Eurl Haeniatol IY9X: 60: 119-124 Prinred in UK - all righrs reserved Copvrighr 0 Munksgaard I998 EUROPEAN JOURNAL OF HAEMATOLOGY ISSN 0902-4441 A comDarison between intravenous iron polymdtose complex (Ferrum Hausman@) and oral ferrous fumarate in the treatment of iron deficiency anaemia in pregnancy Singh K, Fong YF, Kuperan I? A comparison between intravenous iron polymaltose complex (Ferrum Hausmann@) and oral ferrous fumarate in the treatment of iron deficiency anaemia in pregnancy. Eur J Haematol 1998: 60: 119-124. 0 Munksgaard 1998. Abstract: Anaemia is the most common medical disorder in pregnancy with iron deficiency anaemia accounting for the majority of cases. Over 90% of the iron deficiency anaemia is due to red cell iron deficiency associated with depleted iron stores and deficient intake. The two main modalities of treating iron deficiency anaemia are oral or parenteral iron. Ferrous Hausmanna (iron dextrin) is the latest iron preparation which can be used for intravenous parenteral administration as a total dose infusion. This study compares the efficacy of Ferrum Hausmann@ with oral ferrous fumarate therapy in the treatment of iron deficiency anaemia in pregnancy. Our study shows that treatment with intravenous Ferrum HausmannO (iron dextrin) resulted in a significantly better level and rate of increase of haemoglobin (p<O.OOl). Serum ferritin, which is the best indicator of iron stores, was significantly higher (p<O.OOl) in the intravenous group. Other indices of iron status such as serum iron, serum transferrin and zinc protoporphyrin also showed a significant improvement in the intravenous group compared to those given oral iron. The results suggest that intravenous iron as a total dose infusion is able to replenish iron stores more efficiently, completely and at a faster rate than oral iron therapy, thus providing the fuel for stimulation of full erythopoiesis compared to oral iron. There were also no reports of any adverse reactions with intravenous iron dextrin, whereas there were a considerable proportion of women on oral iron therapy who reported side effects. In conclusion, intravenous iron therapy with Ferrous HausmannO (iron dextrin) is a suitable, effective and safe alternative to oral iron therapy in the treatment of iron deficiency anaemia in pregnancy. Anaemia is the most common medical disorder in pregnancy (1). Conservative estimates indicate that 1500 million people are anaemic worldwide, with the majority (1400 million) in the developing world (2). It is a major contributing factor to maternal mortality and morbidity and is also said to increase perinatal morbidity and mortality by causing intra- uterine growth retardation, low birth weight and preterm delivery (3-7). Pathological anaemia of pregnancy is mainly due to iron deficiency (8). Over 90% of anaemia is due to red cell iron deficiency associated with K. Singh', Y. F. Fong' and P. Kuperan' 'Department of Obstetrics and Gynaecology, and 'Department of Haematology, National University Hospital, Lower Kent Ridge Road, Singapore 119074 Key words: iron deficiency anaemia - parenteral iron Correspondence: Kuldip Singh, Associate Professor and Senior Consultant, Department of Obstetrics and Gynaecology, National University Hospital, Lower Kent Ridge Road, Singapore 119074 Accepted for publication 9 October 1997 depleted iron stores and deficient intake (9-1 1). Oral iron is the treatment of choice and almost all women can be treated effectively with oral prepara- tions. However, parenteral iron becomes necessary under certain circumstances and may be justified under the following situations: unable to tolerate side effects of oral iron, inflammatory bowel disease, peptic ulcer, etc., noncompliance, documented iron malabsorption and pregnancies near term. Parenteral iron provides quick and certain cor- rection of the total iron deficit. It not only corrects the anaemia but also builds iron stores. This can be 119
Transcript
Eurl Haeniatol IY9X: 60: 119-124 Prinred in UK - all righrs reserved
Copvr ighr 0 Munksgaard I998 EUROPEAN
JOURNAL OF HAEMATOLOGY ISSN 0902-4441
A comDarison between intravenous iron polymdtose complex (Ferrum Hausman@) and oral ferrous fumarate in the treatment of iron deficiency anaemia in pregnancy Singh K, Fong YF, Kuperan I? A comparison between intravenous iron polymaltose complex (Ferrum Hausmann@) and oral ferrous fumarate in the treatment of iron deficiency anaemia in pregnancy. Eur J Haematol 1998: 60: 119-124. 0 Munksgaard 1998.
