Presentasi

Journal Reading
ABDUL HARIS
DESI RARA ANDIKA
 P : Pasien anak usia 1-17 tahun dengan diagnosis anemia defisiensi besi dan gagal
terapi besi oral
 I : pemberian besi sukrosa IV
 C: -
 O: Peningkatan parameter hematologi
Introduction
 ADB  anemia yang sering terjadi pada anak, penelitian yg dilakukan di israel menyebutkan
bahwa pravalensi ADB 15,5 % pada anak berusia 9-18 bulan
 Pengobatan ADB  Oral  tidak berespon  ketidakpatuhan
 Faktor predisposisi ADB
-kekurangan gizi
-malabsorbsi usus
-pendarahan
-iron absorption inhibitor  susu sapi
Pengobatan ADB

 Perbaikan gizi
 Pemberian preparat besi  IV (besi dekstran, besi glukonat, besi sukrosa)
 Besi sukrosa  tidak ada reaksi anafilaktik pada anak
Methods

 Rancangan penelitian : eksperimental

 Subjek  pasien anak ADB yang ada di OPD.
 Perlakuan  diberikan terapi besi sukrosa dari 1-7-13 sampai 30-12-13
 Kriteria inklusi : pasien berumur 1-17 tahun, diagnosis anemia defisiensi besi
 Ketidakpatuhan : anak yang tidak menkonsumsi pengobatan besi sediaan oral
yang sudah dianjurkan dalam waktu 3 bulan
Daily dosage

 5 mg Fe+++ /kgBB/hari
 Preparat besi diencerkan dengan Nacl 0.9 %
 1 mg Fe+++ dalam 1 ml Nacl 0.9 %

Diberikan 1-1,3 ml/menit  diberikan 3 kali dalam 1 minggu

 Follow up  parameter hematologi dihitung  sebelum perlakuan, 4,10,30 hari
sesudah pemberian terapi besi.
Analisis statistik

Paired T-test
Result  n=50

Kelompok Usia (Tahun) Jumlah pasien Persentase

1-5
15 30
6-10
9 18
11-15
6 12
16-17
20 40
Rentang Hb (g/dL) Jumlah Pasien Persentase

5-6 6 12
6-7 23 46
7-8 18 36
8-9 3 6
 Rata-rata peningkatan
Parameter Hari 0 Hari Ke-4 Hari ke-10 Hari ke-30 P value
pada hari ke-30

Hb (gr/dL) 6,95 ± 0,72 7,75 ± 0,74 9,67 ± 0,77 12,10 ± 0,69* 5,15 ± 0,55* <0,001*

PCV (%) 21,19 ± 2,33 23,65 ± 2,41 29,59 ± 2,71 37,33 ± 2,45* 16,14 ± 2,16* <0,001*

RBC (x 106 sel/mm3) 3,48 ± 0,37 3,88 ± 0,38 4,81 ± 0,43 5,56 ± 0,41* 2,08 ± 0,55* <0,001*

MCH (pg) 23,85 ± 2,6 26,26 ± 3,2 34,00 ± 5,07 35,58 ± 6,56* 11,73 ± 5,52* <0,001*

MCV (fL) 65,62 ± 3,04 68,98 ± 2,61 79,56 ± 5,51 87,92 ± 7,03* 22,30 ± 5,62* <0,001*

* Signifikan (dengan uji t berpasangan)

Efek samping Jumlah pasien Persentase
Phlebitis lokal - -
Gemetar dan kelemahan - -
Nyeri perut sedang 1 2
Nyeri lokal - -
Perubahan warna pada kulit 1 2
Sakit kepala - -
Total 2 4
Discussion

 ADB  masalah umum pada populasi anak

 Tx  suplemen oral  kebanyakan berhasil
 Pada beberapa pasien  gagal terapi  kepatuhan minum obat
 Solusi  Besi sukrosa IV
 Studi  2 pasien responnya sebagian  talasemia beta minor  dihilangkan
 Besi sukrosa  efektif pada bayi yang menjalani pembedahan spinal, operasi elektif, dan aman
pada bayi prematur.
 Kadar feritin & Hb  perbaikan eritropoetik dan penurunan feritin oleh mekanisme feedback
tingkta mRNA.
 Feritin  tidak dinilai  mahal, tidak terjangkau
 Efek samping besi sukrosa  minimal dan reversibel
CRITICAL
APPRAISAL
Title and abstract 1a Identification as a randomised trial in the title Tidak ada

