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Impact of Recipient and Donor Body Mass Index on Survival Outcomes After Intestinal Transplantation: A United Network for Organ Sharing Database Analysis. 受体和供体体重指数对肠道移植后生存结果的影响:器官共享联合网络数据库分析。
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-07-09 DOI: 10.12659/AOT.943994
Prince Addo Ameyaw, Sarpong Boateng, Eugene N Annor, Basile Njei

BACKGROUND Long-term patient survival after intestinal transplantation (IT) remains low compared with other organ transplants despite years of advancement in clinical experience. While patients with extremely high or low body mass index (BMI) are often considered ineligible for IT, the impact of BMI on post-transplant IT survival remains understudied. MATERIAL AND METHODS Using the United Network for Organ Sharing Standard Transplant database, we conducted a retrospective cohort study on patients who underwent IT between April 11, 1994, and September 29, 2021. We assessed the association of recipient and donor BMI at transplant with post-transplant mortality using Kaplan-Meier survival curves and univariate and multivariate Cox regression analyses. RESULTS A total of 1541 patients were included in our final sample. Of these patients, 806 were females (52.5%) and most were in the normal-weight BMI subgroup (54.2%). Obese class II (mean; 36.8±10.92 years) and underweight patients (mean; 37.6±13.37 years) were significantly younger than patients in other BMI categories. The adjusted multivariate model demonstrated an increased risk of mortality in underweight IT recipients compared to normal-weight IT recipients (aHR=1.25, 95% confidence interval [CI], 1.02-1.54; P=0.032).There was no significant association between donor BMI categories and survival in IT recipients. CONCLUSIONS Recipient BMI below normal is associated with an increased risk of mortality after intestinal transplantation and represents a potentially modifiable patient characteristic to improve survival outcomes.

背景与其他器官移植相比,肠移植术(IT)后患者的长期存活率仍然很低,尽管临床经验已积累多年。虽然体重指数(BMI)极高或极低的患者通常被认为不符合肠道移植的条件,但 BMI 对移植后肠道移植存活率的影响仍未得到充分研究。材料和方法 我们利用器官共享联合网络标准移植数据库,对 1994 年 4 月 11 日至 2021 年 9 月 29 日期间接受 IT 的患者进行了一项回顾性队列研究。我们使用 Kaplan-Meier 生存曲线以及单变量和多变量 Cox 回归分析评估了移植时受体和供体体重指数与移植后死亡率的关系。结果 共有 1541 名患者被纳入我们的最终样本。其中 806 名患者为女性(52.5%),大多数患者属于体重指数正常的亚组(54.2%)。肥胖 II 级患者(平均;36.8±10.92 岁)和体重不足患者(平均;37.6±13.37 岁)的年龄明显小于其他 BMI 类别的患者。调整后的多变量模型显示,与正常体重的 IT 受体相比,体重不足的 IT 受体的死亡风险增加(aHR=1.25,95% 置信区间 [CI],1.02-1.54;P=0.032)。结论 受体 BMI 低于正常值与肠道移植后死亡风险增加有关,是一种潜在的可改变患者特征以改善生存结果的方法。
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引用次数: 0
Clonal Hematopoiesis-Associated Gene Mutations Affect Acute Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation in AML Patients. 克隆造血相关基因突变影响急性髓细胞性白血病患者造血干细胞移植后的急性移植物抗宿主疾病
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-07-02 DOI: 10.12659/AOT.943688
Xiaoxuan Wei, Sai Huang, Zhenyang Gu, Jing Liu, Meng Li, Xiangshu Jin, Jian Bo, Fei Li, Yu Jing, Xiaoning Gao, Liping Dou, Daihong Liu, Chunji Gao

BACKGROUND The relationship between clonal hematopoiesis (CH)-associated gene mutations and allogeneic hematopoietic stem cell transplantation (allo-HSCT) has been extensively studied since next-generation sequencing (NGS) technology became widely available. However, research has mainly focused on the relationship between donor CH mutations and transplant prognosis, and research into the relationship between CH mutations in the recipient and acute graft-versus-host disease (aGVHD) is lacking. MATERIAL AND METHODS We analyzed NGS results and their correlation with aGVHD and prognosis in 196 AML patients undergoing allo-HSCT. RESULTS A total of 93 (47.4%) patients had CH mutations. The most frequently mutated genes were DNMT3A (28 of 196; 14.3%), TET2 (22 of 196; 11.2%), IDH1 (15 of 196; 7.7%), IDH2 (14 of 196; 7.1%), and ASXL1 (13 of 196; 6.6%). The incidence of aGVHD was higher in patients older than 45 years old with DTA mutations (DNMT3A, TET2 or ASXL1). DNMT3A mutation but not with TET2 or ASXL1 mutation was an independent risk factor for aGVHD in patients receiving allo-HSCT older than 45 years old. With a median follow-up of 42.7 months, CH mutations were not associated with overall survival and leukemia-free survival. CONCLUSIONS DNMT3A mutation, but not TET2 or ASXL1 mutation, was associated with higher incidence of aGVHD.

