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 Besi, 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 penjelasan tentang
kedua obat tersebut.
Pertanyaan (foreground question)
Apakah pemberian obat terapi besi parenteral lebih efektif dibandingkan dengan terapi besi
oral pada ibu hamil?
PICO
Population
Intervention
Comparison
Outcomes

: Wanita hamil dengan anemia defisiensi besi

: Terapi besi parenteral
: Terapi besi oral
:Meningkatkan kadar besi dalamtubuh

Pencarian Bukti Ilmiah

Alamat website
: http://www.ncbi.nlm.nih.gov
Kata kunci
:iron deficiency anemia AND pregnancy AND oral therapy AND
intravenous therapy
Limitasi
: 5 years ( januari 2008 - desember 2013 )
Hasil Pencarian
:6
Dipilih artikel
:Iron Sucrose Versus Oral Iron Therapy in Pregnancy Anemia
berjudul
REVIEW JURNAL

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:

The aim of this study was to compare the efficacy and tolerance of intravenous iron
sucrose (IVIS) therapy with oral iron (OI) therapy in pregnant women with IDA and to
study the factors influencing treatment.
MATERIALS AND METHODS:

This prospective, randomized clinical trial included pregnant women between 14 and 36
weeks with established IDA who were treated with IVIS or OI (ferrous fumarate). All
patients were monitored for laboratory response and adverse effects. Independent
sample-T test, Chi square test and ANOVA were used for statistical analysis. P < 0.05
was considered significant.
RESULTS:

Although hemoglobin increased in both the groups, increase in the reticulocyte count
and percentage increase in hemoglobin was significantly higher in the IVIS group than in
the OI group (23.62% vs. 14.11%). Serum ferritin was significantly higher in the IVIS
group than in the OI group (P = 0.000). The IVIS group had no major side-effects.
Compliance was good with OI, although 23% had gastrointestinal side-effects. Patient
weight, gestation at diagnosis, initial hemoglobin and ferritin levels did not influence the
response to treatment.
CONCLUSION:

IVIS is safe and effective in the treatment of IDA during pregnancy. Iron stores increased
better with IVIS compared with OI.

CRITICAL APPRAISAL
Validity
1. Apakahterdapatrandomisasidalamkelompokpercobaandanapakahteknik
digunakan ?

yang

Ya, Terdapatpadahal. 2 dan hal. 3bagianmetode.

This prospective randomized clinical trial registered under the Clinical Trial Registry,
India, was carried out from July 2008 to September 2010. Ethical committee
clearance was obtained from the hospital ethical committee. Pregnant women, from
14 to 36 weeks of gestation, with hemoglobin level 6.510.9 g/dL and ferritin levels
less than 27 ng/dL were enrolled after taking informed consent. This cut-off of serum
ferritin was chosen because the lower limit in our laboratory is 27 ng/dL. Women with
severe anemia requiring blood transfusion, bronchial asthma and suspected acute
infection were excluded from the study. Target hemoglobin for the study was 11 g/dL.
Statistical package for social science (SPPS- 16) was used for statistical compilation
and analysis. For statistical analysis of difference between groups, independent
sample-t test, Chi square test or analysis of covariance were applied when appropriate.
Statistical significance was accepted at P < 0.05.

2. Apakahadapertimbangandanpenyertaansemuapasiendalampembuatankesimpul
an ?Ada
2.aMengidentifikasilengkaptidaknya follow up?Terdapatpada

2.bMengidentifikasiadatidaknyaanalisispasienpadakelompokrandomisasisemula
?
Terdapatpada hal.2 bagian material dan metode

This prospective randomized clinical trial registered under the Clinical Trial Registry,
India, was carried out from July 2008 to September 2010. Ethical committee clearance
was obtained from the hospital ethical committee. Pregnant women, from 14 to 36
weeks of gestation, with hemoglobin level 6.510.9 g/dL and ferritin levels less than
27 ng/dL were enrolled after taking informed consent. This cut-off of serum ferritin
was chosen because the lower limit in our laboratory is 27 ng/dL. Women with severe
anemia requiring blood transfusion, bronchial asthma and suspected acute infection
were excluded from the study. Target hemoglobin for the study was 11 g/dL.

3. Apakahadatidaknya blinding padapasien, klinisidanpeneliti ?

Tidak Ada
4. Apakahadapersamaanpadakeduakelompok di awalpenelitian ?Ya
This prospective randomized clinical trial registered under the Clinical Trial Registry,
India, was carried out from July 2008 to September 2010. Ethical committee
clearance was obtained from the hospital ethical committee. Pregnant women, from
14 to 36 weeks of gestation, with hemoglobin level 6.510.9 g/dL and ferritin levels
less than 27 ng/dL were enrolled after taking informed consent. This cut-off of serum
ferritin was chosen because the lower limit in our laboratory is 27 ng/dL. Women with
severe anemia requiring blood transfusion, bronchial asthma and suspected acute
infection were excluded from the study. Target hemoglobin for the study was 11 g/dL.
5. Apakahadapersamaanperlakuanpadakeduakelompokselainperlakukaneksperim
en ?
Ada

Importance
6. Berapakahbesarefekterapi (CER,EER,ARR,ARI,NNT) ?
Outcome (Efek Terapi)

Total

Yes

No

Terapi
Parenteral
(Experimental
)

(a)

(b)

(a+b)

Terapi Oral
(Control)

(c)

(d)

(c+d)

Total
Experimental event rate (EER) = a/ (a+b) =
Control event rate (CER) = c/ (c+d) =
Relative Risk (RR) = EER / CER =
OR =ad/bc =
Relative risk reduction (RRR) =

CEREER
CER

or 1-RR =

Absolute risk reduction (ARR) = CEREER =

Number needed to treat (NNT) =

1
ARR

7. Berapakahpresisiestimasiefekterapi ?

Applicability
8. Apakahadakemungkinanpenerapanpadapasien (spektrumpasiendan setting)?
Ada, terdapat pada halaman 2 bagian material dan metode
This prospective randomized clinical trial registered under the Clinical Trial Registry, India,
was carried out from July 2008 to September 2010. Ethical committee clearance was obtained
from the hospital ethical committee. Pregnant women, from 14 to 36 weeks of gestation, with
hemoglobin level 6.510.9 g/dL and ferritin levels less than 27 ng/dL were enrolled after
2

taking informed consent. This cut-off of serum ferritin was chosen because the lower limit in
our laboratory is 27 ng/dL. Women with severe anemia requiring blood transfusion, bronchial
asthma and suspected acute infection were excluded from the study. Target hemoglobin for
the study was 11 g/dL.

9. Apapotensikeuntungandankerugianbagipasien?
Terdapatpadahal 4 bagian discussion
In this study, the efficacy, safety and tolerability of IVIS in treating pregnancy IDA
was compared with OI therapy. IVIS is safe in pregnancy. It corrects anemia at short
duration and replenishes iron stores better than OI. This has been the observation in
other studies too.(35) Comparison with other studies is difficult because of different
cut-offs used for lab parameters. OI preparations used are also different. As the rate of
increase in hemoglobin is faster, IVIS is suitable for treatment of IDA with lower
hemoglobin in the third trimester. There was a highly significant difference in the
ferritin level after treatment between the two groups, with iron reserves restored only
in the IVIS group, which has also been observed by Bayoumeu et al.(3) Increase in
ferritin is not because of direct intravenous injection of iron complex; rather, it is
because the IVIS complex releases iron rapidly to endogenous iron binding proteins
with no deposition in the parenchymal tissue. It has a half-life of about 6 h.(6) This is
an advantage of IVIS over iron dextran or iron gluconate.