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The clinical effectiveness and safety of roxithromycin (RU 28965, RU), a new macrolide antibiotic, were compared with those of josamycin (JM) using a double-blind method in the treatment of orofacial odontogenic infections. The diseases covered in this study were periodontal infections, pericoronal infections and osteitis of jaws. Drugs were administered for 3 to 7 days at daily doses of 300 mg (RU) and 1,200 mg (JM). A total of 270 cases was evaluated in this study. Results obtained are summarized as follows: 1. The clinical efficacy was evaluated through the judgement of doctors in charge of 247 cases (128 in the RU group and 119 in the JM group) and by a committee on the 3rd day of treatment in 243 cases (126 in the RU group and 117 in the JM group). Clinical efficacy rates according to the committee judgement were 78.6% for the RU group and 82.1% for the JM group. As for the evaluation through the doctors' judgement, they were 79.7% for the RU group and 73.1% for the JM group. There was no significant difference in clinical effectiveness between 2 groups according to these 2 methods of judgement. 2. Some side effects were observed in 4 cases (2.9% out of 136) treated with RU and in 3 cases (2.4% out of 126) treated with JM. No severe symptoms were observed. Abnormal changes in laboratory test values were noted among 7.9% in the RU group and 4.0% in the JM group. There were no significant differences in their safety between the 2 groups. 3. In terms of clinical usefulness, there were no significant differences between the 2 groups as well. From these results, it has been concluded that RU (daily dose 300 mg) is as effective as JM (daily dose 1,200 mg) in the treatment of orofacial odontogenic infections.
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HMR 3647 (telithromycin), a new ketolide, is active on intracellular pathogens. It was previously demonstrated that it inhibits superoxide anion production in a time- and concentration-dependent manner, at concentrations which inhibit 50% of the control response of about 55 microg/ml (5 min) to 30 microg/ml (30 min); these values are similar to those obtained with roxithromycin, a classical erythromycin A derivative. Here we investigated whether these drugs modified the bactericidal activity of human polymorphonuclear neutrophils (PMN) on four strains of Staphylococcus aureus with different profiles of susceptibility to macrolides and ketolides. We found that the main factor involved in killing was the antibacterial potency of the drugs, although combinations of antibiotics with PMN were slightly more active than each component used alone against two of the four strains. In addition, high concentrations of the drugs, which impaired the PMN oxidative burst, did not impair PMN bactericidal activity. Likewise, some cytokines which enhance PMN oxidative metabolism did not modify PMN bactericidal activity in the presence or absence of macrolides or ketolides. These data suggest that oxygen-independent mechanisms contribute to the bactericidal activity of PMN on these strains of S. aureus. Both live and/or heat-killed bacteria impaired the uptake of telithromycin and roxithromycin (but not that of levofloxacin, a quinolone) in a concentration-dependent manner, owing to a modulation of PMN transductional systems involved in the activation of the macrolide carrier.
The efficacy of several antibiotic treatments to eliminate mycoplasma from Vero cells contaminated chronically with Mycoplasma orale II were tested. Minocyclin, Kanamycin, Tylosine and Roxitromycin, at non cytotoxic concentrations, were assayed alone or in different combinations. Mycoplasma contamination was effectively eradicated without recurrence once the following regimen was applied: Incubation of contaminated cells with Tylosine (250 micrograms/ml) for 12 days followed by incubation with Minocycline (5 micrograms/ml) for 10 days. This treatment was not deleterious for cell growth, it was effective after only one application and it was successful to eradicate mycoplasma from other contaminated eukaryotic continuous cell lines.
