[1]吴钰仪,蔡秋晗,胡思源.中药治疗小儿积滞病随机对照试验设计的系统评价及可视化分析[J].西部中医药,2025,38(08):88-93.[doi:10.12174/j.issn.2096-9600.2025.08.16]
　WU Yuyi,CAI Qiuhan,HU Siyuan.Randomized Controlled Trial Designs of Chinese Medicine in the Treatment of Infantile Indigestion: A Systematic Assessement and Visualization Analysis[J].Western Journal of Traditional Chinese Medicine,2025,38(08):88-93.[doi:10.12174/j.issn.2096-9600.2025.08.16]
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中药治疗小儿积滞病随机对照试验设计的系统评价及可视化分析

《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
38
期数:
2025年08期
页码:
88-93
栏目:
二次研究
出版日期:
2025-08-15

文章信息/Info

Title:
Randomized Controlled Trial Designs of Chinese Medicine in the Treatment of Infantile Indigestion: A Systematic Assessement and Visualization Analysis
作者:
吴钰仪, 蔡秋晗, 胡思源
天津中医药大学第一附属医院/国家中医针灸临床医学研究中心，天津 300381
Author(s):
WU Yuyi, CAI Qiuhan, HU Siyuan
First Teaching Hospital of Tianjin University of TCM/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China
关键词:
积滞病; 文献研究; 试验设计; 系统评价; 可视化分析; 小儿
Keywords:
indigestion; literature review; experiment design; systematic assessement; visualization analysis; infantile
分类号:
R272.4
DOI:
10.12174/j.issn.2096-9600.2025.08.16
文献标志码:
A
摘要:
目的系统评价及可视化分析中药治疗小儿积滞病的随机对照试验（randomized controlled trial，RCT），总结现有研究的现状与不足，为优化临床试验设计及指南制定提供依据。 方法检索中国知网、万方、维普、PubMed等数据库中建库至2021年7月30日的相关文献，筛选纳入13篇高质量RCT。采用JADAD量表和Cochrane偏倚风险评估工具进行质量评价，利用CiteSpace软件进行作者合作网络、机构分布及关键词共现等可视化分析，并对受试人群选择、疗程、疗效评价等设计要素进行系统梳理。 结果纳入研究总体质量较高（JADAD评分≥3分），但存在随机方法不明确（23.08%）、分配隐藏高风险（61.54%）等问题。可视化分析显示，2015年为发文量高峰（27篇），核心研究团队以胡思源、李新民等为代表，机构合作网络松散。受试者主要为7岁以下儿童（占95%），诊断多参考《中医儿科学》（53.85%）及《中医病证诊断疗效标准》（30.77%）。疗程集中于1周（61.54%），对照组多采用中成药（69.23%）。有效性评价以症状改善为主，但缺乏标准化量表支持。 结论当前中药治疗小儿积滞病的RCT存在设计异质性高、诊断标准不统一、疗效评价工具不足等问题。建议未来研究明确适应证定位（以中医积滞病为主）、优化受试者纳入标准、采用安慰剂或阳性药对照、开发循证支持的疗效评价量表，并加强多机构协作以提高研究质量。
Abstract:
ObjectiveTo sum up the current state and the deficiency of the existing research by systema-tically assessing and conducting the visualization analysis of Chinese herbs in the treatment of infantile indiges-tion, which could provide the reference for the optimization of clinical trial design and guideline development. MethodsThe relevant literature was searched from CNKI, Wanfang, VIP, PubMed and others between the time of establishing the database and July 30, 2021 for the screening and inclusion of 13 high-quality RCTs. JADAD scale and Cochrane bias risk assessment tool were adopted to perform quality assessment, CiteSpace software was utilized to visualize author collaboration network, institutional distribution and keyword co-occurrence, to systematically sort out the design elements such as the selection of subjects, course of treatment and efficacy evaluation. ResultsThe overall quality of the studies included was high (JADAD scale≥3 points), but there were problems such as unclear randomization method (23.08%) and high risk of hidden allocation (61.54%). Visualization analysis displayed that the amount of the publications peaked in 2015 (27 papers), with the core research team represented by Hu Siyuan and Li Xinmin and loose institutional cooperation networks. The subjects were the children younger than seven years (holding 95%), and the diagnosis mostly referred to pediatrics of traditional Chinese medicine (53.85%) and the criteria for the diagnosis and therapeutic effect evaluation of TCM diseases (30.77%). The course of the treatment lasted for one week (61.54%), and the control group adopted Chinese patent medicine mostly (69.23%). The effect evaluation focused on the improvement of the symptoms, but lacking the support of standardized scales. ConclusionThe problems such as high design heterogeneity, inconsistent diagnostic criteria and insufficient efficacy evaluation tools existed in current RCTs on Chinese medicine in the treatment of infantile indigestion. Future studies should refine indication definitions (mainly infantile indigestion), the optimization of inclusion criteria, the adoption of placebo or positive drug control, and the development of evidence-based efficacy evaluation scales, and strengthen multi-institutional collaboration to enhance the quality of the research.

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备注/Memo

备注/Memo:
吴钰仪（1995—），女，硕士学位，医师。研究方向：中医儿科学。重大新药创制项目“儿童中药新药临床评价技术示范性平台建设”（2020ZX09201-008）。
更新日期/Last Update: 2025-08-15