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The Clinical Trials Of Induction Therapy With 2-Dose Basiliximab Versus 2-Dose Daclizumab In Cadaveric Renal Transplantation

Posted on:2004-03-15Degree:MasterType:Thesis
Country:ChinaCandidate:A M MingFull Text:PDF
GTID:2144360092999194Subject:Organ transplantation
Abstract/Summary:PDF Full Text Request
Objective To compare the efficacy, safety and recipient/graft survival of induction therapy using 2-dose basiliximab with that of 2-dose daclizumab for preventing renal acute rejection (AR) episodes.Methods 105 first renal transplant recipients were divided into daclizumab group (n=35), basiliximab group (n=35) and contral group(n=35). All patients received the triple therapy of cyclosporine (CsA), mycofenolate mofetil (MMF) and prednisone (Pred) as the basis regimen. There were no statistical differences among three groups for age, sex, cold ischemia time/heat ischemia time of donor kidney, complement dependent cyctoxicity (CDC) and level of panel reactive antibody (PRA). Dosage of CsA and Pred, Concentration of CsA during 3 months, counts of total lymphocyte, CD4+, CD8+ and CD25+ cells in the peripheral lymphocyte, level of sIL-2 within 8 weeks, renal and liver function, incidence of acute rejection episodes, side effection during 6 months and recipients/grafts survival after 6-12 months postoperation were compared among three groups.Results1. There were 1, 9 and 17 cases of AR in basiliximab group, daclizumab group and central group during 6 months after transplantation respectively. Immunoprophylaxis using 2 doses monoclonal antibody of anti-CD25 has achieved significant reductions in AR episodes (p <0.05). The AR incidence of basiliximab group is lower than that of daclizumab group.2. There were no first-dose reaction or other subsequent side effects associated with basiliximab or daclizumab. The morbidity of infection wassimilar (p >0.05), and no malignancy was reported in three groups.3. There were not significant differences of the dosage of CsA or Pred and concentration of CsA.4. The percentages of CD4+, CD8+ cells or total lymphocyte cell were very closed after operation in three groups. But the percentage of CD25+ was appearently lower in daclizumab group and basiliximab group versus central group within 7, 8 weeks respectively (p <0.05), and during 6-8 weeks was also lower in basiliximab group compared with daclizumab group(P<0.05).5. sIL-2R levels of daclizumab group and basiliximab group in the peripheral blood, respectively, were lower than central group within 3 weeks and 8 weeks(p<0.05). There was a low express of sIL-2R level in basiliximab group versus daclizumab group during 4-6 weeks (p <0.05).6. Recipient/grafts survival rates were 100%/97.1%, 97.1%/94.3% and 91.4%/85.7% in 3 groups during 6-12 months after renal transplantation respectively. There was no meaningful difference between induction therapy groups and central group (p>0.05).7. Up to 6 months, there were 2, 3 and 6 cases of delayed graft function (DGF) in basiliximab, daclizumab and central group respectively, and all of 11 patients were recovered (p >0.05).Conclusion1. The prophylaxis efficacy of 2-dose basiliximab is better than that of 2-dose daclizumab in preventing AR after renal transplantation for Chinese.2. Therapy using 2-dose basiliximab or 2-dose daclizumab is not associated significant influences to renal function.3. The adverse effects of induction therapy are not increased. Immunoprophylaxis using 2-dose basiliximab or 2-dose daclizumab is safety for renal recipients.4. There is a good recipient/graft survival for immunoprophylaxis groups compared with central group during 6-12 months after renal transplantation.
Keywords/Search Tags:Basiliximab, daclizumab, renal transplantation, acute rejection
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