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Biomedical subjects

H Kopera

Publications and source records attributed to H Kopera.

At least 37 records · Page 2Linked to original sources
PubMed1983

The effect of Bepridil on respiratory and cardiovascular function: a placebo-controlled study.

Bepridil is a novel substance with antianginal and specific antiarrhythmic activities. To investigate its effect on bronchomotor and cardiovascular function a placebo-controlled, randomized, double-blind study was performed in 12 healthy volunteers of both sexes. The test preparations were administered by intravenous infusion. Bepridil was given in a dose of 2 mg/kg, which is sufficient to produce a therapeutic plasma level. With body plethysmography the airway resistance was determined before and 110 min after test drug administration. Oscillatory resistance (Oscillation method, Siregnost FD5, Siemens), blood pressure, and electrocardiogram were recorded before administration of the test preparation and thereafter in short intervals for 20 min and in longer intervals for 2 h. Analysis of the data does not indicate that Bepridil affects respiratory function in other ways than a placebo. Hence Bepridil in therapeutic doses is unlikely to produce untoward effects on the respiratory system. Likewise no unwanted effects on the cardiovascular system were recorded; the observed antitachydardia effect is of therapeutic value. The usefulness of the oscillation method to investigate influences on bronchomotor function has been confirmed.

Adolescent↗
PubMed1980

Cardiovascular effects of mianserin--a comparative study with amitriptyline and a placebo in healthy subjects.

The cardiovascular effects of a tricyclic (amitriptyline) and a tetracyclic (mianserin) antidepressant were compared with those of a placebo in a double-blind randomized group-comparative trial stratified for sex in 18 healthy volunteers. The dose of the test preparations was gradually increased to therapeutic level. Duration of treatment was 8 days. Neither test drug affected objective physical condition, intraocular pressure, blood variables or urinalysis, and the effect on blood pressure was found to be negligible. No impressive differences of untoward cardiac effects between the test preparations could be demonstrated. However, the prolongation of the pre-ejection period in amitriptyline-treated males, indicating a negative effect on myocardial contractility, and the reduction of the left ventricular end-systolic volume by mianserin, probably through increasing the ejection fraction, are observations of possible clinical relevance. They lend further support to the assumption that therapeutic doses of tricyclic antidepressants may produce untoward cardiac effects whereas the tetracyclic mianserin seems devoid of such unwanted properties.

Adolescent↗
PubMed1978

[Cardiotoxicity of mianserin, an antidepressant (author's transl)].

The effect of mianserin on cardiac function was investigated on 60 adults with known heart disease, the drug previously having been shown not to influence the action of phenprocoumon. After satisfactory anticoagulation had been established, all patients were given additionally two different dosage regimens of mianserin or a placebo in a double-blind trial lasting three weeks. The dose was gradually increased to a maximal daily level of 30 mg or 60 mg, respectively, on the sixth day. Heart rate, blood pressure and electrocardiogram were obtained before and after mianserin had been added. There was no statistically significant difference between the three trial groups with respect to the three measured variables.

Adult↗
PubMed1978

Phenprocoumon requirement, whole blood coagulation time, bleeding time and plasma gamma-GT in patients receiving mianserin.

A possible interaction between the tetracyclic antidepressant mianserin and a coumarin derivative has been investigated. Sixty-three subjects, 61 of whom required anticoagulant therapy for a variety of medical conditions, were treated for 5 consecutive weeks with phenprocoumon, in a dose adjusted to reduce the prothrombin time to 15%-25%. After an initial control period of one week, subjects were randomly treated under double-blind conditions with mianserin 3 X 10 mg daily or 3 X 20 mg daily, or with a matching placebo. The dose of mianserin was gradually increased to reach the maximum by the 6th day. Three subjects dropped out and 60 completed the trial. The dose of phenprocoumon and the prothrombin, bleeding, and coagulation times were not significantly affected by administration of mianserin. It can be concluded that there is no clinically important interaction between phenprocoumon and doses of mianserin effective in depression. Sedation was more frequent in patients taking mianserin than in those given placebo.

4-Hydroxycoumarins↗
PubMed1978

Anticholinergic and blood pressure effects of mianserin, amitriptyline and placebo.

1. Eighteen healthy male volunteers were treated at random in double-blind conditions with mianserin, amitriptyline, or placebo for 8 days. Measurements were made of various parameters indicative of anticholinergic and blood pressure effects. 2. Mianserin showed no significant anticholinergic effects on any of the measures used. Compared with placebo, mianserin significantly reduced pupil diameter and tended to increase salivary production and increase the distance of the near point. 3. Amitriptyline showed evidence of anticholinergic effects in that salivary production fell to a level significantly lower than that of the mianserin- or placebo-treated subjects. The distance of the near point tended to increase during amitriptyline treatment. Compared with placebo, amitriptyline also significantly reduced pupil diameter on some occasions. 4. Amitriptyline produced postural hypotension to a statistically significant degree, whereas this effect was not observed during mianserin treatment. 5. In conclusion, mianserin in doses of up to 60 mg daily given to healthy males seemed to lack the anticholinergic effects and postural hypotension associated with amitriptyline treatment.

Accommodation, Ocular↗
PubMed1978

The effect of Org GC 94 on thrombocyte function, blood coagulation and the fibrinolytic system in man.

The effect of a 14 day treatment with Org GC 94 in rising dosage to a maximum of 45 mg/day on thrombocyte function, blood coagulation and the fibrinolytic system was investigated in 16 healthy volunteers in a double-blind comparative trial with placebo. At the same time the influence on some liver function tests and on the general condition of the subjects was followed. Analysis of the data obtained in tests pertaining to platelet function, blood coagulation, fibrinolysis and liver function did not indicate unwanted or harmful effects of Org GC 94. No significant difference in effect between Org GC 94 and placebo was detectable. The general physical condition including appetite and body weight was not affected by Org GC 94. A mild, transient sedative effect of the maximum dose of Org GC 94 is likely and some influence upon concentration (decrease) and mood (indifference or elevation) in some subjects cannot be excluded.

Adolescent↗
PubMed1976

[Oral contraceptives (author's transl)].

A short review of the endocrinological basis of reproduction in the female is followed by a critical survey of the oral contraceptive methods in current use. The composition of the preparations, their use, their biological and use-effectiveness and mode of action are discussed.The importance is emphasized of complying with the basic principles of drug testing in the evaluation of effects of oral contraceptiveson health. Other effects than merely the contraceptive actions of these preparations are described in detail, including not only the undesirable, frequently neglected, yet very important beneficial effects on the drug-users, their children and families.

Abnormalities, Drug-Induced↗