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Biomedical subjects

M De Backer

Publications and source records attributed to M De Backer.

14 recordsLinked to original sources
PubMed1998

Twelve weeks of continuous oral therapy for toenail onychomycosis caused by dermatophytes: a double-blind comparative trial of terbinafine 250 mg/day versus itraconazole 200 mg/day.

BACKGROUND: Dermatophyte infections of the toenail have been difficult to treat, requiring long courses of therapy and having high recurrence rates. New oral antifungal agents with better outcomes and minimal adverse events are needed. OBJECTIVE: The purpose of this study was to compare two newer antifungal compounds, terbinafine and itraconazole, for efficacy and safety in toenail onychomycosis caused by dermatophytes. METHODS: The study was randomized and double-blind. It compared 12 weeks of continuous oral treatment with terbinafine 250 mg/day or itraconazole 200 mg/day for confirmed toenail dermatophyte onychomycosis. Clinical symptoms and mycologic outcome were assessed at weeks 4, 8, 12, 24, 36, and 48. A total of 372 patients (186 in each group) with dermatophyte infection confirmed by microscopy and culture were included in the intent-to-treat analysis. RESULTS: At week 48, a statistically significantly greater percentage of the terbinafine group than itraconazole group showed negative mycology (73% [119 of 163] vs 45.8% [77 of 168]; p < 0.0001) (difference = 27.2%; 95% CI = [17.0%, 37.3%]). The difference was also confirmed clinically (p = 0.001) in the patients who were clinically cured or had only minimal symptoms at the end of the study (76.2% [125 of 164] vs 58.1% [100 of 172]) (difference = 18.1%; 95% CI = [8.24%, 27.9%]). The geometric mean length of healthy nail of the big toe was significantly greater in the terbinafine than itraconazole group (8.1 vs 6.4 mm; p = 0.026). Tolerability was good to very good in almost 90% of patients in both groups, and all reported adverse events were known for these compounds. CONCLUSION: Terbinafine produced higher rates of clinical and mycologic cure at follow-up than did itraconazole.

Administration, Oral↗
PubMed1997

Clinical pharmacokinetics of Neoral in pediatric recipients of primary liver transplants.

Pediatric liver transplant recipients constitute a population characterized by a particularly unpredictable and poor bioavailability of cyclosporin (CyA). Even though several adult studies show that the new oral formulation of CyA, Neoral (NEO), produces better bioavailability and blood level predictability, few data describe its pharmacokinetics in children. We performed a complete analysis of the pharmacokinetics of NEO in ten small children after primary liver transplantation. Three pharmacokinetic profiles were set up with data obtained from tests taken during i.v. administration of CyA, after the first oral NEO dose, and after the last NEO dose before discharge from the hospital. The mean half-lives obtained were 8.1, 7.7, and 6.9 h, respectively, and the bioavailabilities were 22% and 21% for the first and last NEO doses. A large interpatient variability was observed. This was due, in part, to episodes of diarrhea that interfered with the pharmacokinetic evaluation and, in part, to the variability of post-transplant hepatic function. There was a good correlation between CyA trough levels and their related AUCs for both NEO profiles (r = 0.93 and r = 0.74, respectively). We conclude that, even though the pediatric OLT population remains more unpredictable than that of adults, NEO has a relatively rapid half-life and a remarkably improved bioavailability.

Administration, Oral↗
PubMed1996

A 12-week treatment for dermatophyte toe onychomycosis: terbinafine 250 mg/day vs. itraconazole 200 mg/day--a double-blind comparative trial.

Lamisil (terbinafine) 250 mg daily and itraconazole 200 mg daily were compared in the treatment of dermatophyte toe onychomycosis over 12 weeks in a double-blind randomized clinical trial. At the end of follow-up (week 48) treatment with Lamisil led to negative mycology in 73% of patients compared with 45.8% in the itraconazole group (P < 0.0001). Globally the clinical symptoms of the target nail improved, a response which was in favour of Lamisil (P = 0.001). The percentages of patients who were clinically totally cured or who presented with only minimal symptoms were 76.3% for the Lamisil-treated group compared with 58.1% in the itraconazole group. The unaffected nail length for big toes was significantly higher in the Lamisil-treated group (9.1 mm vs. 7.7 mm; P = 0.0298). Onycholysis was also less in the Lamisil group (P = 0.001). We conclude that 12 weeks' continuous oral therapy leads to higher cure rates with Lamisil than with itraconazole and that both drugs are equally well tolerated.