背景自下一代测序(NGS)技术广泛应用以来,克隆造血(CH)相关基因突变与异基因造血干细胞移植(allo-HSCT)之间的关系已得到广泛研究。然而,研究主要集中在供者CH基因突变与移植预后之间的关系,而对受者CH基因突变与急性移植物抗宿主病(aGVHD)之间关系的研究还很缺乏。材料与方法 我们分析了 196 例接受异体 HSCT 的 AML 患者的 NGS 结果及其与 aGVHD 和预后的相关性。结果 共有 93 例(47.4%)患者出现 CH 基因突变。最常见的突变基因是 DNMT3A(196 例中有 28 例;14.3%)、TET2(196 例中有 22 例;11.2%)、IDH1(196 例中有 15 例;7.7%)、IDH2(196 例中有 14 例;7.1%)和 ASXL1(196 例中有 13 例;6.6%)。年龄大于 45 岁且存在 DTA 突变(DNMT3A、TET2 或 ASXL1)的患者发生 aGVHD 的几率更高。在接受allo-HSCT的45岁以上患者中,DNMT3A突变而非TET2或ASXL1突变是发生aGVHD的独立危险因素。中位随访时间为42.7个月,CH突变与总生存期和无白血病生存期无关。结论 DNMT3A 突变与较高的 aGVHD 发生率有关,而 TET2 或 ASXL1 突变与较高的 aGVHD 发生率无关。
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引用次数: 0
Effect of the Organ Donation Quality System on Donation Activity of Warsaw Hospitals. 器官捐献质量体系对华沙医院捐献活动的影响。
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-06-28 DOI: 10.12659/AOT.943520
Edyta Karpeta, Izabella Godlewska, Piotr Małkowski, Maciej Kosieradzki

BACKGROUND Like many other countries, Poland faces a shortage of transplantable organs despite implementing strategies to develop donation programs. Increasing the effectiveness of deceased organ donation programs requires the implementation of protocols and quality standards for the entire process. The aim of this study was to assess the organ donation potential in Warsaw hospitals (with and without implemented donation procedures) in the years 2017-2018, before the COVID-19 pandemic affected donation activity. The obtained results were compared with quality indicators established in the ODEQUS project and the European Commission project "Improving Knowledge and Practices in Organ Donation" (DOPKI). MATERIAL AND METHODS Retrospective analysis was performed of hospitalization and death causes (including deaths in the brain death mechanism) in the hospitals and intensive care units in 2017-2018. We divided 15 Warsaw hospitals into 2 groups: those with implemented quality programs for organ donation (n=4) and those without such programs (n=11). RESULTS Hospitals with procedures obtained significantly higher values than hospitals without procedures, but were lower than the values in DOPKI and ODEQUS. The success rate of the organ donation process after brain death recognition was comparable in all groups. The conversion rate to actual donors was 73% in hospitals with procedures compared to 68% in hospitals without procedures, significantly higher than in the 42% reported in the DOPKI project. CONCLUSIONS Low numbers of brain death declarations in Warsaw hospitals result from low recognition of deaths in the brain death mechanism. Implementing procedures at each hospital level will enable identification of critical points and comparison of solution outcomes.

背景与许多其他国家一样,尽管波兰实施了发展捐献计划的战略,但仍面临着可移植器官短缺的问题。要提高已故器官捐献计划的有效性,就必须在整个过程中实施相关规程和质量标准。本研究的目的是在 COVID-19 大流行影响捐献活动之前,评估 2017-2018 年华沙医院(已实施和未实施捐献程序)的器官捐献潜力。研究结果与 ODEQUS 项目和欧盟委员会 "改善器官捐献知识和实践"(DOPKI)项目中确定的质量指标进行了比较。材料与方法 对 2017-2018 年医院和重症监护室的住院和死亡原因(包括脑死亡机制中的死亡)进行了回顾性分析。我们将 15 家华沙医院分为两组:实施了器官捐献质量计划的医院(4 家)和未实施此类计划的医院(11 家)。结果 实施了程序的医院获得的数值明显高于未实施程序的医院,但低于 DOPKI 和 ODEQUS 的数值。各组脑死亡识别后器官捐献程序的成功率相当。有程序的医院与无程序的医院相比,实际捐献者的转化率分别为73%和68%,明显高于DOPKI项目中报告的42%。结论:华沙医院脑死亡申报率低的原因是脑死亡机制对死亡的识别率较低。在每个医院层面实施程序将有助于识别关键点并比较解决方案的结果。
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引用次数: 0
Post-Donation Regret and Anxiety Among Family Living Liver Donors: The Mediating Roles of Family Relationships and Sense of Mastery. 家庭活体肝脏捐献者捐献后的遗憾和焦虑:家庭关系和主人翁意识的中介作用。
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-06-25 DOI: 10.12659/AOT.944176
Ye Sol Lee, Chin Kang Koh, Nam-Joon Yi

BACKGROUND Post-donation regret in family living liver donors can impact their mental well-being. This study examined whether the relationship between post-donation regret and anxiety is mediated by family relationships and a sense of mastery. MATERIAL AND METHODS We conducted a secondary analysis of de-identified cross-sectional data from a prior study that included 124 living liver donors. These donors underwent partial hepatectomy between January 2011 and March 2021 at a tertiary hospital in Seoul, South Korea. The data included demographic and clinical characteristics, along with the results from administering the following measures: the Post-Donation Regret Scale, Family Relationships Index, Pearlin Mastery Scale, and the Generalized Anxiety Disorder-2 scale. RESULTS Among family living liver donors, 5.6% had anxiety after donation. The total effect of post-donation regret on anxiety was significant (B=0.41, p<0.05). However, the direct effect of regret on anxiety was not significant (B=-0.05, p=0.733). Post-donation regret had indirect effects on anxiety, solely through family relationships (B=0.329, 95% CI=0.130, 0.563) and sequentially through family relationships and mastery (B=0.088, 95% CI=0.008, 0.232), even after controlling for sex, age, postoperative complications, years since donation, and recipient's death. In addition, postoperative complication was a predictor of anxiety (B=0.64, p<0.05). CONCLUSIONS Providing family-centered and mastery-enhancing interventions may help alleviate the anxiety of family living liver donors.