Abstract: Anaemia is the most common medical disorder in pregnancy with iron deficiency anaemia accounting for the majority of cases. Over 90% of the iron deficiency anaemia is due to red cell iron deficiency associated with depleted iron stores and deficient intake. The two main modalities of treating iron deficiency anaemia are oral or parenteral iron. Ferrous Hausmanna (iron dextrin) is the latest iron preparation which can be used for intravenous parenteral administration as a total dose infusion. This study compares the efficacy of Ferrum Hausmann@ with oral ferrous fumarate therapy in the treatment of iron deficiency anaemia in pregnancy. Our study shows that treatment with intravenous Ferrum HausmannO (iron dextrin) resulted in a significantly better level and rate of increase of haemoglobin (p<O.OOl). Serum ferritin, which is the best indicator of iron stores, was significantly higher (p<O.OOl) in the intravenous group. Other indices of iron status such as serum iron, serum transferrin and zinc protoporphyrin also showed a significant improvement in the intravenous group compared to those given oral iron. The results suggest that intravenous iron as a total dose infusion is able to replenish iron stores more efficiently, completely and at a faster rate than oral iron therapy, thus providing the fuel for stimulation of full erythopoiesis compared to oral iron. There were also no reports of any adverse reactions with intravenous iron dextrin, whereas there were a considerable proportion of women on oral iron therapy who reported side effects. In conclusion, intravenous iron therapy with Ferrous HausmannO (iron dextrin) is a suitable, effective and safe alternative to oral iron therapy in the treatment of iron deficiency anaemia in pregnancy.
Anaemia is the most common medical disorder in pregnancy (1). Conservative estimates indicate that 1500 million people are anaemic worldwide, with the majority (1400 million) in the developing world (2). It is a major contributing factor to maternal mortality and morbidity and is also said to increase perinatal morbidity and mortality by causing intra- uterine growth retardation, low birth weight and preterm delivery (3-7).
Pathological anaemia of pregnancy is mainly due to iron deficiency (8). Over 90% of anaemia is due to red cell iron deficiency associated with
K. Singh', Y. F. Fong' and P. Kuperan' 'Department of Obstetrics and Gynaecology, and 'Department of Haematology, National University Hospital, Lower Kent Ridge Road, Singapore 119074
Key words: iron deficiency anaemia - parenteral iron
Correspondence: Kuldip Singh, Associate Professor and Senior Consultant, Department of Obstetrics and Gynaecology, National University Hospital, Lower Kent Ridge Road, Singapore 119074
Accepted for publication 9 October 1997
depleted iron stores and deficient intake (9-1 1). Oral iron is the treatment of choice and almost all women can be treated effectively with oral prepara- tions. However, parenteral iron becomes necessary under certain circumstances and may be justified under the following situations: unable to tolerate side effects of oral iron, inflammatory bowel disease, peptic ulcer, etc., noncompliance, documented iron malabsorption and pregnancies near term.
Parenteral iron provides quick and certain cor- rection of the total iron deficit. It not only corrects the anaemia but also builds iron stores. This can be
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given either by the intramuscular or intravenous route. The main drawback of intramuscular injection is the pain and staining of the skin at the injection site and development of myalgia, arthralgia and abscess formation at the injection site. The benefits of intravenous administration of iron are that it avoids the pain and inconvenience of repeated intra- muscular injections. However, full consideration must be given to possible benefits and risks, e.g. anaphylactic shock, and all safeguards taken: the patient should be admitted, resuscitation equip- ment must be available by the bedside, with the correct technique and infusion rate as advised by the manufacturers.
Iron dextran was the most widely used paren- teral iron preparation suitable for intravenous administration and there is no doubt as to its value in the treatment of iron deficiency (11-13). How- ever, iron dextran has been withdrawn from the market because of an unacceptably high incidence of adverse reactions, and therefore there is a need to find a suitable alternative for this useful method for correction of iron deficiency.
