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Biomedical subjects

P Ball

Publications and source records attributed to P Ball.

At least 19 recordsLinked to original sources
PubMed2005

Circadian function in patients with advanced non-small-cell lung cancer.

This study aimed to evaluate whether patients with advanced non-small-cell lung cancer experience disrupted rest-activity daily rhythms, poor sleep quality, weakness, and maintain attributes that are linked to circadian function such as fatigue. This report describes the rest-activity patterns of 33 non-small-cell lung cancer patients who participated in a randomised clinical trial evaluating the benefits of melatonin. Data are reported on circadian function, health-related quality of life (QoL), subjective sleep quality, and anxiety/depression levels prior to randomisation and treatment. Actigraphy data, an objective measure of circadian function, demonstrated that patients' rest-activity circadian function differs significantly from control subjects. Our patients reported poor sleep quality and high levels of fatigue. Ferrans and Powers QoL Index instrument found a high level of dissatisfaction with health-related QoL. Data from the European Organization for Research and Treatment for Cancer reported poor capacity to fulfil the activities of daily living. Patients studied in the hospital during or near chemotherapy had significantly more abnormal circadian function than those studied in the ambulatory setting. Our data indicate that measurement of circadian sleep/activity dynamics should be accomplished in the outpatient/home setting for a minimum of 4-7 circadian cycles to assure that they are most representative of the patients' true condition. We conclude that the daily sleep/activity patterns of patients with advanced lung cancer are disturbed. These are accompanied by marked disruption of QoL and function. These data argue for investigating how much of this poor functioning and QoL are actually caused by this circadian disruption, and, whether behavioural, light-based, and or pharmacologic strategies to correct the circadian/sleep activity patterns can improve function and QoL.

Aged↗
PubMed2004

A new respiratory fluoroquinolone, oral gemifloxacin: a safety profile in context.

Gemifloxacin is a broad-spectrum quinolone antibacterial with enhanced potency against Gram-positive bacteria, including multi-drug resistant Streptococcus pneumoniae, and retained potency against Gram-negative bacilli and bacterial strains resistant to other antibiotics. It has proven particularly effective in respiratory and urinary tract infection. This review presents safety data from 6775 patients included in clinical trials, receiving either the recommended 320 mg once daily oral dose of gemifloxacin, or standard dose of other quinolones, macrolides or beta-lactams (n = 5248). Studies in healthy volunteer and special populations are also reported. Adverse experiences (AEs) were observed in 44.7% of gemifloxacin-treated patients and 47.5% of those who received comparator drugs. Mild gastro-intestinal adverse drug reactions (ADRs) (diarrhoea 5.1%, nausea 3.9%) predominated. Rash, usually maculo-papular and in no case proceeding to more severe eruptions, was observed in 3.6% of those receiving gemifloxacin. A higher incidence of rash (>20%) was observed in young women and was the subject of further study. Adverse drug reactions suspected or probably related to treatment occurred in 17.4% of patients receiving gemifloxacin and in 20% of those receiving comparator antibiotics. Diarrhoea and nausea were experienced by 3.6 and 2.7%, respectively, of gemifloxacin-treated patients (4.6 and 3.2% of comparators), rash by 2.8% (0.6% of comparators) and headache by 1.2% (1.5% of comparators). Gemifloxacin-related vomiting (0.9%), dizziness (0.8%) and taste perversion (0.3%) were uncommon. Treatment discontinuation followed one or more adverse drug reactions in 2.2% of gemifloxacin-treated patients (0.9% due to rash) and 2.1% of comparator-treated patients. A total of 63 deaths (33 receiving gemifloxacin) occurred in the trial population: none were considered related to treatment. A slight prolongation in QT interval (2.56 ms (S.D. +/-24.5)) was observed in gemifloxacin-treated patients: no cardiac arrhythmias were reported. There was a low incidence of liver function tests (LFTs) classified as of potential clinical concern: gemifloxacin (0.4-1.2%), comparators (0.2-1.3%). Serious adverse events (SAEs), occurring during but not necessarily related to therapy, occurred in 3.6% of gemifloxacin-treated patients (4.3% of comparators). SAEs related to treatment agents were rare (0.4% in each group) and included rash (0.1%) and elevated liver enzymes (<0.1%). Gemifloxacin was well tolerated by the elderly, those with renal or hepatic impairment and when co-administered with omeprazole, digoxin, theophylline, warfarin (with which there were no significant interactions) and Maalox. In conclusion, gemifloxacin 320 mg once daily demonstrated a favourable safety and tolerability profile similar to that of comparator antibiotics, including other quinolones.

Administration, Oral↗
PubMed2003

Oral gemifloxacin once daily for 5 days compared with sequential therapy with i.v. ceftriaxone/oral cefuroxime (maximum of 10 days) in the treatment of hospitalized patients with acute exacerbations of chronic bronchitis.

