Tanigawara Y, Nomura H, Kagimoto N, Okumura K, Hori R. Premarketing population pharmacokinetic study of levofloxacin in normal sub
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- うたろう あわび
- 5 years ago
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1 250 mg500 mg 2.7.5
2 Tanigawara Y, Nomura H, Kagimoto N, Okumura K, Hori R. Premarketing population pharmacokinetic study of levofloxacin in normal subjects and patients with infectious diseases. Biol. Pharm. Bull. 1995; 18: ,180. Jpn J Antibiot. 2000; 53: ,474. Jpn J Antibiot. 2003; 56: ,475. Jpn J Antibiot. 2005; 58: ,639. Jpn J Antibiot. 2006; 59: National Committee for Clinical Laboratory Standards. Performance standards for antimicrobial susceptibility testing; twelfth informational supplement, M100-S7. NCCLS, Wayne, PA, USA, National Committee for Clinical Laboratory Standards. Performance standards for antimicrobial susceptibility testing; twelfth informational supplement, M100-S10. NCCLS, Wayne, PA, USA, National Committee for Clinical Laboratory Standards. Performance standards for antimicrobial susceptibility testing; twelfth informational supplement, M100-S12. NCCLS, Wayne, PA, USA, Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing: Fifteenth informational supplement, M100-S15. CLSI, Wayne, PA, USA, )
3 ; 45: UTI ;45(4): ) ) World Health Organization. Background document: the diagnosis, treatment and prevention of typhoid fever ).. ; 2005; ),. Levofloxacin. Jpn. J. Antibiotics 1992; 45: ),,,,,. XXX VIILevofloxacin. Jpn. J. Antibiotics 1992; 45: ) Joshi S and Amarnath SK. Fluoroquinolone resistance in Salmonella typhi and S. paratyphi A in Bangalore, India. Transactions of the royal society of tropical medicine and hygiene 2007; 101: ) Pokharel BM, Koirala J, Dahal RK, Mishra SK, Khadga PK and Tuladhar NR. Multidrug-resistant and extended spectrum beta-lactamase (ESBL)-producing Salmonella enterica (serotypes Typhi and Paratyphi A) from blood isolates in Nepal: surveillance of resistance and a search for newer alternatives. Int J. of Infect. Dis. 2006; 10:
4 , 1991;39: , 1995;43(11): 3 Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med. 2004; 350: Hori S, Kizu J, Kawamura M. Effects of anti-inflammatory drugs on convulsant activity of quinolones: a comparative study of drug interaction between quinolones and anti-inflammatory drugs. J Infect Chemother. 2003; 9: Park-Wyllie LY, Juurlink DN, Kopp A, Shah BR, Stukel TA, Stumpo C, et al. Outpatient gatifloxacin therapy and dysglycemia in older adults. N Engl J Med 2006; 354:
5 250 mg500 mg 2.7.6
6
7
8
9 I I 1 II III I I 2 3 I I I mg mg I mg I mg I mg I I QT/QTc I I I I mg I mg I I BE BE iv
10 mg mg 2 BE BE PK PK mg PK mg PK mg PK PK PK DDI DDI DDI n = 12 DDI DDI DDI DDI DDI DDI DDI R- S- DDI DDI DDI C max C min t max t min DDI C max C min AUC 0-23h t max t min DDI III III v
11 PPS III III III III III III III MIC MIC 0.06>128 III MIC MIC 0.015>32 III MIC MIC 0.06>128 III MIC MIC 0.015>32 III III III III RTI III RTI III RTI III PPS RTI III PPS RTI III PPS RTI III PPS RTI III PPS RTI III PPS RTI III MIC PPS RTI III :PK / PD PK / PD :PK / PD PK / PD :PK / PD vi
12 RTI III RTI III UTI III UTI III UTI III PPS UTI III PPS UTI III PPS UTI III Clinical outcomepps UTI III Clinical outcomepps UTI III Microbiological outcomepps UTI III Microbiological outcomepps UTI III PPS UTI III PPS UTI III MIC PPS UTI III Clinical outcomepps UTI III Microbiological outcomepps UTI III UTI III UTI III QT QT QT QT QT t max QT/QTc QT t max QTcF QT QT QT vii
13 QT t max QTc Bazett QT t max QTc Fridericia QT QT n = 47 QT t max QTc Bazett QT t max QTc Fridericia QT viii
14 2.7.6 ALP ALT AST AUC AUC 0-t AUC 0-inf AUC last BMI C 24h CI CKCPK CLcr CL nr /F CL r CLSI CL ss /F CL t /F C max COPD CPMP CRP CYP QTc QTc ELISA EMEA FAS FDA GOT GPT γ-gtp HBs HCV HIV HPLC LDH MIC MRT PK / PD PPS PT QTc t Body Mass Index 24 Non-renal Clearance Clinical Laboratory Standards Institute Committee for Proprietary Medicinal Products C P450 QTc QTc Enzyme Linked Immunosorbent Assay European Medicines Agency Full Analysis Set Food and Drug Administration B C Pharmacokinetics / Pharmacodynamics Per Protocol Set Corrected QT ix
15 2.7.6 λ z RTI t max t 1/2 TPEIA UTI Vd/F Vd z Vd z /F Respiratory Tract Infection Urinary Tract Infection Vd z A. baumannii Acinetobacter baumannii A. junii Acinetobacter junii A. johnsonii Acinetobacter johnsonii A. lwoffii Acinetobacter lwoffii B. cepacia Burkholderia cepacia BLNAR β-lactamase-negative ampicillin-resistant Haemophilus influenzae BLNAS β-lactamase-negative ampicillin-susceptible Haemophilus influenzae C. freundii Citrobacter freundii C. koseri Citrobacter koseri C. difficile Clostridium difficile C. freundii Citrobacter freundii CNS coagulase-negative staphylococci E. aerogenes Enterobacter aerogenes E. avium Enterococcus avium E. cloacae Enterobacter cloacae E. coli Escherichia coli E. faecalis Enterococcus faecalis E. faecium Enterococcus faecium G. morbillorum Gemella morbillorum H. influenzae Haemophilus influenzae H. parainfluenzae Haemophilus parainfluenzae K. oxytoca Klebsiella oxytoca K. ozaenae Klebsiella ozaenae K. pneumoniae Klebsiella pneumoniae M. (B.) catarrhalis Moraxella (Branhamella) catarrhalis M. morganii Morganella morganii MRSA Methicillin-resistant Staphylococcus aureus MSSA Methicillin-susceptible Staphylococcus aureus P. aeruginosa Pseudomonas aeruginosa P. agglomerans Pantoea agglomerans P. alcalifaciens Providencia alcalifaciens x