背景:家庭活体肝脏捐献者捐献后的遗憾会影响他们的心理健康。本研究探讨了捐献后遗憾与焦虑之间的关系是否会受到家庭关系和主人翁意识的影响。材料与方法 我们对之前一项研究中的去身份化横断面数据进行了二次分析,该研究包括 124 名活体肝脏捐献者。这些捐献者于 2011 年 1 月至 2021 年 3 月期间在韩国首尔的一家三级医院接受了部分肝切除术。数据包括人口统计学特征、临床特征以及以下测量结果:捐献后后悔量表、家庭关系指数、Pearlin掌握量表和广泛性焦虑症-2量表。结果 在家庭活体肝脏捐献者中,5.6%的人在捐献后有焦虑症。捐献后遗憾对焦虑的总影响是显著的(B=0.41,P<0.05)。
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引用次数: 0
Liver Transplantation from Brain-Dead Donors with Hepatitis B or C in South Korea: A 2014-2020 Korean Organ Transplantation Registry Data Analysis. 韩国乙型或丙型肝炎脑死亡捐献者的肝移植:2014-2020年韩国器官移植登记数据分析》。
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-05-21 DOI: 10.12659/AOT.943588
Hoonsung Park, Hanyoung Lee, Seungmin Baik, Myoung Soo Kim, Jaeseok Yang, Jong Cheol Jeong, Tai Yeon Koo, Deok-Gie Kim, Jae-Myeong Lee

BACKGROUND According to the current guidelines for liver transplantation (LT) of brain-dead donors with hepatitis B or C virus (HBV or HCV) in Korea, grafts from hepatitis B surface antigen (HBsAg)(+) or HCV antibody (anti-HCV)(+) donors must be transplanted only to HBsAg(+) or anti-HCV(+) recipients, respectively. We aimed to determine the current status and outcomes of brain-dead donor LT with HBV or HCV in Korea. MATERIAL AND METHODS This retrospective observational study included all LTs from brain-dead donors in the Korean Organ Transplantation Registry between April 2014 and December 2020. According to donor hepatitis status, 24 HBV(+), 1 HCV(+), and 1010 HBV(-)/HCV(-) donors were included. RESULTS Baseline/final model for end-stage liver disease score (MELD) for HBV(+), HCV(+), and HBV(-)/HCV(-) were 22.4±9.3/27.8±7.8, 16/11, and 33.0±15.4/35.5±7.1, respectively. MELD score of HBV (+) were lower than those of HBV(-)/HCV(-) (P<0.01). Five-year graft and patient survival rates of HBV(+) and HBV(-)/HCV(-) recipients were 81.7%/85.6%, and 76.6%/76.7%, respectively (P=0.73 and P=0.038). One-year graft and patient survival rates of HCV (+) graft recipients were both 100%. CONCLUSIONS No differences in graft and patient survival rates between HBV(+) and HBV(-)/HCV(-) groups were observed. Although accumulating the results of transplants from HBV (+) or HCV(+) grafts to HBV(-) or HCV(-) recipients is not possible owing to domestic regulations, Korea should conditionally permit transplantations from HBV(+) or HCV(+) grafts to HBV(-) or HCV(-) recipients by considering the risks and benefits based on foreign studies. Thereafter, we can accumulate the data from Korea and analyze the outcomes.

