Clinical safety of enamel matrix derivative (EMDOGAIN®) in the treatment of periodontal defects

Abstract The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN® in a large number of patients. An open, controlled study design in 10 Swedish specialist clinics was chosen, with a test group of 107 patients treated with EMDOGAIN® in connection with periodontal surgery at 2 surgical test sites per patient. The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions. A control group of 33 patients underwent flap surgery without EMDOGAIN® at I comparable site. In total 214 test and 33 control surgeries were performed. Serum samples were obtained from test patients for analysis of total and specific antibody levels. 10 of the patients had samples taken before and after the first surgery. 56 other samples were taken after one treatment with EMDOGAIN®, and 63 after 2 treatments. None of the samples, not even from allergy-prone patients after 2 treatments, indicated deviations from established baseline ranges. This indicates that the immunogenic potential of EMDOGAIN® is extremely low when applied in conjunction with periodontal surgery. Comparison between the test and control groups demonstrated the same type and frequency of post-surgical experiences, i.e., reactions caused by the surgical procedure itself. Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery. About half of the patients (44 test and 21 control) were also evaluated after 3 years. There was a significant difference between the test and control results at 8 months post surgery. and this difference had increased further at the 3 year follow-up. The 2.5–3 mm increase in attachment and bone level after treatment with EMDOGAIN® was of the same magnitude as seen in the studies with split-mouth design aiming for lest of effectiveness of EMDOGAIN®.     

Medical home care services for the housebound elderly.

In our health jurisdiction the proportion of elderly people is more than double the national average, and there is a severe shortage of both home care services and long-term care beds. To help the many elderly housebound people without primary medical care we initiated a medical services home care program. The goals were patient identification, clinical assessment, medical and social stabilization, matching of the housebound patient with a nearby family physician willing and able to provide home care and provision of a backup service to the physician for consultation and help in arranging admission to hospital if necessary. In the program's first 2 years 105 patients were enrolled; the average age was 78.9 years. More than 50% were widowed, single, separated or divorced, over 25% lived alone, and more than 40% had no children living in the city. In almost one-third of the cases there had never been a primary care physician, and in another third the physician refused to do home visits. Before becoming housebound 15% had been seeing only specialists. Each patient had an average of 3.2 active medical problems and was functionally quite dependent. Thirty-five of the patients were surveyed after 1 year: 24 (69%) were still at home, and only 1 (3%) was in a long-term care institution; 83% were satisfied with the care provided, and 79% felt secure that their health needs were being met. One-third of the patients or their families said that it was not easy to reach the physician when necessary. We recommend that programs similar to ours be set up in health jurisdictions with a high proportion of elderly people. To recruit and retain cooperative physicians hospital geriatric services must be willing to provide educational, consultative and administrative support.     

First-pass effects of verapamil on the intestinal absorption and liver disposition of fexofenadine in the porcine model.

The aim of this study in pigs was to investigate the local pharmacokinetics of fexofenadine in the intestine and liver by using the pig as a model for drug transport in the entero-hepatobiliary system. A parallel group design included seven pigs (10-12 weeks, 22.2-29.5 kg) in three groups (G1, G2, G3), and a jejunal single-pass perfusion combined with sampling from the bile duct and the portal, hepatic, and superior caval veins was performed. Fexofenadine was perfused through the jejunal segment alone (G1: 120 mg/l, total dose 24 mg) or with two different verapamil doses (G2: 175 mg/l, total dose 35 mg; and G3: 1000 mg/l, total dose 200 mg). The animals were fully anesthetized and monitored throughout the experiment. Fexofenadine had a low liver extraction (E(H); mean +/- S.E.M.), and the given doses of verapamil did not affect the E(H) (0.13 +/- 0.04, 0.16 +/- 0.03, and 0.12 +/- 0.02 for G1, G2, and G3, respectively) or biliary clearance. The E(H) for verapamil and antipyrine agreed well with human in vivo data. Verapamil did not increase the intestinal absorption of fexofenadine, even though the jejunal permeability of fexofenadine, verapamil, and antipyrine showed a tendency to increase in G2. This combined perfusion and hepatobiliary sampling method showed that verapamil did not affect the transport of fexofenadine in the intestine or liver. In this model the E(H) values for both verapamil and antipyrine were similar to the corresponding values in vivo in humans.     

Primary aldosteronism. Study of twenty-six operated cases

A follow-up study of 26 patients operated on for suspicion of primary aldosteronism was made. The preoperative investigative procedures, including serum potassium concentration, urinary aldosterone excretion, and plasma renin activity, could not differentiate between patients with cortical adenomas and those with cortical hyperplasia or normal glands. Preoperative roentgenologic examinations visualized only one third of the adenomas. Altogether 44 of the 52 suprarenal glands had to be explored to reveal the 21 adenomas. Patients with cortical adenoma often became normotensive, in contrast to those with cortical hyperplasia or normal adrenal glands histopathologically. The suprarenal glands were explored from behind according to Nesbit. The complications were few and minor.     

Real-time refinement of subthalamic nucleus targeting using Bayesian decision-making on the root mean square measure.

The subthalamic nucleus (STN) is a major target for treatment of advanced Parkinson's disease patients undergoing deep brain stimulation surgery. Microelectrode recording (MER) is used in many cases to identify the target nucleus. A real-time procedure for identifying the entry and exit points of the STN would improve the outcome of this targeting procedure. We used the normalized root mean square (NRMS) of a short (5 seconds) MER sampled signal and the estimated anatomical distance to target (EDT) as the basis for this procedure. Electrode tip location was defined intraoperatively by an expert neurophysiologist to be before, within, or after the STN. Data from 46 trajectories of 27 patients were used to calculate the Bayesian posterior probability of being in each of these locations, given RMS-EDT pair values. We tested our predictions on each trajectory using a bootstrapping technique, with the rest of the trajectories serving as a training set and found the error in predicting the STN entry to be (mean +/- SD) 0.18 +/- 0.84, and 0.50 +/- 0.59 mm for STN exit point, which yields a 0.30 +/- 0.28 mm deviation from the expert's target center. The simplicity and computational ease of RMS calculation, its spike sorting-independent nature and tolerance to electrode parameters of this Bayesian predictor, can lead directly to the development of a fully automated intraoperative physiological procedure for the refinement of imaging estimates of STN borders.