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The efficacies and safeties of a three-dose regimen of azithromycin (500 mg once daily for 3 days) and a 15-dose regimen of amoxicillin (500 mg three times daily for 5 days) were compared in a double-blind manner in patients with an acute exacerbation of chronic bronchitis. A total of 92% of patients suffered a type 1 exacerbation. Treatment success, defined as cure or major improvement, was achieved in all patients in the azithromycin group by day 5, compared with 23 (92%) of 25 patients in the amoxicillin group. On day 12, these data were 24 of 25 (96%) in the azithromycin group and 20 of 25 (80%) in the amoxicillin group (results were not significantly different). Several pathogens were isolated (MIC ranges [micrograms per milliliter] in parentheses): Haemophilus influenzae or Haemophilus parainfluenzae was isolated 23 times (azithromycin, less than or equal to 0.06 to 32; amoxicillin, 0.12 to 2); Streptococcus pneumoniae was isolated from 11 patients (azithromcyin, less than or equal to 0.06 greater than 256; amoxicillin, less than or equal to 0.06 to 0.25); Moraxella (Branhamella) catarrhalis was isolated from eight patients (azithromycin, less than or equal to 0.06; amoxicillin, less than or equal to 0.06 to 16); and other members of the family Enterobacteriaceae were isolated from eight patients. One patient treated with azithromycin had Legionella pneumophila pneumonia, and another in that group had a significant rise in titer of antibody against influenza A virus. One patient treated with amoxicillin also had a significant rise in titer of antibody against influenza A virus. Microbiological response rates were comparable. One patient who received azithromycin developed abnormal liver function. Two patients treated with amoxicillin developed abnormal liver functions, one developed exanthema, and one treatment was stopped because of nausea. It is concluded that a three-dose (3-day) regimen of azithromycin is as effective clinically and microbiologically as a 15-dose (5-day) regimen of amoxicillin in the treatment of acute exacerbations of chronic bronchitis.
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PMID:Double-blind randomized study comparing the efficacies and safeties of a short (3-day) course of azithromycin and a 5-day course of amoxicillin in patients with acute exacerbations of chronic bronchitis. 132 45

The prophylactic and therapeutic effects of the oral administration of amphotericin B (AMPH) to patients with deep mycosis associated with hematologic diseases were evaluated in an investigation including determination of serum concentrations of the antibiotic. Prophylactic effects were examined in 111 subjects, and the efficacy rates averaged 83.8% at daily doses from 1,200 to 4,800 mg. The efficacy was significantly higher at a dose of 2,400 mg/day than at a dose of 1,200 mg/day (P less than 0.05). The efficacy rate tended to be higher when the length of administration period was 1 month or more. The percentage of the number of days of fever by neutrophil count was significantly less at a daily dose of 2,400 mg than at 1,200 mg in patients with neutrophil count of 1,000 cells/mm3 or less (P less than 0.001). The safety was evaluated in 131 subjects, and adverse effects were found in only 2 cases of nausea for an incidence rate of 1.5%. Therapeutic effects were studied in 12 cases, and efficacy rates averaged 58.3% at daily doses from 2,400 to 7,200 mg. Adverse effects consisted of 1 case of diarrhea among 15 subjects who were evaluated for the safety for an incidence rate of 6.7%. The serum concentrations of the antibiotic were examined in 60 of the prophylactic and therapeutic subjects. Average concentrations of AMPH at 4 hours after the first daily dose of 1,200, 2,400 and 4,800 mg were 0.040, 0.053 and 0.078 micrograms/ml, respectively. Concentrations gradually increased thereafter and reached averages of 0.089, 0.090 and 0.132 micrograms/ml, respectively, for the 3 dose levels on the 7th day. These results indicated that there were no serious adverse effects and serum concentrations were above the Candida MIC values at daily prophylactic and therapeutic doses of 1,200 to 7,200 mg of AMPH. Based on these findings, this drug can be expected to show prophylactic and therapeutic effects with safety in cases of deep mycosis.
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PMID:Prophylactic and therapeutic effects of oral administration of amphotericin B in mycosis associated with hematologic diseases. Study Group of Mycosis in Hematologic Disease. 219 13

In a double-blind randomized study, 155 male patients with uncomplicated urethral gonorrhea were given 200 mg (one capsule with 200 mg and one capsule with placebo; n = 77) or 400 mg (two capsules with 200 mg; n = 78) of enoxacin orally. The cure rates in the 200- and 400-mg treatment groups were 90 and 92%, respectively. The enoxacin MIC for the isolated Neisseria gonorrhoeae strains ranged from 0.015 to 0.12 microgram/ml. Postgonococcal urethritis was diagnosed in 29 (42%) patients in the 200-mg treatment group and 19 (26%) patients in the 400-mg treatment group. Side effects (nausea, headache, and vomiting) occurred in 2 (3%) of the 77 patients in the 200-mg treatment group and in 3 (4%) of the 78 patients in the 400-mg treatment group.
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PMID:Comparative double-blind study of 200- and 400-mg enoxacin given orally in the treatment of acute uncomplicated urethral gonorrhea in males. 311 54