背景根据韩国现行的乙型或丙型肝炎病毒(HBV或HCV)脑死亡供体肝移植(LT)指南,乙型肝炎表面抗原(HBsAg)(+)或HCV抗体(抗-HCV)(+)供体的移植物必须分别移植给HBsAg(+)或抗-HCV(+)受体。我们旨在确定韩国 HBV 或 HCV 脑死亡供体 LT 的现状和结果。材料与方法 这项回顾性观察研究纳入了韩国器官移植登记处在 2014 年 4 月至 2020 年 12 月期间所有脑死亡供体的 LT。根据供体肝炎状态,纳入了 24 名 HBV(+)、1 名 HCV(+)和 1010 名 HBV(-)/HCV(-)供体。结果 HBV(+)、HCV(+)和 HBV(-)/HCV(-)的终末期肝病评分基线/最终模型(MELD)分别为 22.4±9.3/27.8±7.8、16/11 和 33.0±15.4/35.5±7.1。HBV(+)的 MELD 评分低于 HBV(-)/HCV(-)(P
{"title":"Liver Transplantation from Brain-Dead Donors with Hepatitis B or C in South Korea: A 2014-2020 Korean Organ Transplantation Registry Data Analysis.","authors":"Hoonsung Park, Hanyoung Lee, Seungmin Baik, Myoung Soo Kim, Jaeseok Yang, Jong Cheol Jeong, Tai Yeon Koo, Deok-Gie Kim, Jae-Myeong Lee","doi":"10.12659/AOT.943588","DOIUrl":"10.12659/AOT.943588","url":null,"abstract":"<p><p>BACKGROUND According to the current guidelines for liver transplantation (LT) of brain-dead donors with hepatitis B or C virus (HBV or HCV) in Korea, grafts from hepatitis B surface antigen (HBsAg)(+) or HCV antibody (anti-HCV)(+) donors must be transplanted only to HBsAg(+) or anti-HCV(+) recipients, respectively. We aimed to determine the current status and outcomes of brain-dead donor LT with HBV or HCV in Korea. MATERIAL AND METHODS This retrospective observational study included all LTs from brain-dead donors in the Korean Organ Transplantation Registry between April 2014 and December 2020. According to donor hepatitis status, 24 HBV(+), 1 HCV(+), and 1010 HBV(-)/HCV(-) donors were included. RESULTS Baseline/final model for end-stage liver disease score (MELD) for HBV(+), HCV(+), and HBV(-)/HCV(-) were 22.4±9.3/27.8±7.8, 16/11, and 33.0±15.4/35.5±7.1, respectively. MELD score of HBV (+) were lower than those of HBV(-)/HCV(-) (P<0.01). Five-year graft and patient survival rates of HBV(+) and HBV(-)/HCV(-) recipients were 81.7%/85.6%, and 76.6%/76.7%, respectively (P=0.73 and P=0.038). One-year graft and patient survival rates of HCV (+) graft recipients were both 100%. CONCLUSIONS No differences in graft and patient survival rates between HBV(+) and HBV(-)/HCV(-) groups were observed. Although accumulating the results of transplants from HBV (+) or HCV(+) grafts to HBV(-) or HCV(-) recipients is not possible owing to domestic regulations, Korea should conditionally permit transplantations from HBV(+) or HCV(+) grafts to HBV(-) or HCV(-) recipients by considering the risks and benefits based on foreign studies. Thereafter, we can accumulate the data from Korea and analyze the outcomes.</p>","PeriodicalId":7935,"journal":{"name":"Annals of Transplantation","volume":"29 ","pages":"e943588"},"PeriodicalIF":1.1,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11127609/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141070131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association Between FEV₁ Decline Rate and Mortality in Long-Term Follow-Up of a 21-Patient Pilot Clinical Trial of Inhaled Liposomal Cyclosporine Plus Standard-of-Care Versus Standard-of-Care Alone for Bronchiolitis Obliterans Syndrome After Lung Transplantation. 肺移植术后支气管炎闭塞综合征吸入脂质体环孢素加标准护理与单用标准护理的 21 例患者试点临床试验的长期随访中,FEV₁ 下降率与死亡率之间的关系。
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-05-14 DOI: 10.12659/AOT.942823
Aldo Iacono, Marniker Wijesinha, Andreas Völp, Maksim Korotun, Michael Terrin

BACKGROUND The association between forced expiratory volume in 1 second (FEV1) trajectory and mortality in bronchiolitis obliterans syndrome (BOS) is not well defined. Using long-term data from a prior clinical trial of inhaled liposomal cyclosporine A (L-CsA-I) for lung transplant patients with BOS, this study examined the association between longitudinal FEV₁ change and mortality. MATERIAL AND METHODS We analyzed long-term data from a clinical trial which randomized 21 patients with BOS (³20% decrease in FEV1 from personal maximum) to receive L-CsA-I plus standard-of-care (n=11) or standard-of-care (SOC) alone (n=10) for 24 weeks. A joint statistical model, combining a linear mixed model for FEV₁ change and Cox regression for mortality, was utilized to examine the overall association between FEV₁ trajectory and mortality during follow-up. RESULTS The 21 trial participants (10 single, 11 double lung recipients) had a mean FEV₁ of 1.7±0.6 Liters at randomization. Median follow-up post-randomization was 35 months. In joint model analysis, 1 percent FEV₁ decline predicted 1.076-fold increased mortality risk (95% confidence interval: -0.998 to 1.160, p=0.058). FEV₁ decline was reduced by 2.6% per year in L-CsA-I patients compared to SOC (p=0.210), and overall survival at 1/3/5 years was 91%/64%/27% vs 90%/20%/0% for L-CsA-I versus SOC, respectively (p=0.164). CONCLUSIONS In BOS patients, greater longitudinal FEV₁ decline predicts increased mortality. Trends towards prolonged stabilization of FEV₁ and improved survival were observed with L-CsA-I receipt. Further analyses will aid in evaluating the utility of FEV₁ change as a survival predictor, having implications in BOS management and future trial design.

