RESUMO
BACKGROUND: Everolimus (EVL)-based immunosuppressive strategies may permit the reduction of calcineurin inhibitors (CNI) and their side effects, while offering a safe and efficient treatment. Our aim was to describe our experience with EVL in everyday practice and provide information for its optimal utilization. METHODS: Prospective, multicenter study of 181 kidney transplant recipients treated with EVL as part of their immunosuppressive regimen, with a follow-up of 24 months. We studied demographic data, transplant characteristics, clinical information, drugs used, serum creatinine, estimated glomerular filtration rate (eGFR), rejection episodes, and adverse events. RESULTS: In total, 181 renal transplant recipients were included. Of these, 30 (16.6%) received EVL de novo and 151 (83.4%) were converted; median time from transplantation to conversion was 10 (range, 1-312) months. Main reasons for conversion were prevention of interstitial fibrosis and tubular atrophy (23.9%), intolerance to immunosuppressants (11.1%), neoplasia (13.9%), nephrotoxicity (8.9%), and cytomegalovirus infections (8.3%). The eGFR values at baseline, months 12, and 24 were 46.4 ± 27.4 mL/min, 54.8 ± 22.9 mL/min, and 55.9 ± 26.5 ml/min, respectively. Two of 181 (1.1%) patients died, 5 of 181 (2.8%) lost their grafts, 12 of 181 (6.6%) had an episode of acute rejection, 13 of 181 (7.2%) had ≥1 serious event and infection, and 85 of 181 (49.9%) had ≥1 nonserious adverse event or infection. Multivariate analysis showed that increased eGFR at month 24 was associated with lower donor age, shorter time from transplant to EVL introduction, and a baseline eGFR ≥40 mL/min. CONCLUSION: Through different strategies among centers, the inclusion of EVL improved renal function during the first 12 months.
Assuntos
Everolimo/uso terapêutico , Imunossupressores/uso terapêutico , Transplante de Rim , Argentina , Feminino , Seguimentos , Taxa de Filtração Glomerular , Rejeição de Enxerto , Sobrevivência de Enxerto , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de RegistrosRESUMO
Proliferation signal inhibitors, such as everolimus, offer immunosuppression without the toxicity of calcineurin inhibitors. This descriptive and prospective study reports outcomes at 1 year and predictors of improved estimated glomerular filtration rate (eGFR) in 174 renal transplant recipients from a national registry of the use of everolimus. At 1 year after conversion, 48.85% of patients had improved eGFR compared with baseline. The mean time from transplantation to initiation of treatment with everolimus was 47.97 months, the median 22 (range, 0-312) months. The kidneys were from deceased donors in 120 patients (68.79%) and from living donors in 54 (31.21%); 35 (20.83%) were expanded-criteria donors. When comparing the baseline versus 12-month values of laboratory results, total cholesterol levels and platelet counts differed significantly-191.55 ± 43.92 mg/dL versus 204.52 ± 41.29 mg/dL (P < .05) and 213,411 ± 63,231/mm(3) vs 255,571 ± 59,153/mm(3), respectively (P < .05)-but remained within clinically controllable ranges. Glycemia, triglycerides, hematocrit, hemoglobin, and leukocytes remained stable. Logistic regression analysis of baseline variables showed that the only independent prognostic factor for improved eGFR at 1 year was the conversion of patients to everolimus within the first 12 months after transplantation (odds ratio, 2.17; 95% confidence interval, 1.15-4.10). In conclusion, regarding the effectiveness of everolimus in our subjects, the only predictor of improved eGFR identified at 1 year was conversion within 12 months after transplantation.
Assuntos
Rejeição de Enxerto/prevenção & controle , Imunossupressores/uso terapêutico , Transplante de Rim , Sirolimo/análogos & derivados , Adulto , Everolimo , Feminino , Seguimentos , Taxa de Filtração Glomerular , Rejeição de Enxerto/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Sirolimo/uso terapêutico , Resultado do TratamentoRESUMO
OBJECTIVES: To analyze the attitude of physicians towards alerting in CPOE systems in different hospitals in different countries, addressing various organizational and technical settings and the view of physicians not currently using a CPOE. METHODS: A cross-sectional quantitative and qualitative questionnaire survey. We invited 2,600 physicians in eleven hospitals from nine countries to participate. Eight of the hospitals had different CPOE systems in use, and three of the participating hospitals were not using a CPOE system. RESULTS: 1,018 physicians participated. The general attitude of the physicians towards CPOE alerting is positive and is found to be mostly independent of the country, the specific organizational settings in the hospitals and their personal experience with CPOE systems. Both quantitative and qualitative results show that the majority of the physicians, both CPOE-users and non-users, appreciate the benefits of alerting in CPOE systems on medication safety. However, alerting should be better adapted to the clinical context and make use of more sophisticated ways to present alert information. The vast majority of physicians agree that additional information regarding interactions is useful on demand. Around half of the respondents see possible alert overload as a major problem; in this regard, physicians in hospitals with sophisticated alerting strategies show partly better attitude scores. CONCLUSIONS: Our results indicate that the way alerting information is presented to the physicians may play a role in their general attitude towards alerting, and that hospitals with a sophisticated alerting strategy with less interruptive alerts tend towards more positive attitudes. This aspect needs to be further investigated in future studies.
