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Mending a Broken Heart: Treatment of Stress-Induced Heart Failure after Solid Organ Transplantation. 修补破碎的心:实体器官移植后应激性心力衰竭的治疗。
IF 2.5 Q3 SURGERY Pub Date : 2018-02-18 eCollection Date: 2018-01-01 DOI: 10.1155/2018/9739236
N Thao Galván, Kayla Kumm, Michael Kueht, Cindy P Ha, Dor Yoeli, Ronald T Cotton, Abbas Rana, Christine A O'Mahony, Glenn Halff, John A Goss

Stress-induced heart failure, also known as Broken Heart Syndrome or Takotsubo Syndrome, is a phenomenon characterized as rare but well described in the literature, with increasing incidence. While more commonly associated with postmenopausal women with psychiatric disorders, this entity is found in the postoperative patient. The nonischemic cardiogenic shock manifests as biventricular failure with significant decreases in ejection fraction and cardiac function. In a review of over 3000 kidney and liver transplantations over the course of 17 years within two transplant centers, we describe a series of 7 patients with Takotsubo Syndrome after solid organ transplantation. Furthermore, we describe a novel approach of successfully treating the transient, though potentially fatal, cardiogenic shock with a percutaneous ventricular assistance device in two liver transplant patients, while treating one kidney transplant patient medically and the remaining four liver transplant patients with an intra-aortic balloon pump. We describe our experience with Takotsubo's Syndrome and compare the three modalities of treatment and cardiac augmentation. Our series is novel in introducing the percutaneous ventricular assist device as a more minimally invasive intervention in treating nonischemic heart failure in the solid organ transplant patient, while serving as a comprehensive overview of treatment modalities for stress-induced heart failure.

压力引起的心力衰竭,也被称为心碎综合征或Takotsubo综合征,是一种罕见的现象,但在文献中有很好的描述,发病率越来越高。虽然更常与绝经后妇女精神疾病有关,但在术后患者中也发现了这种实体。非缺血性心源性休克表现为双心室衰竭,射血分数和心功能明显下降。在对两家移植中心17年来3000多例肾脏和肝脏移植的回顾中,我们描述了7例实体器官移植后出现Takotsubo综合征的患者。此外,我们描述了一种新的方法,成功治疗短暂性心源性休克,尽管可能致命,经皮心室辅助装置在两个肝移植患者中,同时治疗一个肾移植患者医学和其余四个肝移植患者主动脉内球囊泵。我们描述我们与Takotsubo综合征的经验,并比较三种治疗方式和心脏增强。我们的系列研究新颖地介绍了经皮心室辅助装置作为治疗实体器官移植患者非缺血性心力衰竭的一种微创干预手段,同时对应激性心力衰竭的治疗方式进行了全面概述。
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引用次数: 8
Validation of a Survey Questionnaire on Organ Donation: An Arabic World Scenario. 器官捐献调查问卷的验证:阿拉伯世界的情况。
IF 2.5 Q3 SURGERY Pub Date : 2018-02-08 eCollection Date: 2018-01-01 DOI: 10.1155/2018/9309486
Rajvir Singh, Tulika Mehta Agarwal, Hassan Al-Thani, Yousuf Al Maslamani, Ayman El-Menyar

Objective: To validate a questionnaire for measuring factors influencing organ donation and transplant.

Methods: The constructed questionnaire was based on the theory of planned behavior by Ajzen Icek and had 45 questions including general inquiry and demographic information. Four experts on the topic, Arabic culture, and the Arabic and English languages established content validity through review. It was quantified by content validity index (CVI). Construct validity was established by principal component analysis (PCA), whereas internal consistency was checked by Cronbach's Alpha and intraclass correlation coefficient (ICC). Statistical analysis was performed by SPSS 22.0 statistical package.

Results: Content validity in the form of S-CVI/Average and S-CVI/UA was 0.95 and 0.82, respectively, suggesting adequate relevance content of the questionnaire. Factor analysis indicated that the construct validity for each domain (knowledge, attitudes, beliefs, and intention) was 65%, 71%, 77%, and 70%, respectively. Cronbach's Alpha and ICC coefficients were 0.90, 0.67, 0.75, and 0.74 and 0.82, 0.58, 0.61, and 0.74, respectively, for the domains.

