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Biomedical subjects

E Renner

Publications and source records attributed to E Renner.

At least 19 recordsLinked to original sources
PubMed2001

Pilot study of interferon-alpha with and without amantadine for the treatment of hepatitis C in HIV coinfected individuals on antiretroviral therapy.

BACKGROUND: Concurrent potent therapy of hepatitis C (HCV) and HIV includes at least five antiviral drugs. Drug interactions, toxicity, tolerance and acceptance by patients of such treatment regimens are unknown. STUDY DESIGN: A prospective open randomized pilot trial was conducted to test interferon-alpha (6 million units/day for the 1st month followed by 6 million thrice weekly) and amantadine versus interferon-alpha monotherapy for tolerability and feasibility among HIV and HCV co-infected patients on stable antiretroviral combination therapy. RESULTS: 1,013 HIV-infected patients were consecutively evaluated. 314 were anti-HCV antibody positive; only eight (2.4%) were eligible. Major reasons for exclusion were: normal transaminase levels (34%), ongoing intravenous drug use (33%), or recent change in antiretroviral therapy (31%). Study drugs were stopped in all of the seven patients enrolled because of side effects and/or failure of anti-HCV therapy. CD4 lymphocyte counts and HIV-1 RNA remained stable. CONCLUSION: Among patients on highly active antiretroviral therapy, the addition of interferon-alpha with or without amantadine was inefficient and poorly tolerated, but had no negative influence on HIV infection. Eligibility for the study was unexpectedly low.

Adult↗
PubMed1999

Anti-TNF antibody in Crohn's disease--status of information, comments and recommendations of an international working group.

The chimeric anti-TNF antibody Remicade (Infliximab) has recently been approved for human use by the FDA and is now available on the market. Since there is considerable interest in this kind of treatment among patients with Crohn's disease, an international working group has summarized the presently available information about efficacy, side effects and possible problems of this treatment. Studies show that Remicade is effective in the treatment of active Crohn's disease, maintaining remission and fistulae. The working group does not see Infliximab as a first-line treatment for Crohn's disease. It may be used in active phase recurrent disease, chronic active disease and fistulae if standard treatment was not successful. For the surveillance special attention has to be given to the unknown malignancy rate of Infliximab. Infusion should be performed in an institution, routinely performing intravenous infusions and a two-hour surveillance of the patients should be guaranteed to recognize anaphylactic reactions or acute side effects. There is presently no information indication that the combination with immunosuppressants might increase risks or side effects of this treatment. Due to the limited information available the working group would prefer to use Remicade in studies only and recommends central collection and documentation of all data on efficacy and side effects for the next year.

Antibodies, Monoclonal↗
PubMed1996

Massive proximal femoral osteoarticular allograft.

The implantation of massive allografts is a reconstruction alternative after limb salvage for aggressive bone tumours. It is hoped that durable long-term results can be obtained with these biological reconstructions. Revitalization of the allografts is one of the most important factors with regard to durability. One massive proximal femoral osteoarticular allograft is described that was followed up for 22 years. Twenty-one years after the implantation, a traumatic fracture in the middle of the allograft occurred, and formation of massive callus showed that revitalization even in the central parts of massive allografts is sufficient for fracture healing. This is why it may be justified to expect long-lasting results.

Adult↗
PubMed1995

Concentration-guided strategies in drug development: experience with a cyclosporine analog in transplantation.

