Steroid Avoidance or Withdrawal Regimens in Paediatric Kidney Transplantation: A Meta-Analysis of Randomised Controlled Trials

Background
We combined the outcomes of all randomised controlled trials to investigate the safety and efficacy of steroid avoidance or withdrawal (SAW) regimens in paediatric kidney transplantation compared with steroid-based (SB) regimens.
Methods
A systematic literature search of PubMed, Embase, Cochrane Library, the trials registry and BIOSIS previews was performed. A change in the height standardised Z-score from baseline (ΔHSDS) and acute rejection were the primary endpoints.
Results
Eight reports from 5 randomised controlled trials were included, with a total of 528 patients. Sufficient evidence of a significant increase in the ΔHSDS was observed in the SAW group (mean difference (MD) = 0.38, 95% confidence interval (CI) 0.07–0.68, P = 0.01), particularly within the first year post-withdrawal (MD = 0.22, 95% CI 0.10–0.35, P = 0.0003) and in the prepubertal recipients (MD = 0.60, 95% CI 0.21–0.98, P = 0.002). There was no significant difference in the risk of acute rejection between the groups (relative risk = 1.04, 95% CI 0.80–1.36, P = 0.77).
Conclusions
The SAW regimen is justified in select paediatric renal allograft recipients because it provides significant benefits in post-transplant growth within the first year post-withdrawal with minimal effects on the risk of acute rejection, graft function, and graft and patient survival within 3 years post-withdrawal. These select paediatric recipients should have the following characteristics: prepubertal; Caucasian; with primary disease not related to immunological factors; de novo kidney transplant recipient; with low panel reactive antibody.

背景
本研究整合所有随机对照试验（randomised controlled trials, RCTs）的结果，旨在对比激素规避或撤除（steroid avoidance or withdrawal, SAW）方案与激素基础（steroid-based, SB）方案在儿童肾移植中的安全性与有效性。

方法
本研究对PubMed、Embase、Cochrane图书馆、试验注册库及BIOSIS Previews开展系统性文献检索。本研究的主要终点为基线身高标准化Z评分变化量（ΔHSDS）与急性排斥反应。

结果
本研究共纳入5项随机对照试验的8篇报告，累计纳入528例患者。研究结果显示，激素规避或撤除组的ΔHSDS存在显著升高（均差（mean difference, MD）=0.38，95%置信区间（confidence interval, CI）0.07~0.68，P=0.01），尤其在撤除后第一年（MD=0.22，95%CI 0.10~0.35，P=0.0003）及青春期前移植受者亚组中更为显著（MD=0.60，95%CI 0.21~0.98，P=0.002）。两组间急性排斥反应风险无显著差异（相对危险度（relative risk, RR）=1.04，95%CI 0.80~1.36，P=0.77）。

结论
针对特定人群的儿童同种异体肾移植受者，采用激素规避或撤除方案是合理的：该方案可在撤除后第一年显著改善移植术后生长状况，且对撤除后3年内的急性排斥反应风险、移植物功能及移植物与受者生存的影响极小。符合以下特征的儿童移植受者可采用该方案：青春期前、白种人、原发病与免疫因素无关、初次肾移植受者、群体反应性抗体（panel reactive antibody, PRA）水平较低。