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Lomefloxacin is a new fluoroquinolone antimicrobial agent that has undergone extensive worldwide clinical evaluation. This report summarizes the safety and efficacy of lomefloxacin in the treatment of uncomplicated urinary tract infections, complicated urinary tract infections, acute exacerbations of chronic bronchitis, and for prophylaxis during urinary tract surgery. The clinical data presented are an overview of all clinical studies conducted in the United States to date. The results have been derived from multiple studies in which patients received lomefloxacin or a comparative agent in either blinded or open-label studies. During the course of the clinical program in the United States, lomefloxacin has been compared with oral norfloxacin, ciprofloxacin, and cefaclor, as well as parenteral cefotaxime. In all instances, the once-daily oral administration of lomefloxacin was either equally effective or statistically significantly superior in clinical and/or bacteriologic efficacy to these comparative agents. In addition, the comparators were administered either two or three times per day, except in the surgical prophylaxis studies, in which single doses of each antibiotic were administered preoperatively. These results attest to the value of the convenience and simplicity of the oral dosing regimen for lomefloxacin. During the course of the clinical program, lomefloxacin was well tolerated, with most adverse events of mild to moderate severity. In general, the incidence of adverse events for patients and subjects receiving lomefloxacin was comparable to that observed in patients treated with comparator drugs. The most common adverse events were related to the gastrointestinal tract (nausea and diarrhea), the skin and appendages (photosensitivity), and the central nervous system (dizziness and headache). A sub-analysis of adverse events in the respiratory studies demonstrated that concomitant administration of lomefloxacin and theophylline does not increase the incidence of adverse events when compared to lomefloxacin alone. An additional sub-analysis also showed that the incidence of adverse events in elderly patients was similar to that in younger patients. The results of the U.S. clinical program indicate that lomefloxacin administered orally once daily is effective and well tolerated in a variety of infections of bacterial origin.
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PMID:The U.S. clinical experience with lomefloxacin, a new once-daily fluoroquinolone. 131 63

The association between diseases and symptoms and general hospital care was studied in a geographically defined population of 1040 persons aged 65 years or over (90% of the eligible non-institutionalized elderly). In eight years, 25% of the subjects used over 60 hospital bed-days. In age-controlled analyses high use of hospital care was predicted by chronic urinary infections and in women also by chronic bronchitis, diabetes mellitus and heart failure. Among men, the risk of high use of hospital care was greatest in those reporting chronic urinary infection (risk ratio 1.9), and among women in those reporting chronic bronchitis (2.1) and diabetes (2.0). As far as symptoms were concerned, the highest risks of hospital care were found in men reporting tremor (risk ratio 1.6) and depressive symptoms (1.5); and in women reporting memory disturbances and dizziness (risk ratios 1.9 and 1.7, respectively). High use of care was predicted by six symptoms in men and seven in women. Reported symptoms proved to be better predictors of high use of hospital care than reported diagnoses.
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PMID:Diseases and symptoms as predictors of hospital care in an aged population. A prospective register-based study. 149 34

In this open study the efficacy and tolerability of rufloxacin in a single dose of 400 mg the first day and 200 mg the nine consecutive days was studied in 26 patients with an acute exacerbation of chronic bronchitis. Twenty-two patients were evaluable for efficacy. Four patients stopped treatment prematurely after five days because of clinical cure. At the enrollment visit a pathogen was isolated in the sputum sample in 19 of 22 evaluable patients. The predominant pathogens were Streptococcus pneumoniae and Moraxella catarrhalis. In 17 of these 19 bacteriologically evaluable patients the initial infecting organism was eradicated from specimens obtained within 48 hours after the end of therapy. There was one case of persistent infection caused by S. pneumoniae (MIC 4 mg/l), one patient had a superinfection with Serratia marcescens (MIC 1 mg/l) susceptible to rufloxacin and therapy was stopped after five days due to clinical failure. One week after the end of therapy, 15 patients remained free from infection whilst one patient experienced reinfection with Klebsiella pneumoniae (MIC 0.5 mg/l). Clinical cure or improvement was observed in 21 of 22 patients. Mild adverse events were reported by two of 26 enrolled patients. In one patient, complaining of headache and dizziness, the adverse events were considered possibly study drug related. No abnormal laboratory findings were reported. Nadir plasma levels of rufloxacin were measured and no accumulation in plasma was observed during treatment. A ten day course of an oral single dose of rufloxacin proved efficacious and was well tolerated in patients with an acute exacerbation of chronic bronchitis.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Rufloxacin once daily in acute exacerbations of chronic bronchitis. 191 50

