A 1-year randomized trial of deferasirox alone versus deferasirox and deferoxamine combination for the treatment of iron overload in thalassemia major
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis. 2019
AIM: Iron chelators are extensively used to reduce iron overload. Our purpose was to compare effects of deferasirox versus deferasirox and deferoxamine in patients with thalassemia major. METHODS This randomized and double blind trial was performed on 62 patients. Patients were assigned 1:1 to oral 30 mg/kg deferasirox daily or oral 30 mg/kg deferasirox daily plus SC 50 mg/kg deferoxamine for 5 days a week. Treatment continued for 12 months in both groups. RESULTS Fifty-five patients completed the 1 year of treatment. Mean age was 24.5 years with an excess of females. Combined therapy caused a significant increase in myocardial T2* from 23.1 +/- 7.5 ms at baseline to 27.1 +/- 7.0 ms at 12 months (P < 0.05). This difference was statistically significant between 2 groups at 12 months (P = 0.01). Combined therapy and monotherapy had no significant effect on liver T2*. At 12 months, serum ferritin levels were reduced in two groups; however, the difference was significant (737 +/- 459 mug/ml vs 1085 +/- 919 mug/ml, P < 0.01). CONCLUSION Our study indicates that combined treatment with deferasirox and deferoxmaine is more effective than deferasirox for reduction of iron over load in patients with thalassemia major.
Comparative evaluation of the safety and efficacy of recombinant FVIII in severe hemophilia A patients
Journal of Pharmacopuncture.. 2018;21((2)):76-81.
Objective: This study compared the safety and efficacy of Safacto versus xyntha in patients with severe hemophilia A. Methods: Thirty-three male patients with severe hemophilia A were randomly divided into two groups. Seventeen patients received Safacto and 16 patients received Xyntha for four consecutive times. The dosage of FVIII was 40-50 IU/kg for each injection. Plasma level of FVIII activity was evaluated before every injection, 15 minutes after the injection and one month after the start of the trial. The rate of factor VIII activity, pain and joint motion were also assessed before and after the treatment. Results: Plasma level of FVIII clotting activity in Safacto and Xyntha were 1.96+/-0.5 IU/dl and 1.63+/-0.5 IU/dl and increased to 88.84+/-25.2 IU/dl and 100.09+/-17.8 IU/dl, respectively (P<0.001). Pain score and range of motion improvement were 9.3+/-0.9 and 8.7+/-0.1 in Safacto (P=0.17); and 9.4+/-0.8 and 8.8+/-0.3 in Xyntha (P=0.35), respectively. No allergic or other unfavorable reactions was observed with either of the preparations. Conclusion: This study showed that Safacto has a favorable efficacy and safety profile.
Comparison between IV immune globulin (IVIG) and anti-D globulin for treatment immune thrombocytopenia: a randomized open-label study
Fundamental & Clinical Pharmacology. 2016;30((4):):385-389. 385
OBJECTIVE To compare the effect of IV immune globulin (IVIG) and anti-D globulin (anti-D) for treatment of immune thrombocytopenia (ITP) in children. METHODS A randomized, open-label, single center clinical trial was done in Amir-Kabir Hospital (Arak, Iran). The study was performed on 60 children with ITP, aged from 1 to 15 years. Patients were randomly assigned (1:1) to 50 mug/kg Anti-D or 1g/kg IVIG. Platelet counting was done at baseline, and 3 days, 7 days and 14 days after treatment termination. Safety assessment was done in all patients. RESULTS Anti-D caused a quicker response on the 3rd day of treatment (P <0.001). Both drugs caused a significant rise in number of platelets on the 7th and the 14th day of treatment. Compared to IVIG, except a significant drop in hemoglobin concentration (P < 0.001), anti-D had lower rate of side effects including fever (P < 0.05), allergy (P < 0.01), and headache (P < 0.001). CONCLUSION Our results showed that anti-D was associated with rapid rise of platelets compared to IVIG. In addition, anti-D treatment had acceptable safety profile. This article is protected by copyright. All rights reserved.