bluuebunny/crossref_metadata_2025_split huggingface dataset:
Gemifloxacin: A New Fluoroquinolone Approved for Treatment of Respiratory Infections
Authors: Yoo Bong K , Triller Darren M , Yong Chul-Soon , Lodise Thomas P 
Published: June 2004

OBJECTIVE: To evaluate the microbiology, pharmacokinetic parameters, drug interactions, and results of the available clinical trials of gemifloxacin for the treatment of community-acquired pneumonia (CAP) and acute exacerbation of chronic bronchitis (AECB). DATA SOURCES: MEDLINE (1966–September 2003) was searched for primary and review articles. Data from the manufacturer were also included. Key words included adverse effects, clinical trials, drug interactions, gemifloxacin, and pharmacokinetic parameters. STUDY SELECTION AND DATA EXTRACTION: All articles and product labeling concerning gemifloxacin, a fluoroquinolone antibiotic recently approved by the Food and Drug Administration for treatment of CAP and AECB, were included for review. DATA SYNTHESIS: Compared with currently available fluoroquinolones, gemifloxacin demonstrated improved in vitro activity against Streptococcus pneumoniae (minimum inhibitory concentration for 90% eradication 0.03 μg/mL) and similar activity against gram-negative respiratory pathogens ( Haemophilus influenzae, Moraxella catarrhalis) and atypical pathogens such as Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae. Gemifloxacin, consistent with other available fluoroquinolones, has insufficient activity against methicillin-resistant Staphylococcus aureus to allow clinical use for such infections. Gemifloxacin has adequate bioavailability and a favorable drug interaction profile. Gemifloxacin was comparable to commonly employed nonfluoroquinolone regimens for treatment of CAP and AECB, although the studies were designed to demonstrate equivalence. Gemifloxacin once daily for 5–7 days was well tolerated in controlled and uncontrolled clinical studies. Available clinical data, however, are insufficient to draw clinical or toxicologic distinctions between gemifloxacin and other fluoroquinolones. CONCLUSIONS: Gemifloxacin may be a suitable choice for empiric treatment of CAP or AECB. However, due to the significant history of fluoroquinolone-induced hepatic failure and dermatologic complications, the use of this drug should be closely monitored.
Nonsteroidal Antiinflammatory Drug Use among Patients with GI Bleeding
Authors: Dominick Kelli L , Bosworth Hayden B , Jeffreys Amy S , Grambow Steven C , Oddone Eugene Z , Horner Ronnie D 
Published: June 2004

BACKGROUND: Previous studies have suggested that recommended gastroprotective strategies such as gastroprotective agents (GPAs) and cyclooxygenase (COX) 2 inhibitors may be underutilized among individuals at risk for nonsteroidal antiinflammatory drug (NSAID)-related gastrointestinal (GI) bleeding. OBJECTIVE: To examine the use of traditional NSAIDs, COX-2 inhibitors, and GPAs among patients recently hospitalized for GI bleeding. METHODS: This was a retrospective cohort study of a national sample of 4338 veterans hospitalized for GI bleeding between January and June 1999. Prescription drug use was examined for 6 months following hospitalization. We examined relationships of subject characteristics (age, race, gender, geographic region, diagnosis of arthritis) to prescription of a high-risk NSAID, defined as a traditional NSAID but no GPA within 60 days before or after the NSAID. RESULTS: Approximately 20% of subjects were prescribed an NSAID or COX-2 inhibitor, but only 5% were prescribed a traditional NSAID with no GPA. In a multivariable analysis, subjects <65 years of age and those with arthritis were more likely to be prescribed a traditional NSAID without a GPA. No other subject characteristics were related to receipt of a high-risk prescription. CONCLUSIONS: In a national sample of veterans with a recent hospitalization for GI bleeding, high-risk NSAID prescriptions were uncommon. Underuse of gastroprotective strategies may be more common in patients with less recent GI bleeding—related hospitalization. Strategies to remind physicians and pharmacists to screen for GI risk factors may help to sustain appropriate prescribing and reduce NSAID-related adverse events.
Estimate of Uncertainty of Measurement from a Single-Laboratory Validation Study: Application to the Determination of Lead in Blood
Authors: Patriarca Marina , Castelli Marco , Corsetti Federica , Menditto Antonio 
Published: June 2004

