Small graft size and hepatocellular carcinoma outcomes in living donor liver transplantation: a retrospective multicentric cohort study.

INTRODUCTION: This study examined associations between the graft-to-recipient weight ratio (GRWR) for adult-to-adult living donor liver transplantation (LDLT) and HCC outcomes. MATERIALS AND METHODS: Data from patients in the Korean Organ Transplantation Registry who underwent LDLT for HCC from 2014-2021 were retrospectively reviewed. Patients were categorized using the cutoff GRWR for HCC recurrence determined by an adjusted cubic spline (GRWR<0.7% vs. GRWR≥0.7%). Recurrence-free survival (RFS) and HCC recurrence were analyzed in the entire and a 1:5 propensity-matched cohort. RESULTS: The eligible cohort consisted of 2005 LDLT recipients (GRWR<0.7 [n=59] vs. GRWR≥0.7 [n=1946]). In the entire cohort, 5-year RFS was significantly lower in the GRWR<0.7 than in the GRWR≥0.7 group (66.7% vs. 76.7%, P =0.019), although HCC recurrence was not different between groups (77.1% vs. 80.7%, P =0.234). This trend was similar in the matched cohort ( P =0.014 for RFS and P =0.096 for HCC recurrence). In multivariable analyses, GRWR<0.7 was an independent risk factor for RFS (adjusted HR [aHR] 1.89, P =0.012), but the result was marginal for HCC recurrence (aHR 1.61, P =0.066). In the pretransplant tumor burden subgroup analysis, GRWR<0.7 was a significant risk factor for both RFS and HCC recurrence only for tumors exceeding the Milan criteria (aHR 3.10, P <0.001 for RFS; aHR 2.92, P =0.003 for HCC recurrence) or with MoRAL scores in the fourth quartile (aHR 3.33, P <0.001 for RFS; aHR 2.61, P =0.019 for HCC recurrence). CONCLUSIONS: A GRWR<0.7 potentially leads to lower RFS and higher HCC recurrence after LDLT when the pretransplant tumor burden is high.

Selective hanging maneuver and rubber band retraction technique for pure laparoscopic donor right hepatectomy.

BACKGROUND: Pure laparoscopic donor hepatectomy (PLDH) is an increasingly performed procedure despite its technical difficulties. This study introduced a selective liver parenchymal hanging maneuver and rubber band retraction technique for PLDH. METHODS: We retrospectively reviewed perioperative data from 58 patients who underwent donor right hepatectomy (including right extended) between March 2009 and February 2021. Eighteen patients underwent open donor right hepatectomy (ODRH) and 38 patients underwent pure laparoscopic donor right hepatectomy (PLDRH). RESULTS: All PLDRH donors underwent the procedure without the need for open conversion. The median PLDRH operative time was 396.84 ± 72.459 min, the median PLDRH intraoperative bleeding amount was 496.05 ± 272.591 ml, and the warm ischemic time was 8.77 ± 3.062 min. Compared to ODRH, laparoscopic surgery showed further advantages in terms of postoperative hospital stay (10.94 ± 4.036 days vs. 8.03 ± 2.646 days, respectively, P = 0.01) and estimated blood loss (676.67 ± 321.046 ml vs. 496.05 ± 272.591 ml, respectively, P = 0.033). CONCLUSIONS: The selective liver parenchymal hanging maneuver and rubber band retraction technique is a simple and effective pure laparoscopic procedure for donor hepatectomy. Our results demonstrate the safety and feasibility of this technique.

The effect of donor against recipient one-way HLA mismatch on liver transplantation outcomes from a multicenter registry analysis.

Donor against recipient one-way Human leukocyte antigen (HLA) mismatch (D → R one-way HLA MM) seemed strongly associated with graft-versus-host disease (GVHD). The aim of this study is to investigate the relevance of D → R one-way HLA MM in outcome of liver transplantation (LT). We retrospectively analyzed 2670 patients in Korean Organ Transplantation Registry database between April 2014 and December 2020. The patients were categorized into two groups whether D → R one-way HLA MM or not and evaluated the outcomes of LT between the two groups. 18 patients were found to be D → R one-way HLA MM. The incidence of GVHD (0.3% vs. 22.2%, p < 0.001) and mortality rate (11.6% vs. 38.9%, p = 0.003) was much higher in D → R one-way HLA MM group. D → R one-way HLA MM at 3 loci was seemed to be strongly associated with the incidence of GVHD (OR 163.3, p < 0.001), and found to be the strongest risk factor for patient death (HR 12.75, p < 0.001). Patients with D → R one-way HLA MM at 3 loci showed significantly lower overall survival (p < 0.001) but there were no significant differences in rejection-free survival and death-censored graft survival. D → R one-way HLA MM at 3 loci not only affects the overall survival of LT patients but also the incidence of GVHD.

