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EFFICACY OF A LATEX FOLEY CATHETER WITH

SUSTAINED RELEASE OF CHLORHEXIDINE 1ST REPORT

CLINICAL TRIALS FOR PREVENTION OF URINARY TRACT INFECTION

Hiroshi NAKANO ShOllZOU SEKO

Tooru SU~III and Hiromi NIHIRA

From the Department of Urology llir05hima UniV(f5ity School of Medicine

(Dimtor Prof H Nihria)

Motohiro FUJII and KATSUHlKO OKADA

From the Urological Clinic llir05hima General i105pital

(Chief Dr M Fujii)

Taiji KITAKO

From the Urological Clinic Futami Cmtral i105pital

(Chicj Dr T Aiano)

r-1itsuo KODA~IA Yoshio OHNlsm and Takuya OKUTAJI

From he Urological Clinic OJlomichi Cmeral llo5pial

(Chicj Dr M Kodama)

Seventy five patients requiring urethral catherization for over 21 hours ere treated with

a latex Foley catheter with sustained release of chlorhexidine in a closed drainage system

While the catheter was indwell urinary concentrations of chlorhexidine were maintained

at the level of I to 2flgml in average in almost al patients

The catheter WaS highly effective in preventing the acquisition of catheter-associated bacshy

teriuria in patients with initially sterile urine without systemic antimicrobial therapy The

aquisition rate of bacteriuria was 8 16 23 35 and 74 on day 3 4 5 5 and 7 with the

I 5G8

catheter indwell respeetivel)

The catheter was not elTcetive in eradicating precxisting bacteriuria Cornplieltions of the catheter were minimal

Key words Inling catheter Prevention of urinary trael infection Closed drainage Catheter with sustained release of ehlorhcxidinc

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Supplied by The British Library - The worlds knowledge

11

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~~~~fpoundlW~

Mtlirr~ht-

~ Bacillus sublilis ATCC 6633 ~~5Eiii c L ~ Dx xlOOFx Bx+Dx~ffigr~rJ rG Rij2jUJ l~ r tdliIiiH~(f~liLljlfQ) ~ ~ J ~RIIJ

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correction) -crrts t- E 6~ -CJ t- (l1JtiiJilJFJamp1J1lfQ) 15 ilj-CQ)~n

[1I 1 ~ U1( It 3 B 9 10-CSt-iWItItWjlill iiJillltO 02 I 7J T - 7 Iv i11lI1lllijlft J V~ Q)1~ JiHBshy h ~miUl1iIHIiiRfJJ~middot50(1Up-C mimtlJnn9=ltuJ

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~ -e 11 CS t-rnQ)~mH9lti~Wz5H69A (92) rJ3HGA tjf1 Q) rp-c IIC 10 pgml ~jf Lt- 3 ttQ)

mLt- tgtt (8) -Ctnt- h ~Q)lliljQ) brlmf~lti S marcesctnS ~ Q) I tt~~ ~ (llt~iM~tr~t1i

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Q) Utljmiddot ~ li1~ wrr~ttt-~1UIHj70~ ~lIJt- ~Q)IQ)liE1J Wfillit S marasctns Af morgan ii PsrurJOnlomas III It1rnmViHHilamp Xi~P~lli~Q)lJHRi1Jill ~ Q ~ ts cQ) 7 A~Jl1tj1WIJ~ lt 7 Amttfii-Clt S

T-TlvlXltn ItfLI1JVJJ1iQ)tlttiHIHtts ~ Q) [] (j~-CJIRmmll~~J faualis IJ~~ itlQ) MIC It-FIJ 2 5~10

lElt Wfilj t~V)-Cht- pgml Q)un-CSt- 2filiJ)JQ)Wfliltimm IU L ~r~H 2 LRViP$mWLlWJ ~U~lt 2 lU (E (oli C freulllii S marmwlS C

lJ El ljl(iIJI Table I ElTeet or SR-C catheter on aquisition or bacteriuria after indwelling

1) U tHi)l catheterization in 50 aoaeteriuric patients

f- 1 J vW-Jif Syetemic lIo of ratients jWQ)[iij~1J anti~icrobial Total Abacteriuria Acquired bacteriuria Protection

prophylaxis (Duration of catheter Days) (Duration of catheter Days) (W I t~1~

lIo 35 25 10 711t V 7J Iv ( 42 plusmn 28) (90t27)

itJeQ) 1 bull pltOOOl I pltOl

t I) fijffJQ)(ilJ Yes 15 14 1 93J ( 35 plusmn 25 ) ( 3 )