16 2.7.6 PISP Penicillin-intermediate Streptococcus pneumoniae P. mirabilis Proteus mirabilis P. rettgeri Providencia rettgeri PRSP Penicillin-resistant Streptococcus pneumoniae PSSP Penicillin-susceptible Streptococcus pneumoniae P. vulgaris Proteus vulgaris S. agalactiae Streptococcus agalactiae S. anginosus Streptococcus anginosus S. aureus Staphylococcus aureus S. capitis Staphylococcus capitis S. epidermidis Staphylococcus epidermidis S. haemolyticus Staphylococcus haemolyticus S. maltophilia Stenotrophomonas maltophilia S. marcescens Serratia marcescens S. mitis Streptococcus mitis S. pneumoniae Streptococcus pneumoniae S. salivarius Streptococcus salivarius S. sanguis Streptococcus sanguis S. saprophyticus Staphylococcus saprophyticus O (LVFX) ( )-(S)-9-fluoro-2,3-dihydro-3-methyl-10-( 4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de][1,4]benzoxazine-6-carboxylic acid hemihydrate H 3 C N F N O N H COOH CH 3 CPFX MFLX xi
17
18
19 I 2/4 2. [] HIV HBs HCV TPEIA mmhg 140 mmhg 40 mmhg 90 mmhg 40 /99 / ml 100 ml 210 ml 1200 ml [] mmhg 140 mmhg 40 mmhg 90 mmhg 40 /99 / I II III mg 500 mg mg mg 500 mg 500 mg 1000 mg mg S ) 500 mg S mg S mg S
20 I 3/ mg 500 mg mg mg 500 mg 500 mg 1000 mg 250 mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg 2 1. I 1 II III C maxt maxauc 0-24h AUC 0-72h AUC 0-infC 24ht 1/2CL t/ F Vd z/ FMRTλ zcl r 500 mg ) I C maxc 24ht maxauc 0-24h CL r7 t 1/2 CL ss/ FVd z/ FMRTλ z 1 C max 7 C max 1 C 24h 7 C 24h 1 AUC 0-24h 7 AUC 0-24h h h 2. I C maxt maxauc 0-24h AUC 0-72h AUC 0-infC 24ht 1/2CL t/ FVd z/ FMRT λ zcl r 250 mg750 mg C max AUC 0-72h AUC 0-inft 1/2CL t/fvd Z/FMRTλ z Y X Log (Y) = Log (α) + β Log (X) + error β 95% 4
21 I 4/ % 12 PR QRS QT RR QTc Bazett QTcB Fridericia QTcF QT OTc t max QTc 95% t max t max median QTc C max I 1 II III I BMI 12 a b,c d a b c 500 mg d
22 I 2 3 I BMI 12 a b c a b c I mg mg mg mg mg 500 mg 1 500mg 6
23 mg 1000 mg 1000 mg mg I mg mg mg mg mg mg mg I 1 II III kg cm kg cm I kg cm kg cm 7
24 mg500 mg750 mg 1000 mg t max 1.0 ± ± 0.7 h C max 250 mg 500 mg750 mg 1000 mg 3.72 ± ± ± ± 2.63 µg/ml t 1/ ± ± 2.11 h mean ± SD I 8
25 I C max (µg/ml) t max (h) AUC 0-72h (µgh/ml) AUC 0-inf (µgh/ml) a t 1/2 (h) CL t /F (L/h) Vd z /F (L) CL r (L/h) 250 mg mean n = 9 SD mg mean n = 9 SD mg mean n = 9 SD mg mean n = 9 SD a mg C max AUC 0-72h C max AUC 0-72h Log (Y) = Log (α) + β Log (X) + error C max AUC 0-72h β C max %CI = 0.712, 1.177AUC 0-72h %CI = 1.114, 1.370C max mg AUC 0-72h 250 mg 750 mg C max I 9
26 AUC 0-72h I mg500 mg750 mg 1000 mg mg mean ± SD 77.5 ± 6.7%83.8 ± 3.4%78.9 ± 2.6%77.9 ± 4.4% µg/ml 10
27
28 mg I (µg/ml) n = 7 / n = ± ± ± ± ± ± ± ± ± ± ± ± ± ± 0.15 mean ± SD mg C max C 24h t max AUC 0-24h t 1/2 mean ± SD 9.38 ± 2.92 h 500 mg t 1/ ± 2.11 h C max C 24h t max AUC 0-24h 1 7 C max C 24h AUC 0-24h t max 12
29 mg I mg I n = 9 n = a C max (µg/ml) C 24h (µg/ml) t max (h) AUC 0-24h (µgh/ml) t 1/2 a (h) CL ss /F (L/h) Vd z /F (L) CL r (L/h) mean SD mean SD mean SD mean SD
30 mg ± ± 7.7% 62.3 ± ± 10.3% mg I ± ± ± ± ± 6.0 n = ± ± ± ± ± ± ± ± ± ± 10.6 n = ± ± ± ± ± 10.3 mean ± SD% of dose mg C max mean ± SD 7.35 ± 2.21 µg/ml4.61 ± 1.10 µg/mlauc 0-inf mean ± SD ± 9.68 µgh/ml ± 4.38 µgh/ml C max 1.59AUC 0-inf 1.23 C max (µg/ml) kg (µg/ml) kgauc 0-inf (µgh/ml) kg (µgh/ml) kg C max 1.23AUC 0-inf
31 mg I C max (µg/ml) t max (h) AUC 0-72h (µgh/ml) AUC 0-inf (µgh/ml) a t 1/2 (h) CL t /F (L/h) Vd z /F (L) CL r (L/h) n mean SD n mean SD a mg mg ± 3.4%79.0 ± 6.8% mg I mg
32 C. difficile mg I
33 mg500 mg750 mg 1000 mg 500 mg mg 500 mg mg mg b I 500 mg 500 mg mg 500 mg/ % % a 0.0, , , , b af bmeddra/j V.8.1 % % % %
34 mg QT/QTc t max QTc Fridericia C max QT 450 msec 250 mg mg mg 1 QT 480 msec QTc Bazett Fridericia 450 msec QT 30 msec 250 mg mg mg mg mg mg mg mg mg mg 1 60 msec QTc Bazett 30 msec 1000 mg mg mg mg mg mg mg msec QTc Fridericia 30 msec 18
35 mg mg msec t max QTc Fridericia t max QTc Fridericia C max 19
36 QT QT/QTc I 250 mg > 450 msec > 480 msec 250 mg 500 mg 750 mg 1000 mg 500 mg 500 mg 750 mg 1000 mg 500 mg 500 mg mg mg > 30 msec c > 60 msec mg 1 > 450 msec > 480 QTcB a msec > 30 msec c > 60 msec > 450 msec > 480 QTcF b msec > 30 msec c > 60 msec abazett bfridericia c 20
37 t max QTc Fridericia C max I mg500 mg750 mg C max AUC 0-72h mg mg 7 7 C 24h AUC 0-24h 1 7 t max 500 mg C max AUC 0-inf C max 1.59AUC 0-inf 1.23 C max 1.23AUC 0-inf mg mg mg QT/QTc mg 7 QT/QTc mg 500 mg
38
39 I 2/2 200 mg 500 mg 700 mg 500 mg mg 0509A mg 0506G mg 100 mg mg 500 mg mg 100 mg mg mg 1500 mg C maxt maxauc 0-72h AUC 0-inft 1/2CL t/fvd z/f CL r 1 7 C maxc 24ht maxauc 0-24h CL r7 t 1/2CL ss/fvd z/f 2. a C maxt maxauc 0-72hAUC 0-inft 1/2CL t/fvd z/fcl r 200 mg700 mg C max AUC 0-72h Y X Log (Y) = Log (α) + β Log (X) + error β 95% AUC 0-inf t 1/2CL t/fvd z/fmrtλ z C maxc 24ht maxauc 0-24ht 1/2CL ss/fvd z/fcl r 2. 95% 12 PR QRS QT RR QTc Bazett a MedDRA/J V
40 BMI 12 a b a b BMI 12 a b a b
41 mg 200 mg 700 mg 500 mg I 200 mg mg mg mg mg500 mg700 mg 9 QTc>430 msec mg500 mg700 mg kg cm CLcr mean ± SD 200 mg500 mg 700 mg ± ± ± 14.9 ml/min kg cm CLcr mean ± SD ± 14.7 ml/min 25
42 mg500 mg 700 mg t max 1.1 ± ± 0.8 h 200 mg500 mg 700 mg C max 2.43 ± ± ± 1.95 µg/ml AUC 0-inf ± ± ± 9.12 µgh/ml t 1/2 7.5 ± ± 2.0 mean ± SD I 26
43 I C max (µg/ml) t max (h) AUC 0-72h (µgh/ml) AUC 0-inf (µgh/ml) a t 1/2 (h) CL t /F (L/h) Vd z /F (L) CL r (L/h) 200 mg n mean SD mg n mean SD mg n mean SD a mg C max AUC 0-72h C max AUC 0-72h t 1/2 CL t /FVd z /FMRTλ z Log (Y) = Log (α) + β Log (X) + error C max AUC 0-72h β C max %CI = 0.864, 1.260AUC 0-72h %CI = 1.188, 1.375C max mg AUC 0-72h mg C max I 27
