Arzneimittel Forsch
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Arzneimittel Forsch · Jan 1985
Randomized Controlled Trial Comparative Study Clinical TrialClinical experience and results of treatment with suprofen in pediatrics. 2nd communication: Use of suprofen suppositories as an antipyretic in children with fever due to acute infections/A single-blind controlled study of suprofen versus paracetamol.
The present randomized single-blind trial was performed to study antipyretic effect and tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) suppositories versus paracetamol (acetaminophen) suppositories in pediatric patients with fever of various etiology. The study included a population of 120 patients ranging in age from 2 to 12 years; the subjects' mean rectal temperature was 39.3 degrees C in the beginning of the therapy. The dosage of the suppositories depended upon body weight; medication was applied up to 3 times a day. ⋯ After the treatment pulse and respiratory rate dropped in both age groups on either treatment. The means were within the normal range at all rating times. The only adverse reaction was vomiting; this phenomenon occurred in 4 cases, i.e., in 2 cases each on either drug.
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Arzneimittel Forsch · Jan 1985
Randomized Controlled Trial Clinical Trial Controlled Clinical Trial[Flupirtine in patients with cancer pain].
In a double-blind clinical trial the analgesic efficacy and safety of ethyl-N-(2-amino-6-[4-fluorophenyl-methylamino] pyridin-3-yl)carbamate (flupirtine, designated trademark: Katadolon) as 100-mg capsules were compared to pentazocine capsules 50 mg in 52 patients with severe to very severe cancer pain. The duration of treatment was up to one week, the daily dose up to 6 capsules. The analgesic effect was assessed by a 4-point verbal rating scale. ⋯ Final evaluation demonstrated that flupirtine was significantly more effective than pentazocine in reducing pain. The incidence of side-effects was similar in both treatment groups, flupirtine, however, caused less intensive and less clinically relevant adverse reactions. In conclusion the results indicate that flupirtine is a potent and well tolerated analgesic in the treatment of cancer pain.
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Arzneimittel Forsch · Jan 1985
Clinical Trial Controlled Clinical TrialLong-term effect of etilefrine pivalate on blood pressure in man.
An open and a placebo-controlled double-blind trial were carried out to measure the effect of a long-term treatment (2-6 months) with etilefrine pivalate (K 30 052, Ep) on blood pressure of 60 patients suffering from orthostatic dysregulation. Oral administration of the agent took place once daily, each dose containing 20 mg. While the acute response to a single dose was comparatively weak, long-term administration had a marked and long-lasting effect both on systolic blood pressure (+40.3 mmHg) and blood pressure amplitude (+37.5 mmHg) (p less than 0.01). ⋯ The increase in blood pressure amplitude points to an augmentation of stroke volume, whereas heart rate was virtually unaltered. Peripheral resistance appears not to be increased since diastolic pressure was unchanged. The elevation in blood pressure amplitude was fully reversible within 9 weeks of wash-out, thus hinting at functional rather than structural (sclerotic) changes in the cardiovascular system.
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Arzneimittel Forsch · Jan 1985
Absorption, distribution, excretion and metabolism of orally administered 14C-beta-cyclodextrin in rat.
The absorption, distribution, excretion and metabolism of orally administered universally labelled 14C-beta-cyclodextrin and 14C-glucose were compared in rat. The maximum radioactivity of the blood derived from 14C-beta-cyclodextrin was observed between 4th and 11th h and the value of the maximum in different experiments ranged between 5 and 17 0/00 of the total administered radioactivity. Following 14C-glucose treatment radioactivity reached the maximum within half-an-hour, with values of 15 to 82 0/00. ⋯ Following p.o. administration of different doses of 14C-beta-cyclodextrin the radioactivity peak was detected in the exhaled air between the 4-6th and 6-8th h, respectively, depending on the administered doses, while in case of 14C-glucose treatment it was observed within 2 h. The total radioactivity exhaled by 14C-beta-cyclodextrin treated animals in 24 h was 55 to 64% of the administered radioactivity and 58% in case of 14C-glucose. It is assumed that beta-cyclodextrin is metabolized in rats slower but similarly to glucose, therefore p.o. administered beta-cyclodextrin cannot induce toxic symptoms.
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Arzneimittel Forsch · Jan 1985
[The pharmacologic effect of flupirtine, a structurally new analgesic].
The analgesic potency of ethyl-N-[2-amino-6-(4-fluorophenylmethylamino)pyridin-3-yl]carb ama te (flupirtine, D 9998) in mice and rats in Haffner's test, electro-pain test and Randall-Selitto test (inflammation induced pain) lies between the more potent dextromoramide and methadone and the more weakly active pethidine, dextropropoxyphene, codeine, phenacetin and paracetamol. In comparison to codeine flupirtine is up to 4 times more potent, up to 2 times more active than pethidine and 4 times more potent than dextropropoxyphene in the above-mentioned methods. With one exception of inflammation induced pain, where flupirtine shows an activity of about 1 1/2 times that of phenacetin and paracetamol, both analgesics are about 10 to nearly 30 times less active than flupirtine in other above-mentioned tests. ⋯ In current experiments concerning the mode of action flupirtine exhibits a distinct central analgesic component of action. In spite of its relatively high analgesic potency which corresponds to that of opiates flupirtine does not show any other signs of opiate properties and other potent analgesics. Thus, flupirtine does not develop tolerance in mice and rats after 19 or 17 days of daily administration.(ABSTRACT TRUNCATED AT 400 WORDS)