Total 50 39 11 7fJ 3727) ( 85 t 31

Iln-r

WWW J 105CFUml Ifedian t 1 SO

-~_~-shy

Table 2 Risk of development of bacteriuria after indwelling catheterization of SR-C catheter in 35 abacteriuric patients without systemic antimicrobill prophylaxis

Duration of catheter Days A B C o

1 35 35 0 0 o 0 2 29 29 0 0 o 0 3 26 24 2 2 57 77 4 25 21 2 4 114 160 5 22 17 1 5 143227 6 17 11 1 6 171 353 7 14 5 3 9 257643 B 10 3 0 9 257 750 9 6 2 1 10 2B6 B33

10 4 1 0 10 286 909 11 3 1 0 10 286909 12 3 1 0 10 286 909 13 1 0 0 10 286 100 14 1 0 0 10 286 100 15 1 0 0 10 286 100

1) ER 3~ X 100 2 F=B poundD x 100 Abbrevtation used

A Cumulativemiddotllo of patients with indwelling catheterization of SR-C cHh=ter B No of patients ~Iith abacteriuria C No of patients with acquired bacteriuria 0 Cumulative No of patients infected F CU-ulative percent infected

Table 3 Microorganisms isolated from acquired bacteriuria in II patients after indwelling catheterization of SR-C catheter and their MIC against chlorhexidinc dihydrochrolidc

Microorganism MICmiddot 1

016 031 063 125

S marecscens 11 morganH 1 acruginoBa Pseudomonas sp E coli C freundii

S focealis S epidermidis 1

Totol () 1(8) 1(8) -MIC of the firat-isolated otrain of the

M morganii) -C[Zh Iht- L-n VJIlllrjl fijX(~

mftHt I ffl]t7lhtJn-f-

3 Wii1fiiHllIWLRWtj-lM-t Mbl~ u~8

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MK~Wmm~~L-~WttM~~~ reg~I~

ItuJXi~t-hUt- ~ I) ~61a~~fttt-ctbt- -hshy

I ~Wtjmiddotil Ifj Iht- Wrnjjtr~Rrp7t~~EliH~31 tj~W

fflc bull f~lliMl PJv 4- V~ Itt-t 7gt ~IIC ~

Table 4 lff--t 21f[j)J~Iij J 7gt amp~secti~il

9 OiJ (45) 17 Ittbull f~ b 5 lIHt S faecalis

~illi1U L--C~middot7gttJcmiddot0t-~ S faltais ~~h7gt

mmil 30 ~ kU t- r 7 t ~2il1ftUi-c It Pseudoshy

monas~ bull p-C P aeruginosa n~~ C~(tla

)Igml 25 5 10 25 50 100~

Total( )

2 1

3

I

1 4 2 1

1 1 1

( 30) ( 15) ( 0) ( B) ( B) ( B)

2 2 1

(15) ( 8)

5(38) 4(30) 1(8) 1(8) 13 000) same species of the orgonicmo in a patient

E coli A aniralus K mrumoniae H morganii t~

cmiddot-ct7gt h-I~ ~IIC 7JHt 25pgml 11shy

7~1j-t7gtilbull 7t2itUfipoundj-Clt 5~IOpgml ~

t ~il19tkI 5 tk (3G) ~lht- it 120fItJrp-Cru

1llltf~f)l1iilf+71-C5 t I lIJ c sectpound(j9IitWillJ~

OrJlJilfjtdnt- 27oJ~FiH-17~J~rjIWrnf(~~

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lt IHMlUmU- cnl~lIartlLiif1icf~Jtmil

Jv ~middotmiddotV~ 1M-t7gt ~IIC ~ Table 5 Iff--t

~ltfJ~ E coi S faccalis ~~ I tjltfitfitW3lt


ter n5t

( 30) ( 15) ( lJ) ( 8) ( 8) ( 8)

( 15) ( 8)

Cloo) Itient

morganii ts gml I lshy

middot10 pgml Q)

G20[lIJrlt11

tf~)btWjl(7)

pljJ[ij~Q)a

Itt -C t itchtcgt11 flCft177ltlI 9 IIJIW1ltplZi L

tQ)llilQp

) ff-i

571

S faecalis 2 8 10 (32) S cpidclliIidic 1 1 ( 3) Candida 1 1 ( 3)

Totnl(r) 5(16) 4(13)16(51) 2(7) 2(7) 1(3) 1(3) 31 (100) I

lIot cono i

Table 5 New microorganisms isolnted from preexisting bacteriuria in lJ patients after indwelling catheterizntion of SR-C cntheter and their MIC against chlorhexidinc dihydrochloride