44 AUC 0-72h I mg500 mg 700 mg mg mean ± SD ± 2.6%55.5 ± 6.1% 57.3 ± 4.6% ± 3.0%81.5 ± 5.1% 84.5 ± 2.2% ± 3.1%83.0 ± 5.0% 85.6 ± 2.3% I 28
45 mg C max C 24h t max AUC 0-24h mg I 29
46 mg I C max (µg/ml) C 24h (µg/ml) t max (h) AUC 0-24h (µgh/ml) t 1/2 a (h) CL ss /F (L/h) Vd z /F (L) CL r (L/h) 1 mean n = 8 SD mean n = 8 SD a mg mean ± SD 76.0 ± ± 3.9% mg I ± ± ± ± ± ± ± ± ± ± 3.9 Mean ± SD% of dose mg mg % mg % mg 30
47 mg 500 mg % 1 b I 200 mg 500 mg 700 mg 500 mg % %CI a % 0.0, , , , b af bmeddra/j V.9.0 % % % % mg 500 mg 700 mg %
48 PR QRS QT RR QTc Bazett QTc Bazett mg500 mg 700 mg C max AUC 0-72h % 500 mg C max C 24h t max AUC 0-24h 200 mg 500 mg mg mg mg 500 mg
49
50 BE 2/2 2. (13) (14) 2003 (15) 1 (16) 1 7 (17) 1 14 (18) A 500 mg mg 2 7 B 250 mg mg A 21 B A 20 B A 21 B mg S mg S mg mg C max AUC 0-72h t maxλ zauc 0-inf MRT C max AUC 0-72h 90% 90% mg mg mg mg 2 AUC 0-inft maxmrt λ zt max 90% 2. 34
51 BE day a x c x x x x x x x x x x x x x BMI x x d e x x x x x x x g f x x x x x x g x x x x x x g x x x x x x g HBsHCVHIVTPEIA x x x x x x x g h x i x x x x x b a 1 28 b c 500 mg 1 250mg 2 d 1 e 5 f 5 g 2 2 h 2 i I 500 mg 1 C max AUC 0-72h mean ± SD 7.35 ± 2.21 µg/ml57.86 ± 9.70 µgh/ml 250 mg mg AUC 0-72h C max α = 0.05 β = AUC 0-72h
52 mg A 21 B 20 A A 21 B A A 20 B A 20 mean ± SD 25.7 ± ± 5.40 kgbmi ± 1.50 B ± ± 4.88 kgbmi ± mg mg C max 500 mg µg/ml 250 mg µg/ml 250 mg mg % = % AUC 0-72h µg h/ml µg h/ml % = %
53 2.7.6 AUC 0-inf MRTλ z t max λ z 250 mg 2 P = mg mg 2 BE 500 mg 1 A 1 + B 2 n = mg 2 A 2 + B 1 n = 40 90% a C max (µg/ml) CV% AUC 0-72h (µgh/ml) CV% AUC 0-inf (µgh/ml) CV% MRT (h) CV% λ z (h -1 ) CV% t max b (h) CV% b Compound symmetry a250 mg mg 1 b250 mg mg mg mg %95% = %250 mg %95% = % 37
54 mg mg IU/L49 IU/L 3 ALTGPTASTGOT BE 500 mg 1 A 1 + B mg 2 A 2 + B % % a b b % % af bmeddra / J V mg
55 mg mg mg mg 2 C max AUC 0-72h 250 mg mg 1 90% λ z 250 mg mg mg
56
57 PK 2/2 500 mg C maxt maxauc 0-72hAUC 0-inft 1/2CL t/fvd z/fmrt CL r Superposition C maxc minauc 0-24h PK a) a) a) CLcr b) a b24 CLcr I CLcr 50 ml/min 10 II CLcr 50 ml/min
58 PK/PD mg 500 mg I 12 II I 12 II :00 9:35 1 I I 11 II I 11 mean ± SD 60.1 ± ± kgbmi ± 2.670CLcrCockcroft ± ml/min II ± ± 9.62 kgbmi ± 2.045CLcrCockcroft ± ml/min mg CLcrCockcroft 50 ml/min I 50 ml/min II CLcrCockcroft I II CLcr CLcr I II t 1/2 AUC 0-72h CLcr CLcr t 1/2 AUC 0-72h 42
59 mg PK 43
60 mg CLcrCockcroft PK 44
61 mg PK CLcrmL/min a) C max t max AUC 0-72h AUC 0-inf t 1/2 CL t /F Vd z /F MRT µg/ml h µg h/ml µg h/ml h L/h L h I 80 n Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD II n Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD acockcroft 45
62 2.7.6 AUC 0-72h C max CL t /F CLcrCockcroft CLcr C max CLcr CL t /F AUC 0-72h mg AUC 0-72h C max CL t /F CLcrCockcroft PK n = 22 46
63 mg CLcrCockcroft 50 ml/min I 50 ml/min II CL r I II 24 I II CLcr CLcr I II 0-48 hclcr CLcr 0-48 h mg PK CLcr (h) ml/min a) I 80 n Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD II n Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD acockcroft µg/ml 47
64 mg PK 48
65 mg PK CLcrmL/min a) 0-48 h% CL r L/h I 80 n 5 5 Arithmetic mean Arithmetic SD n 6 6 Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD II n 7 7 Arithmetic mean Arithmetic SD n 4 4 Arithmetic mean Arithmetic SD n Arithmetic mean Arithmetic SD acockcroft mg I 1 II 7 7 C max C min AUC 0-24h I II II CLcrCockcroft ml/min 500 mg 250 mg CLcr 20 ml/min 500 mg 250 mg mg 250 mg mg 125 mg
66
67 /2 PK 500 mg acockcroft I II CLcr ml/min a) C max n µg/ml mean SD C min n µg/ml mean SD AUC 0-24h n µg h/ml mean SD
68 /2 PK CLcr ml/min a) mg mg mg C max n µg/ml mean SD C min n µg/ml mean SD AUC 0-24h n µg h/ml b) mean SD acockcroft b AUC0-48h/2 500 mg 250 mg CLcr ml/min a) mg 250 mg mg 125 mg C max n µg/ml mean SD C min n µg/ml mean SD AUC 0-24h n µg h/ml b) mean SD acockcroft b AUC0-48h/2 52
69 mg I %95%CI = 0.2%, 38.5%II %95%CI = 2.3%, 51.8% I 1 II
70 PK I II % % a) 0.2, , b) c) % af bmeddra/j V.9.1 System Organ Class ; SOC cmeddra/j V.9.1 Preferred Term ; PT % CLcrCockcroft 50 ml/min 50 ml/min 500 mg CLcr 500 mg mg 54
71
72 ml 1 g ±15% C max t max AUC last t 1/2 AUC 0-inf vs. 2 vs. C max t 1/2 AUC last AUC 0-inf t max t 1/2 t max C max AUC last AUC 0-inf P<0.05 Schuirmann 2 2 t 1/2 C max AUC 90% C max AUC 80~125%t 1/2 80~120% 56
73 DDI 1 lb in t max C max DDI 1 mean SD mean SD a 90% a C max ng/ml (0.79, 0.94) t max h 1.0 b (0.8, 4.0) b 2.0 b (0.5, 4.0) b P = c AUC last ng h/ml (0.87, 0.94) AUC 0-inf ng h/ml (0.87, 0.94) t 1/2 h (0.92, 1.15) C max AUC n=24 a 90%ANOVA 2 b c t max P 2 57
74 DDI 1 mean SD mean SD a 90% a C max ng/ml (0.98, 1.15) t max h 1.0 b (0.8, 4.0) b 1.0 b (0.8, 2.0) b P = c AUC last ng h/ml (0.91, 0.98) AUC 0-inf ng h/ml (0.91, 0.98) t 1/2 h (0.86, 1.09) C max AUC a 90%ANOVA 2 b c t max P AUC last AUC 0-inf t 1/2 t max C max ANOVA P 0.05 C max t 1/2 t max P<0.05 t max C max C max t 1/2 133 vs. 160 AUC last AUC 0-inf
75
76 Broca 15%+10% HPLC 20 ng/ml 5 µg/ml 10 µg/ml 5 µg/ml C max t maxauc 0-72h AUC 0-inf % doset 1/2 MRT CL t /FCL r apparent non-renal clearancecl nr /F 6.11 t max 90% 95%CI t max 90% 95%CI
77 kg76.7 kg % 95%CI n=12 DDI 1 C max ng/ml t max h AUC 0-72h ng h/ml AUC 0-inf ng h/ml a mg ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± a % dose t 1/2 h MRTh CL r ml/min CL t /FmL/min CL nr /FmL/min mean ± SDmin - max a ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±
