Clinical Trials Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 6, 2022; 10(31): 11391-11402
Published online Nov 6, 2022. doi: 10.12998/wjcc.v10.i31.11391
Dan Bai Xiao Formula combined with glucocorticoids and cyclophosphamide for pediatric lupus nephritis: A pilot prospective study
Tong-Tong Cao, Li Chen, Xiao-Fang Zhen, Gao-Jie Zhao, Hui-Fang Zhang, Yan Hu
Tong-Tong Cao, Li Chen, Xiao-Fang Zhen, Gao-Jie Zhao, Hui-Fang Zhang, Yan Hu, Department of Traditional Chinese Medicine, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Beijing 100045, China
Author contributions: Cao TT drfted the manuscript; Hu Y revised the manuscript and supervised the study; Cao TT and Chen L performed the experiments; all authors agree to be accountable for all aspects of the work in ensuring integrity and accuracy.
Supported by the Capital Health Research and Development of Special, No. CH2018-2-2092.
Institutional review board statement: This study was reviewed and approved by the Institutional Review Board of Air Force Medical Center.
Conflict-of-interest statement: The authors decare that there are no known conflicts of interest associated with this publication and that there has been no significant financial support for this work that could have influenced its outcome.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is noncommercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Yan Hu, MD, PhD, Director, Doctor, Department of Traditional Chinese Medicine, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, No. 56 Nanlishi Road, Beijing 100045, China. huyan13370115073@163.com
Received: May 31, 2022
Peer-review started: May 31, 2022
First decision: July 14, 2022
Revised: August 1, 2022
Accepted: September 21, 2022
Article in press: September 21, 2022
Published online: November 6, 2022
Processing time: 148 Days and 13.8 Hours
ARTICLE HIGHLIGHTS
Research background

Systemic lupus erythematosus (SLE) diagnosed in childhood or adolescence is more aggressive, and up to 80% of SLE children (also referred to as patients below) have lupus nephritis (LN). Glucocorticoids (GCs) and immunosuppressants were considered routine treatments for patients with LN. However, there is a widespread consensus regarding the toxicity of immunosuppressive agents and the necessity of preventing children from taking these medications over an extended period. Accordingly, there is an increasing need for holistic and optimal therapy that results in a higher rate of remission and fewer side effects.

Research motivation

We aimed to prove that Dan Bai Xiao Formula (DBXF) treatment is effective and safe as a supplementary therapy for LN and that it is superior to routine glucocorticoids (GCs) and cyclophosphamide (CYC) therapy.

Research objectives

To assess the efficacy and safety of DBXF for the resolution of proteinuria and hematuria in children with LN.

Research methods

A 24-wk pilot study was conducted.

Research results

The urine red blood cell count and urine protein level were significantly lower in the traditional Chinese medicine (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 (1.3 ± 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).

Research conclusions

The findings suggest that DBXF treatment is effective and safe as a supplementary therapy for LN; moreover, this treatment is superior to routine GC and CYC therapies. DBXF containing combination treatment may lead to faster proteinuria and hematuria resolution, smoother GC reduction, fewer methylprednisolone pulses, and fewer adverse events.

Research perspectives

The integrated treatment of TCM has been indicated to be beneficial for LN. To increase effectiveness and reduce side effects during the active phase of LN, immunosuppression can be used in conjunction with TCM.