A Phase III,randomized, open‐label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy

Iron deficiency anemia (IDA) is the most common form of anemia worldwide. Although oral iron is used as first‐line treatment, many patients are unresponsive to or cannot take oral iron. This Phase III, open‐label, non‐inferiority study compared the efficacy and safety of ferumoxytol, a rapid, injectable intravenous (IV) iron product with low immunological reactivity and minimal detectable free iron, with IV iron sucrose in adults with IDA of any cause. Patients (N = 605) were randomized 2:1 to receive ferumoxytol (n = 406, two doses of 510 mg 5 ± 3 days apart) or iron sucrose (n = 199, five doses of 200 mg on five nonconsecutive days over 14 days) and followed for 5 weeks. Ferumoxytol demonstrated noninferiority to iron sucrose at the primary endpoint, the proportion of patients achieving a hemoglobin increase of ≥2 g dL^?1 at any time from Baseline to Week 5 (ferumoxytol, 84.0% [n = 406] vs. iron sucrose, 81.4% [n = 199]), with a noninferiority margin of 15%. Ferumoxytol was superior to iron sucrose (2.7 g dL^?1 vs. 2.4 g dL^?1) in the mean change in hemoglobin from Baseline to Week 5 (the alternative preplanned primary endpoint) with P = 0.0124. Transferrin saturation, quality‐of‐life measures, and safety outcomes were similar between the two treatment groups. Overall, ferumoxytol demonstrated comparable safety and efficacy to iron sucrose, suggesting that ferumoxytol may be a useful treatment option for patients with IDA in whom oral iron was unsatisfactory or could not be used. Am. J. Hematol. 89:646–650, 2014. © 2014 Wiley Periodicals, Inc.     

Endometrial and peritoneal macrophages: expression of activation and adhesion molecules

PROBLEM: Macrophages are highly individualized in tissues and their activities are a reflection of systemic and local environmental signals. The expression of activation (CD69, CD71) and adhesion (CD54) molecules on the surface of CD14+ endometrial macrophages at various phases of the menstrual cycle was compared with the cell surface receptors of peritoneal fluid macrophages. METHOD OF STUDY: Two-colour-flow cytometry was used to determine the peritoneal and endometrial macrophage phenotype. RESULTS: Endometrium macrophages expressed a lower level of CD69+ and CD54+ macrophages than peritoneal macrophages. However, CD71 receptors displayed similar expression in both macrophage populations, endometrium and peritoneal, except during the proliferative phase. CONCLUSION: These findings demonstrate the differences between macrophages from endometrium and peritoneal fluid with regard to CD69, CD71 and CD54 expression. In addition, increased numbers of endometrial macrophages in the late secretory phase of the menstrual cycle suggest that they may play a role in menstruation.     

Soluble HLA-G in the peritoneal fluid of women with endometriosis

The aim of this study was to determine the level of soluble HLA-G molecules in the peritoneal fluid of endometriosis patients. The findings demonstrate that a soluble HLA-G level in the peritoneal fluid of women with endometriosis is similar to that of the control group.     

Influence of residual blood autotransfused from cardiopulmonary bypass circuit on clinical outcome after cardiac surgery

Autotransfusion of the residual blood from the cardiopulmonary bypass (CPB) circuit is considered to be one of the methods enabling reduction in the need for transfusion, the possible adverse effects of which are well known and documented. The aim of the study was to evaluate the effectiveness of the autologous autotransfusion of centrifuged red blood cells from the residual blood of the CPB circuit in patients following heart surgery. Three groups of patients who underwent heart surgery were examined. The first group (Group 1) consisted of 37 patients who received all of the residual blood in the bypass circuit after CPB (collected into sterile plastic bags) during the early postoperative period. The second group (Group 2) consisted of 45 patients who did not receive the residual blood following CPB. The third group (Group 3) consisted of 42 patients who underwent reinfusion of centrifuged red blood cells from the residual blood remaining in the CPB circuit during the early postoperative period. Hematocrit (Hct) values 12 hours after the operation were found to be higher in Group 3 compared with those of the first and the second groups (by 13.2% and 11.1%, respectively). Blood loss during the first 12 hours after the operation and during the time spent in the intensive care unit did not differ between the groups. The number of transfusions was significantly lower in Group 3 (28.57%) in comparison with that of Groups 1 and 2 (37.83% and 38.10%, respectively). The rate of infective complications in Group 3 was lower in comparison with both Group 1 and Group 2 (9.2% and 18.1%, respectively). The duration of in-hospital stay in Group 3 was 25.8% shorter than Group 1. We conclude that autotransfusion of centrifuged red blood cells processed from the residual blood of the CPB circuit after CPB was effective in increasing Hct values 12 hours postoperatively, reducing the need for donor blood product transfusions, the rate of infective complications and lenght of stay in hospital.     

Influence of early re-infusion of autologous shed mediastinal blood on clinical outcome after cardiac surgery.