A concentration-guided study was designed to maintain adequate immunosuppression and avoid excessive drug exposure while determining steady-state relative bioavailability of two cyclosporine G (CyG) oral formulations in stable renal transplant patients. In period I (week 1), 26 patients taking cyclosporine A (CyA)-based immunosuppressive regimens entered the study. Doses were titrated to maintain trough concentrations within a predefined range, as measured by fluorescence polarization immunoassay (FPIA). Patients were given an oral solution of CyG in period II (weeks 2-3), and a microemulsion capsule formulation of CyG in period III (weeks 4-5), with dose titration as necessary to achieve trough concentrations in a predefined range, as measured by FPIA. Full pharmacokinetic profiles were obtained on the last day of each study period. Treatment with CyA was reinitiated in period IV (week 6) at the same doses as at study entry. All blood samples were analyzed at the conclusion of the study using CyG- and CyA-specific high-performance liquid chromatography (HPLC). When changing from oral solution to capsule for CyG, an average 19% dose reduction was necessary to compensate for the elevated trough concentrations resulting from the increased bioavailability of the capsule formulation. The concentration-guided strategy was successful in avoiding over-exposure, and resulted in comparable values for area under the concentration-time curve (AUC) for both formulations of CyG. Dose normalization of the pharmacokinetic parameters subsequently allowed calculation of the relative bioavailability. Specifically, a faster rate and greater extent of CyG absorption from the capsule than the oral solution were manifested as a slightly earlier time to peak concentration (tmax), an average 44% increase in the maximum concentration (Cmax), and an average 29% increase in AUC. This experience demonstrated that a concentration-guided trial design allowed a drug development question for a compound with a narrow therapeutic index to be addressed safely and directly in the target patient population.

Administration, Oral↗
PubMed1995

Acute effect of cyclosporin on renal function following the initial changeover to a microemulsion formulation in stable kidney transplant patients.

Potential differences in the acute effect of cyclosporin on renal function when dosed orally as the current market formulation or following a milligram-to-milligram conversion to a new microemulsion formulation were investigated in 14 stable kidney transplant patients. The study consisted of three sequential periods of 2 weeks duration each. Patients entered (period I) and completed (period III) the investigation with the market formulation and received the microemulsion formulation in period II; individualized cyclosporin doses remained unchanged throughout the study. Over one steady-state dosing interval at the end of each study period, whole blood cyclosporin pharmacokinetic profiles were assessed in parallel with endogenous creatinine clearances over sequential 1- to 2-h intervals. The rate and extent of cyclosporin absorption were significantly greater (P < 0.01) from the microemulsion formulation with average increases of 73% in peak concentration and 44% in area under the curve compared to the market formulation. Sequential creatinine clearances exhibited a transient decrease with the nadir occurring on average between 4 and 6 h post dose followed by a rapid return to baseline. Specifically in period I on the market formulation, clearances decreased from a baseline of 71.7 +/- 20.6 to a minimum of 51.1 +/- 17.9 ml/min per 1.73 m2 (similar values in period III) and from 76.8 +/- 24.8 to 53.5 +/- 17.5 ml/min 1.73 m2 in period II on the microemulsion. Neither the baseline nor minimum clearances were significantly different among the study periods.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

Within-day consistency in cyclosporine pharmacokinetics from a microemulsion formulation in renal transplant patients.

A new microemulsion formulation of cyclosporine (Sandimmune Neoral) was compared to the commercially available formulation (Sandimmune) in 11 stable renal transplant patients with regard to the consistency in cyclosporine pharmacokinetics between a daytime fasting, and a nighttime nonfasting administration. Daily cyclosporine doses were individualized and administered in equal, divided doses every 12 h as soft gelatin capsules; doses were kept constant throughout the study. Serial blood samples were obtained over a 24-h period (two consecutive dosing intervals) at steady-state for each formulation, and cyclosporine concentrations were determined in whole blood by a specific radioimmunoassay method. Within-formulation consistency in pharmacokinetic parameters between the daytime and nighttime administrations was assessed in terms of bioequivalence criteria. Following the mg-to-mg conversion from the commercial to the microemulsion formulation, area under the curve (AUC) was increased on average by 30% due to absorption-related pharmacokinetic differences, while trough concentrations remained in the therapeutic range. Within each formulation, AUC was bioequivalent when comparing the daytime fasting to the nighttime nonfasting administration. For the commercial formulation, however, there was considerable variation in absorption rate, dampening of peak-trough fluctuation, and elevation of trough concentration following the nighttime nonfasting dose. By contrast, the microemulsion exhibited a more stable concentration-time profile over the two dosing intervals, with bioequivalence in peak-trough fluctuation and trough concentrations. Hence, the steady-state pharmacokinetics of cyclosporine from the microemulsion formulation exhibit greater within-day consistency compared to the commercial formulation in stable renal allograft recipients.