Microorganism MIe nm1 Total ( r ) 125 25 5 10

P aCrllglnooa 2 1 3 ( 28) C frewidii 2 2 ( 18) E coli 2 ( 9) 11 morganU 1 ( 9) E acrogcnca 1 1 ( 9) S mnrCCGCClS 1 1 ( 9)

S faccalilJ 2 2 (18) Total (r) 3(28) 5(46) 3(28) 11 (IOO) -HIC of the first-isolatod of the same species of the organisms in a patient

ftJlq~2tiJ Lt1iEfYlhJ t 7trL~ Itt t (7)lt ~(7) 063 pgml IJ 5 flampt11 50 pgml ltto t

MQ)R~~-cmm~mlt~~ Wffi~mamp~l~ 4 ~~I1I-C

afTuginosa C freundii t c lpu c Lt f 7 A ~2i11 $J 7 - T Iv (7)11Jilltff Ji]lf-ml -C11~jE(Ytl

ftWIJ~ lth~lO I1llifJiilJtt1-Jgt c f 7 lml1W l)(JZc L-C J 7-7Ivli7i ~liRilll~4~ 71Iv

Q)tJim11~middottn it Candida (7)rrt t~l~ L yen - Birc t0) jJi1J~jiEWc ct -C$Qiflt lt~m

ftJ t h Gmtl UHll L tWPJ(7) p Iv ~ ~ Lt SR-C J7middot-7 Iv lJIYJlJmiddotLtUHgthJgtftOHpound

1Mi ~ ~lIC (7)7(IH1 25 pgml I l - 2 ItUlJlf t (7) t ~~-C 13(JlJlK~1O t --tdgttcgtWillfl(j fj L f 7lo ~Sl1fjWl UrI 3 t (33) 11 IO pgl ( b~ Jgt J 7 - 7 Iv fi)) It 2 fll)T (7)fillifciEG11 (

ml bfLt htQ) r-lIC 7(liliJIilliliilJtt(L ~~Jgt c 90-U 02) t7thtIJ fht l 13amp -C~~(fJi11fiil1rQ)ffilcJltllt IJ C freundii lt ltjii9 L 3 El J)1tl tjEOH1 I O~ ( I ) (7)7lt

2tc t 10pgml l~ r-nc tilt0t t-d~ j~tRillJJ7mfzJt-clt 2 J]JlTVlt1iE~ lt~~(7)1iE~~-C r-lIC Q)lpound1Tj)2URL o-n~lOJgt lI3(1l] (17) 17thtIJ 3 SJ)1b

t 1iEftlJ F-14 (AK 7J) ltIt I EI1ft(7) P afTugishy t1iE1UtU~fc~-cg-~-C 8 (IlJ (II ) ltt

nasa 25 pgml n 5 R amp(7)U gtlgt 25 pgml tiEl1~ Hshy t ~ Q)l 7 1 Iv ~ -UltIHijEjk-gtlQ)Jl1Jvfjpound~tcc I (KM 1) -Cll1J) 13 Q) P arruginosa 25 pgml It~ ltiiZlO-r htQ)hE~Q)tlOtJ 7 -7 Iv JIli1

IJ 3 R ampl 25 pgml tiEI~ F-4 (K K JJ) lt gtcjilrl tjiE1Hi~G1Jrtlt I yJ tffi itJ 7-7

ItfJJ R Q) M morganii 25 pgml 1Jl S amp1 50 pgl I v tl1ampI lt1iEkIJt t1ipoundOU g mi jiEf7J 0-10 (KObull lJ) lt 111J) IJ Q) S faaalis J 7-7Iv(7)0fIll~L-C J 7-7v (7)tifiAJ

5 7 -7 Iv ~~ Iv- co~~l ~~ Iv- 11illi ~nlcoimhMfJlt~cg l-t~nt

5 bullm1JrpC)l1iUiJilJ~l[coiJIqjE

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CO~-C-gJmru1ibt (J lJt~JI tf1iZ~ httfEfJiJ J~ 0-1 (YlL 9]) CO tJ T - T IvwnWJ

rul~cotfliii~1~~ Iig I Ijf--r cot~ilI I 13 sect

2 mg (i1m c L -C It 1~2 glml) coJiXlCi p ~ V ~ n~HlL -C 3 ilr~II~Ibt J tf1tlth

-rt~bb-jEipoundnrcotfttctJ1~ ~bt1gt7gt-t p oj-P- V V 7iJUiJIIJ~tLt t~trpltAWtrJiJ