The clinical efficacy and the safety of ciprofloxacin was studied in 92 patients (aged 26 to 83 years; mean 57.5 years) affected by urinary tract infections (UTI) and respiratory tract infections (RTI) suffering also with various liver diseases. Ciprofloxacin was given orally at different dose regimens: 500 mg b.i.d. (22 cases), 250 mg b.i.d. (20 cases), 500 mg s.i.d. (20 cases) for the treatment of UTIs; 500 mg b.i.d. (ten cases) and 250 mg b.i.d. (20 cases) for the treatment of RTIs. The doses were not correlated to the severity of the infections. Patients were treated for five to 15 days. All the bacteria isolated from sputum or urine before treatment were sensitive to ciprofloxacin (MIC range less than or equal to 0.015 mg/l to 8 mg/l). The clinical and bacteriological responses were favourable in a high percentage of patients both for RTIs and UTIs, irrespective of the dose. Side effects were infrequent (7%) and mild (nausea, gastralgia, oral candidosis), never requiring the interruption of the treatment. No change in the blood chemistry tests was observed at any dose.
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PMID:Efficacy and safety of ciprofloxacin in the treatment of UTIs and RTIs in patients affected by liver diseases. 328 17

Thirty cases of bone and joint infections were treated by a chemotherapy with imipenem/cilastatin sodium (MK-0787/MK-0791). An overall curative rate was 87%. It was 96% in cases of acute inflammatory state and 50% in cases of chronic state. Thirteen cases received surgical intervention with chemotherapy and showed complete healing, but curative rate of 16 cases without surgery was 76%. Twenty strains of microorganisms were isolated and identified from these patients. The MIC of MK-0787 against S. aureus was as small as less than or equal to 0.012 to 0.024 micrograms/ml to a 10(6)/ml suspension. Thus antibacterial action of MK-0787 was very strong. The MIC against E. coli was 0.20 micrograms/ml. Incidence of adverse reactions was small as only in two cases occurred slight nausea. Laboratory examinations of blood, liver and kidney function found no influence of the drug.
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PMID:[Effect of imipenem/cilastatin sodium in thirty cases of bone and joint infection]. 346 87

Ofloxacin, a new fluoroquinolone, was given to fifty patients (29 females and 21 males) aged 25 to 86 years with urinary tract infection or prostatitis. Urinary tract infections usually chronic and associated with urologic anomalies, included 17 cases of cystitis and 19 cases of pyelonephritis. 14 patients had prostatitis. Pathogens recovered from the urine were 26 E. coli, 2 Citrobacter, 4 Proteus mirabilis, 2 Klebsiella, 2 Enterobacter, 3 Serratia, 3 Staphylococcus aureus and 11 Pseudomonas. Minimal inhibitory concentrations of ofloxacin ranged from 0.03 to 0.12 microgram/ml (mean MIC: 0.6 microgram/ml) for 27 nalidixic acid-sensitive strains, and from 0.25 to 4 micrograms/ml (mean MIC: 1 microgram/ml) for 26 nalidixic acid-resistant strains. Ofloxacin was given as single drug therapy in all patients, in a daily dosage of 200 mg b.i.d. in 46 patients and 400 mg b.i.d. in 4 patients, for 7 to 97 days (average 40 days). Follow-up after discontinuation of treatment was 3 to 12 months. Therapeutic results were as follows: 17 cures for the 17 cystitis patients, 17 cures and 2 failures by relapse for the 19 cases of pyelonephritis, and 11 cures, 1 failure by persistence of bacteriuria and failure by relapse for the 14 cases of prostatitis. Digestive disorders, i.e. nausea, abdominal pain, constipation, occurred in 6 patients and required withdrawal of the drug in 1; candidiasis of the tongue was recorded in one patient and digestive complaints with neuropsychic disorders in another. Two patients had short-lived, moderate leukopenia with granulopenia and one had transient worsening of preexisting renal failure. Hepatic tolerance was good.
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PMID:[Ofloxacin (RU 43280): clinical evaluation in urinary and prostatic infections]. 353 29

Imipenem-cilastatin was given in doses of 1 g intravenously every 6 h to 31 patients. Twenty-five patients, with 27 infections, were clinically evaluable and received 20 to 210 g of imipenem for a duration of 5 to 56 days (average 16.3 days). Infections included seven cases of osteomyelitis, seven of bacteremia, five of cellulitis, two of pneumonia, three of pelvic cellulitis, two of intraabdominal abscess, and one each of empyema, mediastinitis, and endometritis. Fifty-five percent of the infections were caused by gram-negative bacilli, 33% were due to gram-positive organisms, and 10% were caused by anaerobes. Twenty-two patients (81%) were cured, three improved, one relapsed, and one became superinfected with a resistant organism. In 5 of 11 cases with Pseudomonas aeruginosa, the imipenem MIC for organisms isolated by the end of treatment was higher than it was initially, raising concern that imipenem should not be used alone to treat Pseudomonas aeruginosa infections. Twenty-one patients had no adverse reaction; of the remaining 10 patients, 4 had nausea, 1 had urticaria, and 6 had mild abnormalities in hepatic function; three episodes of diarrhea included two with Clostridium difficile toxin in stool and one with pseudomembranous colitis, as determined by sigmoidoscopy. Levels of creatinine, hemoglobin, leukocytes, platelets, prothrombin, and urine components were unchanged. Imipenem-cilastatin is a clinically effective antibiotic with freedom from nephrotoxicity and hematological abnormalities in the large doses used in this study.
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PMID:Safety and efficacy of high-dose treatment with imipenem-cilastatin in seriously ill patients. 386 Jan 87

