Efficacy and Safety of Tacrolimus in the Treatment of Pediatric Henoch–Schönlein Purpura Nephritis,Pediatric Drugs

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Efficacy and Safety of Tacrolimus in the Treatment of Pediatric Henoch–Schönlein Purpura Nephritis
Pediatric Drugs ( IF 3.4 ) Pub Date : 2022-05-05 , DOI: 10.1007/s40272-022-00506-1
Dengyan Wu ₁ , Rui Ma ₁ , Xingmin Wang ₂ , Yonghong Yang _{1,

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Affiliation

Background

Children with severe Henoch–Schönlein purpura nephritis (HSPN) may progress to end-stage renal disease without appropriate treatment.

Objective

This study aimed to investigate the efficacy and safety of tacrolimus combined with glucocorticoids in the treatment of pediatric HSPN.

Methods

A total of 87 HSPN patients with urinary protein ≥ 0.75 g/24 h received standard of care, including angiotensin II receptor blockers/angiotensin-converting enzyme inhibitors and glucocorticoids. Patients were divided into three groups and additionally received tacrolimus (n = 30), cyclophosphamide (n = 31), or mycophenolate mofetil (MMF) (n = 26). We monitored outcome measures, including proteinuria, hematuria, and renal function and analyzed the efficacy and side effects in each group.

Results

At 2-month follow-up, the overall efficacy was 93.3%, 83.9%, and 61.5% for tacrolimus, cyclophosphamide, and MMF, respectively (P < 0.05). Urinary protein significantly decreased for all groups. Urinary red blood cell counts significantly decreased for patients treated with tacrolimus (P < 0.001) and cyclophosphamide (P < 0.05), whereas no significant decrease was seen for those receiving MMF (P = 0.09). Although urine β2-microglobulin significantly decreased following 2 months of treatment with all medications, efficacy was greater with tacrolimus than with cyclophosphamide and MMF (P < 0.001). Major adverse events were respiratory and urinary infections, with MMF having the highest infection rate. The cyclophosphamide group also experienced additional adverse events, including arrhythmia, hemorrhagic cystitis, leukocytosis, thrombocytopenia, and hyperglycemia.

Conclusions

These results indicate that tacrolimus is more effective at reducing proteinuria and hematuria and improving renal function, with relatively milder side effects, in the treatment of pediatric HSPN.

Clinical Trial Registration Number

ChiCTR2200055323, retrospectively registered on January 7, 2022.

中文翻译：

他克莫司治疗小儿过敏性紫癜性肾炎的疗效和安全性

背景

患有严重过敏性紫癜性肾炎 (HSPN) 的儿童在没有适当治疗的情况下可能会发展为终末期肾病。

客观的

本研究旨在探讨他克莫司联合糖皮质激素治疗小儿HSPN的疗效和安全性。

方法

共有 87 名尿蛋白≥0.75 g/24 h 的 HSPN 患者接受了标准治疗，包括血管紧张素 II 受体阻滞剂/血管紧张素转换酶抑制剂和糖皮质激素。患者分为三组，另外接受他克莫司（n = 30）、环磷酰胺（n = 31）或霉酚酸酯（MMF）（n = 26）。我们监测了结局指标，包括蛋白尿、血尿和肾功能，并分析了每组的疗效和副作用。

结果

2个月随访时，他克莫司、环磷酰胺和MMF的总有效率分别为93.3%、83.9%和61.5%（P <0.05）。所有组的尿蛋白均显着下降。接受他克莫司（ P < 0.001）和环磷酰胺（P < 0.05）治疗的患者尿红细胞计数显着降低，而接受MMF治疗的患者尿红细胞计数没有显着降低（P = 0.09）。尽管所有药物治疗 2 个月后尿 β2-微球蛋白显着下降，但他克莫司的疗效优于环磷酰胺和 MMF（P< 0.001)。主要不良事件为呼吸道和泌尿系统感染，其中 MMF 的感染率最高。环磷酰胺组还经历了额外的不良事件，包括心律失常、出血性膀胱炎、白细胞增多、血小板减少和高血糖。