Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The concentrations of azithromycin in sinus fluid and mucosal tissue were determined in a total of 23 patients with acute or chronic sinusitis. Five patients with acute sinusitis and four with chronic sinusitis were administered a five-day course of oral azithromycin (500 mg on day 1, 250 mg on days 2-5, all as single doses), and the remaining 14 patients, all with chronic sinusitis, received single oral doses of azithromycin (500 mg). With the five-day regimen, the mean levels of azithromycin in sinus fluid were markedly higher in patients with acute sinusitis (1.34 micrograms/ml) than in patients with chronic sinusitis (0.25 micrograms/ml) 24 h after the first dose. The levels of azithromycin in the sinus fluid increased from the first to the last dose in both patient groups; the mean levels of azithromycin 24 h after the last dose were 2.33 micrograms/ml in acute sinusitis patients and 0.38 micrograms/ml in chronic sinusitis patients. In chronic sufferers, the mean levels of azithromycin in the sinus fluid following a single oral dose were 0.25, 0.41, 0.57 and 0.22 micrograms/ml at 24, 48, 72 and 96 h, respectively, after administration. In these patients the mean sinus drug concentrations were much greater in the mucosal tissue (1.23 micrograms/g) than in the sinus fluid (0.41 micrograms/ml) 48 h after administration of the single dose. There were no treatment-related changes in laboratory function tests, and side effects were described as mild to moderate (five patients complained of nausea, abdominal pain or headache).(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Azithromycin concentrations in sinus fluid and mucosa after oral administration. 166 32

The chemistry, microbiology, pharmacokinetics, therapeutic use, adverse effects, and dosage of amoxicillin-potassium clavulanate, a beta-lactamase-resistant antibiotic combination, are reviewed. Clavulanic acid is a "suicide" inhibitor of bacterial beta-lactamase enzymes and has been effective in preventing destruction of penicillins by these enzymes. Clavulanic acid alone has weak antibacterial activity against most organisms. After oral administration, clavulanic acid is rapidly absorbed; amoxicillin appears to increase its absorption. Absorption of amoxicillin-clavulanic acid is not affected by food. Amoxicillin-clavulanic acid is effective in treating both acute uncomplicated and complicated urinary-tract infections and exacerbations of chronic bronchitis caused by amoxicillin-resistant organisms in adults. It appears to be comparable in efficacy to cefaclor for treating uncomplicated urinary-tract infections in adults and children, acute bronchitis and bronchopneumonia, and acute sinusitis, otitis media, and skin and soft-tissue infections in children. Other infections for which the combination has been effective include cellulitis and intra-abdominal and pelvic sepsis caused by mixed aerobic/anaerobic organisms. Amoxicillin-clavulanic acid has also successfully cured urethritis in men caused by penicillinase-producing Neisseria gonorrhoeae and is superior to amoxicillin alone for beta-lactamase-positive Haemophilus ducreyi infections (chancroid). Diarrhea or loose stools is the most common side effect seen with amoxicillin-clavulanic acid; nausea, vomiting, and skin rash may also occur. Nausea, vomiting, and diarrhea may be lessened by taking the combination with food.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Amoxicillin-potassium clavulanate, a beta-lactamase-resistant antibiotic combination. 639 83

In a primary care setting, the efficacy and safety of ciprofloxacin (CIP) 500 mg b.i.d. were compared with those of cefuroxime axetil (CA) 250 mg b.i.d., each given for 10 days, in a nationwide, open, prospective, randomized trial of 1414 adults with acute sinusitis. Patients were enrolled if they had clinically documented acute sinusitis (ie, rhinosinusitis) (<4 weeks' duration), based on the 1997 American Academy of Otorhinolaryngology--Head and Neck Surgery criteria of either two major or one major and two minor symptoms. The primary efficacy variable was clinical response (resolution or failure) at the posttherapy assessment on study days 14 through 26. The most common presenting major signs and symptoms of acute rhinosinusitis were facial congestion, nasal drainage/purulence, facial pain/pressure, and nasal obstruction/blockage. The minor symptom, headache, was more common and severe than was nasal obstruction/blockage. A total of 1219 patients were clinically evaluable. Clinical resolution was observed in 559 of 613 (91.2%) CIP-treated patients and 546 of 606 (90. 1%) CA-treated patients. The two regimens were statistically equivalent (95% confidence interval, -2.16% to 4.71%). There were 80 drug-related adverse events reported in the CIP-treated patients and 81 drug-related adverse events reported in the CA-treated patients. The main adverse events were nausea (n = 18) and diarrhea (n = 7) in patients treated with CIP and diarrhea (n = 14), nausea (n = 12), headache (n = 7), and vaginitis (n = 7) in those treated with CA. CIP 500 mg b.i.d. was found to be statistically equivalent to CA 250 mg b.i.d. in the treatment of acute rhinosinusitis.
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PMID:Multicenter comparative trial of ciprofloxacin versus cefuroxime axetil in the treatment of acute rhinosinusitis in a primary care setting. Rhinosinusitis Investigation Group. 982 44

