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Revisiones-Clínica-Pronóstico *** Reviews-Clinical-Prognosis

 

AGENTES INMUNOSUPRESORES *** IMMUNOSUPPRESSIVE COMPOUNDS

(Conceptos / Keywords: Immunosuppressive comp; Muromonab-cd3; Sirolimus; Tacrolimus; Cyclosporine; Mycophenolic acid; Antilymphocyte serum; Immunosuppressive comp. used in oncology, etc).

 

Enero / January 2001 --- Marzo / March 2004

 

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[1]

TÍTULO / TITLE:  - A randomized long-term trial of tacrolimus/sirolimus versus tacrolimus/mycophenolate mofetil versus cyclosporine (NEORAL)/sirolimus in renal transplantation. II. Survival, function, and protocol compliance at 1 year.

REVISTA / JOURNAL:  - Transplantation 2004 Jan 27;77(2):252-8.

      ●● Enlace al texto completo (gratuito o de pago) 1097/01.TP.0000101495.22734.07

AUTORES / AUTHORS:  - Ciancio G; Burke GW; Gaynor JJ; Mattiazzi A; Roth D; Kupin W; Nicolas M; Ruiz P; Rosen A; Miller J

INSTITUCIÓN / INSTITUTION:  - Department of Surgery, Division of Transplantation, University of Miami School of Medicine, Miami, FL 33101, USA. gciancio@med.miami.edu

RESUMEN / SUMMARY:  - BACKGROUND: In an attempt to reduce chronic calcineurin inhibitor induced allograft nephropathy in first cadaver and human leukocyte antigen non-identical living-donor renal transplantation, sirolimus (Siro) or mycophenolate mofetil (MMF) was tested as adjunctive therapy, with planned dose reductions of tacrolimus (Tacro) over the first year postoperatively. Adjunctive Siro therapy with a similar dose reduction algorithm for Neoral (Neo) was included for comparison. METHODS: The detailed dose reduction plan (Tacro and Siro, group A; Tacro and MMF, group B; Neo and Siro, group C) is described in our companion report in this issue of Transplantation. The present report documents function, patient and graft survival, protocol compliance, and adverse events. RESULTS: As mentioned (in companion report), group demographics were similar. The present study shows no significant differences in 1-year patient and graft survival but does show a trend that points to more difficulties in group C by way of a rising slope of serum creatinine concentration (P=0.02) and decreasing creatinine clearance (P=0.04). There were more patients who discontinued the protocol plan in group C. Thus far, no posttransplant lymphomas have appeared, and infectious complications have not differed among the groups. However, a greater percentage of patients in group C were placed on antihyperlipidemia therapy, with an (unexpected) trend toward a higher incidence of posttransplant diabetes mellitus in this group. Group A required fewer, and group B the fewest, antihyperlipidemia therapeutic interventions (P<0.00001). CONCLUSIONS: This 1-year interim analysis of a long-term, prospective, randomized renal-transplant study indicates that decreasing maintenance dosage of Tacro with adjunctive Siro or MMF appears to point to improved long-term function, with reasonably few adverse events.

 

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[2]

TÍTULO / TITLE:  - Early outcome after sirolimus-eluting stent implantation in patients with acute coronary syndromes: insights from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry.

REVISTA / JOURNAL:  - J Am Coll Cardiol 2003 Jun 4;41(11):2093-9.

AUTORES / AUTHORS:  - Lemos PA; Lee CH; Degertekin M; Saia F; Tanabe K; Arampatzis CA; Hoye A; van Duuren M; Sianos G; Smits PC; de Feyter P; van der Giessen WJ; van Domburg RT; Serruys PW

INSTITUCIÓN / INSTITUTION:  - Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Dr Molewaterplein 40, NL-3015 GD Rotterdam, the Netherlands.

RESUMEN / SUMMARY:  - OBJECTIVES: This study evaluated the early outcomes of patients with acute coronary syndromes (ACS) treated with sirolimus-eluting stents (SES). BACKGROUND: The safety of SES implantation in patients with a high risk for early thrombotic complications is currently unknown. METHODS: Sirolimus-eluting stents have been utilized as the device of choice for all percutaneous procedures in our institution, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. After four months of enrollment, 198 patients with ACS had been treated exclusively with SES (64% of those treated in the period) and were compared with a control group composed of 301 consecutive patients treated with bare stents in the same time period immediately before this study. The incidence of major adverse cardiac events (MACE) during the first month was evaluated (death, nonfatal myocardial infarction [MI], or re-intervention). RESULTS: Compared with control patients, patients treated with SES had more primary angioplasty (95% vs. 77%; p < 0.01), more bifurcation stenting (13% vs. 5%; p < 0.01), less previous MI (28% vs. 45%; p < 0.01), and less glycoprotein IIb/IIIa inhibitor utilization (27% vs. 42%; p < 0.01). The 30-day MACE rate was similar between both groups (SES 6.1% vs. control patients 6.6%; p = 0.8), with most complications occurring during the first week. Stent thrombosis occurred in 0.5% of SES patients and in 1.7% of control patients (p = 0.4). In multivariate analysis, SES utilization did not influence the incidence of MACE (odds ratio 1.0 [95% confidence interval: 0.4 to 2.2]; p = 0.97). CONCLUSIONS: Sirolimus-eluting stent implantation for patients with ACS is safe, with early outcomes comparable with bare metal stents.  N. Ref:: 25

 

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[3]

TÍTULO / TITLE:  - Pregnancy outcome after cyclosporine therapy during pregnancy: a meta-analysis.

REVISTA / JOURNAL:  - Transplantation 2001 Apr 27;71(8):1051-5.

AUTORES / AUTHORS:  - Bar Oz B; Hackman R; Einarson T; Koren G

INSTITUCIÓN / INSTITUTION:  - The Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children, Toronto, Ontario, Canada.