78 DDI 1 C max t max AUC 0-72h AUC 0-inf b t 1/2 MRT CL r CL t /F % 90%CI 95%CI h 90%CI a 95%CI a % 90%CI 95%CI % 90%CI 95%CI % 90%CI 95%CI % 90%CI 95%CI % 90%CI 95%CI % 90%CI 95%CI % 90%CI 95%CI % CL nr /F 90%CI 95%CI a CI b , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , C max 95%CI , 111.6% , 113.4%t max 95%CI , 0.25h , 0.25h t 1/2 62
79 %CI , 139.3% , 140.6% AUC 0-72h 95%CI , 132.1% , 143.8% 74.4%71.70% 66.04% CL r 119 ml/min91 ml/min77 ml/min 95%CI , 82.2% , 70.6% possibly related > possibly related extremely unlikely related
80 mg C max t max t 1/2 30% AUC 0-72h 27% 38% %71.70% 66.04%CL r 119 ml/min91 ml/min77 ml/min CL r 64
81
82 1 日 2 回 ) を試験 1~3 日目まで 3 日間経口 1 日 4 回 を試験 1~5 日固まで 5 日間経
83 DDI 3/3 1. C maxt maxλ zauc 0-72hAUC 0-inft 1/2CL tvd zmrt CL r 2. a C max AUC 0-72h 90% 2. a MedDRA/J V a) 1 () () ( a ) ) b) b) b) c) c) 72 d) e) f) g) h) LVFX i) c) j) k) l) m) a b c 2 d 1 e24 f 1 2 g h i 5 j k 4872 l 72 m 2 67
84 a) () / ( a) ( ) ) b) b) b) c) c) d) e) f) g) h) LVFX i) c) j) k) l) m) a b c 4 d 1 e24 f1 2 g 1 h i 5 j k 4872 l 72 m I mg mg mg 1 1 t 1/2 4 t 1/
85 t 1/ t max t max 60 t max 2 t max AD mean ± SD 26.3 ± ± 6.38 kgbmi ± ± 13.7 ml/min ± ± 6.38 kgbmi ± ± 16.9 ml/min C max µg/ml CV = 16.4% µg/ml CV = 69
86 % %CI = 0.960, AUC 0-72h µgh/ml CV = 11.6% µgh/ml CV = 11.4% %CI = 1.234, DDI DDI LVFX LVFX + C max AUC 0-72h AUC 0-inf t 1/2 CL t Vd z MRT CL r (µg/ml) (µg h/ml) (µg h/ml) (h) (L/h) (L) (h) (L/h) n Geometric mean Geometric CV% n Geometric mean Geometric CV% C max µg/ml CV = 15.3% µg/ml CV = 12.9% %CI = 1.043, 70
87 AUC 0-72h µgh/ml CV = 7.1% µgh/ml CV = 12.0% %CI = 1.477, DDI DDI LVFX LVFX + C max AUC 0-72h AUC 0-inf t 1/2 CL t Vd z MRT CL r (µg/ml) (µg h/ml) (µg h/ml) (h) (L/h) (L) (h) (L/h) n Geometric mean Geometric CV% n Geometric mean Geometric CV%
88 h 85.32% CV = 5.5% 82.72% CV = 7.4% %CI = 0.943, CL r L/h CV = 11.6% L/h CV = 13.3% %CI = 0.745, DDI h 80.41% CV = 12.2% 76.96% CV = 11.1% %CI = 0.903, 72
89 CL r L/h CV = 11.5% L/h CV = 19.5% %CI = 0.596, DDI %1/12 95%CI = 0.2%, 38.5% 0%0/1295%CI = 0.0%, 26.5% 16.7%2/1295%CI = 2.1%, 48.4% 16.7%2/1295%CI = 2.1%, 48.4% 73
90 2.7.6 C 1 C 1 1 b DDI LVFX LVFX + LVFX LVFX % % a 0.2, , , , b af bmeddra/j V.9.1 % % % % C %1/12 95%CI = 0.2%, 38.5% 0%0/1295%CI = 0.0%, 26.5% 16.7%2/1295%CI = 2.1%, 48.4% 8.3%1/1295%CI = 0.2%, 38.5%
91 mg/100 ml C max AUC 75
92 1 掴年. 月. 日 ~II 月. 日
93 mg 500 mg mg 1/ mg 500 mg mg 1/ mg mg 500 mg mg 1/ mg mg 500 mg mg 1/ mg 500 mg mg 1/ mg mg 1/ Broca 15%+10% AUC HPLC LOQ 20 ng/ml Hz 77
94 Hz Hz Hz Hz adaptive visual multiple choice reaction task Basle well-being scale AUC Student t 2 Student t Wilcoxon kg 79.3 kg AUC 0-6.5h 125 mg mg 125 mg P< mg mg 500 mg P<
95 mg 500 mg t 500 mg mg P mg mg mg mg mg mg mg possibly related 500 mg mg 1 AST21 U/L ALT33 U/LAST18 U/LALT 22 U/L AST ALT 1 17 µmol/l 26.1 µmol/l 1 79
96 mg 500 mg 600 mg % 80
97
98 HPLC R- S DDI n = n = 8 n = SD lb SD in SD /
99 R- S R- S- DDI 2 R- A B % a ANOVA b 90%CI e C max µg/ml 1.59 ± ± NS EQ t max h 1.33 ± ± NS d --- AUC 0-t µgh/ml 75.9 ± ± NS EQ AUC 0-inf µgh/ml 87.0 ± ± NS EQ CL t /FmL/min 2.89 ± ± NS --- t 1/2 h 46.0 ± ± NS --- S- C max µg/ml 1.64 ± ± NS EQ t max h 1.27 ± ± NS d --- AUC 0-t µgh/ml 51.1 ± ± NS EQ AUC 0-inf µgh/ml 54.2 ± ± NS EQ CL t /FmL/min 4.58 ± ± NS --- t 1/2 h 31.9 ± ± NS --- mean ± SDn=15 a BA B/B 100 b ANOVA c C max AUC 0-t AUC 0-90% d t max NS EQ90% 80125% R- R- 1.5 R- C max mean ± SD 1.64 ± 0.28 µg/ml 1.59 ± 0.23 µg/mlcl t /F 2.93 ± 0.92 ml/min 2.89 ± 0.88 ml/min t 1/2 46 R- 2 R- C max AUC 0-t AUC 0-inf 90%80 125% 83
100 2.7.6 S- S- 1.3 S- C max mean ± SD 1.70 ± 0.25 µg/ml 1.64 ± 0.21 µg/mlcl t /F 4.72 ± 1.23 ml/min 4.58 ± 1.17 ml/min t 1/2 32 S- 2 S- C max AUC 0-t AUC 0-90%80 125% 2 PT DDI 2 PT a A B % b ANOVA c 90%CI d PT max e sec 3.5 ± ± NS EQ t max, PT f h 43.2 ± ± NS g --- AUC 0-t PT h sech 186 ± ± NS EQ mean ± SD a PT b BA B/B 100 c ANOVA d PT max AUC 0-tPT 90% e PT f PT max g ANOVA t max, PT h PT0 - t NS EQ 90% 80125% PT 36 PT max 15 2 PT max t max, PT AUC 0-t PT Pt max AUC 0-t PT 90%80125% 84
101 AST ALT remotely related mg
102
103
104 2.7.6 C max C min t max t min C max C min t max t min C max AUC 0-inf AUC 0-11h t 1/2 MRT 90%C max AUC 0-inf AUC 0-11h MRT t max 90%95%Wilcoxon C max t max C min t min - C max t max C min t min 90% kg 78.1 kg
105 DDI 3 C max (ng/ml) AUC 0-t (ng h/ml) AUC 0-inf (ng h/ml) AUC 0-11h (ng h/ml) t 1/2 (h) MRT (h) t max (h) + (CV) * (22.38) (33.05) (33.78) (25.29) (32.47) (23.11) * t max + (CV) * (23.21) (30.45) (31.41) (30.49) (37.73) (28.17) (%) (90%) (99.7, 113.3) (95.8, 104.7) 99.8 (95.6, 104.1) (96.6, 106.5) 97.0 (87.4, 107.6) 94.9 (89.7, 100.3) (100, 111.8) C max C min t max t min C max C min AUC 0-23h t max t min C max C min t max t min DDI 3 C max (mmol/l) C min (mmol/l) t max (h) + (CV) * 6.7 (9.44) (16.92) (CV) * 6.5 (8.81) (14.42) (%) (90%) 98.1 (92.7, 102.1) (99.0, 113.2) (70.7, 100.0) t min (h) (86.6, 115.5) * t max t min 89
106 C max C min AUC 0-23h t max t min DDI 3 C max (µiu/ml) C min (µiu/ml) AUC 0-23h (µiu h/ml) t max (h) t min (h) + (CV) * 94.6 (49.18) ND (55.56) ND (38.80) (CV) * 82.7 (43.46) ND (47.02) ND (42.77) (%) (90%) 90.1 (79.6, 104.5) (100.0, 105.4) (93.9, 128.4) 71.5 (41.7, 100.0) (91.4, 117.5) * t max t min ND: 5 µiu/ml C- 10%
107 (4) 妊娠可能な年齢の女性は投与前の尿妊娠検査が陰性であり かつ投与開始から治療後 7~14
108 III 2/ WBC/mm 3 25 WBC/µL 5 WBC/HPF C 37.5 C 38 C 2 10 WBC/mm 3 25 WBC/µL 5 WBC/HPF WBC/mm3 25 WBC/µL 5 WBC/HPF WBC/mm 3 25 WBC/µL 5 WBC/HPF >100 ml ASTGOT ALTGPT <50 ml/min ) 92
109 III 3/4 4 5 QT WBC< /L < mg WBC< /L < mg FAS PPS mg 0510G mg