In this comparative trial, outpatients with acute sinusitis were randomly assigned to receive levofloxacin (500 mg orally once daily) or amoxicillin-clavulanate (500/125 mg orally 3 times daily) for 10 to 14 days. The success rates (cured and improved) 2 to 5 days after the end of treatment were 88.4% for the 267 clinically evaluable patients who received levofloxacin and 87.3% for the 268 clinically evaluable patients who received amoxicillin-clavulanate. Drug-related adverse events occurred in a smaller percentage of patients in the levofloxacin treatment group (7.4%) than in the amoxicillin-clavulanate treatment group (21.2%). The most common of these were nausea, diarrhea, vaginitis, and abdominal pain for levofloxacin-treated patients and diarrhea, vaginitis, nausea, genital moniliasis, abdominal pain, vomiting, and flatulence for amoxicillin-clavulanate-treated patients. The results of this study show that once-daily administration of levofloxacin is as effective and better tolerated than amoxicillin-clavulanate administered 3 times daily for treating acute sinusitis in adult outpatients.
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PMID:Comparison of the effectiveness of levofloxacin and amoxicillin-clavulanate for the treatment of acute sinusitis in adults. 1043 81

This multicenter, randomized, double-blind trial compared the efficacy and safety of ciprofloxacin (CIP; 500 mg twice daily for 10 days, placebo for 4 days) to those of clarithromycin (CLARI; 500 mg twice daily for 14 days) in 560 adults with clinically documented and radiologically confirmed acute sinusitis. Of 457 efficacy-valid adults (236 CIP, 221 CLARI), clinical resolution plus improvement at the end of therapy was 84% for CIP-treated patients compared to 91% of CLARI recipients (CI95 = -0.131, -0.013). At the 1-month follow-up, more than twice as many CLARI-treated patients, 18 (10%), experienced a relapse, compared to 7 (4%) CIP-treated patients. The combined clinical response analyses (end of therapy and 1 -month follow-up) demonstrated that CIP and CLARI were statistically equivalent (CI95 = -0.106, 0.044). Diarrhea, nausea, headache, and dizziness were the most frequently reported drug-related adverse events in both treatment groups; diarrhea and taste perversion were reported more frequently among CLARI recipients. In summary, the combined end of therapy and follow-up clinical evaluation analyses revealed that CIP and CLARI were equally effective in the management of acute sinusitis, although twice as many relapses were reported among CLARI recipients.
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PMID:Double-blind comparative trial of ciprofloxacin versus clarithromycin in the treatment of acute bacterial sinusitis. Sinusitis Infection Study Group. 1021 83

The aim of this prospective, multicenter, randomized, double-masked clinical trial was to compare the efficacy and safety of moxifloxacin with those of cefuroxime axetil for the treatment of community-acquired acute sinusitis. Five hundred forty-two adult patients with symptoms and radiographic evidence of acute maxillary sinusitis received a 10-day oral regimen of either moxifloxacin (400 mg once daily) or cefuroxime axetil (250 mg twice daily). Acute signs and symptoms at presentation had lasted >7 days but <4 weeks. Clinical response at the end of therapy (7 to 14 days after treatment) was the primary efficacy variable. Four hundred fifty-seven of the patients (223 moxifloxacin, 234 cefuroxime axetil) were included in the clinical efficacy analysis. Moxifloxacin was found to be similar in effectiveness to cefuroxime axetil at the end-of-therapy visit (90% vs. 89%, respectively; 95% confidence interval, -5.1% to 6.2%). Clinical relapse at the follow-up visit was reported for only 8 patients (3 moxifloxacin, 5 cefuroxime axetil). No clinically significant differences were observed with respect to the number of patients experiencing a successful clinical response based on demographic or infection characteristics. Five of the 542 enrolled patients were lost to follow-up. Of the 537 patients in the intent-to-treat population, drug-related adverse events were reported in 37% of moxifloxacin-treated patients and in 26% of cefuroxime axetil-treated patients (P = 0.006). Adverse-event profiles were comparable in the 2 treatment groups, with the exception of nausea, which was reported by 11% of moxifloxacin-treated patients compared with 4% of cef uroxime axetil-treated patients (P = 0.003). In this study, moxifloxacin was as effective as cefuroxime axetil in the treatment of community-acquired acute sinusitis.
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PMID:Comparison of moxifloxacin and cefuroxime axetil in the treatment of acute maxillary sinusitis. Sinusitis Infection Study Group. 1056 63