Assuntos
Atitude do Pessoal de Saúde , Alarmes Clínicos , Internacionalidade , Sistemas de Registro de Ordens Médicas , Corpo Clínico Hospitalar/psicologia , Pesquisas sobre Atenção à Saúde , Humanos , Pesquisa QualitativaRESUMO
Recipients of extended-criteria donor (ECD) kidneys have poorer long-term outcomes compared to standard-criteria donor kidney recipients. We report 3-year outcomes from a randomized, phase III study in recipients of de novo ECD kidneys (n = 543) assigned (1:1:1) to either a more intensive (MI) or less intensive (LI) belatacept regimen, or cyclosporine. Three hundred twenty-three patients completed treatment by year 3. Patient survival with a functioning graft was comparable between groups (80% in MI, 82% in LI, 80% in cyclosporine). Mean calculated GFR (cGFR) was 11 mL/min higher in belatacept-treated versus cyclosporine-treated patients (42.7 in MI, 42.2 in LI, 31.5 mL/min in cyclosporine). More cyclosporine-treated patients (44%) progressed to GFR <30 mL/min (chronic kidney disease [CKD] stage 4/5) than belatacept-treated patients (27-30%). Acute rejection rates were similar between groups. Posttransplant lymphoproliferative disorder (PTLD) occurrence was higher in belatacept-treated patients (two in MI, three in LI), most of which occurred during the first 18 months; four additional cases (3 in LI, 1 in cyclosporine) occurred after 3 years. Tuberculosis was reported in two MI, four LI and no cyclosporine patients. In conclusion, at 3 years after transplantation, immunosuppression with belatacept resulted in similar patient survival, graft survival and acute rejection, with better renal function compared with cyclosporine. As previously reported, PTLD and tuberculosis were the principal safety findings associated with belatacept in this study population.
Assuntos
Rejeição de Enxerto/prevenção & controle , Imunoconjugados/uso terapêutico , Imunossupressores/uso terapêutico , Falência Renal Crônica/cirurgia , Transplante de Rim , Complicações Pós-Operatórias , Abatacepte , Adulto , Ciclosporina/uso terapêutico , Feminino , Seguimentos , Taxa de Filtração Glomerular , Sobrevivência de Enxerto , Humanos , Falência Renal Crônica/complicações , Testes de Função Renal , Transtornos Linfoproliferativos/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Prognóstico , Fatores de Risco , Taxa de SobrevidaRESUMO
The clinical profile of belatacept in kidney transplant recipients was evaluated to determine if earlier results in the BENEFIT study were sustained at 3 years. BENEFIT is a randomized 3 year, phase III study in adults receiving a kidney transplant from a living or standard criteria deceased donor. Patients were randomized to a more (MI) or less intensive (LI) regimen of belatacept, or cyclosporine. 471/666 patients completed ≥3 years of therapy. A total of 92% (MI), 92% (LI), and 89% (cyclosporine) of patients survived with a functioning graft. The mean calculated GFR (cGFR) was â¼21 mL/min/1.73 m(2) higher in the belatacept groups versus cyclosporine at year 3. From month 3 to month 36, the mean cGFR increased in the belatacept groups by +1.0 mL/min/1.73 m(2) /year (MI) and +1.2 mL/min/1.73 m(2) /year (LI) versus a decline of -2.0 mL/min/1.73 m(2) /year (cyclosporine). One cyclosporine-treated patient experienced acute rejection between year 2 and year 3. There were no new safety signals and no new posttransplant lymphoproliferative disorder (PTLD) cases after month 18. Belatacept-treated patients maintained a high rate of patient and graft survival that was comparable to cyclosporine-treated patients, despite an early increased occurrence of acute rejection and PTLD.
