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EVALUATION OF INJECTABLE IRON SUCROSE THERAPY IN CHILDREN WITH IRON DEFICIENCY ANEMIA.

Byline: Nazir Ahmed Malik, Sajid Ali Shah and Syed Fawad Mashhadi

Abstract

Objective: The study was designed to evaluate the response of intravenous iron therapy in children who were unable to tolerate oral iron.

Study Design: Quasi experimental study (pre and post treatment design).

Place and Duration of Study:The study period extended over a period of 2 years from Apr 2011 to Apr 2013 and was carried out in Combined Military Hospitals Okara and Panu Aqil cantt.

Material and Methods: One hundred and forty two children selected through non probability purposive sampling having iron deficiency anemia were included in the study. Iron deficiency anemia was diagnosed by measuring hemoglobin (Hb), red cell indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) and serum ferritin. Total iron deficit was calculated using the formula: Total iron deficit (in mg) = Body weight (kg) x (target hemoglobin-actual hemoglobin) {gm/dl} x 2.4 + depot iron (mg). Dose of iron sucrose to be given i/v (ml) = Total iron deficit/2o mg. Pre treatment and three months post treatment mean Hb levels were compared in the sample and stratified according to gender.

Results: Out of 142 patients 87 (61%) were males and 55 (39%) were females. Mean Hb before treatment was 7.85 +- 0.78 gm/dl while three months post treatment mean Hb was 10.29 +- 0.89 gm/dl (p<0.001).

Conclusion: Parenteral iron therapy is a good alternative for children with iron deficiency anemia who cannot tolerate oral iron due to gastro intestinal side effects.

Keywords: Children, Iron deficiency anemia, Iron sucrose.

INTRODUCTION

Anemia is a global health problem and its global prevalence in young children is 43%1. The most common cause of anemia under five years of age is iron deficiency anemia. Different studies from Pakistan show different prevalence rates 34%, 73% and 41%2-4. Anemia is defined as hemoglobin <11 gm/dl in children below five years of age5. According to WHO global database on anemia, 50.9% of Pakistani children and 39.1% of pregnant women were found to be anemic5.

Many studies have shown that micronutrients have vital role in brain development and their deficiencies can compromise full developmental potential and cognitive development in children6-8. Since ages iron has been used for treatment of anemia. Oral form of iron supplementation is simple, cheap and relatively effective way of treating iron deficiency anemia9.

However in certain conditions like chronic diarrhea or oral intolerance to iron therapy and in non-compliant patients, oral iron cannot be used and iron has to be supplemented by parenteral route. Parenteral iron supplementation has advantages of faster replenishment of body iron stores and rapid increase in hemoglobin. Different parenteral iron preparations are available which are safe and effective.

This study was conducted to assess the efficacy of injectable iron therapy in children with iron deficiency anemia between 1-5 years of age. The purpose of this study was to know about the efficacy of intravenous iron sucrose therapy in children between 1 to 5 years of age with iron deficiency anemia who were unable to tolerate or respond to oral iron therapy.

MATERIAL AND METHODS

A quasi experimental study (before and after comparison) was conducted from April 2011- April 2013 in Paediatric departments of Combined Military Hospitals Okara and Panu Aqil cantts. All outdoor patients with 1 to 5 years of age and having iron deficiency anemia and hemoglobin level between 7 to 10gm/dl were included in the study. Haemoglobin, serum ferritin and red cell indices mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH) and mean corpuscular volume (MCV) were used for diagnosis of iron deficiency anemia. Reticulocyte count and RBC morphology were also requested.

One hundred and forty two children calculated by G Power 3.1.9.2 software (alpha error probability=0.05, effect size=0.5, power=0.80), who were non responsive to oral iron therapy and were unable to tolerate iron therapy due to gastrointestinal side effects were included in the study group through non probability purposive sampling technique. While anemic patients whose anemia was not due to iron deficiency, patients with acute infections and with systemic disease like renal failure, cardiac problem, rheumatoid arthritis and liver disease, patients who were allergic to iron or with any other allergic condition and patients whose Hb level was <7 gm/dl were excluded from the study. Base line Hb was measured in all the patients and on follow up Hb was re-checked on monthly basis for three months after completion of iron therapy. Response was defined as rise in Hb of more than 1.5 gm/dl in three months.

Table: Comparison of pre and post treatment Hb levels.

###Pre-treatment Hb###Post (3 months) treatment###p-value

###(gm/dl) (mean+SD)###Hb (gm/dl) (mean +SD)

Total patients (n=142)###7.85 +- 0.78###10.29 +- 0.89###<0.001

Males (n=87)###7.95 +- 0.74###10.28 +- 0.89###<0.001

Females (n=55)###7.69 +- 0.84###10.30 +- 0.911###<0.001

For calculation of iron deficit, following formula was used:

Total iron deficit (in mg) = Body weight (kg) x (target Hemoglobin-actual Hemoglobin) {gm/dl} x 2.4 + depot iron (mg) 10.

