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Biomedical subjects

S Ferry

Publications and source records attributed to S Ferry.

At least 73 records · Page 4Linked to original sources

Comparison of two long-acting forms of quinidine.

The bioequivalence of two forms of long acting quinidine compounds was assessed (Kinidin durules and Longacor) using drug plasma level and QT ECG changes. Six healthy volunteers received each preparation on two occasions in random order. The wash out period between successive experiments was at least 7 days. There was no difference in tmax, Cmax and AUC for plasma level and adjusted QT. However, between patient variability was large. A 20% difference in plasma levels could not be excluded but the difference in QT max and QT AUC between the two preparations did not exceed 20% (P less than 0.05, Westlake's method). This study illustrates the fact that pharmacodynamic equivalence, let alone therapeutic equivalence, does not necessarily imply plasma level equivalence, as assessed by the current method.

Adult↗

[Somatocrinin induces growth hormone release in a case of growth hormone deficiency of hypothalamic origin in a child].

Somatocrinin (hp-GRF-44), a growth hormone releasing factor, stimulates acute pituitary response in a 11 years and 4 months old boy, with growth hormone deficiency. The capability of the anterior pituitary to secrete growth hormone in response to an IV injection of somatocrinin (120 micrograms 4 micrograms/kg) was documented, therefore proving the hypothalamic origin of the deficit which had been suspected because of association of diabetes insipidus and hyperprolactinemia.

Child↗

[Use of intravenous phenytoin in treatment of partial status epilepticus (author's transl)].

Twenty-two patients with partial status epilepticus were treated with phenytoin (DPH) intravenously (mean daily dose: 18,6 +/- 7,3 mg/kg). Benzodiazepines had been administered unsuccessfully in 18 cases before DPH. Seizures were stopped in 14 cases (less than 2 hours after the end of the initial dose in 13 cases). Failures were usually encountered in patients with severe brain damages. Adverse effects were observed in two patients: choreo-athetosic movements in one case with DPH plasma levels lower than 15 mg/l, cerebellar signs in the second patient whose DPH plasma level was 28 mg/l. As previously suggested by Cranford and al., the authors recommend a single slow intravenous infusion of 20 mg/kg (at a rate not exceeding 1 mg/kg/mn). The determination of DPH plasma concentrations demonstrated that with this procedure effective plasma levels are obtained during the 24 hours following the IV injection. In case of failure or of adverse effects determination of DPH plasma levels may be useful for adjusting the daily DPH dose.

Adult↗

Heterogeneous effect of quinidine on the ventricular depolarization process assessed by the spatial velocity electrocardiogram of the QRS complex. Preliminary report of a new investigative method.

The negative conduction effect of quinidine on each of the successive phases of the ventricular depolarization was investigated using an original noninvasive method: the spatial velocity electrocardiogram of the QRS complex (SVECG-QRS). We performed a randomized placebo-controlled trial in 10 healthy subjects with a single oral dose of quinidine (330 mg) or placebo. Electrocardiographic acquisition and processing (220 recordings for the complete trial) were performed using the Lyon vectorcardiographic program. For each SVECG-QRS curve, the position of seven specific points from A (onset of QRS) to G (end of QRS) were determined precisely. The six successive time intervals between these points (AB-FG) and five velocity values (B-F) were then calculated. The QRS complex was longer under quinidine than placebo (102.4 +/- 1.6 vs. 100.3 +/- 1.5 ms). The difference was at the periphery of statistical significance (p = 0.05), and this lack of statistical difference may be mainly due to the low serum levels of quinidine obtained at the peak of the concentration (1.46 +/- 0.4 mg/1). All six QRS time intervals were longer under quinidine, but only the BC interval was significantly different (9.3 +/- 1.1 vs. 18.8 +/- 1.1 ms; p < 0.05) suggesting a more pronounced negative conduction effect at the onset of ventricular depolarization. No significant modifications were observed for the velocity values. We conclude that (1) the negative conduction effect of quinidine is heterogeneous, but a further study with a higher dose of quinidine (concentration-dependent effect) is required to confirm this hypothesis and (2) the spatial velocity electrocardiogram of the QRS complex allows a detailed analysis of the ventricular conduction phases. The results of the measurement were found to be reproducible. This noninvasive tool could be used in clinical practice to assess effects of antiarrhythmic drugs on successive ventricular depolarization phases.

Administration, Oral↗

[Hospital pharmacy and clinical trials. Requirement of procedures and protocol of administration and distribution of drug].

Law established a holding and a distribution, by the hospital pharmacist, of the clinical trial drugs. These operations can only be achieved with written procedures. Two sorts of procedures are required: general procedures for the whole of trials and special procedures for each of them. In that setting, a protocol for administration and distribution of drug involved in one study is established. It is intended for the three partners of the trial: sponsor, clinical investigator, and pharmaceutical department itself. It gives to these partners all the relevant informations so as to lead the operations and their chronology. This system has been acting in the hospital for a year. It appeared reliable for the three partners in about thirty trials. So, it can be considered as validated.

Clinical Trials as Topic↗

[Methodological analysis of phase IV clinical trials performed in hospital based on the Huriet Law ].

Since the implementation of the 'Huriet law', drugs in phase IV clinical trials are handled by the pharmaceutical Department of the 'Hôpital Neuro-Cardiologique' (Lyon, France). The methodology of these trials is assessed by using a special assessment grid which enables a score for each protocol, with a maximal score of 20 and a minimal one of minus 20. Although many limitations could be advanced, results of this study show that, among 39 assessed trials, 13 trials had weak methodology (score < or = 0), 16 are middle-quality trials (score between 0 and 10) whereas 10 trials only can be considered as having a strong methodology (score > 10). So, a fairly large number of the organized phase IV trials have debatable quality. Moreover, their objective is questionable, that is essentially promotional, in spite of the 'Huriet law' and Persons Protection Committees.

Clinical Trials, Phase IV as Topic↗

[Reflexions before the introduction of a drug prescription survey at hospitals].

The need to know about drug prescribing practices, in order to assess their relevance, has led us to perform a drug prescription study in two medical departments of Cardiology at 'Neuro-Cardiologique Hospital' in Lyon (France). In moving from theoretical project design to its practical achievement, important methodological problems, initially unsuspected, were encountered. For each main point of the study (choices regarding medical department, the person holding the inquiry, data collection, etc.) and any subsidiary operations (data key-boarding, codification and analysis), the main problems encountered are described after considering advantages and limits of potential solutions. We propose useful and relevant questions to be asked, before performing a drug prescription study, even a modest one, or interpreting the results of such a study.

Cardiology Service, Hospital↗