In a randomized, open-label, controlled, multicentre study, the clinical and bacteriological efficacy, safety and tolerability of oral gemifloxacin (320 mg once daily, 5 days) was compared with sequential intravenous (i.v.) ceftriaxone (1 g once daily, maximum 3 days) followed by oral cefuroxime axetil (500 mg twice daily, maximum 7 days) in adult hospitalized patients with acute exacerbations of chronic bronchitis (AECB) (n = 274). The clinical success rates at follow-up (21-28 days post-therapy) in the clinical per-protocol population (the primary endpoint) were 86.8% (105/121) for gemifloxacin vs. 81.3% (91/112) for ceftriaxone/cefuroxime (treatment difference = 5.5,95% CI -3.9,14.9). The corresponding clinical results in the clinical intention-to-treat (ITT) population were 82.6% (114/138) vs. 72.1% (98/136), respectively (treatment difference = 10.5,95% CI 0.7, 20.4).Thus, gemifloxacin had significantly higher clinical success rates than ceftriaxone/cefuroxime. The median time to discharge was 9 days in the gemifloxacin group vs. 11 days in the ceftriaxone/cefuroxime group (P = 0.04, Wilcoxon test). At follow-up, 120/138 (87.0%) gemifloxacin-treated patients had been discharged from hospital, compared with 111/136 (81.6%) ceftriaxone/cefuroxime-treated patients in the clinical ITT population. Both treatments were generally well tolerated and there was no significant difference between the treatment groups in the incidence or type of adverse events reported. A 5-day course of oral gemifloxacin was shown by this study to be at least equivalent to sequential i.v. ceftriaxone/cefuroxime axetil (for up to 10 days) in patients with AECB who require hospital treatment.

Administration, Oral↗
PubMed2002

Calcium diglutamate improves taste characteristics of lower-salt soup.

OBJECTIVE: : To ascertain (1) whether the taste characteristics of a conventionally-salted (150 mM NaCl) soup can be reproduced in soups of substantially lower NaCl level with the help of added glutamate, and (2) whether calcium diglutamate (CDG) is equivalent to monosodium glutamate (MSG) in its effect on the taste of soup. DESIGN: : Cross-sectional, with multiple measurements on each subject. SETTING: : Healthy university students. SUBJECTS: : A total of 107 volunteers, recruited by on-campus advertising. METHODS: : Subjects tasted 32 soups, with all possible combinations of four NaCl concentrations (0-150 mM), four glutamate levels (0-43 mM), and two glutamate types (MSG, CDG). MAIN OUTCOME MEASURES: : Ratings of each soup on six scales (liking, flavour-intensity, familiarity, naturalness of taste, richness of taste, saltiness). RESULTS: : A 50 or 85 mM NaCl soup with added CDG or MSG is rated as high as, or higher than, a 150 mM NaCl soup free of added glutamate on five of the six scales (the exception being saltiness). CDG and MSG have equivalent effects. CONCLUSIONS: : Addition of glutamate allows substantial reductions in Na content of soup, without significant deterioration of taste. CDG and MSG have equivalent effects, but use of CDG permits a greater reduction in Na intake.

Adult↗
PubMed2002

Antibiotic therapy of community respiratory tract infections: strategies for optimal outcomes and minimized resistance emergence.

Widespread, increasing antibiotic resistance amongst the major respiratory pathogens has compromised traditional therapy of the major infective respiratory syndromes, including bacterial pneumonia and acute exacerbations of chronic bronchitis. Guidelines for antibiotic prescribing dating from the 1980s to 1990s, which attempted to address such problems, were commonly too prescriptive and difficult to apply, and took little account of end-user practice or locally prevalent resistance levels. Further confusion was caused by conflicting recommendations emanating from differing specialty groups. The evidence that such guidelines benefited either clinical outcomes or treatment costs has been disputed. They have probably had little effect on resistance emergence. We report the recommendations of an independent, multi-national, inter-disciplinary group, which met to identify principles underlying prescribing and guideline formulation in an age of increasing bacterial resistance. Unnecessary prescribing was recognized as the major factor in influencing resistance and costs. Antibiotic therapy must be limited to syndromes in which bacterial infection is the predominant cause and should attempt maximal reduction in bacterial load, with the ultimate aim of bacterial eradication. It should be appropriate in type and context of local resistance prevalence, and optimal in dosage for the pathogen(s) involved. Prescribing should be based on pharmacodynamic principles that predict efficacy, bacterial eradication and prevention of resistance emergence. Pharmacoeconomic analyses confirm that bacteriologically more effective antibiotics can reduce overall management costs, particularly with respect to consequential morbidity and hospital admission. Application of these principles should positively benefit therapeutic outcomes, resistance avoidance and management costs and will more accurately guide antibiotic choices by both individuals and formulary/guideline committees.

Community-Acquired Infections↗
PubMed2001

Antimicrobial safety and tolerability: differences and dilemmas.