Various strategies have been proposed to decrease allogeneic blood transfusion requirements after cardiac surgery. The aim of the study was to evaluate the efficacy of collected and re-infused autologous shed mediastinal blood on a patient's postoperative course. Ninety patients who underwent heart surgery with cardiopulmonary bypass (CPB) were studied. The patients were divided into two groups: Group 1 (n=41) received the centrifuged autologous shed mediastinal blood collected from the cardiotomy reservoir 4 hours after surgery; in Group 2 (n=49) all shed mediastinal blood was discarded (control group). Haemoglobin (Hb), haematocrit (Hct), C-reactive protein values, and leucocyte count were compared before surgery, at 4 h and 20 h after surgery, and on the fifth postoperative day. We have measured serum procalcitonin (PCT) concentration at 4 h and 20 h after CPB. We assessed drained blood loss within 20 postoperative hours. Leucocyte count, Hb, Hct values, C-reactive protein, and procalcitonin concentration did not differ between the groups before and at 4 h after surgery. Hb, Hct level, and leucocyte count were similar at 20 hours and on the fifth day after surgery. At 20 hours after surgery, an increase of serum PCT concentration (>0.5-2 ng/mL) was more frequent in Group 2 (58.3% vs. 33.3%; p = 0.03). On the fifth postoperative day, C-reactive protein concentration was lower in Group 1 (71.74 +/- 15.23; p <0.01) compared to Group 2 (93.53 +/- 20.3). Postoperative blood loss did not differ between the groups. Requirement for allogeneic blood transfusion was significantly lower in Group 1 (14.6% vs. 38.8%; p < 0.02). Patients in Group 1 developed less infective complications compared with Group 2 (2.4% and 16.3%, respectively; p < 0.05). The length of postoperative in-hospital stay was shorter in Group 1 compared with Group 2 (9.32 +/- 2.55 and 16.45 +/- 6.5, respectively; p < 0.05). We conclude that postoperative re-infusion of autologous red blood cells processed from shed mediastinal blood did not increase bleeding tendency and systemic inflammatory response and was effective in reducing the requirement for allogeneic transfusion, the rate of infective complications and the length of postoperative in-hospital stay.     

Influence of aspirin or heparin on platelet function and postoperative blood loss after coronary artery bypass surgery

The aim of the study was to assess the effect of aspirin or heparin pretreatment on platelet function and bleeding in the early postoperative period after coronary artery bypass grafting (CABG) surgery. Seventy-five male patients with coronary artery disease who underwent CABG with cardiopulmonary bypass (CPB) were studied. The patients were divided into three groups: Group 1 (n=25) included patients receiving aspirin pretreatment, Group 2 (n=22) received heparin pretreatment, and Group 3 (n=28) included patients who received no antiplatelet or anticoagulant pretreatment. Twenty-four hours after surgery, all patients were administered aspirin therapy that was continued throughout their hospitalization period. We assessed the following preoperative blood coagulation indices: activated partial thromboplastin time (aPTT), international normalized ratio (INR), and fibrinogen. We compared platelet count and platelet aggregation induced by adenosinediphosphate (ADP) before surgery, 1 h after surgery, 20 h after surgery and on the seventh postoperative day. We assessed drained blood loss within 20 postoperative hours. Preoperative blood coagulation indices did not differ among the groups. Platelet count was also similar. One hour after surgery, platelet count significantly decreased in all groups (p<0.001), after 20 postoperative hours it did not undergo any marked changes, and on the seventh postoperative day, it significantly increased in all groups (p<0.001). Before surgery, the lowest index of ADP-induced platelet aggregation was found in Group 1 (p<0.05). One hour after surgery, platelet aggregation significantly decreased in all groups, most markedly in Group 3 (p<0.001), yet after 20 h, its restitution tendency and a significant increase in all groups was noted. On the seventh day, a further increase in the statistical mean platelet aggregation value was noted in Groups 2 and 3. Comparison of platelet aggregation after 20 postoperative hours and on the seventh day after surgery revealed a significantly higher than 10% increase of the index in 32% of patients in Group 1 (p<0.05), 27.3% of patients in Group 2 (p<0.05) and in 35.7% of patients in Group 3 (p<0.001). The lowest statistically significant value of postoperative blood loss was noted in Group 2 (p<0.01). Our study has shown that aspirin or heparin pretreatment had no impact on the dynamics of platelet function in the early postoperative period after CABG. The lowest postoperative blood loss was noted in patients pretreated with heparin.     

Use of biplanar radiographs for estimating cross-sectional geometric properties of mandibles

Several radiographic techniques for estimating bone cross-sectional geometric properties of mandibular corpora are compared. A hollow symmetrical model significantly improves estimates compared to solid or hollow symmetrical models that have been used in previous studies. Using this model, biplanar radiographs can give sufficiently accurate information of the amount and distribution of cortical bone in a section given relatively regular subperiosteal and endosteal perimeters.     

Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy

Aim of the study

To investigate the effect of the Inerventions method on gross motor function in children with spastic cerebral palsy (CP).

The effect of CYP2C9, VKORC1 and CYP4F2 polymorphism and of clinical factors on warfarin dosage during initiation and long-term treatment after heart valve surgery

The dosage of warfarin is restricted due to its narrow therapeutic index, so, the required dose must be adapted individually to each patient. Variations in warfarin dosage are influenced by genetic factors, the changes in patient diet, anthropometric and clinical parameters. To determine whether VKORC1 G3730A and CYP4F2 G1347A genotypes contribute to warfarin dosage in patients during initiation and long-term anticoagulation treatment after heart valve surgery. From totally 307 patients, who underwent heart valve surgery, 189 patients (62 %) who had been treated with warfarin more than 3 months, were included into the study. A hierarchical stepwise multivariate linear regression model showed, that during initiation clinical factors can explain 17 % of the warfarin dose variation. The addition of CYP2C9 and VKORC1 G-1639A genotype raises the accuracy about twice—to 32 %. The CYP4F2 G1347A genotype can add again about 2–34 %. During long-term treatment clinical factors explain about 26 % of warfarin dose variation. If the CYP2C9 *2, *3, VKORC1*2 alleles are detected, model can explain about 49 % in dose variation. The *3 allele of VKORC1 raises the accuracy by 1–50 %. The carriers of CYP4F2 A1347A genotype required higher daily warfarin doses during initiation of warfarin therapy after heart valve surgery than comparing to G/G and G/A carriers, but during the longer periods of warfarin use, the dosage of warfarin depended significantly on VKORC1 *3 allele (G3730A polymorphism) and on the thyroid stimulating hormone level in the blood plasma.