110 III 4/ Visit Visit 3 Visit 4 Visit 3 Visit 4 2 Visit 4 Visit 3 Visit 2* Visit 4 Visit 3 MIC Visit 4 * : Visit 2 3 Visit 4 Visit 3 4 Visit 4 Visit 3 MIC 2. C maxc 24hAUC 0-24h % PPS 2. I 500 mg I 500 mg C maxc 24hAUC 0-24h 3. 95% 94
111 III Visit 1 Visit 2 Visit 3 Visit 4 / / / X a X c b b b ) e d f avisit 3 Visit 4 bvisit 1 c d e Visit 3 Visit 3 f % 95% , PK/PD C max / MIC 500 mg 1 1 C max MIC 1 µg/ml C max / MIC 500 mg
112 FAS PPS 1, I 500 mg PPS PPS PPS PPS % mean ± SD 47 ± 16 mean ± SD 62.5 ± 11.3 kg % % % 96
113 % PPS % mean ± SD 40 ± 14 mean ± SD 57.7 ± 9.4 kg % % % % 775 S. aureus % S. pneumoniae % K. pneumoniae % H. influenzae %H. parainfluenzae % 307 E. coli % K. pneumoniae %P. mirabilis % PPS III PPS
114 III PPS n = 775 n = 307 n = 883 n = 362 n = Mean ± SD 47 ± ± ± ± ± 16 kgmean ± SD 62.5 ± ± ± ± ± % % % % % mean ± SD 61.1 ± 10.7 kg 60.9 ± 11.1 kg 63.3 ± ± ± ± 2 CLcr ± 28.4 ml/min 98.9 ± 29.2 ml/min ± 15.5 ml/min N.D %617/69195% = 87.0% 91.6% 87.8%245/27995% = 84.0%91.7% 98
115 III %a b 95% , , , , , , , , 87.0 % a + b %546/73395%CI = 71.3%, 77.6% 86.1%253/29495%CI = 82.1%, 90.0% 99
116 III %a b 95% , , , , , , , , 85.5 % a + b Visit 3 Visit %47/ %50/ %175/ %208/233 H. parainfluenzae 69.2%54/ %62/70 K. pneumoniae 76.9%50/ % 56/60 H. influenzae 70.0%28/ %34/37 S. pneumoniae 79.3% 23/ %22/ %19/ %19/ %109/ %100/116 E. coli 84.9%79/ %75/88 P. mirabilis 100%13/ %11/13 K. pneumoniae 100%13/ %10/ Visit 4 100%2/2 100%47/47 100%3/ %1/1 100
117 Visit 3 Visit Visit 3 Visit %747/ %666/ % 348/ %306/ %399/ %360/375 Visit 3 Visit %290/ %267/ %81/ %74/ %81/ %76/ %101/ %93/98 100%27/ %24/25 101
118 III %a b 95% , , , , , , , , , , , , , , , % a + b , %462/ % 575/ %385/ %415/ %237/ kg 60 kg 96.5%467/ kg 80 kg 97.3%504/ kg 97.0%65/67 102
119 Visit 3 Visit %63/ %54/ % 260/ %226/233 H. parainfluenzae 98.8%84/ %68/70 K. pneumoniae 98.5%67/ %59/61H. influenzae 95.1%39/ %35/37S. pneumoniae 96.9%31/ %25/ %23/ %21/ % 125/ %111/117 E. coli 95.9%93/ %83/89 K. pneumoniae 100%14/14 100%11/11 P. mirabilis 100%13/13 100%13/ Visit 4 100%47/47 100%3/3 100%2/ %1/ Visit 3 Visit 4 Visit 3 Visit %276/ %256/265 Visit 3 Visit %139/ %126/ Visit 3 Visit 4 Visit 3 Visit %291/ %264/272 Visit 3 Visit % 140/ %126/ Visit
120 2.7.6 S. aureus 100% 21/21 S. pneumoniae 96.6%28/29 K. pneumoniae 98.5%64/65 H. influenzae 97.4%37/38H. parainfluenzae 90.5%67/74 E. coli 91.5%86/94 K. pneumoniae 100%13/13P. mirabilis 100%13/ III % a b 95% , 100 S. aureus , 100 S. agalactiae S. pneumoniae , 100 S. mitis β-hemolytic treptococcus , 100 E. faecium , , 95.7 Neisseria spp , 100 M.(B.) catarrhalis , 100 A. baumannii , 100 A. lwoffii , 100 A. junii , 100 E. coli , 100 C. freundii K. pneumoniae , 100 K. ozaenae , 100 K. oxytoca , 100 P. agglomerans E. cloacae , 86.7 E. aerogenes S. marcescens , 100 P. mirabilis , 100 P. vulgaris , 100 P. rettgeri Haemophilus spp , 100 H. influenzae , 100 H. parainfluenzae , 97.2 P. aeruginosa , 84.8 S. maltophilia , 100 % a b 104
121 III % a b 95% , 100 CNS S. aureus , 100 S. epidermidis , 100 S. haemolyticus S. saprophyticus , 100 S. agalactiae S. anginosus , 100 S. mitis S. sanguis E. faecalis , 100 E. faecium , 0.0 Leuconostoc spp G. morbillorum , 97.9 E. coli , 97.1 K. pneumoniae , 100 K. oxytoca E. aerogenes , 100 P. mirabilis , 100 A. johnsonii % a b Visit 3 MIC MIC MIC 0.06 µg/ml µg/ml µg/ml µg/ml 62 1 µg/ml 31 2 µg/ml 18 4 µg/ml 9 8 µg/ml µg/ml µg/ml 3 32 µg/ml 9 MIC 0.5 µg/ml 95.9%301/314 1 µg/ml 93.5%29/31 2 µg/ml 94.4%17/18 4 µg/ml 66.7%6/9 8 µg/ml 87.5%14/1616 µg/ml 76.9%20/26 32 µg/ml µg/ml 66.7%6/9 MIC 0.5µg/mL H. influenzae 1 H. parainfluenzae 5 K. pneumoniae 1 E. cloacae 2 P. aeruginosa 1 β-hemolytic Streptococcus 1 E. coli 1 P. aeruginosa 1 1 µg/ml
122 2.7.6 H. parainfluenzae 1 E. faecium 1 2 µg/m 18 1 S. pneumoniae 1 4 µg/ml 9 3 P. aeruginosa 3 8 µg/ml 16 2 A. baumannii 1 E. coli 1 16 µg/ml 26 6 E. coli 4 P. aeruginosa 1 E. faecium 1 32 µg/ml 9 3 E. coli 3 106
123 MIC MIC 0.06~>128 III Pathogen MIC(µg/mL) <= >128 Total Eradication rate (%) a) 2/2 16/16 1/1 0/1 1/1 20/ S. aureus 2/2 16/16 1/1 1/1 20/ E. faecium 0/1 0/ /78 13/13 7/7 10/11 2/2 1/4 1/2 0/2 1/1 1/1 110/ A. baumannii 3/3 8/8 2/2 0/1 13/ A. lwoffii 1/1 1/1 1/1 3/ A. junii 2/2 2/ E. coli 3/3 2/2 0/1 5/ C. freundii 1/1 1/ K. pneumoniae 52/53 1/1 1/1 1/1 1/1 1/1 57/ K. ozaenae 1/1 1/1 2/ K. oxytoca 3/3 3/ P. agglomerans 1/1 1/ E. cloacae 1/3 1/ E. aerogenes 1/1 1/ S. marcescens 3/3 3/ P. mirabilis 4/4 1/1 5/ P. vulgaris 1/1 1/1 2/ P. rettgeri 1/1 1/ P. aeruginosa 0/1 1/1 1/1 4/5 1/4 0/1 1/1 8/ S. maltophilia 1/1 1/1 2/ Total 74/78 15/15 23/23 11/12 2/3 1/4 2/3 0/2 1/1 1/1 130/ Response rate (%) a) a 107
日本化学療法学会雑誌第61巻第6号
β Moraxella catarrhalis Escherichia coli Citrobacter Klebsiella pneumoniae Enterobacter cloacae Serratia marcescens Proteus Pseudomonas aeruginosa Acinetobacter Bacteroides fragilis β Haemophilus influenzae
日本化学療法学会雑誌第64巻第4号
β β Moraxella catarrhalisescherichia colicitrobacter Klebsiella pneumoniaeenterobacter cloacaeserratia marcescens Proteus Providencia Pseudomonas aeruginosaacinetobacter Bacteroides fragilis β β E. colik.
2.7 臨床概要
2.7 臨床概要 A/G Al-P ALT AST AT- AUC AZM BIPM BP BUN CEZ CFPN-PI CFU CLcr Cmax CNS COPD CPFX CRP CS CYP CVA DBT DHP-I DIC DRPM DRPM-DC FAS γ-gtp GCP GNB GNF-GNR GPB HAM - Staphylococcus C P450 -I Full Analysis
1.Streptococcus pneumoniae, Streptococcus pyogenes JC-1,S.aureus Smith,methicillin (DMPPC)- susceptible S. aureus subsp. aureus (MSSA) TR101, DMPPC-resistant S. aureus subsp. aureus (MRSA) TR102, Staphylococcus
MIC MIC...
