THERAPY

CHEMO

1036

An earlyphase

II studyof Urology,Gifu

University

on FK 037 in urinary

Yukimichi
Department

of Urology,School

infections

Tsukasa-machi,Gifu

500,Japan

Kumamotoof Medicine,Sapporo

Isao

tract

.1994

KawadaSchool of Medicine,40

YoshiakiDepartment

SEPT

Medical

University

Saito

Department of Urology,Tokyo

Kyosai Hospital

Nobuo Kawamura
Department of Urology,School of Medicine,Tokai

University

Sadao Kamidono
Department of Urology,Kobe University,School of Medicine
Hiroyuki Ohmori
Department of Urology,Okayama University,Medical

SchoolJoichi Kumazawa
Department of Urology,Faculty of Medicine,Kyushu University(Received

The clinicalpatients
subjects

efficacyMay

10,1994•EAcceptedand safetywith urinary
consistedofof FK 037,atract infections(UTI)were
inpatients,aged
15 tounderlying
urinarytract
diseasesandintravenously
infused at doses of 0.5,1.0
morning and evening),for
criteria
proposedby theinclusion

June

criteria,the

15,1994)

new parenteralcephempreliminarily
79 years,with

antibiotic,inevaluated.The
complicated
UTI,

no indwelling
catheter.The
and 2.0 g(potency),twice

drug
daily(in5 to 9 days.Clinicalefficacy was evaluatedusingJapaneseUTI Committee.Of
32 patients
who metoverallclinicalefficacyof

FK 037was"excellent"in

was
the
the
the
15

patients,"moderate"in
15 and"poor"in2,anefficacy rate of 93.8%.Only
1patient
showed a clinicaladverse reaction(rash),and
only 1 patient
showed alaboratory
adverse reaction(mildincrease in GPT).These
results showed that FK
037 provided

a goodclinicaleffect,reflecting

its activity

againstgram-positiveand gram-negative
organisms,andthat the drug
significant problems concerning
safety.This
drug,therefore,could
treatmentof UTI.
Key

words:FK

037,urinarytract

infections,early

INTRODUCTION
FK 037 is a novel
developed

by Fujisawa

Its chemicalThisparenteraldrug

structure

cephemPharmaceuticalis illustrated

is a broad-spectrum

phase

is active
negative

Co.,Ltd.

and Pseudomonasin Fig.1.

ventional
that

range

of

II study

antibiotic

antibiotic

a widemight present no
be useful for theagainst both gram-positiveand grambacteria,including
Staphylococcus spp.
aeruginosa,againstparenteralthird-generationarecephemlesswhich con-antibiotics

active1,2).Inof theaddition,VOL.42NO.9

An earlyphase

II study

on FK 037 in UTI

1037

evaluating

subjects,theshouldalsobediseasedifferent between patients
indwelling catheter.Patients
Fig.1.Chemical

structure

FK 037 is characterizedagainstmethicillin-resistantactivity

Staphylococcus

aureus(MRSA)3).FK037 showed a preventive
effect invariousanimalmodels of infection,reflecting
its in vitro antibacterial
activity3,4).The
results
described

above werereportedon Antimicrobial

Chemotherapy5〜13).

Variousof thedrug

in animals

might

give

rise

to

I

trial

Agentstoxicologicalshowedsignificant

nofindings

thatin clini-

cal trial14).

A phaseof FK 037 was

conducted

inhealthy male adults between June and November
1990.The
results showed that FK 037 follows
linear pharmacokinetics
via the kidney afterand has a half-life
recoveryrateinwith extensive elimination
intravenous
drip infusion,in bloodof 2.3 hours and a
95.0%15). The results
and tolerance led to the

urine

of

of its pharmacokinetics

suggestion that FK037 may be useful fortreatment of urinary tract infections(UTI).We

the

have organizeda multi-center
study group andconducted an early phase II trial in complicated
UTI.Wereporthere the results

SUBJECTS

1.Subjects
From patients
underlyingANDurinary

one of 12 participating
July 1991 and79 years were

this study.All
the patients
included instudy gave informed consent to participate.
2.Dosesand Administration
The purpose of this study was to roughlyof the trial.

