[Stable multivariate tests from the viewpoint of confidence intervals].
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Biomedical subjects
Publications and source records attributed to J Läuter.
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A proposal for the multivariate analysis of quality control data is presented. This approach combines exact mathematical evaluation with great clarity of interpretation.
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An investigation of the bioequivalence of a new tablet formulation (amitriptylin 25 von ct) with 28.3 mg amitriptyline hydrochloride (CAS 549-18-8) was performed in a two-way cross-over study with 18 subjects. The relative bioavailability with respect to a reference preparation for AUC related to amitriptyline (CAS 50-48-6) was 99.3% and for Cmax 100.4%. A positive decision for bioequivalence derived from the usual confidence intervals for both parameters related to amitriptyline and the metabolite nortriptyline (CAS 72-69-5), respectively tmax showed no difference. The new formulation was bioequivalent to the reference.
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An investigation in the bioequivalence of a new tablet formulation with 5 mg isosorbide dinitrate (CAS 87-33-2, ISDN 5 von ct) was performed in a two-way cross-over study with 18 subjects. The relative bioavailability with respect to a reference preparation for AUC related to isosorbide dinitrate was 107.5% and for Cmax 112.5%. A positive decision for bioequivalence derived from the usual confidence intervals for both parameters related to isosorbide dinitrate and the metabolites isosorbide-2-nitrate and isosorbide-5-nitrate, respectively. The difference in tmax showed no clinical relevance. The new formulation was bioequivalent to the reference.
An investigation of the bioequivalence of a new allopurinol formulation with 300 mg allopurinol (CAS 315-30-0, allo 300 von ct) was performed in a two-way cross-over study with 18 subjects. The relative bioavailability with respect to a reference preparation for AUC related to oxipurinol was 98.1% and for Cmax 91.7%. A positive decision for bioequivalence derived from the usual confidence intervals for both parameters related to allopurinol and the metabolite oxipurinol, respectively, tmax showed no difference regarding oxipurinol. The new formulation was bioequivalent to the reference.
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Univariate and multivariate analysis of variance and discriminant analysis were performed on newborns with respect to the level of red cell creatine at birth (cord blood) and 12 risk conditions occurring during the last trimester of gestation and birth. 111 of the 174 newborns studied had been at risk. The factor "small for gestational age" (SGA) showed to have a negative coefficient of discriminant function, i.e. it contributes to lower creatine values at birth. Other risks are shown to raise the creatine level. For "adequate for gestational age" (AGA) newborns "Rh-incompatibility", "toxoplasmosis", "premature and/or prolonged rupture of the membranes", "complications of the umbilical cord" and - to a minor degree - "pyelonephritis of the mother", "threatened premature labour", and "toxemia of pregnancy" were shown to be significant risks leading towards high red cell creatine concentrations in cord blood. For the SGA infants "preterm birth", "threatened premature labour", "green amniotic fluid" and "toxemia of pregnancy" were the most important risks relating to high creatine levels of red cells at birth.
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Eighty-eight patients with the stage 1 hypertension according to the WHO classification exercised on a bicycle ergometer for 30 min daily at the heart rate 130-140 beats/min for 28 days. In 42% of the patients the systolic pressure at rest, during exercise, and in the recovery period decreased significantly; in 58% of them the systolic pressure did not sink. The diastolic pressure during exercise sank in those patients whose systolic pressure was reduced by the effect of the exercise, whereas in those patients who did not respond to exercise by a reduction of the systolic pressure, the diastolic pressure did not change, either. The following indicators differentiated the responders and non-responders to exercise: height of systolic pressure during exercise and recovery period, height of diastolic pressure at rest, disturbed glycide metabolism, presence of hypertension in the family history, sports in anamnesis and cardiac index.
The use of the Quantimet for measurements of structural wall reactions of blood vessels (b.v.), visualized selectively by a modification of the ATPase reaction, requires that changes in wall thickness are not mimicked by differences in deposition of the reaction product, by changes of the b.v. lumen, and/or by b.v. elongations, especially meanderings occurring independently of thickenings of vessel walls and caused solely by increase of the intravascular pressure or by vasoconstriction. The article has substantiated the conclusion that these requirements are fulfilled.
Using a modification of the Mg-ATPase reaction, the arterial blood vessels of the microcirculatory bed of the rat including the smallest precapillary vessels are visualized in a grey-level difference against their environment which permits to utilize the automatic image analyser QUANTIMET 720 and the programmable desk-top calculator HEWLETT-PACKARD 9100B. The article describes the method for preparing the sections, the measuring procedure, and the statistical verification of the results by means of the computer assisted two-way analysis of variance as well as studies demonstrating the reliability of the method. It is concluded that the procedure at heart, skeletal muscle and pancreas specimens of the rat demonstrates reliably and effectively changes of the number of vessels and the projected whole vessel wall area as well as differences of enzyme activities. Thus it is possible to detect structural wall reactions and enzyme histochemical changes of arterial blood vessels of the microvasculatory bed including its smallest precapillaries which have been practically inaccessible to histomorphometrical investigations in the past.
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Questionable data may be regarded as significant indicators for a screening. It is the aim of our investigations to develop a screening standard anamnesis in form of a questionaire which allows on the scale of larger groups of population to establish the number of endangered persons and patients who probably suffer from cardiovascular diseases but of the quantity of apparantly healthy persons. In order to recognize regularities of the diagnostics coordination of the individual patient by his answers on the questionnaire the data of 400 diagnostically clarified persons (model experiment) underwent a discriminancy analysis. When the data of unknown test persons are given in, on account of the well-known functions of discriminancy a classification in the groups persons with heart and circulatory diseases or with a healthy heart and circulation or a group diagnosis can be performed, respectively. The evaluation of the data of unknown test persons of a pilot study in 96% resulted in a correct classification in patients with heart and circulatory diseases or persons with healthy heart and circulation, the classification in the above mentioned groups of diagnosis was performed on an average to 57%.
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Of 257 patients with gastric cancer and of 766 persons with different stages of chronic gastritis or normal gastric mucosa, 35 items from epidemiologic studies were used for this analysis. The comparison of epidemiology of chronic gastritis with epidemiology of stomach cancer by univariate and multivariate variance analysis shows numerous common variables (social group; digestive diseases). Furthermore gastric cancer is characterized by variables which give hints to cancerogenous noxes. Gastric cancer patients are distinguished from persons with atrophic gastritis by the following variables: cancerogenes; social class; genetic factors, and digestive diseases. It is suggested that these factors are relevant for stomach cancerogenesis in atrophic gastritis.