ENISOPROST IN RENAL-TRANSPLANTATION

被引:21
|
作者
ADAMS, MB
机构
[1] Froedtert Memorial Lutheran Hospital, Milwaukee, WI
[2] Christ of University, Cincinnati, OH
[3] University of Georgetown, Washington, DC
[4] University of Buffalo General, Buffalo, NY
[5] University/Oregon H.S.C, Portland, OR
[6] UCLA/Harbor, Los Angeles, CA
[7] University of Mount Sinai, New York, NY
[8] Old John Sealy Hosp, Galveston, TX
[9] University of Washington, Seattle, WA
[10] University of Cedars Sinai, Los Angeles, CA
[11] University of Maisonneuve/Rosemont, Montreal
[12] University of Saskatoon, Saskatoon
[13] University of Tennessee, Memphis, TN
[14] University of Montefiore, New York, NY
[15] University of Vermont, Burlington, VT
[16] University of Columbia, New York, NY
[17] Methodist Hosp. Med. Ctr, Dallas, TX
[18] Lackland AFB, San Antonio, TX
[19] Ottawa Civic, Ottawa
[20] Vancouver General, Vancouver
[21] University of St. Paul, Vancouver
[22] Wash. Hospital Center, Washington
[23] New England Deaconess, Boston, MA
[24] Montreal General, Montreal
[25] University of Emory, Atlanta, GA
[26] University of Royal Victoria, Montreal
[27] University of Foothills, Calgary
[28] Methodist Med. Ctr, Jacksonville, FL
[29] Wm. Beaumont Hospital, Royal Oak, MI
[30] UCLA, Los Angeles, CA
[31] University of Miami, Miami, FL
[32] University of St. Joseph’s, Hamilton
[33] University of New Mexico, Albuquerque, NM
[34] Cleveland Clinic Found, Cleveland, OH
[35] UCSF, San Francisco, CA
[36] Mayo Clinic, Rochester, MN
[37] University/V.A, Rochester, MN
关键词
D O I
10.1097/00007890-199202010-00015
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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-mu-g p.o. q.i.d. (EP-50-mu-g), and enisoprost 100-mu-g p.o. q.i.d. (EP-100-mu-g). 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.
引用
收藏
页码:338 / 345
页数:8
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