Abstract
Background: Lead is an environmental pollutant, and human exposure is assessed by monitoring lead concentrations in blood. Because the main source of environmental exposure has been the use of leaded gasoline, its phase-out has led to decreased lead concentrations in the general population. Therefore, validated analytical methods for the determination of lower lead concentrations in blood (&lt;150 μg/L) are needed. In addition, new ISO standards require that laboratories determine and specify the uncertainty of their results.
Methods: We validated a method to determine lead in blood at concentrations up to 150 μg/L by electrothermal atomic absorption spectrometry with Zeeman background correction according to EURACHEM guidelines. Blood samples were diluted (1:1 by volume) with 2 mL/L Triton X-100. NH4H2PO4 (5 g/L) and Mg(NO3)2 (0.5 g/L) were used as modifiers. Matrix-matched standards were used for calibration.
Results: We determined the limits of detection (3.1 μg/L) and quantification (9.4 μg/L). Repeatability and intermediate imprecision within the range 35–150 μg/L were &lt;5.5% and &lt;6.0%, respectively. We assessed trueness by use of certified reference materials, by recovery tests, and by comparison with target values of other reference materials (candidate external quality assessment samples). The expanded uncertainty ranged from 20% to 16% (with a confidence level of 95%) depending on concentration.
Conclusions: This study provides a working example of the estimate of uncertainty from method performance data according to the EURACHEM/CITAC guidelines. The estimated uncertainty is compatible with quality specifications for the analysis of lead in blood adopted in the US and the European Union.
Denaturing HPLC Profiling of the ABCA4 Gene for Reliable Detection of Allelic Variations
Authors: Stenirri Stefania , Fermo Isabella , Battistella Stefania , Galbiati Silvia , Soriani Nadia , Paroni Rita , Manitto Maria Pia , Martina Elisabetta , Brancato Rosario , Allikmets Rando , Ferrari Maurizio , Cremonesi Laura 
Published: June 2004

Abstract
Background: Mutations in the retina-specific ABC transporter (ABCA4) gene have been associated with several forms of macular degenerations. Because the high complexity of the molecular genotype makes scanning of the ABCA4 gene cumbersome, we describe here the first use of denaturing HPLC (DHPLC) to screen for ABCA4 mutations.
Methods: Temperature conditions were designed for all 50 exons based on effective separation of 83 samples carrying 86 sequence variations and 19 mutagenized controls. For validation, samples from 23 previously characterized Stargardt patients were subjected to DHPLC profiling. Subsequently, samples from a cohort of 30 patients affected by various forms of macular degeneration were subjected to DHPLC scanning under the same conditions.
Results: DHPLC profiling not only identified all 132 sequence alterations previously detected by double-gradient denaturing gradient gel electrophoresis but also identified 5 sequence alterations that this approach had missed. Moreover, DHPLC scanning of an additional panel of 30 previously untested patients led to the identification of 26 different mutations and 29 polymorphisms, accounting for 203 sequence variations on 29 of the 30 patients screened. In total, the DHPLC approach allowed us to identify 16 mutations that had never been reported before.
Conclusions: These results provide strong support for the use of DHPLC for molecular characterization of the ABCA4 gene.
The Psychometric and Cardiac Effects of Pseudoephedrine in the Hyperbaric Environment
Authors: Taylor David McD. , O'Toole Kevin S. , Auble Thomas E. , Ryan Christopher M. , Sherman David R. 
Published: June 2004