Outcomes and Risk Factors for Liver Transplantation Using graft-to-Recipient Weight Ratio Less than 0.8 Graft from Living Donors: Multicentric Cohort Study.

OBJECTIVE: To compare graft survival after LDLT in patients receiving GRWR<0.8 versus GRWR≥0.8 grafts and identify risk factors for graft loss using GRWR<0.8 grafts. SUMMARY BACKGROUND DATA: Favorable outcomes after living donor liver transplantation (LDLT) using graft-to-recipient weight ratio (GRWR)<0.8 grafts were recently reported; however, these results have not been validated using multicenter data. METHODS: This multicentric cohort study included 3450 LDLT patients. Graft survival was compared between 1:3 propensity score-matched groups and evaluated using various Cox models in the entire population. Risk factors for graft loss with GRWR<0.8 versus GRWR≥0.8 grafts were explored within various subgroups using interaction analyses, and outcomes were stratified according to the number of risk factors. RESULTS: In total, 368 patients (10.7%) received GRWR<0.8 grafts (GRWR<0.8 group), whereas 3082 (89.3%) received GRWR≥0.8 grafts (GRWR≥0.8 group). The 5-y graft survival rate was significantly lower with GRWR<0.8 grafts than with GRWR≥0.8 grafts (85.2% vs. 90.1%, P=0.013). Adjusted hazard ratio (HR) for graft loss using GRWR<0.8 grafts in the entire population was 1.66 (95% confidence interval [CI] 1.17-2.35, P=0.004). Risk factors exhibiting significant interactions with GRWR<0.8 for graft survival were age ≥60 y, MELD score ≥15, and male donor. When ≥2 risk factors were present, GRWR<0.8 grafts showed higher risk of graft loss compared to GRWR≥0.8 graft in LDLT (HR 2.98, 95% CI 1.79-4.88, P<0.001). CONCLUSIONS: GRWR<0.8 graft showed inferior graft survival than controls (85.2% vs. 90.1%), especially when ≥2 risk factors for graft loss (among age ≥60 y, MELD score ≥15, or male donor) were present.

Changes in glucose metabolism among recipients with diabetes 1 year after kidney transplant: a multicenter 1-year prospective study.

Background: Diabetes mellitus is a common and crucial metabolic complication in kidney transplantation. It is necessary to analyze the course of glucose metabolism in patients who already have diabetes after receiving a transplant. In this study, we investigated the changes in glucose metabolism after transplantation, and a detailed analysis was performed on some patients whose glycemic status improved. Methods: The multicenter prospective cohort study was conducted between 1 April 2016 and 31 September 2018. Adult patients (aged 20 to 65 years) who received kidney allografts from living or deceased donors were included. Seventy-four subjects with pre-transplant diabetes were followed up for 1 year after kidney transplantation. Diabetes remission was defined as the results of the oral glucose tolerance test performed one year after transplantation and the presence or absence of diabetes medications. After 1-year post-transplant, 74 recipients were divided into the persistent diabetes group (n = 58) and the remission group (n = 16). Multivariable logistic regression was performed to identify clinical factors associated with diabetes remission. Results: Of 74 recipients, 16 (21.6%) showed diabetes remission after 1-year post-transplant. The homeostatic model assessment for insulin resistance numerically increased in both groups throughout the first year after transplantation and significantly increased in the persistent diabetes group. The insulinogenic index (IGI30) value significantly increased only in the remission group, and the IGI30 value remained low in the persistent diabetes group. In univariate analysis, younger age, newly diagnosed diabetes before transplantation, low baseline hemoglobin A1c, and high baseline IGI30 were significantly associated with remission of diabetes. After multivariate analysis, only newly diagnosed diabetes before transplantation and IGI30 at baseline were associated with remission of diabetes (34.00 [1.192-969.84], P = 0.039, and 17.625 [1.412-220.001], P = 0.026, respectively). Conclusion: In conclusion, some kidney recipients with pre-transplant diabetes have diabetes remission 1 year after transplantation. Our prospective study revealed that preserved insulin secretory function and newly diagnosed diabetes at the time of kidney transplantation were favorable factors for which glucose metabolism did not worsen or improve 1 year after kidney transplantation.

