Abstract
BackgroundHenoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. Currently, the treatment for HSPN is always selected based on the Kidney Disease Improving Global Outcomes guidelines; however, this approach may lead to undertreatment, especially in patients with persistent proteinuria that does not reach nephrotic levels and/or hematuria and those with a pathological classification between grades 1 and 3 according to the International Study of Kidney Disease in Children. This study was performed to evaluate the curative effect and safety of a traditional Chinese medicine (TCM) integrated treatment program in this type of HSPN.MethodsThis multicenter, open-label, large-sample, randomized controlled trial was performed in China and included 500 children with HSPN exhibiting mild pathological patterns. The treatment group to control group ratio was 2:1, and each group was further stratified into two types, light and heavy, according to urinary protein quantification and pathological type. The treatment group received tripterygium glycosides (TGs), tanshinone IIa sodium sulfonate injection, and Chinese herbs selected based on syndrome differentiation in TCM. The heavy and light subgroups received treatment courses and dosages of TG. In the control groups, the light group received benazepril hydrochloride tablets, low molecular weight heparin calcium injection, dipyridamole tablets, and a Chinese medicine placebo, while the heavy group received the same treatment plus prednisone. All groups were treated for 3 months and then followed up for 9 months. The efficacy and safety of the treatments were then evaluated among the groups.DiscussionCurrently, few treatments are available for HSPN patients with mild pathological patterns indicating light to moderate proteinuria and/or hematuresis. In this large-sample study, we provide a new approach for HSPN that includes an integrated treatment program that incorporates TCM.Trial registrationClinical Trials.gov, NCT03591471. Re-registered on 19 July 2018.
Highlights
Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children
HSPN presents with diverse clinical manifestations, including microscopic hematuria, microalbuminuria to massive proteinuria, nephrotic syndrome (NS), acute rapidly progressive glomerulonephritis (RPGN), and acute renal insufficiency (ARI)
The current treatment strategy for HSPN is mainly based on the Kidney Disease Improving Global Outcomes (KDIGO) guidelines [9]: angiotensin-converting enzyme inhibitors (ACEIs) and/ or angiotensin receptor blockers (ARBs) are recommended for use in patients with HSPN with persistent proteinuria ranging from 0.5 to 1 g/day/1.73 m2; while for those with persistent proteinuria (> 1 g/day/1.73 m2) after treatment with Angiotensin-converting enzyme inhibitor (ACEI)/Angiotensin receptor blocker (ARB) and a glomerular filtration rate above 50 ml/min/1.73 m2, a 6-month course of corticosteroids should be used
Summary
Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. The treatment for HSPN is always selected based on the Kidney Disease Improving Global Outcomes guidelines; this approach may lead to undertreatment, especially in patients with persistent proteinuria that does not reach nephrotic levels and/or hematuria and those with a pathological classification between grades 1 and 3 according to the International Study of Kidney Disease in Children. The current treatment strategy for HSPN is mainly based on the Kidney Disease Improving Global Outcomes (KDIGO) guidelines [9]: angiotensin-converting enzyme inhibitors (ACEIs) and/ or angiotensin receptor blockers (ARBs) are recommended for use in patients with HSPN with persistent proteinuria ranging from 0.5 to 1 g/day/1.73 m2; while for those with persistent proteinuria (> 1 g/day/1.73 m2) after treatment with ACEI/ARBs and a glomerular filtration rate above 50 ml/min/1.73 m2, a 6-month course of corticosteroids should be used. Treatment with platelets and anticoagulants remains controversial, but the evidence-based guideline in China indicates that the addition of anticoagulants and/or antiplatelet aggregation agents could be used to treat HSPN [10]
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