Assuntos
Ciclosporina/uso terapêutico , Imunoconjugados/uso terapêutico , Imunossupressores/uso terapêutico , Transplante de Rim , Abatacepte , Adulto , Taxa de Filtração Glomerular , Sobrevivência de Enxerto , Humanos , Resultado do TratamentoRESUMO
The use of expanded donors or kidneys with preexistent chronic damage remains controversial, but they offer the opportunity to expand the donor pool. We investigated the impact of these conditions as predictors of graft survival among a cohort of recipients with prolonged cold ischemia times and a high incidence of delayed graft function. We included 70 consecutive cadaveric kidney allografts implanted between 2001 and 2005, which had undergone an early graft biopsy. Delayed graft function was present in 84% of cases with moderate or severe preexistent chronic damage in 63% and 27% of biopsies, respectively, and acute rejection was diagnosed in 14.3% of overall cases. The graft survival was 73.3% at 48 months. Primary nonfunctioning kidneys were more frequent using kidneys from expanded compared with standard donors (20.0% vs 0.0%, P < .002). Multivariate analysis showed that only the donor condition (standard vs expanded) was independently associated with graft survival (hazard ratio: 0.12; 95% confidence interval: 0.01-0.87; P < .03). Our results suggested that the donor characteristics prevail over other variables to predict graft outcomes.
Assuntos
Isquemia/patologia , Transplante de Rim/métodos , Insuficiência Renal/mortalidade , Traumatismo por Reperfusão/patologia , Adolescente , Adulto , Idoso , Biópsia , Criança , Pré-Escolar , Estudos de Coortes , Isquemia Fria , Sobrevivência de Enxerto , Humanos , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos , Manejo de Espécimes/métodos , Doadores de Tecidos , Obtenção de Tecidos e Órgãos/normas , Resultado do TratamentoRESUMO
Belatacept, a costimulation blocker, may preserve renal function and improve long-term outcomes versus calcineurin inhibitors in kidney transplantation. This Phase III study (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial) assessed a more intensive (MI) or less intensive (LI) regimen of belatacept versus cyclosporine in adults receiving a kidney transplant from living or standard criteria deceased donors. The co-primary endpoints at 12 months were patient/graft survival, a composite renal impairment endpoint (percent with a measured glomerular filtration rate (mGFR) <60 mL/min/1.73 m(2) at Month 12 or a decrease in mGFR > or =10 mL/min/1.73 m(2) Month 3-Month 12) and the incidence of acute rejection. At Month 12, both belatacept regimens had similar patient/graft survival versus cyclosporine (MI: 95%, LI: 97% and cyclosporine: 93%), and were associated with superior renal function as measured by the composite renal impairment endpoint (MI: 55%; LI: 54% and cyclosporine: 78%; p < or = 0.001 MI or LI versus cyclosporine) and by the mGFR (65, 63 and 50 mL/min for MI, LI and cyclosporine; p < or = 0.001 MI or LI versus cyclosporine). Belatacept patients experienced a higher incidence (MI: 22%, LI: 17% and cyclosporine: 7%) and grade of acute rejection episodes. Safety was generally similar between groups, but posttransplant lymphoproliferative disorder was more common in the belatacept groups. Belatacept was associated with superior renal function and similar patient/graft survival versus cyclosporine at 1 year posttransplant, despite a higher rate of early acute rejection.
Assuntos
Ciclosporina/uso terapêutico , Imunoconjugados/uso terapêutico , Imunossupressores/uso terapêutico , Transplante de Rim/métodos , Abatacepte , Adulto , Feminino , Taxa de Filtração Glomerular , Humanos , Terapia de Imunossupressão , Incidência , Transtornos Linfoproliferativos/etiologia , Transtornos Linfoproliferativos/prevenção & controle , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Fatores de TempoRESUMO
Management of posttransplantation malignancies should include control of the neoplasia and preservation of renal function. Conversion to everolimus (EVL) would potentially have both effects. Twenty-one patients were converted to EVL due to posttransplantation neoplasms. We have presented herein descriptive data and postconversion (PC) outcomes among subjects of mean age 53.6 +/- 10.1 years (range, 36-69), 57.1% were males, undergoing conversion at 108.2 +/- 74.7 (range, 5-316) months after transplantation. All patients received standard immunosuppressive therapy and 9.5% had been induced with thymoglobulin. Malignant neoplasms were as follows: skin (n = 7), gynecological (n = 3), gastrointestinal (n = 3), PTLD (n = 2), renal (n = 2), CNS (n = 1), seminoma (n = 1), Kaposi's sarcoma (n = 1), and prostate cancer (n = 1). PC to EVL, calcineurin inhibitors (CNIs) were discontinued in 18 of 19 patients, mycophenolate in 9/12, and azathioprine in 5/7; all patients continued to receive steroids. In 16 patients (79%) tumors were removed. Chemotherapy was performed in 2 patients with PTLD and radiotherapy was performed in 1 patient with prostate cancer. Mean follow-up was 505 days (range, 59-1151); baseline glomerular filtration rate (GFR) was 53.5 +/- 21.6 mL/min versus 48.5 +/- 25.7 mL/min (P = not significant [NS]) at the last control. One patient experienced graft loss at day 744 after conversion due to chronic rejection. Adverse events were observed in 57% of patients and 28% displayed infections; no patient discontinued EVL. There were 2 deaths: 1 due to an infection and the other due to postsurgical complication. No deaths due to cancer progression were observed. The results observed in this series suggested that conversion to EVL for a posttransplantation neoplasm is a valid therapeutic alternative to preserve graft function and control disease progression.