timatesafetyofthecomplicated

tract

drug

was

0.5,1.0

and

2.0g

To

cephemstudy

antibiotics.

carefully,inproceedwiththeprinciple

the dose in the first

patient in each center was
there was no problem,the

set at 0.5 g,and
ifdose in the second

patient was set
third patient.FK

at 1.0 g and then 2.0 g in the
037 was dissolved in 100 mlof physiologicalsaline solution and intravenously
infused for 1 hour twice a day(inthe morning

who

visitedthebetween

viewpoint of safety,older
patients,who
have ahigher risk of impaired renal function,were
ex-

at

nal

in Japan

15 to
the

set

activity against varicause UTI,and
themethod of conventio-asJune 1992,inpatients
aged
included in this study.From

es-studies of its antibacterial
ous bacteria
which candosages and administrationwithdiseasescenters

UTI

this(potency)basedon the pharmacokinetic
andtolerancedata
obtainedfromthe phaseI
trials,theresults of preclinical studies,including

and

METHODSfromthe correlation
betweenthe dose andof FK 037 in clinical practice.The
dose

evening).The

at 5 to 7 days
withwith and without anwith an indwellingtion and replaced bacteriuria16)Thus,patientswith an indwelling catheter were excluded

andstudies

problems

isusually lower and catheters can present problemsof biofilm,highincidence of polymicrobial
infec-

at the 31 st Inter-science Conference

studiedstatuscatheterareregardedas inappropriate
forevaluationof efficacy since the efficacy rate isof FK 037.

by its moderate

profilesrestricted.Disease

vials

periodof treatment

as a rule.FK
0.5

containingor

was set037 was supplied
1.09(potency)ofdrug.
3.Identification

Determination
Bacteria

ofUrinary

isolatedfrom

Isolatesandof MICwereby the dip slide method(using

urine

cluded from this trial.

24 hours of incubation,bacteria
at each center.Immediately
after

Since early phase II trials are aimed at preliminary evaluationof the safety,efficacy
anddip slides with bacterial
Developmental
Research

pharmacokinetics
of new drugs and should be
performed
with carefulattention
to each patient,welimited the numberof subjects.In

Pharmaceuticalwere counted
counting,thespecimens were sent toLaboratories,Fujisawa

Co.,Ltd.,for

MIC determination.The
determinedaccordingspecimens

Uricult(R)). After

MIC
to theidentification

andof FK 037 wasstandard
agar

CHEMOTHERAPY

1038

dilution method designated by the Japan Societyof Chemotherapy17).The
MIC of methicillin(DMPPC) was also determined for Stapylococcus
spp.
4.Evaluationof Clinical

Efficacy

Urinalysis
and urine culture
before and after treatment.The

were performed
overall clinicalefficacy

responseandbacteriological

were

SEPT.

1994

final closings,Plasma
and urine were collected
and sent to Developmental Research Laboratories,Fujisawa
Pharmaceutical
Co.,Ltd,todetermine
drug concentrationby the discmethod using Bacillus subtilis ATCC 6633 as theassay organism.Standard
curves for blood andurinary concentrations were obtained in human
1/15M phosphate-bufferedplasma,serum
orevaluatedaccordingto the Criteria
for Evaluation of Clinical Efficacy of Antimicrobial
Agentssolution(pHon

1.Numberof Evaluable Patients
Of 40 patients given FK 037,32 were available
for evaluation of clinical efficacy.Eight patientswere excluded from the analysis of clinicalefficacy:2 had bacterial counts of less than 104
cfu/ml before treatment,2
had ineligible disease(prostatitis and acute uncomplicated cystitis),2
violated the age requirement of less than 80

UTI(thethird

edition)proposed

by

RESULTStheJapaneseUTI Committee(theUTI criteria)18).
Apart from evaluation according to the criteria,
clinical efficacy was assessed by each attending
physicianand"excellent"orherclassified"good",

criteria

ed fromthecompletecases.