Conclusion: The questionnaire consists of 39 items on knowledge, attitudes, beliefs, and intention domains which is valid and reliable tool to use for organ donation and transplant survey.

目的验证用于测量器官捐献和移植影响因素的问卷:构建的问卷以 Ajzen Icek 的计划行为理论为基础,共有 45 个问题,包括一般调查和人口统计信息。四位有关该主题、阿拉伯文化以及阿拉伯语和英语的专家通过审查确定了问卷内容的有效性。内容效度指数(CVI)对其进行了量化。结构效度通过主成分分析(PCA)确定,而内部一致性则通过克朗巴赫阿尔法(Cronbach's Alpha)和类内相关系数(ICC)检查。统计分析采用 SPSS 22.0 统计软件包进行:S-CVI/Average 和 S-CVI/UA 的内容效度分别为 0.95 和 0.82,表明问卷内容具有充分的相关性。因子分析表明,各领域(知识、态度、信念和意向)的建构效度分别为 65%、71%、77% 和 70%。各领域的 Cronbach's Alpha 和 ICC 系数分别为 0.90、0.67、0.75 和 0.74,以及 0.82、0.58、0.61 和 0.74:该问卷由知识、态度、信念和意向领域的 39 个项目组成,是用于器官捐献和移植调查的有效而可靠的工具。
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引用次数: 0
Management Strategies for Posttransplant Diabetes Mellitus after Heart Transplantation: A Review. 心脏移植术后糖尿病的治疗策略综述
IF 2.5 Q3 SURGERY Pub Date : 2018-01-29 eCollection Date: 2018-01-01 DOI: 10.1155/2018/1025893
Matthew G Cehic, Nishant Nundall, Jerry R Greenfield, Peter S Macdonald

Posttransplant diabetes mellitus (PTDM) is a well-recognized complication of heart transplantation and is associated with increased morbidity and mortality. Previous studies have yielded wide ranging estimates in the incidence of PTDM due in part to variable definitions applied. In addition, there is a limited published data on the management of PTDM after heart transplantation and a paucity of studies examining the effects of newer classes of hypoglycaemic drug therapies. In this review, we discuss the role of established glucose-lowering therapies and the rationale and emerging clinical evidence that supports the role of incretin-based therapies (glucagon like peptide- (GLP-) 1 agonists and dipeptidyl peptidase- (DPP-) 4 inhibitors) and sodium-glucose cotransporter 2 (SGLT2) inhibitors in the management of PTDM after heart transplantation. Recently published Consensus Guidelines for the diagnosis of PTDM will hopefully lead to more consistent approaches to the diagnosis of PTDM and provide a platform for the larger-scale multicentre trials that will be needed to determine the role of these newer therapies in the management of PTDM.