背景 1 秒用力呼气容积(FEV1)变化轨迹与支气管炎闭塞综合征(BOS)死亡率之间的关系尚未明确。本研究利用之前针对 BOS 肺移植患者的吸入性脂质体环孢素 A(L-CsA-I)临床试验的长期数据,研究了 FEV₁纵向变化与死亡率之间的关系。材料和方法 我们分析了一项临床试验的长期数据,该试验随机抽取了 21 名 BOS 患者(FEV1 从个人最大值下降 ³20%),让他们接受 L-CsA-I 加标准护理(11 人)或单用标准护理(SOC)(10 人),为期 24 周。采用线性混合模型(FEV₁ 变化)和 Cox 回归(死亡率)相结合的联合统计模型,研究随访期间 FEV₁轨迹与死亡率之间的总体关系。结果 21 名试验参与者(10 名单肺受者,11 名双肺受者)在随机化时的平均 FEV₁ 为 1.7±0.6 升。随机化后的中位随访时间为 35 个月。在联合模型分析中,FEV₁下降1%预示死亡风险增加1.076倍(95%置信区间:-0.998至1.160,P=0.058)。与 SOC 相比,L-CsA-I 患者的 FEV₁ 下降率每年降低 2.6%(p=0.210),L-CsA-I 与 SOC 的 1/3/5 年总生存率分别为 91%/64%/27% 与 90%/20%/0% (p=0.164)。结论 在 BOS 患者中,FEV₁ 的纵向下降幅度越大,预示着死亡率越高。接受 L-CsA-I 治疗后,FEV₁ 稳定时间延长,生存率提高。进一步的分析将有助于评估 FEV₁变化作为生存预测指标的效用,对 BOS 的管理和未来的试验设计具有重要意义。
{"title":"Association Between FEV₁ Decline Rate and Mortality in Long-Term Follow-Up of a 21-Patient Pilot Clinical Trial of Inhaled Liposomal Cyclosporine Plus Standard-of-Care Versus Standard-of-Care Alone for Bronchiolitis Obliterans Syndrome After Lung Transplantation.","authors":"Aldo Iacono, Marniker Wijesinha, Andreas Völp, Maksim Korotun, Michael Terrin","doi":"10.12659/AOT.942823","DOIUrl":"10.12659/AOT.942823","url":null,"abstract":"<p><p>BACKGROUND The association between forced expiratory volume in 1 second (FEV1) trajectory and mortality in bronchiolitis obliterans syndrome (BOS) is not well defined. Using long-term data from a prior clinical trial of inhaled liposomal cyclosporine A (L-CsA-I) for lung transplant patients with BOS, this study examined the association between longitudinal FEV₁ change and mortality. MATERIAL AND METHODS We analyzed long-term data from a clinical trial which randomized 21 patients with BOS (³20% decrease in FEV1 from personal maximum) to receive L-CsA-I plus standard-of-care (n=11) or standard-of-care (SOC) alone (n=10) for 24 weeks. A joint statistical model, combining a linear mixed model for FEV₁ change and Cox regression for mortality, was utilized to examine the overall association between FEV₁ trajectory and mortality during follow-up. RESULTS The 21 trial participants (10 single, 11 double lung recipients) had a mean FEV₁ of 1.7±0.6 Liters at randomization. Median follow-up post-randomization was 35 months. In joint model analysis, 1 percent FEV₁ decline predicted 1.076-fold increased mortality risk (95% confidence interval: -0.998 to 1.160, p=0.058). FEV₁ decline was reduced by 2.6% per year in L-CsA-I patients compared to SOC (p=0.210), and overall survival at 1/3/5 years was 91%/64%/27% vs 90%/20%/0% for L-CsA-I versus SOC, respectively (p=0.164). CONCLUSIONS In BOS patients, greater longitudinal FEV₁ decline predicts increased mortality. Trends towards prolonged stabilization of FEV₁ and improved survival were observed with L-CsA-I receipt. Further analyses will aid in evaluating the utility of FEV₁ change as a survival predictor, having implications in BOS management and future trial design.</p>","PeriodicalId":7935,"journal":{"name":"Annals of Transplantation","volume":"29 ","pages":"e942823"},"PeriodicalIF":1.1,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140915683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-Term Outcomes with Prolonged-Release Tacrolimus in Kidney Transplantation: A Retrospective Real-World Data Analysis. 肾移植中使用长效缓释他克莫司的长期疗效:回顾性真实世界数据分析。
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-03-19 DOI: 10.12659/AOT.942167
Wilfried Gwinner, Swapneel Anaokar, Martin Blogg, Birgit Hermann, Carola Del Pilar Repetur, Mario Schiffer

BACKGROUND Long-term real-world outcomes data for kidney transplant recipients (KTRs) converting from immediate-release tacrolimus (IRT) to prolonged-release tacrolimus (PRT) are limited. MATERIAL AND METHODS A retrospective, non-interventional review of adult KTRs treated with PRT for ≥1 month was conducted in Germany. Data were extracted from time of transplant (2008-2014) to 2018. Primary composite endpoints (graft loss, biopsy-confirmed acute rejection, graft dysfunction) and secondary endpoints (all-cause mortality, kidney function course, and tacrolimus dose/trough levels) were analyzed for sub-cohorts: de novo PRT, early conversion from IRT (within 6 months post-transplant), and late conversion (7 months to 3 years). RESULTS Analysis included 163 patients (101 de novo, 12 early converters, and 50 late converters). The overall Kaplan-Meier estimate of freedom from efficacy failure through 5 years was 0.537, (95% confidence interval (CI) 0.455-0.612) (de novo: 0.512 [0.407-0.608]; early converters: 0.500 [0.208-0.736]; late converters: 0.594 [0.443-0.717]). The overall survival rate was 0.925 (95% CI 0.872-0.957) (de novo: 0.900 [0.823-0.945]; early converters: 0.917 [0.539-0.988]; late converters: 0.977 [0.846-0.997]). During follow-up, there was a gradual reduction in tacrolimus dose and trough levels; kidney function remained stable in all cohorts. Multivariable analysis found re-transplantation, organ donor quality, best estimated glomerular filtration rate 8-12 weeks after transplant, and treatment center (between-center differences in age, sex, donor status/quality) were significantly associated with efficacy failure. CONCLUSIONS There was no difference in long-term survival profiles between KTRs who received PRT de novo vs those who converted from IRT, with 5-year survival remaining high in both groups.

