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 aim of this study was to determine whether it is feasible to reduce the overall treatment time from 7 to 4 weeks in patients with non-small cell lung cancer (NSCLC) receiving radiotherapy with cisplatin. This follows an EORTC phase III randomised trial (08844) in which cisplatin given before each radiation dose resulted in improved local control and survival, but which had a relatively long treatment period of 7 weeks [Schaake-Koning et al., N Engl J Med 1992, 326, 524-530]. 38 patients with confirmed NSCLC (2 stage I, 1 stage II, 18 stage IIIA, 17 stage IIIB) received a total tumour dose of 55 Gy/20 fractions/26 days, from January 1992 to March 1994. Daily fractions of 2 Gy (5 times/week) were given to the macroscopic tumour and the non-involved adjacent lymph node areas. During the same session, a dose of 0.75 Gy was given to the macroscopic tumour (simultaneous boost). Cisplatin 6 mg/m2 was administered 1-2 h before each fraction, in an escalating total dose, during week 1 in 3 patients, during weeks 1 and 2 in 6 patients, during weeks 1, 2 and 3 in 5 patients and during the whole treatment in 24 patients. 38 patients were evaluable for acute side-effects (WHO). Maximal therapy-related toxicity (WHO) was grade 3 (nausea/vomiting in 2 patients, oesophagitis in 3 patients, dyspnoea in 3 patients, cough in 1 patient). Late side-effects were evaluated in 34 patients. There was grade 2 oesophagitis in 2 patients; grade 3 toxicity in 8 patients (tiredness in 3 patients, dyspnoea in 3 patients, oesophagitis in 2 patients); grade 4 toxicity in 4 patients (dyspnoea in 3 patients, cough in 1 patient). Pulmonary fibrosis grade 3 occurred in 4 and grade 4 in 6 patients. One patient developed a severe (grade 3) radiation pneumonitis. The low incidence of acute and late side-effects with this treatment, combining daily administration of 6 mg cisplatin with radical radiotherapy using a simultaneous boost technique, indicates that escalation of the radiation dose seems feasible.
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PMID:Feasibility of escalating daily doses of cisplatin in combination with accelerated radiotherapy in non-small cell lung cancer. 886 92

Fifteen patients with stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC) received subcutaneous (s.c.) recombinant, glycosylated, human interferon-beta 1a (Rebif; rHuIFN-beta 1a) on each day of conventionally fractionated radiation therapy (RT) given in 2.0 Gy fractions to 60 Gy in 6 weeks. The rHuIFN-beta 1a was generated in CHO cells by recombinant DNA technology and is identical to natural IFN-beta produced by fibroblasts in primary sequence and glycosylation. Cohorts of three patients each were treated with escalating doses of rHuIFN-beta 1a: 1.5, 3, 6, 12, and 24 MIU/m2 per treatment day. Acute toxicity was assessed according to modified WHO criteria; late toxicity was graded using RTOG late toxicity criteria. The maximum tolerated dose (MTD) of rHuIFN-beta 1a was defined as the dose level immediately below that in which dose-limiting toxicity occurred in > or = two of six patients. Immunomodulatory effects and antigenicity of rHuIFN-beta 1a were assessed by 2-5A synthetase, beta 2-microglobulin, and neopterin levels and by measurement of anti-rHuIFN-beta antibodies, respectively. Fourteen of fifteen patients experienced grades 1-3 acute (early) toxicity (< or = 90 days), which was primarily gastrointestinal: dysphagia/esophagitis (14/15), nausea/vomiting (12/15), anorexia (7/15), and liver transaminasemia (6/15). One of three patients treated with 24 MIU/m2 per treatment day (total rHuIFN-beta 1a dose 672 MIU) died of complications secondary to pneumonia, sepsis, adult respiratory distress syndrome (ARDS), and radiation pneumonitis. Twelve patients were evaluable for late toxicity (> 90 days). Maximum toxicity was grade 0 in five patients, grade 1 in four patients, and grade 5 in one patient (radiation pneumonitis). Clinical responses from the combination were 1/15 CR, 6/15 PR, 6/15 stable disease, and 1/15 progressive disease. The MTD of rHuIFN-beta 1a has been estimated at 12 MIU/m2 per treatment day when given daily during conventional RT to 60 Gy in 6 weeks. Biologic response by rHuIFN-beta 1a alone was reflected by significant and dose-related increases in 2-5A synthetase, beta 2-microglobulin, and neopterin. Radiation therapy alone had no effect on these immune response parameters and did not diminish their augmentation by rHuIFN-beta 1a. There was no association of biologic modulation with clinical response or survival.
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PMID:Recombinant human interferon-beta (rHuIFN-beta) and radiation therapy for inoperable non-small cell lung cancer. 893 64