Physical Performance Decline During the Early Posttransplantation Period Affects Survival After Living Donor Liver Transplantation.

BACKGROUND: Patient physical performance has been emphasized in liver transplant recipients; however, evidence for living donor liver transplantation (LDLT) patients is lacking. This study investigated the impact of physical performance decline during the early posttransplantation period on survival and risk factors for this decline in LDLT recipients. METHODS: From national registry data, 2703 LDLT patients were divided into 2 groups based on the change in their Karnofsky performance status (KPS) between 1 and 6 mo posttransplantation: declined KPS (n = 188) and control (n = 2515). Multivariable analyses were conducted to control for confounders, including posttransplantation complications. RESULTS: Estimated 5-y patient survival rates were 91.6% in the declined KPS group and 96.3% in the control group, favoring the latter ( P = 0.003). The survival hazard of KPS decline was significant in a baseline covariates-adjusted Cox model (hazard ratio [HR], 2.60; 95% confidence interval [CI], 1.37-4.95) and an adjusted model accounting for posttransplantation complications (HR, 3.38; 95% CI, 1.70-6.72). In subgroup analyses, KPS decline independently reduced survival in patients without complications (HR, 3.95; 95% CI, 1.67-9.34), and the trend was similar in patients with complications, although significance was marginal (HR, 3.02; 95% CI, 0.98-9.27). We found that only posttransplantation complications, such as rejection, infection, bile duct complication, and vascular complication, were significant risk factors for KPS decline after LDLT. CONCLUSIONS: Physical performance decline during the early posttransplantation period independently reduced survival rates, and posttransplantation complications were the only significant risk factors for physical performance decline in LDLT recipients.

A Cross-Sectional Analysis of Health Literacy and Compliance to Treatment in Organ Transplant Recipients.

This study was conducted to determine the correlations between health literacy, transplant effects, and compliance to treatment in organ transplant recipients and to identify the factors influencing compliance to treatment. The participants (n = 130; males = 66.9%; mean age = 56.4 years) were organ transplant recipients visiting an organ transplantation center in Seoul, South Korea. The regression model explained 32% of the variance in participants' compliance to treatment. Among the health literacy variables, "Scale 3: Actively managing my health" (ß = 0.38, p = 0.001) and "Scale 4: Social support for health" (ß = 0.25, p = 0.019) had a significant effect on compliance to treatment. In this study, health literacy was identified as a key factor influencing compliance to treatment. Therefore, patients' health literacy should be assessed prior to transplantation to identify potential high-risk patients for treatment nonadherence. In addition, after transplantation surgery, patient-tailored interventions should be developed and provided for self-management that reflects the patient's health literacy level to ultimately enhance patient outcomes.

The Korean Organ Transplantation Registry (KOTRY): an overview and summary of the kidney-transplant cohort.

BACKGROUND: As the need for a nationwide organ-transplant registry emerged, a prospective registry, the Korean Organ Transplantation Registry (KOTRY), was initiated in 2014. Here, we present baseline characteristics and outcomes of the kidney-transplant cohort for 2014 through 2019. METHODS: The KOTRY consists of five organ-transplant cohorts (kidney, liver, lung, heart, and pancreas). Data and samples were prospectively collected from transplant recipients and donors at baseline and follow-up visits; and epidemiological trends, allograft outcomes, and patient outcomes, such as posttransplant complications, comorbidities, and mortality, were analyzed. RESULTS: From 2014 to 2019, there were a total of 6,129 registered kidney transplants (64.8% with living donors and 35.2% with deceased donors) with a mean recipient age of 49.4 ± 11.5 years, and 59.7% were male. ABO-incompatible transplants totaled 17.4% of all transplants, and 15.0% of transplants were preemptive. The overall 1- and 5-year patient survival rates were 98.4% and 95.8%, respectively, and the 1- and 5-year graft survival rates were 97.1% and 90.5%, respectively. During a mean follow-up of 3.8 years, biopsy-proven acute rejection episodes occurred in 17.0% of cases. The mean age of donors was 47.3 ± 12.9 years, and 52.6% were male. Among living donors, the largest category of donors was spouses, while, among deceased donors, 31.2% were expanded-criteria donors. The mean serum creatinine concentrations of living donors were 0.78 ± 0.62 mg/dL and 1.09 ± 0.24 mg/dL at baseline and 1 year after kidney transplantation, respectively. CONCLUSION: The KOTRY, a systematic Korean transplant cohort, can serve as a valuable epidemiological database of Korean kidney transplants.