ttlll htsiJ tiE(YJJlt rF1U~ htstJ tcJg x rpCO~~~nr~~JE~cottllimnllf-cshy

ltcm~iL

- T Iv Willi ff 5 WfMltcoilfr~JmiddotW-tf

f1coV-cc L -citJWtJ T-TlvCOt4iARmiddot11t1iWJilJ~

15trilmHtrJ9)tiHli tgt ItJ l-~1itWm2iu~middotltt tJ

T-Tlv~m-t1i~71 ib7gt ~middotltH~co 3-way

- T IvcoMIIL~t1-C ffiillP-JI-w E1itfiifi1Jz Strli1l iltJilJ ritA-r 7gt1iUmiddotts ctJ~~ Iht)~ ~ fh

lyenlillticJiR1ii1co~fVifJm ~ l CO -C-It tstJ

- t Jt~cot1tt11t-~ -clt[j1I1f3tJtrltm~h -C ~

0 co-C- 3 A fl~j)rtlcoWii1JViIt~co1iE(fJCOruJ-C-ltffitJ~ lshy

m~ Hlmx ilco~I1co1itWraquoJCOf~tUmtJ

I I

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40

0 o-----5~---~~-----1=5-----2O----Jo

Days 01

Fig I In vivo release of chlorhexidine dihydrochloride from the inner surface of SR-C catheter in patient 0-1 (Yll male) 0-0 release rate e- cumulative release

m~ c lJtfiiJilJco~t(f)tl~cofJ~mn~~c t1im~J~itril1JHtfJCOlplusmnADn~fHttJ T - T IvfIAtampn I~ till3ttA-t7gt cltff1iJl1~liCO~HllltsiJ7gt

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I) Center for Disease National Nosocomial Inshy

fections Study Report Annual Summary

1976 February 1978

2) Dukes C Urinry infections after excision

of thc rectum lhe causc and prevenlion

Proc R Soc Med 22 I-II 1928

3) Garibaldi RA Burke JP Britt 1m Iillcr

VA and Smith CD 1lealal colonization and

cathcter associated bacteriuria N Engl J Med 303 316-318 1980

4) Kass Ell and Schnciderman LJ Enlry of


574

bactcria into thc urinary tracts of patients

with inlying catheters N Engl J ~Ied 256

556-557 1957

5) Burke JP Jacobson JA Garibaldi RA

Conti MT and Allining DW Evaluation of

daily meatal care Wilh polr-antibiotic ointshy

ment in prevention of urinary catheter

associated bacteriuria 1 Urol 129 331shy

334 1983

6) Vi ant AC Linton KB and Gillespie WA

Improved method for preventing movement

of indwelling catheters in female patients

Lancet 1 736-737 1971

7) Butler HK and Kunin CM Evaluation of

polymixin catheter lubricant and impregnashy

ted eathetcrs 1 Urol loo 560-566 1968

8) Rubin 11 Effect of catheter replacement on

bacterial counts in urine aspirated from inshy

delling catheters 1 Infect Dis 142 291

1980

9)mRBMmiddotWM~~middotrn~R~middot~ ~~

jj)iG iitW)l1Jti1tl(JM-1T-ro~lmiddott~WgtJ T

- T vO)Dil)c AIflZi 14 801-808 1985

10) K unin C~I and Finkelberg Z Evaluation

of an intraurethral lubricating cathctcr in

prcvention of catheter-induced urinary lract

infections 1 Urol 106 928-930 1971

11) Keresteci AG and Leers WD Indwelling

catheter infection Can ~Ied Assoc 1 109

711-713 1973

12) Robcrts 10-1 Linton KB Pollard BR

Mitchell JP and Gillespie WA Long-term

catheter drainage in male Br 1 Urol 37

63-72 ID65

13) Kunin C-1 and ~lcCormack RC Prevention

of cathetcr-induced urinary-tract infections

by sterile closed drainage N Engl 1 Med 274 1155-1161 1966

14) ~~g~J1 lJMiltIlt bull rwlDJriZyenl=f bull jffillC bull ill

f ~ ~ AJI 10 tOT --i)i$It t) 7 -r 7 of

=j~v-rIHipoundIk~ampLt4)U itW 25 578shy

591 1984

I 5G8

catheter indwell respeetivel)

The catheter was not elTcetive in eradicating precxisting bacteriuria Cornplieltions of the catheter were minimal

Key words Inling catheter Prevention of urinary trael infection Closed drainage Catheter with sustained release of ehlorhcxidinc