Study Objectives. To examine the psychometric and cardiac effects of pseudoephedrine at 1 and 3 atmospheres (atm) of pressure (0 and 66 feet of sea water, respectively), and to make recommendations about the agent's safety in the diving environment.Design. Double‐blind, placebo‐controlled, crossover study.Setting. Monoplace hyperbaric chamber of a university hospital.Subjects. Thirty active divers (mean age 38 yrs).Intervention. A bank of seven tests was used to assess cognitive function during four different simulated dive combinations: placebo‐1 atm, placebo‐3 atm, pseudoephedrine‐1 atm, and pseudoephedrine‐3 atm.Measurements and Main Results. Heart rate and cardiac rhythm were recorded during all dives. Repeated‐measures analysis of variance was used to analyze the effects of pseudoephedrine, depth, and drug‐depth interaction. No significant, independent effects of pseudoephedrine were seen on any of the seven psychometric test scores (p<0.05), although the drug tended to increase anxiety scores (p=0.092). Depth resulted in a significant increase in anxiety scores (p=0.021) and a significant decrease in verbal fluency test scores (p=0.041); it had no significant effects on the other five psychometric tests (p>0.05). Pseudoephedrine caused a significant increase (p=0.036) in mean heart rate, and depth caused a significant decrease (p=0.013). Neither pseudoephedrine nor depth affected cardiac rhythm.Conclusion. Pseudoephedrine does not cause significant alterations in psychometric performance at 3 atm of pressure that might increase the risk of diving. Depth causes significant adverse effects on anxiety levels and semantic memory at 3 atm. Pseudoephedrine and depth have significant but opposite effects on heart rate; although, these effects are unlikely to be clinically significant during diving. It is unlikely that pseudoephedrine adds significant risk to the diver.
The Psychometric and Cardiac Effects of Dimenhydrinate in the Hyperbaric Environment
Authors: Taylor David McD. , O'Toole Kevin S. , Auble Thomas E. , Ryan Christopher M. , Sherman David R. 
Published: June 2004

Study Objectives. To examine the psychometric and cardiac effects of dimenhydrinate at 1 and 3 atmospheres (atm) of pressure (0 and 66 feet of sea water, respectively), and to make recommendations about the drug's safety in the diving environment.Design. Double‐blind, placebo‐controlled, crossover study.Setting. Monoplace hyperbaric chamber of a university hospital.Subjects. Thirty active divers (mean age 38 yrs).Interventions. A bank of seven tests was used to assess cognitive function during four different dive combinations: placebo‐1 atm, placebo‐3 atm, dimenhydrinate‐1 atm, and dimenhydrinate‐3 atm.Measurements and Main Results. Heart rate and cardiac rhythm were recorded during all dives. Repeated‐measures multivariate analysis of variance was used to analyze the effects of dimenhydrinate, depth, and drug‐depth interaction. Dimenhydrinate resulted in a significant decrease in scores of mental flexibility (trail‐making, part B, p<0.05) but had no effect on scores in the six other psychometric tests (p>0.05). It had no effect on mean heart rate (p>0.05), although frequent unifocal ventricular ectopic beats occurred in two subjects after ingestion of the drug. Depth resulted in a significant decrease in verbal memory test scores (p=0.001) and mean heart rate (p<0.001).Conclusion. Dimenhydrinate adversely affects mental flexibility. This effect, when added to the adverse effect of depth on memory, may contribute to the dangers of diving.
Retrospective Evaluation of a Potential Interaction Between Azithromycin and Warfarin in Patients Stabilized on Warfarin
Authors: Beckey Nick P. , Parra David , Colon Amy 
Published: June 2004

Study Objective.To investigate a potential interaction between azithromycin and warfarin.Design.Retrospective case‐control study.Setting.Veterans Affairs medical centerPatients.Fifty‐two patients stable on anticoagulation therapy.Intervention.Patients who received a prescription for azithromycin and warfarin at any time since the hospital was opened, June 1, 1995, to July 22, 1999, were identified through a computerized report generated from the pharmacy prescription package.Measurements and Main Results.Patients having a stable international normalized ratio (INR; defined as a therapeutic INR ± 0.2) for at least two consecutive visits before receiving an azithromycin prescription were reviewed. Changes in INR from before and after addition of azithromycin were compared with changes in a control group. Controls were identified from a computer‐generated report of patients who received a prescription for terazosin and warfarin at any time since the hospital was opened to July 22, 1999 (terazosin was chosen as it has no known interaction with warfarin). These patients also had a stable INR for at least two consecutive visits before receiving the terazosin prescription. In patients with INRs on record within 14 days after starting azithromycin or terazosin (9 patients/group), the average change in INR was 0.18 ± 0.48 in the azithromycin group and 0.07 ± 0.49 in the terazosin group (p=0.60). For patients with an INR on record within 30 days after starting azithromycin or terazosin (26 patients/group), the average change in INR was 0.25 ± 0.67 in the azithromycin group and 0.05 ± 0.55 in the terazosin group (p=0.18).Conclusion.An interaction between azithromycin and warfarin was not observed in this retrospective review of patients with a stable INR receiving the combination.
Safety and Efficacy of HMG‐CoA Reductase Inhibitors for Treatment of Hyperlipidemia in Patients with HIV Infection
Authors: Penzak Scott R. , Chuck Susan K. , Stajich Gregory V. 
Published: June 2004