Factors influencing the self-management of kidney transplant patients based on self-determination theory: a cross-sectional study.

Background: Self-determination theory is useful for explaining how kidney transplant recipients self-manage their postoperative health, including drug regimens, but few studies have applied this theory to transplant recipients. This study aimed to examine the influence of health professionals' autonomy support, autonomous motivation and competence on kidney transplant patients' self-management based on the self-determination theory. Methods: This study included 79 kidney transplant patients from one outpatient clinic in a general hospital in Seoul, Korea. Data on the health professionals' support of patient autonomy and the kidney transplant patients' autonomous motivation, competence, and self-management were collected from self-report questionnaires. Results: The factors that influenced self-management behavior in kidney transplant patients were competence (ß=0.377, P=0.001) and autonomous motivation (ß=0.293, P=0.006). The explanatory power of these variables was 30.1%. Conclusions: This study found that autonomous motivation and competence in kidney transplant patients affected their self-management, indicating that if healthcare professionals enhance patients' competence and autonomous motivation, their self-management can be improved. The development of intervention programs that assist healthcare professionals in strengthening patients' autonomous motivation and competence is recommended.

Safety and metabolic advantages of steroid withdrawal after 6 months posttransplant in de novo kidney transplantation: A 1-year prospective cohort study.

INTRODUCTION: This prospective multicenter study aimed at investigating the safety and metabolic advantages of steroid withdrawal (SW) therapy in kidney transplant recipients with tacrolimus-mycophenolate mofetil-based immunosuppression. METHODS: We analyzed 179 recipients who received kidney transplantation from March 2016 and September 2018. In 179 recipients, 114 patients maintained an immunosuppressive regimen including steroids (steroid continuation [SC] group). The remaining 65 patients were determined to withdraw steroid therapy after 6 months posttransplant (SW group). Metabolic parameters and graft functions of the two groups were evaluated. RESULTS: The estimated glomerular filtration rates at 12 months posttransplant were 67.29 ± 20.29 ml/min/1.73 m2 in SC group and 73.72 ± 17.57 ml/min/1.73 m2 in SW group (p < .001). The acute rejection occurred to four recipients in the SC group (3.5%) and no acute rejection occurred to SW group recipients during the 6-2 months posttransplant period. Oral glucose tolerance tests revealed that recipients in the SW group were more improved in glucose metabolism than the SC group during 6-12 months posttransplant. In addition, cholesterol levels and blood pressure decreased after the withdrawal of steroids in the SW group. CONCLUSION: In conclusion, a 6-month withdrawal of steroids in recipients with low immunological risk and stable graft function can be safely conducted and result in improvement of metabolic profiles. Stable recipients without biopsy-proven acute rejection and proteinuria can safely withdraw from steroids out of a maintenance immunosuppressive regimen 6-months posttransplant. A long-term follow-up study is needed to verify our results.

Insulin Secretion and Insulin Resistance Trajectories over 1 Year after Kidney Transplantation: A Multicenter Prospective Cohort Study.