The chemistry, pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage of ipratropium bromide are reviewed. Ipratropium bromide, a synthetic quaternary isopropyl derivative of atropine, interrupts vagally mediated bronchoconstriction by inhibiting the cyclic guanosine 3',5'-monophosphate system at parasympathetic nerve endings. Ipratropium bromide is poorly absorbed after oral and inhaled administration but diffuses rapidly into tissue after i.v. or i.m. administration. The elimination half-life is 3.2-3.8 hours. After inhalation, the drug is eliminated in the urine and feces. The bronchodilatory effect of ipratropium bromide in stable chronic obstructive pulmonary disease appears to be comparable, and may be superior, to that of the beta-sympathomimetic agents. In acute exacerbations, ipratropium bromide is useful but may not be the preferred agent because of a delayed onset of action (within 15 minutes; mean dose-dependent duration of effect, three to five hours). Combination therapy with other bronchodilating drugs has proved useful. Ipratropium bromide may be a useful adjunctive agent in the treatment of asthma. Since the onset of action is delayed, ipratropium bromide should not be used as single-drug therapy in an acute asthmatic exacerbation. Reported adverse effects, including cough, nausea, palpitations, dry mouth, nervousness, gastrointestinal distress, and dizziness, have been mild. The usual dosage is two inhalations (36 micrograms) four times daily, and the maximum number of doses per day should not exceed 12. Although ipratropium bromide is currently indicated only for maintenance therapy in stable chronic bronchitis and emphysema, it may be useful as adjunctive therapy in asthma and in the management of acute exacerbations of chronic bronchitis and asthma. Additional experience in a variety of chronic obstructive pulmonary disorders will help to clarify the role of ipratropium bromide in the treatment of obstructive pulmonary disease.
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PMID:Use of ipratropium bromide in obstructive lung disease. 297 9

Results are presented from 186 hospitalized patients treated for acute purulent exacerbations of chronic bronchitis with orally administered ciprofloxacin (80 patients), enoxacin (26 patients), ofloxacin (30 patients) or pefloxacin (50 patients). In general, good clinical results were observed in 50-70% of the patients treated, most failures being due to relapses or reinfections with Streptococcus pneumoniae or Pseudomonas aeruginosa. Studies on blood and sputum concentration suggested that gastro-intestinal absorption was not always satisfactory. Unwanted drug effects were noted with all agents studied, generally presenting as stomach pain, nausea, hallucinations, or dizziness. Most adverse drug reactions were seen with enoxacin, often but not always during concomitant treatment with theophylline.
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PMID:The quinolones in chronic bronchitis. 396 Jun 93

Fifteen patients admitted to hospital with acute purulent exacerbations of chronic bronchitis were treated with enoxacin by mouth (three 200 mg capsules twice daily) for ten days. Sputum was cultured before, during and after the treatment course. Serum and sputum concentrations were measured microbiologically at intervals on the first treatment day. Blood was assayed before, and 1, 1 1/2, 2, 2 1/2, 3, 5 and 7 h after the first dose and purulent unhomogenized sputum was tested in samples collected 0-2, 2-4, 4-6 and 6-8 h after this dose. The highest concentrations in serum were usually noted 2 or 2 1/2 h after the medication and ranged from approximately 3 to 6 mg/l (average 4.08 mg/l). The highest sputum concentrations were generally found in the 2-4 or 4-6 h portions, and ranged from 2.2 to 6 mg/l (average 3.68 mg/l). The areas under the serum and sputum concentration-time curves were both calculated to be 17.03 mg/l.h (0-7 h values) whereas the projected 0-12 h values were 25.2 and 26.9 mg/l.h, respectively. The drug concentrations declined slowly in serum and sputum with half-lives of approximately 5 and 4 h. Penetration from blood to sputum as judged on peak to peak ratios was approximately 90%, whereas the AUC value ratios showed penetration ranging from 100 to 107.5%. Unfortunately, 9 of the 15 patients had to abandon the treatment (mostly on the third day) due to unwanted drug effects (principally nausea, but some patients had hallucinations, dizziness or epileptiform attacks) possibly related to interference with theophylline metabolism.
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PMID:Serum and sputum concentrations of enoxacin after single oral dosing in a clinical and bacteriological study. 659 25

Twenty-four patients aged from 3 to 30 years and suffering from advanced cystic fibrosis received several courses of intensive antibiotic therapy combined with prolonged respiratory physiotherapy with postural drainage. Antibiotics included carbenicillin 500 mg/kg/day and aminoglycosides in high dosage (6 mg/kg/day). These treatments were administered to prevent aggravation of chronic bronchitis and to suppress acute exacerbations. Tolerance was satisfactory, and all patients felt better, at least during the first courses. Improvement was also observed in the main respiratory function parameters. In a total of 95 courses only two side-effects (severe dizziness and giant urticaria) were recorded. Intensive courses of combined antibiotic therapy associated with physiotherapy constitute a new way of treating severe, progressive cystic fibrosis. The patients are made comfortable, and their survival time is increased by several years.
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PMID:[Successive courses of intensive therapy in cystic fibrosis (author's transl)]. 720 19