A retrospective study was undertaken in order to compare the efficacy and safety of azithromycin and doxycycline in the treatment of pneumonias caused by Chlamydia spp. Patients with radiologically confirmed pneumonia and positive complement fixation test for chlamydial infection who were hospitalized in the University Hospital of Infectious Diseases, Zagreb during the years 1989-1992 were reviewed. Among them, 83 were treated with azithromycin, given in a total dose of 1.5 g over 5 days (500 mg once daily at day 1 followed by 250 mg at days 2-5, 60 patients) or 3 days (500 mg once daily, 23 patients). Twenty-two patients were treated with doxycycline (100 mg b.i.d. for 10 days). Treatment groups were comparable with respect to age, sex, and severity of signs and symptoms of illness. All the patients were cured. There were no differences in duration of fever after treatment initiation between patients treated with azithromycin (whether pretreated with beta-lactam antibiotics or not) and doxycycline (p > 0.05). In addition, 3- and 5-day azithromycin courses were equally effective (p > 0.05). Both drugs were well tolerated, and only two patients treated with azithromycin reported nausea. It may be concluded that in the treatment of pneumonias caused by Chlamydia spp. azithromycin is as effective and well tolerated as doxycycline.
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PMID:Azithromycin in the treatment of pneumonias caused by Chlamydia spp: a retrospective study. 917 8

Forty five patients at the age of 15 to 84 years with signs of infection requiring active antibacterial therapy were treated with cefotetan. In the majority of the patients pulmonary affections such as double pneumonia, pleurisy or bronchopneumonia were stated. In some patients bronchopulmonary pathological processes were associated with pancreatitis, cholecystitis or other diseases of the gastrointestinal tract. A separate group included patients with diseases of the small pelvis organs (pelvioperitonitis, metroendometritis or prostatitis) and diseases of the urogenital system (pyelonephritis) arachnoiditis. In all the patients except for one with bronchopneumonia at the background of chronic myeloleukemia and agranulocytosis the results of the treatment were good and satisfactory. Cefotetan proved to be efficient in the treatment of purulent affections of the skin and subcutaneous fat (abscesses and phlegmona), trophic disturbances at the background of pathological processes in the vessels and pyoseptic condition. Cefotetan practically had no side effects. Only in 2 patients insignificant nausea during the first 2 days of the treatment was recorded. In some patients the antibiotic intramuscular injections were painful with formation of cold infiltrates. After intravenous administration of cefotetan no adverse reactions were observed.
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PMID:[Effectiveness of cefotetan in clinical practice]. 933 42

The efficacy and safety of grepafloxacin in treating patients with community-acquired pneumonia (CAP) was assessed in an open-label, noncomparative study. Patients (N = 273) received grepafloxacin 600 mg QD for 10 days. A total of 237 patients (87%) completed the study. In assessable patients, the clinical success rate at follow-up (4 to 6 weeks after the last dose) was 89% (211/238 patients). In microbiologically assessable patients, the eradication rate at follow-up was 95% (86/91 isolates). Grepafloxacin was highly effective in the treatment of bacterial CAP caused by Streptococcus pneumoniae (irrespective of penicillin susceptibility), Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, and Staphylococcus aureus and in the therapy of atypical pneumonia caused by Mycoplasma pneumoniae and Legionella pneumophila. Grepafloxacin was well tolerated, with the most frequently reported drug-related adverse events being taste perversion and nausea. Grepafloxacin 600 mg QD for 10 days was highly effective and well tolerated in the treatment of patients with CAP.
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PMID:Efficacy and safety of grepafloxacin 600 mg daily for 10 days in patients with community-acquired pneumonia. 938 85