Ferrum Hausmann@ is the latest iron preparation which can be used for intravenous parenteral administration, although it is registered for intra- muscular application. It is iron dextrin (iron [IIII- hydroxide polymaltose complex) which is very similar to iron dextran in terms of stability, struc- ture and toxicity (14). However, iron dextrin causes none of the well-known dextran-induced anaphy- lactic side effects, as it does not react with iron dextran antibodies. The pharmacokinetic charac- teristic is similar to iron dextran but the terminal half-life is approximately 1 d for iron dextrin compared to 3 d for iron dextran (14-15). Further support for its parenteral use is the fact that the type of polynuclear ferric-hydroxide complexes in iron sucrose, iron dextran and iron dextrin are similar to the physiologically occurring ferritin in their chemical form and structure. The iron is thus bound in a polynuclear, nonionic iron (111)- hydroxide. Iron ions interact strongly with endo- genous iron binding proteins in the body, resulting in denaturation products and partial precipitation which are responsible for the toxicological effects associated with such iron preparations. Thus, the outstanding advantage of dextrin is its low toxicity due to the absence of nonionic iron.
The aim of this study was to compare the efficacy of Ferrum Hausmann@ with oral ferrous fumarate therapy in the treatment of iron deficiency anaemia in pregnancy with regard to the response in haemo- globin level, rate of rise in haemoglobin (Hb), change in iron store status as indicated by the serum ferritin, iron, transferrin and zinc proto- porphyrin levels.
Materials and methods
Study population
The inclusion criteria for the study were: all anaemic women who were literate, 16 yr old or more, who were pregnant with a gestational age of between 20 and 28 wk, with haemoglobin levels below 90 gil and who had iron-deficiency anaemia diagnosed by determining serum ferritin (<20 mg/L), serum iron (< 10 mmol/L), red cell indices (mean corpuscular haemoglobin < 27 pg, mean corpuscular volume <80 fL) after having excluded thalassaemia.
Women with anaemia due to causes other than iron deficiency, e.g. folic acid or vitamin B,, defi- ciency, haemoglobinopathies and chronic bleeding anaemias, were excluded from the study. Those suffering from acute infections, parasitosis, severe disease of the liver and cardiovascular system, kidneys and severe psychiatric disorders were also excluded from the study. Women who had any form of parenteral iron therapy for anaemia within 20 d prior to intended recruitment to this study were excluded. Any woman with a history of allergy, or abnormal reaction to iron therapy, history of alcohol or drug abuse, or if she was not able to comply with the treatment, was also excluded from the study.
The study protocol was approved by the ethical committee of National University Hospital (NUH), Singapore. The first of 100 pregnant women being seen for antenatal care in the Department of Obstetrics and Gynaecology at NUH with iron deficiency and who satisfied the above selection criteria were recruited. Written consent was obtained from the women recruited. The women selected were randomized into 2 treatment arms (50 women each). The first group received parenteral iron via a total dose infusion and the second group received oral iron.
Study design
There was no significant difference between the 2 treatment groups in terms of age, parity, socio- economic status, race, height, weight, history of anaemia in previous pregnancies and obstetric outcome. All women who received the total dose infusion were admitted to our hospital. Half an hour before the start of infusion, they were given an intramuscular injection of promethazine (phen- ergen) 25 mg. The dosage of parenteral iron to be administered was calculated using the formula:
Deficit iron (mg) =0.24 x body weight (Kg) x haemoglobin deficit (g/L) + 500
The haemoglobin deficit was the difference between the target haemoglobin of 150 g/l and the woman’s
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actual haemoglobin level in g/l. The amount of Ferrum Hausmann@ was then calculated by divi- ding the dosage by 50 (1 ml equivalent to 50 mg iron) and added to 500 ml of sterile, normal saline. The first 50 ml were infused slowly at 5-10 drops/ min and the patient observed carefully. If this was well tolerated, the rate was increased to 30 drops/ min, thus completing the entire infusion of 500 ml in about 4 h.
The second group received oral therapy in the form of iron fumarate 200 mg to be taken 3 times daily throughout the study period. The iron tablets were counted before dispensing.
All women recruited into the study were followed-up 4-weekly till about 36 wk gestation. During these visits, a full blood count was done. In addition, all women had their haemoglobin and indices for iron stores checked at 36 wk. Subse- quently, they had weekly antenatal visits until delivery. At delivery, their haemoglobin was meas- ured and at 6 wk postpartum they again had their full blood count and indices for iron stores checked. At each visit, they were questioned with regard to tolerance and compliance of the treatment given. The women on iron therapy were asked to bring their iron tablets and, by simple counting, compli- ance was found to be in order.
Statistical methods
The outcome of treatment was compared at 36 wk, at delivery and at 6 wk postpartum. The difference in treatment effect of intravenous iron and ferrous fumarate was assessed using the analysis of covari- ance (ANCOVA). As the duration of treatment and baseline outcome measures varied between women, these were adjusted to provide a more efficient and unbiased estimate of the treatment effect.
