European journal of clinical pharmacology
-
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.
-
Eur. J. Clin. Pharmacol. · Jan 1995
Randomized Controlled Trial Clinical TrialInfluence of piroxicam coadministration on pharmacodynamic parameters and the plasma concentration/effect relationship of recombinant hirudin (CGP 39393).
Recombinant hirudins are currently under investigation for use in myocardial infarction and unstable angina. In this study the influence of piroxicam on the pharmacodynamics and pharmacokinetics of a recombinant hirudin preparation (CGP 39393) administered intravenously was determined. Twelve healthy, male volunteers received piroxicam 10 mg and matching placebo once daily for 12 days according to a double-blind, randomised cross-over design. ⋯ No change was observed in the platelet adhesion index. Responsiveness parameters according to a sigmoidal Emax-model were obtained from the hirudin-plasma concentration/effect (i.e. APTT-prolongation)-curves after placebo and piroxicam.(ABSTRACT TRUNCATED AT 250 WORDS)
-
Eur. J. Clin. Pharmacol. · Jan 1995
Case Reports4-methylpyrazole monitoring during haemodialysis of ethylene glycol intoxicated patients.
4-methylpyrazole (4-MP) was administered IV during haemodialysis of two ethylene glycol-intoxicated patients with anuric renal failure. The plasma 4-MP concentration decreased after each pass through the dialyser, indicating its dialysability in humans. In these two cases, the extraction coefficient was 0.78 and 0.71, and the mean dialysance was calculated to be 137 and 117 ml.min-1, corresponding to a 4-MP removal rate of 83 and 50 mg.h-1, respectively. ⋯ A recent study in pigs indicated that the amount of 4-MP removed by haemodialysis was significant [8]. No data were available for man. The aim of the study was to evaluate the dialysability of 4-MP in the two intoxicated patients, and to estimate how to compensate for 4-MP elimination during haemodialysis.
-
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.
-
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.