Efficacy and safety of tacrolimus in the treatment of Henoch-Schönlein purpura nephritis: systematic review and meta-analysis.

Abstract

Background: Henoch-Schönlein purpura nephritis (HSPN) is the most severe manifestation of Henoch-Schönlein purpura, significantly impacting patient outcomes. While immunosuppressive therapies like cyclophosphamide (CTX) and mycophenolate mofetil (MMF) are commonly used, evidence regarding the efficacy and safety of tacrolimus (TAC) in HSPN remains limited. This study presents the first systematic review and meta-analysis specifically evaluating the efficacy and safety of tacrolimus (TAC) in treating Henoch-Schönlein purpura nephritis (HSPN), aiming to fill a critical gap in evidence for clinical decision-making.

Methods: This systematic review and meta-analysis, the first focused specifically on TAC in HSPN, included seven studies comprising 727 patients. A comprehensive search was conducted across multiple databases, including the Cochrane Library, PubMed, Embase, Medline, Web of Science, CNKI, Wanfang, SinoMed, VIP, and Embase. Studies comparing TAC with control treatments, such as CTX or MMF, in HSPN patients were included. Odds ratios (ORs) were calculated for dichotomous outcomes, while standardized mean differences (SMDs) with 95% confidence intervals (CIs) were used for continuous variables. Depending on heterogeneity, either random-effects or fixed-effects models were applied. Data synthesis was performed using RevMan software.

Results: A total of seven studies were included. TAC therapy significantly improved clinical efficacy in HSPN patients (OR = 4.43; 95% CI: 2.86-6.87; P < 0.001). Additionally, TAC significantly reduced urine protein levels (SMD = -1.17; 95% CI: -1.83 to -0.51; P < 0.001), serum creatinine (Scr) (SMD = -2.33; 95% CI: -3.00 to -1.65; P < 0.001), and blood urea nitrogen (BUN) (SMD = -1.49; 95% CI: -1.94 to -1.04; P < 0.001). Importantly, there were no significant differences in the incidence of adverse events between the TAC and control groups.

Conclusion: This is the first systematic review and meta-analysis specifically evaluating TAC in HSPN, providing novel evidence that TAC is an effective and safe therapeutic option for these patients. Its potential advantages over conventional immunosuppressive therapies highlight the need for further high-quality, long-term randomized controlled trials to confirm these findings and establish TAC's role in HSPN management.