safety.If

orabnormaltheircausal
the

the

were

exclud-efficacy

as

in-

from

the

of

Safetyincludingthoseclinicalefficacy

excludedaccompanyingofanalyzedandfindings
tothephysician
one

were

symptoms

laboratory
relation

into

were

drug

was

according

with

with
and

clinicalorlaboratory

6.Evaluation
Clinical
physicianonthesafety.The

basis

was

visualanalogue

as

ng

"very

unsatisfactory"

UTI

follows:a"definite",definedas thosereactions.

by

the

attendingclinicalefficacy

evaluation

of

and

clinical

mark

was

made

on

of

10-cm

in length

rangi-

satisfactory"at

one endto "veryscale

at the1 shows(21.9%)

Value

of
of

as

Characteristics

of 32 patients
efficacy.Therenot".

evaluated

method

value

from

was

Table

noted,
classified

to theadverseof Clinicalvalue

2.Background5 grades:"definite","pro-eventsclassified"possible",were

years,and
2 had an indwelling catheter.Safety
was evaluated in all of the patients treatedwith FK 037. Clinical value was assessed in allof the 32 patients who were evaluated for clinical efficacy according to the UTI criteria.

signsbable","possible","unlikely"and"definitely
Patients"probable"

in-of clinicalattendingcriteria

hisviolatedin advance

of

for

"poor",atwhodefinedpatients

evaluationof 4 grades,

evaluation

5.Evaluation
All

one

,"fair",anddiscretion.Patientsclusion

by

into

7.0).

women.In

the

aged

patients,

atb.i.d.,1.0g

b.i.d.,

respectively,throughout

the

0.5g

60 or

received

the

1.0g

b.i.d.

The

drug

were

cated

pyelonephritis

catedcystitis

in 22

then
most

patients,

93.8%).

diagnosed

as

in 10

(31.3%)。

(68.8%).
to46.9%)

immediately
drip

infusion,after

the completionin principle,atorganisms
coli

of intravenous

isolatedthefaecalis(5initialandwascompli-patients

waspredominant.Mononii-

The

shows

and

When
UTI

infection

2

follows:compli-

thepolymicrobial

Escherichia

pati-

treatmentthanin urinepatients

b.i.d.,

2.0g

of(23,71.9%)

urinary concentration
and recovery rateof FK 037 were determinedin someandstudy.Two

periodinfection

blood)concentration,

the drugb.i.d.andcrobialplasma(or8 received

2.0g

7.Pharmacokinetics
peak

age,

at

accordingpatients,by23 (71.9%).

numbered

9 andused was 5 days(30patients

classified

older
13,

ents

commonly

characteristics

distribution

Of these4(15other.

backgroundpatients

The
a

the

who were evaluable
for clinicalwere 25(78.1%)men
and 7

was

more

frequent(9,28.1%).

Table

isolated

beforethecommonmost(9 strains ,21.4%),
strains,11.9%).The

were

criteria,Group

followed

treatment.
organism

by Enterococcus

MIC distribu-

VOL.42

Table

NO.9

2.OrganismsAnisolated

early

phase

Table

1.Backgroundbeforetreatment

II study

on1039

FK 037 in UTI

characteristicsof the patients

tion

is

shown

in

Table

o f 90%thegrowththeevaluable

3.Theof thepatients

drugstrains

inhibitedisolated

at a concentration

from
of

100

μg/ml.

3.Clinical

Efficacy

1)Overall
Evaluation

Clinical Efficacy
of clinical efficacy

cording to the UTI criteria"moderate" and "poor" in 15
vely,ofof 93.8%.

32 evaluableThe

efficacyof FK 037 ac-

was"excellent",15

and 2,respecti-

patients,an
rate

by

efficacy
the

type

rate
of

i

fection was 1/1 in Group 2,6/7
in Group 3,
15/15(100%)in
Group 4 and 8/9 in Group 6(Table 4).The efficacy rate by dosage was 12/
13 (92.3%),8/9
and 8/8 at dosages of 0.5g
b.i.d.,1.0 g b.i.d. and 2.0g b.i.d.,respectively,
indicating that the efficacy rate was high foreach of the dosages used(Table 5).
Table 6 shows the relationship between theeffects on pyuria and bacteriuria, which weretaken as parameters
for evaluating overallclinical efficacy. Pyuria was cleared in 16 patients(50.0%),a)

GPC:Gram-positiveb)

GNR:Gram-negative

cocci
rods

and

bacteriuria

waseliminatedin28

Tablea)

SEPT.