Study Objective. To assess the efficacy and safety of HMG‐CoA reductase inhibitors (statins) in patients with human immunodeficiency virus (HIV) infection and hyperlipidemia.Design. Retrospective analysis.Setting. HIV clinic.Patients. Twenty‐six HIV‐infected patients with hyperlipidemia.Intervention. Five patients received pravastatin, 13 lovastatin, 10 simvastatin, and 2 atorvastatin (total 30 courses).Measurements and Main Results. Reductions in cholesterol and triglycerides were used to assess efficacy; creatine kinase (CK), liver enzymes, and myalgia were markers of statin toxicity. After a median of 8.2 and 7.2 months of treatment, the agents collectively reduced median baseline total cholesterol 27% (354 to 263 mg/dl) and triglycerides 15% (513 to 438 mg/dl), respectively. Two patients, one with marked CK elevations, experienced myalgias with lovastatin, and two experienced transaminase elevations 3 or more times the upper limit of normal.Conclusion. Statins are effective in reducing total cholesterol and triglycerides in HIV‐infected patients, although lipid levels infrequently return to normal. Lovastatin should be avoided in patients receiving concomitant drugs that may potentiate skeletal muscle toxicity with this agent.
Retrospective Evaluation of the Conversion of Amlodipine to Alternative Calcium Channel Blockers
Authors: Parra David , Beckey Nick P. , Korman Lisa 
Published: June 2004

Study Objective. To evaluate the effectiveness, safety, and costs associated with a formulary conversion from amlodipine to alternative calcium channel blockers.Design. Retrospective study.Setting. Veterans Affairs Medical Center.Patients. One hundred patients with hypertension who were receiving amlodipine.Intervention. Data from a random sample of 100 patients who were taking amlodipine and converted to a formulary calcium channel blocker from February 1, 1999—October 30, 1999, were entered into an Excel database for evaluation of the conversion.Measurements and Main Results. Patients were required to have a diagnosis of hypertension and have had two consecutive clinic visits with blood pressure measurements (and no changes in antihypertensive therapy) before conversion. End points were changes in average systolic blood pressure, diastolic blood pressure, and mean arterial pressure (MAP) from the two clinic visits before and after conversion. In addition, data were collected and analyzed with regard to adverse drug reactions, average dosage of the alternative calcium channel blocker, number of additional antihypertensives begun or discontinued, and number of dosage changes in antihypertensives within the two visits after conversion, and the overall cost impact of conversion. Average systolic blood pressure was reduced from 141.6 ± 15.1 to 139.2 ± 15.3 mm Hg after the conversion (NS). Average diastolic blood pressure was significantly reduced from 74 ± 9.5 to 72.6 ± 10.1 mm Hg after conversion (p=0.032), as was MAP (97.0 ± 9.3 to 94.8 ± 10.0 mm Hg, p=0.026). Five patients had other changes in therapy made concurrently at the time of conversion, and 19 had changes after conversion. When these patients were excluded from analysis, the reduction in systolic blood pressure after conversion was significant (141.4 ± 14.5 to 137.7 ± 14.3 mm Hg, p=0.022), as were reductions in diastolic blood pressure (74.4 ± 9.4 to 71.7 ± 9.8 mm Hg, p=0.014) and MAP (96.7 ± 9.1 to 93.7 ± 9.3 mm Hg, p=0.007). Of patients who had postconversion changes in therapy, 8 (42%) were converted to diltiazem ER, nifedipine CC, or doses of felodipine that were 50% of the original dose of amlodipine. The overall cost impact of the conversion was a net savings of $14,858/year for each 100 patients converted.Conclusion. Conversion from amlodipine to other calcium channel blockers resulted in statistically significant reductions in diastolic blood pressure and MAP, and was safe as well as cost‐effective. Conversion to calcium channel antagonists other than felodipine or less than equal dosages of felodipine may require dosage titration. When converting patients from amlodipine, dosages usually should be equal to those of felodipine; if converting to other calcium channel antagonists, the need for adjustments should be anticipated.
Effect of Intravenous Metoprolol or Intravenous Metoprolol plus Glucagon on Dobutamine‐Induced Myocardial Ischemia
Authors: Murthy Dakshina R. , White C. Michael , Katten Deborah , Ahlberg Alan W. , Salloum Ahmad , Heller Gary V. 
Published: June 2004

