[Digitalization problems in old age].
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Biomedical subjects
Publications and source records attributed to W Teufel.
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A double blind cross-over study under acute experimental conditions was carried out in 26 patients with angiographically confirmed occlusion in one or two limbs in order to see whether a change in the formulation of raubasine preparations improves the circulation in diseased limbs. Either 100mg raubasine or placebo tablets were administered in a randomized order. Blood flow at rest and "peak-flow" after total arterial occlusion for 3 min showed a significant improvement under raubasine compared with the pre-occlusion period whilst these parameters were not affected by placebo. Systolic blood pressure and heart rate remained almost constant under raubasine whilst they were reduced under placebo. A similar response was seen in a subgroup of 19 patients with occlusion of the femoral artery. It can thus be said that in the present investigation the new formulation of raubasine preparation (MF 706d) has been shown in a double blind study to improve both the blood flow at rest and the "peak-flow" to a significant degree in patients with arterial occlusions.
It was possible in a controlled double-blind study to demonstrate by means of dynamographic measurements the action of raubasine in patients with cerebrovascular disorders. A new formulation of Lamuran tablets (MF706d) was used for the investigation. This formulation has an improved in-vitro dissolution rate for raubasine that is largely independent of pH. In the raubasine group (10 patients aged 47 to 81 years, including 6 cases of anacidity) there was after one and two weeks treatment with dialy doses of 90 mg raubasine a significant reduction of the raised vascular resistance and pulsewave velocity and systolic blood pressure in the internal carotid artery which indicate an improvement in cerebral haemodynamics. In contrast, no significant changes in these parameters could be found in the placebo group (9 patients aged 52 to 83 years). The therapeutic relevance of the haemodynamic effects was supported by a simultaneous clinical improvement.
The biological availability of digitoxin from Lanicor was compared with that from two different galenical preparations of Card-Lamuran (Card-Lamuran and MF708d both containing equal amounts of active ingredients: 0,125 mg digitoxin and 10 mg raubasine). The patients who were kept on their individually adjusted oral digitoxin maintenance dosage received the three preparations in a randomised order. Additionally, the equivalent dosages of Lanicor and Lanitop were determined from the data on their biological availability. In 24 patients with heart failure (mean age 70.5 years), radioimmunoassay of the glycoside concentration in the serum was performed. The patients were cardially well compensated with Lanicor and it could be assumed that there would be no change in the daily maintenance dosage for the entire period of the study (42 days). Our results show that digitoxin had the same bio-availability from Lanicor and the two different galenical preparations of Card-Lamuran and MF708d. Patients can therefore safely be switched from one of these preparations to the other. On average, doses of Lanicor 1.55 times higher than those of Lanitop must be given to obtain the same serum glycoside concentrations. The variation of this factor was no greater than the variation in serum concentrations of digitoxin during continued maintenance therapy with Lanicor. The mean serum concentrations of digitoxin under maintenance therapy in our geriatric patients (mean value 2.1 mg/ml) were higher than the digitoxin concentrations published in the literature for younger patients (average 1.4 ng/ml). The calculated daily maintenance doses providing a digitoxin concentration of 1.4 mg/ml were ca. 0.3 mg Lanicor and ca. 0.2 mg Lanitop. This is somewhat less than generally assumed. This agrees with the clinical experience that the glycoside maintenance dosage in elderly patients is generally less than in middle-aged patients.
A new slow-release isosorbide dinitrate preparation (ISDN retard, Boehringer Mannheim) was investigated in a controlled study (double blind/cross over) in 20 patients with clear symptoms of coronary insufficiency after myocardial infarction, comparing the ECG on effort with that under placebo treatment. A favourable effect on the symptoms of coronary insufficiency could be demonstrated under standardised conditions on a bicylce ergometer 4 hours after oral ingestion of ISDN. The ST interval of the ECG was significantly lowered (p less than or equal to 0.025) under comparable cardiac work. The prolonged action of ISDN retard was also shown by a significant reduction in systolic and diastolic blood pressure at rest, during and after effort. Simultaneously, there was a slight but not-significant rise in heart rate.