The distribution of haemoglobin and transferrin was approximately normal. On the other hand, there was skewness in the distribution of iron, ferritin and zinc protoporphyrin at baseline and 36 wk of gestation as well as at postpartum. For ease and consistency in the interpretation of results, all these variables and the duration of treatment were transformed using natural logarithm to fulfill the statistical assumption with regard to normality, although for the sake of clarity the values were given as means of untransformed data.
The treatment effect at 36 wk gestation, at delivery and postpartum was evaluated based on “intention to treat” principle. This approach is unbiased, but has the disadvantage that possible drug effects might be diluted if a substantial pro- portion of patients have switched treatment. As about 26% of patients on oral treatment had switched to intravenous treatment at 36 wk of
gestation, further analysis was conducted in rela- tion to the actual treatment received. In all analyses comparing the outcome of treatment in the two different arms, oral treatment was used as the reference for comparison.
All statistical procedures in this study were generated using SPSS for Windows.
Results
Haemoglobin and other indices for iron status
The mean haemoglobin level for the intravenous group and oral group was 81 g/l and 86 g/l, respec- tively (p<O.Ol). All other indices for iron stores (serum iron, ferritin, transferrin and red cell zinc protoporphyrin level) were not statistically dif- ferent between the 2 groups at recruitment (Table 1).
As can be seen from Table 2, there was a highly statistically significant difference in haemoglobin, serum iron, ferritin and transferrin between intra- venous and oral iron treatment groups at 36 wk. An improvement in haemoglobin level, which was the end-point and objective of treatment, was shown to be better in the intravenous group with a 14% higher haemoglobin level than the oral treatment group (p<O.OOl) . Similarly, except for zinc pro- toporphyrin, all other indices for iron status showed a statistically better result in the intra- venous group than the oral group. Ferritin, which is the best indicator of iron stores, showed the most significant change at 36 wk with a 22-fold increase over that of the oral treatment group (p<O.OOl). Serum iron in the intravenous group was 1.9 times that of the oral group (p<O.OOl) and transferrin, which increases in proportion to the severity of iron deficiency, was lowered significantly in the intravenous group compared to the oral group (p <0.001), again confirming that iron deficiency had been corrected at a significantly faster rate in the intravenous group. Red cell zinc protopor- phyrin level was lower in the intravenous group but the difference was not statistically significant (p=O.lS).At delivery, the haemoglobin level of
Table 1. Mean haemoglobin level and indices for iron status at recruitment by treatment group
Variable Parenteral Oral pvalue
Mean haemoglobin level (g/l) k S D 81kO.1 86k0.1 c0.01 Mean iron level (mmol/l) SD 3.6 f0.4 4.8 f 0.5 0.05 Mean ferritin level (mg/l) f SD 7.1 k0.4 8.1 k 0 . 5 0.09 Mean transferrin level (mg/dl)fSO 491.1 f 12.7 479.6k 12.4 0.52 Mean zinc protoporphyrin level
Img/gHb)k SD 6.5k0.5 5.4k0.4 0.10
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Table 2 . Evaluation of treatment effect on haemoglobin level and other iron indices at 36 wk gestation
Estimated ratio of Variable Parenteral Oral means’ (95% CI) pvalue
Haemoglobin (g/l)
Iron (mmol/l)+SD 20.9f2.1 15.1 f1 .6 1.90 (1.38-2.63) <0.001 Ferritin (mg/ l )kSD 426.4k57.2 20.2k2.1 21.94 (16.30-29.531 <0.001 Transferrin (mg/dl)
118 gm/l in the intravenous group was still signifi- cantly higher than that of 112 g d l in the oral group (p=0.002), although the increase in haemoglobin level in the intravenous group had dropped to 7% at delivery. At 6 wk postpartum, the haemoglobin was 5% higher in the intravenous group than the oral group. This difference was still statistically significant (p=0.025) (Table 3). All indices for iron status were better in the intravenous group than compared with the oral group even at 6 wk post- partum (Table 3), although this did not achieve statistical significance for zinc protoporphyrin. Serum iron in the intravenous group was 1.3 times that of the oral group (p=0.012) and serum ferritin levels, which give the most accurate assessment of iron stores, was significantly higher in the intra- venous iron group @<0.001). In addition, trans- ferrin levels were also statistically lower in the intravenous group (p<O.OOl), indicating again that iron stores are replete. Red cell zinc protopor- phyrin which increases in iron deficiency was in the normal range in both groups, although the absolute value was still lower in the intravenous group; the difference did not achieve statistical significance (p = 0.094).
