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®.     

Use of neuroendocrine effects in discrimination between CNS-active drugs in the rat

Different psychotropic drugs were investigated in order to determine their effect on the release of prolactin and corticosterone and their influence on the tuberoinfundibular dopamine (TIDA) neuron activity. The results were used in a principal component analysis, which grouped the psychotropic drugs into different clusters. In the plot showing these clusters the anxiolytic drugs were found to be grouped together and differ from the antidepressant drugs by their potent ability to increase plasma corticosterone. The antipsychotic drugs formed a separate group being clustered together. Typical neuroleptic and atypical antipsychotic drugs could be separated within the cluster by their different effects on plasma prolactin and corticosterone and on TIDA neuron activity. The results indicate that the neuroendocrine profiles of antidepressant and anxiolytic drugs are different from those of antipsychotic drugs and that the neuroendocrine measurements could be a useful tool in the early classification of psychotropic drugs. © 1993 Wiley-Liss, Inc.     

Factors influencing the variations of ejection fraction during exercise in chronic aortic regurgitation

The influence of left ventricular volume variations and regurgitant fraction variations upon left ventricular ejection fraction, during exercise was examined using equilibrium radionuclide angiography in patients suffering from aortic regurgitation. Ejection fraction (EF), regurgitant fraction (RF), end diastolic volume (EDV) and end systolic volume (ESV) variations from rest to peak exercise were determined in 44 patients suffering from chronic aortic regurgitation (AR) and in 8 healthy volunteers (C). In C, EF increased (+0.10±0.03, P<0.01) and ESV decreased significantly (-23%±12%, P<0.01) RF and EDV did not vary significantly. In AR patients, EF, EDV and ESV did not vary significantly because of important scattering of individual values. Changes in EF and ESV were inversely correlated (r=-0.79, P<0.01) and RF decreased significantly (-0.12±0.10, P<0.01). Volumes and EF changes during exercise occurred in three different ways. In a 1st subgroup of 7 patients, EF increased (+0.09±0.03, P<0.05) in conjunction with a reduction of ESV (-24%±12%, P<0.05) without a significant change in EDV. In a 2nd group of 22 patients. EF decreased (-0.04±0.07, P<0.01) in association with an increase in ESV (+17%±16%, P<0.01) and no change in EDV. In a 3rd subgroup of 15 patients, EF decreased (-0.02±0.06, P<0.01) despite a reduction in ESV (-7%±6%, P<0.01) because of a dramatic EDV decrease (-10%±6%, P<0.05). In this subgroup, changes in EF were inversely correlated with changes in ESV (r=-0.55, P<0.01) and positively related to EDV variations (r=0.42, P=0.02). EDV related to EDV variations (r=0.42, P=0.02). EDV changes were weakly, but significantly, correlated to RF decrease (r=0.39, P<0.05). We conclude that changes in left ventricular ejection fraction during exercise in patients with chronic aortic regurgitation are significantly related in some patients to changes in ventricular loading conditions as well as contractile state. Therefore, a correct interpretation of EF changes during exercise requires the simultaneous determination of changes in LV volumes.Abbreviations EDV end diastolic volume - EF ejection fraction - ESV end systolic volume - LV left ventricle - RV right ventricle