靶向释放布地奈德（TRB）治疗后IgA肾病早期反应的影响因素：一项多中心研究的初步结果
Factors influencing early response of IgA nephropathy following targeted-release budesonide (TRB) treatment: preliminary results from a multicenter study.
作者信息
Keskinis Christodoulos, Moysidou Eleni, Kapsia Eleni, Vaios Vasilios, Bintas Christos, Trivyza Maria, Christodoulou Michalis, Lioulios Georgios, Stai Stamatia, Nikolaidou Christina, Pateinakis Panagiotis, Papasotiriou Marios, Liakopoulos Vassilios, Marinaki Smaragdi, Stangou Maria
机构信息
School of Medicine, Aristotle University of Thessaloniki (AUTH), Thessaloniki, Greece.
Department of Nephrology, Papageorgiou Hospital, Thessaloniki, Greece.
出版信息
Clin Kidney J. 2024 Nov 19;18(1):sfae364. doi: 10.1093/ckj/sfae364. eCollection 2025 Jan.
BACKGROUND
Formation of galactose-deficient IgA1 (Gd-IgA1) immunoglobulin is the initial step in the immunological cascade leading to IgA nephropathy (IgAN). Targeted-release budesonide (TRB), an evidence-based regimen without major side-effects, has recently been approved for IgAN treatment; herein we present our preliminary real-world data regarding prompt response to TRB.
METHODS
Patients with primary IgAN who remained with Uprot >1 g/24 h despite conventional treatment for 6 months were started on TRB, and re-evaluated at 3 (T3) and 6 (T6) months. Reduction of proteinuria by ≥30%, at T3 and T6 was regarded as very early (VER) and early response (ER), respectively. Kidney biopsies were evaluated according to Oxford classification (MEST-C) score.
RESULTS
Thirty-seven IgAN patients, male/female 26/11, mean ± standard deviation age 50.38 ± 14.32 years and mean time since diagnosis 45.65 ± 56.67 months, were included. Seventeen (45.94%) patients demonstrated VER, increasing to 29 (78.3%) as ER ( = .004). Patients who demonstrated VER had a shorter time interval since diagnosis compared with non-VER, 29.41 ± 6.96 vs 65.37 ± 17.64 months ( = .05), and preserved estimated glomerular filtration rate at diagnosis and T0, while time since diagnosis was the main factor associated with ER, 38.36 ± 19.6 vs 78.67 ± 18.64 months, in ER and non-ER respectively ( = .05). Patients with M0, E0, S0 and T0 had no significant changes during T0-T6, while patients with M1, E1, S1 and even T1 had significantly reduced proteinuria ( = .006, = .0011, < .0001 and < .0001, respectively).
CONCLUSIONS
Almost half of the patients showed proteinuria reduction after TRB treatment at 3 months, and the proportion increased significantly at 6 months. Patients likely to have a prompt proteinuria reduction were relatively close to diagnosis, retained kidney function and had active lesions in kidney biopsy.
背景
半乳糖缺陷型IgA1（Gd-IgA1）免疫球蛋白的形成是导致IgA肾病（IgAN）免疫级联反应的起始步骤。靶向释放布地奈德（TRB）是一种无重大副作用的循证治疗方案，最近已被批准用于IgAN治疗；在此，我们展示了关于TRB快速反应的初步真实世界数据。
方法
尽管接受了6个月的常规治疗，但24小时尿蛋白定量仍>1g的原发性IgAN患者开始使用TRB治疗，并在3个月（T3）和6个月（T6）时进行重新评估。在T3和T6时蛋白尿减少≥30%分别被视为极早期反应（VER）和早期反应（ER）。根据牛津分类（MEST-C）评分对肾活检进行评估。
结果
纳入37例IgAN患者，男/女为26/11，平均年龄±标准差为50.38±14.32岁，诊断后平均时间为45.65±56.67个月。17例（45.94%）患者表现出VER，ER时增加至29例（78.3%）（P = 0.004）。与未出现VER的患者相比，出现VER的患者自诊断以来的时间间隔更短，分别为29.41±6.96个月和65.37±17.64个月（P = 0.05），且在诊断时和T0时保留了估计肾小球滤过率，而自诊断以来的时间是与ER相关的主要因素，ER组和非ER组分别为38.36±19.6个月和78.67±18.64个月（P = 0.05）。M0、E0、S0和T0的患者在T0 - T6期间无显著变化，而M1、E1、S1甚至T1的患者蛋白尿显著减少（分别为P = 0.006、P = 0.0011、P < 0.0001和P < 0.0001）。
结论
几乎一半的患者在TRB治疗3个月后蛋白尿减少，6个月时这一比例显著增加。蛋白尿可能迅速减少的患者相对接近诊断时间，保留了肾功能，且肾活检有活动性病变。
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