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Biomedical subjects

A Böhm

Publications and source records attributed to A Böhm.

At least 19 recordsLinked to original sources
PubMed1992

[Aesthesiometry of the cornea after refractive corneal surgery].

The corneal sensibility was examined with the aesthesiometer of Draeger in 41 patients after refractive corneal surgery, 31 patients after radial keratotomy, 5 after epikeratophakia, 5 after excimer laser ablation. It could be shown that after radial corneal incisions the sensibility remains normal. After epikeratophakia the corneal sensibility is asensible even 3 years after operation. The lenticle periphery shows an increase of sensibility after 6 months. Excimer patients with "haze" showed a significant hyposensibility in the centre. The central sensibility showed normal values after a normal corneal wound healing.

Adult↗
PubMed1992

Presentation of results from bioequivalence studies.

Based on general guidelines and requirements for the design and analysis of bioequivalence studies, specific recommendations are made for the presentation of results, both in tabular and graphical form. This is done by means of two examples, one of a single-dose study and one of a multiple-dose study. The recommendations in this paper are twofold. Firstly, a complete and rather detailed presentation of results is given, which practically corresponds to the standard of research reports. Secondly, a subset of this is suggested for publication. It gives the essential results for bioequivalence assessment in a standardized form. From an editorial point of view, it would be highly appreciated if the papers submitted for publication were always accompanied by a complete presentation including the individual concentration/time data and the various steps of calculation. This would speed up peer review and ultimately improve and harmonize the standard of bioequivalence publications.

Adult↗
PubMed1992

Presentation of results from bioequivalence studies.

Based on general guidelines and requirements for the design and analysis of bioequivalence studies, specific recommendations are made for the presentation of results, both in tabular and graphical form. This is done by means of two examples, one of a single-dose study and one of a multiple-dose study. The recommendations in this paper are twofold. Firstly, a complete and rather detailed presentation of results is given, which practically corresponds to the standard of research reports. Secondly, a subset of this is suggested for publication. It gives the essential results for bioequivalence assessment in a standardized form. From an editorial point of view, it would be highly appreciated if the papers submitted for publication were always accompanied by a complete presentation including the individual concentration/time data and the various steps of calculation. This would speed up peer review and ultimately improve and harmonize the standard of bioequivalence publications.

Delayed-Action Preparations↗
PubMed1991

[Chronotherapy concept and the pharmacokinetic validation of a theophylline retard preparation for once-nightly administration (Euphylong)].

Many patients with asthma often experience a deterioration of symptoms at night and in the early morning resulting in sleep disruption and possibly impaired daily performance. A bronchodilator agent which exerts its maximal effect overnight to control nocturnal symptoms, without a worsening of the disease during the daytime, should improve the treatment of asthma. In the case of theophylline, it has been shown in asthmatic patients that a chronotherapeutically optimized formulation which provides the highest serum theophylline concentrations during the critical early morning hours resulted in better airflow levels overnight than the conventional twice daily regimen without loss of airflow in the afternoon. During clinical routine, this chronotherapeutically optimized drug delivery can only be ensured if there is no food interaction. In particular, dose dumping must be excluded. One absolute prerequisite for this is the pH-independent drug release in vitro. In addition to a "state-of-the-art" biopharmaceutic formulation, an easy-to-use guidance for individualizing the theophylline dose should be provided. This in turn is only possible if the concentration/time profiles show good reproducibility between subjects, from day to day, and for different dose levels. Finally, batch-to-batch bioequivalence has to be ensured. It is shown that Euphylong satisfies all of the above requirements.

Asthma↗
PubMed1991

[Efficacy of a theophylline retard preparation administered at 3 different intake times additionally to basic medication].

In this randomised crossover study in 26 outpatients with bronchial asthma the efficacy of a new once-daily theophylline formulation given in addition to a baseline medication was investigated; moreover, under steady state conditions, the effect of three evening intake times (6, 8 and 10 p.m.) on 24-hour pharmacokinetics and peak-expiratory flow profiles was evaluated. The theophylline dose had been individually titrated. The pharmacodynamic results show a marked improvement in 24-hour lung function data after adding theophylline to a drug therapy including inhalative anti-cholinergics in 50% of the treated outpatients. No significant differences between the pharmacokinetic characteristics and the 24-hour averages (mesors) of peak expiratory flow at the three different intake times 6, 8 and 10 p.m. were found; however, intake at 10 p.m. resulted in the highest nocturnal excess of serum theophylline concentrations and the highest peak expiratory flow during the early morning hours between 2 and 6 a.m.

