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Biomedical subjects

F Maillard

Publications and source records attributed to F Maillard.

At least 19 recordsLinked to original sources

Biochemical markers (without markers of infection) of the risk of preterm delivery. Implications for clinical practice.

BACKGROUND: New biochemical markers for the risk of spontaneous preterm birth (SPB) give a more precise and earlier diagnosis than the usual ones. We reviewed the data about the principal markers. RESULTS: Using studies with good methodology and a large number of subjects, we observe that the predictive value of these new markers is somewhat higher than those of the usual markers. Fetal fibro-nectin (FNf) and cervical ultrasound undeniably improve the identification of patients at risk of preterm birth, both in the general population and in these threatened preterm delivery. However no management has yet been demonstrated efficacious, especially in a general population so any recommendations for their systematic utilisation is premature. Other biochemical markers (salivary estriol, serum CRH, etc.) are still under assessment and should not be used outside research protocols. IMPLICATION FOR PRACTICE: It is appropriate to integrate either FNf or cervical ultrasound into daily clinical practice for patients with signs of preterm labor. These new indicators are of special use when the diagnosis is uncertain with the standard markers (uterine contractions, digital examination). Among these patients, they should reduce the number of hospitalizations and of useless treatments, because of their good negative predictive value. At the same time, for patients poorly 'labeled' by the clinical examination, they should allow the application of intensive management (intravenous tocolysis, corticoids, in utero transfers). CONCLUSION: Future studies should evaluate these tests in everyday practice. The objective is not to predict preterm birth but to prevent either it or its negative consequences. This goal will be met when we have an effective treatment, without associated adverse effects, to offer patients after a positive test result.

Biomarkers↗

Neurological and physical maturation in normal growth singletons from 37 to 41 weeks' gestation.

An evaluator blinded to gestational age (GA) assessed a cohort of 397 singletons born at between 37 and 41 week's gestation, by looking at 11 criteria exploring neurological maturity and 12 criteria exploring physical maturity. The analysis of correlation coefficients shows various degrees of association between GA and each of the criteria examined. A highly significant correlation (p < 0.001) was found for 4 neurological criteria defining passive tone in limbs and sucking reflex. The activity of flexor muscles of the neck and crossed extension reflex were also associated with maturity but weakly (p < 0.01). A highly significant correlation (p < 0.001) was found for 8 of the physical criteria, skin colour and texture, lanugo, ear firmness, genitalia, breast size, nipple formation and plantar skin creases. Oedema, skull firmness and ear form were also associated but weakly. With multivariate analysis combining the neurological and physical criteria, predictive values ranked in the following order: 1) plantar skin, 2) breast size, 3) sucking reflex, 4) scarf sign, 5) skin colour, 6) genitalia, 7) popliteal angle, 8) return to flexion of forearms, 9) dorsiflexion angle. In conclusion, a score based on physical and neurological criteria is associated with duration of pregnancy (r2 = 0.32) between 37 and 41 weeks' gestation. Such an instrument allows us to study fetal maturity as a variable independent of GA, and therefore makes it possible to identify various influences that may modify maturational rate during the last weeks of pregnancy.

Cohort Studies↗

[Clinical importance of fetal pulse oximetry. I. Methodological evaluation. Multicenter study. French Study Group on Oximetry of Fetal Pulse].

OBJECTIVE: To evaluate the feasibility of intrapartum fetal pulse oximetry, the distribution of fetal oxygen saturation values, and the relation with the neonatal outcome in a population with an abnormal fetal heart rate (FHR). STUDY DESIGN: A prospective multicenter observational study, from June 1994 to November 1995. Fetal oxygen saturation was continuously recorded using a Nellcor N-400 fetal pulse oximeter in case of abnormal FHR during labor. Simultaneous readings of fetal oxygen saturation and of fetal blood analysis (FBA) were obtained at inclusion and before birth. Feasibility, adverse effects, distribution of fetal oxygen saturation values and relation with neonatal outcome were assessed. RESULTS: 74 patients were included. From 172 attempted sensor placements, the procedure was impossible in three cases and fetal oxygen saturation values were obtained in 164 cases (95.3%). Physicians considered sensor placement an easier task than FBA attempt (easy in 87.5% vs 78.9% for FBA, p = 0.03). The mean reliable signal time (+/- SD) was 64.7 +/- 32% during the first stage. There were no serious adverse effects in the study population. The mean fetal oxygen saturation during the first stage of labor was 42.2 +/- 8.0% (10th-90th centile range: 30-53%). Fetal oxygen saturation was significantly correlated with scalp pH (r = 0.29; p = 0.01) but not with neonatal umbilical artery pH or gas values. There was a significant association between a low fetal oxygen saturation (< 30%) and a poor neonatal condition. CONCLUSION: The feasibility of fetal pulse oximetry is satisfactory in clinical practice. It is easy to use and provides a fair rate of recorded values, even in a population with suspicion of fetal distress. A low fetal oxygen saturation is significantly associated with an abnormal neonatal outcome.

