Dan Bai Xiao Formula combined with glucocorticoids and cyclophosphamide for pediatric lupus nephritis: A pilot prospective study

BACKGROUND: Patients with lupus nephritis (LN) typically undergo long-term treatment with glucocorticoids (GCs) and immunosuppressants. There is a growing demand for optimal therapy with better remission results and fewer side effects. Sustained traditional Chinese medicine (TCM) might be quite valuable for multitarget therapy, reducing the total dosage of GCs and minimizing the side effects of immunosuppressants. AIM: To evaluate whether Dan Bai Xiao Formula (DBXF) can reduce the exposure to GCs and cyclophosphamide (CYC) and to assess the efficacy and safety of DBXF for the resolution of proteinuria and hematuria in children with LN. METHODS: A 24-wk pilot study was conducted at Beijing Children’s Hospital. Children with active LN were divided into either a TCM group or a control group. Children in the TCM group received DBXF combined with GCs and CYC, and the ones in the control group received GCs and CYC every 4 wk for 24 wk. The primary endpoints of this trial were urinary protein excretion of < 150 mg/d and normal serum albumin concentration and renal function. RESULTS: The trial included 78 children, of whom 38 received GCs and CYC treatment (control group) and the remaining 40 received DBXF combined with GCs and CYC treatment (TCM group). At week 24, the TCM group showed a better rate of complete remission (42.5%); however, there was no significant difference compared with the control group (31.5%, P > 0.05). The urine red blood cell count and urine protein level were significantly lower in the TCM group than in the control group at weeks 4, 12, and 24 (P < 0.05). Furthermore, patients in the TCM group had a lower proportion of methylprednisolone pulses than those in the control group (1.30 ± 1.41 vs 3.05 ± 2.02, P < 0.0001). The ending GC dose was significantly lower in the TCM group than in the control group (P < 0.001). Moreover, more hepatic function damage, gastrointestinal adverse effects, and hypertension were observed in the control group than in the TCM group (P < 0.05). CONCLUSION: The findings suggest that DBXF treatment is effective and safe as a supplementary therapy for LN and is superior to routine GC and CYC therapy. DBXF containing combination treatment possibly results in a faster resolution of proteinuria and hematuria, smoother GC reduction, fewer methylprednisolone pulses, and fewer adverse events.