BACKGROUND: We investigated the changing patterns of insulin secretion and resistance and risk factors contributing to the development of post-transplant diabetes mellitus (PTDM) in kidney recipients under tacrolimus-based immunosuppression regimen during 1 year after transplantation. METHODS: This was a multicenter prospective cohort study. Of the 168 subjects enrolled in this study, we analyzed a total 87 kidney transplant recipients without diabetes which was assessed by oral glucose tolerance test before transplantation. We evaluated the incidence of PTDM and followed up the index of insulin secretion (insulinogenic index [IGI]) and resistance (homeostatic model assessment for insulin resistance [HOMA-IR]) at 3, 6, 9 months, and 1 year after transplantation by oral glucose tolerance test and diabetes treatment. We also assessed the risk factors for incident PTDM. RESULTS: PTDM developed in 23 of 87 subjects (26.4%) during 1 year after transplantation. More than half of total PTDM (56.5%) occurred in the first 3 months after transplantation. During 1 year after transplantation, insulin resistance (HOMA-IR) was increased in both PTDM and no PTDM group. In no PTDM group, the increase in insulin secretory function to overcome insulin resistance was also observed. However, PTDM group showed no increase in insulin secretion function (IGI). Old age, status of prediabetes and episode of acute rejection were significantly associated with the development of PTDM. CONCLUSION: In tacrolimus-based immunosuppressive drugs regimen, impaired insulin secretory function for reduced insulin sensitivity contributed to the development of PTDM than insulin resistance during 1 year after transplantation.

Development of video-based educational materials for kidney-transplant patients.

INTRODUCTION: Treatment adherence has been evaluated as a major predictor of long-term outcome, and education has been suggested to improve adherence. Considering the characteristics of adult learners, it is necessary to implement educational programs that meet the needs of transplant patients. Multimedia education may be well-suited for this. This study aims to develop video education materials in accordance with transplant patients' self-care needs. METHODS: This study includes a literature review and patient interviews aimed at developing video education materials for the self-care needs of patients who underwent renal transplant surgery at a university hospital in Seoul. Ten patients were interviewed about the desired educational content, accessibility, and other preferences. After verifying the validity of the data, the video scenarios were produced and satisfaction surveys were conducted. RESULTS: Eleven self-care education items were identified through interviews with 10 kidney transplant patients. The expert validation of video-based educational content result was high (mean CVI = 0.94). The mean score of the patients' satisfaction evaluation of the completed 7-minute video instructional materials was also high (4.55 on a 5-point Likert scale). CONCLUSION: Findings indicate that the video education materials will meet the needs of adult learners and mitigate the limitations of the existing education programs by increasing interest and motivation and may contribute to increased treatment adherence and ultimately, positively effect self-care for new transplant patients.

Clinical Study of Standard- vs Reduced-Dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Kidney Transplantation: A Prospective Randomized Trial.

BACKGROUND: The lowering of calcineurin inhibitor exposure is possibly considered as the proper strategy to prevent calcineurin inhibitor-induced nephrotoxicity in kidney transplant. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) vs standard-dose tacrolimus with reduced-dose MMF. METHODS: A prospective, multicenter, open-label, randomized, and parallel-group clinical trial was conducted at 4 transplant centers in Korea. A total sample size was 108, and eligible patients were randomly assigned in a 1:1 ratio to either reduced-dose tacrolimus with standard-dose MMF (the study group) or standard-dose tacrolimus with reduced-dose MMF (the control group) for 6 months in de novo kidney transplant recipients. Graft function, the incidence of efficacy failure, and adverse events were compared. RESULTS: The mean estimated glomerular filtration rate at 6 months post-transplantation was 69.83 ± 16.68 mL/min/1.73 m2 in the study group and 69.92 ± 17.55 mL/min/1.73 m2 in the control group (P > .05). The overall incidence of biopsy-proven acute rejection was 3.64% (n = 2) in the study group, compared to 3.77% (n = 2) in the control group (P > .05). There was no graft loss, death, or loss of follow-up in either group. CONCLUSION: In conclusion, the results suggest that tacrolimus minimization with standard-dose MMF provides adequate immunosuppression with proper renal function and similar rate of incidence of acute rejection compared with the regimen including standard-dose tacrolimus with reduced-dose MMF.

Serum creatinine level at 1-month posttransplant can independently predict long-term graft survival and functional status.

