Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial
Abstract Background Henoch-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, especia...
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| Format: | Article |
| Language: | English |
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BMC
2019-08-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3484-3 |
| _version_ | 1818276429149765632 |
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| author | Ying Ding Xia Zhang Xianqing Ren Wensheng Zhai Liyun He Jianping Liu Chen Yao Shanshan Han Long Wang |
| author_facet | Ying Ding Xia Zhang Xianqing Ren Wensheng Zhai Liyun He Jianping Liu Chen Yao Shanshan Han Long Wang |
| author_sort | Ying Ding |
| collection | DOAJ |
| description | Abstract Background Henoch-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. Methods This 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. Discussion Currently, 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 registration Clinical Trials.gov, NCT03591471. Re-registered on 19 July 2018. |
| first_indexed | 2024-12-12T22:45:30Z |
| format | Article |
| id | doaj.art-73051b5d0451489dbf2d9ede07875aaa |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T22:45:30Z |
| publishDate | 2019-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-73051b5d0451489dbf2d9ede07875aaa2022-12-22T00:09:13ZengBMCTrials1745-62152019-08-0120111110.1186/s13063-019-3484-3Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trialYing Ding0Xia Zhang1Xianqing Ren2Wensheng Zhai3Liyun He4Jianping Liu5Chen Yao6Shanshan Han7Long Wang8Pediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCMPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCMPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCMPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCMClinical Evaluation Department, China Academy of Chinese Medical SciencesEvidence-Based Medicine Center, Beijing University of TCMMedical Statistics Department, Peking University First HospitalPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCMPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCMAbstract Background Henoch-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. Methods This 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. Discussion Currently, 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 registration Clinical Trials.gov, NCT03591471. Re-registered on 19 July 2018.http://link.springer.com/article/10.1186/s13063-019-3484-3Henoch-Schönlein purpura nephritisTraditional Chinese medicineTripterygium glycosidesStudy protocol |
| spellingShingle | Ying Ding Xia Zhang Xianqing Ren Wensheng Zhai Liyun He Jianping Liu Chen Yao Shanshan Han Long Wang Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial Trials Henoch-Schönlein purpura nephritis Traditional Chinese medicine Tripterygium glycosides Study protocol |
| title | Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial |
| title_full | Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial |
| title_fullStr | Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial |
| title_full_unstemmed | Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial |
| title_short | Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial |
| title_sort | traditional chinese medicine versus regular therapy in henoch schonlein purpura nephritis in children study protocol for a randomized controlled trial |
| topic | Henoch-Schönlein purpura nephritis Traditional Chinese medicine Tripterygium glycosides Study protocol |
| url | http://link.springer.com/article/10.1186/s13063-019-3484-3 |
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