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Anal and transanal tumor operations are safe and are associated with a very low morbidity. Perianal and anal lesions as well as low rectal tumors can be excised by direct exposure using an anal retractor. For lesions situated in the middle or upper third of the rectum, special instrumentation, such as transanal endoscopic microsurgery (TEM) and transanal endoscopic operation (TEO) should be used to avoid unnecessary R1 resections. Fatal complications are extremely rare and most complications, such as urinary retention or temporary subfebrile temperatures, are minor. Suture line dehiscences are usually clinically unremarkable. Major complications comprise significant hemorrhage and opening of the peritoneal cavity. The latter must be recognized intraoperatively and can usually be managed by primary suturing. Infections, abscess formation, rectovaginal fistula, injury of the prostate or even urethra are extremely rare complications.

Transanal endoscopic operation (TEO) is a minimally invasive treatment option for certain rectal tumors. The TEO procedure has evolved as a new technique from transanal endoscopic microsurgery (TEM) which was developed by G. Buess. Apart from the excision of benign lesions this method can also be applied in patients with low-risk T1 carcinoma if size and localization permit complete resection (R0). Using these strict criteria for patient selection one can expect an excellent oncological outcome. However, it must to be stressed that local excision is always part of the diagnostic work-up and that the definitive histology needs to be appreciated. In cases of unfavorable histology (i.e. high risk or higher T stage) radical salvage resection should be performed. Functional results and quality of life are very good following TEO or TEM procedures, especially when comparing the outcome with that of radical rectal resection or abdominoperineal excision.

The occurrence of 4 bone fractures associated with birth by Caesarean section (CS) prompted us to examine the incidence and predisposing factors of bone injuries sustained during birth.The 4 cases with fractures were evaluated retrospectively and discussed in combination with a short review of the literature.With the increasing number of Caesarean sections the incidence of birth trauma has decreased. Nevertheless, when performing a CS there is still a risk of serious trauma to the neonate, including bone fractures. A Caesarean section for breech presentation constitutes a predisposition for femoral fractures. When diagnosed early and treated properly, the prognosis for these fractures is good without sequelae and one can expect a satisfactory clinical outcome for the child. We suggest that the possibility of this complication be mentioned when counselling the mother and getting informed consent.

The university departments of child psychiatry in Cologne and Berlin were compared to assess whether quantitative differences in reported abnormal psychosocial situations (Axis 5 MAS of ICD-10) are due to a difference in patient population or coding practices or to particular regional conditions.Data were analyzed for 593 patients seen in Cologne in 1992/93 and for 685 patients seen in Berlin in the same period. The broader social situation was described by sociodemographic data from the respective city.Berlin showed about twice as many psychosocial stressors per patient as Cologne. Consistent relationships between axis 5 stress ratings and other parameters indicated the validity of the data. Only a few points of inconsistency in the data were found. The sociodemographic data for both cities revealed a greater number of single parents as well a a higher rate of suicide in Berlin.Indicators for the validity of the clinical data analyzed were found. Some special internal clinical and regional conditions were identified as contributing to the quantitative differences between the two university departments.

The pharmacokinetics and pharmacodynamics of cloprednol after oral administration in doses of 2.5 to 15 mg to healthy volunteers were determined. The half-life of cloprednol ranged from 1.8 h to 2.7 h, the oral clearance (CL/F) was determined to be 15-22 l/h. Since cloprednol shows nonlinear plasma protein binding, the plasma concentrations were converted to their free, unbound concentrations for the PK/PD-analysis. Due to this nonlinearity, the half-life of free, unbound cloprednol was shorter than that of the total drug. For the assessment of pharmacodynamics, differential white blood cell counts were obtained over 24 hours. An integrated pharmacokinetic-pharmacodynamic (PK/PD) approach using a modified Emax-model was applied to link unbound corticosteroid concentrations to the effect on lymphocytes and granulocytes. The E50 value for unbound cloprednol ranged from 3.6 to 4.7 ng/ml and 1.2 to 4.6 ng/ml for granulocytes and lymphocytes, respectively. The PK/PD model allowed a good prediction of the observed effects and was consistent with reported values for glucocorticoid receptor binding affinities for cloprednol.

The pharmacokinetics and pharmacodynamics of methylprednisolone were investigated after intravenous administration of methylprednisolone phosphate to healthy subjects at seven different doses (16 to 1000 mg). Forty different pharmacodynamic parameters were followed for 1 week. The pharmacodynamic data were analyzed as a function of time as well as cumulative effects in form of the areas under the effect-time curves. Statistically significant dose-dependent effects of methylprednisolone were observed for 15 pharmacodynamic parameters. Highly significant (P less than or equal to 0.0001) effects were increases in glucose levels, number of white blood cells, and segmented granulocytes as well as a decrease in the number of lymphocytes. For these pharmacodynamic effects an integrated pharmacokinetic/pharmacodynamic model was derived that translates the methylprednisolone plasma concentration-time profiles into effect-time profiles. This model allows prediction of pharmacodynamic effects for any single dose in the range studied at any time point.

The pharmacokinetics of methylprednisolone and two methylprednisolone esters, the phosphate and the hemisuccinate, were investigated after intravenous administration of the esters to 12 healthy male subjects in two different doses (250 and 1000 mg). Methylprednisolone was formed more rapidly from phosphate than from hemisuccinate. During the first 30 min methylprednisolone levels were three to four times higher after phosphate administration than after hemisuccinate. The mean residence time of the hemisuccinate was significantly longer and the total-body clearance lower than those of the phosphate. Whereas very little of the phosphate (mean, 1.7%) was eliminated unchanged into the urine, there were significant amounts of hemisuccinate (mean, 14.7%) excreted renally and therefore not bioavailable. Methylprednisolone saliva levels paralleled plasma levels; the average saliva/plasma ratio was 0.22. Neither phosphate nor hemisuccinate could be detected in saliva. An average of 7.2% of the administered dose was eliminated in the form of methylprednisolone in urine. Renal clearance was 24 ml/min and not dose or prodrug dependent. For both doses endogenous hydrocortisone levels were lowered after 24 hr. For the 1000-mg dose the depression was still significant after 48 hr. The results indicate that methylprednisolone phosphate results in a faster and more efficient conversion to its active form, methylprednisolone, than methylprednisolone hemisuccinate.