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Biomedical subjects

E M Zola

Publications and source records attributed to E M Zola.

11 recordsLinked to original sources
PubMed1998

Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure. Survanta in Term Infants Study Group.

OBJECTIVE: The purpose of this study was to determine whether surfactant (beractant) administration to term newborns in respiratory failure and at risk for requiring extracorporeal membrane oxygenation (ECMO) treatment would significantly reduce the incidence of severe complications through 28 days of age and the need for ECMO. STUDY DESIGN: A multicenter (n = 44), randomized, double-blind, placebo-controlled trial was conducted. Infants weighing 2000 gm or more with gestational ages of 36 weeks or greater were stratified by diagnosis (meconium aspiration syndrome, sepsis, or idiopathic persistent pulmonary hypertension of the newborn) and oxygenation index (15 to 22, 23 to 30, 31 to 39) and then randomly assigned to receive four doses of beractant, 100 mg/kg (n = 167), or air placebo (n = 161) before ECMO treatment and four additional doses during ECMO, if ECMO was required. The incidence of untoward effects (including hemorrhagic, neurologic, pulmonary, renal, cardiovascular, infectious, metabolic, and technical complications) occurring before and after randomization and through 28 days of age or discharge were recorded. RESULTS: The two treatment groups were comparable in baseline parameters, including birth weight, sex, gestational age, oxygenation index, and primary diagnosis. There was no difference in the incidence of severe complications. The need for ECMO therapy was significantly less in the surfactant group than in the placebo group (p = 0.038); this effect was greatest within the lowest oxygenation index stratum (15 to 22; p = 0.013). CONCLUSIONS: Use of surfactant, particularly in the early phase of respiratory failure, significantly decreases the need for ECMO in the treatment of term newborns with respiratory failure, without increasing the risk of complications.

Biological Products↗
PubMed1994

Differential absorption of amoxicillin from the human small and large intestine.

Differences in extent of amoxicillin absorption from various regions of the gastrointestinal tract were determined and compared with the same dose administered orally. Nine healthy men were intubated at a proximal (duodenum or jejunum) or distal (ileum or colon) site with use of a 15-foot double lumen nasointestinal tube. Amoxicillin solutions (375 mg in 120 ml water) were delivered on 2 successive days as a bolus or a 4-hour infusion. Subjects were reintubated at another site and amoxicillin administration was repeated. Subjects with colonic intubation received only infusions. Finally, all subjects received an oral dose of amoxicillin solution. Plasma samples were obtained at 16 time points over a 10-hour period and assayed for amoxicillin by use of an HPLC method. Area under the concentration-time curve and the maximum plasma concentration were computed to evaluate amoxicillin absorption. Amoxicillin absorption was rate and site dependent in the gastrointestinal tract. The drug was well absorbed in the duodenum and jejunum, with no significant differences in absorption when administered as a bolus or 4-hour infusion, but absorption was decreased and rate dependent in the ileum, where more drug was absorbed as an infusion compared with a bolus. Amoxicillin was unabsorbed when infused in all colonic regions.

Adult↗
PubMed1993

Comparison of three dosing procedures for administration of bovine surfactant to neonates with respiratory distress syndrome.

A multicenter, randomized, double-blind, controlled trial compared three beractant (Survanta) administration procedures in the treatment of neonatal respiratory distress syndrome. Infants weighing > or = 600 gm with respiratory distress syndrome who required assisted ventilation were treated within 8 hours of birth with beractant administered intratracheally. Procedure A required administration in two fractional doses after removal of the infant from the ventilator. Procedure B required administration in two fractional doses through a neonatal suction valve and did not require removal of the infant from the ventilator, and procedure C required administration in four fractional doses during removal from the ventilator. Procedure C is the method used in all previous beractant studies. Of the 299 infants enrolled, 103 were randomly assigned to procedure A, 100 to procedure B, and 96 to procedure C. The results indicate no significant differences among the treatment groups in the clinical outcome measures of fractional inspired oxygen, mean airway pressure, and arterial-alveolar ratio of partial pressure of oxygen at 72 hours of life, or in the incidences of air leaks, pulmonary interstitial emphysema, or death through 72 hours of life. There were no significant differences in the lowest heart rates recorded during administration of doses, but there was less oxygen desaturation during administration of dose 1 with procedure B than with procedure A (p = 0.001), and more reflux of beractant after procedure B than after procedure C (p = 0.007). We conclude that the three procedures are equally effective and can be used to administer beractant safely and effectively. Procedure B has the advantage of allowing administration without interrupting mechanical ventilation.