Assuntos
Imunossupressores/uso terapêutico , Transplante de Rim/imunologia , Neoplasias/imunologia , Complicações Pós-Operatórias/imunologia , Sirolimo/análogos & derivados , Adulto , Idoso , Soro Antilinfocitário/uso terapêutico , Colesterol/sangue , Everolimo , Feminino , Seguimentos , Taxa de Filtração Glomerular , Humanos , Imunossupressores/efeitos adversos , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Neoplasias/radioterapia , Neoplasias/cirurgia , Contagem de Plaquetas , Neoplasias da Próstata/radioterapia , Proteinúria , Sirolimo/uso terapêutico , Fatores de Tempo , Triglicerídeos/sangueRESUMO
Factor V Leiden and mutation of prothrombin gene G20210A have been associated with poor results in the early post-kidney transplantation period. Its long-term importance in stable patients has yet to be evaluated. We studied the prevalence of these inherited mutations and their relationship to thrombotic events in 82 Argentine renal transplant recipients with adequate long-term kidney function. In aggregate, 7.2% of patients were carriers of these mutations; however, their presence did not show any association with thrombotic events or renal function alterations. The routine evaluation for these mutations does not seem to be cost-effective in renal transplant patients.
Assuntos
Fator V/genética , Transplante de Rim/fisiologia , Mutação , Protrombina/genética , Adolescente , Adulto , Portador Sadio , Criança , Creatinina/sangue , Primers do DNA , Feminino , Rejeição de Enxerto/epidemiologia , Rejeição de Enxerto/genética , Sobrevivência de Enxerto/genética , Humanos , Masculino , Pessoa de Meia-Idade , Trombose/epidemiologia , Trombose/genéticaRESUMO
One of the concerns regarding the pandemic of novel influenza A/H1N1 virus is its potential to hamper transplant programs if the decision is made that organs from donors with influenza A/H1N1 should not be used. Evidence of transmissibility through organ transplantation is speculative at best. We report the outcome of 2 kidney transplant recipients who received kidneys from the same deceased donor, in whom the diagnosis of infection by the novel virus became available only after engraftment. The donor also had received a complete course of antiviral treatment before donation. The recipients were transplanted at 2 different facilities and were managed differently. Neither recipient developed flu syndrome, and both had an uneventful outcome. It is possible to speculate that kidneys from donors who have had confirmed influenza A/H1N1 and who have received antiviral treatment can be safely used in transplantation.
Assuntos
Surtos de Doenças , Vírus da Influenza A Subtipo H1N1 , Influenza Humana/epidemiologia , Transplante de Rim , Obtenção de Tecidos e Órgãos , Adolescente , Antivirais/uso terapêutico , Criança , Feminino , Saúde Global , Humanos , Influenza Humana/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Resultado do TratamentoRESUMO
Several microbial pathogens can modulate the host apoptotic response to infection, which may contribute to immune evasion. Various studies have reported that infection with the sexually transmitted disease pathogen Neisseria gonorrhoeae can either inhibit or induce apoptosis. N. gonorrhoeae infection initiates at the mucosal epithelium, and in women, cells from the ectocervix and endocervix are among the first host cells encountered by this pathogen. In this study, we defined the antiapoptotic effect of N. gonorrhoeae infection in human endocervical epithelial cells (End/E6E7 cells). We first established that N. gonorrhoeae strain FA1090B failed to induce cell death in End/E6E7 cells. Subsequently, we demonstrated that stimulation with N. gonorrhoeae protected these cells from staurosporine (STS)-induced apoptosis. Importantly, only End/E6E7 cells incubated with live bacteria and in direct association with N. gonorrhoeae were protected from STS-induced apoptosis, while heat-killed and antibiotic-killed bacteria failed to induce protection. Stimulation of End/E6E7 cells with live N. gonorrhoeae induced NF-kappaB activation and resulted in increased gene expression of the NF-kappaB-regulated antiapoptotic genes bfl-1, cIAP-2, and c-FLIP. Furthermore, cIAP-2 protein levels also increased in End/E6E7 cells incubated with gonococci. Collectively, our results indicate that the antiapoptotic effect of N. gonorrhoeae in human endocervical epithelial cells results from live infection via expression of host antiapoptotic proteins. Securing an intracellular niche through the inhibition of apoptosis may be an important mechanism utilized by N. gonorrhoeae for microbial survival and immune evasion in cervical epithelial cells.