50 mg 10% 2.7.36 2.7.36 2.7.36... 1 1.6... 1 2.6... 3 3.6... 5 3.16... 5 3.26... 12 3.36... 16 4.6... 17 5.6... 19 6.6... 20 2.7.3.3.16-1 MIC... 9 2.7.3.3.16-2 MIC... 10 2.7.3.3.16-3 MIC E. coli... 11
THE JAPANESE JOURNAL OF ANTIBIOTICS 48-8 Enterococcus avium 5Š, Corynebacterium xerosis 10Š, Corynebacterium pseudodiphtheriticum 10Š, Corynebacterium
THE JAPANESE JOURNAL OF ANTIBIOTICS 48-8 Enterobacter spp., Serratia spp., Burkholderia cepacia, Flavobacterium spp., Alcaligenes spp. THE JAPANESE JOURNAL OF ANTIBIOTICS 48-8 Enterococcus avium 5Š, Corynebacterium
THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 June 2015 Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis % 2 S. pneumon
June 2015 THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 189 49 1 : 14 1 2 2 3 1 2 3 2015 4 3 1 : 14 CVA/AMPC 1 : 14 27 CVA/AMPC 1 : 14 88.5% Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis
R06_01
Staphylococcus aureus (MSSA) PCG (N=118,334) 57,369 (48.5%) 判定不能 :3 (0.0%) 60,962 (51.5%) CEZ (N=143,723) I:42 (0.0%) 143,635 (99.9%) R:46 (0.0%) CVA/AMPC (N=19,281) R:14 (0.1%) 19,265 (99.9%) 判定不能 :2
600mg 600mg CTD 2 2.5 2.5 Page 3 2.5...7 2.5.1...7 2.5.2...27 2.5.3...28 2.5.4...42 2.5.5...55 2.5.6...79 2.5.7...97 2.5 Page 5 73 67 31 48 48A 102 104 105 106 ALP ALT(GPT) AST(GOT) AUC AUEC BID BUN
THE JAPANESE JOURNAL OF ANTIBIOTICS 63 13 243 ( 37 ) 2007 12 2008 5 19 863 methicillin-susceptible Staphylococcus aureus (MSSA) Escherichia coli levof
242 ( 36 ) THE JAPANESE JOURNAL OF ANTIBIOTICS 63 _ 3 prulifloxacin * ** ** CMC * ** 2010 2 22 Prulifloxacin ulifloxacin (UFX) 3 1 2003 12 2004 5 19 534 2 2005 12 2006 5 19 805 3 THE JAPANESE JOURNAL OF
CHEMOTHERAPY aureus 0.10, Enterococcus faecalis 3.13, Escherichia coli 0.20, Klebsiella pneumoniae, Enterobacter spp., Serratia marcescens 0.78, Prote
aureus 0.10, Enterococcus faecalis 3.13, Escherichia coli 0.20, Klebsiella pneumoniae, Enterobacter spp., Serratia marcescens 0.78, Proteus mirabilis 3.13, Proteus vulgaris 1.56, Citrobacter freundii 0.39,
Table 1. Antibacterial activity of cefdinir, cefixime, cefteram, cefuroxime, cefaclor and amoxicillin against standard strains Inoculum size: 108 cells/ml CFDN: cefdinir, CFIX: cefixime, CFTM: cefteram,
日本化学療法学会雑誌第57巻第5号
in vitro Key words Streptococcus pneumoniae β Haemophilus influenzae Escherichia coli I Table. Antibacteriallevofloxacinactivityagainstclinicalisolates Organism Year Susceptibility(%)(Numberofstrains)
VOL.48 NO.7 lase negative staphylococci, Escherichia coli, Klebsiella spp., Citrobacter freundii, Enterobacter spp., indole-positive Proteus, Serratia
ceftazidime, cefpirome, cefepime, cefoperazone/sulbactam (2: 1), imipenem Staphylococcus aureus oxacillin coagulase negative staphylococci Escherichia coli piperacillin Klebsiellac spp. Citrobacter Pseudomonas
CHEMOTHERAPY APRIL 1992 Acinetobacter calcoaceticus Staphylococcus aureus, Escherichia coli P. aeruginosa E. eoli, Klebsiella pneumoniae Serratia marc
APRIL 1992 Acinetobacter calcoaceticus Staphylococcus aureus, Escherichia coli P. aeruginosa E. eoli, Klebsiella pneumoniae Serratia marcescens P. aeruginosa P. aeruginosa Streptococcus pyogenes Streptococcus
CHEMOTHERAPY Methicillin-resistant S.aureus(MRSA) coccus epidermidis 105 Streptococcus pyogenes E.faecali senterococcus avium Enterococcus faecium Str
cefaclor(ccl),cefuroxime(cxm),cefixime (CFIX),cefteram(CFTM),cefdinir(CFDN) pneumoniae,streptococcus pyogenes Moraxella catarrhalis,haemophilus influenzae,escherichia coli, Klebsiella pneumoniae,proteus
日本化学療法学会雑誌第58巻第4号
Escherichia coli Enterococcus faecalisstreptococcus agalactiae Klebsiella pneumoniae Staphylococcus epidermidis E. colie. faecalispseudomonas aeruginosa K. pneumoniae S. agalactiae E. coli E. coli μ p
_02三浦.indd
36, 7-11, 2016 IPD PCV 5 3 80% 1 invasive pneumococcal disease ; IPD 2010 7 PCV7 2013 13 PCV13 IPD IPD 2,3 2015 1 2015 12 5 1 IPD 2015 1 12 IPD 5 IPD 1 4 2 5 http://pneumocatch.jp/ 5 Statens Serum Institut
Feb THE JAPANESE JOURNAL OF ANTIBIOTICS ,4 2,4 2,4 2,3,4 2,3,4 2,3, ,3, Garenoxacin GRNX Levofloxacin LV
Feb. 2016 THE JAPANESE JOURNAL OF ANTIBIOTICS 69 1 27 27 1,4 2,4 2,4 2,3,4 2,3,4 2,3,4 2 1 2,3,4 1 2 3 4 2015 10 21 9 Garenoxacin GRNX Levofloxacin LVFX Sitafloxacin STFX Moxifloxacin MFLX Pharmacokinetics-Pharmacodynamics
Staphylococcus sp. K.pneumoniae P.mirabilis C.freundii E. cloacae Serratia sp. P. aeruginosa ml, Enterococcus avium >100ƒÊg/ml
CHEMOTHERAPY SEPT. 1992 cefoperazone ceftazidime (CAZ), imipenem (IPM) Staphylococcus sp., Enterococcus (CPZ), faecalis, Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae,
2 2 THE JAPANESE JOURNAL OF ANTIBIOTICS 69 1 Feb Neisseria gonorrhoeae ceftriaxone CTRX % 2010 CTRX 20 FQ staphylococci, E. faecium, N.
Feb. 2016 THE JAPANESE JOURNAL OF ANTIBIOTICS 69 1 1 1 2013 69 11,762 2015 11 16 1994 2013 69 19 11,762 FQ 33 Streptococcus pyogenes, Streptococcus pneumoniae, Moraxella catarrhalis, Haemophilus influenzae
epidermidis, Enterococcus faecalis, Enterococcus Klebsiella pneumoniae, Proteus mirabilis, indolepositive Proteus spp., Enterobacter spp., Serratia
epidermidis, Enterococcus faecalis, Enterococcus Klebsiella pneumoniae, Proteus mirabilis, indolepositive Proteus spp., Enterobacter spp., Serratia Table 3. Overall clinical efficacy of cefozopran in
mg (1) (2) QT (3) 1 400mg 1 1 2
17 8 10 400mg 14 9 30 1 400mg 1 C21H24FN3O4 HCl 437.89 1 6 8 7 [(4aS, 7aS) [3,4 b] 6 ] 4 1,4 3 1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-octahydropyrrolo[3,4-b]pyridine -6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic
CHEMOTHERAPY
CHEMOTHERAPY VOL.41 S-2 Laboratory and clinical evaluation of teicoplanin CHEMOTHERAPY AUG. 1993 VOL.41 S-2 Laboratory and clinical evaluation of teicoplanin Table 1. Comparative in vitro activity of teicoplanin
ヒビスコール液A カタログ
1 2 3 2002 10 Centers for Disease Control and Prevention CDC A 1. 2. 0.2% 3. 1 A 2 3 4 5 6 7 1 1 1. 2. 3. 2 1. 1 0.2% 10 Pseudomonas aeruginosa ATCC 27853 20 20 Proteus vulgaris ATCC 13315 30 20 Escherichia
(1) ) ) (2) (3) (4) (5) (1) (2) b (3)..
... -1... -1... -2... -6.... -1 (1)... -1 1)... -1 2)... -14 (2)... -19 (3)... -52 (4)... -18 (5)... -136.... -196 (1)... -196 (2) b... -224 (3)... -233.... -251.... -286.... -289 (1)... -289 (2)... -32
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Seminal paper Anhalt JP Pioneering paper Claydon MA Kishnamurthy T Enterobacter B. cereus Routine identification paper Eigner U Seng P Cherkaoui A Saureus S. Saureus* S. Vagococcus Haemophilus Mycobacterium
Feb THE JAPANESE JOURNAL OF ANTIBIOTICS Tebipenem pivoxil 1 1, Meiji Seika 2 Meiji Seika G 3 Meiji Seika Tebipen
Feb. 2016 THE JAPANESE JOURNAL OF ANTIBIOTICS 69 1 53 53 Tebipenem pivoxil 1 1, 3 2 2 1 1 Meiji Seika 2 Meiji Seika G 3 Meiji Seika 2015 12 15 Tebipenem pivoxil 10% 2010 4 2013 3 3,547 3,540 3,540 3,331
日本化学療法学会雑誌第65巻第4号
Mycoplasma pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae M. pneumoniae Key words Mycoplasma pneumoniae Mycoplasma pneumoniae M. pneumoniae I M. pneumoniae M. pneumoniae M. pneumoniae
R01
1. 集計対象医療機関数 (1,792 医療機関 ) 13.2% (7 医療機関 ) 900 床以上 N=53 86.8% (46 医療機関 ) 19.2% (70 医療機関 ) 500 899 床 N=365 80.8% (295 医療機関 ) JANIS 参加 * 200 499 床 N=2,231 43.4% (968 医療機関 ) 56.6% (1,263 医療機関 ) JANIS 参加 200
日本化学療法学会雑誌第59巻第5号
Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis S. pneumoniae H. influenzae M. catarrhalis S. pneumoniae H. influenzae M. catarrhalis S. pneumoniae H. influenzae M. catarrhalis S.
