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EVIDENCE BASED MEDICINE

Skenario

Seorang wanita berusia 28 tahun dengan usia kehamilan 28 minggu datang ke poliklinik 

diantar suaminya dengan keluhan pucat, mudah lemah dan lelah selama 2 minggu terakhir.

Akhir-akhir ini sering disertai dengan demam, dan mimisan. Menurutsuaminya dia terlihat

lebih pucat dari biasanya. Dari hasil pemeriksaan lab, dokter menyatakan bahwa wanita ini

terkena Anemia Defisiensi esi, sehingga disarankan untuk terapi besi oral. Suami pasien

mengatakan pada dokternya bahwa dia pernah mendengar tentang terapi besi parenteral dan

menanyakan terapi yang lebih efektif untuk istrinya. Dokter memberikan pen!elasan tentang

kedua obat tersebut.

Pertanyaan (foreground question)Apakah pemberian obat terapi besi parenteral lebih efektif dibandingkan dengan terapi besi

oral pada ibu hamil"

PICO

• #opulation $ %anita hamil dengan anemia defisiensi besi

• &nter'ention $ (erapi besi parenteral

• )omparison $ (erapi besi oral

• *utcomes $Meningkatkan kadar besi dalamtubuh

Pencarian Bukti I!ia"Alamat website $ http://www.ncbi.nlm.nih.gov

+ata kunci $iron deficiency anemia AD pregnancy AD oral therapy AD

intra'enous therapy

imitasi $ years / !anuari 2008 - desember 201 3

4asil #encarian $ 5

Dipilih artikel

 ber!udul

$&ron Sucrose 6ersus *ral &ron (herapy in #regnancy Anemia

#EVIE$ %&#NA'

 ABSTRACT

BACKGROUND:

Iron deficiency anemia (IDA) is the most common medical problem in pregnancy.

Parenteral iron is a useful treatment, although iron dextran use decreased due to

anaphylaxis. Iron sucrose is a newer agent that has overcome the shortcomings of iron

dextran.

OBJECTIVE:

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he aim of this study was to compare the efficacy and tolerance of intravenous iron

sucrose (I!I") therapy with oral iron (#I) therapy in pregnant women with IDA and to

study the factors influencing treatment.

MATERIALS AND METHODS:

his prospective, randomi$ed clinical trial included pregnant women between %& and '

 wees with established IDA who were treated with I!I" or #I (ferrous fumarate). All

patients were monitored for laboratory response and adverse effects. Independent

sample*T  test, +hi suare test and A-#!A were used for statistical analysis.  P   /./0

 was considered significant.

RESULTS:

 Although hemoglobin increased in both the groups, increase in the reticulocyte countand percentage increase in hemoglobin was significantly higher in the I!I" group than in

the #I group (1'.12 vs. %&.%%2). "erum ferritin was significantly higher in the I!I"

group than in the #I group ( P  3 /.///). he I!I" group had no ma4or side*effects.

+ompliance was good with #I, although 1'2 had gastrointestinal side*effects. Patient

 weight, gestation at diagnosis, initial hemoglobin and ferritin levels did not influence the

response to treatment.

CONCLUSION:

I!I" is safe and effective in the treatment of IDA during pregnancy. Iron stores increased

 better with I!I" compared with #I.

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CRITICAL APPRAISAL

Validity

1. Aaka"terdaatrando!isasidaa!keo!okercoaandanaaka"teknik yang

digunakan *

7a, (erdapatpadahal. 2 dan hal. bagianmetode.

(his prospecti'e randomied clinical trial registered under the )linical (rial 9egistry,

&ndia, was carried out from :uly 2008 to September 2010. ;thical committee

clearance was obtained from the hospital ethical committee. #regnant women, from

1< to 5 weeks of gestation, with hemoglobin le'el 5.=10.> g?d and ferritin le'els

less than 2@ ng?d were enrolled after taking informed consent. (his cut-off of serum

ferritin was chosen because the lower limit in our laboratory is 2@ ng?d. %omen with

se'ere anemia reuiring blood transfusion, bronchial asthma and suspected acute

infection were eBcluded from the study. (arget hemoglobin for the study was 11 g?d.

Statistical package for social science /S##S- 153 was used for statistical compilation

and analysis. Cor statistical analysis of difference between groups, independent

sample-t test, )hi suare test or analysis of co'ariance were applied when appropriate.

Statistical significance was accepted at # 0.0.