背景 肾移植受者(KTR)从速释他克莫司(IRT)转为长效他克莫司(PRT)的长期实际结果数据有限。材料与方法 在德国对接受 PRT 治疗≥1 个月的成年 KTR 进行了回顾性、非干预性审查。提取了从移植时间(2008-2014 年)到 2018 年的数据。分析了子队列的主要复合终点(移植物丢失、活检证实的急性排斥反应、移植物功能障碍)和次要终点(全因死亡率、肾功能病程和他克莫司剂量/量程水平):新PRT、从IRT早期转换(移植后6个月内)和晚期转换(7个月至3年)。结果 分析包括 163 名患者(101 名新发患者、12 名早期转换患者和 50 名晚期转换患者)。5年内免于疗效失败的总体卡普兰-梅耶估计值为0.537(95%置信区间(CI)为0.455-0.612)(新患者:0.512 [0.407-0.608];早期转化者:0.500 [0.208-0.208]):0.500 [0.208-0.736];晚期转换者:0.594 [0.443-0.717]).总生存率为 0.925(95% CI 0.872-0.957)(新发病例:0.900 [0.823-0.945];早期转化病例:0.917 [0.5%CI]):0.917[0.539-0.988];晚期转化者:0.977[0.838-0.988]:0.977 [0.846-0.997]).随访期间,他克莫司的剂量和谷值水平逐渐降低;所有组群的肾功能均保持稳定。多变量分析发现,再次移植、器官捐献者质量、移植后8-12周最佳估计肾小球滤过率和治疗中心(中心间的年龄、性别、捐献者状况/质量差异)与疗效失败显著相关。结论 从头接受 PRT 的 KTR 与从 IRT 转为 PRT 的 KTR 之间在长期存活率方面没有差异,两组患者的 5 年存活率都很高。
{"title":"Long-Term Outcomes with Prolonged-Release Tacrolimus in Kidney Transplantation: A Retrospective Real-World Data Analysis.","authors":"Wilfried Gwinner, Swapneel Anaokar, Martin Blogg, Birgit Hermann, Carola Del Pilar Repetur, Mario Schiffer","doi":"10.12659/AOT.942167","DOIUrl":"10.12659/AOT.942167","url":null,"abstract":"<p><p>BACKGROUND Long-term real-world outcomes data for kidney transplant recipients (KTRs) converting from immediate-release tacrolimus (IRT) to prolonged-release tacrolimus (PRT) are limited. MATERIAL AND METHODS A retrospective, non-interventional review of adult KTRs treated with PRT for ≥1 month was conducted in Germany. Data were extracted from time of transplant (2008-2014) to 2018. Primary composite endpoints (graft loss, biopsy-confirmed acute rejection, graft dysfunction) and secondary endpoints (all-cause mortality, kidney function course, and tacrolimus dose/trough levels) were analyzed for sub-cohorts: de novo PRT, early conversion from IRT (within 6 months post-transplant), and late conversion (7 months to 3 years). RESULTS Analysis included 163 patients (101 de novo, 12 early converters, and 50 late converters). The overall Kaplan-Meier estimate of freedom from efficacy failure through 5 years was 0.537, (95% confidence interval (CI) 0.455-0.612) (de novo: 0.512 [0.407-0.608]; early converters: 0.500 [0.208-0.736]; late converters: 0.594 [0.443-0.717]). The overall survival rate was 0.925 (95% CI 0.872-0.957) (de novo: 0.900 [0.823-0.945]; early converters: 0.917 [0.539-0.988]; late converters: 0.977 [0.846-0.997]). During follow-up, there was a gradual reduction in tacrolimus dose and trough levels; kidney function remained stable in all cohorts. Multivariable analysis found re-transplantation, organ donor quality, best estimated glomerular filtration rate 8-12 weeks after transplant, and treatment center (between-center differences in age, sex, donor status/quality) were significantly associated with efficacy failure. CONCLUSIONS There was no difference in long-term survival profiles between KTRs who received PRT de novo vs those who converted from IRT, with 5-year survival remaining high in both groups.</p>","PeriodicalId":7935,"journal":{"name":"Annals of Transplantation","volume":"29 ","pages":"e942167"},"PeriodicalIF":1.1,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10960500/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140157387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Use of LCP-Tacrolimus (LCPT) in Kidney Transplantation: A Delphi Consensus Survey of Expert Clinicians. 在肾移植中使用 LCP-Tacrolimus (LCPT):临床专家德尔菲共识调查。
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-03-12 DOI: 10.12659/AOT.943498
Alexander Wiseman, Tarek Alhamad, Rita R Alloway, Beatrice P Concepcion, Matthew Cooper, Richard Formica, Christina L Klein, Vineeta Kumar, Nicolae Leca, Fuad Shihab, David J Taber, Sarah Mulnick, Donald M Bushnell, Monica Hadi, Suphamai Bunnapradist