移植后糖尿病(PTDM)是一种公认的心脏移植并发症,与发病率和死亡率增加有关。先前的研究对PTDM的发病率产生了广泛的估计,部分原因是采用了不同的定义。此外,关于心脏移植后PTDM治疗的已发表数据有限,而且关于新型降糖药物治疗效果的研究也很缺乏。在这篇综述中,我们讨论了已建立的降糖疗法的作用,以及支持以肠促胰岛素为基础的疗法(胰高血糖素样肽- (GLP-) 1激动剂和二肽基肽酶- (DPP-) 4抑制剂)和钠-葡萄糖共转运蛋白2 (SGLT2)抑制剂在心脏移植后PTDM治疗中的作用的基本原理和新出现的临床证据。最近出版的PTDM诊断共识指南有望为PTDM的诊断提供更一致的方法,并为大规模的多中心试验提供平台,以确定这些新疗法在PTDM管理中的作用。
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引用次数: 19
A Single Perioperative Injection of Dexamethasone Decreases Nausea, Vomiting, and Pain after Laparoscopic Donor Nephrectomy 腹腔镜供肾切除术后单次围手术期注射地塞米松可减少恶心、呕吐和疼痛
IF 2.5 Q3 SURGERY Pub Date : 2017-01-22 DOI: 10.1155/2017/3518103
Shigeyoshi Yamanaga, A. Posselt, C. Freise, Takaaki Kobayashi, M. Tavakol, Sang-Mo Kang
Background. A single dose of perioperative dexamethasone (8–10 mg) reportedly decreases postoperative nausea, vomiting, and pain but has not been widely used in laparoscopic donor nephrectomy (LDN). Methods. We performed a retrospective cohort study of living donors who underwent LDN between 2013 and 2015. Donors who received a lower dose (4–6 mg)  (n = 70) or a higher dose (8–14 mg) of dexamethasone (n = 100) were compared with 111 donors who did not receive dexamethasone (control). Outcomes and incidence of postoperative nausea, vomiting, and pain within 24 h after LDN were compared before and after propensity-score matching. Results. The higher dose of dexamethasone reduced postoperative nausea and vomiting incidences by 28% (P = 0.010) compared to control, but the lower dose did not. Total opioid use was 29% lower in donors who received the higher dose than in control (P = 0.004). The higher dose was identified as an independent factor for preventing postoperative nausea and vomiting. Postoperative complication rates and hospital stays did not differ between the groups. After propensity-score matching, the results were the same as for the unmatched analysis. Conclusion. A single perioperative injection of 8–14 mg dexamethasone decreases antiemetic and narcotic requirements in the first 24 h, with no increase in surgical complications.
背景围手术期单剂量地塞米松(8-10 mg)据报道可减少术后恶心、呕吐和疼痛,但尚未广泛用于腹腔镜供肾切除术(LDN)。方法。我们对2013年至2015年间接受LDN的活体捐赠者进行了回顾性队列研究。接受较低剂量(4-6 mg)  (n=70)或更高剂量(8-14 mg)地塞米松(n=100)与111名未接受地塞米松的供体(对照)进行比较。24小时内术后恶心、呕吐和疼痛的结果和发生率 在倾向评分匹配前后比较LDN后h。后果与对照组相比,较高剂量的地塞米松使术后恶心和呕吐发生率降低了28%(P=0.010),但较低剂量的地塞米松没有。接受更高剂量的供体的阿片类药物总使用量比对照组低29%(P=0.004)。更高剂量被确定为预防术后恶心和呕吐的独立因素。两组的术后并发症发生率和住院时间没有差异。在倾向得分匹配后,结果与不匹配分析相同。结论单次围手术期注射8-14 mg地塞米松降低前24小时的止吐和麻醉需求 h、 手术并发症没有增加。
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引用次数: 15
Risk Balancing of Cold Ischemic Time against Night Shift Surgery Possibly Reduces Rates of Reoperation and Perioperative Graft Loss 冷缺血时间与夜班手术的风险平衡可能降低再手术率和围手术期移植物损失
IF 2.5 Q3 SURGERY Pub Date : 2017-01-19 DOI: 10.1155/2017/5362704
N. Emmanouilidis, Julius Boeckler, B. Ringe, A. Kaltenborn, F. Lehner, Hans-Friedrich Koch, J. Klempnauer, H. Schrem
Background. This retrospective cohort study evaluates the advantages of risk balancing between prolonged cold ischemic time (CIT) and late night surgery. Methods. 1262 deceased donor kidney transplantations were analyzed. Multivariable regression was used to determine odds ratios (ORs) for reoperation, graft loss, delayed graft function (DGF), and discharge on dialysis. CIT was categorized according to a forward stepwise pattern ≤1h/>1h, ≤2h/>2h, ≤3h/>3h,…, ≤nh/>nh. ORs for DGF were plotted against CIT and a nonlinear regression function with best R2 was identified. First and second derivative were then implemented into the curvature formula k(x) = f′′(x)/(1 + f′(x)2)3/2 to determine the point of highest CIT-mediated risk acceleration. Results. Surgery between 3 AM and 6 AM is an independent risk factor for reoperation and graft loss, whereas prolonged CIT is only relevant for DGF. CIT-mediated risk for DGF follows an exponential pattern f(x) = A · (1 + k · e(I · x)) with a cut-off for the highest risk increment at 23.5 hours. Conclusions. The risk of surgery at 3 AM–6 AM outweighs prolonged CIT when confined within 23.5 hours as determined by a new mathematical approach to calculate turning points of nonlinear time related risks. CIT is only relevant for the endpoint of DGF but had no impact on discharge on dialysis, reoperation, or graft loss.
