Baragetti Ivano, Del Vecchio Lucia, Ferrario Francesca, Alberici Federico, Amendola Andrea, Russo Elisa, Ponti Serena, Di Palma Anna Maria, Pani Antonello, Rollino Cristiana, Giannese Domenico, Boscutti Giuliano, Sorrentino Annasara, Colturi Carla, Brunori Giuliano, Lazzarin Roberta, Catapano Fausta, Cozzolino Mario, Feriozzi Sandro, Pozzi Claudio
Department of Nephrology, Bassini Hospital, Cinisello Balsamo, Italy.
Department of Nephrology, Sant'Anna Hospital, ASST Lariana, Como, Italy.
J Nephrol. 2025 Jan;38(1):225-234. doi: 10.1007/s40620-024-02071-x. Epub 2024 Oct 6.
Systemic steroids are recommended for patients with IgA nephropathy (IgAN) and proteinuria. However, there are concerns about their safety due to an excess of serious adverse events (SAEs) in previous randomised trials. This study evaluates the incidence of SAEs in IgAN patients receiving different treatment regimens in clinical practice.
Multicentre, retrospective, observational cohort study of 1209 patients (M/F: 864/345, mean age: 41.73 ± 14.92 years) with biopsy-proven IgAN treated with renin angiotensin system (RAS) inhibitors (RASI) (n = 285), intravenous + oral steroids (n = 633), oral steroids (n = 99), steroids + immunosuppressants (n = 192).
A total of 119 (9.8%) adverse events were reported, of which 67 (5.5%) were considered treatment-emergent, and 36 (2.9%) were SAEs (n = 23, 63.8% were infections). One patient died due to sepsis. A significant association was observed between AEs and immunosuppression [8 (2.8%) in RASI, 60 (9.4%) in steroids + immunosuppressants, 14 in oral steroids (14.1%) and 37 pts (19.2%) in steroids + immunosuppressants (p < 0.01)], age and estimated glomerular filtration rate (eGFR), but not with proteinuria and sex. On multivariate analysis, only older age was associated with the occurrence of SAEs.
According to our findings, the incidence of SAEs during therapy with steroids alone or associated with immunosuppressors is lower in everyday clinical practice than in randomised clinical trials.
对于IgA肾病（IgAN）和蛋白尿患者，推荐使用全身性类固醇。然而，由于既往随机试验中严重不良事件（SAEs）过多，人们对其安全性存在担忧。本研究评估了在临床实践中接受不同治疗方案的IgAN患者中SAEs的发生率。
对1209例经活检证实为IgAN的患者（男/女：864/345，平均年龄：41.73±14.92岁）进行多中心、回顾性、观察性队列研究，这些患者接受了肾素血管紧张素系统（RAS）抑制剂（RASI）治疗（n = 285）、静脉注射+口服类固醇治疗（n = 633）、口服类固醇治疗（n = 99）、类固醇+免疫抑制剂治疗（n = 192）。
共报告了119例（9.8%）不良事件，其中67例（5.5%）被认为是治疗中出现的，36例（2.9%）为SAEs（n = 23，63.8%为感染）。1例患者因败血症死亡。观察到不良事件与免疫抑制之间存在显著关联[RASI组8例（2.8%），类固醇+免疫抑制剂组60例（9.4%），口服类固醇组14例（14.1%），类固醇+免疫抑制剂组37例（19.2%）（p < 0.01）]，与年龄和估计肾小球滤过率（eGFR）有关，但与蛋白尿和性别无关。多因素分析显示，只有年龄较大与SAEs的发生有关。
根据我们的研究结果，在日常临床实践中，单独使用类固醇或与免疫抑制剂联合使用时SAEs的发生率低于随机临床试验。
