia 1 23 sjia 2 CRP* IL-6 3 CRP* CRP* *C 9
14 sjia MAS 1 8mg/kg 2 CRP IL-6 1 8mg/kg 2 1 CRP CRP CRP mg/kg/ CRP CRP log r= CRP CRP IL-6 CRP 4 20 mg/ml 25 kg 50 ml25 kg mL (ml) = (kg) 8 (mg/kg) 20 (mg/ml) 5 (1) (2) 1 (1) 1.2 ((2)2) ) (2) Infusion Reaction 10
15 1 Infusion Reaction (2) 10mL/hr kg 50mL 1 25kg 100mL 1 1 RA P 25.0% MTX8mg/ 16/64 MTX ACR 64 #1 20% RA 24 8mg/kg/4 MTX 80.3% MTX 49/61 61 DMARDs RA Total 52 # mg/kg/ #1: ACR #2: 2 pjia JIA 30% 50% 70% JIA #3 94.7% 94.7% 57.9% pjia 12 18/19 18/19 11/19 #3:Giannini JIA 11
16 3 sjia P 8mg/2 3 2 sjia mg/kg/ % 4/ % 16/ sjia 56 8mg/kg 2 3 JIA 30% CRP0.5mg/dL 6 2 JIA 30% CRP1.5mg/dL 4 8mg/kg 2 248mg/kg/2 CRP 3 7 CRP ESR Hb 8mg/kg/ mg/kg mg/kg/ mg/kg % mg/kg %22 1.0mg/kg %4 2.0mg/kg %10 1 8mg/kg mg/kg 2 CRP ESR 93.3% 14 /15 2mg/kg mg/kg mg/kg mg/kg 12
17 mg/kg 8mg/kg ACR 20%8mg/kg 78.2%43/55 4mg/kg 57.4%31/ %6/53 8mg/kg 2 P0.0018mg/kg 4mg/kg ACR 50%ACR 70% 8mg/kg 4mg/kg 163 8mg/kg 47/ % 166 4mg/kg 39/ % 85 26/ % 49 HDL ASTALT 4mg/kg 8mg/kg 8mg/kg 4 8mg/kg 1 8mg/kg mg/kg CRP 4mg/kg 8mg/kg 3 CRP 2mg/kg/2 CRP 3 4mg/kg/2 5 8mg/kg/2 3 JIA 30%50% 702mg/kg % %4mg/kg %87.5%50.0%8mg/kg 3 100%100%100% mg/kg 8mg/kg 2 2 8mg/kg 1 8mg/kg 3 (1) mg/kg CRP CRP 8mg/kg 13
18 2 248mg/kg % % % 25 8mg/kg 8mg/kg 8mg/kg 2 1 8mg/kg (2) 28 8mg/kg % CRPmg/dL 8.7± ±1.7** 0.9±2.0** mg/dl 639± ±149** 317±138** ESRmm/hr 114±34 63±36** 48±40** 0100mm 29.9± ±17.2* 17.7±16.5** Hbg/dL 9.2± ±1.9** 12.0±2.1** g/dl 2.7± ±0.5** 3.7±0.5** 0.05p0.01 t n=24-28sd 1 (1) 8 mg/ + + 8mg/kg/424 ACR 20% 25.0%80.3%P0.001 ADL MHAQ
19 0.32P0.001MCID (minimum clinically important differences) % 67.2%P %22/ %17/ %10/61 (2) DMARDs 8 mg/kg/4 DMARD 52 Modified Sharp Score 52 X Total 88.5%139/ P Total mg/kg 2 3 JIA 30% CRP 0.5 mg/dl JIA 30% CRP 1.5 mg/dl JIA 30% % 85.7%67.9% % %P0.001 P
20 % χ Log Rank Test: χ % mg/kg 4 3 8mg/kg ± 0.66 mg/kg/mean ± SD 0.7 mg/kg/ 8.2 mg/kg/ 1,394 1, % ACR ACR 20%70.22 ± 32.32%Mean± SD ACR 50%48.66 ± 39.07%ACR 70%27.94 ±33.88% 150/ %1,320 8 mg/kg 2 118mg/kg CRP ESR 90%100%JIA 30%50%70100% 100%90% mg mg
21 mg/kg % RA 14MRA 80CrCL CrCL CrCL ACR2028.6%4/ % % % mg/kg 4 3 JIA #2 30%50%70% 94.7%94.7%57.9% %
22 6IL-6 IL-6 IL-6R IL-6 gp130 IL-6R IL-6R IL-6 IL-6R gp130 IL-6 1) IL-6 IL-6 in vitro g/ IL-6 IL-6R IgG1 IL-6 IL-6 2) IL-6 IL-6 in vitro IL-6 IL-6 IL-6 IL-6 IL-6 3) IL-6 1% 1 IL-6 7 CRP CRP IL IL-6 4) 18
23 -1(3) mg/kg 1 Cmax kel CLtotal T1/2 MRT mg/kg n Cmax g/ml AUCfinite hrg/ml T1/2 hr kel /hr CLtotal ml/hr/kg MRT hr Vdss ml/kg ±0.6 11±6 17± ± ±2.3 25± ± ± ±73 33± ± ±0.2 47±5 58.4± ± ±222 49± ± ±0.1 69±8 57.3± ± ±569 74± ± ± ± ±8.3 AUCfinite SD kel CLtotal MRT Vdss 1 8mg/kg 2 (1) 31 8 mg/kg 1 AUCfinite = ± 5749hr g/ml ± SDT1/2 = 133 ± 25.7hr CLtotal = 0.4 ± 0.1 ml/hr/kg Vdss= 78.5 ± 16.8 ml/kg 19
24 ) (2) 1) mg/kg 2 2 CLtotal T1/2 C1hr AUCfinite T1/2 CLtotal MRT Vdss mg/kg g/ml hr g/ml hr ml/hr/kg hr ml/kg ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± SD ) 18 mg/kg 2) mg/kg ± SD 9.8 ± 7.5g/mL ± 8.6 g/ml 20 20
