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Biomedical subjects

G A Gibson

Publications and source records attributed to G A Gibson.

At least 19 recordsLinked to original sources

Selective perturbation of early endosome and/or trans-Golgi network pH but not lysosome pH by dose-dependent expression of influenza M2 protein.

Many sorting stations along the biosynthetic and endocytic pathways are acidified, suggesting a role for pH regulation in protein traffic. However, the function of acidification in individual compartments has been difficult to examine because global pH perturbants affect all acidified organelles in the cell and also have numerous side effects. To circumvent this problem, we have developed a method to selectively perturb the pH of a subset of acidified compartments. We infected HeLa cells with a recombinant adenovirus encoding influenza virus M2 protein (an acid-activated ion channel that dissipates proton gradients across membranes) and measured the effects on various steps in protein transport. At low multiplicity of infection (m.o.i.), delivery of influenza hemagglutinin from the trans-Golgi network to the cell surface was blocked, but there was almost no effect on the rate of recycling of internalized transferrin. At higher m.o.i., transferrin recycling was inhibited, suggesting increased accumulation of M2 in endosomes. Interestingly, even at the higher m.o.i., M2 expression had no effect on lysosome morphology or on EGF degradation, suggesting that lysosomal pH was not compromised by M2 expression. However, delivery of newly synthesized cathepsin D to lysosomes was slowed in cells expressing active M2, suggesting that acidification of the TGN and endosomes is important for efficient delivery of lysosomal hydrolases. Fluorescence labeling using a pH-sensitive dye confirmed the reversible effect of M2 on the pH of a subset of acidified compartments in the cell. The ability to dissect the role of acidification in individual steps of a complex pathway should be useful for numerous other studies on protein processing and transport.

Adenoviridae

Economic impact of a drug information service.

OBJECTIVE: A cost-avoidance model was developed to determine potential cost savings or "avoidance" that results from a drug information service (DIS) responding to drug information requests. DESIGN: Patient-specific questions received by the DIS were reviewed and evaluated. A panel determined whether a drug misadventure event may have occurred if the DIS had not been consulted. Potential outcomes from drug information requests were classified using a decision-tree model. A severity rating was then attached to each applicable request to predict potential cost savings of the DIS. RESULTS: Seventy-seven of the 570 drug information responses received in the six-week study period had assessable potential cost savings to the institution. During the study interval, potential cost savings were estimated to be $195,000. Projected to one year, potential cost savings reached $1.7 million. Of the savings noted, most were attributable to prevention of increased monitoring or additional treatment. Using a sensitivity analysis, annual potential cost savings ranged from $417,792 to $2,052,740 per year. Based on the estimated annual costs related to maintaining a DIS of $145,950, the resultant range of benefit/cost ratio is 2.9:1 to 13.2:1. CONCLUSIONS: This model demonstrates that the DIS at our institution provides potential cost savings. This model may be modified to evaluate potential cost savings in other areas of pharmacy practice.

Cost Savings

Management of postoperative paralysis of diaphragm in infants and children.

During an 8-month period, 86 consecutive infants and children under 2 years of age underwent palliative or corrective cardiac surgery, of whom 11 subsequently developed phrenic nerve injury (PNI). This was seen most frequently following classic or modified Blalock-Taussig shunts. The diagnosis was established by ultrasound screening of the diaphragm, and patients were initially managed expectantly with ventilatory support. In nine patients no further management was necessary with demonstrated return of diaphragmatic function. The remaining two patients underwent plication of the diaphragm. The mean time to diaphragmatic recovery was 40.8 days and was more prolonged in patients with paradoxical, as opposed to absent, diaphragmatic movement. There were no deaths in the series. A further retrospective review of 241 patients of similar age undergoing similar surgery over the preceding 2 years revealed evidence of PNI in 11 (4.6%). Recovery of diaphragmatic function was documented in all except one patient who died. Based on these results we believe that although PNI is associated with considerable morbidity, and frequently a long stay in Intensive Care, there is evidence of spontaneous recovery of diaphragmatic function in 90% of the patients. Consequently, plication of the diaphragm can usually be avoided. Ultrasound scanning is extremely useful in establishing the diagnosis and offers assistance in predicting prognosis and deciding management.

Algorithms

Gentamicin pharmacokinetics in postpartum women with endomyometritis.