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The aim of this work was to develop and optimize a robust HPLC method for the separation and quantitation of ambroxol hydrochloride and roxithromycin utilizing Design of Experiment (DoE) approach. The Plackett-Burman design was used to assess the impact of independent variables (concentration of organic phase, mobile phase pH, flow rate and column temperature) on peak resolution, USP tailing and number of plates. A central composite design was utilized to evaluate the main, interaction, and quadratic effects of independent variables on the selected dependent variables. The optimized HPLC method was validated based on ICH Q2R1 guideline and was used to separate and quantify ambroxol hydrochloride and roxithromycin in tablet formulations. The findings showed that DoE approach could be effectively applied to optimize a robust HPLC method for quantification of ambroxol hydrochloride and roxithromycin in tablet formulations. Statistical comparison between results of proposed and reported HPLC method revealed no significant difference; indicating the ability of proposed HPLC method for analysis of ambroxol hydrochloride and roxithromycin in pharmaceutical formulations.
Adverse events and laboratory abnormalities were monitored over 35 days after the commencement of treatment in 45 open studies conducted in Europe, South America, Africa and Asia. These studies were to assess the clinical efficacies of azithromycin and comparator antimicrobial agents in the treatment of paediatric acute bacterial infections. Children (6 months-16 years of age) had been treated with an oral suspension of azithromycin (10 mg/kg given once daily for 3 consecutive days) or with the approved oral dosing regimen of the comparator (amoxycillin, co-amoxiclav, cefixime, cefaclor, clarithromycin, erythromycin, penicillin V, cloxacillin, or roxithromycin). Adverse events were recorded in 232/2655 (8.7%) children treated with azithromycin and in 180/1844 (9.8%) who received comparator treatment. The majority of the treatment-related adverse events were classed as being of only mild or moderate severity and were gastrointestinal: 140 (5.3%) in azithromycin- and 120 (6.5%) in comparator-treated children. Co-amoxiclav was responsible for proportionately more of such events than any other agent. Treatment was discontinued prematurely due to an adverse event in 34 (1.3%) azithromycin- and in 31 (1.7%) comparator-treated children. Incidences of clinically significant laboratory abnormalities were low and occurred with comparable frequency in both treatment groups. The present analysis confirms that azithromycin can be safely used to treat bacterial infections in children of all ages.
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Lansoprazole is a benzimidazole derivative that effectively decreases gastric acid secretion, regardless of the primary stimulus, via inhibition of gastric H+,K(+)-adenosine triphosphatase (ATPase). It provides effective symptom relief and healing of peptic ulcer and reflux oesophagitis after 4 to 8 weeks of therapy and appears to prevent recurrence of lesions when administered as maintenance therapy. When administered at therapeutic dosages, lansoprazole produced higher healing rates than ranitidine or famotidine in patients with duodenal and gastric ulcers. Lansoprazole heals duodenal ulcers more rapidly than ranitidine or famotidine. Relief of ulcer symptoms in lansoprazole recipients is at least equivalent to, and tends to be more rapid than, that in patients receiving histamine H2-receptor antagonists. In comparisons with omeprazole 20 mg/day, lansoprazole 30 mg/day produced duodenal ulcer healing more rapidly and reduced ulcer pain to a greater extent at 2 weeks, but overall healing rates were similar after 4 weeks of therapy. At therapeutic dosages, lansoprazole produces superior healing and symptom relief of reflux oesophagitis in comparison with ranitidine, and it tends to relieve heartburn more effectively than omeprazole, although both agents produce equivalent healing. Healing of peptic ulcers or reflux oesophagitis refractory to histamine H2-receptor antagonists occurs after 8 weeks in the majority of patients treated with lansoprazole, and lansoprazole and omeprazole demonstrate similar efficacy in patients with refractory peptic ulcers. In patients with Zollinger-Ellison syndrome, lansoprazole effectively controls mean basal gastric acid output. Lansoprazole is generally well tolerated in clinical trials. The incidence of adverse effects is similar to that of omeprazole, ranitidine and famotidine in comparative studies. Combination therapy with lansoprazole and antibacterial agents such as amoxicillin, tinidazole, roxithromycin and/or metronidazole appears to eradicate Helicobacter pylori in 22 to 80% of patients with this organism. Limited data also suggest that lansoprazole may have superior activity against H. pylori in comparison with omeprazole, although the clinical relevance of this preliminary finding requires further confirmation. Thus, lansoprazole may be considered as alternative to existing antisecretory agents available for the treatment of acid-related disorders, particularly because it may provide more rapid healing and relief of symptoms.