Adult↗

[Clinical importance of fetal pulse oximetry. II. Comparative predictive values of oximetry and scalp pH. Multicenter study].

OBJECTIVE: To compare the predictive value of intrapartum fetal pulse oximetry to that of fetal blood analysis for an abnormal neonatal outcome in case of abnormal fetal heart rate (FHR). STUDY DESIGN: A prospective multicenter observational study, from June 1994 to November 1995. Fetal oxygen saturation was continuously recorded using a Nellcor N-400 fetal pulse oximeter in case of abnormal FHR during labor. Simultaneous readings of fetal oxygen saturation and fetal blood analysis obtained before birth, i.e. either at full dilatation, or before cesarean section when indicated, were compared with the neonatal status. The criteria for an abnormal neonatal outcome were 1) an umbilical arterial blood pH < or = 7.15 and 2) a combined variable including: 5 min. Apgar score < or = 7, umbilical arterial pH < or = 7.15, secondary respiratory distress, transfer in a neonatal care unit, or neonatal death. RESULTS: At a 7.20 threshold for fetal scalp pH, and 30% for fetal oxygen saturation (i.e. the tenth centile in the study population), the predictive value of fetal pulse oximetry was similar to that of fetal blood analysis for an arterial umbilical pH < or = 7.15, and for an abnormal neonatal outcome (positive predictive value 56% vs 55%, negative predictive value 81% vs 82%, sensitivity 29% vs 35%, and specificity 93% vs 91% respectively). The receiver operating curve showed similar performance of either technique for cut-off values < or = 7.20 for fetal blood pH and < or = 30% for fetal oxygen saturation, whereas fetal pulse oximetry became superior at higher thresholds. CONCLUSION: The predictive value of intrapartum fetal pulse oximetry can be favorably compared with that of fetal blood analysis. Randomized controlled management trials can now be performed to assess potential clinical benefits of this new tool.

Female↗

Multicenter study on the clinical value of fetal pulse oximetry. I. Methodologic evaluation. The French Study Group on Fetal Pulse Oximetry.

OBJECTIVE: Our purpose was to evaluate the feasibility of intrapartum fetal pulse oximetry, the distribution of fetal oxygen saturation values, and the relationship with the neonatal outcome in a population with an abnormal fetal heart rate. STUDY DESIGN: A prospective multicenter observational study was performed from June 1994 to November 1995. Fetal oxygen saturation was continuously recorded with use of a Nellcor N-400 fetal pulse oximeter in case of an abnormal fetal heart rate during labor. Simultaneous readings of fetal oxygen saturation and fetal blood analysis were obtained at inclusion and before birth. Feasibility, adverse effects, distribution of fetal oxygen saturation values, and relationship with neonatal outcome were assessed. RESULTS: One hundred seventy-four patients were included. From 172 attempted sensor placements, the procedure was impossible in three cases and fetal oxygen saturation values were obtained in 164 cases (95.3%). Physicians considered sensor placement an easier task than an attempt at fetal blood analysis (easy in 87.5% vs 78.9% for fetal blood analysis, p = 0.03). The mean reliable signal time (+/- SD) was 64.7% +/- 32% during the first stage. There were no serious adverse effects in the study population. The mean fetal oxygen saturation during the first stage of labor was 42.2% +/- 8.0% (10th to 90th percentile range 30% to 53%). Fetal oxygen saturation was significantly correlated with scalp pH (r = 0.29, p = 0.01) but not with neonatal umbilical artery pH or gas values. There was a significant association between low fetal oxygen saturation (< 30%) and poor neonatal condition. CONCLUSION: The feasibility of fetal pulse oximetry is satisfactory in clinical practice. It is easy to use and provides a fair rate of recorded values, even in a population with suspicion of fetal distress. A low fetal oxygen saturation is significantly associated with an abnormal neonatal outcome.