Biological Products↗
PubMed1993

Treatment Investigational New Drug experience with Survanta (beractant).

From September 1989 through July 1991, before commercial availability, Survanta (beractant intratracheal suspension), a modified bovine-derived surfactant used for prevention and treatment of neonatal respiratory distress syndrome, was made available to 231 neonatal intensive care units in the United States and Canada under a Treatment Investigational New Drug protocol. Results of this open clinical experience are reported. Investigators could give one dose of Survanta soon after birth to neonates weighing 600 to 1250 g (prevention strategy). Neonates weighing 600 to 1750 g who were not treated at birth could begin Survanta therapy if respiratory distress syndrome developed within 8 hours of birth (rescue strategy). All neonates could receive up to three more doses over the first 48 hours of life at minimum intervals of 6 hours if they met retreatment criteria. Qualifications for enrollment closely matched those used in previous randomized controlled clinical trials. This report includes results from 8168 neonates who completed the study. Treatment Investigational New Drug rates for intracranial hemorrhage, patent ductus arteriosus, pulmonary hemorrhage, pulmonary air leaks, bronchopulmonary dysplasia, death or bronchopulmonary dysplasia, pulmonary interstitial emphysema, pretreatment sepsis, and posttreatment sepsis were less than for treated neonates in the controlled trials and survival was equivalent across studies. Problems with treatment administration were reported with 30.4% of doses, while adverse events were reported in 0.5% of neonates. The results of the Treatment Investigational New Drug protocol revealed no new safety concerns associated with the widespread use of Survanta and confirmed the safety profile established in earlier controlled trials.

Biological Products↗
PubMed1984

Determinants of carbamazepine and carbamazepine 10,11-epoxide binding to serum protein, albumin and alpha 1-acid glycoprotein.

The binding of carbamazepine and carbamazepine 10,11-epoxide to serum, albumin and alpha 1-acid glycoprotein (AAG) was determined and compared at drug concentrations ranging from 0.5 to 400 mg/l using equilibrium dialysis and liquid chromatography. The total binding of carbamazepine in serum was determined primarily by albumin and to a lesser extent (20-30%) by AAG. Modified Scatchard plots for carbamazepine binding in serum were biphasic, suggesting the presence of two binding sites on serum protein. Association constants characterizing the first (k1 = 2.4 X 10(4) l/mol) and second (k2 = 4.6 X 10(2) l/mol) binding sites agreed with those measured for AAG and albumin respectively. Modified Scatchard plots for carbamazepine 10,11-epoxide binding in serum were linear and serum binding was largely accounted for by binding to albumin. The epoxide metabolite did not bind to AAG. Carbamazepine binding to AAG was drug concentration-dependent over the concentration range considered to be therapeutic, while the percent binding values for carbamazepine and epoxide binding to albumin and serum from a normal individual were constant over this range. Computer simulations showed that physiological extremes in AAG and albumin concentrations can result in a range of carbamazepine unbound fractions of 0.17 to 0.47. These data suggest that normal variations in concentrations of both proteins may be the principal cause of interpatient variability in serum protein binding of carbamazepine.

Blood Proteins↗
PubMed1984

Efficacy of a timed-release antihistamine/decongestant tablet for symptoms of nasal allergy.