25 ) mg/kg C1hr AUCfinite T1/2 CLtotal MRT g/ml hr g/ml hr ml/hr/kg hr Vdss ml/kg ± ± 2511 N.A. N.A. N.A. N.A ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± 13.9 ± SDN.A.: 3 7 C1hr AUCfiniten=57 15 :C1hr AUCfiniten=7 n=415 n= mg/kg g/ml
26 C1hr AUCfinite T1/2 CLtotal MRT Vdss g/ml hr g/ml hr ml/hr/kg hr ml/kg ± ± 5193 N.A. N.A. N.A. N.A ± ± ± ± ± ± ± ± 7611 N.A. N.A. N.A. N.A ± ± ± ± ± ± ± ± 3571 N.A. N.A. N.A. N.A ± ± ± ± ± ± 11.2 ± SDN.A. (2 7n= n= n=4 5) mg/kg ±17.5µg/mL 6 T1/2 MRT 6 mg/kg C1hr AUCfinite T1/2 CLtotal MRT Vdss g/ml hrg /ml hr ml/hr/kg hr ml/kg ± ± ± ± ± ± ± ± ± ± ± ± ±SD -1(3) 22
27 -1(3) -1(3) mg/kg mg/kg IgG IgG 125 I- 5mg/kg TCA
28 I- IL-6 14 TCA 125 I- 125 I- IL-6 IgG IL-6 IL-6 IL mg/kg 1 1 8mg/kg 125 I- 5mg/kg % 2.4% TCA 5.24% 24
29 125 I -6 (1) -6 (1) 25
30 IL-6 CRP IL-6 1.(3)(7) 2)4) sjia IL-6 (3)(7) 2)4 26
31 1 2 1 IL-6 EB 1(3)(7) 2)4) 2 80 (1) 1 VI VI (1) [] (2) X [ X ] (3) [] (4) (5) 27
32 3(5) 3)4) (1) IL-6R 2 1) (2) Infusion Reaction Infusion Reaction Infusion Reaction 201 Infusion Reaction % 7 3.5% 7 3.5% Infusion Reaction Infusion Reaction Infusion Reaction 5 28
33 (3) 1) 2) 500/L 3) IL-6 1) 2) 500/L 3) )4)) (4) CRP X CT IL-6 29
34 IL-6 CRP 32) CRP sjia pjia )4)) (5) X CT TNF- IL-6 IL (0.3%) TNF IL-6 30
35 (6) IL-6 6 (7) (0.6%) (8) LDL 3 LDL mg/dl93.8 mg/dl mg/dl 12 Atherogenic index 431 * % % pjia sjia 31
36 * 601 (9) 3 ALTGPT AST(GOT) DMARD (10) IL-6 IL-6 IL-6 IL-6R IL-6 pjia IL-6 sjia MAS IL-6 20 CRP IL-6 32
37 (11) 35 QT gp130 gp130 * gp130 IL-6 pjia sjia (MRA213JP) 61 MTX QTc pjia sjia (0.8%) 1 pjia19 sjia *(5) 33
38 % % %LDL % %ALTGPT % 1) (0.4%) ) IL-6R % (1) 2)7.8%6.4%3.4%3.3% 0.9%0.4%0.4%0.3% 0.1% IL
39 MRA009JP 16.7%(9/54 ) 8mg/kg 23.6%(13/55 ) MRA213JP MTX 25.0%(16/64 ) 39.3%(24/61 )MRA012JP 51.0%(74/145 ) 58.0%(91/157 ) (12.9%) X 3) X CT -- ) 4) X CT ) # 6 1 NSAID CRP 35
40 5) 7.0% (7.0%) / 2 sjia NCI /L 2635 DMARDs 1000/L 1 77 (2.9%) 2 9 (0.3%) (0.3%) 3 36
41 6) ) sjia IL-6 (10) IL-6 (11) 37
42 5% 1%5% 0.5%1% 90.0% 37.3% LDL HDL LDH ALTGPTAST GOTγ-GTP CKCPK Al-P T ST T TAT FDPD BUN NAG CRP DNA ) G ) ) 2 DNA % % % sjia pjia 4 (0.5%) 38
43 (94.3) 585 (97.3) 18 (94.7) 115 (89.8) 751 (95.9) (85.7) 469 (78.0) 17 (89.5) 101 (78.9) 617 (78.8) (1.0) 6 (0.8) 2 (0.3) 2 (0.3) 1 (0.8) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.8) 1 (0.1) 2 (0.3) 1 (0.8) 3 (0.4) 4 (0.7) 4 (0.5) 4 (0.7) 4 (0.5) 3 (0.5) 1 (0.8) 4 (0.5) 23 (3.8) 2 (10.5) 20 (15.6) 45 (5.7) 1 (2.9) 29 (4.8) 1 (5.3) 7 (5.5) 38 (4.9) 2 (0.3) 2 (0.3) 1 (2.9) 2 (0.3) 3 (0.4) 2 (5.7) 1 (0.2) 3 (0.4) 2 (5.7) 23 (3.8) 1 (0.8) 26 (3.3) 1 (0.2) 1 (0.1) 9 (1.5) 1 (0.8) 10 (1.3) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 2 (5.7) 43 (7.2) 1 (5.3) 2 (1.6) 48 (6.1) 1 (2.9) 19 (3.2) 1 (5.3) 8 (6.3) 29 (3.7) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 3 (2.3) 3 (0.4) 2 (0.3) 2 (0.3) 2 (5.7) 8 (1.3) 3 (2.3) 13 (1.7) 7 (1.2) 3 (2.3) 10 (1.3) 4 (0.7) 4 (0.5) 2 (5.7) 36 (6.0) 2 (10.5) 41 (32.0) 81 (10.3) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 3 (0.5) 9 (7.0) 12 (1.5) 3 (2.3) 3 (0.4) 39