Assuntos
Apoptose , Colo do Útero/microbiologia , Proteínas Inibidoras de Apoptose/fisiologia , Neisseria gonorrhoeae/patogenicidade , Apoptose/efeitos dos fármacos , Proteína 3 com Repetições IAP de Baculovírus , Proteína Reguladora de Apoptosis Semelhante a CASP8 e FADD/genética , Caspase 3/fisiologia , Células Cultivadas , Colo do Útero/patologia , Feminino , Gonorreia/imunologia , Humanos , Proteínas Inibidoras de Apoptose/genética , NF-kappa B/fisiologia , Porinas/fisiologia , Proteína Serina-Treonina Quinase 2 de Interação com Receptor/genética , Estaurosporina/farmacologia , Ubiquitina-Proteína LigasesRESUMO
Infobuttons are context-specific links between clinical information systems and other online information resources. The objective of this study is to describe a French Infobutton, which will be sold in the French-speaking Health Information market.
Assuntos
Centros Médicos Acadêmicos/organização & administração , Informação de Saúde ao Consumidor/métodos , Informação de Saúde ao Consumidor/organização & administração , Indústrias/organização & administração , Internet , Software , França , Integração de SistemasRESUMO
Patient medical record systems (MRS) merely offer static applications, in which mostly unstructured text is linked to coded data. In these applications the more common presentation is a time oriented one, which does not allow easily for data and information retrieval. Concept oriented views based on supper-concepts (metaterms) initially defined in CISMeF to optimize Web medical search, was implemented in our MRS as specialties views. This work shows that these terminological tools are able to facilitate information retrieval.
Assuntos
Apresentação de Dados/normas , Sistemas Computadorizados de Registros Médicos/normas , Indexação e Redação de Resumos , França , Humanos , Armazenamento e Recuperação da Informação/normas , Classificação Internacional de Doenças , Bibliotecas Médicas , Medical Subject Headings , Design de Software , Vocabulário ControladoRESUMO
BACKGROUND: Mycophenolate mofetil (MMF) is effective in renal transplant patients but concerns remain over its gastrointestinal (GI) tolerability. Enteric-coated mycophenolate sodium (EC-MPS; myfortic) has been developed with the intention of improving mycophenolic acid-related GI tolerability. METHODS: Data were pooled in a planned analysis of three subprotocols of the myfortic Prospective Multicenter Study (myPROMS). In a 6-month study, efficacy and safety of converting stable renal transplant recipients from MMF to a bioequivalent dose of EC-MPS for mycophenolic acid exposure were evaluated. Treatment efficacy was recorded and graft function was assessed by measuring serum creatinine and estimating creatinine clearance. Adverse events (AEs) and infections were monitored and the incidence of EC-MPS dose changes was recorded. RESULTS: A total of 588 patients were recruited, 564 (96%) of whom completed the study. The rate of treatment failure (defined as biopsy-proven acute rejection, graft loss, or death) was 1.9%, with no episodes of graft loss and only one death reported during the study. Renal function remained stable throughout the trial. EC-MPS was well tolerated; the majority of AEs were mild or moderate in severity. Dose reductions or interruptions were required by 6.3% and 1.9% of patients, respectively. Gastrointestinal AEs occurred in 138 patients (23.5%). The rate of dose adjustment as a result of a GI AE was 2.2%. CONCLUSIONS: Equimolar conversion from MMF to EC-MPS in maintenance renal transplant patients was safe and maintained efficacy.
Assuntos
Transplante de Rim/imunologia , Ácido Micofenólico/análogos & derivados , Adolescente , Adulto , Idoso , Criança , Gastroenteropatias/induzido quimicamente , Gastroenteropatias/prevenção & controle , Humanos , Pessoa de Meia-Idade , Ácido Micofenólico/administração & dosagem , Ácido Micofenólico/efeitos adversos , Ácido Micofenólico/uso terapêutico , Seleção de Pacientes , Reoperação/estatística & dados numéricos , Comprimidos com Revestimento Entérico , Falha de Tratamento , Resultado do TratamentoRESUMO
OBJECTIVE: Diabetes is one of the main causes of end-stage renal disease (ESRD) and admission to hemodialysis, and the demand for kidney transplantation in this population has increased. Our aim was to evaluate the clinical aspects and survival of diabetic patients with kidney transplants by comparing them with the nondiabetic population. MATERIALS AND METHODS: Patients transplanted during the period from 1994 to 2003 were evaluated for this study. The transplant and demographic characteristics were analyzed by the chi-square test and Student t test according to the type of variable. Kaplan-Meier curves and the log-rank test were used to evaluate the graft and patient survival. RESULTS: From a total of 523 consecutive renal transplants, 35 (6.6%) were diabetics who were older than nondiabetics (47 +/- 11 years vs 37 +/- 16, P < .002). Patients received immunosuppression with cyclosporine (84.3%), tacrolimus (11.2%), azathioprine (46.6%), mycophenolate mofetil (43.5%), and steroids (all patients). The diabetic patients had a higher percentage of living donors (33.5% vs 17.2%; P = .04). Graft survival rates at 1, 3, and 5 years were 82.7%, 70.9%, and 63.0% in the diabetic patients and 87.6%, 79.0%, and 72.5% (P = .6) in the nondiabetic patients. Patient survival at 5 years was 90.5% in diabetic patients vs 89.0% in nondiabetic patients (P = .9). CONCLUSIONS: No differences were found in our series in transplant complications or survival in the diabetic patients compared with the nondiabetic patients. Kidney transplants, even with living donors, must be offered to well-selected diabetic patients without reservations.