The activity, pharmacokinetics, pharmacodynamics, efficacy, safety, drug interactions, and dosage and administration of moxifloxacin are reviewed. Moxifloxacin is an oral 8-methoxyquinolone antimicrobial approved in December 1999 for use in the treatment of acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, and community-acquired pneumonia. This fluoroquinolone is active against common community-acquired respiratory pathogens (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis), atypical pathogens, and many anaerobes. Moxifloxacin has an absolute bioavailability of 90% after oral administration and a mean elimination half-life of 12 hours. The drug is not a substrate or inhibitor of the hepatic cytochrome P-450 isoenzyme system thereby avoiding many potential drug interactions. Moxifloxacin has limited phototoxic potential. In clinical trials, moxifloxacin had clinical success rates of 88-97% and bacteriologic eradication rates of 90-97%. Reported adverse effects were primarily gastrointestinal (nausea, diarrhea) and were mild to moderate in severity. Moxifloxacin prolongs the QT interval by a mean + S.D. of 6 +/- 26 milliseconds above baseline and should be used with caution in patients with proarrhythmic conditions and avoided in patients receiving antiarrhythmia agents, such as quinidine, procainamide, amiodarone, and sotalol. The standard oral dosage is 400 mg once a day. Dosage adjustment is unnecessary in patients with renal dysfunction or mild to moderate hepatic dysfunction. Moxifloxacin is a safe and effective antimicrobial that will be useful for treating acute sinusitis, acute bacterial exacerbations of chronic bronchitis, and community-acquired pneumonia.
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PMID:Moxifloxacin: clinical efficacy and safety. 1125 73

Respiratory tract infections (RTIs), the most common indication for outpatient antimicrobial therapy, impose a heavy medical and societal burden and present a difficult therapeutic challenge in the face of increasing pathogen resistance worldwide. Gatifloxacin is a new broad-spectrum fluoroquinolone with excellent activity against prevalent respiratory bacteria, including penicillin-resistant Streptococcus pneumoniae and atypical pathogens. A multicenter, open-label, noncomparative surveillance study carried out in Mexico evaluated the safety and efficacy of oral gatifloxacin 400 mg once daily in 17,923 adult outpatients with community-acquired pneumonia (CAP) (n = 3322), acute exacerbations of chronic bronchitis (AECB) (n = 5885), and acute bacterial sinusitis (n = 8716). Voluntary, unpaid physician participation contributed to an unbiased study design. Physician-assessed global rate of cure or improvement was 96.3%; efficacy was 95.8% in CAP, 96.1% in AECB, and 96.4% in sinusitis. The incidences of relapse (1.5%) and therapeutic failure (0.7%) were low. The most commonly reported adverse events, nausea (2.76%), headache (2.20%), and dizziness (1.33%), were generally mild and self-limited. Oral gatifloxacin 400 mg once daily is effective and safe for patients with CAP, AECB, and acute sinusitis.
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PMID:Multicenter evaluation of the efficacy and safety of gatifloxacin in Mexican adult outpatients with respiratory tract infections. 1131 29

In this prospective, multicentre, randomised, non-blinded phase III clinical trial, 475 adult patients with acute sinusitis received a 10-day oral regimen of either moxifloxacin (400 mg once daily) or amoxicillin clavulanate (875 mg twice daily). The primary measure of efficacy was clinical resolution. Secondary outcome measures included clinical relapse at follow-up and evaluation of patient reported outcomes. Of 471 adults comprising the intent-to-treat population (234 moxifloxacin, 237 amoxicillin/clavulanate), moxifloxacin treatment was statistically equivalent to amoxicillin/clavulanate at the test-of-cure visit (85% vs 82%; 95% CI -6%, 13%). Analysis of the efficacy evaluable population, confirmed statistical equivalence (86% vs 84%; 95% CI -7%, 13%). Of note, by day 3 of treatment, significantly more moxifloxacin-treated patients (n = 47; 24%), than amoxicillin/clavulanate-treated patients (n = 28; 14%), reported feeling better (p < 0.02). Frequency of drug-related adverse events were similar between groups: nausea (11% moxifloxacin, 5% amoxicillin/clavulanate) and diarrhoea (3% moxifloxacin, 10% amoxicillin clavulanate). In conclusion, once-daily moxifloxacin is as effective and safe as twice-daily amoxicillin/clavulanate in the treatment of acute sinusitis. Moxifloxacin is associated with more rapid symptomatic relief.
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PMID:Moxifloxacin versus amoxicillin clavulanate in the treatment of acute maxillary sinusitis: a primary care experience. 1145 78

Accurate and complete safety data are indispensable for the proper evaluation of the benefit-to-harm ratio of medical interventions. We evaluated whether a systematic review and meta-analysis of standardized safety data is feasible by requesting information on side effects directly from the investigators of all 38 antibiotic trials on acute sinusitis published in the last decade. We requested standardized information on gastrointestinal toxicity outcomes, including hospitalizations, discontinuations, and days with nausea/vomiting, diarrhea, or both. Responses were received only for 16 trials (42%), and safety data were contributed only for 9 trials (24%). In some trials, safety data had not been collected, had been lost, or had been transferred to other companies. The odds of data retrieval was higher in general medical journals (P =.024) and independently improved with an increase in sample size (P =.064). The available information suggested side effects may equal or exceed in severity the marginal treatment benefits. Interpretation of safety data was further complicated by heterogeneity or lack of information of use of concomitant drugs, mode of collection of safety information, use of blinding, and other study design parameters. Availability of standardized information for performing meta-analysis of safety data may be limited. Standardized reporting, prospective collection, and long-term availability of safety information should be improved.
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PMID:Standardized retrieval of side effects data for meta-analysis of safety outcomes. A feasibility study in acute sinusitis. 1206 4


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