Table 3. Evaluation of treatment effect on haemoglobin level and other iron indices at postpartum
There were 13 (26%) women who were on oral treatment who did not respond to oral treatment and therefore had to be switched to intravenous iron treatment at 36 wk gestation. All 13 showed an average rise of 38 g/1 (mean haemoglobin 83 g/l at 36 wk vs. 121 g/l at 6 wk postpartum) over their previous uncorrected haemoglobin levels 0, <0.001). Since it is arguable that analysis by “intention to treat” included this group of nonresponders to oral treatment in the oral group, and therefore might possibly affect the outcome of oral treatment result at 6 wk postpartum, a subanalysis was carried out leaving out these 13 non-responders in the oral treatment group, i.e. 50 women with intravenous iron therapy vs. 37 women with oral iron therapy. At delivery, with the above subanalysis, the haemo- globin level of 118 g d l was still statistically higher in the intravenous group than that of 115 gm/l in the oral group (p=0.043). At 6 wk postpartum, the results of this subanalysis remained similar to the results based on the original “intention to treat” principle.
Rate of change of haemoglobin level and other iron indices
The rate of change for haemoglobin level and other indices were calculated at 36 wk and the difference in the rate of change per week between the 2 groups using oral treatment as reference were tested for statistical significance (Table 4).
As expected, there was a faster rise in serum ferritin levels (p<O.OOl) for the intravenous group since a total dose infusion which is supposed to replenish all iron stores were given. Similarly, for transferrin (p <0.001) and zinc protoporphyrin (p=0.04), these parameters reflect the improve- ment in iron status of the patient and therefore would occur at a faster rate with total dose infusion. More importantly, it was found in our trial that there was a significantly faster rate of rise in haemoglobin level (0.3 g/wk) with the intravenous group compared to oral group (p <0.001). Although there was a faster rate of rise in serum iron levels this did not achieve statistical significance (p=0.097).
Estimated ratio of Variable Parenteral Oral means’ (95% CI) pvalue
Table 4. Difference in rate of change for haemoglobin level and other iron indices at 36 wk
Haemoglobin (g/l)
Iron (mmol/ l IkSD 13.3k0.7 11.4k0.7 1.29 (1.06-1.58) 0.012 Ferritin (mg/ I )kSD 200.5f208 108.1 f19.9 3.01 (1.97-4.6) <0.001 Transferrin (mg/dl)
Zinc protoporphyrin
f SD 125f0.1 119kO.2 1.05 (1.01-1.09) 0.025
f SD 238.3 f 5.3 280.7 f 10.8 0.86 (0.79-0.93) <0.001
Comparison of oral and parenteral iron in pregnancy
Side-effects
All women in the intravenous group reported good tolerance in contrast to about half those on oral iron. No side effects, such as fever, flushing, headache, vomiting, myalgia or arthralgia, were reported for the intravenous group. Various side effects such as nausea, vomiting, constipation and diarrhoea, were reported for the oral group.
Obstetric outcome
There was no difference in obstetric outcome between the 2 groups in terms of mode of delivery, gestational age at delivery and occurrence of post- partum haemorrhage, blood loss at delivery, gender of baby, birth weight, incidence of intrauterine growth retardation, malformation rate and Apgar scores at 1 and 5 min after delivery .
Discussion
Although oral iron is the first choice for treating iron deficiency anaemia, intravenous iron becomes necessary under certain circumstances (7). Oral iron is effective in treating iron deficiency anaemia, but its efficacy depends very much on patient compliance. The most common reason for failure of treatment is lack of compliance, related to the length of time of treatment and to gastrointestinal side-effects (16). With oral iron, stores would not be replenished unless the woman continues to take oral iron for 3-6 months after restoration of normal haematological values (7). Although it is often stated that there is no advantage in paren- teral administration as far as response to therapy is concerned (17), and haemoglobin is said to rise at a similar rate, iron stores are more efficiently replenished with parenteral iron (17). Several authors have shown that, in cases of severe anae- mia, parenteral iron is the only effective therapy to supply enough iron for erythropoiesis (18-20). Others have said that oral preparations do not stimulate erythropoiesis quickly and reliably enough
Our study shows that intravenous iron treatment with Ferrum Hausmann@ (iron dextrin) resulted in a significantly better level of haemoglobin (p<O.OOl) and also other parameters of iron status at 36 wk gestation compared with oral treatment (Table 2). The haemoglobin level remained statis- tically higher (p =0.002) for the intravenous group at delivery compared with the oral group. Again, at 6 wk postpartum, the haemoglobin level was significantly higher (p=0.025).