BACKGROUND LCPT (Envarsus XR®) is a common once-daily, extended-release oral tacrolimus formulation used in kidney transplantation. However, there are minimal evidence-based recommendations regarding optimal dosing and treatment in the de novo and conversion settings. MATERIAL AND METHODS Using Delphi methodology, 12 kidney transplantation experts with LCPT experience reviewed available data to determine potential consensus topics. Key statements regarding LCPT use were generated and disseminated to the panel in an online Delphi survey. Statements were either accepted, revised, or rejected based on the level of consensus, perceived strength of evidence, and alignment with clinical practice. Consensus was defined a priori as ≥75% agreement. RESULTS Twenty-three statements were generated: 14 focused on de novo LCPT use and 9 on general administration or LCPT conversion use. After 2 rounds, consensus was achieved for 11/14 of the former and 7/9 of the latter statements. In a de novo setting, LCPT was recognized as a first-line option based on its safety and efficacy compared to immediate-release tacrolimus. In particular, African Americans and rapid metabolizer populations were identified as preferred for first-line LCPT therapy. In a conversion setting, full consensus was achieved for converting to LCPT to address neurological adverse effects related to immediate-release tacrolimus and for the time required (approximately 7 days) for steady-state LCPT trough levels to be reached. CONCLUSIONS When randomized clinical trials do not replicate current utilization patterns, the Delphi process can successfully generate consensus statements by expert clinicians to inform clinical decision-making for the use of LCPT in kidney transplant recipients.

背景 LCPT(Envarsus XR®)是肾移植中常用的一种每日一次的缓释口服他克莫司制剂。然而,关于肾移植和肾移植转归中的最佳剂量和治疗方法的循证建议却少之又少。材料和方法 12 位具有 LCPT 经验的肾移植专家采用德尔菲法对现有数据进行了审查,以确定可能达成共识的主题。通过在线德尔菲调查生成了有关 LCPT 使用的关键声明并分发给专家小组。根据共识程度、感知的证据强度以及与临床实践的一致性,对声明进行接受、修改或拒绝。共识的先验定义为≥75%的一致意见。结果 产生了 23 项声明:其中 14 项声明侧重于 LCPT 的重新使用,9 项声明侧重于一般管理或 LCPT 的转换使用。经过两轮讨论,前者的 11/14 份声明和后者的 7/9 份声明达成了共识。与速释他克莫司相比,LCPT 具有安全性和有效性,因此被认为是新用药的一线选择。特别是非裔美国人和快速代谢人群被认为是 LCPT 一线治疗的首选。在转换治疗中,针对速释他克莫司引起的神经系统不良反应以及达到稳态 LCPT 谷值水平所需的时间(约 7 天),患者完全同意转用 LCPT。结论 当随机临床试验无法复制当前的使用模式时,德尔菲流程可以成功地由临床专家达成共识,为肾移植受者使用 LCPT 的临床决策提供依据。
{"title":"Use of LCP-Tacrolimus (LCPT) in Kidney Transplantation: A Delphi Consensus Survey of Expert Clinicians.","authors":"Alexander Wiseman, Tarek Alhamad, Rita R Alloway, Beatrice P Concepcion, Matthew Cooper, Richard Formica, Christina L Klein, Vineeta Kumar, Nicolae Leca, Fuad Shihab, David J Taber, Sarah Mulnick, Donald M Bushnell, Monica Hadi, Suphamai Bunnapradist","doi":"10.12659/AOT.943498","DOIUrl":"10.12659/AOT.943498","url":null,"abstract":"<p><p>BACKGROUND LCPT (Envarsus XR®) is a common once-daily, extended-release oral tacrolimus formulation used in kidney transplantation. However, there are minimal evidence-based recommendations regarding optimal dosing and treatment in the de novo and conversion settings. MATERIAL AND METHODS Using Delphi methodology, 12 kidney transplantation experts with LCPT experience reviewed available data to determine potential consensus topics. Key statements regarding LCPT use were generated and disseminated to the panel in an online Delphi survey. Statements were either accepted, revised, or rejected based on the level of consensus, perceived strength of evidence, and alignment with clinical practice. Consensus was defined a priori as ≥75% agreement. RESULTS Twenty-three statements were generated: 14 focused on de novo LCPT use and 9 on general administration or LCPT conversion use. After 2 rounds, consensus was achieved for 11/14 of the former and 7/9 of the latter statements. In a de novo setting, LCPT was recognized as a first-line option based on its safety and efficacy compared to immediate-release tacrolimus. In particular, African Americans and rapid metabolizer populations were identified as preferred for first-line LCPT therapy. In a conversion setting, full consensus was achieved for converting to LCPT to address neurological adverse effects related to immediate-release tacrolimus and for the time required (approximately 7 days) for steady-state LCPT trough levels to be reached. CONCLUSIONS When randomized clinical trials do not replicate current utilization patterns, the Delphi process can successfully generate consensus statements by expert clinicians to inform clinical decision-making for the use of LCPT in kidney transplant recipients.</p>","PeriodicalId":7935,"journal":{"name":"Annals of Transplantation","volume":"29 ","pages":"e943498"},"PeriodicalIF":1.1,"publicationDate":"2024-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10944009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140206212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Retrospective Study of Long-Term Outcomes in 16 ABO-Incompatible Deceased Donor Pediatric Liver Transplants from a National Transplant Center at Helsinki University Hospital, Finland, 1987-2022. 1987-2022年芬兰赫尔辛基大学医院国家移植中心对16例ABO血型不相容死亡供体小儿肝脏移植手术长期结果的回顾性研究。
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-02-13 DOI: 10.12659/AOT.941929
Timo Jahnukainen, Inna Sareneva, Jouni Lauronen, Elisa Ylinen, Juuso Tainio, Arno Nordin, Maria Hukkinen, Mikko P Pakarinen, Hannu Jalanko

