Multicenter Real-World Study of Huaiqihuang Granules in the Treatment of Pediatric Henoch-Schonlein Purpura Nephritis

Abstract Background: Henoch-Schonlein purpura nephritis (HSPN) is one of the most common secondary glomerular diseases. Effective treatment of HSPN is particularly important. The therapeutic efficacy of Huaiqihuang(HQH) granules for HSPN has only been investigated in small, single-center studies. Multicentered, large sample, real-world study is still lacking. Methods: In this real-world study, 835 children with HSPN from 21 hospitals were divided into isolated hematuria and proteinuria groups. Patients were treated with Huaiqihuang granules combined with conventional treatment (HQH group) or conventional treatment alone (control group). The remission rate of HQH group and control group were compared using life table method, factors associated with remission were identified using Cox regression analyses, and the incidence of adverse events was observed. Results: Patients were aged 8.85 ± 2.86 years on average, and 58% were male. In 154 HSPN patients with isolated hematuria. The 12th week remission rate of HQH group was 58.31 %( 95%CI, 49.38%–67.50%) while that in the control group was 26.99 %( 95%CI, 15.03%–45.52%), the hazard ratio(HR) of HQH treatment for hematuria remission was 2.77 (95% CI, 1.57–4.89; p < 0.01) in multivariate Cox regression analysis. Of 681 patients with proteinuria, those treated with HQH had 12th week remission rate of 76.81%( 95% CI,72.97%– 80.45%) while those in the control group was 67.70 %(95% CI, 60.00%–75.18%),the HR of HQH treatment for proteinuria remission was 1.23(95% CI, 1.01–1.50; p = 0.04) in multivariate Cox regression analysis.Stratified analysis indicated in patients with non-nephrotic-range proteinuria, the HR of HQH treatment for proteinuria remission were 1.26 (95% CI, 1.01–1.59; p = 0.04) The incidence of adverse reactions did not differ between the Huaiqihuang and control groups (p < 0.05). Conclusion: Huaiqihuang granules combined with conventional treatment can significantly increase the remission rate in cases of isolated hematuria HSPN and HSPN with proteinuria and be a protective factor on isolated hematuria HSPN and non-nephrotic-range proteinuria (NNRP)-type HSPN, with good safety.