Assuntos
Diabetes Mellitus Tipo 1/cirurgia , Nefropatias Diabéticas/cirurgia , Transplante de Rim , Seleção do Doador , Humanos , Imunossupressores/uso terapêutico , Transplante de Rim/imunologia , Transplante de Rim/mortalidade , Estudos Retrospectivos , Análise de Sobrevida , Resultado do TratamentoRESUMO
Patients with delayed graft function (DGF) are at risk of increased incidence for acute rejection episodes (ARE). Mycophenolate mofetil or induction therapy has produced a reduction in ARE incidence. An open, prospective, 3-month trial was performed in a group of Argentinian renal transplant recipients. We recruited 46 patients, 71.7% men, aged 41.7 +/- 13.8 years; including 36 (78.3%) recipients of cadaveric donors (CD) who were aged 43.4 +/- 15.5 years with a cold ischemia time of 19.4 hours +/- 5.4 minutes, and 10 (27.7%) recipients of living donors (LD) aged 37.8 +/- 12.9 years. HLA mismatches >or= 3 were observed in 58.4% of CD and in 7% of LD. All patients received two doses of basiliximab (20 mg each, days 0 and 4), cyclosporine microemulsion (CsA-ME) monitored by the second-hour concentrations (C2), enteric-coated mycophenolate sodium (EC-MPS; 720 mg twice a day, and steroids. A 58% incidence of DGF was observed. At the end of the third month the incidence of biopsy-proven ARE was 15%, with a median serum creatinine of was 1.54 +/- 0.42 mg/dL, including three grafts lost. Two patients died. No patient required EC-MPS dose discontinuation but 20% of patients required dose adjustments. The absence of discontinuations and the low incidence of dose adjustments of EC-MPS in this high-risk de novo population provided support of a suitable tolerability profile for this EC-MPS, and the possibility to impact efficacy results.
Assuntos
Sobrevivência de Enxerto/efeitos dos fármacos , Imunossupressores/uso terapêutico , Transplante de Rim/imunologia , Ácido Micofenólico/uso terapêutico , Adulto , Ciclosporina/administração & dosagem , Ciclosporina/uso terapêutico , Emulsões , Feminino , Humanos , Imunossupressores/administração & dosagem , Doadores Vivos , Masculino , Pessoa de Meia-Idade , Ácido Micofenólico/administração & dosagem , Comprimidos com Revestimento EntéricoRESUMO
The immunosuppressant mycophenolate mofetil (MMF; CellCept) has greatly improved transplant recipients' clinical outcomes, but its efficacy may be limited by dose adjustments due to adverse events (AEs). An enteric-coated formulation of mycophenolate sodium (EC-MPS; myfortic), designed to improve gastrointestinal tolerability is now available. This Latin-American, prospective, multicenter, open-label, 6-month trial assessed the safety and tolerability of converting renal transplant recipients from MMF to EC-MPS. In total, 237 renal transplant recipients (stable > or = 3 months' posttransplant) receiving MMF (< or =1000 mg b.i.d.) were enrolled. Adults (n = 218) were converted to EC-MPS 720 mg b.i.d. (equimolar to MMF 1000 mg b.i.d.) even if they were initially receiving <1000 mg MMF b.i.d. (ie, 47 adults received a higher than equimolar dose of EC-MPS). Children (n = 19) were converted to EC-MPS 450 or 432 mg/m2 b.i.d. Patients also received cyclosporine microemulsion (Neoral) and corticosteroids. There were three acute rejections and no graft failures. The incidence of AEs was 59.9% (in those receiving a higher than equimolar EC-MPS dose it was 57.4%). In all, 22% of patients had gastrointestinal AEs, 37% had infections, and 4.8% had hematological AEs. Only 24 patients (10%) had an AE-related dose reduction. Seven of these patients had received higher than equimolar doses of EC-MPS. Patients can be safely converted from different doses of MMF to a standard dose of EC-MPS. The requirement for EC-MPS dose reduction to manage AEs was relatively low. Use of EC-MPS is a valid alternative for renal transplant recipients receiving maintenance MMF treatment.
