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Biomedical subjects

E Abadie

Publications and source records attributed to E Abadie.

At least 19 recordsLinked to original sources
PubMed1990

[How and when to create a pediatric file for authorization to market a new drug. A proposal of the SNIP clinical group (National Syndicate of Pharmaceutical Industry)].

In order to recommend the pediatric use of a new drug, the registration file should include several types of studies. Existing data on toxicological and pharmacological studies in animal and human have to be thoroughly examined. In addition, the splitting potential of single doses to be adapted to the child should be studied, according to the galenic formula. In all cases, the clinical file should have one pharmacokinetic study on acute intake of one or several doses in the specific age bracket. When the efficacy of a drug has been demonstrated in adults for the same disease, and if the results are extrapolated to children, the file should include one or several open studies designs in order to assess the tolerability. On the contrary, for example when the disease is different in or specific for children, one or several double blind randomized studies against reference treatment are necessary. All those studies should show the therapeutical value of the drug, and should allow precise recommendations for the dosages, depending on the body weight and/or the body surface compatible with the galenic formula.

Child↗
PubMed1986

Erythrocyte adhesion to cultured endothelium and glycaemic control in type 1 (insulin-dependent) diabetic patients.

The relation between blood glucose control and erythrocyte adhesion to cultured human vascular endothelial cells was studied in 12 Type 1 (insulin-dependent) diabetic patients. Erythrocyte adhesion was measured before, 8 days and 6 weeks after continuous subcutaneous insulin infusion (CSII). Compared to controls, erythrocyte adhesion expressed as an adhesion ratio was increased in 10 diabetic patients at the first examination (adhesion ratio greater than 1.52). After 8 days, adhesion ratio was normalized in 5 patients. After 6 weeks, adhesion ratio was normal in 7 patients and significantly lower in the group of 12 patients (p less than 0.01). The adhesion ratio was significantly correlated with glycosylated haemoglobin values (p less than 0.001). Insulin did not directly affect erythrocyte adhesion. Adequate insulin treatment modifies erythrocyte adhesion through a metabolic effect which needs longer than 1 week to be effective.

Adult↗
PubMed1986

[How to determine the optimal dosage of a drug].

Determining the optimal dosage is an important step in the development of any drug, as it will provide a basis to demonstrate the effectiveness of that drug at different dosage levels. This determination is mainly attempted in phase II, notably by means of dose-response studies, but it is obvious that data obtained at every stage in the life of the drug will provide a better approach to dosage recommendations. Several examples are discussed.

Clinical Trials as Topic↗
PubMed1986

[Quality assurance of clinical trials].

A quality assurance system for clinical trials entails the definition, prior to the trial, of a number of procedures (the "good clinical practices") ensuring that it will be correctly conducted and the verification that these procedures have been respected. Setting up a clinical trial quality assurance system involving the manufacturer, university staff and public authorities should result in trials that are better performed. The role and responsibilities of each party are discussed, together with the consequences to be expected from the introduction of good clinical practices in France.

Clinical Trials as Topic↗
PubMed1985

[Pathogenesis of tachycardia in hyperthyroidism. Value of Holter monitoring and the use of a beta-blocker].

The mechanisms of tachycardia in hyperthyroidism were investigated by means of Holter recordings of heart rate in 45 patients, 33 of whom had sinus rhythm and were left untreated. In the remaining 12 patients, recordings were taken after 3 days of treatment with either propranolol (120 mg/day; 6 patients) or pindolol (15 mg/day; 6 patients). Propranolol is a beta-blocker devoid of intrinsic sympathetic activity whereas pindolol possesses such activity. Changes in heart rate under the influence of each of these drugs were compared with those observed in 96 controls similarly treated. The difference in baseline heart rare between day and night was significantly higher (p less than 0.01) in patients with hyperthyroidism (17 +/- 1 QRS/min) than in controls (13 +/- 1 QRS/min). Day and night heart rates were increased by pindolol, the increase in night heart rate being significantly greater (p less than 0.05) in patients with hyperthyroidism (23.4 +/- 4.9%) than in controls (11.6 +/- 2.6%). These results suggest that sinus tachycardia in hyperthyroidism is related to an increase in the number of myocardial beta-adrenoceptors. They also indicate that thyrotoxicosis should not be treated with beta-blockers possessing intrinsic sympathetic activity.

Adolescent↗
PubMed1985

[Effects of nifedipine on carbohydrate metabolism in the non-insulin dependent diabetic].

The aim of this prospective, randomized, double-blind, placebo controlled study was to investigate the effect of nifedipine on carbohydrate metabolism in diabetic patients after a 3-day and a 3-month course of treatment. Sixteen non obese, well controlled non-insulin dependent diabetics, (HbA1 less than 10%), with moderate untreated hypertension were divided in two groups: nifedipine (group N, 8 patients) and placebo (group P, 8 patients). An oral glucose tolerance test (OGTT, 75 g glucose) and an arginine infusion were performed before, after a 3-day, and a 3-month course, either of nifedipine 30 mg/D or placebo. Blood samples obtained during OGTT were assayed for glucose and insulin, and during arginine infusion for insulin, glucagon and growth hormone. The differences between basal and peak values during tests were compared between both groups before and after treatment using Wilcoxon's rank sum test. Neither acute nor chronic administration of nifedipine or placebo modified the glucose tolerance. However, basal insulin levels were reduced by 3 month-administration of nifedipine (from 19 +/- 2 micromicrons/ml to 10 +/- 1 micromicrons/ml, p = 0,01). Otherwise the basal and peak hormonal values during tests were not significantly affected by nifedipine either at the start of after 3 months of treatment. These results suggest that nifedipine, when given in standard dosage for 3 months, has minor effects on carbohydrate metabolism in non-insulin dependent diabetic patients.