The pharmacokinetics of gentamicin in postpartum women with endomyometritis were characterized and models for predicting patient pharmacokinetic parameters were developed using multiple regression analysis. Fifty-one women 13-34 years of age received gentamicin in combination with either ampicillin or clindamycin to treat endomyometritis. Forty-three women delivered by cesarean section and 8 women had vaginal deliveries. Gentamicin serum concentrations were determined at steady-state to compute the elimination rate constant (Kc), half-life (t1/2), apparent volume of distribution (Vd), and total body clearance (Cl). Gentamicin dosages were individualized using a one-compartment intermittent infusion model to achieve steady-state peak and trough concentrations of 6.5 and less than 2 micrograms/mL, respectively. The mean gentamicin t1/2 was 2.8 +/- 0.9 h; the mean apparent Vd was 21 +/- 8 L; and the mean total body Cl was 89.5 +/- 31.7 mL/min. Multiple regression analysis revealed that total body weight (TBW) was the best predictor for the apparent Vd, described by the equation Vd = 0.146 TBW + 8.153 (r = 0.56, p = 0.00005). Total body weight and creatinine clearance (Clcr) were included as predictors for total body Cl, described by the equation Cl = 0.264 TBW + 0.337 Clcr + 3.416 (r = 0.68, p = 0.00005). Age and serum creatinine (SCr) were included in the models for the Ke, described by the equation Ke = -3.770 x 10(-3) age -0.115 SCr + 0.449 (r = 0.42, p less than 0.004). Additional patient factors need to be identified to explain the variance in these pharmacokinetic parameters.

Adolescent

Lack of probenecid effect on nonrenal excretion of ceftriaxone in anephric patients.

Probenecid has been shown to decrease renal and biliary excretion of organic acids. In a randomized crossover study, the effect of coadministered probenecid on nonrenal excretion of ceftriaxone was studied in six functionally anephric patients in whom ceftriaxone is eliminated exclusively by nonrenal or presumably by biliary excretion. Each patient received 0.5 g IV ceftriaxone without and with probenecid (0.5 g at 10 and 2 hours prior to ceftriaxone and 0.5 g q12h X 3 doses post ceftriaxone). Serial blood samples were collected over 48 hours and plasma analyzed for ceftriaxone by high performance liquid chromatography (HPLC). Pharmacokinetic analysis was based on a model-independent approach. Probenecid did not significantly affect the disposition of ceftriaxone in this study, thus suggesting that nonrenal excretion of ceftriaxone is not inhibited by probenecid.

Adult

Comparison of gentamicin immunoassays using univariate and multivariate analyses.

Gentamicin concentrations, pharmacokinetic parameters, and calculated doses from enzyme multiplied immunoassay (EMI) and fluorescence polarization immunoassay (FPIA) were compared in 79 samples from 39 patients. Associations between patient factors and the differences between assay results were also assessed. Concentrations were lower when measured by EMI than by FPIA in 71 of the 79 samples (p less than 0.001). Mean EMI values for elimination rate constant, volume of distribution, clearance, dose, and daily dose were 10-20% higher than mean FPIA values (p less than or equal to 0.01). Dosing intervals calculated from EMI and FPIA data were different in 20 pairs of intervals and varied depending on the length of calculated interval. Univariate and multivariate analyses revealed that renal function and the presence or absence of cardiovascular disease, cimetidine, or ranitidine, and heparin were related to differences between the assay results. EMI and FPIA yielded different results for gentamicin concentrations, pharmacokinetic parameters, and calculated daily doses in the clinical setting. Such differences could result in toxic or subtherapeutic doses being administered and may be related, in part, to various patient factors.

Adult

Vancomycin concentrations in infected and noninfected human bone.

Concentrations of vancomycin in bones of 14 patients undergoing total hip arthroplasty (group 1) and 5 patients with osteomyelitis (group 2) were studied. Group 1 received vancomycin, 15 mg/kg intravenously, 1 h prior to anesthesia. Group 2 received doses adjusted to achieve peak levels in serum of 20 to 30 micrograms/ml and trough levels of less than 12 micrograms/ml; bone specimens were collected during surgical debridement. The specimens were pulverized and eluted into phosphate buffer, and the supernatants were analyzed for vancomycin content by fluorescence polarization immunoassay. In group 1, vancomycin was detectable in all cancellous specimens with a mean concentration of 2.3 +/- 4.0 micrograms/g (range, 0.5 to 16 micrograms/g); 10 of 14 cortical specimens had detectable vancomycin; the mean cortical concentration was 1.1 +/- 0.8 micrograms/g (range, not detectable to 2.6 micrograms/g). In group 2, vancomycin was detectable in only two of five cortical bone specimens (mean concentration, 5.9 +/- 3.5 micrograms/g). Cancellous bone was obtained in one patient; the vancomycin concentration was 3.6 micrograms/g. In most patients the vancomycin levels in bones were higher than the MIC for susceptible staphylococci following single prophylactic doses. In the few infected patients studied, penetration was variable and deserves further study.