Assuntos
Transplante de Rim/imunologia , Ácido Micofenólico/análogos & derivados , Adolescente , Adulto , Criança , Creatinina/sangue , Feminino , Humanos , Imunossupressores/administração & dosagem , Imunossupressores/efeitos adversos , Imunossupressores/uso terapêutico , América Latina , Masculino , Ácido Micofenólico/administração & dosagem , Ácido Micofenólico/efeitos adversos , Ácido Micofenólico/uso terapêutico , Complicações Pós-Operatórias/epidemiologia , Segurança , Neoplasias Cutâneas/epidemiologia , Comprimidos com Revestimento EntéricoRESUMO
The early urinary tract infection (EUTI) in kidney transplant recipients is an infection develop during the first 3 months post transplant surgery. The effect of EUTI on graft survival and risk factors have been scarcely studied. Our objetives were the evaluation of risk factors to EUTI, the assessment of the causal agent and graft survival impact. A retrospective analysis of kidney transplantation, period 1997-2000 in Hospital Privado-Centro Médico de Córdoba was carried out. There were two groups of patients with (EUTI group) and without EUTI (control group). Cox model was used to analyze risk factors and Kaplan-Meier method for graft survival. A total of 226 consecutive patients received kidney transplantation. In 55 patients (24.3%) EUTI was detected. Risk factors for EUTI were: invasive urological maneuvers (RR = 4.34, CI 95% 1.42-13.21), diabetes mellitus (RR = 3.79, CI 95% 1.42-10.14), cytomegalovirus infection (RR = 2.9, CI 95% 1.02-8.24) and previous transplants (RR = 2.83, CI 95% 1.08-7.45). Delayed graft function was associated with lower incidence of EUTI (RR = 0.38, CI 95% 0.15-0.94). The causal agents were: Klebsiella pneumoniae (36%), Pseudomonas aeruginosa (24%) and Escherichia coli (9%). Graft survival at 2 years was similar in EUTI (87.2%) and control group (81.2%, p = 0.32). This series shows that invasive urological maneuvers were the main risk factors for EUTI. Graft survival was similar. High prevalence of non coli bacteria need further evaluation.
La infección urinaria temprana del injerto (IUTI), definida como infección urinaria sintomática en los primeros 3 meses del trasplante, su efecto sobre la sobrevida del injerto y los factores de riesgo han sido poco estudiados. Los objetivos del presente análisis fueron conocer factores de riesgo para IUTI,analizar agentes causantes e impacto en la sobrevida del injerto. En forma retrospectiva se analizaron pacientesque recibieron trasplante renal durante 1997-2000 en el Hospital Privado Centro Médico de Córdoba. Sedividió en dos grupos de pacientes, según presencia (grupo IUTI) o ausencia (grupo control) de IUTI. Los factores de riesgo se analizaron con el modelo de riesgos proporcionales de Cox y la sobrevida del injerto con elmétodo de Kaplan-Meier. Recibieron trasplante renal 226 pacientes consecutivos. La IUTI se presentó en 55(24.3%). Factores de riesgo asociados con IUTI: antecedentes de maniobras urológicas invasivas (RR=4.34,IC 95% 1.42-13.21), diabetes mellitus (RR=3.79, IC 95% 1.42-10.14), infección por citomegalovirus (RR=2.9,IC 95% 1.02-8.24) y antecedente de trasplante previo (RR=2.83, IC 95% 1.08-7.45). El retardo en la función delinjerto (RR=0.38, IC 95% 0.15-0.94) se asoció con menor incidencia de IUTI. Agentes más frecuentes: Klebsiellapneumoniae (36%), Pseudomonas aeruginosa (24%) y Escherichia coli (9%). La sobrevida del injerto a los 2años en el grupo IUTI (87.2%) no fue diferente del control (81.2%, P = 0.32). En esta serie las maniobras urológicas invasivas fueron el principal factor de riesgo asociado a IUTI. No hubo disminución de la sobrevida del injerto asociada a IUTI. La alta prevalencia de uropatógenos no coli requiere mayor evaluación
Assuntos
Feminino , Adulto , Humanos , Masculino , Complicações Pós-Operatórias/etiologia , Sobrevivência de Enxerto , Infecções Urinárias/etiologia , Transplante de Rim , Complicações Pós-Operatórias/microbiologia , Métodos Epidemiológicos , Infecções Urinárias/epidemiologia , Infecções Urinárias/microbiologia , Klebsiella pneumoniae/isolamento & purificação , Pseudomonas aeruginosa/isolamento & purificação , Rejeição de Enxerto/etiologiaRESUMO