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11

569








Catheter









~~~~fpoundlW~

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m-~~~Mm




















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Iln-r


-~_~-shy



1 35 35 0 0 o 0 2 29 29 0 0 o 0 3 26 24 2 2 57 77 4 25 21 2 4 114 160 5 22 17 1 5 143227 6 17 11 1 6 171 353 7 14 5 3 9 257643 B 10 3 0 9 257 750 9 6 2 1 10 2B6 B33

10 4 1 0 10 286 909 11 3 1 0 10 286909 12 3 1 0 10 286 909 13 1 0 0 10 286 100 14 1 0 0 10 286 100 15 1 0 0 10 286 100





016 031 063 125

















)Igml 25 5 10 25 50 100~

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2 1

3

I

1 4 2 1

1 1 1

( 30) ( 15) ( 0) ( B) ( B) ( B)

2 2 1

(15) ( 8)













ter n5t

( 30) ( 15) ( lJ) ( 8) ( 8) ( 8)

( 15) ( 8)

Cloo) Itient


middot10 pgml Q)

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tf~)btWjl(7)

pljJ[ij~Q)a


tQ)llilQp

) ff-i

571


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lIot cono i





















I

il

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I

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0htJiJmiddot--gtt







1976 February 1978









574



556-557 1957






334 1983




Lancet 1 736-737 1971







1980



- T vO)Dil)c AIflZi 14 801-808 1985







711-713 1973




63-72 ID65







591 1984

569








Catheter









~~~~fpoundlW~

Mtlirr~ht-



m-~~~Mm




















Total 50 39 11 7fJ 3727) ( 85 t 31

Iln-r


-~_~-shy



1 35 35 0 0 o 0 2 29 29 0 0 o 0 3 26 24 2 2 57 77 4 25 21 2 4 114 160 5 22 17 1 5 143227 6 17 11 1 6 171 353 7 14 5 3 9 257643 B 10 3 0 9 257 750 9 6 2 1 10 2B6 B33

10 4 1 0 10 286 909 11 3 1 0 10 286909 12 3 1 0 10 286 909 13 1 0 0 10 286 100 14 1 0 0 10 286 100 15 1 0 0 10 286 100





016 031 063 125

















)Igml 25 5 10 25 50 100~

Total( )

2 1

3

I

1 4 2 1

1 1 1

( 30) ( 15) ( 0) ( B) ( B) ( B)

2 2 1

(15) ( 8)













ter n5t

( 30) ( 15) ( lJ) ( 8) ( 8) ( 8)

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tf~)btWjl(7)

pljJ[ij~Q)a


tQ)llilQp

) ff-i

571


Totnl(r) 5(16) 4(13)16(51) 2(7) 2(7) 1(3) 1(3) 31 (100) I

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I

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0htJiJmiddot--gtt







1976 February 1978









574



556-557 1957






334 1983




Lancet 1 736-737 1971







1980



- T vO)Dil)c AIflZi 14 801-808 1985







711-713 1973




63-72 ID65







591 1984



1 35 35 0 0 o 0 2 29 29 0 0 o 0 3 26 24 2 2 57 77 4 25 21 2 4 114 160 5 22 17 1 5 143227 6 17 11 1 6 171 353 7 14 5 3 9 257643 B 10 3 0 9 257 750 9 6 2 1 10 2B6 B33

10 4 1 0 10 286 909 11 3 1 0 10 286909 12 3 1 0 10 286 909 13 1 0 0 10 286 100 14 1 0 0 10 286 100 15 1 0 0 10 286 100





016 031 063 125

















)Igml 25 5 10 25 50 100~

Total( )

2 1

3

I

1 4 2 1

1 1 1

( 30) ( 15) ( 0) ( B) ( B) ( B)

2 2 1

(15) ( 8)













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pljJ[ij~Q)a


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571


Totnl(r) 5(16) 4(13)16(51) 2(7) 2(7) 1(3) 1(3) 31 (100) I

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0htJiJmiddot--gtt







1976 February 1978









574



556-557 1957






334 1983




Lancet 1 736-737 1971







1980



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711-713 1973




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591 1984

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Lancet 1 736-737 1971







1980



- T vO)Dil)c AIflZi 14 801-808 1985







711-713 1973




63-72 ID65







591 1984




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556-557 1957






334 1983




Lancet 1 736-737 1971







1980



- T vO)Dil)c AIflZi 14 801-808 1985







711-713 1973




63-72 ID65







591 1984

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1976 February 1978









574



556-557 1957






334 1983




Lancet 1 736-737 1971







1980



- T vO)Dil)c AIflZi 14 801-808 1985







711-713 1973




63-72 ID65







591 1984

574



556-557 1957






334 1983




Lancet 1 736-737 1971







1980



- T vO)Dil)c AIflZi 14 801-808 1985







711-713 1973




63-72 ID65







591 1984

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