Evaluation of efficacy and tolerability of RB tone forte tablet in the treatment of pregnancy anaemia.

摘要

In India < 90% of anaemia cases are estimated to be due to iron deficiency, because high iron requirements during pregnancy are not easily fulfilled by dietary intake. Ferrous ascorbate is widely prescribed iron salt in India but still no trial of ferrous ascorbate in Indian patients has been published. The study is to aim the evaluation of efficacy and tolerability of RB Tone forte tablet in the treatment of pregnancy anaemia. Fifty-five pregnant women (> 18 years) with haemoglobin value between 8 and 11 g/dl in 13th week of pregnancy were included in the study. The duration of study was 6 months. Study drug RB Tone forte tablet, (Medley pharmaceutical, Mumbai) containing ferrous ascorbate equivalent to elemental iron 100 mg + folic acid 1.5 mg + elemental zinc 22.5 mg was prescribed once daily to all pregnant women from 13th week of pregnancy for a duration of 6 months. Haemoglobin was assessed at the beginning of the therapy and at the end of the trial. Study included birth weight and gestational age as outcomes because of a need for more information on the functional consequences of iron supplementation during pregnancy. Tolerability was evaluated based on the global assessment by the investigator and patients on a 3-point scale marked as excellent/good/poor. Fifty patients were included for final analysis, 5 patients lost to follow-up. Haemoglobin levels increased from the mean baseline value of 8.950 +/- 0.1422 g/dl to 11.91 +/- 0.07840 g/dl, with mean increase of 2.964 +/- 0.1624 g/dl at the end of trial (p < 0.0001). Mean birth weight of infants (n = 50) was found to be 3079 +/- 25.10 g. Mean gestational age at the time of delivery was 38 weeks. No preterm delivery was reported, As per investigators assessment about tolerability of trial drug, 48% of patients reported good, 46% excellent and 6% reported poor tolerability. As per patient's assessment about tolerability 92% of patients reported good to excellent tolerability and 8% reported poor tolerability. All patients reported excellent gastro-intestinal tolerability of study drug. Positive effect on pregnancy outcome like gestational age and birth weight is mainly attributed to vasodilating property of ferrous ascorbate and beneficial effect of zinc. Ferrous ascorbate must be preferred as first choice of oral iron salt due to positive effect on haemoglobin value, vasodilating property and superior tolerability.