44 2 (5.7) 32 (5.3) 1 (5.3) 3 (2.3) 38 (4.9) 7 (1.2) 7 (0.9) 3 (8.6) 41 (6.8) 6 (4.7) 50 (6.4) 3 (8.6) 9 (1.5) 13 (10.2) 25 (3.2) 2 (0.3) 3 (15.8) 11 (8.6) 16 (2.0) 2 (0.3) 1 (0.8) 3 (0.4) 1 (0.8) 1 (0.1) 16 (2.7) 1 (5.3) 19 (14.8) 36 (4.6) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 3 (0.5) 4 (0.5) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (1.6) 2 (0.3) 1 (0.8) 1 (0.1) 2 (5.7) 15 (2.5) 17 (2.2) 27 (77.1) 315 (52.4) 14 (73.7) 65 (50.8) 421 (53.8) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 1 (0.8) 1 (0.1) 1 (2.9) 1 (0.2) 3 (2.3) 5 (0.6) 1 (0.2) 1 (0.1) 2 (0.3) 2 (1.6) 4 (0.5) 1 (2.9) 11 (1.8) 1 (5.3) 10 (7.8) 23 (2.9) 3 (0.5) 1 (0.8) 4 (0.5) 3 (0.5) 3 (0.4) 27 (4.5) 13 (10.2) 40 (5.1) 3 (0.5) 3 (2.3) 6 (0.8) 2 (0.3) 2 (0.3) 5 (0.8) 5 (0.6) 1 (0.8) 1 (0.1) 6 (17.1) 49 (8.2) 5 (26.3) 32 (25.0) 92 (11.7) 2 (5.7) 41 (6.8) 2 (10.5) 10 (7.8) 55 (7.0) 1 (0.2) 1 (0.1) 5 (0.8) 5 (0.6) 4 (0.7) 4 (0.5) 2 (0.3) 2 (0.3) 1 (2.9) 1 (0.2) 2 (0.3) 2 (0.3) 2 (0.3) 1 (0.8) 1 (0.1) 4 (11.4) 6 (1.0) 9 (7.0) 19 (2.4) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 40
45 1 (2.9) 22 (3.7) 1 (5.3) 3 (2.3) 27 (3.4) 4 (0.7) 1 (5.3) 2 (1.6) 7 (0.9) 9 (1.5) 7 (5.5) 16 (2.0) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 1 (2.9) 29 (4.8) 30 (3.8) 1 (2.9) 8 (1.3) 1 (5.3) 1 (0.8) 11 (1.4) 3 (0.5) 3 (0.4) 1 (0.2) 1 (0.1) 26 (4.3) 6 (31.6) 43 (33.6) 75 (9.6) 4 (11.4) 20 (3.3) 3 (2.3) 27 (3.4) 5 (0.8) 5 (0.6) 4 (0.7) 4 (0.5) 1 (0.2) 2 (1.6) 3 (0.4) 1 (0.8) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 4 (0.7) 4 (0.5) 1 (2.9) 1 (0.1) 2 (5.7) 2 (0.3) 6 (4.7) 10 (1.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) β 1 (0.8) 1 (0.1) 1 (0.2) 1 (0.8) 2 (0.3) 1 (0.8) 1 (0.1) 2 (0.3) 2 (0.3) 2 (0.3) 1 (0.8) 3 (0.4) 1 (2.9) 1 (0.1) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 5 (0.8) 3 (2.3) 8 (1.0) 1 (0.2) 1 (0.8) 2 (0.3) 1 (2.9) 1 (0.1) 2 (5.7) 40 (6.7) 4 (3.1) 46 (5.9) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 3 (0.5) 3 (0.4) 4 (0.7) 4 (0.5) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 4 (0.7) 1 (5.3) 5 (0.6) 2 (1.6) 2 (0.3) 41
46 6 (1.0) 6 (0.8) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.2) 2 (0.3) 3 (0.5) 3 (0.4) 5 (0.8) 1 (0.8) 6 (0.8) 1 (2.9) 9 (1.5) 10 (1.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 30 (5.0) 2 (1.6) 32 (4.1) (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 5 (0.8) 5 (0.6) 2 (1.6) 2 (0.3) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 3 (8.6) 27 (4.5) 1 (5.3) 9 (7.0) 40 (5.1) (2.9) 2 (0.3) 3 (2.3) 6 (0.8) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 12 (2.0) 1 (0.8) 13 (1.7) 2 (5.7) 2 (0.3) 5 (0.8) 1 (5.3) 2 (1.6) 8 (1.0) 42
