Jurnal Nisrina Ariesta Syaputri

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CLINICAL TRIAL OF

LAMIVUDINE IN CHLIDRENWITH CHRONIC HEPATITIS

B

Oleh: Nisrina Ariesta Syaputri

FK UNSRI2011

Journal Reading

Maureen M Jonas! M " ! et al#he Ne$ %ngland Journal O& Medi'ine 2002: (0)*+: 1,0-.1,1/



Background

Chronic Hepatitis B is widespread diseasethat afects more than 350 milion peopleworldwide, or approximately 5 percent o the

world’s population

!ypically, the "irus is acti"ely replicating inthe in ected children as demonstrated #y the

presence o hepatitis B e antigen $HBe%g& inthe serum and high serum le"els o hepatitisB "irus $HB'& ()%



Cont’

!herpeutic options or adults withchronic hepatitis B include thenucleoside analogue lami"udine $*pi"ir

HB', +laxo mith-line& and the cytokineinter eron al a

.nter eron al a therapy is cum#ersome to

deli"er, is uncom orta#le to recei"e, andhas undesira#le side efects



/# ecti"e !o assess the sa ety and e1cacy olami"udine treatment in children withchronic hepatitis B



2ethod !his randomi ed, dou#le4#lind, place#o4controlled studywas conducted #etween eptem#er 667 and 8uly 9000 at:0 centers in )orth %merica, outh %merica and *urope

Eligibility requireme t! i "lu#e#$an age #etween 9 and ; years at enrollment,seropositi"ity or hepatitis B sur ace antigen $HBs%g& or atleast < months #e ore enrollment,seropositi"ity or HBe%g,undetecta#le le"els o anti#ody against HBe%g $anti4HBe&,

serum alanine aminotrans erase "alues that were more than3 times the upper limit o the normal range $#ut less than

500 .= per liter& or at least 3 months #e ore enrollment,e"idence o in>ammation on li"er #iopsy, : andmeasura#le HB' ()% in serum on #ranchedchain ()% assay



Cont’

P%tie t! &ere e'"lu#e# i($they had recei"ed inter eron within thepre"ious 9 months or systemic anti"iralagents,

immunomodulatory drugs, cytotoxic agents, orcorticosteroids within the pre"ious < monthsthey were coin ected with the humanimmunode?ciency "irus, hepatitis C "irus, orhepatitis ( "irus or they had decompensated

li"er disease, renal insu1ciency, pancreatitis,a clinically signi?cant coexisting medicalillness, or other types o li"er disease



Si glet) term e&b)r ! &it* BA % # + ,- *)ur! )(%ge admitted to ).C= were prospecti"ely enrolledTerm e&b)r &it* .*y!i)l)gi"%l /%u #i"e % #&it*)ut BA were studied as controls

erum li"er en ymes were measured at @ 9: hours, 9:4;9hours and at <4 9 days o age or cases and at 4< days oage or controlsB% was de?ned #y minute %pgar core @; or delayed ora#sent cry with hyphoxic ischemic encephalophaty $H.*&B%4associated li"er in ury was de?ned as serum alanineaminotrans erase $%A!& ele"ation #eyond 9 ( a#o"e themean o control su# ects at any o the three time points



esult<0 controls and <9 cases were enrolled

!hirty4?"e cases $5<D& de"eloped B%4associated

li"er in ury $%A!E7 .=FA& !hey had higher serumle"els o %A!, % ! and A(H than the control in ants,with peak at 9:4;9 hours.n controls, serum li"er en yme le"els weresigni?cantly higher in appropriate4 or4date $%G(&

#a#ies than small4 or4date $ G(& #a#ies erumen yme pattern and extent o ele"ation werecompara#le #etween G( and %G( #a#ies(egree o serum li"er en yme ele"ation had norelationship with se"erity o hypoxic encephalopathy



Conclussionerum li"er en yme ele"ation is

common in B% it peaks at 9:4;9 hoursollowed #y a sharp decline #y <4 9

days o age Iattern and extent oen yme ele"ation are compara#le#etween G( and %G( #a#ies



• ingleton new#orns with B% deli"ered at J3; weeks +%admitted within ;9 hours o #irth and )ew#orns withphysiological aundice without B% in ).C= o(epartment o Iediatrics, 'i"ekananda Iolyclinic and.nstitute o 2edical ciences, Aucknow, .ndia, #etween2ay 900; and %pril 9007

Iopulation

• erum li"er en yme pattern

.nter"ention

• )ew#orns with physiological aundice without B%

Comparison

• 2or#idity and mortality neonatal

/utcome



'alidity.s the ocus o this study in accordance with theo# ecti"eK

Les !he o# ecti"e is to study temporal pattern o serum li"eren yme le"els in new#orns with hepatic in ury associatedwith #irth asphyxia

(oes the author use the right methodK

Les !his study used case control method in which new#orn withphysiological aundice without B% as controls and new#ornwith B% were enrolled in the study



Cont’.s the su# ect o this study taken properlyK

Les

!he su# ect o this study already ul?ll the inclusionand exclusion that appropriate in this study

.s the article collected in accordance with thepurpose o re"iewK

Les !his article meet the criteria that the author wants



.mportant !his 8ournal is .mportant, #ecauseM

(ata on the temporal pattern o serumle"els o li"er en ymes a ter B% are "eryscanty, this study may help todiferentiate hepatic in ury due to B%

rom that without B% and to determine

the #a#y’s outcome



%pplica#le !his ournal can #e used as there erence a#out the li"er en yme le"elin new#orn #irth asphyxia with hepaticin ury



T*i! 0)ur %l$'alid .mportant and %pplica#le



!H%)-L/=

Jurnal Nisrina Ariesta Syaputri

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