European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Jan 1995
Randomized Controlled Trial Comparative Study Clinical TrialComparative efficacy of hamamelis distillate and hydrocortisone cream in atopic eczema.
In a double-blind, randomized, paired trial lasting 14 days in 72 patients with moderately severe atopic eczema, hamamelis distillate cream (5.35 g hamamelis distillate with 0.64 mg ketone/100 g) was compared with the corresponding drug-free vehicle and 0.5% hydrocortisone cream, and reductions of the basic criteria of severe atopic eczema (delta values of the sum scores), i.e. itching, erythema and scaling, were evaluated. Thirty-six patients in each group were treated, which allowed the detection of a 10% difference between verum and control (confirmatory study). Effects were compared using Wilcoxon's test. ⋯ Unwanted cutaneous reactions occurred in six patients, although due to their inflammatory nature and their confinement to vehicle-treated patients, they may not represent true adverse effects but rather a lack of efficacy. The results prove the superiority of low-dose hydrocortisone cream over hamamelis distillate cream, and the therapeutic outcome following this preparation was no better than following the base preparation. The mild, yet unmistakable anti-inflammatory effect of hamamelis cream in experimental models of inflammatory skin disease was thus not reflected by an efficacy in patients with atopic eczema greater than that obtained from the base preparation.
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According to the World Health Organisation, a country's morphine consumption is an important indicator of progress in cancer pain relief. Due to its very high opioid consumption, Denmark is often pointed out as a country worthy of imitation. The aim of the present study was to analyse Danish opioid consumption in order to elucidate the usage pattern and to identify the consumers. ⋯ The consumption of long acting opioids (sustained release morphine, methadone, buprenorphine) and short acting opioids (others) increased by 1427% and 105%, respectively. Analysis of a sample of 1854 prescriptions for opioids revealed that less than 10% of the prescriptions were issued for cancer pain conditions. It is concluded: that if other countries consider Denmark as worthy of imitation in opioid treatment for cancer pain, attention should be paid to the pattern of the Danish opioid consumption, which is outstanding with respect to quantity but the quality may be questionable.
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Eur. J. Clin. Pharmacol. · Jan 1995
CSF concentrations and clinical effects following intravenous dixyrazine premedication.
Single concurrent plasma and lumbar spinal fluid samples were collected from twenty-two patients given IV dixyrazine 0.15 mg/kg, 10-106 min earlier in an open study. Dixyrazine penetrated rapidly into the spinal fluid; the CSF/P ratio was 0.3 by 10 min after drug administration and persisted at that level during the study period. The uncontrolled sedative and anxiolytic effects assessed by the patients were slight, and were correlated with the CSF drug concentrations only during the first 30 min after medication.
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Eur. J. Clin. Pharmacol. · Jan 1995
Randomized Controlled Trial Comparative Study Clinical TrialThe cognitive and psychomotor effects of opioid analgesics. II. A randomized controlled trial of single doses of morphine, lorazepam and placebo in healthy subjects.
Twelve subjects (8 male) took part in a randomised double blind four way crossover design study comparing four treatments: (i) morphine sulphate 10 mg, (ii) morphine sulphate 15 mg, (iii) lorazepam 1 mg (positive control) and (iv) placebo. Cognitive function was assessed using choice reaction time, number vigilance, memory scanning, immediate and delayed word recall, word recognition, picture recognition, critical flicker fusion threshold (CFFT) and subjective measures of alertness, calmness and contentment. Lorazepam produced a marked impairment in the tests of attention and memory. ⋯ Morphine 15 mg produced a significant improvement in accuracy on the choice reaction time test at the 2, 4 and 6 h assessments. These results show minimal impairment of cognitive and psychomotor function after single oral doses of morphine and with possible improvement in one test. Further studies are required to examine the effect of repeated doses.
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Eur. J. Clin. Pharmacol. · Jan 1995
Randomized Controlled Trial Clinical TrialRecovery characteristics following anaesthesia with sevoflurane or propofol in adults undergoing out-patient surgery.
The aim of the study was to compare recovery characteristics in adult patients following general anaesthesia either with the new investigational volatile agent sevoflurane or with propofol. Accordingly, two groups of 25 adults undergoing outpatient surgery were entered into a prospective, randomised study. ⋯ Modified Aldrete scores were also higher in this group within the first hour after anaesthesia than in the propofol group. Sevoflurane appears to be a useful alternative to propofol in outpatient anaesthesia.