47 2 (5.7) 4 (0.7) 1 (0.8) 7 (0.9) 1 (0.2) 2 (1.6) 3 (0.4) 1 (2.9) 21 (3.5) 4 (21.1) 7 (5.5) 33 (4.2) (0.2) 2 (1.6) 3 (0.4) 1 (5.3) 1 (0.8) 2 (0.3) 1 (2.9) 16 (2.7) 3 (15.8) 5 (3.9) 25 (3.2) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 2 (5.7) 7 (1.2) 9 (1.1) (2.9) 1 (0.1) 1 (2.9) 2 (0.3) 3 (0.4) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 8 (22.9) 35 (5.8) 1 (0.8) 44 (5.6) (5.7) 2 (0.3) 4 (0.5) 5 (0.8) 5 (0.6) 1 (0.2) 1 (0.1) 10 (1.7) 10 (1.3) 1 (2.9) 1 (0.1) 1 (2.9) 1 (0.1) 1 (2.9) 2 (0.3) 3 (0.4) 1 (0.8) 1 (0.1) 2 (0.3) 2 (0.3) 2 (5.7) 2 (0.3) 1 (0.2) 1 (0.1) 2 (5.7) 13 (2.2) 15 (1.9) 1 (2.9) 15 (2.5) 1 (0.8) 17 (2.2) (0.2) 1 (0.1) 1 (2.9) 11 (1.8) 1 (0.8) 13 (1.7) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 9 (25.7) 90 (15.0) 2 (10.5) 15 (11.7) 116 (14.8) (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 43
48 1 (0.2) 1 (0.1) 25 (4.2) 1 (0.8) 26 (3.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 1 (0.2) 1 (0.1) 6 (17.1) 50 (8.3) 1 (5.3) 13 (10.2) 70 (8.9) 4 (11.4) 12 (2.0) 16 (2.0) 3 (0.5) 1 (0.8) 4 (0.5) 1 (5.3) 1 (0.1) 1 (2.9) 3 (0.5) 4 (0.5) 2 (0.3) 2 (0.3) 1 (2.9) 2 (0.3) 3 (0.4) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 8 (22.9) 93 (15.5) 1 (5.3) 26 (20.3) 128 (16.3) (2.9) 1 (0.2) 2 (0.3) 2 (1.6) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.8) 2 (0.3) 4 (0.7) 4 (0.5) 1 (2.9) 1 (0.1) 5 (0.8) 1 (0.8) 6 (0.8) 1 (0.2) 1 (0.1) 1 (2.9) 3 (0.5) 5 (3.9) 9 (1.1) 1 (0.2) 1 (0.1) 4 (11.4) 6 (1.0) 10 (1.3) 1 (2.9) 30 (5.0) 11 (8.6) 42 (5.4) 9 (1.5) 1 (5.3) 3 (2.3) 13 (1.7) 2 (0.3) 1 (0.8) 3 (0.4) 2 (0.3) 2 (0.3) 10 (1.7) 10 (1.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.2) 2 (0.3) 1 (2.9) 4 (0.7) 1 (0.8) 6 (0.8) 1 (2.9) 2 (0.3) 3 (0.4) 1 (0.2) 2 (1.6) 3 (0.4) 2 (0.3) 1 (0.8) 3 (0.4) 44
49 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (2.9) 1 (0.2) 2 (0.3) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.8) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 4 (0.7) 4 (0.5) 2 (0.3) 2 (0.3) 1 (2.9) 1 (0.1) 4 (0.7) 4 (0.5) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 3 (2.3) 3 (0.4) 3 (8.6) 23 (3.8) 1 (0.8) 27 (3.4) (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 3 (0.5) 1 (0.8) 4 (0.5) 7 (1.2) 7 (0.9) 4 (0.7) 4 (0.5) 1 (2.9) 3 (0.5) 4 (0.5) 1 (2.9) 5 (0.8) 6 (0.8) 4 (11.4) 29 (4.8) 33 (4.2) (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 9 (1.5) 9 (1.1) 2 (0.3) 2 (0.3) 2 (5.7) 5 (0.8) 7 (0.9) 45
50 1 (0.2) 1 (0.1) 3 (8.6) 4 (0.7) 7 (0.9) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 3 (8.6) 67 (11.1) 15 (11.7) 85 (10.9) (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 4 (0.7) 2 (1.6) 6 (0.8) 2 (0.3) 2 (0.3) 2 (5.7) 40 (6.7) 11 (8.6) 53 (6.8) 2 (1.6) 2 (0.3) 2 (0.3) 1 (0.8) 3 (0.4) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 5 (0.8) 5 (0.6) 3 (0.5) 3 (0.4) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 2 (5.7) 2 (0.3) 4 (0.5) 1 (0.2) 1 (0.1) 18 (51.4) 171 (28.5) 6 (31.6) 40 (31.3) 235 (30.0) (0.5) 1 (5.3) 1 (0.8) 5 (0.6) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 4 (11.4) 31 (5.2) 1 (0.8) 36 (4.6) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 2 (0.3) 2 (1.6) 4 (0.5) 4 (0.7) 4 (0.5) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (2.9) 4 (0.7) 1 (0.8) 6 (0.8) 1 (2.9) 1 (0.1) 1 (0.8) 1 (0.1) 46
