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Biomedical subjects

R Dahan

Publications and source records attributed to R Dahan.

36 records · Page 2Linked to original sources

[Choice of a statistical test in a clinical or therapeutic study].

The results of clinical trials are only valid if the right statistical test for the type of study performed is applied. The authors suggest a method, accessible to all physicians, that should facilitate the choice between various tests and enable the readers of clinical trial papers to detect errors in the presentation of the results. Starting from an answer to four questions (what kind of data is investigated, how many samples are studied and are they independent, and what is the purpose of the study?) the mental process is developed in the form of a flow chart, each terminal branch of which leads to the correct statistical test or tests.

Clinical Trials as Topic↗

Continuous subcutaneous infusion of glucagon by portable pump in non beta cell tumor hypoglycemia.

Subcutaneous infusion of glucagon by portable pump appears to give very effective symptomatic relief from non beta cell tumor hypoglycemia when surgery, radiotherapy and chemotherapy are impossible or ineffective. This mode of glucagon administration was proposed in a patient who had severe nocturnal hypoglycemic attacks. The aim of the study was to specify the modes of utilization and to test the efficiency and the tolerance of this treatment. Glucagon was infused at 400 micrograms/h during every 12 hour night. Because of the hepatic action of glucagon it is very important to use this treatment with an adequate diet and to stop the infusion during the day to reconstitute the glycogen overload. This mode of glucagon administration was very effective in over 6 months of use and well tolerated.

Blood Glucose↗

[Surgical treatment of Basedow's disease. I--Traditions and new methods in preparation for thyroidectomy: use of dexamethasone].

The combination of dexamethasone (2 mg every 6 hours) carbimazole (15 mg every 8 hours) and potassium iodide (XV drops every 8 hours) has been proposed in the preparation of 21 patients with hyperthyroid Graves' disease for surgery. The combination was administered for 6 days and the subtotal thyroidectomy was performed on day 7. All patients had normal serum Triiodothyronine levels after 4 days of such treatment. This combined drug therapy appears to be a rapid, sage and effective preparation for thyroid surgery in patients with Graves' disease and should replace conventional preparation with carbimazole and potassium iodide and beta-blocker preparation in all cases where there are no contra-indications to the use of corticosteroids.

Adult↗

A single blind normal volunteer bioavailability study of a new microencapsulated potassium chloride tablet compared with two reference potassium formulations.

A single blind placebo controlled, cross-over study comparing a new microencapsulated potassium chloride tablet (MET) with two reference formulations of oral potassium, potassium chloride solution (PS) and potassium chloride wax-matrix tablets (WMT), was performed in 12 normal healthy volunteers. Urinary potassium excretion was the main criterion of comparison. Results showed that all three formulations have excellent bioavailability. This indicates that potassium absorption in the stomach is similar to that in more distant portions of the gut. The slow-release characteristics of both MET and WMT were confirmed. Clinical and pharmacological tolerance was excellent and no side-effects were reported with any of the potassium formulations studied.

Administration, Oral↗

[Evaluation of unexpected and toxic effects of omeprazole (Mopral) reported to the regional centers of pharmacovigilance during the first 22 postmarketing months].

Omeprazole has been marketed in France since 1989, for the healing of peptic ulcers, erosive reflux esophagitis and the Zollinger Ellison syndrome. It is a proton pump inhibitor which inhibits the acid secretion in the stomach. In the majority of the clinical trials, omeprazole has been found to be well tolerated: headache, dizziness, skin rash, constipation have just been noted. Since September 1989, 143 adverse reactions have been reported to pharmacovigilance centres and Astra France: 37 neurological and psychiatric side effects, especially confusion in patients with hepatic diseases and/or advanced age; 35 cutaneous reactions, generally rash and urticaria; 22 hematological effects: leucopenia and agranulocytosis have been reported but the relation with omeprazole is very uncertain; 10 gastrointestinal effects, generally diarrhoea, nausea, vomiting and abdominal pain; 8 hepatic disorders, especially moderate elevation of aminotransferases. This study confirms the safety of this drug, during short treatment; the frequency of notified adverse effects is about 1/12 200 treatments of 4 weeks. The ministry of health, has decided, in november 1991, to inform the prescribers of this potential toxicity of omeprazole, particularly, of the risk of confusion, hepatotoxicity and leucopenia.

Adolescent↗

[Pre-clinical and clinical electrophysiological studies for the prediction of iatrogenic proarrhythmic effect (torsade de pointes)].

The risk of drug-induced torsade de pointes, a potentially lethal ventricular arrhythmia, raises the problem of the early detection of the effects of any new chemical entity (NCE) on ventricular repolarization since prolongation of myocardial repolarization is a major trigger among others (hypokalaemia, bradycardia, congenital abnormalities in cellular ionic channels) for this arrhythmia. During pre-clinical studies, the effects of a range of concentrations (10(-9) M to 10(-4) M) of NCE on the duration of the action potential of Purkinje and left ventricular myocardial cells (guinea-pig and rabbit) have to be measured. If these effects are present, the duration of QT interval on ECG recorded in animal studies (dogs) has to be carefully measured and correlated with plasma concentrations of NCE and/or its metabolite(s). During clinical trials, additional studies have to be performed in order to document QT interval-plasma concentration relationships and the influence of heart rate on QT interval duration. Ambulatory ECG recordings will attest to the safety of the NCE and precautions for use of the drug will be established according to our knowledge of predisposing factors for a proarrhythmic effect. Should there be a notification of a case of torsade de points after a new drug has been launched, urgent consultations with the drug file will be necessary in order to assess which pre-clinical and clinical studies may be needed for a better evaluation of the benefit/risk ratio of the new drug.

Animals↗