针刺治疗脓毒症胃肠功能障碍的核心结局指标集构建
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1.天津中医药大学第一附属医院,天津 300381;2.中医国家临床医学研究中心,天津 300381;3.天津中医药大学研究生院,天津 301617

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R574

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Outcome indicators in clinical trials of acupuncture intervention for gastrointestinal dysfunction in sepsis
Author:
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1. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China.2. National Clinical Research Center for Chinese Medicine, Tianjin 300381.3. Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin 301617

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    摘要:

    汇总分析目前针刺干预脓毒症胃肠功能障碍的临床随机对照试验(RCTs)的结局指标的报告情况,总结归纳结局指标的类型、提出适当的建议以促进临床研究进展。 通过系统检索了 4 个中文数据库,3个英文数据库以及 1 个临床试验注册中心,筛选出针刺辅助治疗脓毒症胃肠功能障碍的 RCTs,并使用Cochrane 进行偏倚风险评价。 经过筛选最终纳入了 30 篇临床研究,其中,中文 28 篇,英文 2 篇,并提取到 39种结局指标,主要概括为 8 类:中医病证、临床有效率、胃肠功能、病情程度、影像学检查、血清学标志物、炎症指标、安全性。 多数研究存在的偏倚风险不明确、研究方法学质量相对不足、结局指标主次不分、结局指标使用不规范、缺乏针刺特色等问题。 鉴于此,本文中收集并归纳针刺治疗脓毒症胃肠功能障碍的核心结局指标,明确脓毒症胃肠功能障碍针刺治疗结局指标的局限性,明确研究缺陷并提升临床研究的方法学质量。

    Abstract:

    Summarize and analyze the reporting of outcome indicators in current clinical randomized controlled trials (RCTs) on acupuncture intervention for gastrointestinal dysfunction in sepsis, summarize the types of outcome indicators, and put forward appropriate suggestions to promote the progress of clinical research. Four Chinese and three English databases and one clinical trial registry were systematically searched to screen out RCTs of needleassisted treatment for gastrointestinal dysfunction in sepsis. The risk of bias was assessed using the Cochrane risk of bias tool. After screening, a total of 30 clinical studies were finally retrieved, including 28 Chinese and two English studies. Thirty-nine outcome indicators were extracted and mainly summarized into eight categories: Traditional Chinese Medicine syndromes, clinical effective rate, gastrointestinal function, disease severity, imaging examinations, serological markers, inflammatory indicators, and safety. Most studies had problems such as unclear risk of bias, poor quality of research method ologies, confusion of primary and secondary outcome measures, nonstandard use of outcome measures, and lack of acupuncture characteristics. We therefore collected and summarized the core outcome indicators of acupuncture treatment for gastrointestinal dysfunction in sepsis, clarified the limitations of the outcome indicators of acupuncture treatment for gastrointestinal dysfunction in sepsis, and identified research deficiencies to improve the method ological quality of clinical research.

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张译方,王思昀,缪长宏,许欣宜,王元翀,肖 璐,郭梦圆.针刺治疗脓毒症胃肠功能障碍的核心结局指标集构建[J].中国比较医学杂志,2026,36(1):80~91.

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  • 收稿日期:2025-07-31
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  • 在线发布日期: 2026-02-10
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