Outcomes in kidney transplant recipients treated with immediate-release tacrolimus capsules versus extended-release tacrolimus capsules: A cohort study.
Outcomes in kidney transplant recipients treated with immediate-release tacrolimus capsules versus extended-release tacrolimus capsules: A cohort study.
复制标题
使用速释他克莫司胶囊与缓释他克莫司胶囊治疗的肾移植受者的结果：一项队列研究。
DOI：
10.1111/ctr.14840
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发表时间：
2023
影响因子：
2.1
通讯作者：
Reese,PeterP
中科院分区：
文献类型：
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作者：
Ha,YoonheeP;Divard,Gillian;Mitra,Nandita;Putt,MaryE;Pallet,Nicolas;Loupy,Alexandre;Anglicheau,Dany;Trofe-Clark,Jennifer;Legendre,Christophe;Bloom,RoyD;Reese,PeterP
介绍先前的随机试验和观察性研究通常报告了肾移植受者（KTR）接受速释他克莫司（IR-TAC）与缓释他克莫司（ER-TAC）治疗的结局相似。然而，许多这些先前的研究集中在低免疫风险的患者，样本量小，随访时间短，并排除了与移植物丢失相关的结果，如慢性排斥反应。方法为了解决这些局限性，我们在一个单一的移植中心进行了一项848例KTR的队列研究，这些KTR通常具有高免疫风险，并接受了IR-TAC胶囊治疗。（589例患者，65.9%）或ER-TAC胶囊（289例患者，34.1%）。所有患者在移植后接受指定的维持免疫抑制方案至少3个月。之后，他克莫司制剂由每位患者的移植肾病学家决定。对于两个治疗组，我们比较了从移植后3个月开始的3年内发生急性或慢性抗体介导的排斥反应（AMR）、急性或慢性T细胞介导的排斥反应、新发DSA和/或移植物丢失的复合结局的风险。与接受ER‐TAC胶囊治疗的患者相比，接受IR‐TAC胶囊治疗的KTR发生复合结局的风险增加;然而，这一结果并不显著（调整HR 1.24，95% CI 0.92 - 1.68，p = 0.163）。使用倾向评分（adj HR 1.25，95%CI 0.93 - 1.68，p = 0.146）用治疗加权的逆概率（IPTW）获得了类似的结果。结论这些结果表明，与IR-TAC胶囊相比，ER-TAC胶囊并不能降低具有普遍高免疫风险的KTR的不良结局风险。
IntroductionPrior randomized trials and observational studies have generally reported similar outcomes in kidney transplant recipients (KTRs) treated with immediate‐release tacrolimus (IR‐TAC) versus extended‐release tacrolimus (ER‐TAC). However, many of these previous studies focused on patients with low immunological risks, had small sample sizes and brief follow‐up periods, and excluded outcomes associated with graft loss, such as chronic rejection.MethodsTo address these limitations, we conducted a cohort study of 848 KTRs at a single transplantation center who had generally high immunological risks and were treated with either IR‐TAC capsules (589 patients, 65.9%) or ER‐TAC capsules (289 patients, 34.1%). All patients received their designated maintenance immunosuppressive regimen for at least 3 months post‐transplantation. Afterwards, tacrolimus formulation was at the discretion of each patient's transplant nephrologist. For the two treatment groups, we compared the hazards of experiencing a composite outcome of acute or chronic antibody‐mediated rejection (AMR), acute or chronic T‐cell‐mediated rejection, de novo DSA, and/or graft loss over a 3‐year period starting at 3 months post‐transplantation.ResultsIn a multivariable Cox proportional hazards regression model, KTRs treated with IR‐TAC capsules had an increased hazard of experiencing the composite outcome when compared to patients treated with ER‐TAC capsules; however, this result was not significant (adj HR 1.24, 95% CI .92–1.68,p= .163). Similar results were obtained with inverse probability of treatment weighting (IPTW) using a propensity score (adj HR 1.25, 95% CI .93–1.68,p= .146).ConclusionThese findings suggest that when compared to IR‐TAC capsules, ER‐TAC capsules do not reduce the hazard of poor outcomes in KTRs with generally high immunological risks.