Adult

Relationship of steady-state serum concentrations of amiodarone and desethylamiodarone to therapeutic efficacy and adverse effects.

The relationship of steady-state serum levels of amiodarone and its major metabolite, desethylamiodarone, to therapeutic and toxic effects was evaluated in 111 patients treated for supraventricular and ventricular arrhythmias. All patients were treated for more than two months (mean 10 +/- 7), and repeated serum levels determined at least two months apart were within 0.5 mg/liter of each other. Effective control of arrhythmias during steady-state therapy was achieved in 91 patients (82 percent of the study populations); recurrent arrhythmias or sudden death did not correlate with levels. An adverse drug effect necessitating cessation of therapy and/or concomitant medical therapy for the adverse effect occurred in 12 patients (11 percent); an additional 33 patients (30 percent) had an adverse effect that did not require change in therapy. The mean serum concentrations of amiodarone and desethylamiodarone associated with adverse drug effects were higher (2.6 +/- 1.2 mg/liter and 2.0 +/- 0.8 mg/liter) than those in patients without adverse effects (2.1 +/- 1.0 mg/liter and 1.5 +/- 0.7 mg/liter), p less than 0.05. An amiodarone serum concentration of 2.5 mg/liter or more had a positive predictive value of 76 percent for identifying patients with an adverse effect. The level of desethyl metabolite of amiodarone correlated directly with the serum amiodarone concentration (r = 0.82). Measurement of desethylamiodarone did not increase the sensitivity or specificity of the amiodarone level alone in the identification of patients at risk for adverse drug effects.

Adult

Biliary excretion of imipenem-cilastatin in hospitalized patients.

Imipenem-cilastatin concentrations in bile were measured in 12 cholecystectomy patients (group 1) and 12 patients with common duct drainage (group 2). Six patients in each group received 0.5 g, and six received 1.0 g intravenously over 30 to 60 min. In group 1, bile was collected a mean of 85 min postinfusion. The mean concentrations of imipenem in bile were 1.3 microgram/ml after the 0.5-g dose and 3.5 micrograms/ml after the 1.0-g dose. The mean concentrations of cilastatin in bile were 9.0 micrograms/ml after the 0.5-g dose and 38.0 micrograms/ml after the 1.0-g dose. In patients with common duct drainage, bile was collected predose and 0 to 2, 2 to 3, 3 to 4, and 4 to 6 h postinfusion. Peak imipenem concentrations in bile were 4.4 micrograms/ml after the 0.5-g dose and 8.6 micrograms/ml after the 1.0-g dose. Peak cilastatin concentrations in bile were 4.6 micrograms/ml for the 0.5-g dose and 10.9 micrograms/ml for the 1.0-g dose. Peak imipenem concentrations in bile occurred a mean of 2.3 h after administration of the drug; cilastatin peak concentrations occurred at a mean of 2.4 h. Less than 0.3% of each drug was recovered in the bile. Our results suggest that imipenem enters bile by simple diffusion and in most patients attains concentrations sufficient to inhibit susceptible organisms. In contrast, cilastatin had a bimodal entry into bile. Some patients had very high concentrations in bile, whereas others had very low or undetectable concentrations, suggesting that cilastatin may be actively secreted into the bile.

Adult

Imipenem pharmacokinetics and body fluid concentrations in patients receiving high-dose treatment for serious infections.