RESUMEN / SUMMARY:  - BACKGROUND: Cyclosporine (CsA) therapy must often be continued during pregnancy to maintain maternal health in such conditions as organ transplantation and autoimmune disease. This meta-analysis was performed to determine whether CsA exposure during pregnancy is associated with an increased risk of congenital malformations, preterm delivery, or low birthweight. METHODS: Various health science databases were searched to identify relevant articles. Articles selected for inclusion in the study were required to be free of any apparent selection bias and report outcomes in at least 10 newborns exposed to CsA in utero, specifically commenting on the presence or absence of congenital malformations. Article selection and data extraction were performed by two independent reviewers, with adjudication in cases of disagreement. To assess risks of CsA exposure, a summary odds ratio was calculated. Prevalence of malformations was calculated as a rate for all cyclosporine-exposed live births and for the subgroups identified. Ninety-five percent confidence intervals were constructed for both the odds ratio and prevalence rates. RESULTS: Fifteen studies (6 with control groups of transplant without use of cyclosporine; total patients: 410) met the inclusion criteria for major malformations, 10 for preterm delivery (4 with control groups; total patients: 379) and 5 for low birth weight (1 with control groups; total number of patients: 314). The calculated odds ratio of 3.83 for malformations did not achieve statistical significance (CI 0.75-19.6). The overall prevalence of major malformations in the study population (4.1%) also did not vary substantially from that reported in the general population. OR for prematurity [1.52 (CI 1.00-2.32)] did not reach statistical significance although the overall prevalence rate was 56.3%. The OR for low birth weight [1.5 (CI 0.95-2.44 based on 1 study)]. CONCLUSIONS: CsA does not appear to be a major human teratogen. It may be associated with increased rates of prematurity. More research is needed to evaluate whether cyclosporine increases teratogenic risk.

 

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[4]

TÍTULO / TITLE:  - Renal function as a predictor of long-term graft survival in renal transplant patients.

REVISTA / JOURNAL:  - Nephrol Dial Transplant. Acceso gratuito al texto completo a partir de los 2 años de la fecha de publicación.

      ●● Enlace a la Editora de la Revista http://ndt.oupjournals.org/ 

      ●● Cita: Nephrology Dialysis Transplantation: <> 2003 May;18 Suppl 1:i3-6.

AUTORES / AUTHORS:  - First MR

INSTITUCIÓN / INSTITUTION:  - Research and Development, Fujisawa Healthcare, Inc., Deerfield, IL 60015, USA. roy_first@fujisawa.com

RESUMEN / SUMMARY:  - Acute rejection is a major risk factor for kidney graft failure. However, as acute rejection has been progressively reduced by recent immunosuppressive regimens, other risk factors are becoming increasingly important. Evidence is accumulating that early renal function predicts long-term outcome. A recent registry survey of more than 100 000 kidney transplants found that 6- and 12-month serum creatinine levels, as well as the change between 6 and 12 months, are strongly associated with long-term graft survival. A survey of paediatric renal transplant recipients showed that poor creatinine clearance (<50 ml/min) as early as 30 days post-transplant predicted an annual rate of graft loss of 13% compared with <3% in patients with 30-day clearance >50 ml/min. This association between early renal function and long-term outcome was confirmed in multicentre studies. Renal transplant recipients (n=572) with 6-month serum creatinine levels >1.5 mg/dl suffered 3-year graft loss of 19.3% compared with only 8.5% in patients with levels <1.6 mg/dl (P<0.001). Significantly fewer patients receiving tacrolimus had 12-month serum creatinine levels >1.5 mg/dl compared with cyclosporin (42 versus 54%, P<0.05). Interestingly, a single-centre study (n=436) found that while glomerular filtration rate (GFR) at 6 months post-transplant had remained stable over the last decade, the rate of loss of renal function had decreased. A lower rate of GFR loss was associated with absence of rejection, use of mycophenolate mofetil rather than azathioprine and use of tacrolimus rather than cyclosporin (P<0.01). In conclusion, early measures of renal function allow identification of those patients at highest risk of graft failure and provide an invaluable tool for improving outcomes by tailored immunosuppression. The choice of such immunosuppression should be guided not only by its ability to prevent rejection, but also by its impact on renal function.  N. Ref:: 11

 

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[5]

TÍTULO / TITLE:  - Cyclosporin trough levels: is monitoring necessary during short-term treatment in psoriasis? A systematic review and clinical data on trough levels.

REVISTA / JOURNAL:  - Br J Dermatol 2002 Jul;147(1):122-9.

AUTORES / AUTHORS:  - Heydendael VM; Spuls PI; Ten Berge IJ; Opmeer BC; Bos JD; de Rie MA

INSTITUCIÓN / INSTITUTION:  - Department of Dermatology, Academic Medical Center, University of Amsterdam, PO Box 22660, the Netherlands.

RESUMEN / SUMMARY:  - BACKGROUND: Cyclosporin is an effective treatment for severe plaque psoriasis. Unfortunately, its use may be limited by time- and dose-related nephrotoxicity. Serum trough levels may be useful for monitoring the risk of nephrotoxicity. OBJECTIVES: To determine whether monitoring of trough levels is necessary in psoriasis patients undergoing short-term treatment with cyclosporin. METHODS: A computerized and manual literature search identified studies on adults with plaque-type psoriasis treated with cyclosporin < or = 5 mg kg-1 daily, in which trough levels were measured in whole blood. Number of patients, treatment duration, formulation and dosage, renal function tests and trough levels were extracted. The association between renal function and trough levels was investigated. Additionally, in a randomized controlled trial on cyclosporin vs. methotrexate in moderate to severe psoriasis, cyclosporin trough levels were measured frequently in 20 patients during 12 weeks of treatment. The Pearson correlation coefficient between serum creatinine and cyclosporin trough levels was calculated. RESULTS: Fifty-six articles were found concerning cyclosporin trough level measurements in psoriasis patients, of which eight were analysed. Many studies were excluded due to inappropriate cyclosporin dosages used. As data were heterogeneous and lacked various key parameters, a correlation study and a meta-analysis could not be performed. Instead, a quantitative description of the literature was given. No high mean trough levels or elevations of serum creatinine were described. In our clinical study, all the mean trough levels in 17 patients treated with cyclosporin 3 mg kg-1 daily were within the therapeutic range (< 200 ng mL-1). Elevated trough levels were found in two of three patients treated with cyclosporin 3-5 mg kg-1 daily. No signs of renal dysfunction were seen. CONCLUSIONS: The literature does not provide a definitive answer on whether monitoring cyclosporin trough levels in patients with psoriasis should be standard practice. Our own data show no need for cyclosporin trough level monitoring during short-term treatment with cyclosporin 3 mg kg-1 daily. However, when cyclosporin doses are > 3 mg kg-1 daily, monitoring may be indicated.  N. Ref:: 32

 

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[6]

TÍTULO / TITLE:  - Prospects for treatment of paraquat-induced lung fibrosis with immunosuppressive drugs and the need for better prediction of outcome: a systematic review.