Adult↗
PubMed1991

[Long-term stability of morning serum theophylline level in asthma patients under minimally 1-year therapy with Euphylong].

The long-term stability of morning serum theophylline concentrations (STC) and peak expiratory flow (PEF) was investigated for at least one year in 21 asthmatic patients who received individualised theophylline doses in addition to a baseline medication (beta 2-agonists, corticosteroids, anticholinergics by MDI). All patients had previously participated in a randomised crossover study with the new sustained-release theophylline formulation Euphylong, so that 24-hour steady-state STC profiles were available. During the 15 (13-18) months' follow-up, the theophylline dose was increased by about 6% on average; the largest increase of 33% (from 750 mg to 1000 mg) occurred in 4 patients. The morning STCs between 8 and 9 a.m. were intra-individually averaged over the longest interval with a constant dose; median and range were 11.6 (9.7-15.8) mg/l. The coefficient of variation was less than 10% in 8 patients and between 11 and 20% in 10 patients. The corresponding peak-flow values were 474 (239-622) l/min with a coefficient of variation of up to 10% in 16 patients and between 11 and 20% in 3 patients. The long-term study over more than one year confirmed the reproducibility of the Euphylong plateau profile previously found in controlled short-term pharmacokinetic studies and clinical trials.

Adult↗
PubMed1991

[Using the condom--on coping with a necessary evil].

Social aspects of condom use are mentioned by outlining some sections of the historical development of condom use (early and pre-history, family history in England during the 19th century, combat against syphilis, the "birth-strike-debate" in the German social democratic party). A few results of an own questionnaire research about students' sexuality (n = 666) are presented. They give some hints about a change in the use of different contraceptional techniques in comparison with former studies done in the sixties and at the beginning of the eighties. Condom users and non-users seem to be different in terms of concepts of partnership, sexual contentment and aids preventive behaviour. Finally we discuss some psychological aspects of condom use with regard to the--sparse--relevant literature and to an own qualitative study of the motivation of users and non-users.

Adaptation, Psychological↗
PubMed1990

[Implanting an atrial pacemaker].

Twelve single chamber atrial demand (AAI) pacemakers have been implanted for the control of the symptomatic sick sinus syndrome and hypersensitive carotis sinus syndrome at the Postgraduate Medical University during the last year. The patient selection was based upon the long-term monitoring and the electrophysiological studies. In the presence of the intact atrioventricular conduction the "pysiological" pacing has been maintained using "J" shaped endocavital atrial electrodes being connected with simple or multiprogrammable generators. Late AV block was not observed. Authors propose the spreading of AAI stimulation due to its hemodynamical advantages comparing with VVI pacing.

Aged↗
PubMed1989

Ultraviolet-induced formation of micronuclei and sister chromatid exchange in cultured fibroblasts of patients with cutaneous malignant melanoma.

Genetically enhanced sensitivity to ultraviolet (UV) radiation may play an important role in the development of cutaneous malignant melanoma (CMM). This was studied in cultured fibroblasts of 26 CMM patients and controls by micronucleus (MN) test and sister chromatid exchange (SCE) after UV irradiation (375 J/m2). Sister chromatid exchange and MN formation were used as parameters to detect the UV-induced genotoxic damage in the individual cell strains. We found that the UV-induced level of MN was significantly increased in CMM patients (p = 0.0005), being most pronounced in the familial cases (p = 0.0001). Ultraviolet-induced SCE was also elevated in CMM patients (p = 0.001), but there was no difference between familial and nonfamilial cases. The present findings indicate that genetic predisposition contributes to the development of CMM in a subset of CMM patients and may be due to an enhanced susceptibility to UV light.

Adult↗
PubMed1988

Pharmacokinetic profile of a new sustained-release theophylline pellet formulation for once-daily evening administration.

