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| 中医药治疗儿童癫痫的临床研究评价指标及相关问题 |
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吴上彬1,2, 朱征3, 陈芯莹1, 杨京华1, 王辉4
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1.广东省中医院儿科, 广州 510000;2.广东省中医院文子源学术流派传承工作室, 广州 510000;3.天津中医药大学研究生院, 天津 301617;4.天津中医药大学循证医学中心, 天津 301617
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| 摘要: |
| [目的] 系统梳理中医药治疗儿童癫痫随机对照试验的评价指标，为中医药治疗儿童癫痫核心指标集研究奠定基础。[方法] 系统检索中国期刊全文数据库（CNKI）、万方数据库（WanFang Data）、中国生物医学文献数据库（SinoMed）、PubMed、The Cochrane Library、Embase数据库中的中医药治疗儿童癫痫的随机对照试验，检索时限为建库至2021年6月31日。由两名研究者按照纳入排除标准独立进行文献筛选和信息提取，对评价指标进行标化和归类，并进行描述性统计。[结果] 共纳入57个随机对照试验，治疗时间为15~720 d。纳入患者数最少为37例，最多为190例。使用了95个评价指标，共计206次。指标经规范化后共21个评价指标，按功能属性归为5个指标域。[结论] 中医药治疗儿童癫痫的临床研究评价指标，存在指标名称使用不规范、未明确主要指标和次要指标名称及数量、安全性指标选用不规范、忽视经济性指标和远期预后指标等问题。亟需建立符合癫痫和中医药治疗特点的核心指标集，为中医药治疗儿童癫痫的临床研究设计提供参考。 |
| 关键词: 儿童 癫痫 临床研究 评价指标 |
| DOI：10.11656/j.issn.1672-1519.2022.08.17 |
| 分类号:R742.1 |
| 基金项目:国家自然科学基金项目（82074583）；广东省中医院岭南儿科文子源学术流派传承工作室建设项目，中医二院[2013（]E43613）。 |
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| Clinical research evaluation outcomes and related problems of traditional Chinese medicine in the treatment of childhood epilepsy |
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WU Shangbin1,2, ZHU Zheng3, CHEN Xinying1, YANG Jinghua1, WANG Hui4
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1.Department of Pediatrics, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou 510000, China;2.Wen Ziyuan Academic School Inheritance Studio of Lingnan Pediatrics of Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510000, China;3.Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;4.Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
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| Abstract: |
| [Objective] This study systematically sorted out the evaluation outcomes of the randomized controlled trials of traditional Chinese medicine for the treatment of childhood epilepsy,aiming to provide a preliminary research basis for the research on the core outcome set of traditional Chinese medicine for the treatment of childhood epilepsy. [Methods] Randomized controlled trials of traditional Chinese medicine in the treatment of childhood epilepsy in CNKI,WanFang Data,SinoMed,PubMed,The Cochrane Library,and Embase databases were systematically searched. Two researchers independently screened the literature and extracted information according to the inclusion and exclusion criteria,standardized and classified the evaluation outcomes,and performed descriptive statistics on the results. [Results] A total of 57 randomized controlled trials were included,with treatment durations ranging from 15 to 720 days. The minimum number of patients included was 37 and the maximum was 190. The included studies used 95 evaluation outcomes,a total of 206 times. After the indicators are normalized,there are a total of 21 evaluation outcomes,which are classified into 5 domains. [Conclusion] The evaluation outcomes of clinical research on the treatment of childhood epilepsy with traditional Chinese medicine have problems such as irregular use of outcome names,unclear names and quantities of primary and secondary outcomes,irregular selection of safety outcomes, and neglect of economic outcomes and long-term prognosis outcomes. It is urgent to establish a core outcome set that conforms to the characteristics of epilepsy and traditional Chinese medicine treatment to provide guidance for clinical research design of traditional Chinese medicine in the treatment of childhood epilepsy. |
| Key words: child epilepsy clinical trial outcome |