The adverse drug reactions associated with antimicrobials have become a topic of major importance and concern in the last few years. Antimicrobial toxicity may take many forms, varying from mild, transient phenomena to dramatic, life-threatening events such as seizures or cardiac arrhythmias. We review the toxicity of antimicrobials in general and of the fluoroquinolones in particular and attempt to explain the adverse events by use of structure-adverse event relationships where possible. There are currently 5 main mechanisms that can be invoked to explain antimicrobial toxicity: direct effects, hypersensitivity, changes in microbial flora, drug interactions, and microbial lysis. The adverse drug reactions seen with fluoroquinolones are explained on the basis of these 5 mechanisms. The various organ systems affected by the fluoroquinolones are considered; then individual members of the fluoroquinolone class are reviewed. The unexpected and dramatic problems encountered with temafloxacin and trovafloxacin are discussed as well.

Anti-Infective Agents↗
PubMed2001

Efficacy and safety of gemifloxacin 320 mg once-daily for 7 days in the treatment of adult lower respiratory tract infections.

An open-label, non-comparative study assessed the clinical and bacteriological efficacy of gemifloxacin (320 mg, once-daily for 7 days) in lower respiratory tract infections (LRTI). Patients with acute exacerbation of chronic bronchitis (AECB, n=261) or community-acquired pneumonia (CAP, n=216) were enrolled into the study. Clinical success rates at follow-up (days 21-28) in the intent-to-treat (ITT) population were high, 83.1% in AECB patients (95% CI: 77.9, 87.4) and 82.9% in CAP patients (95% CI: 77.0, 87.5). High bacteriological success rates were achieved (bacteriological ITT population), 91.2% (52/57) in AECB patients (95% CI: 80.0, 96.7) and 77.9% (60/77) in CAP patients (95% CI: 66.8, 86.3). Gemifloxacin was well tolerated with a low incidence of adverse events. Gemifloxacin treatment resulted in high clinical and bacteriological success rates and is a well-tolerated therapy for the treatment of LRTIs.

Adult↗
PubMed2001

Future of the quinolones.

New fluoroquinolones and fluoronaphthyridones continue to provide the mainstay of antibiotic development, despite recent events associated with unexpected or uncharacteristically severe adverse drug reactions. These have included hepatotoxicity caused by trovafloxacin (suspended), cardiotoxicity associated with grepafloxacin, and phototoxicity caused by clinafloxacin (both withdrawn). Prolongation of the QT interval appears to be an emergent class effect, the implications of which are not yet fully understood. However, the second-generation agents ciprofloxacin and, latterly, levofloxacin have excellent safety profiles and provide standard optimal choices for therapy of a wide range of gram-negative pathogens. They are also useful for many respiratory infections, though the use of ciprofloxacin in pneumococcal pneumonia has been questioned and continued use of levofloxacin may act as a selection pressure for emergence of quinolone-resistant Streptococcus pneumoniae. Active conservation measures may be required to protect the class from this problem because alternatives, should high-level penicillin-resistance continue to spread, are few. The new 8-methoxy quinolones (moxifloxacin and gatifloxacin) are more highly potent against both penicillin-susceptible and multidrug-resistant S. pneumoniae, while retaining activity against enterobacteria. Clinical Phase III development has shown them to produce very satisfactory clinical and bacteriologic responses in respiratory infections and to be remarkably free of clinically significant adverse effects. Postmarketing surveillance of moxifloxacin in Germany has revealed no additional concerns. These agents are now licensed in many countries, including the United States, and add a further, broad-based respiratory dimension to the future of the class.

4-Quinolones↗
PubMed2001

Efficacy of gemifloxacin in acute exacerbations of chronic bronchitis: a randomised, double-blind comparison with trovafloxacin.

This randomised, double-blind, double-dummy, multinational study compared the efficacy and safety of gemifloxacin with trovafloxacin in the treatment of acute exacerbations of chronic bronchitis. There were 617 patients randomised: 303 to gemifloxacin and 314 to trovafloxacin. Clinical success rates at follow-up (clinical per-protocol population) were 91.5% for gemifloxacin and 87.6% for trovafloxacin. For the intent-to-treat population, the clinical efficacy of gemifloxacin was statistically significantly superior to that of trovafloxacin. In general, the in vitro activity of gemifloxacin against the major respiratory bacterial pathogens was superior to that of other antibiotics tested. Per-patient bacteriological success rates at follow-up (bacteriology per-protocol population) were 86.8% for gemifloxacin and 82.4% for trovafloxacin. Both agents were well tolerated. The clinical and bacteriological efficacy of a once-daily 5-day course of gemifloxacin is at least as good as that of a similar regimen of trovafloxacin in the treatment of acute exacerbations of chronic bronchitis.

Adult↗
PubMed2001

Life's matrix: water in the cell.

Water is a profoundly unusual liquid, and its peculiarities may make it uniquely suited to act as life's matrix. Even if this were not so, however, we should expect the effects of nanometre-scale confinement and inhomogeneities owing to surface effects to alter the liquid's properties in the cell relative to those in the bulk. Whether water's unusually high degree of local structure makes such influences even more marked than for 'normal' liquids remains an open question, with potentially important consequences for biomolecular interactions.

Animals↗