Adult↗
PubMed1984

[Prevalence of antinuclear antibodies in hypertensive diabetics treated with acebutolol].

Acebutolol may induce the development of antinuclear antibodies and, exceptionally, of a lupus-like syndrome. The purpose of this study was to evaluate the prevalence of antinuclear antibodies in hypertensive diabetics under long-term treatment with acebutolol. Seventy-eight normal subjects, 75 diabetics under antidiabetic therapy only, and 75 hypertensive diabetics who received acebutolol in mean doses of 478 +/- 242 mg/day for at least one year were investigated. The 3 groups were comparable with regard to age and sex. Antinuclear antibodies were detected in 18.6% of diabetics under acebutolol, as against 3.8% and 1.3% respectively of subjects in the other groups (p less than 0.01). There was no correlation between the levels of antinuclear antibodies and the dosage or duration of acebutolol treatment. None of the sera tested contained antinative DNA antibodies, and none of the hypertensive diabetics exhibited signs of lupus-like syndrome.

Acebutolol↗
PubMed1984

[Diabetes and heterozygotic sickle-cell anemia: study of erythrocyte deformability].

The erythrocyte filterability of 25 diabetics, 6 patients with sickle cell trait ( HbAS ) and diabetes mellitus, and 25 controls was studied. Erythrocyte filterability was estimated by a filtration technique with washed erythrocytes. Red cell filterability was significantly decreased in diabetic patients compared to control subjects and this abnormality was correlated with the extent and severity of vascular complications. The values of erythrocyte filterability in diabetics + HbAs and diabetic patients were in the same range. These results suggest that HbAS does not influence the abnormalities of erythrocyte filterability observed in diabetes mellitus.

Adult↗
PubMed1983

[Coronary insufficiency in hypercholesterolemic xanthomatosis. Angiographic aspects].

Coronary arteriography for severe coronary artery disease was carried out in 21 patients with hypercholesterolaemic xanthomatosis (group I) and in 42 patients with serum lipids (group II). Both groups were matched with regard to age, sex and cardiovascular risk factors (hypertension, smoking habits, diabetes). The films were examined by an observer unaware of the patients' clinical features; the severity of the lesions observed was assessed by means of a coronary score system. Group I patients had significantly more severe coronary artery lesions and a significantly higher incidence (52% versus 7%; p less than 0.001) of left main coronary artery stenosis carrying a high risk of sudden death. The percentages of affected vessels amenable to surgery and abnormalities in left ventricular function were similar in both groups. It therefore seems reasonable to envisage early coronary angiography followed, if necessary, by aorto-coronary bypass in patients with hypercholesterolaemic xanthomatosis who experience anginal attacks, show ECG abnormalities on exercise and have persistent pain after myocardial infarction.

Adult↗
PubMed1983

[Metabolic hypercorticism diagnosed during dental care].

Excess amounts of adrenocortical hormones might be clinically observed most notably in the upper part of the face. The diagnosis of Cushing's syndrome depends on a simple laboratory evaluation. Computer scanning may be of considerable value in localising adrenal tumors and differentiating them from bilateral hyperplasia, which has a pituitary origin.

Adrenocortical Hyperfunction↗
PubMed1983

[Hirsutism, diagnostic steps].

Hirsutism is currently observed, especially by stomatologists. Nowadays it is possible to treat efficiently this common disease after undertaking a simple laboratory evaluation. However it will take a few months in most cases to observe a clinical efficacy of treatment.

Female↗
PubMed1983

[Histiocytosis X with partial antehypophyseal deficiencies. 2 cases].

Diabetes insipidus is the most common endocrine disturbance associated with chronic multifocal form of histiocytosis X. Involvement of the hypothalamus can lead to growth hormone deficiency and short stature in children. Two cases with hypogonadism, growth hormone deficiency and diabetes insipidus are reported. In a 22-year-old man plasma testosterone was low and increased after administration of human chorionic gonadotrophin. Cutaneous and lytic bone lesions disappeared after treatment with Vinblastin. Partial diabetes insipidus was treated with clofibrate. A 59-year-old woman was found to have low pituitary gonadotrophins that failed to rise after administration of gonadotropin-releasing hormone and hyperprolactinemia. Fatal outcome was associated with polyuria, bone, cutaneous, gut and hypothalamic infiltration by histiocytes. There was no direct involvement of the anterior pituitary gland.

Adult↗
PubMed1983

Coronary angiography in diabetic and non-diabetic patients with severe ischaemic heart disease.

In this retrospective study, the coronary angiograms of 36 diabetic and 36 non-diabetic patients, with severe ischaemic heart disease, were compared. Patient groups were closely matched for age, sex, cardiovascular risk factors, duration and functional disability of angina. Coronary angiograms were assessed by an independent observer without knowledge of the clinical status of the patients, and graded using a coronary score system. Left ventricular function was analyzed using computerized angiographic data. The same percentage of diabetic and non-diabetic patients had three-vessel disease. The mean coronary score per patient was similar in the two groups. Diabetic and non-diabetic patients had a statistically similar percentage of diseased vessels considered suitable for coronary bypass surgery. Left ventricular function was similar in the two groups. Thus diabetic patients with symptomatic coronary artery disease should be considered for angiographic evaluation using the same criteria as non-diabetics.

Coronary Angiography↗