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Trauma und Berufskrankheit -     

Assessment of bioequivalence after subcutaneous and intramuscular administration of urinary gonadotrophins

The objective was to demonstrate bioequivalence between s.c. and i.m. administration of Humegon (FSH/LH ratio 1:1) and Normegon (FSH/LH ratio 3:1). In two randomized, single-centre, cross-over studies, 18 healthy volunteers on each formulation were assigned to one of the two administration sequences. Subjects were given single doses of one of the above gonadotrophins after endogenous gonadotrophin production had first been suppressed using high-dose oral contraceptive. Subsequently, rate (Cmax, tmax) and extent (AUC) of absorption of follicle stimulating hormone (FSH) and luteinizing hormone (LH) were determined for 14 days. For Cmax and AUC, analysis of variance (ANOVA) was performed on log-transformed data and for tmax ANOVA was performed on ranks. Intramuscular and s.c. injections of Humegon were bioequivalent with respect to the main pharmacokinetic parameters, being AUC and Cmax of FSH absorption. Intramuscular and s.c. injections of Normegon were bioequivalent with respect to the AUC of FSH and not bioequivalent with respect to the Cmax of FSH. For tmax of FSH as well as for most LH variables of both preparations, bioequivalence could not be proven due to the high intra- and interindividual variability and/or concentrations being close to the detection limit. Thus, the main pharmacokinetic FSH variables after i.m. and s.c. administration of Humegon and Normegon were bioequivalent.      

Peridural fibrosis in lumbar disc surgery--pathogenesis, clinical problems and prophylactic attempts

Postoperative peridural fibrosis is unavoidable adverse effect of lumbar disc surgery. This process is disadvantageous both to the patient and to the surgeon. It is assumed that peridural fibrosis is responsible for as much as 25% of all Failed Back Surgery Syndrome. In case of reherniated discs requiring reoperation epidural scar may cause technical difficulties. Thus the prevention or inhibition of postoperative peridural fibrosis and adhesions is an essential goal for successful lower back surgery. The authors review new opinions on pathophysiology of peridural fibrosis, clinical aspects of the process, results of experimental approaches for limiting peridural fibrosis and perspective of anti-adhesion gel Adcon-L.     

Posttraumatic ectopic calcification as an additional pathologic factor of brachial plexus palsy

The authors describe a case of a 54-year-old male, who was attacked with a broken bottle and wounded in left supraclavicular region. No neurologic deficit was observed immediately after injury. Some days later signs of upper trunk brachial plexus palsy were detected. Gradually symptoms of the Erb syndrome have developed. He was operated on 5 months after injury. During surgery no discontinuity of the brachial plexus was found. Unexpectedly there were an inner scar and free bony fragment compressing the upper trunk and the suprascapular nerve. Both the scar and bony fragment were carefully dissected and removed. Result of surgery: pain relief, restoration of normal sensation and partial restoration of biceps function.     

Hypospadias trends in two US surveillance systems

OBJECTIVE: Hypospadias is a common congenital anomaly, the cause of which is unknown. Unexplained increases in the rates of hypospadias occurred in five European countries in the 1970s and 1980s. We examined data from two birth defects surveillance systems in the United States for evidence of similar trends. METHODOLOGY: The Metropolitan Atlanta Congenital Defects Program (MACDP) provided birth prevalence rates from 1968 to 1993. The nationwide Birth Defects Monitoring Program (BDMP) provided rates from 1970 to 1993. MACDP data are population-based and could be categorized by the severity of the hypospadias. BDMP data allowed analysis of rate trends for the four census regions of the United States. RESULTS: Data from both surveillance systems showed an approximate doubling of hypospadias rates in the 1970s and 1980s. MACDP data showed that the rate of severe cases increased while the ratio of mild to severe cases decreased. BDMP data showed that hypospadias rates increased markedly in all four regions of the United States. CONCLUSIONS: The observed increases are unlikely to be attributable to increased sensitivity of the surveillance systems or the identification of more mild cases by physicians over time, because either trend would have increased rather than decreased the ratio of mild to severe cases. If real, these trends represent the largest number of cases and the first report of an increase in hypospadias rates outside of Europe. Additional investigation of a possible increase in hypospadias rates is warranted.