51 7 (20.0) 42 (7.0) 3 (2.3) 52 (6.6) 1 (2.9) 4 (0.7) 5 (0.6) 2 (0.3) 2 (0.3) 2 (0.3) 2 (0.3) 5 (0.8) 5 (0.6) 1 (0.2) 1 (0.1) 9 (1.5) 1 (0.8) 10 (1.3) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 9 (1.5) 2 (10.5) 8 (6.3) 19 (2.4) 3 (8.6) 6 (1.0) 9 (1.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (2.9) 1 (0.1) 1 (2.9) 1 (0.1) 1 (2.9) 1 (0.1) 5 (14.3) 66 (11.0) 3 (15.8) 27 (21.1) 101 (12.9) 1 (0.2) 1 (0.1) 3 (8.6) 3 (0.5) 2 (1.6) 8 (1.0) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 22 (62.9) 247 (41.1) 9 (47.4) 64 (50.0) 342 (43.7) (2.9) 4 (0.7) 1 (0.8) 6 (0.8) 7 (1.2) 7 (0.9) 3 (8.6) 13 (2.2) 2 (10.5) 9 (7.0) 27 (3.4) 3 (8.6) 1 (0.8) 4 (0.5) 5 (14.3) 27 (4.5) 2 (1.6) 34 (4.3) 1 (0.8) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 4 (0.7) 5 (0.6) 17 (2.8) 1 (5.3) 6 (4.7) 24 (3.1) 1 (0.2) 1 (0.1) 6 (1.0) 6 (0.8) 1 (2.9) 26 (4.3) 1 (5.3) 12 (9.4) 40 (5.1) 7 (20.0) 39 (6.5) 2 (10.5) 17 (13.3) 65 (8.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 1 (0.2) 1 (0.1) 6 (1.0) 6 (0.8) 10 (1.7) 2 (10.5) 1 (0.8) 13 (1.7) 47
52 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 5 (0.8) 5 (0.6) 4 (0.7) 4 (0.5) 1 (2.9) 21 (3.5) 2 (1.6) 24 (3.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 2 (0.3) 2 (0.3) 1 (0.8) 1 (0.1) 1 (2.9) 1 (0.1) 5 (0.8) 5 (0.6) 13 (2.2) 4 (3.1) 17 (2.2) 5 (0.8) 5 (0.6) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 5 (0.8) 2 (1.6) 7 (0.9) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (5.3) 1 (0.8) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 4 (11.4) 19 (3.2) 1 (5.3) 5 (3.9) 29 (3.7) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 11 (1.8) 11 (1.4) 3 (8.6) 19 (3.2) 5 (3.9) 27 (3.4) 2 (1.6) 2 (0.3) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (2.9) 7 (1.2) 8 (1.0) 2 (0.3) 2 (0.3) 1 (2.9) 14 (2.3) 15 (1.9) 5 (14.3) 56 (9.3) 3 (15.8) 11 (8.6) 75 (9.6) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 3 (8.6) 9 (1.5) 1 (0.8) 13 (1.7) 1 (0.2) 1 (0.1) 2 (5.7) 17 (2.8) 7 (5.5) 26 (3.3) 48
53 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 2 (0.3) 2 (0.3) 1 (2.9) 4 (0.7) 5 (0.6) 2 (0.3) 2 (0.3) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 4 (11.4) 38 (6.3) 2 (1.6) 44 (5.6) (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 5 (0.8) 5 (0.6) 1 (0.2) 1 (0.1) 2 (5.7) 3 (0.5) 2 (1.6) 7 (0.9) 2 (5.7) 25 (4.2) 27 (3.4) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 24 (68.6) 223 (37.1) 10 (52.6) 61 (47.7) 318 (40.6) (2.9) 5 (0.8) 8 (6.3) 14 (1.8) 3 (0.5) 