背景这项回顾性队列研究评估了延长冷缺血时间(CIT)和深夜手术之间风险平衡的优势。方法。对1262例死亡供肾移植进行了分析。多变量回归用于确定再次手术、移植物损失、移植物功能延迟(DGF)和透析出院的比值比(OR)。CIT按≤1h/>1h的正向逐步模式分类, ≤2h/>2h, ≤3h/>3h,…, ≤nh/>nh。DGF的OR与CIT作图,并确定了具有最佳R2的非线性回归函数。然后将一阶导数和二阶导数应用到曲率公式k(x)=f′′(x)/(1+f′(x)2)3/2中,以确定CIT介导的风险加速的最高点。后果上午3点至6点之间的手术是再次手术和移植物丢失的独立风险因素,而CIT延长仅与DGF相关。CIT介导的DGF风险遵循指数模式f(x)=A·(1+k·e(I·x)),最高风险增量的截止时间为23.5小时。结论。根据一种新的数学方法来计算非线性时间相关风险的转折点,当限制在23.5小时内时,在凌晨3点至6点进行手术的风险超过了延长的CIT。CIT仅与DGF终点相关,但对透析、再手术或移植物丢失的出院没有影响。
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引用次数: 9
Blood Transfusions and Tumor Biopsy May Increase HCC Recurrence Rates after Liver Transplantation 输血和肿瘤活检可能增加肝移植后HCC的复发率
IF 2.5 Q3 SURGERY Pub Date : 2017-01-05 DOI: 10.1155/2017/9731095
D. Seehofer, R. Öllinger, T. Denecke, M. Schmelzle, A. Andreou, E. Schott, J. Pratschke
Introduction. Beneath tumor grading and vascular invasion, nontumor related risk factors for HCC recurrence after liver transplantation (LT) have been postulated. Potential factors were analyzed in a large single center experience. Material and Methods. This retrospective analysis included 336 consecutive patients transplanted for HCC. The following factors were analyzed stratified for vascular invasion: immunosuppression, rejection therapy, underlying liver disease, age, gender, blood transfusions, tumor biopsy, caval replacement, waiting time, Child Pugh status, and postoperative complications. Variables with a potential prognostic impact were included in a multivariate analysis. Results. The 5- and 10-year patient survival rates were 70 and 54%. The overall 5-year recurrence rate was 48% with vascular invasion compared to 10% without (p < 0.001). Univariate analysis stratified for vascular invasion revealed age over 60, pretransplant tumor biopsy, and the application of blood transfusions as significant risk factors for tumor recurrence. Blood transfusions remained the only significant risk factor in the multivariate analysis. Recurrence occurred earlier and more frequently in correlation with the number of applied transfusions. Conclusion. Tumor related risk factors are most important and can be influenced by patient selection. However, it might be helpful to consider nontumor related risk factors, identified in the present study for further optimization of the perioperative management.
介绍。在肿瘤分级和血管侵袭的基础上,已经假设了肝移植(LT)后HCC复发的非肿瘤相关危险因素。在大型单中心实验中分析潜在因素。材料和方法。本回顾性分析包括336例连续肝癌移植患者。对以下因素进行血管侵犯分层分析:免疫抑制、排斥治疗、潜在肝脏疾病、年龄、性别、输血、肿瘤活检、腔静脉置换术、等待时间、Child Pugh状态和术后并发症。具有潜在预后影响的变量被纳入多变量分析。结果。5年和10年生存率分别为70%和54%。有血管侵犯的5年复发率为48%,无血管侵犯的复发率为10% (p < 0.001)。对血管侵犯进行分层的单因素分析显示,年龄超过60岁、移植前肿瘤活检和输血是肿瘤复发的重要危险因素。输血仍然是多变量分析中唯一显著的危险因素。与输血次数相关的复发时间早、频率高。结论。肿瘤相关的危险因素是最重要的,可受患者选择的影响。然而,考虑本研究确定的非肿瘤相关危险因素可能有助于进一步优化围手术期管理。
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引用次数: 13
Retrospective Study Looking at Cinacalcet in the Management of Hyperparathyroidism after Kidney Transplantation. cinacalet治疗肾移植后甲状旁腺功能亢进的回顾性研究。
IF 2.5 Q3 SURGERY Pub Date : 2017-01-01 Epub Date: 2017-03-13 DOI: 10.1155/2017/8720283
Habib Mawad, Hugues Bouchard, Duy Tran, Denis Ouimet, Jean-Philippe Lafrance, Robert Zoël Bell, Sarah Bezzaoucha, Anne Boucher, Suzon Collette, Vincent Pichette, Lynne Senécal, Michel Vallée