The early urinary tract infection (EUTI) in kidney transplant recipients is an infection develop during the first 3 months post transplant surgery. The effect of EUTI on graft survival and risk factors have been scarcely studied. Our objetives were the evaluation of risk factors to EUTI, the assessment of the causal agent and graft survival impact. A retrospective analysis of kidney transplantation, period 1997-2000 in Hospital Privado-Centro Médico de Córdoba was carried out. There were two groups of patients with (EUTI group) and without EUTI (control group). Cox model was used to analyze risk factors and Kaplan-Meier method for graft survival. A total of 226 consecutive patients received kidney transplantation. In 55 patients (24.3%) EUTI was detected. Risk factors for EUTI were: invasive urological maneuvers (RR = 4.34, CI 95% 1.42-13.21), diabetes mellitus (RR = 3.79, CI 95% 1.42-10.14), cytomegalovirus infection (RR = 2.9, CI 95% 1.02-8.24) and previous transplants (RR = 2.83, CI 95% 1.08-7.45). Delayed graft function was associated with lower incidence of EUTI (RR = 0.38, CI 95% 0.15-0.94). The causal agents were: Klebsiella pneumoniae (36%), Pseudomonas aeruginosa (24%) and Escherichia coli (9%). Graft survival at 2 years was similar in EUTI (87.2%) and control group (81.2%, p = 0.32). This series shows that invasive urological maneuvers were the main risk factors for EUTI. Graft survival was similar. High prevalence of non coli bacteria need further evaluation.(AU)
La infección urinaria temprana del injerto (IUTI), definida como infección urinaria sintomática en los primeros 3 meses del trasplante, su efecto sobre la sobrevida del injerto y los factores de riesgo han sido poco estudiados. Los objetivos del presente análisis fueron conocer factores de riesgo para IUTI,analizar agentes causantes e impacto en la sobrevida del injerto. En forma retrospectiva se analizaron pacientesque recibieron trasplante renal durante 1997-2000 en el Hospital Privado ¹ Centro Médico de Córdoba. Sedividió en dos grupos de pacientes, según presencia (grupo IUTI) o ausencia (grupo control) de IUTI. Los factores de riesgo se analizaron con el modelo de riesgos proporcionales de Cox y la sobrevida del injerto con elmétodo de Kaplan-Meier. Recibieron trasplante renal 226 pacientes consecutivos. La IUTI se presentó en 55(24.3%). Factores de riesgo asociados con IUTI: antecedentes de maniobras urológicas invasivas (RR=4.34,IC 95% 1.42-13.21), diabetes mellitus (RR=3.79, IC 95% 1.42-10.14), infección por citomegalovirus (RR=2.9,IC 95% 1.02-8.24) y antecedente de trasplante previo (RR=2.83, IC 95% 1.08-7.45). El retardo en la función delinjerto (RR=0.38, IC 95% 0.15-0.94) se asoció con menor incidencia de IUTI. Agentes más frecuentes: Klebsiellapneumoniae (36%), Pseudomonas aeruginosa (24%) y Escherichia coli (9%). La sobrevida del injerto a los 2años en el grupo IUTI (87.2%) no fue diferente del control (81.2%, P = 0.32). En esta serie las maniobras urológicas invasivas fueron el principal factor de riesgo asociado a IUTI. No hubo disminución de la sobrevida del injerto asociada a IUTI. La alta prevalencia de uropatógenos no coli requiere mayor evaluación(AU)
Assuntos
Feminino , Adulto , Humanos , Masculino , Sobrevivência de Enxerto , Transplante de Rim , Complicações Pós-Operatórias/etiologia , Infecções Urinárias/etiologia , Métodos Epidemiológicos , Rejeição de Enxerto/etiologia , Klebsiella pneumoniae/isolamento & purificação , Complicações Pós-Operatórias/microbiologia , Pseudomonas aeruginosa/isolamento & purificação , Infecções Urinárias/epidemiologia , Infecções Urinárias/microbiologiaRESUMO
Between 1994-2001 we have performed 57 bone biopsies for diagnostic purposes in symptomatic CRF patients. We analyzed here 52 samples where the material was optimal for study, and divided them into 2 periods according to when the biopsy was performed: 1994-1996 and 1997-2001, to verify changes in the spectrum of renal osteodystrophy. Mean serum values were: serum calcium 9.9 +/- 1.8 mg/dl, phosphate 5.8 +/- 3.2 mg/dl, alkaline phosphatase 693.9 +/- 968.9 Ul/L, iPTH 562.0 +/- 598.5 pg/ml, serum aluminum 65.7 +/- 79.3 ug/L and bone aluminum 22.8 +/- 22.4 ug/g. Hyperparathyroidism was the most common histological diagnosis as severe in 13 patients (25%), or as mild in 14 (27%). Ten patients had osteomalacia (19%), adynamic bone disease was diagnosed in 5 (9.6%) and mixed renal osteodystrophy in 10 (19.2%). Low bone turnover patients showed higher bone and serum aluminum than high bone turnover patients. We observed a relative increment in high turnover bone disease in the later period (1997-2001) without changes in low turnover bone disease. These data showed a high prevalence of hyperparathyroidism and aluminum-related low turnover bone disease, with no significant changes between the two time-periods analyzed here.