REVISTA / JOURNAL:  - Qjm. Acceso gratuito al texto completo a partir de los 2 años de la fecha de publicación.

      ●● Enlace a la Editora de la Revista http://qjmed.oupjournals.org/ 

      ●● Cita: QJM: <> 2003 Nov;96(11):809-24.

AUTORES / AUTHORS:  - Eddleston M; Wilks MF; Buckley NA

INSTITUCIÓN / INSTITUTION:  - Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, UK. eddlestonm@eureka.lk

RESUMEN / SUMMARY:  - BACKGROUND: Acute paraquat self-poisoning is a significant problem in parts of Asia, the Pacific and the Caribbean. Ingestion of large amounts of paraquat results in rapid death, but smaller doses often cause a delayed lung fibrosis that is usually fatal. Anti-neutrophil (‘immunosuppressive’) treatment has been recommended to prevent lung fibrosis, but there is no consensus on efficacy. Aim: To review the evidence for the use of immunosuppression in paraquat poisoning, and to identify validated prognostic systems that would allow the use of data from historical control studies and the future identification of patients who might benefit from immunosuppression. DESIGN:Systematic review. METHODS: We searched PubMed, Embase and Cochrane databases for ‘paraquat’ together with ‘poisoning’ or ‘overdose’. We cross-checked references and contacted experts, and searched on [www.google.com] and [www.yahoo.com] using ‘paraquat’, ‘cyclophosphamide’, ‘methylprednisolone’ and ‘prognosis’. RESULTS: We found ten clinical studies of immunosuppression in paraquat poisoning. One was a randomized controlled trial (RCT). Seven used historical controls only; the other two were small (n = 1 and n = 4). Mortality in controls and patients varied markedly between studies. Three of the seven non-RCT controlled studies measured plasma paraquat; analysis using Proudfoot’s or Hart’s nomograms did not suggest that immunosuppression increased survival in these studies. Of 16 prognostic systems for paraquat poisoning, none has been independently validated in a large cohort. DISCUSSION: The authors of the RCT have performed valuable and difficult research, but their results are hypothesis-forming rather than conclusive; elsewhere, the use of historical controls is problematic. In the absence of a validated prognostic marker, a large RCT of immunosuppression using death as the primary outcome is required. This RCT should also prospectively test and validate the available prognostic methods, so that future patients can be selected for this and other therapies on admission.  N. Ref:: 57

 

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[7]

TÍTULO / TITLE:  - A benefit-risk assessment of basiliximab in renal transplantation.

REVISTA / JOURNAL:  - Drug Saf. Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://www.csmwm.org/ 

      ●● Cita: Drug Safety: <> 2004;27(2):91-106.

AUTORES / AUTHORS:  - Boggi U; Danesi R; Vistoli F; Del Chiaro M; Signori S; Marchetti P; Del Tacca M; Mosca F

INSTITUCIÓN / INSTITUTION:  - Division of General Surgery and Transplants, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy. uboggi@med.unipi.it

RESUMEN / SUMMARY:  - Interleukin-2 (IL-2) and its receptor (IL-2R) play a central role in T lymphocyte activation and immune response after transplantation. Research on the biology of IL-2R allowed the identification of key signal transduction pathways involved in the generation of proliferative and antiapoptotic signals in T cells. The alpha-chain of the IL-2R is a specific peptide against which monoclonal antibodies have been raised, with the aim of blunting the immune response by means of inhibiting proliferation and inducing apoptosis in primed lymphocytes. Indeed, basiliximab, one of such antibodies, has proved to be effective in reducing the episodes of acute rejection after kidney and pancreas transplantation. The use of basiliximab was associated with a significant reduction in the incidence of any treated rejection episodes after kidney transplantation in the two major randomised studies (placebo 52.2% vs basiliximab 34.2% at 6 months, European study; placebo 54.9% vs basiliximab 37.6% at 1 year, US trial). Basiliximab and equine antithymocyte globulin (ATG) administration resulted in a similar rate of biopsy-proven acute rejection at 6 months (19% for both) and at 12 months (19% and 20%, respectively). The use of basiliximab appears not to be associated with an increased incidence of adverse events as compared with placebo in immunosuppressive regimens, including calcineurin inhibitors, mycophenolate mofetil or azathioprine and corticosteroids, and its safety profile is superior to ATG. Moreover, a similar occurrence of infections is noted in selected studies (65.5% after basiliximab vs 65.7% of controls), including cytomegalovirus infection (17.3% vs 14.5%), and cytokine-release syndrome is not observed. Finally, economic analysis demonstrated lower costs of overall treatment in patients treated with basiliximab. Therefore, the use of basiliximab entails a very low risk, allows safe reduction of corticosteroid dosage and reduces the short- and mid-term rejection rates. However, the improvement in the long-term survival of kidney grafts in patients treated according to modern immunosuppressive protocols is still to be demonstrated. These conclusions are based on a systematic review of the scientific literature, indexed on Medline database, concerning the mechanism of action, therapeutic activity, safety and pharmacoeconomic evaluation of basiliximab in renal transplantation.  N. Ref:: 62

 

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[8]

TÍTULO / TITLE:  - Conventional treatment of Crohn’s disease: objectives and outcomes.

REVISTA / JOURNAL:  - Inflamm Bowel Dis 2001 May;7 Suppl 1:S2-8.

