Outcomes indicators in randomized controlled trials of traditional Chinese medicine for postinfectious cough

ZHANG Xinyi; JIN Xin; RENAGULI·Aisikaer; ZHANG Hongchun

doi:10.16025/j.1674-1307.2026.04.002

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Outcomes indicators in randomized controlled trials of traditional Chinese medicine for postinfectious cough

更新时间：2026-06-10

- Outcomes indicators in randomized controlled trials of traditional Chinese medicine for postinfectious cough
- Beijing Journal of Traditional Chinese Medicine Vol. 45, Issue 4, Pages: 437-443(2026)
- 作者机构：
  
  1.北京中医药大学研究生院，北京 100029
  2.中日友好医院中西医结合肺病一部，北京 100029
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2026.04.002
  CLC：
- Received：11 January 2025，
  
  Published：25 April 2026
- 稿件说明：
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张欣怡，靳鑫，热那古力·艾斯卡尔，等.中医药治疗感染后咳嗽随机对照试验结局指标的系统分析［J］.北京中医药，2026，45（4）：437-443.

ZHANG Xinyi,JIN Xin,RENAGULI·Aisikaer ,et al.Outcomes indicators in randomized controlled trials of traditional Chinese medicine for postinfectious cough[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(04):437-443.
张欣怡，靳鑫，热那古力·艾斯卡尔，等.中医药治疗感染后咳嗽随机对照试验结局指标的系统分析［J］.北京中医药，2026，45（4）：437-443. DOI： 10.16025/j.1674-1307.2026.04.002.

ZHANG Xinyi,JIN Xin,RENAGULI·Aisikaer ,et al.Outcomes indicators in randomized controlled trials of traditional Chinese medicine for postinfectious cough[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(04):437-443. DOI： 10.16025/j.1674-1307.2026.04.002.

摘要

目的

系统分析中医药治疗感染后咳嗽（PIC）的随机对照试验（RCT）的结局指标，为研究设计提供参考。

方法

检索8个中英文数据库，筛选中医药治疗PIC的RCT，提取样本量、伦理审批情况、研究证型、干预措施、疗程与随访情况、结局指标等信息，并评估研究的偏倚风险和质量。

结果

共纳入208项RCT，单项研究的样本量为20~480例，59项（28.37%）提及伦理审批，最常见干预和对照措施为中药内服和常规西药，风邪犯肺证是最常见的研究证型，疗程多为7~14 d（88.94%），24项RCT（11.54%）报告了随访情况。208项RCT共报告了146种结局指标，根据指标功能属性可分为症状体征类（50%）、理化检查类（24.65%）、安全性指标类（10.65%）、中医病证类（9.13%）、生活质量类（3.85%）、远期预后类（1.72%）。常见的结局指标类型为症状体征（23.08%），其次为安全性指标+症状体征（16.83%）。

结论

中医药治疗PIC的RCT在结局指标设计方面存在中医结局指标应用不足、结局指标主次不明确、复合结局指标应用欠规范、较少关注远期结局指标和生活质量指标等问题。

Abstract

Objective

To systematically analyze the outcome indicators used in randomized controlled trials （RCTs） of traditional Chinese medicine （TCM） for postinfectious cough （PIC）， and to provide references for study design.

Methods

Eight Chinese and English databases were searched to identify RCTs of TCM for PIC. Information including sample size， ethical approval， syndrome type， intervention measures， treatment duration and follow-up， and outcome indicators was extracted. The risk of bias and study quality were also assessed.

Results

A total of 208 RCTs were included， with sample sizes ranging from 20 to 480 cases. Among them， 59 studies （28.37%） mentioned ethical approval. The most common intervention and control measures were oral Chinese medicine and conventional Western medicine. Wind evil invading the lung syndrome was the most common syndrome type. Treatment duration was mainly 7–14 days （88.94%）， and 24 RCTs （11.54%） reported follow-up. A total of 146 outcome indicators were reported across the 208 RCTs. According to their functional attributes， the indicators were categorized into symptoms and signs （50.00%）， physical and chemical examinations （24.65%）， safety indicators （10.65%）， TCM disease and syndrome indicators （9.13%）， quality-of-life indicators （3.85%）， and long-term prognosis indicators （1.72%）. The most common type of outcome indicator was symptoms and signs alone （23.08%）， followed by safety indicators combined with symptoms and signs （16.83%）.

Conclusion

RCTs of TCM for PIC have several deficiencies in outcome indicator design， including insufficient application of TCM-specific outcome indicators， unclear distinction between primary and secondary outcome indicators， nonstandardized use of composite outcome indicators， and insufficient attention to long-term outcome indicators and quality-of-life indicators

关键词

Keywords

references

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