Euphylong is a new anhydrous theophylline sustained-release pellet formulation developed for once-daily administration in the evening in normal and slow metabolizers, and unequally divided twice-daily administration in fast metabolizers. Its pharmacokinetics have been investigated with respect to bioavailability, peak-trough fluctuation, nocturnal plateau profile, food effects, predictability and reproducibility between subjects and from day to day. To this end, 7 single-dose and 4 multiple-dose, randomized, cross-over studies were performed in a total of 168 healthy, normal, male volunteers. In order to match the dosage strengths of three reference products, capsules containing different amounts of pellets--also referred to as Euphylong pellets--have been used. Absolute bioavailability of theophylline from Euphylong was 88 and 100%, depending on the rate and the total dose of the intravenous reference infusions. Relative bioavailability ranged between 85 and 112%, depending on the reference formulations. The peak-trough fluctuation was reduced for Euphylong pellets in comparison with other once-daily theophyllines, by more than 30% in the case of a reference tablet. In contrast to another once-daily theophylline capsule, Euphylong pellets seem to be hardly affected by meals. Moreover, in view of the known variability of theophylline pharmacokinetics both between subjects and from day to day, the nocturnal plateau profile, which is characteristic of Euphylong, is extremely reproducible. The nocturnal excess is consistently 30-40% and the plateau time is consistently 11-12 h in normal metabolizers. The long nocturnal plateau profile together with the high reproducibility of Euphylong pharmacokinetics enable an easy and safe adjustment of the dose tailored to the needs of the individual patient. In addition, the time of the evening dose and its relationship to meals is not critical in the case of Euphylong pellets. Particularly patients presenting with nocturnal asthma, which is one of the major areas of theophylline therapy, should have a clinically relevant benefit from Euphylong.

Absorption↗
PubMed1987

Absolute bioavailability of theophylline from a sustained-release formulation using different intravenous reference infusions.

The effect of different intravenous infusions on the absolute bioavailability of theophylline from a sustained-release formulation has been investigated. Oral administration of 750 mg theophylline (2 capsules Euphylong 375) was referenced to intravenous aminophylline infusions corresponding to 506 mg theophylline over 8 h (63 mg.h-1) in Study 1, and to 749 mg theophylline over 14 h in Study 2. A reduction in the infusion rate from 69 to 33 mg.h-1 was made in Study 2 after 8 h in order to mimic the concentration/time profile of the oral formulation as closely as possible. The absolute bioavailability was 100 (89, 115)% in Study 1 and 88 (73, 105)% in Study 2. The lower clearance values and, as a consequence, the lower bioavailability ratios observed with the higher intravenous dose, although not significant, indicate that the absolute bioavailability of theophylline might appear to depend on the choice of the intravenous reference standard.

Adult↗
PubMed1986

Aggressive behavior induces release of nerve growth factor from mouse salivary gland into the bloodstream.

Intraspecific fighting induced by 6-8 weeks of social isolation results in massive release of nerve growth factor (NGF) into the bloodstream of adult male mice. The amount of circulating NGF is highly correlated with the number of fighting episodes. Biological, radioimmunological, immunohistochemical, and ultrastructural studies show that NGF is discharged from the salivary gland into the blood within minutes after fighting and reaches the highest level 3-4 hr later. Adrenergic innervation of the salivary gland or adrenalectomy does not abolish the NGF release. Corticotropic hormones do not induce NGF increase in the blood. Daily administrations of highly purified NGF (3 micrograms per g of body weight) result in a considerable increase in the volume of adrenal glands. These findings are unequivocable evidence for a physiological role of the mouse salivary glands as a major source of blood NGF.

Adrenalectomy↗
PubMed1983

[Enteral or parenteral feeding therapy. Comparative clinical study].

We investigated 20 patients - randomized into two groups - in a period of six postoperative days. We wanted to prove, whether parenteral and enteral feeding show differences in their nutritional effect. Both, parenteral and enteral nutrition had the same content of calories and nitrogen. The application of parenteral nutrition proceeded via central venous catheter and of enteral nutrition via tube feeding into the first part of the jejunum. There were no differences to be shown between both groups. Changes of the investigated datas from day to day had been typical changes within the postaggression syndrome. It was proven that tube feeding could be started in the early postoperative period. The tube diet was well tolerated and totally absorbed in the intestine. We believe that this form of tube feeding with a special diet may be a definite alternative to parenteral nutrition in patients within intensive care units and after surgery also in the very early postoperative period.

Adult↗