BACKGROUND The use of ABO-incompatible liver transplants (ABO-ILTs) from deceased donors has become more common due to the shortage of available donor livers and increased transplant waiting times. This retrospective study from a national transplant center at Helsinki University Hospital, Finland, aimed to assess the long-term outcomes of ABO-incompatible deceased donor pediatric liver transplants between 1987 and 2022. MATERIAL AND METHODS Sixteen (9.5%) of the 169 pediatric liver transplantations were ABO-ILTs. The median age at transplantation was 5.0 (0.5-15.4) years. Reasons for ABO-ILTs were acute liver failure (18.75%), malignancy (12.5%), small body size and long waiting time (25%), and other reasons (43.75%). The median post-transplant follow-up time was 147 (0.72-353) months. Patient and graft survival and occurrence of surgical complications were compared to ABO-identical transplants, and anti-ABO antibody titers were analyzed. RESULTS The 1-, 3-, and 5-year patient survivals were comparable between the ABO-I and ABO-compatible groups, being 81.3%, 73.9%, and 73.9% (ABO-I) and 87.5%, 82.5%, 77.9% (ABO-compatible), respectively. Three patients with ABO-ILTs died of sepsis and multiorgan failure during the first 3 months after transplantation. The occurrence of biliary complications and early vascular thrombosis (<30 days after transplantation) did not differ significantly between recipients with an ABO-ILT vs ABO-compatible liver graft. CONCLUSIONS The findings from this study support findings from previous studies that outcomes after ABO-incompatible liver transplants in children were comparable to outcomes from ABO-identical liver transplants.

背景由于可用供体肝脏的短缺和移植等待时间的延长,使用已故供体进行ABO不相容肝脏移植(ABO-ILT)已变得越来越普遍。这项来自芬兰赫尔辛基大学医院国家移植中心的回顾性研究旨在评估1987年至2022年期间ABO不相容死亡供体小儿肝移植的长期结果。材料和方法 在169例小儿肝移植中,有16例(9.5%)为ABO-ILT。移植时的中位年龄为 5.0(0.5-15.4)岁。ABO-ILT的原因包括急性肝功能衰竭(18.75%)、恶性肿瘤(12.5%)、体型小和等待时间长(25%)以及其他原因(43.75%)。移植后随访时间的中位数为 147(0.72-353)个月。将患者和移植物的存活率以及手术并发症的发生率与ABO血型相同的移植进行了比较,并对抗ABO抗体滴度进行了分析。结果 ABO-I 组和 ABO 相容组患者的 1 年、3 年和 5 年存活率相当,分别为 81.3%、73.9% 和 73.9%(ABO-I 组)以及 87.5%、82.5% 和 77.9%(ABO 相容组)。3名ABO-ILT患者在移植后的头3个月死于败血症和多器官功能衰竭。胆道并发症和早期血管血栓形成((
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引用次数: 0
Immunoprotective Effect of Liver Allograft on Patients with Combined Liver and Kidney Transplantation. 肝移植对肝肾联合移植患者的免疫保护作用
IF 1.1 4区 医学 Q3 SURGERY Pub Date : 2024-02-06 DOI: 10.12659/AOT.942763
Joon-Young Kim, Hye Bin Kim, Jin-Myung Kim, Hye Eun Kwon, Young Hoon Kim, Youngmin Ko, Frances S Sung, Joo Hee Jung, Chung Hee Baek, Hyosang Kim, Su-Kil Park, Sung Shin, Hyunwook Kwon

BACKGROUND Simultaneous liver-kidney transplantation (SLKT) and kidney transplantation (KT) after liver transplantation (LT) provide potential treatment options for patients with end-stage liver and kidney disease. There is increasing attention being given to liver-kidney transplantation (LTKT), particularly regarding the immune-protective effects of the liver graft. This retrospective, single-center, observational study aimed to evaluate the clinical outcomes of KT in LTKT patients - either SLKT or KT after LT (KALT) - compared to KT alone (KTA). MATERIAL AND METHODS We included patients who underwent KT between January 2005 and December 2020, comprising a total of 4312 patients divided into KTA (n=4268) and LTKT (n=44) groups. The LTKT group included 11 SLKT and 33 KALT patients. To balance the difference in sample sizes between the 2 groups, we performed 3: 1 propensity score matching (PSM). RESULTS There was no significant difference in graft survival between the groups. However, the LTKT group exhibited significantly superior rejection-free survival compared to the KTA group (P.

背景 肝移植(LT)后同时进行肝肾移植(SLKT)和肾移植(KT)为终末期肝肾疾病患者提供了潜在的治疗选择。人们越来越关注肝肾移植(LTKT),尤其是肝脏移植的免疫保护作用。这项回顾性、单中心观察性研究旨在评估肝肾移植(LTKT)患者的临床疗效(SLKT或LT后KT(KALT))与单纯KT(KTA)的比较。材料和方法 我们纳入了 2005 年 1 月至 2020 年 12 月期间接受 KT 的患者,共计 4312 人,分为 KTA 组(n=4268)和 LTKT 组(n=44)。LTKT 组包括 11 名 SLKT 和 33 名 KALT 患者。为了平衡两组样本量的差异,我们进行了 3:1 倾向评分匹配(PSM)。结果 两组的移植物存活率无明显差异。但是,与 KTA 组相比,LTKT 组的无排斥反应存活率明显更高(P.
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引用次数: 0
期刊
Annals of Transplantation
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