In a review of the US Bayer ciprofloxacin (CIP) database, an analysis was undertaken to summarize the effectiveness and tolerability of CIP 750 mg BID in the treatment of patients with acute exacerbations of chronic bronchitis (AECB) and pneumonia. In five controlled studies, comparator (COMP) agents included ampicillin, intravenous cefuroxime/cefaclor, and other unspecified agents. Primary efficacy end points were clinical success (resolution plus improvement) and bacteriologic eradication at the end of therapy. The incidence of adverse events for CIP 750 mg BID was compared with that for COMP and with that in the CIP 500-mg-BID AECB and pneumonia clinical trials database. In five uncontrolled studies, 443 patients received CIP 750 mg BID; in 5 controlled trials comprising 344 patients, 169 received CIP 750 mg BID and 175 received COMP. Clinical success for CIP was 93% (368/396) and 99% (160/162), respectively, in the uncontrolled and controlled studies versus 98% (156/160) for COMP agents. Corresponding bacteriologic eradication rates for CIP 750-mg-BID-treated patients were 77% (273/356) and 95% (122/128), respectively, and 77% (96/125) for COMP agents. Overall bacteriologic eradication by organism for CIP 750 mg BID included Streptococcus pneumoniae 96% (51/53), Haemophilus influenzae 98% (92/94), Haemophilus parainfluenzae 100% (56/56), Moraxella catarrhalis 100% (14/14; 13 of 14 organisms were isolated in patients with AECB), and Pseudomonas aeruginosa 66% (135/204). Drug-related adverse events were reported in 113 (26%) CIP 750-mg-BID-treated patients in uncontrolled trials and in 62 (37%) CIP 750-mg-BID- and 61 (35%) COMP-treated patients in controlled trials. In the combined data from the CIP 750-mg-BID uncontrolled and controlled trials, adverse events occurred with similar frequency compared with COMP except for nausea (CIP 10%, COMP 7%) and diarrhea (CIP 3%, COMP 13%). In conclusion, CIP 750 mg BID provided excellent clinical success rates in the treatment of patients with AECB and pneumonia. CIP 750 mg BID was well tolerated compared with the COMP agents administered.
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PMID:Efficacy and tolerability of twice-daily ciprofloxacin 750 mg in the treatment of patients with acute exacerbations of chronic bronchitis and pneumonia. 952 11