3 (0.4) 1 (2.9) 5 (0.8) 1 (0.8) 7 (0.9) 1 (2.9) 4 (0.7) 5 (0.6) 1 (2.9) 7 (1.2) 2 (1.6) 10 (1.3) 1 (0.2) 2 (1.6) 3 (0.4) 3 (8.6) 12 (2.0) 1 (5.3) 2 (1.6) 18 (2.3) 1 (0.2) 1 (0.1) 3 (8.6) 2 (0.3) 4 (3.1) 9 (1.1) 1 (2.9) 2 (0.3) 3 (0.4) 5 (14.3) 46 (7.7) 4 (21.1) 21 (16.4) 76 (9.7) 9 (1.5) 1 (5.3) 6 (4.7) 16 (2.0) 1 (2.9) 16 (2.7) 2 (1.6) 19 (2.4) 1 (0.2) 2 (1.6) 3 (0.4) 11 (31.4) 56 (9.3) 1 (5.3) 8 (6.3) 76 (9.7) 1 (2.9) 7 (1.2) 8 (1.0) 1 (2.9) 1 (0.1) 1 (5.3) 8 (6.3) 9 (1.1) 2 (0.3) 2 (0.3) 2 (5.7) 2 (0.3) 8 (1.3) 8 (1.0) 8 (1.3) 9 (7.0) 17 (2.2) 1 (2.9) 1 (0.8) 2 (0.3) 49
54 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 3 (0.5) 3 (0.4) 2 (0.3) 2 (0.3) 5 (0.8) 1 (5.3) 1 (0.8) 7 (0.9) 10 (28.6) 45 (7.5) 8 (6.3) 63 (8.0) 7 (1.2) 7 (0.9) 1 (0.2) 1 (0.1) 1 (2.9) 6 (1.0) 7 (0.9) 1 (0.2) 1 (0.1) 1 (2.9) 4 (0.7) 5 (0.6) 1 (0.2) 1 (0.1) 1 (2.9) 2 (0.3) 3 (0.4) 1 (2.9) 1 (0.2) 2 (0.3) 1 (0.2) 1 (0.1) 2 (5.7) 20 (3.3) 1 (0.8) 23 (2.9) 3 (0.5) 3 (0.4) 1 (0.2) 1 (0.1) 2 (5.7) 15 (2.5) 2 (10.5) 16 (12.5) 35 (4.5) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 1 (0.8) 3 (0.4) 1 (0.2) 1 (0.1) 10 (28.6) 76 (12.6) 1 (5.3) 13 (10.2) 100 (12.8) (8.6) 6 (1.0) 9 (1.1) 1 (0.8) 1 (0.1) 1 (0.8) 1 (0.1) 6 (17.1) 15 (2.5) 1 (0.8) 22 (2.8) 1 (2.9) 1 (0.2) 2 (0.3) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.8) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 50
55 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 6 (1.0) 2 (1.6) 8 (1.0) 1 (2.9) 2 (0.3) 2 (1.6) 5 (0.6) 11 (1.8) 11 (1.4) 3 (8.6) 5 (0.8) 8 (1.0) 1 (2.9) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.8) 2 (0.3) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 1 (0.8) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (2.9) 5 (0.8) 1 (5.3) 7 (0.9) 1 (0.2) 1 (0.1) 4 (3.1) 4 (0.5) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 2 (5.7) 29 (4.8) 6 (4.7) 37 (4.7) (0.5) 3 (0.4) 2 (0.3) 1 (0.8) 3 (0.4) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 4 (0.7) 4 (3.1) 8 (1.0) 2 (0.3) 2 (0.3) 4 (0.7) 1 (0.8) 5 (0.6) 1 (2.9) 1 (0.2) 2 (0.3) 2 (0.3) 2 (0.3) 51
56 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 4 (11.4) 27 (4.5) 3 (2.3) 34 (4.3) (0.8) 1 (0.1) 3 (0.5) 3 (0.4) 2 (0.3) 2 (0.3) 1 (2.9) 1 (0.2) 2 (0.3) 1 (2.9) 3 (0.5) 4 (0.5) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.2) 2 (0.3) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 6 (1.0) 6 (0.8) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.8) 2 (0.3) 21 (60.0) 84 (14.0) 14 (10.9) 119 (15.2) (0.2) 1 (0.1) 1 (2.9) 2 (0.3) 3 (0.4) 6 (17.1) 5 (0.8) 11 (1.4) 4 (11.4) 12 (2.0) 1 (0.8) 17 (2.2) 2 (5.7) 1 (0.2) 5 (3.9) 8 (1.0) 1 (0.2) 1 (0.1) 4 (0.7) 4 (0.5) 3 (8.6) 3 (0.5) 6 (0.8) 1 (2.9) 5 (0.8) 6 (0.8) 3 (8.6) 4 (0.7) 7 (0.9) 52
