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巴利昔单抗诱导联合延迟他克莫司治疗方案在心脏移植受者中的影响——与标准基于他克莫司的三联免疫抑制方案的比较

Influence of Induction Therapy Using Basiliximab With Delayed Tacrolimus Administration in Heart Transplant Recipients - Comparison With Standard Tacrolimus-Based Triple Immunosuppression.

机构信息

Department of Transplant Medicine, National Cerebral and Cardiovascular Center.

Department of Cardiovascular Surgery, National Cerebral and Cardiovascular Center.

出版信息

Circ J. 2020 Nov 25;84(12):2212-2223. doi: 10.1253/circj.CJ-20-0164. Epub 2020 Nov 3.

Abstract

BACKGROUND

Appropriate indications and protocols for induction therapy using basiliximab have not been fully established in heart transplant (HTx) recipients. This study elucidated the influence of induction therapy using basiliximab along with delayed tacrolimus (Tac) initiation on the outcomes of high-risk HTx recipients.

METHODS AND RESULTS

A total of 86 HTx recipients treated with Tac-based immunosuppression were retrospectively reviewed. Induction therapy was administered to 46 recipients (53.5%) with impaired renal function, pre-transplant sensitization, and recipient- and donor-related risk factors (Induction group). Tac administration was delayed in the Induction group. Induction group subjects showed a lower cumulative incidence of acute cellular rejection grade ≥1R after propensity score adjustment, but this was not significantly different (hazard ratio [HR]: 0.63, 95% confidence interval [CI]: 0.37-1.08, P=0.093). Renal dysfunction in the Induction group significantly improved 6 months post-transplantation (P=0.029). The cumulative incidence of bacterial or fungal infections was significantly higher in the Induction group (HR: 10.6, 95% CI: 1.28-88.2, P=0.029).

CONCLUSIONS

These results suggest that basiliximab-based induction therapy with delayed Tac initiation may suppress mild acute cellular rejection and improve renal function in recipients with renal dysfunction, resulting in its non-inferior outcome, even in high-risk patients, when applied to the appropriate recipients. However, it should be carefully considered in recipients at a high risk of bacterial and fungal infections.

摘要

背景

巴利昔单抗诱导治疗在心移植(HTx)受者中的适应证和方案尚未完全确立。本研究阐明了巴利昔单抗诱导治疗联合延迟使用他克莫司(Tac)对高危 HTx 受者结局的影响。

方法和结果

回顾性分析了 86 例接受 Tac 为基础的免疫抑制治疗的 HTx 受者。对存在肾功能不全、移植前致敏和受者及供者相关危险因素的 46 例(53.5%)受者给予诱导治疗(诱导组)。在诱导组中延迟使用 Tac。经倾向评分调整后,诱导组急性细胞排斥反应≥1R 的累积发生率较低,但差异无统计学意义(风险比 [HR]:0.63,95%置信区间 [CI]:0.37-1.08,P=0.093)。移植后 6 个月时,诱导组肾功能障碍明显改善(P=0.029)。诱导组细菌或真菌感染的累积发生率明显较高(HR:10.6,95% CI:1.28-88.2,P=0.029)。

结论

这些结果表明,巴利昔单抗诱导治疗联合延迟使用 Tac 可能抑制轻度急性细胞排斥反应,并改善肾功能不全受者的肾功能,从而获得非劣效性结局,即使在高危患者中也是如此,但对于细菌和真菌感染风险较高的受者,应谨慎考虑。

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