Abstract:
:To evaluate the pharmacokinetic properties of the new microemulsion formulation of cyclosporine (Sandimmun Neoral), a double-blind, prospective study in stable renal transplant recipients was performed. The patients were randomized on a 4:1 basis either to receive Sandimmun Neoral (n = 45) or continue on regular Sandimmun (n = 12). Before randomization, a steady-state pharmacokinetic profile study was performed in all patients while they were still on regular Sandimmun. Pharmacokinetic assessments were then performed after 8 and 12 weeks and after 1 year. A milligram-to-milligram dose conversion was shown to be adequate to maintain the patients within a predefined target therapeutic window. Changes in pharmacokinetic parameters after conversion to Sandimmun Neoral were consistent with an increased rate and extent of cyclosporine absorption from the Neoral formulation. This was reflected by a shorter time to reach peak concentration and also by a mean increase in peak concentration by 67%, and an overall mean increase in drug exposure (area under the curve) by 34%. These findings were also confirmed 1 year after conversion. Furthermore, significantly reduced intraindividual variability in pharmacokinetic parameters was found, as well as improvements in the correlation between trough concentrations and area under the curve after conversion to Sandimmun Neoral. In conclusion, our results indicate an improved and consistent absorption of cyclosporine from the Neoral formulation, which should make clinical management easier and safer.
journal_name
Transplantationjournal_title
Transplantationauthors
Wahlberg J,Wilczek HE,Fauchald P,Nordal KP,Heaf JG,Olgaard K,Hansen JM,Lokkegaard H,Mueller EA,Kovarik JMdoi
10.1097/00007890-199510150-00005subject
Has Abstractpub_date
1995-10-15 00:00:00pages
648-52issue
7eissn
0041-1337issn
1534-6080journal_volume
60pub_type
临床试验,杂志文章,多中心研究,随机对照试验相关文献
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abstract:BACKGROUND:To maximize the renal donor pool, cadaveric pediatric en bloc kidneys have been transplanted as a dual unit by some transplant centers. We compared the short- and long-term outcomes of adult recipients of cadaveric pediatric en bloc renal transplants versus those of matched recipients of cadaveric adult kidn...
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journal_title:Transplantation
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abstract::The safety of the use of kidneys procured from a hepatitis C virus (HCV)-positive cadaver donors in transplantation has recently been the subject of controversy. One factor that is important in determining the transmission of the virus and/or viral liver disease is the total viral inoculum to which the renal allograft...
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journal_title:Transplantation
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pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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更新日期:1998-01-15 00:00:00
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journal_title:Transplantation
pub_type: 杂志文章
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更新日期:2018-10-01 00:00:00
abstract::Pretransplant sera of 474 kidney graft recipients were tested for IgG-anti-F(ab')2 gamma activity. The patients had significantly higher IgG-anti-F(ab')2 gamma activity than healthy controls (P = 0.0004). Serum lymphocytotoxic antibodies were correlated with IgG-anti-F(ab')2 gamma (P = 0.004), whereas CMV infection an...
journal_title:Transplantation
pub_type: 杂志文章
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journal_title:Transplantation
pub_type: 杂志文章
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journal_title:Transplantation
pub_type: 杂志文章
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更新日期:1996-12-15 00:00:00
abstract::Polyclonal rabbit antirat thymocyte serum (ATS) has been shown to form in situ glomerular immune aggregates following perfusion into normal rat kidney ex vivo. This may be due to the presence of T-cell-like epitopes in the rat kidney, or it may be a result of contaminating anti-connective-tissue antibodies in ATS. To ...
journal_title:Transplantation
pub_type: 杂志文章
doi:10.1097/00007890-198606000-00015
更新日期:1986-06-01 00:00:00
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pub_type: 杂志文章
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journal_title:Transplantation
pub_type: 杂志文章
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更新日期:2003-09-27 00:00:00
abstract::A retrospective study of the 99 surviving heart and lung transplant (HLT) recipients at one center showed that 31% had significant anemia (hemoglobin less than 100g/L) six months after transplantation. Chronic anemia persisted in 18% of HLT recipients two years posttransplantation. A similar study of 100 heart transpl...
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更新日期:1992-06-01 00:00:00
abstract::Glutathione is important in cellular defense against oxidative stress. We postulated that administration of N-acetylcysteine (NAC), a glutathione precursor, might help maintain or replenish hepatic glutathione stores, thereby reducing reperfusion injury in liver grafts after warm ischemia. Eighteen pigs were subjected...
journal_title:Transplantation
pub_type: 杂志文章
doi:10.1097/00007890-199501150-00002
更新日期:1995-01-15 00:00:00
abstract::Millions of people want to donate their organs after they die for transplantation, and many of them have registered their wish to do so or told their family and friends about their decision. For most of them, however, this wish is unlikely to be fulfilled, as only a small number of deaths (1% in the United Kingdom) oc...
journal_title:Transplantation
pub_type: 杂志文章,评审
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更新日期:2017-03-01 00:00:00
abstract::With advances in microsurgery and molecular biology, the mouse model for organ transplantation has become increasingly popular. However, knowledge about these models is limited, as only a small number of centers have experience with murine models. In this study, we compared the rejection pattern after liver, kidney, h...
journal_title:Transplantation
pub_type: 杂志文章
doi:10.1097/00007890-199611150-00016
更新日期:1996-11-15 00:00:00
abstract::Patients receiving allogeneic marrow transplantation for hematologic malignancies commonly are conditioned with total body irradiation (TBI) and given methotrexate (MTX) in an attempt to prevent graft-versus-host disease. To study the effects of TBI with or without MTX on bronchoalveolar cells and proteins, we perform...
journal_title:Transplantation
pub_type: 杂志文章
doi:10.1097/00007890-198404000-00003
更新日期:1984-04-01 00:00:00
abstract:BACKGROUND:Evidence on prevalence and correlates of pretransplant medication nonadherence (MNA) is limited. The present study explored self-reported prevalence and correlates of MNA before heart, liver, and lung transplantation. METHODS:This cross-sectional descriptive study included 174 patients: 69 lung, 33 heart, a...
journal_title:Transplantation
pub_type: 杂志文章
doi:10.1097/01.tp.0000158430.06507.87
更新日期:2005-06-15 00:00:00
abstract::Pregnancy after solid organ transplantation, although considered high risk for maternal, fetal, and neonatal complications, has been quite successful. Tacrolimus pharmacokinetic changes during pregnancy make interpretation of whole blood trough concentrations particularly challenging. There are multiple factors that c...
journal_title:Transplantation
pub_type: 杂志文章,评审
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更新日期:2013-04-15 00:00:00
abstract::Although ELISA on purified HLA molecules for detecting anti-HLA antibody (P-S ELISA) does detect some antibodies previously missed by the conventional complement dependent cytotoxicity method (C Cytotox), HLA ELISA should not fail to detect antibodies already detected by the conventional reference method to be able to...
journal_title:Transplantation
pub_type: 杂志文章
doi:10.1097/00007890-199611270-00031
更新日期:1996-11-27 00:00:00