VOL.32 S-7 CHEMOTHERAPY Table 1 MIC of standard strains of CTRX Fig. 2 Cumulative curves of MIC S. aureus (26 strains )
CHEMOTHERAPY OCT. 1984 Fig. I Chemical structure of CTRX VOL.32 S-7 CHEMOTHERAPY Table 1 MIC of standard strains of CTRX Fig. 2 Cumulative curves of MIC S. aureus (26 strains ) CHEMOTHERAPY Fig. 3 Cumulative
366 12 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 Dec. 2012 1 8 DNA 2,3 16 12 20 171 2008 12 2010 11 2 3,558 4.44% 1.65% 1.17% 90% 9 Escherichia coli -
Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 365 11 sita oxacin 1 1 1 1 1 1 2 2 3 3 1 1 1 2 3 2012 9 14 sita oxacin STFX 50 mg 10% 2008 1 2008 12 2010 11 2 STFX 1,452 91.4% 1,235/1,351 95.9% 466/486
概要 (2004 年分 ) 本サーベイランスは 参加医療機関において血液および髄液から分離された各種細菌の検出状況や薬剤感受性パターンの動向を把握するとともに 新たな耐性菌の早期検出等を目的とする これらのデータを経時的に解析し臨床の現場に還元することによって 抗菌薬の安全で有効な使用方法や院内感染制御における具体的かつ確実な情報を提供する 検体 ( ) 内は施設数 2002 年 2003 年 2004
クラビット点滴静注 5 mg / 2 ml (5 群 ) 疾患別臨床効果 (5 群 ) 原因菌別臨床効果 (5 群 ) 非定型病原体 (5 群 ) 微生物学的効果 (5 群 ) 日本の臨
クラビット点滴静注 5 mg / 2 ml 目次 1. (5 群 ) 背景及び概観...6 1.1 (5 群 ) 臨床試験の概要...6 1.1.1 (5 群 ) 日本比較試験...9 1.1.2 (5 群 ) 日本一般臨床試験...1 1.2 (5 群 ) 目標とする適応症及び適応菌種に対する有効性評価...1 1.2.1 (5 群 ) 日本の臨床試験成績の統合データ... 11 1.2.2 (5
概要 (2006 年 1 2 3 月分 ) 本サーベイランスは 参加医療機関において血液および髄液から分離された各種細菌の検出状況や薬剤感受性パターンの動 向を把握するとともに 新たな耐性菌の早期検出等を目的とする これらのデータを経時的に解析し臨床の現場に還元することによって 抗菌薬の安全で有効な使用方法や院内感染制御における具体的かつ確実な情報を提供する 検体 2005 年 2006 年 10~12
Staphylococcus epidermidis Streptococcus pneumoniae Staphylococcus epidermidis Streptococcus pneumontae S. epidermidis Table 1. Summary of the organis
Staphylococcus aureus S. aureus (MRSA) vancomycin (VCM), arbekacin (ABK) Streptococcus pneumoniae cefuzonam (CZON), cefpirome (CPR) S. pneumoniae Enterococcus faecalis ampicillin (ABPC), imipenem (IPM)
CHEMOTHERAPY DEC (NFLX), ofloxacin (OFLX), ciprofloxacin (CPFX) Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterococcus faecali
CHEMOTHERAPY DEC. 1988 (NFLX), ofloxacin (OFLX), ciprofloxacin (CPFX) Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterococcus faecalis Pseudomonas aeruginosa, Serratia ma- Fig. 1. Chemical
第65回日本化学療法学会東日本支部総会 抄録
鍵 76 Clostridioides difficile C. difficile 77 γ γ Mycobacterium avium 78 79 Clostridium difficile Treponema pallidum 80 81 82 in vitro in vitro 83 鍵 Treponema pallidum 84 Chlamydia trachomatis Mycoplasma
CHEMOTHERAPY JUN Citrobacter freundii 27, Enterobacter aerogenes 26, Enterobacter cloacae 27, Proteus rettgeri 7, Proteus inconstans 20, Proteus
VOL. 32 S-4 CHEMOTHERAPY Fig. 1 Chemical structure of sodium cefoperazone Fig. 2 Chemical structure of sodium cefoperazone CHEMOTHERAPY JUN. 1984 Citrobacter freundii 27, Enterobacter aerogenes 26, Enterobacter
ｽﾗｲﾄﾞ ﾀｲﾄﾙなし
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CHEMOTHERAPY FEB Table 1. Activity of cefpirome and others against clinical isolates
VOL.39 S-1 CHEMOTHERAPY FEB. 1981 Table 1. Activity of cefpirome and others against clinical isolates VOL.39 S-1 CHEMOTHERAPY FEB. 1991 72 M, 55.5 kg 66 F, 53 kg Chronic bronchitis Bronchopneumonia Peak
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19 11 13 300 18 3 31 1300mg 4 6 C 15 H 22 FN 3 O 6 359.35 + -1-5--β-D--5--1,2--2- -4- 19 11 13 300 18 3 31 A B B A 30 1 2 21 7 1 1 1.31m 2 900mg 1.31m 2 1.64m 2 1,200mg 1.64m 2 1,500mg B 30 1 2 14 7 1
Table 1. Antimicrobial drugs using for MIC
Table 1. Antimicrobial drugs using for MIC Table 2. Susceptibilities determined with the VITEK 2 system and agar dilution reference by interpretive eategory for Staphylococcus aureus Table 3. Interpretive
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CHEMOTHERAPY
CHEMOTHERAPY CHEMOTHERAPY Table 1 Antibacterial activity of Sulbactam/CPZ against standard strains MIC mg/ml Inoculum size 106 CFU/ml * Sulbactam/CPZ= 1: 1 ** Concentration of Sulbactam+ CPZ CHEMOTHERAPY
Table 1 Sensitivity distribution of clinical isolates 1. Escherichia coli Inoculum size: 106cells/ml 2. Klebsiella pneumoniae 3. Enterobacter cloacae 4. Serratia marcescens Inoculum size: 106cells/nil
CHEMOTHERAPY NOV S. aureus, S. epidermidis, E. coli, K. pgeumoniae, E. cloacae, S. marcescens, P. mirabilis, Proteus, P. aeruginosa Inoculum siz
VOL.33 S-5 CHEMOTHERAPY 381 Fig. 1 Chemical structure of HAPA-B Chemical name 1-N-[(2S)-3-Amino-2-hydroxypropiony1]-4-0-(6-amino- 6-deoxy-a-D-glucopyranosyl)-6-013-deoxy-4-C-methyl- 3-(methylamino)-ƒÀ-L-arabinopyranosyl]-2-deoxystreptamine
Streptococcus pneumoniae,streptococcus pyogenes,streptococcus agalactiae,neisseria gonorrhoeae,h.influenzae,moraxella subgenus Branhamella catarrharis
Streptococcus pneumoniae,streptococcus pyogenes,streptococcus agalactiae,neisseria gonorrhoeae,h.influenzae,moraxella subgenus Branhamella catarrharis, E.coil,Klebsiella pneumoniae,klebsiella oxytoca,proteus
CHEMO THE RAPY OCT. 1994
bilis (0.78), Proteus vulgaris (1.56), Enterococcus faecalis (3.13), Staphylococcus epidermidis (6.25), Klebsiella pneumoniae (6.25), Morganella morganii (6.25), Escherichia coli (12.5), Providencia rettgeri
400 46 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 Dec. 2012 LVFX 100 mg 3 / 7 150 mg 2 / 7 2 2006 2008 9 LVFX PK PD 2009 7 100 mg 1 3 500 mg 1 1 AUC/MIC
Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 399 45 2012 11 5 LVFX 500 mg 1 1 20 Chlamydia trachomatis C. trachomatismycoplasma genitalium M. genitalium LVFX 1 500 mg 1 1 7 22 22 C. trachomatis 17
Fig.1 Chemical structure of BAY o 9867
Fig.1 Chemical structure of BAY o 9867 CHEMOTHERAPY 43 Table 3 Antibacterial spectrum of gram negative bacteria Medium:Heart infusion agar (Nissui) Method:Agar dilution (Streak) CHEMOTHERAPY DEC 1985
- 1 -
- 1 - - 1 - ... 1... 2... 4... 5... 9... 11... 14... 16... 20... 21... 22... 23... 23 - 1 - - 2 - - 3 - - 4 - - 5 - - 6 - - 7 - - 8 - - 9 - ( ) - 10 - - 11 - Pseudomonas aeruginosa Escherichia coli Staphylococcus
Table 1.Quality control of MICs for reference strains Table 2.Antimicrobial activity of gatifloxacin against aerobic bacteria Table 4.Antimicrobial activity of gatifloxacin and other quinolones against
Table 1. Antibacterial activitiy of grepafloxacin and other antibiotics against clinical isolates
Table 1. Antibacterial activitiy of grepafloxacin and other antibiotics against clinical isolates Table 2-1. Summary of patients treated with grepafloxacin for respiratory infection 1) Out: outpatient,
200mg 2005 3 876179 2002 3 3 200mg VFEND for Intravenous Use (1) (2) [4.1 ] (3) [4.2 ] (1) [1] (2) (3) [1] 3
70( 70 ) THE JAPANESE JOURNAL OF ANTIBIOTICS 57 1 Feb. Meropenem 2002 * * * * * * * * * * * * * * * * * * * * * * NTT Feb. THE JAPANESE JOURNAL OF ANTIBIOTICS 57 1 71( 71 ) * * * * 2003 12 22 Meropenem
Fig. 1 Chemical structure of DL-8280
Fig. 1 Chemical structure of DL-8280 Fig. 2 Susceptibility of cl in ical isolates to DL4280 Fig. 5 Susceptibility of clinical isolates to DL-8280 Fig. 3 Susceptibility of clinical isolates to DL-8280 Fig.