Study Objective. To determine the effect of metoprolol on dobutamine stress testing with technetium‐99m sestamibi single‐photon emission computed tomography imaging and ST‐segment monitoring, and to assess the impact of intravenous glucagon on metoprolol's effects.Design. Randomized, double‐blind, placebo‐controlled trial.Setting. Community hospital.Patients. Twenty‐two patients with known reversible perfusion defects.Intervention. Patients underwent dobutamine stress tests per standard protocol. Before dobutamine was begun, no therapy was given during the first visit, and patients were randomized on subsequent visits to receive metoprolol or metoprolol plus glucagon 1 mg. Metoprolol was dosed to achieve a resting predobutamine heart rate below 65 beats/minute or a total intravenous dose of 20 mg.Measurements and Main Results. Metoprolol reduced maximum heart rate 31%, summed stress scores 29%, and summed difference scores 43% versus control. Metoprolol plus glucagon also reduced the maximum heart rate 29% versus control. Summed stress and summed difference scores were not significantly reduced, although they were 18% and 30% lower, respectively, than control. No significant differences were found in any parameter between metoprolol and metoprolol‐glucagon.Conclusion. During dobutamine stress testing, metoprolol attenuates or eliminates evidence of myocardial ischemia. Glucagon 1 mg, although somewhat effective, does not correct this effect to the extent that it can be administered clinically.
Gender Differences in Metered‐Dose Inhaler‐Spacer Device Technique
Authors: Chafin Carol C. , Tolley Elizabeth A. , George Christa M. , Demirkan Kutay , Kuhl David A. , Pugazhenthi Muthiah , Self Timothy H. 
Published: June 2004

Study Objective. To determine whether gender affects the correct use of a metered‐dose inhaler (MDI)‐spacer device.Design. Prospective, observational study.Setting. University classrooms.Patients. Eighty‐three students in their third year of a Doctor of Pharmacy program.Intervention. Students were given the device and received 20 minutes of education on its use. They then were asked to perform the technique. Assessment and retraining were done, as necessary, by clinicians who were experienced with the device. Students returned 1 week later to perform the technique again.Measurements and Main Results. The performance of men versus women was analyzed with X2 tests and the Student's t test. Power analysis indicated that 30 students were needed in each group.Conclusion. There were no significant differences between men and women in proper MDI‐spacer technique.
Oxandrolone in Trauma Patients
Authors: Gervasio Jane M. , Dickerson Roland N. , Swearingen Jessica , Yates Mary E. D. , Yuen Ceaminia , Fabian Timothy C. , Croce Martin A. , Brown Rex O. 
Published: June 2004

Study Objective. To determine the effect of oxandrolone administration on nutritional and clinical outcomes after multiple trauma.Design. Prospective, randomized, double‐blind, placebo‐controlled study.Setting. Level 1 trauma center in a university teaching hospital.Patients. Sixty‐two patients requiring enteral nutrition, 60 of whom completed the study.Intervention. Patients were randomized to receive either oxandrolone 10 mg or placebo twice/day for a maximum of 28 days.Measurements and Main Results. Total urinary nitrogen, prealbumin, nitrogen balance, total body water, and body cell mass were measured on day 1 of enteral nutrition and then at day 7, day 10, and study exit. Patients were assessed daily for metabolic and infectious complications. The two groups were similar for demographics and dosage of enteral nutrition. Measurement of total urinary nitrogen at study entry showed both groups to be highly catabolic (oxandrolone 17.2 ± 4.9, placebo 19.1 ± 10.8 g/day, NS). On days 7 and 10, total urinary nitrogen increased in both groups; however, there was no significant difference between groups. Nitrogen balance was negative throughout the study in each group. Body cell mass decreased slightly in both groups over the study period. Prealbumin serum concentrations increased significantly in both groups at day 10 and study exit compared with study entry. The groups did not differ significantly for length of hospital stay (oxandrolone 30.8 ± 17.9, placebo 27.0 ± 25.7 days), length of intensive care unit stay (oxandrolone 17.1 ± 7.8, placebo 15.5 ± 9.7 days), and frequency of pneumonia or sepsis (oxandrolone 48, placebo 43 episodes).Conclusion. Oxandrolone 20 mg/day does not have obvious benefit in nutritional and clinical outcomes during the first month after multiple trauma.