Adult↗
PubMed1994

Dairy calcium, bone metabolism, and prevention of osteoporosis.

Single-photon absorptiometry was used to measure the bone mineral content of young adults, osteoporotic patients, and age-matched controls without bone disease. A retrospective dietary survey was made to study the relationship between calcium intake and bone mineral content at different periods of life. The bone mineral content and bone mineral density of young adults are directly related to the calcium intake through milk and diary products. Calcium intake through milk and milk products in childhood and adolescence had been significantly lower in patients than in the controls; for the later periods of life (both the 20 to 30 yr prior to the study and at the time of the study), no significant differences existed between the calcium intakes of the two groups. Adequate calcium intake also protected against increased bone resorption, as evidenced in particular by the reduced serum osteocalcin, a parameter of bone turnover. The data support the hypothesis that adequate calcium intake through milk and milk products in childhood and adolescence is a decisive marker for attaining maximum bone mass (peak adult bone mass) and for the prevention of osteoporosis. The recommended dietary allowances of calcium have been fixed to 1200 mg/d for the age group between 10 and 24 yr. However, in Germany, calcium was undersupplied by up to 50% in the diet of children and adolescents.

Adolescent↗
PubMed1993

Assessment of lidocaine metabolite formation in comparison with other quantitative liver function tests.

In clinical practice, the seriousness of liver disease is assessed based on the combined information from clinical examination, routine biochemical tests, and liver histology. Recently, the assessment of hepatic lidocaine metabolism has been proposed as a quantitative liver function test offering valuable additional information. To evaluate whether this new liver function test reflects the combined clinical assessment, we prospectively measured lidocaine metabolism in 111 patients with well characterized liver disease. In addition, lidocaine test results were compared with the aminopyrine breath test and the galactose elimination capacity. Lidocaine (1 mg/kg) was injected i.v. and serum concentrations of its main metabolite monoethylglycinexylidide were determined after 15 min. The results varied widely and the means (+/- S.D.) were similar among patients with mild liver disease (46 +/- 23 ng/ml), but significantly (P < 0.05) lower among patients with Child class A cirrhosis (19 +/- 11 ng/ml) or Child class B or C cirrhosis (21 +/- 19 ng/ml). The [13C]aminopyrine breath test, however, gave a better discrimination among patients with increasing severity of liver disease than lidocaine metabolite formation. The galactose elimination capacity finally best separated patients with mild liver disease from those with cirrhosis. The correlations between any two of the different quantitative liver function tests were weak (R2 consistently < 0.2). We conclude that lidocaine metabolite formation, like other quantitative liver function tests that are based on the microsomal metabolism of model compounds, quantitates a very particular enzymatic reaction which may not be representative for the functional reserve of the entire organ.

Adolescent↗
PubMed1993

Osteoporosis and bone metabolic parameters in dependence upon calcium intake through milk and milk products.

The bone mineral content of young adults as well as of osteoporotic patients and age-matched controls without bone disease was measured by single-photon absorptiometry. A retrospective nutrition survey was additionally made to study the relationship between bone mineral content and calcium intake in different periods of life. The bone mineral content and bone mineral density of young adults is directly related to the calcium intake through milk and dairy products. The osteoporotics had a significantly lower bone mineral content than the controls. Calcium intake through milk and milk products in childhood and adolescence had been significantly lower in the patients than in the controls, whereas in the later periods of life (20-30 years prior to the study and at the time of the study) there were no significant differences between the calcium intakes of the two groups. It was also found that an adequate intake of calcium protected against increased bone resorption, as evidenced in particular by the reduced levels of serum osteocalcin, a parameter of bone turnover. In conclusion it can be stated that the data support the hypothesis that adequate calcium intake through milk and milk products in childhood and adolescence is a decisive marker for obtaining a maximum bone mass (peak adult bone mass) and for the prevention of osteoporosis. Furthermore, it can be stated that increased calcium intake in the later years may not reduce the accelerated risk of osteoporosis resulting from inadequate calcium intake during childhood and adolescence.