57 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 7 (20.0) 12 (2.0) 2 (1.6) 21 (2.7) 1 (2.9) 1 (0.1) 1 (2.9) 2 (0.3) 3 (0.4) 2 (5.7) 14 (2.3) 2 (1.6) 18 (2.3) 3 (0.5) 3 (0.4) 5 (14.3) 20 (3.3) 6 (4.7) 31 (4.0) 1 (2.9) 1 (0.2) 2 (0.3) 2 (5.7) 3 (0.5) 5 (0.6) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (1.6) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 25 (71.4) 436 (72.5) 2 (10.5) 78 (60.9) 541 (69.1) (2.9) 1 (0.1) 5 (14.3) 87 (14.5) 27 (21.1) 119 (15.2) 4 (11.4) 62 (10.3) 20 (15.6) 86 (11.0) β 8 (6.3) 8 (1.0) 1 (0.2) 1 (0.8) 2 (0.3) 1 (2.9) 29 (4.8) 3 (2.3) 33 (4.2) 1 (2.9) 4 (0.7) 5 (0.6) 2 (0.3) 2 (0.3) 1 (0.8) 1 (0.1) 4 (11.4) 271 (45.1) 17 (13.3) 292 (37.3) 2 (5.7) 11 (1.8) 1 (0.8) 14 (1.8) 3 (0.5) 3 (0.4) 25 (4.2) 25 (3.2) 1 (2.9) 2 (0.3) 3 (0.4) 4 (11.4) 3 (0.5) 7 (0.9) 53
58 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 11 (1.8) 10 (7.8) 21 (2.7) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 1 (2.9) 1 (0.1) 5 (14.3) 45 (7.5) 17 (13.3) 67 (8.6) 5 (0.8) 4 (3.1) 9 (1.1) 2 (0.3) 2 (0.3) 1 (2.9) 6 (1.0) 1 (0.8) 8 (1.0) 1 (2.9) 1 (0.1) 2 (5.7) 39 (6.5) 1 (0.8) 42 (5.4) 7 (20.0) 7 (0.9) 1 (0.2) 1 (0.1) 7 (20.0) 119 (19.8) 126 (16.1) 2 (5.7) 20 (3.3) 4 (3.1) 26 (3.3) 1 (2.9) 14 (2.3) 15 (1.9) 1 (2.9) 1 (0.1) 4 (0.7) 4 (0.5) 2 (5.7) 4 (0.7) 6 (0.8) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 5 (0.8) 5 (0.6) 1 (2.9) 2 (0.3) 1 (0.8) 4 (0.5) 1 (2.9) 13 (2.2) 14 (1.8) 19 (3.2) 19 (2.4) 2 (5.7) 14 (2.3) 16 (2.0) 2 (0.3) 2 (0.3) 4 (11.4) 2 (0.3) 6 (0.8) 5 (0.8) 5 (0.6) γ 3 (8.6) 53 (8.8) 56 (7.2) 9 (1.5) 6 (4.7) 15 (1.9) 1 (0.2) 1 (0.1) 9 (1.5) 9 (1.1) 1 (0.2) 1 (0.1) 1 (2.9) 20 (3.3) 1 (5.3) 4 (3.1) 26 (3.3) 9 (1.5) 9 (1.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.2) 2 (0.3) 54
59 1 (2.9) 2 (0.3) 3 (0.4) 1 (2.9) 41 (6.8) 42 (5.4) 1 (0.8) 1 (0.1) 2 (5.7) 146 (24.3) 148 (18.9) 1 (2.9) 11 (1.8) 1 (5.3) 19 (14.8) 32 (4.1) 2 (0.3) 2 (0.3) 1 (2.9) 1 (0.1) 9 (25.7) 32 (5.3) 14 (10.9) 55 (7.0) 5 (0.8) 5 (0.6) 2 (5.7) 14 (2.3) 2 (1.6) 18 (2.3) 10 (1.7) 2 (1.6) 12 (1.5) 3 (0.5) 3 (0.4) 1 (2.9) 1 (0.2) 2 (0.3) 5 (0.8) 5 (0.6) 1 (2.9) 1 (0.1) 6 (1.0) 6 (0.8) 4 (11.4) 2 (0.3) 6 (0.8) 3 (0.5) 3 (0.4) 2 (5.7) 1 (0.2) 3 (0.4) 1 (0.2) 1 (0.1) 4 (0.7) 4 (0.5) 2 (5.7) 62 (10.3) 4 (3.1) 68 (8.7) 2 (5.7) 10 (1.7) 12 (1.5) 3 (8.6) 1 (0.2) 4 (0.5) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 9 (1.5) 9 (1.1) 2 (5.7) 2 (0.3) 4 (0.5) 1 (2.9) 6 (1.0) 7 (0.9) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (0.3) 2 (0.3) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 1 (2.9) 1 (0.2) 2 (1.6) 4 (0.5) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 2 (5.7) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 3 (8.6) 6 (1.0) 1 (0.8) 10 (1.3) 1 (0.2) 1 (0.1) 1 (2.9) 1 (0.1) 55
60 3 (0.5) 3 (0.4) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 3 (0.5) 3 (0.4) 1 (0.2) 1 (0.1) 4 (11.4) 24 (4.0) 4 (3.1) 32 (4.1) 1 (2.9) 1 (0.1) 1 (2.9) 7 (1.2) 8 (1.0) 1 (0.2) 1 (0.1) 6 (1.0) 6 (0.8) 2 (5.7) 2 (0.3) 1 (0.2) 1 (0.1) A 1 (0.2) 1 (0.1) 1 (2.9) 8 (1.3) 3 (2.3) 12 (1.5) (0.8) 1 (0.1) 2 (0.3) 2 (0.3) 1 (2.9) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) 1 (0.2) 1 (0.8) 2 (0.3) 1 (0.2) 1 (0.1) 1 (0.2) 1 (0.1) 1 (0.8) 1 (0.1) (0.8) 1 (0.1) MedDRA/J ver.8.0j 56