Serum ferritin level, which is the best indicator of iron stores, was significantly higher (p<O.OOl) in
(21).
the intravenous group than the oral group at 36 wk, and at 6 wk postpartum. This reinforces the obser- vation that parenteral iron is able to replenish iron stores more efficiently, completely and at a faster rate than oral iron therapy. This is certainly an advantage as far as preventing iron deficiency anaemia is concerned, because most women will stop taking iron supplements once there is haema- tological improvement or when they have reached the end of their pregnancy (7, 13, 22). This means that their iron stores are far from replete and thus would be at risk of iron deficiency anaemia subse- quently. This has also been shown by Bhatt (7), who followed-up 2 series of women, 1 with total dose infusion with iron dextran and the other with oral iron. These women were followed in the next pregnancy and their haemoglobin level was esti- mated. It showed at 72% of the women who had total dose infusion of iron dextran in the previous pregnancy maintained a haemoglobin level of more than 10 g/dl. Of those who were given oral iron in the previous pregnancy, only 18% had haemo- globin more than 10 g/dl.
Other indices of iron status showed a significant improvement in the intravenous group compared to the oral group. Serum iron concentrations reflect the balance between the flow of iron into and out of the plasma pool and thus, when iron stores are depleted, the serum concentration will generally be reduced. Conversely, when iron stores are filled, the serum iron will also increase. The serum iron concentration in the intravenous group was signifi- cantly higher than the oral group both at 36 wk and at 6 wk postpartum (p<O.OOl and p=0.012, respectively), thus suggesting that intravenous iron treatment results in a better and more complete replenishment of iron stores that persists even up to 6 wk postpartum.
For serum transferrin, which is a transport protein for iron, it increases in iron deficiency and decreases when iron stores are filled. At both 36 wk and at 6 wk postpartum, serum transferrin level was signifi- cantly lower in the intravenous group (p<O.OOl), again demonstrating that iron stores were more replete with intravenous treatment. Zinc protopor- phyrin, which is an indicator of iron deficient erythropoiesis and which increases in iron defi- ciency, was lower in the intravenous group than compared to the oral group, although this did not achieve statistical significance (p=0.15 at 36 wk and p=0.094 at 6 wk postpartum).
Our results showed that the group treated with intravenous iron had a significantly faster rate of rise in haemoglobin level of 0.3 g/l/wk than the group treated with oral iron (p<O.OOl) (Table 4). This could be an added advantage in treatment with parenteral intravenous iron therapy. A possible
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explanation could be that as total dose infusion with iron dextrin replenished the iron stores com- pletely, this would provide the fuel for stimulation of full erythropoiesis, whereas oral iron which replenished iron stores at a slower rate would result in a slower rate of rise in haemoglobin. The fact that other indices of iron status which include fer- ritin, transferrin and zinc protoporphyrin improved at a significantly faster rate with intravenous iron therapy lends further evidence to this observation.
Although at 36 wk gestation the group on oral therapy was still anaemic compared with the parenteral group (Table 2), there was still a lag period of a few wk before delivery of the fetus. Thus at the time of delivery, the haemoglobin value in the oral group was marginally lower than the parenteral group. Thus it is not surprising that there was no statistical difference in the birth weight of the babies in the 2 groups studied.
There has always been a fear of rare anaphylactic reactions (13, 23) and other adverse side effects with parenteral iron therapy (16-17). However, in our study with iron dextrin, there were no reports of any adverse reactions. In France, where iron dextrin has been used widely by the manufacturers for intramuscular administration for many years, no severe allergic side effects have been reported (14).
Conclusion
In summary, our results show that parenteral intravenous therapy with iron dextrin for iron- deficiency anaemia is effective and efficacious, with a faster rate of improvement in haemoglobin level and other indices of iron status with no adverse side-effects. It certainly has merits and is a suitable and safe alternative to oral iron therapy in the treatment of severe iron deficiency anaemia.
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