AimTo evaluate the use of recombinant human fibroblast growth factor (rhFGF)‐2 in combination with deproteinized bovine bone mineral (DBBM) compared with rhFGF‐2 alone, in the treatment of intrabony periodontal defects.Materials and MethodsPatients with periodontitis who had received initial periodontal therapy and had intrabony defects of ≥ 3 mm in depth were enrolled. Sites were randomly assigned to receive a commercial formulation of 0.3% rhFGF‐2 + DBBM (test) or rhFGF‐2 alone (control). Clinical parameters and a patient‐reported outcome measure (PROM) were evaluated at baseline and at 3 and 6 months postoperatively.ResultsTwenty‐two sites in each group were evaluated. A significant improvement in clinical attachment level (CAL) from baseline was observed in both groups at 6 months postoperatively. CAL gain was 3.16 ± 1.45 mm in the test group and 2.77 ± 1.15 mm in the control group, showing no significant difference between groups. Radiographic bone fill was significantly greater in the test group (47.2%) than in the control group (29.3%). No significant difference in PROM between groups was observed.ConclusionsAt 6 months, no significant difference in CAL gain or PROM between the two treatments was observed, although combination therapy yielded an enhanced radiographic outcome.
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In this 35-year-old woman with chronic glomerulonephritis and uremic encephalopathy, the basal ganglia bilaterally, internal capsules and periventricular white matter showed hypodensity on CT, low signal intensity on T1-weighted MRI and high signal intensity on T2-weighted MRI. Following a series of dialyses, her clinical symptoms and blood chemistry improved. The CT and MRI returned to normal. These reversible abnormalities may be caused by reversible ischemic change, but disorders of cerebral metabolism and uremic toxins may contribute.
The safety profile of ProHance in special populations was evaluated by analyzing data extracted from the database of phase I-III studies which included data on 2,656 ProHance injections of which 119 in pediatric patients, 814 in elderly patients and 30 in patients with varying degrees of renal impairment (moderate, severe or end stage requiring hemodialysis). ProHance was administered at doses ranging from 0.1 mmol/kg to 0.3 mmol/kg and was found to be safe in all patient populations irrespective of age and of pre-existing renal impairment. There appeared to be no correlation between incidence of adverse events and dose level in these special populations and the higher dose level of 0.3 mmol/kg could be safely administered also to patients with end stage renal disease requiring hemodialysis, from whom the contrast medium was rapidly and efficiently dialysed.
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