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中国全科医学 ›› 2024, Vol. 27 ›› Issue (29): 3696-3703.DOI: 10.12114/j.issn.1007-9572.2023.0381

• 综述与专论 • 上一篇    

儿童紫癜性肾炎临床研究结局指标的范围综述

佟静涵1, 吴晓明2, 孙雅欣3, 李姝凝3, 梁琛1, 董恒1, 车刚4, 刘畅2, 胡艳2,*(), 刘雅莉5,*()   

  1. 1．100045　北京市，国家儿童医学中心　首都医科大学附属北京儿童医院
    2．100045　北京市，国家儿童医学中心　首都医科大学附属北京儿童医院中医科
    3．100069　北京市，首都医科大学中医药学院
    4．735100　甘肃省嘉峪关市第一人民医院
    5．100045　北京市，国家儿童医学中心　首都医科大学附属北京儿童医院临床流行病学与循证医学中心
  • 收稿日期:2023-11-11 修回日期:2024-04-11 出版日期:2024-10-15 发布日期:2024-07-16
  • 通讯作者: 胡艳, 刘雅莉


  • 作者贡献：

    佟静涵、吴晓明负责论文撰写；孙雅欣、李姝凝负责文献提取；梁琛、董恒负责数据处理及分析；车刚负责论文撰写的初步修改；刘畅负责临床数据的提供及整理；刘雅莉、胡艳负责研究思路的制定及论文修订和质量控制。

  • 基金资助:
    北京市研究型病房建设示范单位项目(BCRW2202101); 北京市中医药科技发展重点项目(BJZYZD-2023-03); 首都医科大学"本科生科研创新"项目(XSKY2021337)

Clinical Study Outcome Indicators for Henoch-Schonlein Purpura Nephritis: a Scoping Review

TONG Jinghan1, WU Xiaoming2, SUN Yaxin3, LI Shuning3, LIANG Chen1, DONG Heng1, CHE Gang4, LIU Chang2, HU Yan2,*(), LIU Yali5,*()   

  1. 1. National Center for Children's Health/Beijing Children's Hospital, Capital Medical University, Beijing 100045, China
    2. National Center for Children's Health/Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China
    3. School of Traditional Chinese Medicine, Capital Medical University, Beijing 100069, China
    4. First People's Hospital of Jiayuguan City, Gansu Province, Jiayuguan 735100, China
    5. National Center for Children's Health/Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China
  • Received:2023-11-11 Revised:2024-04-11 Published:2024-10-15 Online:2024-07-16
  • Contact: HU Yan, LIU Yali

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摘要： 背景 过敏性紫癜是一种好发于儿童期的血管炎性疾病，部分患儿会累及肾脏，临床上称为紫癜性肾炎。目前不同研究建议的干预措施不尽相同，对于相应干预措施所采用的结局指标存在较大差异。 目的 调查分析我国紫癜性肾炎临床研究结局指标现状，为该领域核心结局指标集的建立提供参考依据。 方法 系统检索中国知网、中国生物医学文献数据库、维普网、万方数据知识服务平台，PubMed，Cochrane Library，Embase及Web of Science，收集公开发表的紫癜性肾炎相关研究，检索时限均为2010年1月—2021年6月。中文数据库采用题名或关键词结合主题词的检索策略进行检索，英文数据库采用主题词结合自由词的方式进行检索。由两名研究员按照纳入与排除标准独立筛选文献和提取资料，并对结局指标数据进行处理分析。 结果 共纳入紫癜性肾炎的随机对照研究148篇，紫癜性肾炎研究结局指标以理化指标为主，症状类指标较少。结局指标出现频次依次为临床疗效（121次，81.76%），不良反应（74次，50.00%），24 h尿蛋白（68次，45.95%），尿红细胞（43次，29.05%），复发率（20次，13.51%）。仅2篇文献明确区分主要和次要结局指标。 结论 国内紫癜性肾炎研究结局指标种类繁多，以理化指标为主，异质性较大。研究关注疗效指标而对不良反应的关注度不足。因此有必要建立紫癜性肾炎临床干预性研究结局指标集，为同类研究选择结局指标及指导临床决策提供参考依据。

关键词: 紫癜性肾炎, 过敏性紫癜, 儿童, 结局指标, 结局指标集, 范围综述

Abstract:

Background

Henoch-Schonlein purpura is a vascular inflammatory illness that develops in childhood and in some children involves the kidneys, clinically known as Henoch-Schonlein purpura nephritis. Different studies have suggested different interventions, and there is a wide variation in the outcome indicators used for the intervention approaches.

Objective

To investigate and analyze the current status of clinical research outcome indicators for Henoch-Schonlein purpura nephritis in China, so as to provide a reference basis for the establishment of a core set of outcome indicators in this field.

Methods

CNKI, CBM, VIP, Wanfang Data, PubMed, Cochrane Library, Embase and Web of Science were systematically searched to collect publicly available Henoch-Schonlein purpura nephritis studies from January 2010 to June 2021. The Chinese databases were searched using the search strategy of title or keywords combined with subject terms, and the English databases were searched using subject terms combined with free words. Two investigators independently screened the literature and extracted information according to the inclusion and exclusion criteria, processed and analyzed the data on outcome indicators.

Results

A total of 148 randomized controlled trials of Henoch-Schonlein purpura nephritis were included, and the outcome indicators of Henoch-Schonlein purpura nephritis studies were mainly physical and chemical indicators, with fewer symptomatic indicators. The highest frequency of outcome indicators were clinical efficacy (121 times, 81.76%), adverse reactions (74 times, 50.00%), 24-hour urine protein (68 times, 45.95%), urinary red blood cells (43 times, 29.05%), and recurrence rate (20 times, 13.51%). The division between primary and secondary outcome indicators was clearly distinguished in only two articles.

Conclusion

There are several indicators for the research outcomes of Henoch-Schonlein purpura nephritis in China, primarily physical and chemical variables, with significant variation. The research focuses on efficacy measures but ignores adverse reactions. As a result, it is necessary to establish a set of outcome indicators for clinical intervention studies on Henoch-Schonlein purpura nephritis in order to provide a reference basis for selecting outcome indicators and guiding clinical decision-making in future similar studies.

Key words: IgA vasculitis nephritis, Henoch-Schonlein purpura, Child, Outcome indicators, Set of outcomes, Scoping review

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