Evaluation of a biosimilar recombinant alpha epoetin in the management of anemia in hemodialysis patients

Background: The efficacy of human recombinant erythropoietins (rHuEPOs) in the treatment of anemia with different etiologies is proven. Development of biosimilar rHuEPO products with lower cost and wider availability is important for the care of anemic patients. Objective: The aim of the present study was to determine the bioequivalence and safety of a biosimilar rHuEPO (Pastopoitin^®) and compare it with the innovator product Eprex^®, as a standard rHuEPO. Methods: One hundred and seven anemic patients on stable hemodialysis were recruited to this randomized double-blind comparative trial and assigned to either subcutaneous Pastopoitin (n = 50) or Eprex (n = 57). Each study group received rHuEPO at a dose of 80–120 IU/kg/week in 2–3 divided doses for a period of 3 months. Hematologic parameters including Hemoglobin, hematocrit, RBC, EBC, platelet, MCV, MCH and MCHC were checked every 2 weeks. Blood iron, ferritin, TIBC, creatinine, BUN and electrolytes (Na, K, Ca and P) were evaluated monthly over the 3 months. Results: A significant increase in hemoglobin, hematocrit and RBC was observed by the end of study in both Pastopoitin and Eprex groups (p < 0.001). However, these factors were not significantly different between the groups, neither at baseline nor at the end of study (p > 0.05). Likewise, the groups were comparable regarding MCV, MCH, MCHC, iron, ferritin, TIBC, creatinine, BUN and electrolytes at baseline as well as at the end of trial. Adverse events were not serious and occurred with the same frequency in the study groups. Conclusion: Pastopoitin showed comparable efficacy and safety profile with Eprex in anemic patients on hemodialysis. Hence, Pastopoitin may be considered as a rHuEPO with a lower cost and wider availability compared with the innovator product Eprex.     

Optimization of Hormonal Combinations for In Vitro Regeneration of Lesser Periwinkle (Vinca minor L.) and Assessment of Genetic Homogeneity

Proceedings of the National Academy of Sciences, India Section B: Biological Sciences - Lesser Periwinkle (Vinca minor L.) is an important source of valuable secondary metabolites. To survey the...     

Relationship between stuttering severity in children and their mothers speaking rate.

CONTEXT AND OBJECTIVE: Stuttering is a complex disease that influences occupational, social, academic and emotional achievements. The aim of this study was to correlate the stuttering severity index with speaking rates of mothers and children. DESIGN AND SETTING: Cross-sectional study, at the child rehabilitation clinics of Tehran city. METHODS: 35 pairs of mothers and their children who stuttered were studied. There were 29 boys and six girls, of mean age 8.5 years (range: 5.1-12.0). Speech samples from the mother-child pairs were audiotaped for approximately 15 minutes, until a reciprocal verbal interaction had been obtained. This sample was then analyzed in accordance with a stuttering severity index test and speaking rate parameters. RESULTS: The research results outlined a significant relationship between the mothers speaking rate and their childrens stuttering severity. CONCLUSION: The results suggest that the mothers speaking rate should be incorporated in the assessment and treatment of stuttering.     

Oral contraceptives and bone mineral density: A population-based study

OBJECTIVE: We sought to test the hypothesis that exposure to oral contraceptives protects the skeleton. STUDY DESIGN: Multiple regression techniques were used to analyze data for a random sample of 710 Australian women (age range, 20-69 years). Bone mineral density was measured at the lumbar spine, proximal femur, whole body, and distal forearm. Oral contraceptive exposure was assessed by a questionnaire. RESULTS: Women exposed to oral contraceptives had a 3.3% greater mean bone mineral density adjusted for body mass index and age at the lumbar spine (partial r (2) = 0.009; P =.014). Adjusted mean vertebral bone mineral density was 3.3% greater for premenopausal women (partial r (2) = 0.008; P <.05), but the effect did not reach significance among postmenopausal women. Higher bone mineral density was associated with increased duration of exposure, with a mean increase of 3.2% associated with the first 5 years and a further 0.2% with >/=5 years of exposure. No association was detected at other sites. CONCLUSION: Exposure to oral contraceptives may be associated with higher lumbar spine bone mineral density.     

Platelet count and MPV,routinely measured but ignored parameters used in conjunction with the diagnosis of acute coronary syndrome: single study center in Iranian population, 2010

Background

Myocardial infarction is the major cause of morbidity and mortality in industrialized countries. Platelet count and the mean platelet volume (MPV), a simple and reliable indicator of platelet size which correlates with platelet activation, might associate with troponin in acute chest pain.

Methods

We analyzed MPV of 851 patients who were admitted to Rasoul-e-Akram Hospital with acute chest pain during the year 2010. Two blood samples were taken from each patient within 4 hours of their arrival for routine hematology, including platelet count and MPV, and cardiac troponin T. Also, electrocardiograms of the patients were recorded. Association of MPV and platelet count with troponin was observed.

Results

The patients in troponin positive group, who had also ischemic electrocardiographic changes, had higher MPV values than non- acute coronary syndrome (ACS) patients with normal cardiac troponin T levels (9.9 vs 9.5 fl with p< 0.001). In troponin negative group, the mean of platelet count was higher than that in the positive group (221683 vs 198814/µl with p< 0.001).

Conclusion

MPV and platelet count are inexpensive laboratory tests which can be measured in association with other laboratory biomarkers in patients presenting with acute chest pain.This could help to lower hospitalization rates and also avoid misdiagnosis and having complications of patients with ACS.