Background: After the year 2000, kidney transplants with high immunologic risk and deceased donors increased rapidly in Korea. At the same time, the medical community developed special pretransplant and early posttransplantation management protocols. Our team evaluated the effect of early graft stabilization on long-term graft survival and functional status using databases from a high-volume kidney transplantation center. Methods: We included 1,895 kidney transplant patients from a total of 1,976 performed between 2005 and 2018. Early graft failure within 1 month (n=9), loss to follow-up (n=2), pediatric recipient or donor (n=37), and combined organ transplantation (n=33) cases were excluded. We grouped the cases at 1-month posttransplantation by serum creatinine quantiles (1.0 mg%, 1.23 mg%, and 1.52 mg%). Results: After an average of 95 months of follow-up (maximum 189 months), the high-serum creatinine group (4th quantile) showed significantly poorer graft survival than other groups (1st to 3rd quantile) (P<0.05). In multiple Cox regression analysis, a high serum creatinine level (4th quantile) at 1-month posttransplant is an independent risk factor for graft failure with a hazard ratio of 1.799 (P=0.013). The quantile group by serum creatinine shows a persistent, significant difference of functional graft status (glomerular filtration rate by Modification of Diet in Renal Disease method) among quantile groups beyond ten years posttransplant. Conclusions: Serum creatinine level at 1-month posttransplant is a strong independent predictor of graft survival and functional graft status beyond ten years posttransplant.

Which patients with intestinal obstruction need surgery? The delta neutrophil index as an early predictive marker.

PURPOSE: Predicting the need for surgical intervention among patients with intestinal obstruction is challenging. The delta neutrophil index (DNI) has been suggested as a useful marker of immature granulocytes, which indicate an infection or sepsis. In this study, we evaluated the impact of the DNI as an early predictor of operation among patients with intestinal obstruction. METHODS: A total of 171 patients who were diagnosed with postoperative intestinal obstruction were enrolled in this study. Medical records, including data for the initial CRP level, WBC count, and DNI were reviewed. Receiver operating characteristic (ROC) curves were generated to clarify the optimal DNI cutoff values for predicting an operation. RESULTS: Among the 171 patients, 38 (22.2%) needed surgical intervention. The areas under the initial CRP, WBC, and DNI ROC curves were 0.460, 0.449, and 0.543, respectively. The optimal cutoff value for predicting further surgical intervention according to the initial DNI level was 4.3%. The accuracy of the cutoff value was 74.9%, the sensitivity was 23.7%, and the specificity was 89.5% (positive predictive value, 23.7%; negative predictive value, 89.5%). In the multivariate analysis, initial DNI levels ≥ 4.3% were significantly associated with surgical intervention (odd ratio, 3.092; 95% confidence interval, 1.072-8.918; P = 0.037). CONCLUSION: The initial DNI level in patients with intestinal obstruction may be a useful predictor for determining the need for surgical intervention.

Clinical significance of lactate clearance for the development of early allograft dysfunction and short-term prognosis in deceased donor liver transplantation.

This retrospective study evaluated lactate clearance (LC), measured at 6, 12, 18, and 24 hours after reperfusion, as a predictor of early allograft dysfunction (EAD) and short-term outcomes in patients receiving deceased donor liver transplantation. Of 181 transplant recipients, 44 (24.3%) developed EAD and had lower LCs than those who did not develop EAD. A receiver operating characteristic analysis showed that LC determined at 6 hours showed the highest area under curve value of 0.828 (95% confidence interval [CI]: 0.755-0.990) for predicting the development of EAD at a cutoff value of 25.8% with 76.7% sensitivity and 77.9% specificity. LC values that fell below the cutoff values were significantly associated with EAD in a multivariate analysis, with values at 6 hours having the highest adjusted odds ratio (11.891, 95% CI: 4.469-31.639). In-hospital and 6 month mortalities were higher in patients with LC values below the cutoffs compared with those above the cutoff values at each time point. Thus, LC calculated shortly after reperfusion of an allograft is significantly discriminative for the development of EAD and is associated with short-term prognosis after deceased donor liver transplantation.

De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial.