Target Hb was 13 gm/dl. Depot iron was 15 mg/kg body weight. Dose of iron sucrose to be given i/v (ml) = Total iron deficit/20 mg. All the patients were subjected to sensitivity test by giving a test dose of 0.51ml diluted in normal saline by slow i/v infusion. For any sign of adverse reaction patients' vital signs were monitored for 30 minutes. Facilities for cardiopulmonary resuscitation along with necessary medication were readily made available. In cases who were not sensitive, the total dose was diluted in 100ml normal saline and slowly infused over 4-6 hours. During the infusion patients were closely monitored for any adverse reaction.

Data were recorded on a structured pre designed proforma. Qualitative variables like gender were presented in percentages. Mean +- SD (standard deviation) was used to present quantitative variables like age, Hb (baseline) and Hb (post 1, 2 and 3 months follow up). Paired sample "t" test was applied (where applicable) to find out the significant difference between the pre and post treatment Hb levels. Independent samples "t" test was applied to find out significant difference in mean Hb levels between the groups. A p-value <0.05 was considered as significant. Data was entered and analysed in Statistical Package For Social Sciences (SPSS) 20.0

RESULTS

Out of 142 patients, 87 (61.3%) were males while 55 (39%) were females. Mean age of the patients was 23.11 +- 12.38 months (22.19 +- 12.19 months in males; 24.67 +- 12.63 months in females). Pretreatment mean Hb was 7.85 +- 0.78 gm/dl. Pretreatment mean Hb in males and females was 7.95 +- 0.74 gm/dl and 7.69 +- 0.84 gm/dl respectively (p=0.062).

After one month of treatment mean Hb was 8.0 +- 0.77 gm/dl which was insignificant when compared with the pretreatment Hb (p=0.99). Two months post treatment Hb 9.43 +- 0.79 gm/dl vs 7.85 +- 0.78 gm/dl (pretreatment Hb) was found to be significant (p<0.001). Three months post treatment mean Hb (10.29 +- 0.89 gm/dl) when compared with the pretreatment mean Hb was found to be highly significant (p<0.001) (table).

Three months post treatment mean Hb was 10.28 +- 0.89 gm/dl in males which was found to be highly significant (p<0.001) when compared with pretreatment mean Hb in males. Post three months mean Hb was 10.30 +- 0.911 gm/dl in females and it was also found to be highly significant (p<0.001) when compared with pretreatment mean Hb of the females. However difference of three months post treatment mean Hb of males and females (10.28 +- 0.89 vs 10.30 +- 0.91 gm /dl) was found to be insignificant (p=0.954).

Only 3/142 (2.1%) patients had mild side effects like rash, shivering and fever. Serious side effects like hypotension or shock were not observed in any patient.

DISCUSSION

Iron is an essential trace element which plays a vital role in many body functions like synthesis of hemoglobin, energy metabolism, myoglobin formation, neurotransmitter production, collagen formation and normal functioning of the immune system11, 12. In general population one of the main causes of anemia is iron deficiency. Anemia due to iron deficiency is associated with increased mortality and morbidity in children12, 13.

Patients of chronic renal failure on erythropoietin therapy who are dependent on hemodialysis and patients with iron deficiency anemia not responding to oral therapy have been treated successfully for years with intravenous iron14. Iron dextran, a high molecular weight iron compound, was used extensively in the past but its use was associated with life threatening anaphylaxis. Therefore, use of iron dextran and other iron preparations had been very limited in children with hematological disorders.

At present, there are many parenteral iron preparations available which include iron sucrose, ferric gluconate, low molecular weight iron dextran and the newest preparation ferumoxytol. These preparations have a much better safety profile than HMW iron dextran and have now replaced HMW dextran for treatment of anemia in both children and adults13. FDA has approved intravenous (IV) iron sucrose for non-dialysis dependent patients with anemia in 2000.

Intravenous iron therapy is superior to oral iron treatment and has several advantages such as faster and higher increase in hemoglobin levels and replenishment of body iron stores. For these reasons, modern parenteral formulations of iron have emerged as effective and safe alternatives for management of iron deficiency anemia.

This study revealed that 142 patients who completed the study showed good response and there was significant rise in the Hb (2.43gm/dl) 3 months after a single dose replacement therapy. Both males and females showed equal response and there was no significant statistical difference. Similar results were observed by Akin et al15 who found a mean rise of 1.8 gm/dl, 6 weeks after the treatment. There is limited data from Pakistan regarding use of injectable iron in children in iron deficiency anemia however one small scale study revealed almost similar resuts16. Similar results were also found by Plummer et al17 and Wall et al18 who found a mean rise of 2 gm/dl in Hb levels.