Objectives. The primary objective of this study is to evaluate the use of cinacalcet in the management of hyperparathyroidism in kidney transplant recipients. The secondary objective is to identify baseline factors that predict cinacalcet use after transplantation. Methods. In this single-center retrospective study, we conducted a chart review of all patients having been transplanted from 2003 to 2012 and having received cinacalcet up to kidney transplantation and/or thereafter. Results. Twenty-seven patients were included with a mean follow-up of 2.9 ± 2.4 years. Twenty-one were already taking cinacalcet at the time of transplantation. Cinacalcet was stopped within the first month in 12 of these patients of which 7 had to restart therapy. The main reason for restarting cinacalcet was hypercalcemia. Length of treatment was 23 ± 26 months. There were only 3 cases of mild hypocalcemia. There was no statistically significant association between baseline factors and cinacalcet status a year later. Conclusions. Discontinuing cinacalcet within the first month of kidney transplantation often leads to hypercalcemia. Cinacalcet appears to be an effective treatment of hypercalcemic hyperparathyroidism in kidney transplant recipients. Further studies are needed to evaluate safety and long-term benefits.

目标。本研究的主要目的是评估cinacalcet在肾移植受者甲状旁腺功能亢进治疗中的应用。次要目的是确定预测移植后肾细胞使用的基线因素。方法。在这项单中心回顾性研究中,我们对2003年至2012年接受移植并接受cinacalcet至肾移植和/或之后的所有患者进行了图表回顾。结果。27例患者入组,平均随访2.9±2.4年。21人在移植时已经服用了cinacalcet。这些患者中有12人在第一个月内停药,其中7人不得不重新开始治疗。重新启动cinacalcet的主要原因是高钙血症。疗程23±26个月。轻度低钙3例。基线因素与一年后的身体状况之间没有统计学上的显著关联。结论。在肾移植的第一个月内停用cinacalcet通常会导致高钙血症。Cinacalcet似乎是一种有效的治疗高钙血症甲状旁腺功能亢进肾移植受者。需要进一步的研究来评估安全性和长期效益。
{"title":"Retrospective Study Looking at Cinacalcet in the Management of Hyperparathyroidism after Kidney Transplantation.","authors":"Habib Mawad,&nbsp;Hugues Bouchard,&nbsp;Duy Tran,&nbsp;Denis Ouimet,&nbsp;Jean-Philippe Lafrance,&nbsp;Robert Zoël Bell,&nbsp;Sarah Bezzaoucha,&nbsp;Anne Boucher,&nbsp;Suzon Collette,&nbsp;Vincent Pichette,&nbsp;Lynne Senécal,&nbsp;Michel Vallée","doi":"10.1155/2017/8720283","DOIUrl":"https://doi.org/10.1155/2017/8720283","url":null,"abstract":"<p><p><i>Objectives.</i> The primary objective of this study is to evaluate the use of cinacalcet in the management of hyperparathyroidism in kidney transplant recipients. The secondary objective is to identify baseline factors that predict cinacalcet use after transplantation. <i>Methods.</i> In this single-center retrospective study, we conducted a chart review of all patients having been transplanted from 2003 to 2012 and having received cinacalcet up to kidney transplantation and/or thereafter. <i>Results.</i> Twenty-seven patients were included with a mean follow-up of 2.9 ± 2.4 years. Twenty-one were already taking cinacalcet at the time of transplantation. Cinacalcet was stopped within the first month in 12 of these patients of which 7 had to restart therapy. The main reason for restarting cinacalcet was hypercalcemia. Length of treatment was 23 ± 26 months. There were only 3 cases of mild hypocalcemia. There was no statistically significant association between baseline factors and cinacalcet status a year later. <i>Conclusions.</i> Discontinuing cinacalcet within the first month of kidney transplantation often leads to hypercalcemia. Cinacalcet appears to be an effective treatment of hypercalcemic hyperparathyroidism in kidney transplant recipients. Further studies are needed to evaluate safety and long-term benefits.</p>","PeriodicalId":45795,"journal":{"name":"Journal of Transplantation","volume":"2017 ","pages":"8720283"},"PeriodicalIF":2.5,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1155/2017/8720283","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34893356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 8
Analysis of Risk Factors for Kidney Retransplant Outcomes Associated with Common Induction Regimens: A Study of over Twelve-Thousand Cases in the United States. 与常见诱导方案相关的肾脏再移植结果风险因素分析:对美国超过 1.2 万例病例的研究。
IF 2.5 Q3 SURGERY Pub Date : 2017-01-01 Epub Date: 2017-09-24 DOI: 10.1155/2017/8132672
Alfonso H Santos, Michael J Casey, Karl L Womer