CHEMOTHERAPY1040

ND:not3.Sensitivityof clinical isolates

done

Table

のExcellent+moderate/no.

4.Overalla)

5. Overall

Excellent+moderate/no.

b)

2.0

clinical efficacy related to type of infectionof patientsTablepatients

distribution

1994

clinical efficacy accordingt

daily doseof patientsg•~2•¨1.0g•~2(87.5%)

2)Clinical
Efficacy as Assessed by Attending
PhysicianTable 7 shows clinical efficacy as assessed by
the attending physician:it was"excellent"in17,"good"in 12,"fair"in
1 and"poor"in
2 of 32
evaluable patients.The
efficacy rate was 90.6%,
almost the same as that evaluated by the UTI
criteria.The
efficacy rates by diagnosis were 9/
10 (90.0%)and
20/22(90.9%)in
patients withcomplicated pyelonephritis and complicated cystitis,
respectively.
3)Bacteriological
Response

Of 42 bacterial isolates,41(97.6%)
were eradicated with FK 037,and
only 1 strain of P.
aeruginosa(MIC:25,ug/ml)persisted,indicatingthat a high eradication rate was obtained with
FK 037(Table 8).Bacteria
occurring newly inthe urine after treatment were 4 strains in 4 ofthe 32 patients evaluated for clinical efficacy:
two strains of Enterococcus faecium,one strainof P.aeruginosaand one strain of Canada
albicans(Table 9).The MICs for the P.aeruginox
strain and two E.faecium strains were 50,400
and>400μg/ml,

4.Safety

respectively.

VOL.42

NO.9

An

a)

phase

Table

6.Effects

Excellent+moderate/no.of
Table

a)

early

on pyuria

and bacteriuria

efficacy

as assessedby attending

evaluatedfor safety,only
years of age,complicatedcystitis),who
showed anwasadversegiven FK 037 0.5 g b.i.d.,reaction
considered
to beattributable

to administrationof the drug,withtherelation"

possible".Thedeveloped justthe drug.Since
after

the

pletedeffects.

without

Of the 40 patients,only

administrationof the drug.It(22→48),in GPTandobtained

13

monthsof

14,within

the

were

no

abnormalotherlaboratoryrashinfusion,treatment

classified

the

value

evaluatedattention,andcom-

physician

in

side

of no clinical

any

other

5.Clinical1(2.5%,male,63

was

given 0.5 g b.i.d.,showeda laboratory
adversereaction
which was suspected
to be related todataa mildresultingcystitis),who

which

was

drip

age,complicateddrip infusion ofand disappeared

reaction

careful

of

was

drug

with

years

drug

the

intravenous

was continued

physicianastoafter intravenous
it was mild

1041

patients

Of the 40 patients1(2.5%,male,70

causalon FK 037 in UTI

patients

7.ClinicalExcellent+moderate/no.of

II study

Tableassessedwascausalan increase

relationas"possible".The
later

showednormalchangesinto thefollow-up
a GPT

range.There
GOT,Al-P

or

test

values.The

attending

that

this

event

was

evaluatedbyabnormalsignificance.
Value

10 shows

clinical

value

as

SEP7.1994

CHEMOTHERAPY

1042

Table 8.Bacteriologicala)Regardlessb)of bacterial

count

GPC: Gram-positive

cocci

GNR: Gram-negative

rods

c)

response to treatment

Table
Table

9.Strainsa)

appearingafter

10.Clinicalvaluetreatment(Cumulative percentage%)

a)

the

Regardlessof bacterial

attendingcountphysicianon the basis

efficacy and safety.Except
had a low score because
all patients

had scoresof clinicalfor the patient whoof an adverse reaction,of 60 or higher.

