Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome

Nephrotic syndrome in children, particularly steroid-dependent (SDNS) or frequently relapsing (FRNS) types, poses significant treatment challenges. While glucocorticoids are initial mainstays, second-line immunosuppressants like tacrolimus or rituximab are often required. Rituximab, a monoclonal antibody targeting CD20 on B-lymphocytes, has shown promise. Targeted nursing care, a patient-centered approach involving joint goal-setting and personalized interventions, aims to improve adherence and overall well-being. This study aimed to evaluate the synergistic effect of rituximab therapy combined with a structured targeted nursing care program compared to tacrolimus with the same targeted nursing care.

A total of 91 pediatric patients (aged 6-15 years) with SDNS or FRNS were enrolled from January 2021 to June 2023. They were randomized into a study group (n=46, rituximab + targeted nursing) and a control group (n=45, oral tacrolimus + targeted nursing). Both groups received baseline glucocorticoid therapy. The study group received intravenous rituximab (375 mg/m² weekly for 12 weeks). The control group received oral tacrolimus (0.05-0.1 mg/kg/day, adjusted to trough levels). Both groups received identical targeted nursing care protocols.

Outcomes compared included clinical efficacy (remission status), quality of life (IS-LQ questionnaire), incidence of adverse reactions, and recurrence rate over a 6-month follow-up. Peripheral blood CD19+ B-cell counts were monitored in the rituximab group. The study was approved by the institutional ethics committee, and informed consent was obtained.

Inclusion criteria

• Diagnosis of primary pediatric nephrotic syndrome, specifically steroid-dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS), as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. (SDNS is defined as relapse occurring during tapering of glucocorticoids or within 14 days of discontinuation; FRNS is defined as ≥2 relapses within 6 months of initial response or ≥4 relapses in any 12-month period).
• Age between 6 and 15 years.
• Normal intellectual development and the ability to understand and communicate.
• Informed consent obtained from the guardians and assent from children capable of understanding.

Exclusion criteria

• Steroid-resistant nephrotic syndrome (SRNS).
• Severe renal insufficiency (according to KDIGO criteria or other relevant standards).
• Cognitive or mental disorders.
• Worsening condition upon admission necessitating intensive care.
• Parents unable to provide long-term care or unwilling to participate.
• Interruption of hospitalization for any reason.
• Prior treatment with rituximab or tacrolimus.
• Co-existing significant kidney, urinary system diseases (other than NS), or severe active urinary tract infection.
• Significant liver function impairment.
• Known hypersensitivity to rituximab or tacrolimus.