AUTORES / AUTHORS:  - Rutgeerts PJ

INSTITUCIÓN / INSTITUTION:  - Inflammatory Bowel Disease Unit, University of Leuven, Belgium.

RESUMEN / SUMMARY:  - Despite conventional medical and/or surgical intervention, endoscopic and symptomatic relapse is common among individuals with Crohn’s disease (CD). Treatment goals have therefore been refocused to include achieving control of active disease and maintaining remission with agents associated with a minimum of toxic adverse effects. Conventional treatment regimens have been used with varying success in regard to these therapeutic goals. Traditionally, aminosalicylates have been considered effective in inducing a response in some patients with mild-to-moderate CD but have demonstrated little or no long-term benefit in controlled clinical trials. Glucocorticosteroid therapy is associated with higher rates of response in patients with active CD; however, clinical benefits are frequently offset by the common occurrence of corticosteroid-related toxicity. Oral controlled-release budesonide has demonstrated comparable efficacy to prednisolone with less risk for adverse effects, although many questions remain regarding the long-term use of this agent. Response to standard immunosuppressive agents such as azathioprine and 6-mercaptopurine in patients with active disease may require 3 to 6 months from initiation of treatment. These agents are therefore considered most valuable as maintenance therapy, providing consistent long-term benefit in patients with chronic refractory or corticosteroid-dependent disease. Although the incidence of allergic adverse effects is relatively low with azathioprine/6-mercaptopurine, more serious adverse effects, including bone marrow suppression, hepatotoxicity, pancreatitis, and infectious complications, can occur. Limited success in the treatment of perianal disease has been achieved with antibiotics such as metronidazole and the immunosuppressives cyclosporine and azathioprine/6-mercaptopurine. Although broader use of immunosuppressive agents has allowed improvement in the maintenance of remission in patients with CD, long-term safety data with these agents are lacking, concerns about toxicity and the potential risk for neoplasia remain, and attenuation of response with chronic immunosuppressive use can occur. Therefore, innovative therapeutic approaches are needed to meet key treatment goals often not addressed by conventional therapies.  N. Ref:: 48

 

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[9]

TÍTULO / TITLE:  - Pharmacokinetic, pharmacodynamic, and outcome investigations as the basis for mycophenolic acid therapeutic drug monitoring in renal and heart transplant patients.

REVISTA / JOURNAL:  - Clin Biochem 2001 Feb;34(1):17-22.

AUTORES / AUTHORS:  - Shaw LM; Korecka M; DeNofrio D; Brayman KL

INSTITUCIÓN / INSTITUTION:  - Departments of Pathology & Laboratory Medicine and Surgery, University of Pennsylvania Medical Center, Philadelphia, PA, USA. shawlmj@mail.med.upenn.edu

RESUMEN / SUMMARY:  - Mycophenolate mofetil is widely used in combination with either cyclosporine or tacrolimus for rejection prophylaxis in renal and heart transplant patients. Although not monitored routinely nearly to the degree that other agents such as cyclosporine or tacrolimus, there is an expanding body of experimental evidence for the utility of monitoring mycophenolic acid, the primary active metabolite of mycophenolate mofetil, plasma concentration as an index of risk for the development of acute rejection. The following are important experimentally-based reasons for recommending the incorporation of target therapeutic concentration monitoring of mycophenolic acid: (1) the MPA dose-interval area-under-the-concentration-time curve, and less precisely, MPA predose concentrations predict the risk for development of acute rejection; (2) the strong correlation between mycophenolic acid plasma concentrations and expression of important cell surface activation antigens, whole blood pharmacodynamic assays of lymphocyte proliferation and median graft rejection scores in a heart transplant animal model; (3) the greater than 10-fold interindividual variation of MPA area under the concentration time curve values in heart and renal transplant patients receiving a fixed dose of the parent drug; (4) drug-drug interactions involving other immunosuppressives are such that when switching from one to another (eg, from cyclosporine to tacrolimus or vice-versa) substantial changes in MPA concentrations can occur in patients receiving a fixed dose of the parent drug; (5) significant effects of liver and kidney diseases on the steady-state total and free mycophenolic acid area under the concentration time curve values; (6) the need to closely monitor mycophenolic acid when a major change in immunosuppression is planned such as steroid withdrawal. Current investigations are focused on determination of the most optimal sampling time and for mycophenolic acid target therapeutic concentration monitoring. Further investigations are needed to evaluate the pharmacologic activity of the newly described acyl glucuronide metabolite of mycophenolic acid which has been shown to inhibit, in vitro, inosine monophosphate dehydrogenase.  N. Ref:: 37

 

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[10]

TÍTULO / TITLE:  - Cryptococcus neoformans infection in organ transplant recipients: variables influencing clinical characteristics and outcome.

REVISTA / JOURNAL:  - Emerg Infect Dis. Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://www.cdc.gov/ 

      ●● Cita: Emerging Infectious Diseases: <> 2001 May-Jun;7(3):375-81.

AUTORES / AUTHORS:  - Husain S; Wagener MM; Singh N

INSTITUCIÓN / INSTITUTION:  - Veterans Affairs Medical Center and University of Pittsburgh, Thomas E. Starzl Transplantation Institute, Pittsburgh, Pennsylvania 15240, USA.

RESUMEN / SUMMARY:  - Unique clinical characteristics and other variables influencing the outcome of Cryptococcus neoformans infection in organ transplant recipients have not been well defined. From a review of published reports, we found that C. neoformans infection was documented in 2.8% of organ transplant recipients (overall death rate 42%). The type of primary immunosuppressive agent used in transplantation influenced the predominant clinical manifestation of cryptococcosis. Patients receiving tacrolimus were significantly less likely to have central nervous system involvement (78% versus 11%, p =0.001) and more likely to have skin, soft-tissue, and osteoarticular involvement (66% versus 21%, p = 0.006) than patients receiving nontacrolimus- based immunosuppression. Renal failure at admission was the only independently significant predictor of death in these patients (odds ratio 16.4, 95% CI 1.9-143, p = 0.004). Hypotheses based on these data may elucidate the pathogenesis and may ultimately guide the management of C. neoformans infection in organ transplant recipients.  N. Ref:: 74

 

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[11]

TÍTULO / TITLE:  - International Federation of Clinical Chemistry/International Association of Therapeutic Drug Monitoring and Clinical Toxicology working group on immunosuppressive drug monitoring.