In a double-blind study, a timed-release tablet containing carbinoxamine maleate 8 mg and pseudoephedrine hydrochloride 120 mg was compared with placebo for the treatment of signs and symptoms of nasal allergy. Ninety-four adults with rhinitis caused by grass or ragweed allergy were paired according to severity of symptoms and nasal congestion, then assigned randomly to drug or placebo. After baseline measurements were taken, three doses of drug or placebo were given at 12-hour intervals. The active drug was significantly better than placebo in relieving the following symptoms: nasal congestion, nose blowing, sneezing, nasal pruritus, rhinorrhea, ophthalmic pruritus, and sniffles. Improvement over baseline in mean total nasal air flow also was greater in subjects given active drug. The incidence of nonspecific symptoms, including possible drug side effects, was similar between groups. We conclude that the timed-release tablet is safe and effective therapy for the treatment of signs and symptoms of nasal allergy.

Adult↗
PubMed1984

Evaluation of drugs used in the prophylaxis of neonatal conjunctivitis.

Administration of silver nitrate 1% solution into the eyes of the newborn has proven effective in the prophylaxis of gonococcal neonatal conjunctivitis. Silver nitrate, however, is not active against Chlamydia trachomatis, the most common cause of neonatal conjunctivitis. Also, silver nitrate commonly is associated with substantial chemical irritation. For these reasons, alternative agents are receiving increasing attention. Recently, erythromycin 0.5% and tetracycline 1% ophthalmic ointments were recommended by the Centers for Disease Control Venereal Disease Control Division for prophylaxis of neonatal conjunctivitis. Erythromycin has proven at least as effective as silver nitrate for gonococcal prophylaxis, can prevent chlamydial conjunctivitis in infants born to Chlamydia-positive mothers, and is associated with minimal complications. Clinical studies, however, demonstrating significant differences between erythromycin and tetracycline ophthalmic ointments are lacking. Well-controlled clinical studies comparing silver nitrate, erythromycin, and tetracycline prophylaxis are needed to determine the relative effectiveness of these agents.

Chlamydia Infections↗
PubMed1984

Issues facing nutrition support teams.

Nutrition is a sophisticated science now recognized as an important medical discipline, and an NST is one excellent way to deliver nutrition care. Specialty training in clinical dietetics and clinical pharmacy provides individuals with increased knowledge in the areas of enteral and parenteral nutrition, respectively, although overlap exists. Both professional groups have a responsibility to document the cost savings associated with nutrition support and to unite to reinforce the accomplishments of the team and advance into the new horizons of home care.

Dietary Services↗
PubMed1983

Comparative effects and analgesic efficacy of the agonist-antagonist opioids.

Pentazocine, butorphanol, nalbuphine, and buprenorphine are mixed agonist-antagonist opioids that are effective analgesics, with less abuse potential than the agonists morphine, propoxyphene, and codeine. The dual properties of the agonist-antagonists are largely explained by their varying actions at the postulated three types (mu, chi, and sigma) of opioid receptors. The agonist-antagonists are classified as either morphine-like or nalorphine-like, based on their acute effects and withdrawal symptoms after chronic dosing. Buprenorphine is morphine-like, while the other drugs are nalorphine-like. These agents vary in the duration of analgesia, with pentazocine having a mean action of three hours and buprenorphine greater than six hours. The hemodynamic effects of nalbuphine and buprenorphine generally resemble those of morphine, while pentazocine and butorphanol increase cardiac workload, blood pressure, and pulmonary artery pressure. The agonist-antagonists have ceilings for respiratory depression, whereas the agonists produce dose-dependent depression. Agonist-antagonists generally produce less increase in biliary ductal pressure than does morphine. The major clinical limitations are that agonist-dependent patients may experience unpleasant subjective effects, when treated with the agonist-antagonists, and the nalorphine-like agents can produce psychotomimetic effects. More clinical experience is needed to rank the abuse potential within this group of opioids. The newer agents are being studied for oral use in acute and chronic pain.

Analgesics↗