6.Pharmacokinetics
The

FK 037 concentration

was monitored
Measurements(1 hour after the
drug concentration
initial dosing,andstart of infusion),when
theis assumed to peak,onthetreatment
day 4 or the final

dosing(treatment

day 5).Thein plasma(orblood)are givenin Table 11.One
patient(patientno.1),who
was given 0.5g b.i.d.,had
blood concentrationsof

20.4μg/ml

after

both

dosings.Another

patient

1.0g

plasmab.i.d.,had

μg/ml

in 3 patients studied in this trial.
were done at the end of infusion

resultsand91.0μg/ml

theinitial(patient

concentrations
after

the

and

final

no.2),given
initialof 65.3
dosingand after dosing on treatment

day 4,respectivelY.

Theno.3),who

othergiven1.0g

patient(patientb.i.d.,had92.7 μg/ml

and

was
62.9μg/VOL.42NO.9

An

early

Table

Concentrationa)b)Conc.:c)Bloodjust after intravenous

theconcentrationin

no.1ontreatment

patient

sion.The
after

the

and

urinaryon1043

FK 037 in UTI

concentrationof FK 037

drip infusion

concentration

ly.Drug

1,240μg/ml

11.Plasma

II study

concentrationml,after

in

phase

initialat

final

0-2 hours

urinarystart

andrecoveryof infusion

closings,respective-

urine

after

was
day

2,and

the

start

rate
was

withinas

notedmonitored

high

of

only

2 patients

1.0g

was

patients

treatedinfu-

obtainedat

12 hours
asinb.i.d.and

100%.

equal
in

to or higher

than

were

2.0g b.i.d.,respectively]."Poor"response

includingtreated

0.5g

with

those

0.5g

in clinicalpractice.Phase

be

as

high

the

urinarysuggests

be sufficientlyI

drip

suggestof

FK 037

after

of

0.25g

could

infusionthat

1,000μg/ml.Consideringabout

concentration

activity
againstof complicatedthateffective

trialsconcentration

as

who

available

antibiotics.This

urinary
intravenous

cathetercurrently

b.i.d.may

rates(76.3‑96.2%)20〜25)

othercephem60-minefficacy

theof FK 037 were

indwelling

FK 037 at

peak

given
all

dosages

without

parenteral

the

were

FK 037.The

three

DISCUSSION
1.Clinical
Efficacy
The efficacy of antibacterial
agents againstcomplicated UTI can be evaluated objectively
using the UTI criteria by observing the courseof pyuria and bacteriuria.The
main purpose ofthis early phase II trial was to evaluate preliminarily the safety,efficacy
and pharmacokinetics
of FK 037 in patients.A
rough estimate of theclinical dosage of the drug in an early phase II
trial can lead to finding the optimal dosage ofthe drug in the next phase19).Since we believethat objective criteria should be used to estimate the clinically recommended dosage,we
will discuss it mainly based on the results obtained accoraing to the UTI criteria,whichwere not influenced by the attending physician's
subjectivity.
The overall clinical efficacy rate in this study
was 93.8%[92.3%,88.9%(8/9)and100%(8/8)
in patients given 0.5g b.i.d.,1.0g
b.i.d.and
was

with

these

patients

who

b.i.d.,respectively,of

and

its

antibacterial

the major causative
organisms
UTI,FK
037,at0.25g b.i.d.,

could provide sufficient clinical effect.
The bacteriologicalresponseof FK 037 wasshown

to be so good

eradicate

only 1 strainof P.aeruginosa(MIC:25

The

of

μg/ml).

that

MICs

strains

isolated

rangedfrom≦0.025

hibited

the

urine
to

concentrationof

25μg/ml.

aureus,theMICs

1 MRSA(MICtobacterial
treatment

The

drug

in-

of

the

strainsataOf

3 isolates

of

S.

DMPPC

and

failedfor

before400μg/ml.