Administration, Oral↗
PubMed1995

The use of Sandimmun (cyclosporin A) in severe refractory rheumatoid arthritis: the Belgian experience.

OBJECTIVE: To investigate practicability, efficacy and tolerability of low starting doses of Sandimmun (cyclosporin A) (2.5 mg/kg daily) in patients with severe refractory rheumatoid arthritis in the short (6 months) and middle (12 months) term. METHODS: Fifty-nine patients, presenting with active and severe rheumatoid arthritis unresponding to conventional DMRADs were allowed to start Sandimmun at the dose of 2.5 mg/kg daily. This dose was progressively increased by steps of 25 mg daily up to a maximum of 5 mg/kg daily according to the renal function and blood pressure. RESULTS: A mean maintenance dose of 3.9 mg/kg daily was reached after 5 months and maintained throughout the study. Twenty-one patients (36%) completed the one year study. The reasons for discontinuation were: inefficacy (13), adverse events (17), both inefficacy and adverse events (5) and non-compliance (3). For those patients who completed the trial, clinical relevant improvements were observed within 3 months of treatment and were maintained until the end of the study for the Lee functional and the Ritchie articular index, as well as for the number of tender and swollen joints. No changes for the grip strength, the biological and immunological parameters were observed. Mean serum creatinine values rose from 0.81 mg/dl at start to 1.1 mg/dl after 5 months of therapy and remained at that level throughout the study. In patients who discontinued, the serum creatinine level nearly normalized after one month of Sandimmun withdrawal. One hundred and sixty-two side effects were reported of which most were minor and known to occur with Sandimmun. Twenty-two cases (37% of patients) dropped out for adverse events before 1 year treatment. The criteria to withdraw the patients from the study differed greatly from centre to centre. CONCLUSIONS: Managing RA patients presenting with very long and severe disease remains difficult. Therefore low dose Sandimmun (2.5-5 mg/kg daily) appears to be a valuable therapeutic opportunity in RA patients refractory to various other conventional drugs, including methotrexate.

Adolescent↗
PubMed1994

Two-week oral treatment of tinea pedis, comparing terbinafine (250 mg/day) with itraconazole (100 mg/day): a double-blind, multicentre study.

In this randomized double-blind trial, two new antifungal compounds were compared in patients with interdigital or more extensive forms of tinea pedis. Two weeks of oral treatment with either terbinafine, an allylamine and new chemical entity, 250 mg daily, or itraconazole 100 mg daily, was given to 366 patients (184 terbinafine, 182 itraconazole). Of 13 patients who did not return after the first visit, 11 were lost to follow-up (five on terbinafine, six on itraconazole) and two reported adverse events. Another nine patients (three on terbinafine and six on itraconazole) were excluded because it was uncertain to which group they were randomized. A central laboratory performed both the mycology and safety tests. In 355 patients who received the study medications and were available for analysis of side-effects, 18 out of 179 (10.0%) in the terbinafine group and 10 out of 176 (5.7%) in the itraconazole group reported adverse events. No new clinically significant laboratory abnormalities were seen after treatment. At week 8 the efficacy analysis in 117 patients with mycologically confirmed dermatophyte infections (51 on terbinafine, 66 on itraconazole) showed that clinical symptoms were absent or minimal in 94.1% of the terbinafine and 72.7% of the itraconazole group (P = 0.0095); mycology was negative in 86.3% of the terbinafine and 54.5% of the itraconazole group (P = 0.0002). With terbinafine, negative mycology at week 8 was 81.3% in the interdigital and 88.6% in the more extensive forms of tinea pedis; with itraconazole mycology was negative in 65.0% and 50.0% of patients, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed1993

Phenotypic effects in Saccharomyces cerevisiae after regulated expression of beta-(1,3)-glucanase from Nicotiana plumbaginifolia.