We studied registry data of 12,944 adult kidney retransplant recipients categorized by induction regimen received into antithymocyte globulin (ATG) (N = 9120), alemtuzumab (N = 1687), and basiliximab (N = 2137) cohorts. We analyzed risk factors for 1-year acute rejection (AR) and 5-year death-censored graft loss (DCGL) and patient death. Compared with the reference, basiliximab: (1) one-year AR risk was lower with ATG in retransplant recipients of expanded criteria deceased-donor kidneys (HR = 0.56, 95% CI = 0.35-0.91 and HR = 0.54, 95% CI = 0.27-1.08, resp.), while AR risk was lower with alemtuzumab in retransplant recipients with >3 HLA mismatches before transplant (HR = 0.63, 95% CI = 0.44-0.93 and HR = 0.81, 95% CI = 0.63-1.06, resp.); (2) five-year DCGL risk was lower with alemtuzumab, not ATG, in retransplant recipients of African American race (HR = 0.54, 95% CI = 0.34-0.86 and HR = 0.73, 95% CI = 0.51-1.04, resp.) or with pretransplant glomerulonephritis (HR = 0.65, 95% CI = 0.43-0.98 and HR = 0.82, 95% CI = 0.60-1.12, resp.). Therefore, specific risk factor-induction regimen combinations may predict outcomes and this information may help in individualizing induction in retransplant recipients.

我们研究了 12,944 名成人肾脏再移植受者的登记数据,这些受者按所接受的诱导方案分为抗胸腺细胞球蛋白 (ATG) 组(N = 9120)、阿利珠单抗组(N = 1687)和巴利昔单抗组(N = 2137)。我们分析了1年急性排斥反应(AR)和5年死亡校正移植物丢失(DCGL)以及患者死亡的风险因素。与参照物巴利昔单抗相比:(1) ATG在扩大标准死者供肾再移植受者中的1年AR风险较低(HR = 0.56,95% CI = 0.35-0.91和HR = 0.54,95% CI = 0.27-1.08),而阿来珠单抗在移植前HLA错配>3的再移植受者中的AR风险较低(HR = 0.63,95% CI = 0.44-0.93和HR = 0.81,95% CI = 0.63-1.06,resp.);(2)在非裔美国人种的再移植受者中,阿仑珠单抗的5年DCGL风险较低(HR = 0.54,95% CI = 0.34-0.86 和 HR = 0.73,95% CI = 0.51-1.04,resp.)或有移植前肾小球肾炎(HR = 0.65,95% CI = 0.43-0.98 和 HR = 0.82,95% CI = 0.60-1.12,resp.)。因此,特定的风险因素-诱导方案组合可预测预后,这一信息有助于对再移植受者进行个体化诱导。
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引用次数: 0
The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial. CECARI研究:依维莫司(Certican®)起始和钙调磷酸酶抑制剂停药对肾功能不全的维护性心脏移植受者:一项多中心、随机试验。
IF 2.5 Q3 SURGERY Pub Date : 2017-01-01 Epub Date: 2017-02-20 DOI: 10.1155/2017/6347138
Jan Van Keer, David Derthoo, Olivier Van Caenegem, Michel De Pauw, Eric Nellessen, Nathalie Duerinckx, Walter Droogne, Gábor Vörös, Bart Meyns, Ann Belmans, Stefan Janssens, Johan Van Cleemput, Johan Vanhaecke