61 0.4% (1) (2) (1) (2)IgG IgG 57
62 sjia pjia ) 2) 1) 2) 1.2 3) 1) 80 2) 1) 2) 3) 58
63 (1) % % % % pjiasjia 1 IgE 24mg/kg
64 pjia sjia (%) % IgE (7.3) (5.3) (11.1) pjia ( N=601 N=344 (N=19) IgE IgE IgE 0/601( 0.0) 1/601(0.2) 0/344(0.0) 0/344(0.0) 0/19(0.0) 0/19(0.0) 2(mg/kg) 0/5(0.0) 0/5(0.0) 10/123(8.1) 11/123(8.9) 0/0 0/0 4(mg/kg) 0/59(0.0) 3/59(5.1) 3/112(2.7) 7/112(6.3) 0/0 0/0 8(mg/kg) 4/537(0.7) 11/537(2.0) 0/109(0.0) 0/109(0.0) 1/19(5.3) 1/19(5.3) (%) 4/601(0.7) 15/601(2.5) 13/344(3.8) 18/344(5.2) 1/19(5.3) 1/19(5.3) () sjia ( (N=128) (N=18) (N=35) (%) (N=1145) IgE IgE IgE IgE 0/128(0.0) 0/128(0.0) 0/18(0.0) 0/18(0.0) 0/35(0.0) 0/35(0.0) 0/1145(0.0) 1/1145(0.1) 2(mg/kg) 0/11(0.0) 0/11(0.0) 1/6(16.7) 0/6(0.0) 1/7(14.3) 1/7(14.3) 12/152(7.9) 12/152(7.9) 4(mg/kg) 0/0 0/0 0/6(0.0) 0/6(0.0) 0/6(0.0) 0/6(0.0) 3/183(1.6) 10/183(5.5) 8(mg/kg) 0/117(0.0) 11/117(9.4) 1/6(16.7) 0/6(0.0) 0/35(0.0) 0/35(0.0) 6/823(0.7) 23/823(2.8) (%) 0/128(0.0) 11/128(8.6) 2/18(11.1) 0/18(0.0) 1/35(2.9) 1/35(2.9) 21/1145(1.8) 46/1145(4.0) pjia ( N=601 N=344 (N=19) IgE IgE IgE - 1(0.2) (0.2) - 2(0.6) (0.7) - 8(2.3) (0.3) 1(0.3) 6(1.7) 1(5.3) - 4-3(0.5) 12(3.5) 2(0.6) * 4(0.7) 4(0.7) (5.3) (%) 4(0.7) 15(2.5) 13(3.8) 18(5.2) 1(5.3) 1(5.3) () sjia ( (N=128) (N=18) (N=35) (%) (N=1145) IgE IgE IgE IgE (0.1) 1-7( 5.5) 2( 11.1) (0.2) 10(0.9) 2-3( 2.3) - - 1(2.9) 1(2.9) 1(0.1) 16(1.4) 3-1( 0.8) (0.2) 9(0.8) (1.1) 5(0.4) 5 * (0.4) 5(0.4) (%) - 11( 8.6) 2( 11.1) - 1(2.9) 1(2.9) 21(1.8) 46(4.0) * mg/kg 1. 60
65 (2)(DMARD) DMARD 3 ALTGPT ASTGOTDMARD 8 mg/kg+dmard 103/1582 (6.5%)+DMARD 18/1170 (1.5%) 8 mg/kg 6/288 (2.1%)MTX 14/284 (4.9%) (9) (3) pjiasjia MTX DMARDs 1.1 (4) in vitro IL-6 CYPs IL-6 CYPs IL-6 CYPs IL-6 CYP3A4CYP2C19 CYP2D6 IL-6 CYPs in vitro IL-6 CYP IL-6 CYP1A2CYP2CCYP2E1CYP3A mrna IL-6 CYP3A4 mrna IL-6 -naphthoflavone CYP1A1 CYP1A2 rifampicin CYP3A4 mrna CYP3A4 IL-6 rifampicin phenobarbital CYP3A4 61
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67 (11) 6) IL-6 IL-6Cardiotropin1CT-1Leukemia Inhibitory FactorLIF IL-11Ciliary Neurotrophic FactorCNTFOncostatin MOSM (6) IL-6 IL-6 IL IL
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69 0, 6, 30, 150 mg/kg 0, 1, 10, 100 mg/kg (mg/kg) >150 >100 2 () 0, 2, 10, 50 mg/kg/ 1 2 () 0, 2, 10, 50 mg/kg/ 0, 0.4, 2, 10, 50 mg/kg/ (mg/kg) , 2, 10, 50 mg/kg/ , 1, 10, 100 mg/kg/ 100 0, 5, 16, 50 mg/kg/ 50 () 0, 5, 16, 50 mg/kg/ 0, 5, 50 mg/kg/ (mg/kg) 50 0, 0.5, 5, 50 mg/kg/ 50 0, 2, 10, 50 mg/kg/ 10 in vitro 0, 47.3, 96.4, 189, 379, 757 µg/plate in vitro 0, 47.3, 96.4, 189, 379, 757 µg/plate in vitro 0, 189.3, 378.5, 757 µg/ml 0.5 ml (30 mg/ml) 0.2 ml (30 mg/ml) 10µg/animal 1, 10 mg/kg 65
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