A recombinant yeast strain was constructed of which the cell wall porosity could be reversibly and conditionally modulated. This strain expresses the Nicotiana plumbaginifolia beta-(1,3)-glucanase under control of the Saccharomyces cerevisiae GAL1 promoter and the mating factor alpha 1 prepro-sequence. The following phenotypic effects were observed after expression of this enzyme: (a) expressed beta-(1,3)-glucanase is toxic to the producing yeast cells, which is reflected by a strong growth inhibition; as beta-(1,3)-glucanase could be detected only inside the cells, it seems to interfere with cell wall growth from within the cell; (b) after induction of glucanase, the recombinant strain lost up to 20% of some periplasmic enzymes, as evidenced by the release of normally periplasmic-associated invertase; (c) preliminary growth in a synthetic medium containing galactose significantly increased the transformation efficiency of the recombinant yeast strain.

Base Sequence↗
PubMed1981

Efficacy of intravenous disopyramide in acute cardiac arrhythmias.

The efficacy of intravenous disopyramide was studied during 200 episodes of supraventricular and ventricular arrhythmias in 160 patients, mainly presenting with acute myocardial infarction or cardiac failure. Disopyramide 50 mg was administered in a few seconds and any remaining dose within 2 to 5 min. The overall success rate was 80.5%. Intravenous disopyramide was more effective in patients with ventricular arrhythmias (85%) than in those with supraventricular arrhythmias (76%). Dose dependent prolongation of the PR interval, QRS time and the QT interval occurred in 16.32 and 20% of the cases, respectively. The adverse effects were aggravation of the arrhythmias, decrease of blood pressure and anticholinergic activity.

Acute Disease↗
PubMed1978

The use of a test for the differential diagnosis of hypercalciuria.

28 renal stone formers (18 men and 10 women) with idiopathic hypercalciuria (IH) and 27 controls have been subjected to a test proposed for the diagnosis of absorptive, resorptive and renal hypercalciurias. Fasting serum calcium concentration, urinary calcium and cyclic AMP excretion were measured after overnight fasting and an oral load of calcium. Absorptive hypercalciuria was demonstrated in 14 patients. High fasting urinary calcium first suggested resorptive or renal hypercalciurias in 5 other patients, but since fasting urinary calcium was normalized following cellulose phosphate therapy, absorptive hypercalciuria was more likely. Renal hypercalciuria was a possibility in 1 single case. Both fasting and post-load urinary calcium were normal in 7 men and 1 woman. The test did not appear as useful as expected since it was of no diagnostic value in about 30% of the cases and erroneously suggested resorptive or renal hypercalciuria in about 15% of the cases. On the other hand it indicated that absorptive IH is common and renal IH exceptional.

Adult↗
PubMed1976

The origin of urinary hydroxylysyl glycosides in Paget's disease of bone and in primary hyperparathyroidism.

The urinary excretion of glucosyl-galactosyl-hydroxylysine and of galactosyl-hydroxylysine were studied in Paget's disease of bone and in primary hyperparathyroidism. Both metabolites were increased in these diseases. Although glucosyl-galactosyl-hydroxylysine is not abundant in bone collagen, it is possible that a part of it originates from calcified tissue.

Alkaline Phosphatase↗
PubMed1976

Parathyroid hormone plasma level in untreated chronic renal failure and in hemodialyzed patients.

In 42 untreated patients at various stages of chronic renal failure, plasma level of parathyroid hormone was directly proportional to the degree of renal failure and inversely proportional to the serum calcium level. Plasma parathyroid hormone levels were frequently elevated in 21 patients undergoing regular dialysis treatment, in spite of normal levels of serum total calcium and magnesium. Serum-ionized calcium levels measured in dialyzed patients were usually reduced and inversely correlated with the creatinine levels. Parathyroid hormone levels were correlated with the creatinine levels, but the inverse relationship with ionized calcium was not significant.

Adult↗
PubMed1975

[Development of elastin of human aortas during ontogenesis].

The formation of the elastic fiber was followed up in nine human aortas from foetus or newborn. During this period of ontogenesis an evolution of the elastic residue with increasing age was observed. There was a decrease in the association of structural glycoproteins or microfibrils with elastin. The insolubility of elastin increased with age, together with the increasing crosslinkage of the fiber, characterized by the ratio (sum of desmosines/lysine).

Aorta↗