80%

of

of

drug

FK 037fromgrowthwere>400,6.25

the

1.56μg/ml,

for

these

strains

respectively,of DMPPC:≧12.5μg/ml).The

MICs of FK 037 for these strains

12.5,3.13

and

they

were

This

suggestswere

0.78μg/ml,respectively,andcompletely

with

FK 037 could

FK 037.
forthe treatmentof MRSA
infections,althoughmore cases should be investigated.Althoughallthe strains

thateradicatedbe usefulof Enterococcus

spp.were

eradicated,

the MIC of FK 037 for Enterococcus
μg/ml

in

1

strain,100μg/ml

400μg/ml

in2

spp.wasin

2

25

strains

and

that

the

strains,indicating

antibacterial
activityof FK 037 was not
sufficient against Enterococcus spp.
Two strains of E.faecium,oneof P.aeruginosaand one of C.albicans appeared newly in theurine after treatment,andthe MIC of FK 037
could be determined in the two strains of E.
faecfum(>400and

400μg/ml)and

P.aeruginosa(50μg/ml),These1
MIC

strain2patients

who

showedvaluesone

withdiabetes,who

had

been

operatedon

within1 monthhyperplasia
ment

and

had

"poor"

was

were

beforepolymicrobial

nosa(MIC:25μg/ml)and

0.5 g b.i.d.,benignprostatic

FK 037 treat-

infection.P.aerugiEnterococcus

ccus sp.was
eradicatednosa remainedat aPyuria(3+)ofa bacterialEnteroco-with FK 037,P.aerugibacterial
count of 103.

this patient remained

poor"

after

2.Safety
Of all the patients
showedunchanged

count

106),

treatment

by

count

104).

E.faecium(MIC:400μg/ml,bacterial
Pyuriaremained

thus

was

with

FK 037,theassessedunchanged(++

as
renal

to

"poor".Aftercalculiwere

wasconsidered

beof diabetes

and1 patient

reaction(rash).Theby

to be almost

normalrange,and
to presentany

3.Pharmacokinetics
Thepeak bloodinat the upper limit

the drug did notproblems
concerning

concentrations

after drip intravenous
this study were similar
andinfusionto those

60.0μg/ml

atof

FK 037determinedinin the phase I
doses

of

0.5

1.0 g,respectively).The

urinary

andthisrecoveryrate of thestudy were favorable

drug determined
and also similar

those

in the phaseat 0-2hours

1,350μg/ml

andnormal renal
to 62 years)

singleintoconcentration

dosingof 0.5 g was

24‑hourrecovery

rate

was

included

in

study

had

this

functionand their age(range59
was higher than that of healthy

includedin the phase

49 years,average
40.8 years
range 27-49
years,averagegroup).

However,theFK 037 weresimilarhealthy

andconcentration

I trial(urinary

after

94.8%).Patientsoftreatment

reaction
was noted
in GPT).However,it

safety.

1.0 g+),andremovedbealso

FK 037,only

adverseA laboratory
adverseonly 1 patient(increaseadultsduring

could

could

becausegiven

a clinicalE.faecalis(MIC:100μg/ml,bacterial

replaced

and

case

consideredintractablebilateral renal calculi.

trial15)(31.9

wasdiabetes

treatment.This

on treatment,andthus was assessed as "poor".
Subsequently,thepatient was treated with
tosufloxacin(450 mg/day),but
the response wasalso poor.
The other patient,who
was given 1.0 g b.i.
d.,hada past history of cerebral thrombosisand had bilateral renal calculi and diabetes.
The patient was given an oral antibiotic inanother hospital before treatment,but
did not
respond adequately.The
causative organism was
which

had

response

considered intractable,inthe former case,thebacteriological effect of FK 037 suggests that
this drug is not sufficiently effective against P.
aeruginosa at a dose of 0.5 g b.i.d. In the latter
case,inspite of eradication of E. faecalis,E.
faecium appeared and pyuria was not changedof theappearsp.(MICnot determined)
were isolated withcount of 10 before treatment.Although"rash developed just after the initial dosing.The
rash was mild and the treatment
was continued.

response,

given

for

extracorporeal
shock wave lithotripsy,andsultamicillin(1,125 mg/day) was given.However,this case was intractable and pyuria was notcleared.
Although both of the patients who showed

of

high.
Of

SEPT.1994

CHEMOTHERAPY

1044

adults,suggesting

I trial(range

30-

in the 0.5 g group;
37.7 years in thepharmacokinetics

in thesethatpatients

andthe pharmacokine-

VOL.42NO.9

An

early

phase II

study

tics of the drug do not vary with the age range
studied.
In conclusion,FK

037,asresponse

withoutanysignificant

problems

3)Mine, Y, et al.: Excellent activity of FK 037,
a novel parenteral broad-spectrum cephalosporin,
against methicillin-resistant
staphylococci.
Jblood)andurinary concentrain patientswere similar tothoseadultsasdetermined