Amoxicillin in single oral doses of 2.0 g, 2.0 g plus 1.0 g probenecid, or 3.0 g was compared with ampicillin 3.5 g plus 1.0 g probenecid in the treatment of 203 males with uncomplicated acute gonococcal urethritis. Cure rates above 95% were produced by all treatments except the 2.0-g amoxicillin dose, which cured 89% of patients. Of 198 pretreatment gonococcus isolates tested by an agar dilution technique for susceptibility to penicillin G, ampicillin and amoxicillin, over 50% showed relative resistance (MIC > 0.06 mug/ml) to the antibiotics. However, amoxicillin was somewhat more active against isolates showing considerable resistance (MIC >/= 1.0 mug/ml) to penicillin G or ampicillin. Adverse effects of amoxicillin were few: two patients reported transient nausea and six noted short-lived diarrhea. No hypersensitivity reactions were observed.
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PMID:Comparison of amoxicillin and ampicillin in single-dose oral treatment of males with gonococcal urethritis. 421 59

Laboratory and clinical comparative investigations with cefotiam (CTM) and cefazolin (CEZ) were performed to confirm efficacy and safety in surgical, biliary tract infections. The following results were obtained. 1) The MICs of CTM against organisms, 20 strains, which were isolated from bile of patients with cholecystitis, were studied, especially those of CTM against E. coli and Klebsiella were 0.2 - greater than or equal to 100 micrograms/ml and 0.1--12.5 micrograms/ml, respectively, considerably lower than those of CEZ. And moreover against CEZ-resistant Proteus morganii and Serratia marcescens, CTM showed potent activities, that is, MIC values, 12.5--50 micrograms/ml and 0.78 microgram/ml, respectively. 2) In cholecystectomized patients, 2 grams of CTM was injected intravenously, followed by determination of bile concentration in gallbladder, common bile duct and concentration of gallbladder and liver tissue about 2 hours after administration. The mean bile concentrations of CTM in gallbladder and common bile duct were 1,213.2 micrograms/ml and 1,287.8 micrograms/ml, respectively. The peak concentration of CTM was 2,919.0 micrograms/ml. The mean concentrations of CTM in gallbladder and liver tissue were 28.5 micrograms/g and 45.7 micrograms/g, respectively. On the other hand, the mean bile concentrations of CEZ in gallbladder and common bile duct were 138.7 micrograms/ml and 128.8 micrograms/ml, respectively. 3) Bile concentrations of CTM was compared with those of CEZ by crossover method. The concentration of CTM was 37.7 micrograms/ml even at 5 or 6 hours after 2 grams intravenously administration. CTM showed extremely higher concentration than CEZ in bile. 4) The clinical effect was studied in 6 cases of surgical, biliary tract infections. The results were excellent in 2 cases, good in 3 cases and poor in 1 case, and the clinical efficacy was 83%. 5) CTM was administered to 6 patients who showed negative to intracutaneous reaction test. Nausea, itching, and eruption were observed in each 1 case after intravenously administration of CTM 2 g, however these adverse reactions disappeared within several hours. Throughout the course of treatment, any unusual laboratory findings related to CTM were not observed.
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PMID:[Laboratory and clinical investigations of cefotiam in surgical biliary tract infections]. 629 Jun 99

Clinical studies with long acting amoxicillin (L-AMPC) have been carried out and the following results were obtained. 1. Forty-two patients with acute bacterial infections in the oral region were administrated orally L-AMPC at a daily dose of 1 gram. The clinical results obtained were classified as excellent in 3 cases, good in 28 cases, and the overall efficacy was 75.6%. 2. The antibacterial activity of AMPC was determined for 66 strains isolated from patients with oral infections. Of the strains tested, Gram positive cocci showed high sensitivity with MIC's less than 1.56 mcg/ml, while the sensitivity of PC resistance strains of S. aureus, K. pneumoniae and P. vulgaris was lower. 3. There was 1 case of transaminase elevation in the laboratory finding. 4. Five patients reported the following side effects, eruption 3, diarrhea 2, nausea 1, anorexia 1 and malaise 1. From the results of the present study, it is considered that L-AMPC is a useful antibiotic in the treatment of acute bacterial infections in oral region.
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PMID:[Clinical studies of long acting amoxicillin in oral surgery]. 655 93


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