In this 3-year, open-label, multicenter study, 57 maintenance heart transplant recipients (>1 year after transplant) with renal insufficiency (eGFR 30-60 mL/min/1.73 m2) were randomized to start everolimus with CNI withdrawal (N = 29) or continue their current CNI-based immunosuppression (N = 28). The primary endpoint, change in measured glomerular filtration rate (mGFR) from baseline to year 3, did not differ significantly between both groups (+7.0 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p = 0.18). In the on-treatment analysis, the difference did reach statistical significance (+9.4 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p = 0.047). The composite safety endpoint of all-cause mortality, major adverse cardiovascular events, or treated acute rejection was not different between groups. Nonfatal adverse events occurred in 96.6% of patients in the everolimus group and 57.1% in the CNI group (p < 0.001). Ten patients (34.5%) in the everolimus group discontinued the study drug during follow-up due to adverse events. The poor adherence to the everolimus therapy might have masked a potential benefit of CNI withdrawal on renal function.

在这项为期3年、开放标签、多中心的研究中,57名肾功能不全(eGFR 30-60 mL/min/1.73 m2)的维护者心脏移植受者(移植后>1年)被随机分组,开始使用依维莫司并停用CNI (N = 29)或继续目前基于CNI的免疫抑制(N = 28)。主要终点肾小球滤过率(mGFR)从基线到第3年的变化在两组之间没有显著差异(依维莫司组为+7.0 mL/min,而CNI组为+1.9 mL/min, p = 0.18)。在治疗分析中,差异确实具有统计学意义(依维莫司组为+9.4 mL/min, CNI组为+1.9 mL/min, p = 0.047)。全因死亡率、主要不良心血管事件或治疗急性排斥反应的复合安全性终点在两组之间没有差异。依维莫司组非致命性不良事件发生率为96.6%,CNI组为57.1% (p < 0.001)。依维莫司组有10例(34.5%)患者在随访期间因不良事件停药。依维莫司治疗依从性差可能掩盖了CNI停药对肾功能的潜在益处。
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引用次数: 7
Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored. 将稳定的肾移植受者转换为通用的他克莫司是可行和安全的,但必须进行监测。
IF 2.5 Q3 SURGERY Pub Date : 2017-01-01 Epub Date: 2017-01-26 DOI: 10.1155/2017/5646858
Fernando González, René López, Elizabeth Arriagada, René Carrasco, Natalia Gallardo, Eduardo Lorca

Background. Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods. Forty-one stable Prograf (Astellas) receiving kidney transplant patients were switched to a generic tacrolimus (Sandoz) in a 1 : 1 dose ratio and were followed up for up to 8 months. All other drugs were maintained as per normal practice. Results. Neither tacrolimus doses nor their trough blood levels changed significantly after the switch, but serum creatinine did: 1.62 ± 0.90 versus 1.75 ± 0.92 mg/dL (p < 0.001). At the same time, five graft biopsies were performed, and two of them showed cellular acute rejection. There were nine infectious episodes treated satisfactorily with proper therapies. No patient or graft was lost during the follow-up time period. Conclusion. Switching from brand name tacrolimus to a generic tacrolimus (Sandoz) is feasible and appears to be safe, but it must be monitored carefully by treating physicians.

背景。他克莫司是用于肾移植患者的主要免疫抑制药物。在智利卫生部授权实施这一转变后,我们研究了用仿制药替代品牌产品是一个有争议的问题。方法。41例稳定的接受肾移植的Prograf (Astellas)患者以1:1的剂量比例切换到通用的他克莫司(Sandoz),随访长达8个月。所有其他药物维持正常操作。结果。切换后,他克莫司剂量及其谷血水平均未发生显著变化,但血清肌酐变化明显:1.62±0.90 mg/dL vs 1.75±0.92 mg/dL (p < 0.001)。同时,进行了5例移植活检,其中2例出现细胞急性排斥反应。通过适当的治疗,有9例感染发作得到满意的治疗。随访期间无患者或移植物丢失。结论。从品牌他克莫司切换到非专利他克莫司(山德士)是可行的,似乎是安全的,但必须由治疗医生仔细监测。
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引用次数: 5
期刊
Journal of Transplantation
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