REVISTA / JOURNAL:  - Ther Drug Monit 2002 Feb;24(1):59-67.

AUTORES / AUTHORS:  - Holt DW; Armstrong VW; Griesmacher A; Morris RG; Napoli KL; Shaw LM

INSTITUCIÓN / INSTITUTION:  - Analytical Unit, St George’s Hospital Medical School, London, UK. d.holt@sghms.ac.uk

RESUMEN / SUMMARY:  - Issues surrounding the measurement and interpretation of immunosuppressive drug concentrations have been summarized in a number of consensus documents. The Scientific Division of the International Federation of Clinical Chemistry has formed a working group in collaboration with the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. This paper sets out the goals of the working group in light of the developments that have occurred in the field of immunosuppressive drug monitoring since the publication of the last consensus documents.

 

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[12]

TÍTULO / TITLE:  - Controlling the incidence of infection and malignancy by modifying immunosuppression.

REVISTA / JOURNAL:  - Transplantation 2001 Dec 27;72(12 Suppl):S89-93.

AUTORES / AUTHORS:  - Soulillou JP; Giral M

RESUMEN / SUMMARY:  - Long-term outcomes in renal transplantation have improved over the years but are still a matter of concern. Because patients typically require lifelong immunosuppression, the risks of cancer and infection associated with immunosuppressive agents continue to demand attention. Physicians strive endlessly to find the right balance between the level of immunosuppression required to prevent rejection and the level that will minimize dose-dependent side effects. Data presented in this paper suggest that some renal transplant recipients might have more than necessary immunosuppression during maintenance therapy and that reducing the immunosuppressant dose can decrease cancer incidence, without worsening long-term patient or allograft survival. Additionally, data were examined suggesting that immunosuppressive agents might be associated with different risks for cancer, specifically, the potential advantage of reduced cancer risk for sirolimus and sirolimus derivatives in comparison with standard immunosuppressive agents. Although promising, these preliminary results are from preclinical studies, and further study is warranted.  N. Ref:: 42

 

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[13]

TÍTULO / TITLE:  - St John’s wort (Hypericum perforatum): drug interactions and clinical outcomes.

REVISTA / JOURNAL:  - Br J Clin Pharmacol 2002 Oct;54(4):349-56.

AUTORES / AUTHORS:  - Henderson L; Yue QY; Bergquist C; Gerden B; Arlett P

INSTITUCIÓN / INSTITUTION:  - Pharmacovigilance Group, Medicines Control Agency, UK. leigh.henderson@mca.gsi.gov.uk

RESUMEN / SUMMARY:  - AIMS: The aim of this work is to identify the medicines which interact with the herbal remedy St John’s wort (SJW), and the mechanisms responsible. METHODS: A systematic review of all the available evidence, including worldwide published literature and spontaneous case reports provided by healthcare professionals and regulatory authorities within Europe has been undertaken. RESULTS: A number of clinically significant interactions have been identified with prescribed medicines including warfarin, phenprocoumon, cyclosporin, HIV protease inhibitors, theophylline, digoxin and oral contraceptives resulting in a decrease in concentration or effect of the medicines. These interactions are probably due to the induction of cytochrome P450 isoenzymes CYP3A4, CYP2C9, CYP1A2 and the transport protein P-glycoprotein by constituent(s) in SJW. The degree of induction is unpredictable due to factors such as the variable quality and quantity of constituent(s) in SJW preparations. In addition, possible pharmacodynamic interactions with selective serotonin re-uptake inhibitors and serotonin (5-HT(1d)) receptor-agonists such as triptans used to treat migraine were identified. These interactions are associated with an increased risk of adverse reactions. CONCLUSIONS: In Sweden and the UK the potential risks to patients were judged to be significant and therefore information about the interactions was provided to health care professionals and patients. The product information of the licensed medicines involved has been amended to reflect these newly identified interactions and SJW preparations have been voluntarily labelled with appropriate warnings.  N. Ref:: 44

 

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[14]

TÍTULO / TITLE:  - Risk factors for bronchiolitis obliterans: a systematic review of recent publications.

REVISTA / JOURNAL:  - J Heart Lung Transplant 2002 Feb;21(2):271-81.

AUTORES / AUTHORS:  - Sharples LD; McNeil K; Stewart S; Wallwork J

INSTITUCIÓN / INSTITUTION:  - Medical Research Council (MRC) Biostatistics Unit, University Forvie Site, Papworth Everard, Cambridge, United Kingdom. linda.sharples@mrc-bsu.cam.ac.uk

RESUMEN / SUMMARY:  - BACKGROUND: Obliterative bronchiolitis remains the major limitation to long-term survival after lung transplantation. A thorough understanding of the factors that confer high risk of developing obliterative bronchiolitis or its physiologic surrogate bronchiolitis obliterans syndrome is important to help define therapeutic strategies. METHODS: We performed a systematic review of studies published since the beginning of 1990. The review excluded non-human studies, publications before 1990, small (less than 25 patients) studies that were predominantly concerned with investigating the pathogenesis of obliterative bronchiolitis, studies solely concerned with diagnosis or treatment of obliterative bronchiolitis, and overlapping studies from the same center. Onset of bronchiolitis obliterans syndrome or obliterative bronchiolitis was the outcome of interest. RESULTS: Acute rejection plays an important role in obliterative bronchiolitis and bronchiolitis obliterans syndrome onset, and late rejection is a significant risk factor. Lymphocytic bronchitis/bronchiolitis is also a risk factor, with some evidence that late onset is associated with greater risk. The effects of cytomegalovirus, other infectious organisms, and human leukocyte antigen matching are less clear and require further confirmation. There is little evidence that recipient and donor characteristics play a major role. CONCLUSIONS: This systematic review supports the view that obliterative bronchiolitis arises from alloimmunologic injury marked by clinically apparent acute rejection episodes and that inflammatory conditions, including viral infections or ischemic injury, may also play a role. Implications for therapy are discussed.  N. Ref:: 28

 

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[15]

TÍTULO / TITLE:  - Kidney transplantation from living-unrelated donors: comparison of outcome with living-related and cadaveric transplants under current immunosuppressive protocols.

REVISTA / JOURNAL:  - Urology 2003 Dec;62(6):1002-6.

AUTORES / AUTHORS:  - Chkhotua AB; Klein T; Shabtai E; Yussim A; Bar-Nathan N; Shaharabani E; Lustig S; Mor E

INSTITUCIÓN / INSTITUTION:  - National Centre of Urology, Tbilisi, Georgia.

RESUMEN / SUMMARY:  - OBJECTIVES: Living-unrelated donors may become an additional organ source for patients on the kidney waiting list. We studied the impact of a combination of calcineurin inhibitors and mycophenolate-mofetil together with steroids on the outcomes of living-related (LRD), unrelated (LUR), and cadaver transplantation. METHODS: Between September 1997 and January 2000, 129 patients underwent LRD (n = 80) or LUR (n = 49) kidney transplantation, and another 173 patients received a cadaveric kidney. Immunosuppressive protocols consisted of mycophenolate-mofetil with cyclosporine-Neoral (41%) or tacrolimus (59%) plus steroids. We compared the patient and graft survival data, rejection rate, and graft functional parameters. RESULTS: LRD recipients were younger (33.6 years) than LUR (47.8 years) and cadaver (43.7 years) donor recipients (P <0.001). HLA matching was higher in LRD patients (P <0.001). Acute rejection developed in 28.6% of LUR versus 27.5% of LRD transplants and 29.7% of cadaver kidney recipients (P = not significant). The creatinine level at 1, 2, and 3 years after transplant was 1.63, 1.73, and 1.70 mg% for LRD patients; 1.48, 1.48, and 1.32 mg% for LUR patients; and 1.75, 1.68, and 1.67 mg% for cadaver kidney recipients (P = not significant), respectively. No difference in patient survival rates was found among the groups. The 1, 2, and 3-year graft survival rates were significantly better in recipients of LRD (91.3%, 90.0%, and 87.5%, respectively) and LUR transplants (89.8%, 87.8%, and 87.8%, respectively) than in cadaver kidney recipients (81.5%, 78.6%, 76.3%, respectively; P <0.01). CONCLUSIONS: Despite HLA disparity, the rejection and survival rates of LUR transplants under current immunosuppressive protocols are comparable to those of LRD and better than those of cadaveric transplants.

 

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[16]

TÍTULO / TITLE:  - Therapeutic drug monitoring of immunosuppressant drugs in clinical practice.

REVISTA / JOURNAL:  - Clin Ther 2002 Mar;24(3):330-50; discussion 329.

AUTORES / AUTHORS:  - Kahan BD; Keown P; Levy GA; Johnston A

INSTITUCIÓN / INSTITUTION:  - Division of Immunology and Organ Transplantation, University of Texas Health Science Center at Houston Medical School, 77030, USA. Barry.D.Kahan@uth.tmc.edu

RESUMEN / SUMMARY:  - BACKGROUND: Therapeutic drug monitoring (TDM) is essential to maintain the efficacy of many immunosuppressant drugs while minimizing their toxicity. TDM has become more refined with the development of new monitoring techniques and more specific assays. OBJECTIVE: This article summarizes current data on TDM of the following immunosuppressant drugs used in organ transplantation: cyclosporine, tacrolimus, sirolimus, everolimus, and mycophenolate mofetil. METHODS: Published data were identified by a MEDLINE search of the English-language literature through March 2001 using the terms therapeutic drug monitoring, cyclosporine, tacrolimus, sirolimus, everolimus, and mycophenolate mofetil. Relevant conference abstracts were also included. RESULTS: TDM of cyclosporine has been well studied, and recent findings indicate that monitoring of drug levels 2 hours after dosing is a more sensitive predictor of outcome than trough (C0) monitoring. C0 levels are being used more widely in TDM of tacrolimus; however, the relationship between C0 and area under the curve has varied widely in clinical trials, with correlations ranging from 0.11 to 0.92. The use of TDM of sirolimus, everolimus, and mycophenolate mofetil is evolving rapidly. CONCLUSIONS: TDM of immunosuppressant drugs that have a narrow therapeutic index is an increasingly useful tool for minimizing drug toxicity while maximizing prevention of graft loss and organ rejection.  N. Ref:: 85

 

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[17]

TÍTULO / TITLE:  - Therapeutic monitoring of mycophenolate mofetil in organ transplant recipients: is it necessary?

REVISTA / JOURNAL:  - Clin Pharmacokinet 2002;41(5):319-27.

AUTORES / AUTHORS:  - Mourad M; Wallemacq P; Konig J; de Frahan EH; Eddour DC; De Meyer M; Malaise J; Squifflet JP

INSTITUCIÓN / INSTITUTION:  - Department of Kidney and Pancreas Transplantation, University Hospital Saint Luc, Universite Catholique de Louvain, Brussels, Belgium. Michel.Mourad@chir.ucl.ac.be

RESUMEN / SUMMARY:  - Adequate immunosuppression minimising the risk of organ rejection with acceptable tolerability of the used drugs is a crucial step in organ transplantation. The primary goal is to maintain a consistent time-dependent target concentration by tailoring individual dosage leading to the best efficacy and tolerability combination. The use of therapeutic drug monitoring (TDM) to optimise immunosuppressive therapy is routinely employed for maintenance drugs such as cyclosporin and tacrolimus. The question whether therapeutic monitoring of mycophenolic acid (MPA) in organ transplant recipients treated with mycophenolate mofetil is necessary is not definitely answered. The correlation of mycophenolic acid pharmacokinetic parameters with efficacy and toxicity makes the therapeutic monitoring of this drug promising. However, further studies are mandatory to draw the best guidelines in order to achieve higher levels of evidence that MPA-TDM may improve patient outcome.  N. Ref:: 63

 

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[18]

TÍTULO / TITLE:  - Role of chiral chromatography in therapeutic drug monitoring and in clinical and forensic toxicology.

REVISTA / JOURNAL:  - Ther Drug Monit 2002 Apr;24(2):290-6.

AUTORES / AUTHORS:  - Williams ML; Wainer IW

INSTITUCIÓN / INSTITUTION:  - Department of Oncology, Leicester University, Leicester, United Kingdom.

RESUMEN / SUMMARY:  - Advances in chiral chromatographic separations have given pharmacologists and toxicologists the tools to examine unexpected clinical results involving chiral drugs. The ability to unravel complex phenomena associated with drug transport and drug metabolism is presented in this manuscript. The relation between the chirality of the drug mefloquine and the intracellular concentrations of the drug cyclosporine is illustrated by examining the effect of the enantiomers of mefloquine on the transport activity of P-glycoprotein (Pgp). These studies were conducted using a liquid chromatographic column containing immobilized Pgp. The results demonstrated that (+)-mefloquine competitively displaced the Pgp substrate cyclosporine whereas (-)-mefloquine had no effect on cyclosporine-Pgp binding. The data suggest that cyclosporine cellular and CNS concentrations can be increased through the concomitant administration of (+)-mefloquine. The use of chirality in clinical and forensic situations is also illustrated by the metabolism of the enantiomers of ketamine (KET). The plasma concentrations of (+)-KET and (-)-KET and the norketamine metabolites (+)-NK and (-)-NK were measured in rat plasma using enantioselective gas chromatography. The separations were accomplished using a gas chromatography chiral stationary phase based on beta-cyclodextrin. The pharmacokinetic profiles of (+)-, (-)-KET and (+)-, (-)-NK were determined in control and protein-calorie malnourished (PCM) rats to determine the effect of PCM on ketamine metabolism and clearance. The results indicate that PCM produced a significant and stereoselective decrease in KET and NK metabolism. The data suggest that the effects of environmental factors (smoking, alcohol use, diet) and drug interactions (coadministered agents) can be measured using the changes in stereochemical metabolic and pharmacokinetic patterns of KET and similar drugs.  N. Ref:: 33

 

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[19]

TÍTULO / TITLE:  - Long-term kidney transplant survival.

REVISTA / JOURNAL:  - Am J Kidney Dis 2001 Dec;38(6 Suppl 6):S44-50.

AUTORES / AUTHORS:  - Hariharan S

INSTITUCIÓN / INSTITUTION:  - Froedert Memorial Hospital, Medical College of Wisconsin, Milwaukee, WI 53226, USA. hari@mcw.edu

RESUMEN / SUMMARY:  - With improvements in short-term kidney graft survival, focus has shifted towards long-term survival. There has also been a substantial improvement in long-term survival as measured by kidney half-life. Long-term graft failure is secondary to chronic allograft nephropathy (CAN), recurrent disease, and death with a functioning graft. CAN is secondary to a combination of chronic rejection, chronic cyclosporine toxicity, and/or donor kidney disease. Risk factors for chronic rejection have been attributed to both immunological and nonimmunological causes. With a marked reduction in acute rejection rates-an important risk factor for CAN-there is a substantial improvement in kidney half-life. There are still nonimmunological factors, such as donor age, that adversely affect long-term graft survival. In addition, African-American recipients continue to have a shorter graft half-life. Recurrent disease is becoming an important cause of late graft failure. Despite the introduction of various potent immunosuppressive agents, there has been little or no impact on the prevalence as well as progression of recurrent diasease. With the reduction of acute rejection rates and improved short- and long-term graft survival, further improvements of long-term graft survival will be an important focus in the 21st century.  N. Ref:: 45

 

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[20]

TÍTULO / TITLE:  - Studies of Pediatric Liver Transplantation (SPLIT): year 2000 outcomes.

REVISTA / JOURNAL:  - Transplantation 2001 Aug 15;72(3):463-76.

INSTITUCIÓN / INSTITUTION:  - c/o The EMMES Corporation, 401 N. Washington Street, Suite 700, Rockville, MD 20850, USA. splitpub@emmes.com

RESUMEN / SUMMARY:  - BACKGROUND: Initiated in 1995, the Studies of Pediatric Liver Transplantation (SPLIT) registry database is a cooperative research network of pediatric transplantation centers in the United States and Canada. The primary objectives are to characterize and follow trends in transplant indications, transplantation techniques, and outcomes (e.g., patient/graft survival, rejection, growth parameters, and immunosuppressive therapy.) METHODS: As of June 15, 2000, 29 centers registered 1144 patients, 640 of whom received their first liver-only transplant while registered in SPLIT. Patients are followed every 6 months for 2 years and yearly thereafter. Data are submitted to a central coordinating center. RESULTS: One/two-year patient survival and graft loss estimates are 0.85/0.82 and 0.77/0.72, respectively. Risk factors for death include: in ICU at transplant (relative risk (RR)=2.63, P<0.05) and height/weight deficits of two or more standard deviations (RR=1.67, P<0.05). Risk factors for graft loss include: in ICU at transplant (RR=1.77, P<0.05) and receiving a cadaveric split organ compared with a whole organ (RR=2.3, P<0.05). The percentage of patients diagnosed with hepatic a. and portal v. thrombosis were 9.7% and 7%, respectively; 15% had biliary complications within 30 days. At least one re-operation was required in 45%. One/two-year rejection probability estimates are 0.60/0.66. Tacrolimus, as primary therapy posttransplant, reduces first rejection risk (RR=0.70, P<0.05). Eighty-nine percent of school-aged children are in school full-time, 18 months posttransplant. CONCLUSIONS: This report provides one of the first descriptions of characteristics and clinical courses of a multicenter pediatric transplant population. Observations are subject to patient selection biases but are useful for generating hypothesis for future studies.

 

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[21]

TÍTULO / TITLE:  - New strategies to optimize clinical outcomes with cyclosporine in liver transplantation.

REVISTA / JOURNAL:  - Gastroenterol Hepatol. Acceso gratuito al texto completo a partir de los 2 años de la fecha de publicación.