With the introduction of piperacillin/tazobactam to the North American market, hospitals have been faced with the task of making a decision regarding its formulary role. In view of its broad spectrum of activity, piperacillin/tazobactam could be considered as a formulary alternative to imipenem. To evaluate the formulary feasibility of substituting piperacillin/tazobactam for imipenem, a comparative assessment of these agents in the empiric treatment of serious bacterial infections was undertaken at this tertiary care hospital. This trial was conducted as a randomized, double-blind, single-center study. Consenting adult patients (>16 years of age) who were prescribed imipenem were randomized to receive either 4 g of i.v. piperacillin/tazobactam or imipenem 500 mg of i.v. Q6H with or without concurrent antibiotics. Doses were adjusted according to renal function. There were no restrictions regarding the use of nonstudy antibiotics before and during the study period. Patients with beta-lactam allergies or meningitis or who had received greater than 72 h of previous imipenem therapy were excluded. Patients were evaluated at the end of treatment, at discharge, and at 30 days postdischarge. Endpoints included both clinical and microbiologic efficacy as well as drug toxicity. Over the 433-day study period, 360 imipenem treatment courses were initiated. Of these, 150 treatment courses (75 piperacillin/tazobactam courses and 75 imipenem courses) met study criteria and were subsequently randomized. The distribution of prescriber services for enrolled patients was similar to that for all patients receiving imipenem during the study period (p = 0.15). Also, there were no statistically significant differences in demographic parameters between enrolled and excluded patients. For those patients enrolled in the study, demographic characteristics, treatment course indication(s), and accompanying antibiotics were similar across treatment arms. The mean duration of study drug therapy was 7.7 days (SD, 6.2) for imipenem and 7.5 days (SD, 6.7)for piperacillin/tazobactam (p = 0.84). In the majority of cases, treatment discontinuation occurred as a result of a favorable treatment course outcome, stepdown to a narrower spectrum parenteral agent, or stepdown to an oral agent and did not differ between study drugs (p = 0.73). Clinical and microbiologic treatment course outcomes were also similar across treatment arms. Clinical outcome was deemed successful or improved for 68% of imipenem and 70% of the piperacillin/tazobactam treatment courses (p = 0.54). Fifty-three percent of treatment courses were microbiologically confirmed. Of the 58 courses that were assessed for microbiological outcome, 93% demonstrated successful eradication of the causative pathogens. There was no difference between study drugs (96% imipenem; 90% piperacillin/tazobactam; p = 0.61). The proportion of treatment courses with at least one adverse event was similar between the study drugs (p = 1.0). Nausea and/or vomiting were/was observed more commonly in the imipenem arm (p = 0.03). Discontinuation of therapy due to drug toxicity occurred in 16% of imipenem and 5% of piperacillin/tazobactam treatment courses (p = 0.06). There was no statistically significant difference between the mean treatment course cost for imipenem ($762; range, $55-$3192) versus piperacillin/tazobactam ($696; range, $79-$2967; p = 0.59). In summary, piperacillin/tazobactam seems to represent a suitable alternative to imipenem for several clinical indications including intraabdominal infections, pneumonia, febrile neutropenia, and skin/soft tissue infections in which the causative pathogens are susceptible. However, in view of the prevalence of multiresistant Gram-negative aerobic pathogens at this institution, we do not believe that imipenem can be removed from the drug formulary. In addition, at the currently studied dosing regimen, there seems to be no evidence of a direct cost advantage associated with
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PMID:Piperacillin/tazobactam versus imipenem: a double-blind, randomized formulary feasibility study at a major teaching hospital. 963 10

The introduction of quadruple induction therapy after liver transplantation with the murine anti-interleukin-2 receptor (IL-2R) antibody (BT563) has decreased the incidence of serious side effects, such as tachycardia, hypertension, rash, fever and nausea since it does not lyse its target cell. To investigate the immunosuppressive efficacy of BT563, a placebo-controlled trial was performed and BT563 was added to the standard triple induction after liver transplantation. Forty consecutive recipients of primary orthotopic liver transplants (OLT) (median age 47 yr [range 18-65]) were randomized. All patients received triple immunosuppression with cyclosporine A (CyA), prednisolone (PRED) and azathioprine (AZA). In addition, 19 patients received BT563 (Biotest, Dreieich, Germany) at a dose of 10 mg/d from day 0 until day 12. The remaining 21 patients received a placebo infusion at the same days after transplantation. Minimal follow-up for all patients was 3 yr. Patient survival at 3 yr was 74% in the BT563 group and 90% in placebo group. Similar results were observed for graft survival. Two acute rejection episodes were detected in the BT563 group and 9 acute rejections (5 steroid-resistant) were observed in the placebo group (p < 0.034). The incidences of sepsis, pneumonia, cholangitis, urinary tract infections as well as cytomegalo-virus (CMV) infections were similar in both groups. Side effects of the BT563 therapy and/or post-transplant lymphoproliferative disease (PTLD) were not detected. Quadruple induction therapy with BT563 significantly reduces the incidence of rejection episodes after liver transplantation, while infectious complications and/or PTLD is not increased. Therefore, the anti-IL2 receptor antibody BT563 constitutes a safe and efficient addition to the immunosuppressive induction regimen following OLT.
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PMID:A randomized, placebo-controlled trial with anti-interleukin-2 receptor antibody for immunosuppressive induction therapy after liver transplantation. 968 24