Adult↗

Multicenter study on the clinical value of fetal pulse oximetry. II. Compared predictive values of pulse oximetry and fetal blood analysis. The French Study Group on Fetal Pulse Oximetry.

OBJECTIVE: Our purpose was to compare the predictive value of intrapartum fetal pulse oximetry with that of fetal blood analysis for an abnormal neonatal outcome in case of an abnormal fetal heart rate. STUDY DESIGN: A prospective multicenter observational study was conducted from June 1994 to November 1995. Fetal oxygen saturation was continuously recorded with a Nellcor N-400 fetal pulse oximeter in case of an abnormal fetal heart rate during labor. Simultaneous readings of fetal oxygen saturation and fetal blood analysis obtained before birth (i.e., either at full dilatation or before cesarean section when indicated) were compared with the neonatal status. The criteria for an abnormal neonatal outcome were (1) an umbilical arterial blood pH < or = 7.15 and (2) a combined variable including 5-minute Apgar score < or = 7, umbilical arterial pH < or = 7.15, secondary respiratory distress, transfer in a neonatal care unit, or neonatal death. RESULTS: At a 7.20 threshold for fetal scalp pH and 30% for fetal oxygen saturation (i.e., the 10th percentile in the study population), the predictive value of fetal pulse oximetry was similar to that of fetal blood analysis for an arterial umbilical pH < or = 7.15 and for an abnormal neonatal outcome (positive predictive value 56% vs 55%, negative predictive value 81% vs 82%, sensitivity 29% vs 35%, and specificity 93% vs 91%, respectively). The receiver-operator characteristic curve showed similar performance of either technique for cutoff values < or = 7.20 for fetal blood pH and < or = 30% for fetal oxygen saturation, whereas fetal pulse oximetry became superior at higher thresholds. CONCLUSION: The predictive value of intrapartum fetal pulse oximetry can be favorably compared with that of fetal blood analysis. Randomized controlled management trials can now be performed to assess potential clinical benefits of this new tool.

Apgar Score↗

[Evaluation of urinary rapid strip-tests for screening of urinary infection in pregnant women].

Repeated screening for asymptomatic bacteriuria using a reagent strip-test was conducted in a population of 859 pregnant women. The women performed 4,125 tests at home, and 2,867 tests were performed by the nursing staff at the antenatal clinics. The tests done by the women at home had a higher predictive value than the tests done in the antenatal clinics (24% versus 10%). The sensitivity was 47%, specificity 90% and negative predictive value 98.8%. The tests performed by the women at home were well accepted and detected.

Ambulatory Care↗

Epidemiologic survey of patients treated with growth hormone in France in the period 1959-1990: preliminary results.

Because the delivery of growth hormone (GH) was centralized from 1977 in France, it has been possible to conduct, during the second half of 1990, a nationwide survey of the health status of patients treated with GH from the year 1959. A questionnaire regarding the 5,546 patients recorded for the period 1959-1990 was sent to the prescribers or the patients. 5,418 more or less completely documented reports were obtained. The mean age of the patients at the onset of GH treatment was 11.0 +/- 4.1 years. 1,937 of them had at this time some important disease associated with GH deficiency. The mean duration of treatment was 3.99 +/- 3.05 years. 3,446 patients were still under follow-up. Very recent information (1990-1991) was given for 82.7% of patients, less recent data (1985-1989) for 13.4%. For 3.9%, no data beyond 1985 were obtained. 77 patients had died, 38 from neoplastic disease (mainly recurrence of a primary malignancy), 10 from accident, 3 by suicide, 7 with neurological disease [only 1 case of Creutzfeldt-Jakob disease (CJD) was reported at the time of the survey], the others from various causes. No abnormal frequency of posttreatment leukemia, lymphoma, malignancies, hip diseases, glucose intolerance or other disease focusing attention, was found in the survey. From the time when this survey was completed (December 1990) to that of this report (May 1992), other cases of CJD have been reported in France: 3 ascertained, 7 clinically resembling but not yet certain. These 10 patients were treated for complete GH deficiency, 6 of congenital or neonatal cause and 4 after neurosurgery.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Combination ultrafiltration and 6 M urea treatment of human growth hormone effectively minimizes risk from potential Creutzfeldt-Jakob disease virus contamination.