In this study only few patients had mild side effects and the same was observed by Plummer et al,17 Wall et al18 and Siddiqui19 et al.

CONCLUSION

Parenteral iron therapy is a good alternative in children who are suffering from iron deficiency anemia and cannot tolerate oral iron due to its gastro-intestinal side effects.

CONFLICT OF INTEREST

This study has no conflict of interest to declare by any author.

REFERENCES

1. McLean E, Cogswell M, Egli I, Wojdyla D, De Benoist B. Worldwide prevalence of anaemia, WHO vitamin and mineral nutrition information system, 1993-2005. Public Health Nutr. 2009; 12(4): 444-454.

2. Ullah I, Zahid M, Sthanadar AA, Sthanadar IA, Ali PA, Khan MI, et al. Iron Deficiency Anemia in School Age Children in District Karak Khyber Pakhtunkhwa Province, Pakistan. OJBD. 2014; 4(2): 9-15.

3. Khan SHM, Sohail M, Ali A, Akhtar N, Khan H, Rasool F. Symptoms-Based Evaluation of Iron Deficiency Anemia in Students of Bahawalpur Correlated with their Eating Habits. Trop J Pharm Res. 2014; 13(5): 769-72.

4. Akhtar S, Ghaffar F. Prevalence of Anemia in under five-year-old Children in the Kuwait Teaching Hospital Peshawar, Khyber Pakhtunkhwa. PUTAJ Humanities and Social Sciences. 2014; 21(2): 165-71.

5. Organization WH. Worldwide prevalence of anaemia 1993-2005: WHO global database on anaemia. 2008.

6. Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B, et al. Developmental potential in the first 5 years for children in developing countries. The Lancet. 2007; 369(9555): 60-70.

7. Walker SP, Wachs TD, Gardner JM, Lozoff B, Wasserman GA, Pollitt E, et al. Child development: risk factors for adverse outcomes in developing countries. The lancet. 2007; 369(9556): 145-57.

8. Lozoff B, Jimenez E, Smith JB. Double burden of iron deficiency in infancy and low socioeconomic status: a longitudinal analysis of cognitive test scores to age 19 years. Arch Pediatr Adolesc Med. 2006; 160(11): 1108-13.

9. Schroder O, Mickisch O, Seidler U, de Weerth A, Dignass AU, Herfarth H, et al. Intravenous iron sucrose versus oral iron supplementation for the treatment of iron deficiency anemia in patients with inflammatory bowel disease-a randomized, controlled, open-label, multicenter study. Am. J. Gastroenterol. 2005; 100(11): 2503-9.

10. http://www.globalrph.com/irondeficit.htm

11. Munoz M, Villar I, Garcia-Erce JA. An update on iron physiology. World J. Gastroenterol. 2009; 15(37): 4617.

12. Hersko C. Prevalence and causes of iron deficiency anaemia. In: Beaumont C, Beris P, Beuzard Y, Brugnara C, editors. Disorders of iron homeostasis, erythrocytes, erythropoiesis. Paris: European School of Haematology; 2006: 409-19.

13. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006; 21(2): 378-82.

14. Morgan HE, Gautam M, Geary DF. Maintenance intravenous iron therapy in pediatric hemodialysis patients. Pediatr Nephrol. 2001; 16(10): 779-83.

15. Akin M, Atay E, Oztekin O, Karadeniz C, Karakus YT, Yilmaz B, et al. Responsiveness to parenteral iron therapy in children with oral iron-refractory iron-deficiency anemia. Pediatr Hematol Oncol. 2014; 31(1): 57-61.

16. Iqbal M, Malik B. Parenteral iron therapy in malnourished children. Pakistan Armed Forces Med J. 2006; 56: 271-5.

17. Plummer ES, Crary SE, McCavit TL, Buchanan GR. Intravenous low molecular weight iron dextran in children with iron deficiency anemia unresponsive to oral iron. Pediatr Blood Cancer. 2013; 60(11): 1747-52.

18. Wall GC, Pauly RA. Evaluation of total-dose iron sucrose infusions in patients with iron deficiency anemia. Am J Health Syst Pharm. 2008; 65(2): 150-3.

19. Siddiqui SS, Jaybhaye DL, Kale A, Kakade J, Engade M, Haseeb M. Efficacy and safety of intravenous iron sucrose therapy in a group of children with iron deficiency anemia. Int J Contemp Pediatr. 2015; 2(1): 12-6.
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Publication:Pakistan Armed Forces Medical Journal
Date:Oct 31, 2016
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