探讨采取利妥昔单抗(RTX)治疗儿童非复杂性激素依赖型肾病综合征(SDNS)的疗效和安全性。

选择2021年1月至2022年9月于郑州大学第一附属医院诊治的2例非复杂性SDNS患儿(患儿1、2)为研究对象。采用回顾性分析方法，分析这2例患儿的临床病例资料。在2例患儿有明显激素不良反应发生及血清CD20⁺B淋巴细胞计数较高(约为500个/μL)情况下，首次采取RTX治疗后进行随访，随访中若患儿血清CD20⁺B淋巴细胞计数≥50个/μL，则重复采取RTX治疗，2例患儿均累计采取RTX治疗3次。RTX治疗方案：静脉滴注，剂量为375 mg/(m²·次)×1次，最大剂量500 mg/次。采用患儿肾病综合征(NS)无复发缓解时间、激素不良反应改善情况，以及RTX静脉输注时及治疗结束后的药物相关不良反应发生情况为观察指标，评估采取RTX治疗非复杂性SDNS的有效性及安全性。本研究经郑州大学第一附属医院伦理委员会批准(审批文号：2022-KY-1267)。2例患儿监护人对诊治均知情同意，并签署知情同意书。

①本研究2例非复杂性SDNS患儿均为男性，入院年龄均约为7岁，病程均约为4年，院外采用糖皮质激素治疗4⁺年，均出现库欣面容、高眼压等激素不良反应，本次入院前NS均已经复发2次。②对2例患儿均采取RTX重复治疗3次，3次治疗的方案相同。首次RTX治疗结束后第7天时，2例患儿外周血CD20⁺B淋巴细胞计数均<50个/μL，随访至4~6个月后，均逐渐上升，再次采取RTX治疗后可下降。③每次采取RTX静脉输注治疗时，2例患儿均未发生输液反应。自首次采取RTX治疗结束后，2例患儿的NS完全缓解期均>12个月，在治疗期与完全缓解期内均无严重感染发生，激素不良反应改善，并顺利停用激素。

采取RTX治疗能延长非复杂性SDNS患儿的完全缓解期，改善激素不良反应。采取RTX治疗非复杂性SDNS患儿相对有效、安全，但尚需大样本研究进一步证实。

To investigate the efficacy and safety of rituximab (RTX) for treatment of uncomplicated steroid-dependent nephrotic syndrome (SDNS) in children.

Two cases of children (boys) with uncomplicated SDNS (children 1 and 2) treated in the First Affiliated Hospital of Zhengzhou University from January 2021 to September 2022 were selected into study. The clinical case data of 2 children were retrospectively analyzed. As 2 children with significant steroid adverse reactions and high serum CD20⁺ B lymphocyte counts of about 500/μL, they were given first RTX treatment then followed up, and RTX treatment was repeated if the children′s serum CD20⁺ B lymphocyte counts were ≥50/μL during the follow-up, and they both were treated with RTX for 3 times. RTX treatment regimen: intravenous drip at a dose of 375 mg/(m² · time) × 1 time, with a maximum dose of 500 mg/time. The effectiveness and safety of RTX for treatment of uncomplicated SDNS children were evaluated by time to relapse-free remission of nephrotic syndrome (NS), improvement of steroid adverse effects in children, and occurrence of drug-related adverse effects at the time points of RTX intravenous infusion and after the end of treatment. This study was approved by the Ethics Committee of the First Affiliated Hospital of Zhengzhou University (Approval No. 2022-KY-1267). The guardians of 2 children gave informed consent to the diagnosis and treatment, and signed the informed consent forms.

① The 2 children (boys) with uncomplicated SDNS in this study were admitted at the age of about 7 years old, both courses of disease were about 4 years, and were treated with glucocorticoids outside the hospital for 4⁺ years, both had steroid adverse reactions such as Cushing′s face and high intraocular pressure, and both had 2 recurrences of NS before this admission. ② RTX treatment were repeated for 3 times in both children, with the same treatment regimen for all 3 times. The peripheral blood CD20⁺ B lymphocyte count was <50/μL in both children on day 7 after the first RTX treatment, which gradually increased after 4-6 months of follow-up and could decrease after RTX treatment again. ③ Every time when RTX intravenous infusion treatment was taken, no infusion reaction occurred in any of the 2 children. Since the end of the first RTX treatment, their complete remission periods of NS were >12 months, no serious infection occurred in treatment period and complete remission period, and the adverse steroid reactions improved and the steroid was successfully discontinued.

RTX treatment can prolong the complete remission period of children with uncomplicated SDNS and improve the steroid adverse effects. RTX is relatively effective and safe for treatment of children with uncomplicated SDNS, but needs to be further confirmed in a large sample study.