Although genetically engineered human growth hormone (hGH) is now commercially available, native pituitary-derived hGH is still used by physicians in many countries for the treatment of hormone deficiency states. We describe a method using ultrafiltration and 6 M urea that reduced infectivity in human pituitary tissue that had been deliberately contaminated with scrapie virus (an animal analogue of human Creutzfeldt-Jakob disease virus) from an initial level of 10(9.7) infectious units to just 5 infectious units. Based on estimates of the frequency of contamination and infectivity levels in batches of human pituitaries, the use of this protocol to prepare GH from cadaveric human glands yields a calculated probability of exposure to a contaminated vial of not greater than 1 in 3.2 million recipients; therefore, native hormone prepared by this method may be considered to be essentially risk-free. The same methodology may be useful in the preparation of other hormones, such as prolactin, for which no synthetic substitutes are currently available, as well as biological products derived from sheep or cattle, that may be infected with scrapie or bovine spongiform encephalopathy.

Animals↗

[Characteristics of human growth hormone produced by genetically engineered mammalian cells].

Saizen is human growth hormone produced by mammalian cells by genetic engineering. It is identical with hypophyseal GH as regards various physical and chemical parameters. A number of tests did not reveal an alien protein at the 1 ppm level, nor the presence of viruses, and the DNA level is below the detection range. According to these results Saizen is a highly purified growth hormone.

Growth Hormone↗

Zopiclone, the third generation hypnotic: a clinical overview.

Effective and safe hypnotics exist especially since the introduction of benzodiazepines (BZD) which appeared to bring major advantages over barbiturates. Ideally a new hypnotic should induce and maintain sleep without producing residual effect during the day and should be devoid of abuse and dependence potential. Zopiclone is a new hypnotic belonging to the cyclopyrrolone chemical class. Its elimination half-life is 5 to 6 h, no accumulation exists upon repeated administration, and its pharmacokinetic profile is not substantially modified in elderly and renal failure patients. Placebo-controlled studies have shown that zopiclone 7.5 mg is an effective hypnotic, and that it can improve all sleep variables in insomniacs. Its effects on sleep stages differ from those observed with BZD hypnotics: REM sleep is substantially unaffected by zopiclone and slow wave sleep is either unaffected or increased. Objective and subjective measurements during the day after bedtime administration of zopiclone, showed lack of residual effects and no residual impairment of cognitive functions. Zopiclone discontinuation is not accompanied by rebound effect and relevant withdrawal symptoms. Specific "craving effect" studies in alcoholics did not show an abuse potential for zopiclone. Side-effects are represented mainly by bitter taste and dry mouth with a minimal incidence of CNS depressant effects. Studies on the effects of zopiclone on respiratory functions failed to show detrimental effects. Efficacy and safety data on zopiclone suggest that this new drug can represent a useful alternative to existing hypnotics.

Azabicyclo Compounds↗

Zopiclone versus triazolam in insomniac geriatric patients: a specific increase in delta sleep with zopiclone.

This double-blind study was performed on 10 aged insomniac patients who received, during 15 days, either triazolam (0.25 mg) or zopiclone (7.5 mg) at bed time. This in-patient period was bounded by two ambulatory periods of 5 days each, and two in-patient periods of 3 days each, during which the patients received a placebo tablet at bed time. Thirteen sleep recordings per patient were performed before (3 nights), upon initiation of active treatment (3 nights), at the end of the active treatment period (3 nights) and during the following 3 "withdrawal" nights. A clear improvement of sleep patterns was observed with both drugs, although opposite effects on delta sleep were observed, namely a decrease with triazolam and an increase with zopiclone. A carry-over effect of the enhancement of delta sleep by zopiclone took place during the first 3 withdrawal nights. As is well known, sleep problems become increasingly common with age. Epidemiological studies show that although they only represent 11% of the population. Americans over 60 years old are prescribed about 40% of sleeping pills (Mendelson, 1980). Disturbed sleep in this population is often associated with medical disorders or induced by drugs like beta-adrenergic blockers. It must be admitted, however, that, possibly due to the association with medical or situational problems there have been only few attempts to assess the efficiency of hypnotic drugs in elderly insomniac patients. These are the reasons why in this study the effectiveness of zopiclone was compared to that of triazolam in insomniac patients aged over 60 years.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

Comparative study of the effects of zopiclone and placebo on respiratory function in patients with chronic obstructive respiratory insufficiency.

