Linked Life Data

1738927

Source:http://linkedlifedata.com/resource/pubmed/id/1738927

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
1992-3-13
pubmed:abstractText
Prostaglandins of the E-series (PGE) mediate a wide variety of physiologic processes and have been shown to have regulatory roles in cell immunity. Previous animal and human trials have shown lower incidence of acute rejection when prostaglandins are administered in conjunction with standard immunosuppressives. This study evaluated the effects of the PGE analogue, enisoprost (EP), in a multicenter (39 centers) prospective, randomized, double-blind trial in 374 patients undergoing renal transplantation. Groups were placebo, enisoprost 50 micrograms p.o. q.i.d. (EP-50 micrograms), and enisoprost 100 micrograms p.o. q.i.d. (EP-100 micrograms). Patients received cyclosporine, azathioprine, corticosteroids, and Minnesota antilymphocyte globulin or OKT3 according to each center's protocol. Prophylactic antibody therapy (MALG or OKT3) was not randomized. Two hundred fifty-five patients completed the 8-week study period. Of the 119 patients who were withdrawn, 73 did so because of an adverse event. Rejection episodes occurred in 98 of 374 patients (26%). There was no statistically significant difference in the incidence of rejection between placebo- and EP-treated patients (P = 0.782). There was no significant difference in episodes of cyclosporine nephrotoxicity between placebo- and EP-treatment groups (P = 0.883). There was also no difference between incidence of acute tubular necrosis, duration of initial hospitalization, or need for rehospitalization between placebo- and EP-treated groups. Administration of EP was associated with frequent adverse events including elevation of body temperature, dyspepsia, and diarrhea. Antibody-treated patients had a higher percentage of black recipients, higher mean body weight, greater cold ischemic times, fewer living-related donors, and higher panel reactivity. Patients not receiving antibody prophylaxis were better matched immunologically than those receiving either MALG or OKT3. Despite these immunologic differences, there was no significant difference in the incidence of rejection in patients who did or did not receive antibody prophylaxis. Cyclosporine toxicity was more common in MALG-treated patients (P = 0.02). Renal function was worse in antibody-treated patients. There was no detectable effect of enisoprost on the incidence of acute rejection, renal function, or hospitalization in a multicenter prospective, randomized, double-blind trial in 374 patients undergoing renal transplantation.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Feb
pubmed:issn
0041-1337
pubmed:author
pubmed:issnType
Print
pubmed:volume
53
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
338-45
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed:year
1992
pubmed:articleTitle
Enisoprost in renal transplantation. The Enisoprost Renal Transplant Study Group.
pubmed:affiliation
Froedtert Memorial Lutheran Hospital, Department of Transplant Surgery, Milwaukee, WI 53226.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial