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Clinical transplantation 33건

  1. [해외논문]   A national survey of valganciclovir dosing strategies in pediatric organ transplant recipients  

    Shaikh, S. , Jasiak-Panek, N. , Park, J. M.
    Clinical transplantation v.32 no.9 ,pp. n-a , 2018 , 0902-0063 ,

    초록

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    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

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  2. [해외논문]   Cardiopulmonary, biomarkers, and vascular responses to acute hypoxia following cardiac transplantation   SCI SCIE SCOPUS

    Sanz‐ (Cardiology Department, Montreal Heart Institute and Université) , de la Garza, Maria (de Montréal, Montreal, Quebec, Canada) , Iannino, Nadia (Cardiology Department, Montreal Heart Institute and Université) , Finnerty, Vincent (de Montréal, Montreal, Quebec, Canada) , Mansour, Asmaa (Cardiology Department, Montreal Heart Institute and Université) , Blondeau, Lucie (de Montréal, Montreal, Quebec, Canada) , Gayda, Mathieu (Division of the Montreal Heart Institute, Montreal Health Innovations Coordinating Center (MHICC), Montreal, Quebec, Canada) , Chaar, Diana (Division of the Montreal Heart Institute, Montreal Health Innovations Coordinating Center (MHICC), Montreal, Quebec, Canada) , Sirois, Martin G. (Cardiology Department, Montreal Heart Institute and Université) , Racine, Normand (de Montréal, Montreal, Quebec, Canada) , de Denus, Simon (Cardiology Department, Montreal Heart Institut) , Harel, Franç , ois , White, Michel
    Clinical transplantation v.32 no.9 ,pp. e13352 , 2018 , 0902-0063 ,

    초록

    Abstract Previous studies have suggested good adaptation of cardiac transplant (CTx) recipients to exposure to a high altitude. No studies have investigated the cardiopulmonary and biomarker responses to acute hypoxic challenges following CTx. Thirty‐six CTx recipients and 17 age‐matched healthy controls (HC) were recruited. Sixteen (16) patients (42%) had cardiac allograft vasculopathy (CAV). Cardiopulmonary responses to maximal and submaximal exercise at 21% O 2 , 20‐minutes hypoxia (11.5% O 2 ), and following a 10‐minute exposure to 11.5% O 2 using 30% of peak power output were completed. Vascular endothelial growth factor (VEGF), interleukin‐6 (IL‐6), suppression of tumorigenicity 2 (ST2) were measured at baseline and at peak stress. Endothelial peripheral function was assessed using near‐infrared spectroscopy. Compared with HC, CTx presented a lesser O 2 desaturation both at rest (−19.4 ± 6.8 [CTx] vs −24.2 ± 6.0% O 2 [HC], P 2 [HC], P

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    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

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  3. [해외논문]   Adding to the mounting evidence for geographic inequity in liver transplantation: Hospital length of stay   SCI SCIE SCOPUS

    Kueht, Michael (Michael E. DeBakey Department of Surgery, Division of Abdominal Transplantation and Division of Hepatobiliary Surgery, Baylor College of Medicine, Houston, Texas ) , Goss, John A. (Michael E. DeBakey Department of Surgery, Division of Abdominal Transplantation and Division of Hepatobiliary Surgery, Baylor College of Medicine, Houston, Texas ) , Rana, Abbas (Michael E. DeBakey Department of Surgery, Division of Abdominal Transplantation and Division of Hepatobiliary Surgery, Baylor College of Medicine, Houston, Texas)
    Clinical transplantation v.32 no.9 ,pp. e13336 , 2018 , 0902-0063 ,

    초록

    Abstract Background Severe geographic inequities in liver transplantation have persisted for years. Previous investigators have demonstrated 90‐day transplant rates varying from 14% to 82% and death rates varying from 18% to 86%.[1][Gentry SE, 2013] The aim of this analysis was to utilize a robust multivariate analysis to investigate whether geographic inequities affected the length of stay after liver transplantation. Methods We conducted a unique Kaplan‐Meier analysis with the event being discharge from the hospital and length of stay as the time to the event, using a cohort of 66 674 recipients listed in the UNOS database from 2002 to 2016. Multivariate Cox regression using 43 covariates was used for time‐to‐event analysis. Results Region 9 (0.82; CI 0.79‐0.85), Region 2 (0.85; CI 0.83‐0.88), and Region 10 (0.96; CI 0.93‐0.99) were statistically significant factors for prolonged hospital stay. The following covariates were the most significant factors for prolonged hospital stay: serum sodium >150 mEq/L (0.70; CI 0.62‐0.78), ICU admission (0.77; CI 0.74‐0.80), hospital admission (0.81; 0.79‐0.83), region 9 (0.82; CI 0.79‐0.85), and ventilator dependence (0.82; CI 0.76‐0.88). Conclusion In this analysis, we demonstrate regional disparities in hospital length of stay that are significant in robust multivariable Cox regression analysis. We hope the transplant community will take immediate measures to correct geographic inequities.

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    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

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  4. [해외논문]   Complete resolution of severe dilated cardiomyopathy in a pediatric hemodialysis patient being considered for a combined heart‐kidney transplant   SCI SCIE SCOPUS

    Escamilla, Daniel (Department of Pediatrics, University of California Davis Medical Center, Sacramento, California ) , Dayan, Jonathan (Department of Pediatrics, University of California Davis Medical Center, Sacramento, California ) , Butani, Lavjay (Department of Pediatrics, University of California Davis Medical Center, Sacramento, California)
    Clinical transplantation v.32 no.9 ,pp. e13379 , 2018 , 0902-0063 ,

    초록

    Abstract Background Severe geographic inequities in liver transplantation have persisted for years. Previous investigators have demonstrated 90‐day transplant rates varying from 14% to 82% and death rates varying from 18% to 86%.[1][Gentry SE, 2013] The aim of this analysis was to utilize a robust multivariate analysis to investigate whether geographic inequities affected the length of stay after liver transplantation. Methods We conducted a unique Kaplan‐Meier analysis with the event being discharge from the hospital and length of stay as the time to the event, using a cohort of 66 674 recipients listed in the UNOS database from 2002 to 2016. Multivariate Cox regression using 43 covariates was used for time‐to‐event analysis. Results Region 9 (0.82; CI 0.79‐0.85), Region 2 (0.85; CI 0.83‐0.88), and Region 10 (0.96; CI 0.93‐0.99) were statistically significant factors for prolonged hospital stay. The following covariates were the most significant factors for prolonged hospital stay: serum sodium >150 mEq/L (0.70; CI 0.62‐0.78), ICU admission (0.77; CI 0.74‐0.80), hospital admission (0.81; 0.79‐0.83), region 9 (0.82; CI 0.79‐0.85), and ventilator dependence (0.82; CI 0.76‐0.88). Conclusion In this analysis, we demonstrate regional disparities in hospital length of stay that are significant in robust multivariable Cox regression analysis. We hope the transplant community will take immediate measures to correct geographic inequities.

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    무료다운로드 유료다운로드

    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

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  5. [해외논문]   Changes in bone microarchitecture following kidney transplantation—Beyond bone mineral density   SCI SCIE SCOPUS

    Sharma, Ashish K. (Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia) , Toussaint, Nigel D. (Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia) , Elder, Grahame J. (Department of Renal Medicine, Westmead Hospital, Westmead, Sydney, Australia) , Rajapakse, Chamith S. (Departments of Radiology and Orthopaedic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania ) , Holt, Stephen G. (Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia) , Baldock, Paul (Osteoporosis and Bone Biology Division, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia) , Robertson, Patricia L. (Department of Medicine (RMH), University of Melbourne, Parkville, Victoria, Australia) , Ebeling, Peter R. (Monash University, Clayton, Victoria, Australia) , Sorci, Olivia R. (Departments of Radiolo) , Masterson, Rosemary
    Clinical transplantation v.32 no.9 ,pp. e13347 , 2018 , 0902-0063 ,

    초록

    Abstract Bone disease in kidney transplant recipients (KTRs) is characterized by bone mineral density (BMD) loss but bone microarchitecture changes are poorly defined. In this prospective cohort study, we evaluated bone microarchitecture using non‐invasive imaging modalities; high‐resolution magnetic resonance imaging (MRI), peripheral quantitative computed tomography (pQCT), dual energy X‐ray absorptiometry (DXA), and the trabecular bone score (TBS) following kidney transplantation. Eleven KTRs (48.3 ± 11.2 years) underwent MRI (tibia), pQCT (radius) and DXA at baseline and 12 months post–transplantation. Transiliac bone biopsies, performed at transplantation, showed 70% of patients with high/normal bone turnover. Compared with baseline, 12‐month MRI showed deterioration in indices of trabecular network integrity—surface to curve ratio (S/C; −15%, P =< 0.03) and erosion index (EI; +19%, P =< 0.01). However, cortical area increased (+10.3%, P =< 0.04), with a non‐significant increase in cortical thickness (CtTh; +7.8%, P =< 0.06). At 12 months, parathyroid hormone values (median 10.7 pmol/L) correlated with improved S/C ( r = 0.75, P =< 0.009) and EI ( r = −0.71, P =< 0.01) while osteocalcin correlated with CtTh ( r = 0.72, P =< 0.02) and area ( r = 0.70, P =< 0.02). TBS decreased from baseline (−5.1%, P =< 0.01) with no significant changes in BMD or pQCT. These findings highlight a post–transplant deterioration in trabecular bone quality detected by MRI and TBS, independent of changes in BMD, underlining the potential utility of these modalities in evaluating bone microarchitecture in KTRs.

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    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

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  6. [해외논문]   VA‐ECMO for cardiogenic shock in the contemporary era of heart transplantation: Which patients should be urgently transplanted?   SCI SCIE SCOPUS

    Habal, Marlena V. (Division of Cardiology, Department of Medicine, Columbia University Medical Center, New York, New York ) , Truby, Lauren (Division of Cardiology, Department of Medicine, Columbia University Medical Center, New York, New York ) , Ando, Masahiko (Division of Cardiothoracic Surgery, Department of Surgery, Columbia University Medical Center, New York, New York ) , Ikegami, Hirohisa (Division of Cardiothoracic Surgery, Department of Surgery, Columbia University Medical Center, New York, New York ) , Garan, Arthur R. (Division of Cardiology, Department of Medicine, Columbia University Medical Center, New York, New York ) , Topkara, Veli K. (Division of Cardiology, Department of Medicine, Columbia University Medical Center, New York, New York ) , Colombo, Paolo (Division of Cardiology, Department of Medicine, Columbia University Medical Center, New York, New York ) , Takeda, Koji (Division of Cardiothoracic Surgery, Department of Surgery, Columbia University Medical Center, New York, New York ) , Takayama, Hiroo (Division of Cardiothoracic Surgery, Department of Surgery, Columbia University Medical Center, New York, New York ) , Naka, Yoshifumi (Division of) , Farr, Maryjane A.
    Clinical transplantation v.32 no.9 ,pp. e13356 , 2018 , 0902-0063 ,

    초록

    Abstract With the impending United Network for Organ Sharing (UNOS) heart allocation policy giving VA‐ECMO supported heart transplant (HT) candidates highest priority status (Tier 1), identifying patients in cardiogenic shock (CS) with severe and irreversible heart failure (HF) appropriate for urgent HT is critically important. In a center where wait times currently preclude this approach, we retrospectively reviewed 119 patients (ages 18‐72) with CS from 1/2014 to 12/2016 who required VA‐ECMO for >24 hours. Underlying aetiologies included postcardiotomy shock (45), acute coronary syndromes (33), and acute‐on‐chronic HF (16). Eighty‐four percent of patients (100) had ≥1 contraindication to HT with 61.3% (73) having preexisting contraindications (eg, multiorgan dysfunction and substance abuse), and 68.1% (81) experienced preclusive complications (eg, renal failure, coagulopathy, and infection). Potential HT candidates were significantly more likely to survive to discharge (potential HT candidates 84.2% vs preexisting contraindications 43.8% vs contraindications developing on VA‐ECMO 33.3%, P = 0.001). Among potential HT candidates, 11 (68.8%) were discharged without advanced therapies and 4 received durable left ventricular assist device (25.0%). Importantly, 1‐year survival was 100% for the 11 patients with follow‐up. Thus, further work is critical to define appropriate candidates for HT from VA‐ECMO while avoiding preemptive transplantation in those with otherwise favorable outcomes.

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    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

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  7. [해외논문]   Impact of donor coronary angiography on kidney transplantation outcomes   SCI SCIE SCOPUS

    Lesouhaitier, Mathieu (Division of Nephrology, CHU Rennes, Rennes, France) , Legeai, Camille (Agence de la Biomédecine, Paris, France) , Savoye, Emilie (Agence de la Biomédecine, Paris, France) , Cantrelle, Christelle (Agence de la Biomédecine, Paris, France) , Pipien, Isabelle (Agence de la Biomédecine, Paris, France) , Macher, Marie‐ (Agence de la Biomédecine, Paris, France) , Alice (Division of Nephrology, CHU Rennes, Rennes, France) , Vigneau, Cé (Agence de la Biomédecine, Paris, France) , cile , Dorent, Richard
    Clinical transplantation v.32 no.9 ,pp. e13355 , 2018 , 0902-0063 ,

    초록

    Abstract Coronary angiography (CA) is the gold standard evaluation of coronary artery disease in potential multi‐organ donors. This use of iodinated contrast media could lead to contrast‐induced acute kidney injury and consequently to delayed graft function (DGF). All patients in France who received a kidney from a 45‐70‐year‐old donor without medical contraindication for cardiac donation and with at least one cardiovascular risk factor were included. Recipients of preemptive kidney transplant or multi‐organ transplant, or who died within the first 8 days post‐transplantation were excluded. Data were obtained from CRISTAL database. From March 2012 to June 2014, 892 kidneys from 483 donors were transplanted. DGF was reported in 38.9% of the 375 kidney recipients grafted with a kidney from the 217 donors who had CA and in 45.5% of the 440 kidney recipients who received a kidney from the 257 donors without CA. Multivariate analysis showed that CA or repeated injection of iodinated contrast media did not influence the risk of DGF. CA did not increase the risk of primary non‐function, the duration of DGF or post‐transplantation hospital stay and did not affect the graft function at 1 year. Evaluation of potential multi‐organ donors with CA does not affect kidney graft outcomes.

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    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

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  8. [해외논문]   A case‐control study of the risk factors for developing aspergillosis following cardiac transplant   SCI SCIE SCOPUS

    Cook, Jennifer C. (Department of Pharmacy, Duke University Hospital, Durham, North Carolina ) , Cook, Abigail (Loyola Medicine, Loyola University Health System, Maywood, Illinois ) , Tran, Richard H. (Pharmaceutical Product Development, Morrisville, North Carolina ) , Chang, Patricia P. (UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina ) , Rodgers, Jo E. (UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina)
    Clinical transplantation v.32 no.9 ,pp. e13367 , 2018 , 0902-0063 ,

    초록

    Abstract Background Invasive aspergillosis (IA) is a significant cause of morbidity and mortality following cardiac transplantation; however, data regarding the predictors of IA in this patient population are limited. Methods We conducted a case‐control study to identify the risk factors for IA in patients who underwent cardiac transplantation at a single center from 1986 to 2008 (Cohort 1) and 2009 to 2015 (Cohort 2). Cases of IA were matched to two controls from the same year of transplantation, and data were collected from the date of cardiac transplantation to the date of documented Aspergillus infection for each case, or for an equivalent number of days for each control. Univariate and multivariate logistic regressions were used to identify independent predictors of IA in Cohort 1. After 2009, targeted antifungal prophylaxis with oral voriconazole was initiated in patients with risk factors for IA. The incidence of IA was compared pre‐ and postintervention. Results IA was identified in 23 of 189 (8.0%) patients within Cohort 1. Significant risk factors for IA on multivariate analysis included an increased number of pretransplant hospitalizations (OR 1.81, 95% CI 1.19‐2.76) and posttransplant acute cellular allograft rejection (ACR) (OR 1.99, 95% 1.06‐3.75). Following the implementation of targeted antifungal prophylaxis in 2009, IA was identified in 2 of 107 (2.0%) patients in Cohort 2. Conclusions Increased pretransplant hospitalizations and posttransplant ACR episodes represent significant risk factors for IA following cardiac transplant. Targeted antifungal prophylaxis in at‐risk patients reduces the incidence of IA.

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    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

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  9. [해외논문]   Hepatitis C virus (HCV) RNA level in plasma and kidney tissue in HCV antibody‐positive donors: Quantitative comparison   SCI SCIE SCOPUS

    Shike, Hiroko (Department of Pathology, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania ) , Kadry, Zakiyah (Division of Transplantation, Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania ) , Imamura‐ (Department of Pharmacology, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania ) , Kawasawa, Yuka (Department of Pathology, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania ) , Greene, Wallace (Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania ) , Riley, Thomas (Gift of Life Donor Program, Organ Procurement Organization, Philadelphia, Pennsylvania ) , Nathan, Howard M. (Gift of Life Donor Program, Organ Procurement Organization, Philadelphia, Pennsylvania ) , Hasz, Rick D. (Division of Transplantation, Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania) , Jain, Ashokkumar
    Clinical transplantation v.32 no.9 ,pp. e13358 , 2018 , 0902-0063 ,

