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A multicenter, randomized, open-label, phase III study was conducted to compare the efficacy and safety of intravenous ferric derisomaltose (FDI) versus saccharated ferric oxide (SFO) in Japanese patients with iron deficiency anemia associated with menorrhagia. FDI can be administered as a single dose up to 1000 mg, whereas SFO has a maximum single dose of 120 mg. The primary endpoint, which was the maximum change in hemoglobin concentration from baseline, was noninferior for the FDI group compared with the SFO group. The incidence of treatment-emergent adverse events was lower in the FDI group (66.2%) than in the SFO group (90.8%). Notably, the incidence of serum phosphorus level < 2.0 mg/dL was significantly lower in the FDI group (8.4%) than in the SFO group (83.2%), and severe hypophosphatemia (≤ 1.0 mg/dL) occurred in 6.7% of SFO‑treated patients compared with none in the FDI group. The percentage of patients who achieved the cumulative total iron dose during the 8-week treatment period was higher in the FDI group (92.8%) than in the SFO group (43.2%). The study met its primary endpoint, and also demonstrated the tolerability of a high dose of FDI per infusion, with a lower incidence of hypophosphatemia. [ABSTRACT FROM AUTHOR]

The production of soluble fms-like tyrosine kinase 1 (sFLT1) by exogenous chymotrypsin in trophoblast cells through protease-activated receptor (PAR) 2 was investigated to identify the role of a chymotrypsin-like serine protease in preeclampsia (PE) pathogenesis. We evaluated the expression of chymotrypsin, FLT1, and sFLT1 in monolayers of immortalized human trophoblast cells derived from placenta (TCL-1 cells). To investigate whether chymotrypsin enhances the production and release of sFLT1 through PAR-2, we examined changes in sFLT1 protein levels in conditioned medium by enzyme-linked immunosorbent assay and sFLT1 messenger RNA (mRNA) levels by real-time polymerase chain reaction in TCL-1 cells treated with exogenous chymotrypsin in the presence or absence of a PAR-2 antagonist or a chymotrypsin inhibitor (TPCK). We also examined changes in PAR-2 expression in TCL-1 cells treated with tumor necrosis factor (TNF) α in the presence or absence of a polyclonal anti-TNF-α antibody. Western blot analysis showed that TCL-1 trophoblast cells expressed chymotrypsin, FLT1, and sFLT1. Compared with the control cells, the sFLT1 level in the conditioned medium and sFLT1 mRNA level in cells were both significantly enhanced when treated with a PAR-2 agonist or chymotrypsin for 6 hours. In contrast, the sFLT1 level in the medium and sFLT1 mRNA level in cells treated with a PAR-2 agonist or chymotrypsin were suppressed in the presence of a PAR-2 antagonist or a chymotrypsin inhibitor. The PAR-2 expression was upregulated by TNF-α, which was suppressed in the presence of TNF-α antibodies. These results indicate that chymotrypsin-like serine protease enhances sFLT1 production through PAR-2 in trophoblast cells and thus plays an important additional role in PE pathogenesis. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study was to investigate whether baseline stiffness of the uterine corpus and cervix accurately estimated by acoustic radiation force impulse (AFRI) elastography changed after placental delivery. Methods: Eleven patients with normal vaginal delivery underwent ARFI elastography before, immediately after, and 1 and 2 h after placental delivery, and the shear wave velocity was measured to determine the stiffness. Each measurement was performed in triplicate to obtain a mean ± SD. Results: The shear wave velocity of the uterine corpus before, immediately after, and 1 and 2 h after placental delivery was 1.81 ± 0.60, 3.04 ± 0.76, 3.12 ± 0.95, and 2.72 ± 0.81 m/s, respectively, and the shear wave velocity of the uterine cervix was 1.35 ± 0.45, 1.87 ± 0.57, 1.68 ± 0.59, and 1.70 ± 0.5 m/s, respectively. The stiffness of the uterine corpus significantly changed over time, although that of the uterine cervix was not significantly altered. The stiffness of the uterine corpus was significantly higher immediately after and 1 and 2 h after placental delivery as compared with that before placental delivery. The uterine corpus had a significantly higher stiffness than the uterine cervix at each of the four time points examined. Conclusion: ARFI elastography may be useful to assess uterine involution using the shear wave velocity. [ABSTRACT FROM AUTHOR]