Schijvens Anne M, Teeninga Nynke, Dorresteijn Eiske M, Teerenstra Steven, Webb Nicholas J, Schreuder Michiel F
Department of Pediatric Nephrology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, Amalia Children's Hospital, Nijmegen, the Netherlands.
Department of Pediatric Nephrology, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, the Netherlands.
Eur J Pediatr. 2021 Sep;180(9):2849-2859. doi: 10.1007/s00431-021-04035-w. Epub 2021 Mar 28.
Steroids are the cornerstone of the treatment of childhood nephrotic syndrome. The optimal duration for the first episode remains a matter of debate. The aim of this study is to determine whether the 8 weeks International Study of Kidney Disease in Children (ISKDC) regimen is equally effective as the 12 weeks steroid regimen from the German society of pediatric nephrology (Arbeitsgemeinschaft für Pädiatrische Nephrologie [APN]). An individual patient data (IPD) meta-analysis of randomized controlled trials reporting on prednisolone treatment for a first episode of childhood nephrotic syndrome was conducted. European trials aimed at investigating the ISKDC and/or APN steroid regimen were selected. The lead investigators of the selected trials were requested to provide the IPD of the specific treatment groups. Four trials included European cohorts using dosing schedules according to the regimens studied. IPD of two trials were available. A significant difference was found in time to first relapse after cessation of steroid treatment between the 8 and 12 weeks treatment group with a median time to relapse of 29 and 63 days, respectively. Moreover, relapse rate ratios during total follow-up were 51% higher for the 8 weeks regimen. Finally, younger children have a significantly lower time to first relapse and frequently relapsing nephrotic syndrome.Conclusions: The results of this IPD meta-analysis suggest that the 8 weeks steroid regimen for a first episode of steroid-sensitive nephrotic syndrome may not be equally effective as the 12 weeks steroid regimen. Moreover, this study highlights the importance of using uniform definitions to enable accurate comparison and interpretation of trial results.Trial registration: Registration number: CRD42020199244, date of registration 16-08-2020 What is Known: • Steroids are the cornerstone of the treatment of childhood nephrotic syndrome, however the optimal duration for the first episode remains a matter of debate. • Currently, the 8 weeks ISKDC protocol and 12 weeks APN protocol are among the most frequently used protocols in Europe. What is New: • The 8 weeks steroid regimen for a first episode of steroid-sensitive nephrotic syndrome may not be equally effective as the 12 weeks steroid regimen for the treatment of a first episode of nephrotic syndrome. • Younger children have a significantly shorter time to first relapse and time to frequent relapsing nephrotic syndrome.
类固醇是儿童肾病综合征治疗的基石。首次发作的最佳疗程仍存在争议。本研究的目的是确定8周的儿童肾病国际研究（ISKDC）方案是否与德国儿科肾脏病学会（儿童肾脏病协作组[APN]）的12周类固醇方案同样有效。对报告泼尼松龙治疗儿童肾病综合征首次发作的随机对照试验进行了个体患者数据（IPD）荟萃分析。选择了旨在研究ISKDC和/或APN类固醇方案的欧洲试验。要求所选试验的主要研究者提供特定治疗组的IPD。四项试验纳入了根据所研究方案使用给药方案的欧洲队列。有两项试验的IPD可用。在8周和12周治疗组之间，类固醇治疗停止后至首次复发的时间存在显著差异，复发的中位时间分别为29天和63天。此外，8周方案在总随访期间的复发率比高出51%。最后，年龄较小的儿童首次复发时间显著缩短，且频繁复发肾病综合征。结论：本IPD荟萃分析的结果表明，类固醇敏感型肾病综合征首次发作的8周类固醇方案可能不如12周类固醇方案有效。此外，本研究强调了使用统一定义以准确比较和解释试验结果的重要性。试验注册：注册号：CRD42020199244，注册日期2020年8月16日已知信息：• 类固醇是儿童肾病综合征治疗的基石，然而首次发作的最佳疗程仍存在争议。• 目前，8周的ISKDC方案和12周的APN方案是欧洲最常用的方案。新发现：• 类固醇敏感型肾病综合征首次发作的8周类固醇方案在治疗肾病综合征首次发作时可能不如12周类固醇方案有效。• 年龄较小的儿童首次复发时间和频繁复发肾病综合征的时间显著缩短。