    초록

    Abstract Kidney transplant from donors with hepatitis C virus (HCV) antibody has been limited to HCV viremic recipients only, due to concern of the HCV transmission. However, the new antiviral medications provide an opportunity to expand the utilization of these donors. To study the risk of HCV transmission in kidney transplantation, we used discarded donor kidneys and determined HCV RNA levels by quantitative real‐time PCR in bilateral (right and left) kidney biopsies and plasma from 14 HCV antibody‐positive donors (sensitivity: 15 international unit (IU)/mL plasma; 1.8 IU/50 nL kidney). In three NAT‐negative donors, HCV RNA was negative in plasma and kidney. In all 11 NAT‐positive donors, HCV RNA was positive in plasma (range: 5807‐19 134 177 IU/mL) but negative in six kidneys from four donors with plasma HCV RNA P =< 0.75) and between kidney and plasma ( r = 0.86). When normalized by volume, HCV RNA median (range) was 49 (0‐957) IU/50 nL plasma and 1.0 (0‐103) IU/50 nL kidney, significantly lower in kidney ( P =< 0.005) than in plasma (14‐fold). Plasma HCV RNA can be used to predict the kidney HCV load. Future studies are needed if plasma/kidney HCV levels can be used to stratify donors for transmission risk and recipients for post‐transplant management in extended utilization of HCV antibody‐positive donors.

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    회원님의 원문열람 권한에 따라 열람이 불가능 할 수 있으며 권한이 없는 경우 해당 사이트의 정책에 따라 회원가입 및 유료구매가 필요할 수 있습니다.이동하는 사이트에서의 모든 정보이용은 NDSL과 무관합니다.

    NDSL에서는 해당 원문을 복사서비스하고 있습니다. 아래의 원문복사신청 또는 장바구니담기를 통하여 원문복사서비스 이용이 가능합니다.

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  10. [해외논문]   Once‐daily, prolonged‐release tacrolimus vs twice‐daily, immediate‐release tacrolimus in de novo living‐donor liver transplantation: A Phase 4, randomized, open‐label, comparative, single‐center study   SCI SCIE SCOPUS

    Shin, Min‐ (Division of Hepatobiliary Pancreatic Surgery and Transplantation, Department of Surgery, Chosun University College of Medicine, Gwangju, Korea) , Ho (Division of Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea) , Song, Gi‐ (Division of Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea) , Won (Division of Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea) , Lee, Sung‐ (Division of Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea) , Gyu (Division of Hepatobil) , Hwang, Shin , Kim, Ki‐ , Hun , Ahn, Chul‐ , Soo , Moon, Deok‐ , Bog , Ha, Tae‐ , Yong , Jung, Dong‐ , Hwan , Park, Gil‐ , Chun , Yun, Young‐ , In , Kim, Wan‐ , Jun , Kang, Woo‐ , Hyoung , Kim, Seok‐ , Hwan , Jiang, Hongsi , Lee, Sungmin , Tak, Eun‐ , Young
    Clinical transplantation v.32 no.9 ,pp. e13376 , 2018 , 0902-0063 ,

    초록

    Randomized, open-label, comparative, single-center, Phase 4, 24-week study comparing pharmacokinetics (PK), safety, and efficacy of once-daily, prolonged-release tacrolimus (PR-T) with twice-daily, immediate-release tacrolimus (IR-T) in adult de novo living-donor liver transplant (LDLT) recipients in Korea. All patients received intravenous tacrolimus from Day 0 (transplantation) for 4 days and were randomized (1:1) to receive oral PR-T or IR-T from Day 5. PK profiles were taken on Days 6 and 21. Primary endpoint: area under the concentration-time curve over 24 hour (AUC(0-24)). Predefined similarity interval for confidence intervals of ratios: 80%-125%. Secondary endpoints included: tacrolimus concentration at 24 hour (C-24), patient/graft survival, biopsy-confirmed acute rejection (BCAR), treatment-emergent adverse events (TEAEs). One-hundred patients were included (PR-T, n = 50; IR-T, n = 50). Compared with IR-T, 40% and 66% higher mean PR -T daily doses resulted in similar AUC(0-24) between formulations on Day 6 (PR-T:IR-T ratio of means 96.8%), and numerically higher AUC(0-24) with PR-T on Day 21 (128.8%), respectively. Linear relationship was similar between AUC(0-24) and C-24, and formulations. No graft loss/deaths, incidence of BCAR and TEAEs similar between formulations. Higher PR-T vs IR-T doses were required to achieve comparable systemic exposure in Korean de novo LDLT recipients. PR-T was efficacious; no new safety signals were detected.

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