Retrospective Comparative Study of Tacrolimus and Cyclophosphamide Treatment in Pediatric Lupus Nephritis.

Lupus nephritis (LN) is a kidney injury caused by systemic lupus erythematosus (SLE) and can lead to serious impairment of renal function. Glucocorticoid (GC) combined with cyclophosphamide (CTX) is currently a commonly used treatment for LN; however, it is associated with several limitations, including a high proportion of refractory cases, a high recurrence rate after remission, and a long treatment cycle. The purpose of this study was to evaluate the safety and efficacy of Tacrolimus (Tac) combined with GC in the treatment of lupus nephritis. This retrospective cohort study included 112 pediatric LN patients at Inner Mongolia Autonomous Region People's Hospital (January 2022 to June 2025), divided into two groups (n = 56 each): Tac group [Tac + GC] and CTX group (CTX + GC), with a treatment duration of 6 months. Primary endpoints included post-treatment overall response rate, pre/post-treatment renal function, and disease activity scores. Secondary endpoints included immune-inflammatory markers, immune function parameters, anti-dsDNA antibody positivity rate (pre/post-treatment), and adverse reaction incidence. Baseline characteristics showed no significant difference between the two groups (P > 0.05). Post-treatment, the Tac group had a significantly higher complete remission rate than the CTX group (P < 0.05). Both groups exhibited improved renal function, reduced immune-inflammatory markers, immunoglobulins, and anti-dsDNA positivity (P < 0.05), and increased complement C3 and C4 levels (P < 0.05). The Tac group showed more pronounced improvements and a lower overall adverse reaction incidence (P < 0.05). Tac combined with GC can improve renal function and immune-inflammatory status in children with lupus nephritis, with good safety.