BACKGROUND: Most of the previous studies reported that tacrolimus (TAC) with sirolimus (SRL) was associated with worse post-transplant outcomes in kidney transplantation, compared with TAC with mycophenolate mofetil (MMF). These might be attributable to high-dose SRL. However, outcomes using low-dose SRL with TAC for kidney transplantation are uncertain. The aim of this study was to assess the efficacy and safety of low-dose SRL with extended-release tacrolimus (ER-TAC) versus MMF with ER-TAC. METHODS: We randomly assigned 158 renal transplant patients to receive low-dose SRL or MMF in combination with ER-TAC and corticosteroid. The primary endpoint was the composite efficacy failure rate, including biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up, within 12 months post-transplantation. This trial is registered with ClinicalTrial.gov (number NCT01680952). RESULTS: The efficacy failure rate was 6.6% in the low-dose SRL group and 13.3% in the MMF group in the intention-to-treat population (absolute difference, 6.8%; 95% confidence interval, -2.8% to 16.3%). The incidence of BPAR within 12 months post-transplantation was 5.3% in the low-dose SRL group and 13.3% in the MMF group (P = 0.09). The mean estimated glomerular filtration rate at 12 months post-transplantation was 53.2 mL/min/1.73 m2 in the low-dose SRL group and 52.4 mL/min/1.73 m2 in the MMF group (P = 0.76). The incidences of adverse events and serious adverse events were similar between groups. CONCLUSION: Low-dose SRL with ER-TAC was not inferior to MMF with ER-TAC with respect to efficacy and safety. When used for immunosuppression in kidney transplantation, low-dose SRL with ER-TAC can effectively prevent acute rejection and preserve renal function.

Impact of Pre-Transplant Bacterial Infections on Post-Operative Outcomes in Patients after Liver Transplantation.

BACKGROUND: In contrast to studies evaluating the negative effect of bacterial infections on clinical outcomes after liver transplantation, there is little evidence with regard to pre-transplant bacterial infections. We aimed to investigate the impact of pre-transplant bacterial infections on post-transplant outcomes in patients after liver transplantation. PATIENTS AND METHODS: We retrospectively analyzed clinical data from 33 consecutive patients who underwent primary liver transplantations. Patients were divided into two groups based on the occurrence of a bacterial infection within the 30 days before transplantation. RESULTS: Of the 33 patients, 23 patients did not have pre-transplant bacterial infections, while 10 patients did have pre-transplant bacterial infections. Pre-transplant bacterial infections were urinary tract infections (n = 4), spontaneous bacterial peritonitis (n = 3), and one each of pneumonia, bacteremia, and cellulitis. There were no differences in clinical characteristics between the two groups. Post-operative clinical outcomes, including post-operative bacterial infection, intensive-care unit re-admission, 30-day re-hospitalization, and 90-day mortality rate were not significantly different between the two groups. The two-year overall survival rate was 76.7% in patients with pre-transplant infections and 80.0% in those without pre-transplant infections. CONCLUSIONS: Patients with pre-transplant bacterial infections did not have inferior clinical outcomes, compared with those without pre-transplant bacterial infections.

Low-dose mycophenolate mofetil in tablet form or capsule form combined with tacrolimus in the early period after kidney transplantation: a prospective randomized trial
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AIMS: The tablet form (500 mg) of mycophenolate mofetil (MMF) provides more convenience of taking drugs and cost-effectiveness than the capsule form (250 mg). We examined the efficacy and safety of MMF in its different forms combined with tacrolimus in kidney transplant recipients. METHODS: This multicenter, 26-week, randomized trial was performed to compare the efficacy and safety of the tablet form of MMF versus the capsule form of MMF in 156 kidney transplant recipients. Allograft function, the incidence of efficacy failure (biopsy-proven acute rejection (BPAR), death, graft loss, or loss to follow-up), and adverse events were compared. RESULTS: The mean dose (mg/day) of MMF at 26 weeks was comparable: 1,052.6 ± 194.2 in the tablet group vs. 1,155.6 ± 298.1 in the capsule group (p = 0.063). Trough levels of tacrolimus at 26 weeks were comparable. The mean estimated glomerular filtration rate of the tablet group at 26 weeks post-transplant was not inferior to that of the capsule group. The incidence of efficacy failure was similar in the two groups: tablet group, 5.2% and capsule group, 7.7% (difference -2.5%; 95% confidence interval -5.22 - 10.21%). The incidence of BPAR until 26 weeks post-transplant in the tablet group was 3.9%, compared to 7.7% in the capsule group (p = 0.346). There was no significant difference in the incidence of discontinuations and serious adverse events between the groups. CONCLUSION: Low-dose MMF in tablet form combined with tacrolimus can be considered as an efficacious and safe immunosuppressive regimen in the early period after kidney transplantation.
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