1b Structured summary of trial design, methods, Hal 12

results, and conclusions
Introduction 2a Scientific background and explanation of Hal 12
Background and rationale
objectives

2b Specific objectives or hypotheses Hal 12-13

Methods 3a Description of trial design (such as parallel, Tidak ada
Trial design factorial) including allocation ratio

3b Important changes to methods after trial Tidak ada

commencement (such as eligibility criteria),
with reasons
Participants
Interventions 4a Eligibility criteria for participants Hal 13
 4b Settings and locations where the data Hal 13
were collected
5 The interventions for each group with Hal 13
sufficient details to allow replication,
including how and when they were
actually administered
Outcomes 6a Completely defined pre-specified Tidak ada
primary and secondary outcome
measures, including how and when
they
were assessed
6b Any changes to trial outcomes after Tidak ada
the trial commenced, with reasons
Sample size 7a How sample size was determined Tidak ada

7b When applicable, explanation of any Tidak ada

interim analyses and stopping
guidelines
Randomisation: 8a Method used to generate the random Tidak ada
Sequence allocation sequence
Generation
8b Type of randomisation; details of any Tidak ada
restriction (such as blocking and block
size)
Allocation
concealment
Mechanism 9 Mechanism used to implement the Tidak ada
random allocation sequence (such as
sequentially numbered containers),
describing any steps taken to conceal
the sequence until interventions were
assigned
Implementation 10 Who generated the random allocation Tidak ada
sequence, who enrolled participants,
and who assigned participants to
interventions
Blinding 11a If done, who was blinded after Tidak ada
assignment to interventions (for
example, participants, care providers,
those
11b If relevant, description of the similarity Tidak ada
of interventions
Statistical methods 12a Statistical methods used to compare Tidak ada
groups for primary and secondary
outcomes
12b Methods for additional analyses, such Tidak ada
as subgroup analyses and adjusted
analyses
Results
Participant flow (a 13a For each group, the numbers of participants who were Semua sampel
diagram is strongly randomly assigned, received intended treatment, and mendapatkan terapi
recommended) were analysed for the primary outcome yang sama
Hal 14 untuk hasil
parameter hematologi

13b For each group, losses and exclusions after randomisation, Tidak ada, namun di
together with reasons bagian diskusi
dijelaskan di hal 14-15

14a Dates defining the periods of recruitment and follow-up Hal 14 Tabel 3

Recruitment 14b Why the trial ended or was stopped Tidak dijelaskan
Baseline data 15 A table showing baseline demographic and clinical Hal 14 tabel 1 (usia),
characteristics for each group tidak menjelaskan
variasi klinis dan
demografi yang lainnya
Lanjutan...
Numbers 16 For each group, number of participants (denominator) Hal 14
analysed included in each analysis and whether the analysis was
by original assigned groups
Outcomes and 17a For each primary and secondary outcome, results for Sebelumnya dijelaskan di
estimation each group, and the estimated effect size and its bagian metode
precision (such as 95% confidence interval)
17b For binary outcomes, presentation of both absolute and Hal 14 dan 15
relative effect sizes is recommended
Ancillary 18 Results of any other analyses performed, including Hal 14
analyses subgroup analyses and adjusted analyses, distinguishing
pre-specified from exploratory
Harms 19 All important harms or unintended effects in each group Hal 14 (tabel 4)
Discussion
Limitations 20 Trial limitations, addressing sources of Hal 15 (tidak digunakan
potential bias, imprecision, and, if relevant, kadar feritin)
multiplicity of analyses

Generalisability 21 Generalisability (external validity, Hal 15 (kegunaaan besi

applicability) of the trial findings sukrosa)
Interpretation
22 Interpretation consistent with results, Hal 15
balancing benefits and harms, and
considering other relevant evidence

Other Information
Registration 23 Registration number and name of trial Tidak ada
registry
Protocol 24 Where the full trial protocol can be Tidak ada
accessed, if available
Funding 25 Sources of funding and other support (such Tidak ada
as supply of drugs), role of funders