Pharmacokinetics and tolerability of a bioadhesive buccal testosterone tablet in hypogonadal men

OBJECTIVE: A phase I single centre, open label study of the pharmacokinetics and tolerability of a buccal testosterone tablet (COL 1621) was carried out. DESIGN: Twelve testosterone-deficient males were treated with the buccal tablet twice daily for 7 consecutive days. Multiple blood samples were drawn for testosterone, dihydrotestosterone (DHT), bioavailable testosterone and sex hormone-binding globulin (SHBG). RESULTS: After COL 1621, means+/-S.D. serum testosterone level increased to a peak concentration of 26.6+/-5.8 nmol/l (7.7+/-1.7 ng/ml) at 4.8+/-5.8 h and stayed in the eugonadal range. Steady state was achieved within the first 24 h and was maintained in the normal range. The bioavailable testosterone, DHT and free testosterone index followed a pattern very similar to that of testosterone. The mean serum testosterone to DHT ratio was within the normal male range throughout treatment. There was only one treatment-related adverse event (headache). Two-thirds of patients indicated that treatment with COL 1621 was acceptable and that the tablet was convenient to use. Six patients (50.0%) preferred COL 1621 to their previous testosterone replacement therapy, two patients gave preference to their previous treatment and three patients found both treatments to be equally acceptable. Data for one patient was not available. CONCLUSION: We conclude that COL 1621 can efficiently elevate serum testosterone and DHT levels in hypogonadal men within the first day of application, achieve a steady state within 24 h and maintain serum testosterone in the normal range with a twice-daily treatment regimen. COL 1621 provides an effective alternative oral testosterone replacement therapy that gives physiological levels of testosterone and is well tolerated by the patients.     

Epidemiological,clinical and parasitological data concerning intestinal amebiasis in northern Tunisia

In order to evaluate the principal characteristics of the intestinal amoebiasis in the north of Tunisia, one retrospective study review all cases diagnosed in principal gastroenterologic sections of the hospitals of Tunis. Twenty height cases of intestinal amoebiasis, 10 of which have an inflammatory bowel disease associated were included. Watery stools containing blood and mucus were the most important symptoms (25 cases). The endoscopic exam showed for all the cases non specific lesions. The diagnosis was based on histologic exam in 21 cases, on the positivity of serologic tests in 3 cases and on the presence of E. histolytica/dispar cysts in stools in 6 cases. In two cases, the diagnosis was made by therapeutic test.     

Ionomic profiling of pericardial fluid in ischemic heart disease

Metals are essential cofactors that play a crucial role in heart function at the cell and tissue level. Information regarding the role of metals in the pericardial fluid and its ionome in ischemic heart disease (IHD) is limited. We aimed to determine the association of elements in pericardial fluid and serum samples of IHD patients and their correlation with systolic and diastolic function. IHD patients have been studied with systolic and diastolic dysfunction categorized on the basis of echocardiographic parameters. We measured concentrations of sixteen elements in the pericardial fluid and serum of 46 patients obtained during open heart surgery with IHD by ICP-MS. The levels of chromium and nickel in pericardial fluid were significantly higher as compared with serum samples of IHD patients (p < 0.05). The chromium, nickel and manganese levels in pericardial fluid were lower in patients with ejection fraction (EF) < 45% as compared to EF > 45% (p < 0.05). There was no significant difference in pericardial concentrations of elements in diastolic dysfunction grade 0–1 with 2 in IHD patients. We also found that decreased concentration of these elements in pericardial fluid is associated with decreased systolic function. These results suggest that pericardial fluid concentrations of these metals may reflect the extent of ischemic heart disease. These findings are hypothesis generating with regards to a role in the pathogenesis of the disorder.

Metals are essential cofactors that play a crucial role in heart function at the cell and tissue level.     

Proliferative Activity in Oral Carcinomas Studied with Ag-NOR and Electron Microscopy

This study was conducted on 61 patients (27 males and 34 females). The age ranged from 27 to 81 years (mean 54 years). All suffered from oral squamous cell carcinoma and were treated by surgery and deep X-ray therapy (DXT). The UICC and TNM classification and staging recommendations were used for evaluation of the patients. All sections were stained with Ag-NORs stain for examination of the proliferative activity of the squamous cell carcinomas. Biopsies were also taken from another 6 cases—3 cases with normal striated muscle and 3 cases from normal oral mucosa—and served as controls. Statistical studies of Ag-NOR scores were classified into 3 scores: the p values of score I (ANOVA test) were .0001, score II (ANOVA test) was .0001, and score III (ANOVA test) was 06. Both scores I and II were highly significant and score III was significant. Electron microscopy (EM) showed tumor cells with irregular shape and size and with remarkable division of nuclei and chromatin clumps emarginated toward nuclear membrane, and some cases showed chromatin condensed at one pole of the nucleus. Few mitochondria with dilated cristae (?) and abundant rough endoplasmic reticulum (RER) were observed. Few apoptotic changes were noted. This study showed a high proliferation in poorly differentiated squamous cell carcinomas. The amount of Ag-NOR in poorly differentiated squamous cell carcinomas was a prognostic factor and represented an unfavorable prognostic feature in squamous cell carcinoma of the oral mucosa.     

Macrophage activation syndrome following Acinetobacter baumannii sepsis

Macrophage activation syndrome (MAS) is a systemic disorder with a high mortality, commonly associated with rheumatological conditions, but which can also occur as a complication of several infections. Here we present a case of MAS following Acinetobacter baumannii sepsis. Early institution of therapy with prednisolone, cyclosporine, colistin, and polymyxin resulted in a prompt clinical recovery. There are very few reported cases of Acinetobacter-related MAS that have been successfully treated.     

Bilateral chylothorax following neck dissection

Background: Bilateral chylothorax, as a complication of neck dissection, is extremely rare, and was first described in 1907. Ten cases are reported in the literature. Methods. This presentation illustrates an additional case of bilateral chylothorax occurring after neck dissection. Anatomic and physiologic considerations are presented and possible mechanisms of pathogenesis are discussed. Results. Chylothorax has two major complications: respiratory and metabolic. The modern concepts of treatment are summarized. Conclusions. After neck dissection, the clinician should suspect chylothorax if the patient had respiratory embarrassment and an abnormal chest x-ray postoperatively. © 1995 Jons Wiley & Sons, Inc.