Absorptiometry, Photon↗
PubMed1993

[The cost aspects of organ transplantation].

The costs of different transplantation procedures are analysed. The costs which are not covered by the regular hospital allowance are presented using kidney transplantation as an example. It can be demonstrated that the main costs of transplantation arise from post-operative medication. At the moment these costs are not completely covered by the special remunerations for kidney transplantation. Nevertheless kidney transplantation is the most cost-saving of all kidney replacement therapy procedures: during a three-year-treatment period a successful kidney transplantation will save 53% of costs in comparison to home dialysis, 49% compared to CAPD and 61% in the case of Limited-Care-dialysis.

Cost Control↗
PubMed1991

Microscopic hematuria: advances in identification of glomerular dysmorphic erythrocytes.

The high diagnostic sensitivity and specificity of microscopically visible, typically glomerular dysmorphic erythrocytes for identification of the cause of glomerular bleeding have been recognized worldwide. Although glomerular dysmorphic erythrocytes are simple to detect on phase contrast microscopy, immediate microscopic diagnosis still is indispensable, since a change in the morphology of the erythrocytes with restriction of the diagnostic relevance is anticipated because of the high autolytic potency of the urine. It may be postulated that this need for immediate diagnosis has led to the method being neglected owing to the high work load at hospitals and physician offices. Moreover, a physician who does not perform microscopic investigations or who lacks experience with the method will not be able to use this diagnostic technique, since it appeared to be impossible to transport urine samples by mail. In the context of a study comprising 30 patients, of whom 10 had histologically confirmed glomerulonephritis, we have shown that glomerular dysmorphic erythrocytes have a manifest form stability for at least 3 days. The preservative used was thimerosal. Also, the urine can be investigated independent of time even after alcoholic Papanicolaou staining without an alteration of erythrocyte morphology. The practicality of the form stability of glomerular erythrocytes can be exploited in everyday medical routine. There are well founded prospects that the rate of early diagnosis of glomerulonephritis will increase.

Erythrocytes, Abnormal↗
PubMed1991

[Diagnosis of glomerular microhematuria. Study of general practice-relevant form stability and stainability of dysmorphic glomerular erythrocytes].

The high diagnostic sensitivity and specificity of microscopically visible, typically glomerular dysmorphic erythrocytes for identification of the cause of glomerular bleeding is now recognized all over the world. Although glomerular dysmorphic erythrocytes are simple to detect in phase-contrast microscopy, immediate microscopic diagnosis is still indispensable, since a change in the morphology of the erythrocytes with reduced accuracy of the diagnosis must be anticipated because of the high autolytic potency of urine. It may be postulated that this need for immediate diagnosis has led to neglect of the method, owing to the high workload in hospitals and doctor's surgeries. Moreover, a physician who does not carry out microscopic investigations him/herself or who lacks experience with the method has not been able to use this diagnostic technique, since it appeared impossible to send urine samples by post. In the context of a pilot study comprising 30 patients, 10 of whom had developed histologically confirmed glomerulonephritis, we have shown that glomerular dysmorphic erythrocytes have manifest form stability for at least 3 days. The preservative used was thiomersal. Also, the urine can be investigated regardless of the time lapse since sampling, even after Papanicolaou alcohol staining, with no alteration of erythrocyte morphology by alcoholic dehydration, which would limit the value of the diagnosis. The practicability of the form stability of glomerular erythrocytes can be exploited in everyday medical routine. This would increase the rate of early diagnosis of glomerulonephritis and make it more likely that patients will receive adequate nephrological therapy in good time.

Erythrocyte Deformability↗