Long-term administration of zopiclone in 6 patients with severe chronic obstructive respiratory insufficiency with stable ventilatory function did not demonstrate any depressant action on respiratory blood gases recorded during the daytime and in ambient air. The sedative action of this agent was manifested by a modest decrease in ventilatory response parameters which, however, was not statistically significant. Polysomnographic recordings did not reveal any worsening of desaturation periods both with respect to incidence and amplitude. There was a non-significant trend towards an increase in the number of obstructive apnoea episodes without any notable ventilatory impact.

Airway Resistance↗

Steady state pharmacokinetics of zopiclone during multiple oral dosing (7.5 mg nocte) in patients with severe chronic renal failure.

Zopiclone is a new hypnotic cyclopyrrolone with a short elimination half-life (5.3 h). The pharmacokinetic profile of this drug was studied in 7 chronic renal failure (CRF) patients given 7.5 mg nocte for 7 consecutive nights. The pharmacokinetic values obtained were compared with the corresponding values found in healthy young volunteers given the same repeated dosage regimen. C max and T max were not significantly different between the two groups but the C min of unchanged zopiclone (at 24 h) post-dosing was significantly (p less than 0.001) higher in CRF patients (8.16 +/- 5.34 ng/ml) than in healthy volunteers (1.90 +/- 0.82 ng/ml). The AUC values in CRF patients were also significantly increased during the seventh day (742 +/- 212 h ng/ml) compared to healthy subjects (408 +/- 66.5 h ng/ml) and the elimination half-life of zopiclone was also longer in CRF patients (about 8 h) than in the reference group (about 5 h). Nevertheless, the accumulation ratios remained similar in the two groups (1.09 +/- 0.18 in CRF patients and 1.02 +/- 0.2 in healthy subjects). Thus no evident accumulation of zopiclone appeared in the CRF patients. As in the healthy subjects, no metabolites were detected in the plasma of the CRF patients although at steady state the urinary excretion of zopiclone and its N-oxide and N-desmethyl derivatives (2.03% +/- 1.52% and 1.99 +/- 0.65% of the dose, respectively) was significantly decreased compared to healthy subjects (3.7% +/- 2.1% and 32.6% +/- 4.5%, respectively). Zopiclone thus represents a safe alternative to benzodiazepine hypnotic therapy in patients with renal impairment.

Administration, Oral↗

Inactivation of human immunodeficiency virus during human growth hormone production.

Since human immunodeficiency virus (HIV) has been found in the brains of AIDS patients, the possibility was investigated that preparations of human growth hormone (hGH) extracted from human pituitary glands harbor infectious HIV. It was found that the procedure used for extracting hGH, i.e. a combination of acid pH and 10% ethanol, totally inactivates HIV infectivity.

Antiviral Agents↗

Human pituitary growth hormone (hGH) and Creutzfeldt-Jakob disease: results of an epidemiological survey in France, 1986.

An epidemiological inquiry has been done in France after the notification in the USA and England of four cases of Creutzfeldt-Jakob disease in patients previously treated with hGH. Between 1959, when hGH treatment in France was started, and August 1985, the date the survey began, 1698 patients were registered for treatment. Current information (less than three months old) was obtained for 1620 patients (95.4%). Death was reported in 31 patients, but none could be related to Creutzfeldt-Jakob or similar disease. Pathological events were observed in 213 living patients (13.1%). Among them, four were diseases classified as possibly related to a viral infection. The first case had acute lymphoid leukaemia; the second case had polyradiculoneuritis associated with hepatitis. In both cases the disease resolved completely. Two other patients had acute encephalitis which started less than two years after the onset of treatment and which resolved spontaneously. Even though the acute evolution and the spontaneous clinical recovery are not consistent with Creutzfeldt-Jakob disease, a relationship with hGH therapy could not be completely excluded. Finally, five treated children had later malignancies which raises the question of the long-term secondary effects of hGH upon cellular proliferation.

Adolescent↗