Tazobactam/Piperacillin (TAZ/PIPC) is a newly developed intravenous antibiotics, in which TAZ, a new potent inhibitor of beta-lactamases, is combined with PIPC, a well-established beta-lactam antibiotics, at the ratio of 1:4. In this study, we clinically evaluated efficacy of the drug in 14 pediatric patients with various infections, and pharmacokinetic study was applied to 3 patients. Range of age was from 1-month to 15 1/4-year. Patients consisted of 9 cases of pneumonia, 3 urinary tract infection, 1 acute otitis media, and 1 left sacroiliitis with sepsis. Standard dose of TAZ/PIPC was 50 mg/kg/dose and administered 2-4 times per day with intravenous injection or drip infusion. Two cases of pneumonia were excluded because of non-bacterial infection. Nine causative pathogens including 3 Gram-positive cocci and 6 Gram-negative bacilli were detected in 7 patients, of which 5 Gram-negative strains produced bete-lactamase. All of cases showed 100% of efficacy rate and bacteriological eradication rate. It was noted that beta-lactamase-producing E. coli and B. catarrhalis were eradicated efficiently by TAZ/PIPC, which should be resistant to PIPC alone according to MIC data. Non-serious diarrhea and discomfort of back with nausea were observed in one each patients as side effects. Both of side effects were transient, and improved with anti-diarrheic agent or cessation of the drug, respectively. As abnormal laboratory test results, moderate increases of the eosinophils and platelets counts as well as moderate elevation of the transaminases were observed in 2 separate patients. Pharmacokinetics study showed that Cmax, T1/2, and AUC were similar to the data reported in adult patients. Urinary recovery rate in the first 6 hours also resemble the data from adult patients. Based on above results, TAZ/PIPC is a useful agents pediatric infections by beta-lactamase producing strains also.
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PMID:[Clinical studies of tazobactam/piperacillin (TAZ/PIPC) in pediatric patients]. 969 64

Azathioprine is a drug commonly used for the treatment of inflammatory bowel disease, organ transplantation and various autoimmune diseases. Hepatotoxicity is a rare, but important complication of this drug. The cases reported to date can be grouped into three syndromes: hypersensitivity; idiosyncratic cholestatic reaction; and presumed endothelial cell injury with resultant raised portal pressures, venoocclusive disease or peliosis hepatis. The components of azathioprine, 6-mercaptopurine and the imidazole group, may play different roles in the pathogenesis of hepatotoxicity. The strong association with male sex, and perhaps with human leukocyte antigen type, suggests a genetic predisposition of unknown type. Many of the symptoms of hepatotoxicity, such as nausea, abdominal pain and diarrhea, can be nonspecific and can be confused with a flare-up of inflammatory bowel disease. As well, the subtype resulting in portal hypertension can occur without biochemical abnormalities. A 63-year-old man with Crohn's disease who is presented developed the rare idiosyncratic form of azathioprine hepatotoxicity, but also had a severe disabling steroid myopathy, peripheral neuropathy, resultant deep venous thrombosis and pulmonary embolism related to immobility, and a nosocomial pneumonia. His jaundice and liver enzyme levels improved markedly on withdrawal of the drug, returning to almost normal in five weeks. Treating inflammatory bowel disease effectively while trying to limit iatrogenic disease is a continuous struggle. Understanding the risks of treatment is the first important step. There must be a low threshold for obtaining liver function tests, especially in men, and alertness to the need to discontinue the drug or perform a liver biopsy should patients on azathioprine develop liver biochemical abnormalities, unexplained hepatomegaly or signs of portal hypertension.
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PMID:Cholestatic hepatocellular injury with azathioprine: a case report and review of the mechanisms of hepatotoxicity. 981 67


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