      ●● Enlace a la Editora de la Revista http://db.doyma.es/ 

      ●● Cita: Gastroenterología & Hepatología: <> 2002 Apr;25(4):289-93.

AUTORES / AUTHORS:  - Levy GA

INSTITUCIÓN / INSTITUTION:  - Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.  N. Ref:: 25

 

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[22]

TÍTULO / TITLE:  - Incidence and spectrum of infections in lung transplanted patients: comparison of four different immunosuppressive protocols.

REVISTA / JOURNAL:  - Transplant Proc 2001 Feb-Mar;33(1-2):1620-1.

AUTORES / AUTHORS:  - Treede H; Reichenspurner H; Meiser BM; Kur F; Furst H; Vogelmeier C; Briegel J; Reichart B

INSTITUCIÓN / INSTITUTION:  - University Hospital Grosshadern, Munich, Germany.

 

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[23]

TÍTULO / TITLE:  - Donor specific transfusion in kidney transplantation: effect of different immunosuppressive protocols on graft outcome.

REVISTA / JOURNAL:  - Transplant Proc 2001 Aug;33(5):2787-8.

AUTORES / AUTHORS:  - Barbari A; Stephan A; Masri MA; Joubran N; Dagher O; Kamel G

INSTITUCIÓN / INSTITUTION:  - Department ofNephrology and Transplantation, Rizk Hospital, Beirut, Lebanon.

 

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[24]

TÍTULO / TITLE:  - Strategies to reduce toxicities and improve outcomes in renal transplant recipients.

REVISTA / JOURNAL:  - Pharmacotherapy 2002 Mar;22(3):316-28.

AUTORES / AUTHORS:  - Lo A; Alloway RR

INSTITUCIÓN / INSTITUTION:  - Department of Surgery, University of Cincinnati Medical Center, Ohio 45267-0585, USA.

RESUMEN / SUMMARY:  - Ongoing improvements in immunosuppression and posttransplantation care have dramatically improved patient and graft outcomes after transplantation. The frequency of graft loss due to acute rejection has declined considerably as a result of the availability of a variety of more potent immunosuppressive agents and probably also because of refined clinical care and follow-up. Complications of long-term administration of corticosteroids (steroids) and calcineurin inhibitors, however, have become increasingly apparent as patients live longer with their transplant, and attention is shifting to long-term issues. Use of both steroids and calcineurin inhibitors is associated with metabolic toxicities such as hypertension, hyperlipidemia, diabetes, bone loss, and cataracts. These contribute to posttransplantation morbidity and may negatively affect patient and allograft survival. A variety of troublesome cosmetic side effects, such as hirsutism, gingival hyperplasia, alopecia, obesity, and cushingoid appearance, also are associated with these drugs. These effects can detract from patient self-esteem and compliance with the immunosuppressive regimen. In the past 2 decades, the introduction of second-generation immunosuppressive drugs, such as tacrolimus, mycophenolate mofetil, sirolimus, and anti-interleukin-2 receptor monoclonal antibodies, has provided some alternatives to classic immunosuppressant choices. Patients experiencing undesirable adverse events now can be converted to another immunosuppressive regimen that ultimately will improve graft and patient survival rates and improve quality of life after transplantation.  N. Ref:: 99

 

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[25]

TÍTULO / TITLE:  - Outcomes in kidney transplantation.

REVISTA / JOURNAL:  - Semin Nephrol 2003 May;23(3):306-16.

AUTORES / AUTHORS:  - Djamali A; Premasathian N; Pirsch JD

INSTITUCIÓN / INSTITUTION:  - Department of Medicine and Surgery, University of Wisconsin Medical School, Madison, WI 53792, USA.

RESUMEN / SUMMARY:  - It is estimated that there are greater than 100000 kidney transplant recipients with a functioning graft in the United States. Recent advances in immunosuppression have improved short-term graft survival rates and decreased early mortality by decreasing the incidence and therapy for acute rejection episodes. For those accepted on the waiting list, transplant prolongs patient survival compared with remaining on dialysis. During the 1990s, 3 new immunosuppressive drugs were introduced in clinical kidney transplantation. All were approved for use by the Food and Drug Administration after large, controlled, randomized trials. Mycophenolate mofetil (MMF), when combined with cyclosporine (CSA) and prednisone, lowered acute rejection rates by nearly 50% compared with control. Tacrolimus compared with CSA also significantly reduced acute rejection rates in kidney transplant recipients, but was associated with a significant increase in posttransplant diabetes mellitus (PTDM) in the early trials. When evaluated in combination with MMF, the incidence of PTDM was much lower. At the end of the decade, sirolimus was shown in several randomized trials to lower acute rejection rates and is believed to be less nephrotoxic compared with calcineurin inhibitors. All of the randomized trials were not statistically powered to assess long-term superiority. Registry analyses have been performed that appear to show some long-term benefit of immunosuppressive therapy with MMF. Other outcome assessments in kidney transplant recipients include risk factors for chronic allograft nephropathy, hypertension, hyperlipidemia, and bone disease. Although there are few randomized trials, understanding of the significance of these common complications has progressed and strategies for therapy and intervention have been developed. This article focuses on the randomized trials of immunosuppressive therapy and complications associated with use of these drugs. In addition, we review the current management and intervention for the comorbidities associated with the long-term clinical management of the kidney transplant recipient.  N. Ref:: 78

 

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[26]

TÍTULO / TITLE:  - Promising early outcomes with a novel, complete steroid avoidance immunosuppression protocol in pediatric renal transplantation.

REVISTA / JOURNAL:  - Transplantation 2001 Jul 15;72(1):13-21.

AUTORES / AUTHORS:  - Sarwal MM; Yorgin PD; Alexander S; Millan MT; Belson A; Belanger N; Granucci L; Major C; Costaglio C; Sanchez J; Orlandi P; Salvatierra O Jr

INSTITUCIÓN / INSTITUTION:  - Department of Surgery, Stanford University Medical Center, 703 Welch Road, Suite H-5, Palo Alto, CA 94304, USA.

RESUMEN / SUMMARY:  <