Antibiot

4)ofsafety.Plasma(ortions of the drugin healthy

FK 037 in UTI

given at three different

dosages in this trial,was
shown to provide ahigh efficacy rate and favorable
bacteriologicalto late phase II dose-finding
ACKNOWLEDGEMENTin the

The authors
are deeply indebted
following participating
investigators.
Department
SapporoAkifumiof

Urology,School

toofMedical
University:
Yokoo,Department

6)

trials.
all

the

Medicine

Takaoki
Hirose,of Urology,Tok-yo Kyosai Hospital: Yasushi Saiko,Department
of Urology,Schoolof Medicine,Tokai
University: Toshiya
Ishida,Department
Tokai University
Oiso Hospital:of Urology,
Keishi Okada,

Department
of Urology,Gifu
Universityof Medicine: Yoshihi to Ban,Yasuhisa

SchoolItoh,

Department of Urology,Kobe
University,Schoolof Medicine: Soichi Arakawa,Shigenori
Miyazaki,Departmentof
Hospital: Nobuo
Department
Kakogawa
ment

Akaeda,Department
Koseinenkin
Hospital:
Yagi,Department
Hospital: Kenji

Urology,Hiroshima

Atomic-Bomb

Municipal
Maruyama,of Urology,Hyogo
Prefectural
Hospital: Hideo
Ohshima,Depart-of Urology,Tsuyama

Teruaki
KyushuHiroo
Rosai

Urology,Nishiwaki
Kataoka,Satoshi

Hospital:ofTetsuoUrology,
Omoto,of Urology,Kyushu
Itoh,Department
Red

Survivors

CentralCrossof

Hospital

Hospital: Hiroshi&

Hirata,Noriyoshi
1)

Miyazaki,Misao
Sakumoto.
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1047

037の 泌尿 器 科 領域 感 染 症 に対 す る前 期 第II相 試験 成 績
河

田 幸

道

岐阜大学医学部泌尿器科学教室.

熊

本

悦

明

札幌医科大学医学部泌尿器科学教室

斎

藤

功

東京共済病院泌尿器科

河

村

信

夫

東海大学医学部泌尿器科学教室

守 殿

貞

夫

神戸大学医学部泌尿器科学教室

大

森

弘

之

岡山大学医学部泌尿器科学教室
能

澤

津

一

九州大学医学部泌尿器科学教室:執 筆 者

新 しい注 射 用セ フ ェム剤FK 037の 泌尿 器科 領域感 染症 に対 する臨床効 果 と安全性 を予 備的に検 討 した。 対 象 は尿路 に基 礎疾 患 を有 す るカ テー テル非 留置 の複雑 性尿 路感 染症 で,15歳
以 上80歳 未 満 の入院 患者 とした。用法 ・用 量 は1回0.5g(力価),1.0g(力価)ま たは2.0g(力 価)を 朝 ・夕 の1日2回,5〜9日
間点 滴 静注 し,UTI薬 効 評価 基準 に従 い臨床効 果 を
判 定 した。UTI薬 効評 価 基準 に合致 した32例 にお け る臨床 効果 は著効15例,有 効15例,無効2例 で有効 率 は93.8%で あ った。 副作 用 は1例 に発疹 が み られ,臨 床検査 値 の異常変動 は1
例 に軽度 のGPT上昇 が認 め られ たのみ であ った。以上 の成績 か ら,本 剤 はグ ラム 陽性菌 か ら
グラム陰性 菌 まで幅 広 い抗菌 スペ ク トル を有 してお り,こ れ を反映 して臨床 試験 にお いて も優れ た効 果 を示 し,安 全性 も特 に問題 が ない こ とか ら,泌 尿器科領 域感 染症 に対 して有用性 が期待 され る薬 剤 であ る と考 え られ る。
*

岐阜市司町50