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      Chinese herbal medicine for the treatment of Henoch–Schönlein purpura nephritis in children : A prospective cohort study protocol

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          Abstract

          Introduction:

          Henoch–Schönlein purpura nephritis (HSPN) involves the renal impairment of Henoch–Schönlein purpura and can easily relapse into life-threatening late nephropathy in severe cases. Although there is a lack of validated evidence for its effectiveness, Chinese herbal medicine (CHM) is one of the most commonly used methods in China to treat HSPN. It is thus need to report the protocol of a prospective cohort trial using CHM to investigate the effectiveness, safety and advantages for children with HSPN.

          Methods and analysis:

          This large, prospective, multicenter cohort study started in May 2015 in Shenyang. Six hundred children diagnosed with HSPN were recruited from 3 institutions and are followed-up every 2 to 4 weeks till May 2020. Detailed information of participants includes general information, history of treatment, physical examination, and symptoms of TCM is taken face-to-face at baseline.

          Ethics and dissemination:

          This study has received ethical approval from the ethics committee of institutional review board of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine (No.2016CS(KT)-002-01). Articles summarizing the primary results and ancillary analyses will be published in peer-reviewed journals.

          Trial registration:

          Clinical Trials Registration: NCT02878018.

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          Most cited references20

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          Clinical update: Henoch-Schönlein purpura.

          Frank T Saulsbury (2007)
          Article 0 comments Cited 66 times – based on 0 reviews     Review now
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            Early prednisone therapy in Henoch-Schönlein purpura: a randomized, double-blind, placebo-controlled trial.

            T Ormälä, M Antikainen, M Ala-Opas … (2006)
            To evaluate the efficacy of early prednisone therapy in preventing renal and treating extrarenal and renal symptoms in Henoch-Schönlein purpura (HSP) in a placebo-controlled trial. A total of 171 patients (84 treated with prednisone and 87 receiving placebo) were included and followed up for 6 months. The endpoints were renal involvement at 1, 3, and 6 months and healing of extrarenal symptoms. The analyses were performed on an intent-to-treat basis. Prednisone (1 mg/kg/day for 2 weeks, with weaning over the subsequent 2 weeks) was effective in reducing the intensity of abdominal pain (pain score, 2.5 vs 4.8; P = .029) and joint pain (4.6 vs 7.3; P = .030). Prednisone did not prevent the development of renal symptoms but was effective in treating them; renal symptoms resolved in 61% of the prednisone patients after treatment, compared with 34% of the placebo patients (difference = 27%; 95% confidence interval = 3% to 47%; P = .024). The general use of prednisone in HSP is not supported, but patients with disturbing symptoms may benefit from early treatment, because prednisone reduces extrarenal symptoms and is effective in altering (but not preventing) the course of renal involvement.
            Article 0 comments Cited 64 times – based on 0 reviews     Review now
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              A nationwide survey on epidemiological characteristics of childhood Henoch-Schönlein purpura in Taiwan.

              Eric Chuang, B Chiang, Y. Lin … (2005)
              To evaluate the annual incidence and other epidemiological characteristics of Henoch-Schönlein purpura (HSP) among children in Taiwan. The records of patients were derived from the research database of the Bureau of National Health Insurance, Taiwan, Republic of China, from January 1999 to December 2002. Children younger than 17 yr of age with the diagnosis of HSP were included into this study. Data for each patient including sex, age, date of onset and length of hospitalization were recorded and analysed. A total of 2759 cases were included with an annual incidence of 12.9 (11.8-13.4) per 100 000 children <17 yr of age. The occurrence of HSP had a peak at the age of 5 to 6 yr. In this study, 1118 (40.5%) patients had been hospitalized at some stage. There were 1454 males and 1305 females, for a male to female ratio of 1.11. Males had a higher annual incidence before the age of 10 yr (P = 0.04), and had a lower incidence than females at older ages (P = 0.02). Disease onset was more common in autumn and winter, and no apparent change in seasonal pattern was noted over 4 yr. Insurance claim data provide useful information on the epidemiology of HSP in Taiwan. Childhood HSP in Taiwan, with an incidence of 12.9 per 100 000 children, occurs commonly in autumn and winter; and at the age of 5 to 6 yr. The characteristics presented in this study may provide valuable data for understanding and further studies of HSP.
              Article 0 comments Cited 42 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Medicine (Baltimore)
                Journal ID (iso-abbrev): Medicine (Baltimore)
                Journal ID (publisher-id): MEDI
                Title: Medicine
                Publisher: Wolters Kluwer Health
                ISSN (Print): 0025-7974
                ISSN (Electronic): 1536-5964
                Publication date Collection: June 2018
                Publication date (Electronic): 15 June 2018
                Volume: 97
                Issue: 24
                Electronic Location Identifier: e11064
                Affiliations
                [a ]Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
                [b ]Liaoning University of Traditional Chinese Medicine
                [c ]Department of Pediatric Nephrology, Shengjing Hospital of China Medical University
                [d ]First Affiliated Hospital of China Medical University, Shenyang, China.
                Author notes
                [∗ ]Correspondence: Jun Zhang, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, 33 Bei Ling Street, Huanggu, Shenyang, China (e-mail: anne_freedom@ 123456163.com ).
                Article
                Publisher ID: MD-D-18-03399 Accession ID: 11064
                DOI: 10.1097/MD.0000000000011064
                PMC ID: 6024032
                PubMed ID: 29901610
                SO-VID: 87e1a0e7-4b75-43d1-996d-d47571e78949
                Copyright © Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc.
                License:

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                Date received : 16 May 2018
                Date accepted : 21 May 2018
                Categories
                Subject: 3700
                Subject: Research Article
                Subject: Study Protocol Clinical Trial
                Custom metadata
                OPEN-ACCESS TRUE

                Keywords: chinese herbal medicine,cohort study,henoch–schönlein purpura nephritis,protocol
                Data availability:
                Keywords: chinese herbal medicine, cohort study, henoch–schönlein purpura nephritis, protocol

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