In a multicenter study the efficacy and safety of oral fleroxacin at 400 mg once a day and amoxicillin at 500 mg three times daily for 7 days were compared for the treatment of patients with acute bacterial exacerbations of chronic bronchitis due to drug-susceptible bacteria. A total of 194 patients were enrolled, 102 in the fleroxacin group and 92 in the amoxicillin group. Of those enrolled, 22 in the fleroxacin group and 30 (29 for clinical efficacy) in the amoxicillin group were included in the efficacy analysis. All were included in the safety analysis. Clinical success was noted in 21 (95%) of 22 fleroxacin-treated patients and 22 (76%) of 29 amoxicillin-treated patients. Bacteriologic cure was obtained in 21 (95%) of 22 of the fleroxacin group and 18 (60%) of 30 of the amoxicillin group. One Haemophilus parainfluenzae strain persisted with fleroxacin. Persisting organisms with amoxicillin included Haemophilus influenzae (four), Haemophilus parainfluenzae (three), Escherichia coli (two), Streptococcus pneumoniae (one), Neisseria species (one), and Proteus mirabilis (one). Adverse events were reported by 41% of 102 patients receiving fleroxacin and 15% of 92 patients receiving amoxicillin. Insomnia, dizziness, and nausea occurred more frequently with fleroxacin. Fleroxacin may be indicated for the treatment of acute bacterial infection in chronic bronchitis known to be due to Haemophilus species and Moraxella catarrhalis. The 92% incidence of resistance among the S. pneumoniae isolates recovered from all enrolled patients suggests that fleroxacin may not be useful for such infections.
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PMID:Efficacy of fleroxacin versus amoxicillin in acute exacerbations of chronic bronchitis. 845 69

Respiratory symptoms and ventilatory capacity were studied in a group of 74 sewage workers employed in cleaning the city sewage system of Zagreb, Croatia. Workers were studied by their work stations: closed channels (N = 26), drainage (N = 31), and other sewage workers (N = 17). The prevalence of chronic respiratory symptoms was higher in closed channel and drainage workers than in controls, particularly for chronic cough (range: 41.9-46.2% vs. 14.3%), chronic phlegm (range: 38.7-46.2% vs. 14.3%), chronic bronchitis (range: 32.3-42.3% vs. 8.6%), and chest tightness (range: 29.0-53.8% vs. 0%). In the first two groups of sewage workers there was a high prevalence of acute symptoms which developed during the work shift, being particularly pronounced for eye irritation (range: 16.1-26.9%), dyspnea (16.1-23.1%), dizziness (range: 6.5-23.1%), throat burning (9.7-19.2%), and skin irritation (range: 22.6-26.9%). Baseline ventilatory capacity was significantly decreased compared to predicted values in sewage workers; in particular, values for FEF50 and FEF25 were reduced, suggesting obstructive changes in smaller airways. Our data indicate that sewage workers experience frequent acute and chronic respiratory symptoms and exhibit objective evidence of respiratory dysfunction.
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PMID:Respiratory function in sewage workers. 850 53

This study was designed to examine the efficacy and tolerability of ambroxol (Ambrosol) on the symptomatology of chronic bronchitis among in- and out-patients. Seventy patients were included in the trial and divided into two random groups. The patients were treated in a double-blind way with either Ambrosol or a placebo for 2 months. The physician and the patient assessed the following points: the feeling general well-being, the symptoms of a cold and of fever, the need for treatment with antibiotics, the amount, viscosity and colour of sputurn, the difficulty in expectoration, the severity of coughing and any changes in breathlessness while at rest. In order to carry out these subjective assessments we used a scoring system. We observed that, breathlessness while at rest and the rate of exacerbation was significantly lower in the Ambrosol group after 2 weeks of therapy. Sputum viscosity, difficulty in expectoration and severity of coughing were reduced in this group after 4 or 8 weeks. Throughout the 2-month period of therapy, the tolerability of ambroxol was good. A total of 4 patients reported side-effects of various degrees of severity. One patient stopped the therapy due to these side-effects (dizziness). There was no significant difference in the number of side-effects between the two groups (Ambrosol vs Placebo).
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PMID:[Clinical evaluation of efficacy and tolerance of oral treatment with ambroxol in patients with chronic bronchitis]. 919 Feb 45


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