Ebm baru 1102010105

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 biasan biasanya ya.. Dari hasil pemeriksaan pemeriksaan lab, dokter dokter menyatakan 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 Apakah pemberian pemberian obat terapi besi parenteral parenteral lebih efektif dibandingkan dibandingkan dengan terapi besi oral pada ibu hamil" PICO #op #opulat ulatio ion n • &nt &nter'e r'ention • )omparison • *utcomes •

$ %anita ita hamil amil deng dengan an anem anemia ia defis efisie iens nsii besi besi $ (erapi api besi parent enteral $ (e (erapi be besi or oral $Meningkatkan kadar besi dalamtubuh

Pencarian Bukti I!ia" Alamat website $ http://www.ncbi.nlm.nih.gov +ata ku kunci $iron de deficiency anemia AD pr pregnancy AD or oral th therapy AD intra'enous therapy imitasi $  years / !anuari 2008 - desember 201 3 4asil #encarian $5 Dipilih artikel $&ron Sucrose 6ersus 6ersus *ral &ron (herapy in #regnancy Anemia  ber!udul #EVIE$ %&#NA'

 AB ST R AC T 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:

1

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 '  wees 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 suare 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 count and 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.

2

CRITICAL APPRAISAL Validity

1. Aaka"terdaatrando!isasidaa!keo!okercoaandanaaka"teknik digunakan *

yang

7a, (erdapatpadahal. 2 dan hal. bagianmetode. (his prospecti'e randomied 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 reuiring 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 suare test or analysis of co'ariance were applied when appropriate. Statistical significance was accepted at #  0.0.

+, Aaka"adaerti!angandanenyertaanse!uaasiendaa!e!uatankesi!u an *Ada +,aMengidentifikasiengkatidaknya foo- u*.erdaatada

+,Mengidentifikasiadatidaknyaanaisisasienadakeo!okrando!isasise!ua *

(erdapatpada hal.2 bagian material dan metode

2

(his prospecti'e randomied 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 reuiring blood transfusion, bronchial asthma and suspected acute infection were eBcluded from the study. (arget hemoglobin for the study was 11 g?d.

/, Aaka"adatidaknya inding adaasien0 kinisidaneneiti *

(idak Ada 1, Aaka"adaersa!aanadakeduakeo!ok di a-aeneitian *2a

(his prospecti'e randomied 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 reuiring blood transfusion, bronchial asthma and suspected acute infection were eBcluded from the study. (arget hemoglobin for the study was 11 g?d. 3, Aaka"adaersa!aanerakuanadakeduakeo!okseainerakukanekseri! en *

Ada

2

 Importance 4, Beraaka"esarefekterai (CE#0EE#0A##0A#I0NN.) *

*utcome /;fek (erapi3 (otal 7es

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 CER− EER

9elati'e risk reduction /9993 E

CER

 or 1-99 E

Absolute risk reduction /A993 E );9 −;;9 E 1

 umber needed to treat /(3 E

 ARR

 E

6, Beraaka"resisiesti!asiefekterai *

 Applicability 7, Aaka"adake!ungkinaneneraanadaasien (sektru!asiendan setting)*

Ada, terdapat pada halaman 2 bagian material dan metode (his prospecti'e randomied 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 2

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 reuiring blood transf usion, bronchial asthma and suspected acute infection were eBcluded from the study. (arget hemoglobin for the study was 11 g?d.

8, Aaotensikeuntungandankerugianagiasien*

(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