Linked Life Data

6227235

Source:http://linkedlifedata.com/resource/pubmed/id/6227235

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4B
pubmed:dateCreated
1983-12-17
pubmed:abstractText
The overall safety pattern of fenbufen has been evaluated in a total of 2,667 patients: 1,667 of them in domestic clinical studies and 1,000 in foreign pivotal studies. Comparisons of several hundred patients--each receiving aspirin, indomethacin, and placebo--were made. Detailed analysis of all reported adverse effects demonstrated that fenbufen is a relatively safe nonsteroidal anti-inflammatory drug. The incidence and severity of adverse gastrointestinal experiences in patients treated with fenbufen were less than those in patients treated with either aspirin or indomethacin. Life-table analysis showed that during the first three months of therapy, the overall incidence and severity of gastrointestinal reactions due to fenbufen therapy were similar to those observed with placebo therapy. Cutaneous disorders were reported in more fenbufen- than placebo-treated patients during the first month of therapy, thereafter, the incidence was the same. Clinical laboratory results were evaluated in the 1,667 patients who received fenbufen in domestic studies. Elevations of alkaline phosphatase and serum glutamic oxaloacetic transaminase levels, occurred occasionally with eosinophilia, particularly during the first four weeks of therapy with fenbufen. In the majority of cases, however, these abnormal values returned to normal or near-normal values with continuance of fenbufen therapy. No cases of drug-related jaundice have been reported either in clinical trials or from countries where fenbufen is marketed. No clinically significant changes were observed in other laboratory parameters including total bilirubin, blood urea nitrogen, white blood cell count, platelets, hematocrit, hemoglobin, and stool occult blood. In summary, fenbufen was well tolerated and provides a good therapeutic ratio, particularly in respect to gastrointestinal intolerance.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
0002-9343
pubmed:author
pubmed:issnType
Print
pubmed:day
31
pubmed:volume
75
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
84-90
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
1983
pubmed:articleTitle
Side effect and safety data for fenbufen.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study