ABSTRACT
Nowadays, bypassing agents such as recombinant activated factor VII (rFVIIa) and activated prothrombin complex concentrates (aPCC) are used to treat bleeding episodes in the Hemophilia patients with inhibitors. AryoSeven® is an Iranian biogeneric rFVIIa with homogeneity of efficacy and the nature to NovoSeven in a comparative trial. The current clinical trial aimed to evaluate the cost-effectiveness of FEIBA and AryoSeven® by Decision Analytic Model according to the Iranian healthcare system. An open label, multi-center, cross-over clinical trial was designed. Patients were categorized into 3 groups based on their prior tendency to one or none of the products. To determine the premium therapeutic strategy, the Incremental cost-effectiveness ratio (ICER) was calculated. Protocol F led to more treatment success in group F than the other groups (P= 0.03). Also, there was a significant statistical difference between the mean of effectiveness scores in the groups using protocol F (P = 0.01). The effectiveness of protocol F and A were 89% and 72%, respectively. ICER cost US$ to manage an episode of bleeding to get one more unit of effectiveness using FEIBA VS. AryoSeven. Although the results showed that AryoSeven was more cost-effective compared to FEIBA, the two strategies were undominated. In other words, both medicines can be applied in the first line of the treatment if the cost of FEIBA was reduced. The present clinical trial was registered at IRCT website, under ID No.2013020612380N1.
ABSTRACT
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ABSTRACT
BACKGROUND: Iron deficiency is a public problem in women, which contributes to the high percentage of deferred blood donations in this group. This study evaluated the effect of iron supplementation in improving iron stores to promote safe blood donation in women. STUDY DESIGN AND METHODS: A total of 412 female blood donors were randomly recruited for the study. The volunteers were scheduled for an initial visit and three subsequent visits at 4-month intervals for possible repeat donation. Each volunteer was given 21 tablets of 150 mg of ferrous sulfate or placebo to be taken three times daily for 1 week after each blood donation. Their hemoglobin (Hb) concentration, hematocrit (Hct), serum ferritin, total iron-binding capacity (TIBC), and percent saturation of the TIBC were tested throughout the course of the study. RESULTS: The group taking ferrous sulfate showed no significant difference between the mean initial and final result for any of the values other than Hb values, whereas there was a significant decline in mean Hb, Hct, serum iron, serum ferritin, and percent saturation in the group taking placebo. Hb concentrations declined significantly in both groups; however, it was more severe in the placebo group when compared to the ferrous sulfate group. The relative risk of iron deficiency in placebo group was 3.6 (95% confidence interval = 1.73-7.74). CONCLUSION: The results indicate that supplementation therapy can be considered as one of the strategies to promote safe blood donation in women. A quantity of 150 mg of elemental iron per day as ferrous sulfate, however, is not the correct dose for Iranian female donors.
