大剂量与小剂量皮质类固醇加来氟米特治疗 IgA 肾病的临床疗效和安全性。

Clinical efficacy and safety of full-dose versus half-dose corticosteroids plus leflunomide for IgA nephropathy.

机构信息

Department of Nephrology, The Second Affiliated Hospital of Nanchang University, No. 1, Minde Road, Donghu District, Nanchang, 330006, P.R. China.

出版信息

BMC Nephrol. 2021 Nov 4;22(1):364. doi: 10.1186/s12882-021-02555-z.

DOI:10.1186/s12882-021-02555-z

PMID:34736419

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8567572/

Abstract

BACKGROUND

The results of leflunomide (LEF) in patients with IgA nephropathy (IgAN) were inconsistent.

METHODS

A total of 149 kidney biopsy-confirmed IgAN patients with an estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m and protein excretion levels ≥0.75 g/d were enrolled, with 65 subjects receiving half-dose CS plus LEF (LEF group), and the 84 counterpart patients accepting full-dose corticosteroid (Full CS group). The primary outcomes included the complete remission (CR) rates and incidence of adverse events (AEs). The secondary outcomes were the overall remission (OR) rates and a combined event (eGFR reduced ≥30%, end-stage renal disease [ESRD], hemodialysis, peritoneal dialysis or kidney transplantation).

RESULTS

During the 18 months of follow-up, the CR rates were 72 and 64% in the LEF and Full CS groups (P = 0.299), respectively. The proportion of patients with OR rates in the LEF group and Full CS group was 89% versus 75%, respectively (P = 0.027). Serious AEs were observed only in the Full CS group (P = 0.017). The incidences of total AEs (P = 0.036) and infections (P = 0.024) were lower in the LEF group than in the Full CS group.

CONCLUSIONS

LEF combined with half-dose CS is superior to full-dose CS in the treatment of IgAN.

摘要

背景

来氟米特（LEF）治疗 IgA 肾病（IgAN）的结果不一致。

方法

共纳入 149 例经肾活检证实的 IgAN 患者，估计肾小球滤过率（eGFR）≥50 ml/min/1.73 m2，蛋白尿排泄水平≥0.75 g/d，其中 65 例接受半剂量 CS 加 LEF（LEF 组），84 例接受全剂量皮质类固醇（Full CS 组）。主要结局包括完全缓解（CR）率和不良事件（AE）发生率。次要结局包括总缓解（OR）率和联合事件（eGFR 降低≥30%、终末期肾病[ESRD]、血液透析、腹膜透析或肾移植）。

结果

在 18 个月的随访中，LEF 组和 Full CS 组的 CR 率分别为 72%和 64%（P=0.299）。LEF 组和 Full CS 组的 OR 率分别为 89%和 75%（P=0.027）。仅在 Full CS 组观察到严重 AE（P=0.017）。LEF 组总 AE（P=0.036）和感染（P=0.024）的发生率低于 Full CS 组。