CHEMOTHERAPY
VOL.40 S-1 coagulase negative Staphylococcus sp, methicillin- resistant Staphylococcus aureus (MRSA), Enterococcus faecalis, Escherichia coli, Citrobacter freundii, Klebsiella pneumoniae, Enterobacter
pneumoniae 30, C. freundii 32, E. aerogenes 27, E. cloacae 32, P. mirabilis 31, P. vulgaris 34, M. morganii 32, S. marcescens 31, H. influenzae 27, P.
pneumoniae 30, C. freundii 32, E. aerogenes 27, E. cloacae 32, P. mirabilis 31, P. vulgaris 34, M. morganii 32, S. marcescens 31, H. influenzae 27, P. aeruginosa 30, P. maltophilia pyogenes 32, Escherichia
４月号 学会特集号 １２２２４７／１６）一般演題目次
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 48 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 49 60 61 62 63 64 65 66 67 68
CHEMOTHERAPY OCT. 1994 Tazobactam Piperacillin Fig. I. Chemical structures of tazobactam and piperacillin. Table 1. Media used for preculture and MIC determination BHIB: Brain heart infusion broth (Difco),
) Meropenem Chemotherapy (Tokyo) ) panipenem/betamipron Chemotherapy (Tokyo) ) Meropenem Chemotherapy (Toky
2.7 2.7.5 1) 199846410-437 2) UTI ( )UTI ( 3 )Chemotherapy (Tokyo) 1986 34408-441 3) () 199745762-778 4) 1992 5) 199543 6) Chemotherapy (Tokyo) 199139687-689 7) Imipenem/Cilastatin sodium (MK-0787/MK-0791)
日本化学療法学会雑誌第57巻第6号
Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis S. pneumoniae S. pneumoniae β β H. influenzae S. pneumoniae H. influenzae M. catarrhalis Key words Otalgia Fever Item Crying,Iritation,
1.8.2 Page MIC () MIC 50 / MIC 90 µg/ml Candida albicans (54) / Candida glabrata (25) 0.25 / 0.5 Candida guilliermondii a) (2)
1.8.2 Page1 1.8.2 96% 2002 40 B 1 123 (1) in vitro 1) in vitro C. glabrata C. krusei 1 2 19951997 3 1999 2002 MIC MIC 2 1.8.2 Page2 1 19951997 MIC () MIC 50 / MIC 90 µg/ml Candida albicans (54) 0.016 /
CHEMOTHERAPY JUNE 1993 Table 1. Background of patients in pharmacokinetic study
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VOL.42 S-1 methicillin-susceptible Staphylococcus aureus (MSSA), Staphylococcus epidermidis, Enterococcus faecalis, Escherichia coli, Klebsiella pneum
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日本化学療法学会雑誌第51巻第2号
piperacillin piperacillin PIPC. g Cmax CL PIPC CL CLR CLNR CL PIPC g g Cmax PIPC Key words: piperacillin Piperacillin PIPC PIPC g g PIPC Cmax g g ml g g ml g g ml T T T PIPC g g T Ccr ml min AUCCmax PIPC
公開情報 2016 年 1 月 ~12 月年報 ( 全集計対象医療機関 ) 院内感染対策サーベイランス検査部門 Citrobacter koseri Proteus mirabilis Proteus vulgaris Serratia marcescens Pseudomonas aerugino
公開情報 2016 年 1 月 ~12 月年報 ( 全集計対象医療機関 ) 院内感染対策サーベイランス検査部門 検査部門におけるサーベイランスの概要と目的 本サーベイランスの目的は 細菌検査により検出される主要な細菌の分離頻度とその抗菌薬感受性を継続的に収集 解析し 医療機関における主要な細菌ならびに薬剤耐性菌の分離状況を明らかにすることである サーベイランスの対象となる主要菌ならびに薬剤耐性菌の分離率は
日本化学療法学会雑誌第53巻第S-1号
Doripenem in vitro Doripenem in vitro 7 7 3 DRPM in vitro DRPM 00 DRPM Staphylococcus Streptococcus µ gml MIC90 Moraxella catarrhalishaemophilus influenzae µ gml MIC90 imipenem IPM panipenem meropenemmepm
日本化学療法学会雑誌第65巻第3号
μ Key words Chlamydia trachomatis C. trachomatis I Table1.Observation items, categories and scores Observation item Category Score Body temperature () Lower abdominal pain Uterine corpus tenderness Condition
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19 10 16 0.5g 1g 1g 18 8 2 1 0.5g 1 1g 1 1g 1-6 C 18 H 16 N 8 N a2 O 7 S 3 3½H 2 O 661.60 (6R,7R)-7-[(Z)-2-( -4-)-2- ]-3-(6- -2- -5- -2,5--1,2,4- -3- )-8- -5--1- [4.2.0] -2--2-3½ Disodium(6R,7R)-7-[(Z)-2-(aminothiazol-4-yl)-2-methoxyiminoacetylamino]-3-(6-hyd
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Streptococcus pneumoniae Haemophilus influenzae S. pneumoniae H. influenzae Key words β Streptococcus pneumoniae Haemophilus influenzae S. pneumoniae H. influenzae μ μ S. pneumoniae H. influenzae S. pneumoniae
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2001 2002 Guidelines for the Prevention and Treatment of Infective Endocarditis (JCS 2003) h 1 1 2 3 4 5 6 7 8 9 2 1 2 3 1 2 3 4 1 2 5 1 2 1 G Streptococcus viridans Streptococcus bovis 2 G Streptococcus
Oct THE JAPANESE JOURNAL OF ANTIBIOTICS Pseudomonas aeruginosa 186 P. aeruginosa piperacillin PIPC, taz
Oct. 2016 THE JAPANESE JOURNAL OF ANTIBIOTICS 69 5 327 27 2013 2014 2016 7 5 2013 2014 Pseudomonas aeruginosa 186 P. aeruginosa piperacillin PIPC, tazobactam/piperacillin TAZ/PIPC, ceftazidime CAZ, cefepime
CHEMOTHERAPY JUNE 1987 Table1 Media used *BHIB, brain heart infusion broth (Difco); /3 -NAD, S -nicotinamidoadeninedinucleotide (Sigma Chemical Co.);
VOL.35 S-2 CHEMOTHERAPY Fig.1 Chemical structure of carumonam CHEMOTHERAPY JUNE 1987 Table1 Media used *BHIB, brain heart infusion broth (Difco); /3 -NAD, S -nicotinamidoadeninedinucleotide (Sigma Chemical
Fig.2. Sensitivity distribution of clinical isolates of S. epidermidis (24 strains, 106 CFU/ml) Staphylococcus aureus Staphylococcus epider- midis Ent
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VOL. 23 NO. 3 CHEMOTHERAPY 1067 Table 2 Sensitivity of gram positive cocci isolated from various diagnostic materials Table 3 Sensitivity of gram nega
1066 CHEMOTHERAPY MAR. 1975 Table 1 Sensitivity of standard strains VOL. 23 NO. 3 CHEMOTHERAPY 1067 Table 2 Sensitivity of gram positive cocci isolated from various diagnostic materials Table 3 Sensitivity
coccus aureus Corynebacterium sp, Haemophilus parainfluenzae Klebsiella pneumoniae Pseudornonas aeruginosa Pseudomonas sp., Xanthomonas maltophilia, F
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日本化学療法学会雑誌第57巻第S-2号
µ µ Key words µ µ µ I Table1. Subjectprofilesin(A)singleand(B)multiple-dosestudies (A)Single-dosestudy Age (yr) Height (cm) Bodyweight (kg) BMI (kg/m ) Ccr(Cockcroft) (ml/min) Ethnicity dose(mg) n 5 5.1±.,3
日本化学療法学会雑誌第56巻第1号
β β β β β Streptococcus pneumoniaehaemophilus influenzaemoraxella catarrhalismycoplasma pneumoniaechlamydia pneumoniae β Key wordsβ mys nilc laci ngis Table. Assessmentschedule Parameters Patientcharacteristics
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µ µ α µ µ µ µ µ µ β β α γ µ Enterococcus faecalis Escherichia coli Legionella pneumophila Pseudomonas aeruginosa Streptococcus viridans α β 正解表正解記号問題 No. 正解記号問題 No. e(4.5) 26 e 1 a(1.2) 27 a 2
日本化学療法学会雑誌第55巻第S-1号
µ µ Key words Streptococcus pneu- moniae S. pneumoniae µ µ I γ H H C HN F F O N O CO H H C SO H H O Fig.. ChemicalstructureofGRNX. γ γ II Haemophilus influenzae Pseudomonas aeruginosa Streptococcus intermedius
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Table 1. Antibacterial spectrum SBT ABPC ABPC CPZ : sulbactamiampicillin : ampicillin : cefoperazone
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