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A pathogenic vancomycin-resistant Staphylococcus aureus (VRSA) isolate (MIC > or =64 microg ml(-1)) was obtained from a Kolkata hospital in June 2005. Species identification was confirmed by Gram staining, standard biochemical tests and PCR amplification of the nuc gene, which encodes the thermostable nuclease that is highly specific for S. aureus. The VRSA isolate was also resistant to beta-lactams (amoxicillin, ampicillin, cefepime, cefotaxime, cefuroxime, cephalexin and meticillin), chloramphenicol, streptomycin, macrolides (erythromycin and roxithromycin), clindamycin, rifampicin and trimethoprim-sulfamethoxazole. However, the isolate was susceptible to gentamicin (an aminoglycoside) and ciprofloxacin (a fluoroquinolone). The resistance to vancomycin was inducible in vitro, because the MIC of vancomycin increased from 64 microg ml(-1) initially to 1024 microg ml(-1) during culture of this VRSA strain in the presence of vancomycin. The VRSA isolate contained a large plasmid ( approximately 53.4 kb) and four small plasmids of approximately 6, 5.5, 5.1 and 1.5 kb. The large plasmid of approximately 53.4 kb harboured the vancomycin-resistance genes vanHAX, which was confirmed by PCR amplification using the same plasmid as template and, separately, primers specific for the 2.61 kb vanHAX gene cluster, vanH (969 bp), vanA (1032 bp) and vanX (609 bp). The VRSA isolate was also positive for mecA. Vancomycin resistance was successfully transferred from this VRSA donor to a vancomycin-sensitive recipient S. aureus clinical isolate by a broth mating procedure. The MIC of vancomycin for the transconjugant was 32 microg ml(-1), as against 2 microg ml(-1) for the parent strain. Nucleotide sequencing of the PCR product showed partial homology with van genes of an enterococcal transposon Tn1546-like element. This is believed to be the first Indian S. aureus isolate that has been shown to be phenotypically vancomycin-resistant, presumably due to a vanHAX analogue.
We report two cases of lupus miliaris disseminatus faciei (LMDF) in which oral tranilast was effective. In case 1, the patient was a 33-year-old woman who had developed pale red papules on her face, especially around her eyes and lower jaw, approximately 7 months previously. Examination of a skin biopsy specimen revealed epithelioid cell granulomas accompanied by caseous necrosis, and a diagnosis of LMDF was made. The patient was treated successively with azithromycin, roxithromycin and minocycline hydrochloride, but there was no improvement. When we tried oral tranilast therapy, flattening of the papules was observed 2 weeks after the start of treatment, and by 1 month the papules had almost disappeared. In case 2, the patient was a 39-year-old man who had broken out in erythematous papules on both upper and lower eyelids, with some accompanied by scaling, 2 years before the initial examination. Pathological specimen revealed epithelioid cell granulomas accompanied by caseous necrosis, and a diagnosis of LMDF was made. There was no improvement when treated orally with minocycline hydrochloride or doxycycline hydrochloride, and treatment was switched to oral tranilast therapy. After 1 month of treatment, the papules had almost disappeared. We concluded that oral tranilast therapy should be tried as a treatment for intractable LMDF.
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To determine the efficacy and safety of a triple therapy regimen using lansoprazole, roxithromycin, and metronidazole on the basis of multicentre outpatient care in an open pilot study.
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There is limited evidence from one small study to support the use of systemic antibiotics for the curative treatment of chronic rhinosinusitis in adults. Further good quality trials, with large sample sizes, are needed to evaluate the use of antibiotics in chronic rhinosinusitis.