+, Aaka"adaerti!angandanenyertaanse!uaasiendaa!e!uatankesi!u

an *Ada

+,aMengidentifikasiengkatidaknya foo- u*.erdaatada

+,Mengidentifikasiadatidaknyaanaisisasienadakeo!okrando!isasise!ua

*

(erdapatpada hal.2 bagian material dan metode

2

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(his prospecti'e randomied clinical trial registered under the )linical (rial 9egistry,

&ndia, was carried out from :uly 2008 to September 2010. ;thical committee clearance

was obtained from the hospital ethical committee. #regnant women, from 1< to 5

weeks of gestation, with hemoglobin le'el 5.=10.> g?d and ferritin le'els less than

2@ ng?d were enrolled after taking informed consent. (his cut-off of serum ferritin

was chosen because the lower limit in our laboratory is 2@ ng?d. %omen with se'ereanemia reuiring blood transfusion, bronchial asthma and suspected acute infection

were eBcluded from the study. (arget hemoglobin for the study was 11 g?d.

/, Aaka"adatidaknya inding adaasien0 kinisidaneneiti *

(idak Ada

1, Aaka"adaersa!aanadakeduakeo!ok di a-aeneitian *2a

(his prospecti'e randomied clinical trial registered under the )linical (rial 9egistry,

&ndia, was carried out from :uly 2008 to September 2010. ;thical committee

clearance was obtained from the hospital ethical committee. #regnant women, from

1< to 5 weeks of gestation, with hemoglobin le'el 5.=10.> g?d and ferritin le'els

less than 2@ ng?d were enrolled after taking informed consent. (his cut-off of serum

ferritin was chosen because the lower limit in our laboratory is 2@ ng?d. %omen with

se'ere anemia reuiring blood transfusion, bronchial asthma and suspected acute

infection were eBcluded from the study. (arget hemoglobin for the study was 11 g?d.

3, Aaka"adaersa!aanerakuanadakeduakeo!okseainerakukanekseri!

en *

Ada

2

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 Importance

4, Beraaka"esarefekterai (CE#0EE#0A##0A#I0NN.) *

*utcome /;fek (erapi3

(otal7es o

(erapi

#arenteral

/;Bperimental

3

(a) () (a5)

(erapi *ral

/)ontrol3

(c) (d) (c5d)

.ota

;Bperimental e'ent rate /;;93 E a? /aFb3 E

)ontrol e'ent rate /);93 E c? /cFd3 E

9elati'e 9isk /993 E ;;9 ? );9 E

*9 Ead?bc E

9elati'e risk reduction /9993 ECER− EER

CER  or 1-99 E

Absolute risk reduction /A993 E );9 −;;9 E

 umber needed to treat /(3 E1

 ARR  E

6, Beraaka"resisiesti!asiefekterai *

 Applicability

7, Aaka"adake!ungkinaneneraanadaasien (sektru!asiendan setting)*

Ada, terdapat pada halaman 2 bagian material dan metode

(his prospecti'e randomied clinical trial registered under the )linical (rial 9egistry, &ndia,

was carried out from :uly 2008 to September 2010. ;thical committee clearance was obtained

from the hospital ethical committee. #regnant women, from 1< to 5 weeks of gestation, with

hemoglobin le'el 5.=10.> g?d and ferritin le'els less than 2@ ng?d were enrolled after

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taking informed consent. (his cut-off of serum ferritin was chosen because the lower limit in

our laboratory is 2@ ng?d. %omen with se'ere anemia reuiring blood transfusion, bronchial

asthma and suspected acute infection were eBcluded from the study. (arget hemoglobin for

the study was 11 g?d.

8, Aaotensikeuntungandankerugianagiasien*

(erdapatpadahal < bagian discussion

&n this study, the efficacy, safety and tolerability of &6&S in treating pregnancy &DA

was compared with *& therapy. &6&S is safe in pregnancy. &t corrects anemia at short

duration and replenishes iron stores better than *&. (his has been the obser'ation in

other studies too./=3 )omparison with other studies is difficult because of different

cut-offs used for lab parameters. *& preparations used are also different. As the rate of

increase in hemoglobin is faster, &6&S is suitable for treatment of &DA with lower

hemoglobin in the third trimester. (here was a highly significant difference in the

ferritin le'el after treatment between the two groups, with iron reser'es restored only

in the &6&S group, which has also been obser'ed by ayoumeu et al./3 &ncrease in

ferritin is not because of direct intra'enous in!ection of iron compleBG rather, it is

 because the &6&S compleB releases iron rapidly to endogenous iron binding proteins

with no deposition in the parenchymal tissue. &t has a half-life of about 5 h./53 (his is

an ad'antage of &6&S o'er iron deBtran or iron gluconate.

2