Serum, urine, tissue, and body fluids were collected from 40 adult patients who were receiving imipenem/cilastatin treatment for serious infections. Thirty-two patients were given 1 g every 6 h (4 g/day), and eight received 500 mg (2 g/day). Mean peak concentrations in serum were 34.9 +/- 4.0 micrograms/ml for the 1-g dose and 26.6 +/- 2.5 micrograms/ml for the 500-mg dose. Trough levels were 3.1 and 1.0 micrograms/ml, respectively. No evidence of drug accumulation was found after comparing peaks measured early in the treatment with those measured late. Peak levels were only marginally increased when infusions were given over 30 versus 60 min. The mean serum half-life was 82.0 +/- 25.3 min, with a range of 50 to 138 min. The apparent volume of distribution was 0.35 +/- 0.13 liter/kg, and the mean total body clearance was 0.183 +/- 0.067 liter/kg per h. Creatinine clearance correlated directly with the plasma elimination rate and inversely with the serum half-life. Moreover, total body clearance fell as the age of the patient rose. The mean urinary recovery was 39.1 +/- 12.8% (range, 15.0 to 59.2%) and did not correlate with creatinine clearance until it was below 15 ml/min. Of 20 specimens of various gastrointestinal secretions, 13 had imipenem concentrations that were low, but above the MIC for most resident flora. Pus, sputum, and bone all had concentrations of the drug sufficient to inhibit the infecting organisms, and these levels reflected generally excellent clinical responses.

Adult

Influence of high-dose pentobarbital on theophylline pharmacokinetics: a case report.

The effect of high dose pentobarbital coma therapy on the total body clearance of theophylline (CLT) was evaluated in a neurosurgical patient. Preinduction and induction CLT were 4.22 and 8.02 L/h, respectively, which represented a 95% increase in the CLT as a consequence of pentobarbital therapy. Although barbiturates have been shown to induce hepatic microsomal enzymes, previous reports minimize their effect on CLT in humans. This case report demonstrates remarkable alterations in the CLT as a result of high doses of pentobarbital, necessitating the need for substantial dosage adjustments of theophylline.

Aminophylline

Safety and efficacy of high-dose treatment with imipenem-cilastatin in seriously ill patients.

Imipenem-cilastatin was given in doses of 1 g intravenously every 6 h to 31 patients. Twenty-five patients, with 27 infections, were clinically evaluable and received 20 to 210 g of imipenem for a duration of 5 to 56 days (average 16.3 days). Infections included seven cases of osteomyelitis, seven of bacteremia, five of cellulitis, two of pneumonia, three of pelvic cellulitis, two of intraabdominal abscess, and one each of empyema, mediastinitis, and endometritis. Fifty-five percent of the infections were caused by gram-negative bacilli, 33% were due to gram-positive organisms, and 10% were caused by anaerobes. Twenty-two patients (81%) were cured, three improved, one relapsed, and one became superinfected with a resistant organism. In 5 of 11 cases with Pseudomonas aeruginosa, the imipenem MIC for organisms isolated by the end of treatment was higher than it was initially, raising concern that imipenem should not be used alone to treat Pseudomonas aeruginosa infections. Twenty-one patients had no adverse reaction; of the remaining 10 patients, 4 had nausea, 1 had urticaria, and 6 had mild abnormalities in hepatic function; three episodes of diarrhea included two with Clostridium difficile toxin in stool and one with pseudomembranous colitis, as determined by sigmoidoscopy. Levels of creatinine, hemoglobin, leukocytes, platelets, prothrombin, and urine components were unchanged. Imipenem-cilastatin is a clinically effective antibiotic with freedom from nephrotoxicity and hematological abnormalities in the large doses used in this study.

Adult

Obtaining reimbursement for clinical pharmacokinetic monitoring.

A method of obtaining reimbursement for clinical pharmacokinetic monitoring is described. The process included reviewing the existing literature, observing the practices of others providing similar services, collecting workload and expense data, selecting an equitable fee, and presenting third party payers with evidence of the service's need, documentation, and effectiveness. The average patient was monitored by the pharmacokinetic service for 8.4 days and had 5.1 serum samples drawn. The physician received 3.1 dosing recommendations. An average of 4.3 hours was spent monitoring each patient with an average cost of $86. Of the several alternatives for charging considered, an inclusive charge of $10 per patient day was chosen. Blue Cross reimbursement criteria for pharmacokinetic monitoring stipulated that (1) the service must be physician initiated; (2) documentation of services provided must appear as a permanent part of the patient's record; (3) service provided must be identified with a specific group of patients rather than applied equally to all patients in the institution; and (4) evidence of reduced morbidity, mortality, or length of hospital stay would help. During 1981, $37,470 in charges was generated for pharmacokinetic monitoring services with reimbursement being received from third party programs, insurance companies, and private patients.

Humans