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评估接受低剂量依维莫司、以他克莫司为基础的最小化四联免疫抑制方案的肾移植受者的短期和长期结局。

To evaluate the short and long term outcomes of renal transplant recipients with low dose everolimus, tacrolimus-based minimal quadruple immunosuppressive regimen.

作者信息

Sailaja K, Rao Ch Umamaheswara, Reddy V S, Rao P Purnachandra, Sahariah S

机构信息

Department of Nephrology and Transplantation, Krishna Institute of Medical Sciences, Secunderabad, India.

PAS International Medical Collage, Hospital USTM, Ri-Bhoi, India.

出版信息

Immunopharmacol Immunotoxicol. 2025 Oct;47(5):590-598. doi: 10.1080/08923973.2025.2542130. Epub 2025 Aug 5.

DOI:10.1080/08923973.2025.2542130
PMID:40754854
Abstract

BACKGROUND

The primary goal of the post-transplant maintenance therapy is to keep equilibrium between minimizing the drug side effects and managing the long-term graft survival. In this prospective (10 years follow-up) study, we compared the short term and long-term outcomes of two different immunosuppression regimens.

OBJECTIVE

The aim of the study is to evaluate the long term outcome following renal transplantation with a combination of low dose quadruple immunosuppression.

METHODS

Group I ( = 25) comprised of low dose everolimus (0.5 mg/bd) (EVR), low dose Tacrolimus (1 mg/bd), low dose mycophenolate sodium (360 mg/bd) and prednisolone. Group II ( = 29) consisted of standard triple drug regimen of tacrolimus (3 mg/bd), mycophenolate sodium (720 mg/bd) and prednisolone. Renal function, rejection episodes, adverse events, graft and patient survival were analyzed.

RESULTS AND DISCUSSION

There was an improvement in the renal function from 1-year post transplant to the end of the study period in Group I. The mean serum creatinine at 10 years was 1.54 ± 0.44 and in Group II it was 2.1 ± 0.7 mg/dl with a statistical significance of  = 0.005. Mean eGFR at 10 years in Group I was 57.8 and in Group II it was 46.7 ml/mt/1.73m ( = < 0.05). There was no statistical difference between the two groups in rejection rates (Group I-12% Group II -17.24% ( = 0.65), graft loss (Group I-12% vs Group II-27%( = 0.26) and the patient loss was (Group I -12% vs Group II 24%( = 0.36). Drug related adverse events were insignificant. Proteinuria and hyperlipidemia were comparable between the groups.

CONCLUSION

The low dose quadruple immunosuppression protocol was a better option for long-term graft survival with fewer complications.

摘要

背景

移植后维持治疗的主要目标是在尽量减少药物副作用和维持长期移植物存活之间保持平衡。在这项前瞻性(10年随访)研究中,我们比较了两种不同免疫抑制方案的短期和长期结果。

目的

本研究旨在评估低剂量四联免疫抑制联合肾移植后的长期结果。

方法

第一组(n = 25)由低剂量依维莫司(0.5mg/每日两次)(EVR)、低剂量他克莫司(1mg/每日两次)、低剂量麦考酚钠(360mg/每日两次)和泼尼松龙组成。第二组(n = 29)由他克莫司(3mg/每日两次)、麦考酚钠(720mg/每日两次)和泼尼松龙的标准三联药物方案组成。分析肾功能、排斥反应、不良事件、移植物和患者存活率。

结果与讨论

第一组从移植后1年到研究期末肾功能有所改善。10年时的平均血清肌酐在第一组为1.54±0.44,在第二组为2.1±0.7mg/dl,统计学意义为p = 0.005。第一组10年时的平均估算肾小球滤过率为57.8,第二组为46.7ml/分钟/1.73平方米(p < 0.05)。两组在排斥率(第一组-12%,第二组-17.24%(p = 0.65))、移植物丢失(第一组-12%对第二组-27%(p = 0.26))和患者丢失率(第一组-12%对第二组24%(p = 0.36))方面无统计学差异。药物相关不良事件不显著。两组间蛋白尿和高脂血症情况相当。

结论

低剂量四联免疫抑制方案是长期移植物存活且并发症较少的更好选择。

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