甲基强的松龙冲击治疗后口服强的松与单纯口服强的松治疗结节病性肾小管间质性肾炎的疗效及安全性：一项随机、开放标签、对照临床试验

Efficacy and safety of methylprednisolone pulse followed by oral prednisone vs. oral prednisone alone in sarcoidosis tubulointerstitial nephritis: a randomized, open-label, controlled clinical trial.

作者信息

Mahevas Matthieu, Audard Vincent, Rousseau Alexandra, Cez Alexandre, Guerrot Dominique, Verhelst David, Delahousse Michel, Hanrotel Catherine, Pillebout Evangeline, Daugas Eric, Krastinova Evguenia, Valeyre Dominique, Boffa Jean-Jacques

机构信息

Service de Médecine Interne, Centre National de Référence des Cytopénies Auto-immunes de l'adulte, Hôpital Henri Mondor, Universite Paris Est Creteil, Assistance Publique Hôpitaux de Paris, Créteil, France.

Nephrology and Renal Transplantation Department, Hopital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France.

出版信息

Nephrol Dial Transplant. 2023 Mar 31;38(4):961-968. doi: 10.1093/ndt/gfac227.

DOI:10.1093/ndt/gfac227

PMID:36066903

Abstract

BACKGROUND

We determine the benefit of pulsed methylprednisolone for improving kidney function in patients with sarcoidosis tubulointerstitial nephritis.

METHODS

We conducted a multicenter, prospective, randomized, open-label, controlled trial in patients with biopsy-proven acute tubulointerstitial nephritis caused by sarcoidosis at 21 sites in France. Patients were randomly assigned to receive a methylprednisolone pulse 15 mg/kg/day for 3 days, then oral prednisone (MP group) or oral prednisone 1 mg/kg/day alone (PRD group). The primary end point was a positive response at 3 months, defined as a doubling of estimated glomerular filtration rate (eGFR) compared with the eGFR before randomization.

RESULTS

We randomized 40 participants. Baseline eGFR before PRD was 22 mL/min/1.73m2 {interquartile range [IQR], 16-44} and before MP was 25 mL/min/1.73m2 (IQR, 22-36) (P = .3). The two groups did not differ in underlying pathological lesions, including mean percentage of interstitial fibrosis and intensity of interstitial infiltrate. In the intent-to-treat population, the median eGFR at 3 months did not significantly differ between the PRD and MP groups: 45 (IQR, 34-74) and 46 (IQR, 39-65) mL/min/1.73m2. The primary end point at 3 months was achieved in 16 of 20 (80%) PRD patients and 10 of 20 (50%) MP patients (P = .0467). The eGFR was similar between the two groups after 1, 3, 6, and 12 months of treatment. For both groups, eGFR at 1 month was strongly correlated with eGFR at 12 months (P < .0001). The two groups did not differ in severe adverse events.

CONCLUSION

Compared with a standard oral steroid regimen, intravenous MP may have no supplemental benefit for renal function in patients with tubulointerstitial nephritis caused by sarcoidosis.Trial Registration: ClinicalTrials.gov: NCT01652417; EudraCT: 2012-000149-11.

摘要

背景

我们确定了脉冲式甲泼尼龙对改善结节病性肾小管间质性肾炎患者肾功能的益处。

方法

我们在法国21个地点对经活检证实由结节病引起的急性肾小管间质性肾炎患者进行了一项多中心、前瞻性、随机、开放标签、对照试验。患者被随机分配接受甲泼尼龙脉冲剂量15mg/kg/天，共3天，然后口服泼尼松（MP组）或单独口服泼尼松1mg/kg/天（PRD组）。主要终点是3个月时的阳性反应，定义为与随机分组前的估计肾小球滤过率（eGFR）相比，eGFR翻倍。

结果

我们随机分配了40名参与者。PRD组随机分组前的基线eGFR为22mL/min/1.73m²{四分位间距[IQR]，16 - 44}，MP组随机分组前的基线eGFR为25mL/min/1.73m²（IQR，22 - 36）（P = 0.3）。两组在潜在病理病变方面无差异，包括间质纤维化的平均百分比和间质浸润强度。在意向性治疗人群中，PRD组和MP组3个月时的eGFR中位数无显著差异：分别为45（IQR，34 - 74）和46（IQR，39 - 65）mL/min/1.73m²。3个月时，20名PRD组患者中有16名（80%）达到主要终点，20名MP组患者中有10名（50%）达到主要终点（P = 0.0467）。治疗1、3、6和12个月后，两组的eGFR相似。两组中，1个月时的eGFR与12个月时的eGFR密切相关（P < 0.0001）。两组在严重不良事件方面无差异。