| 摘要: |
| 目的:系统评价儿童急性支气管炎的安慰剂效应,并探索其影响因素。方法:系统检索CNKI、VIP、万方、SinoMed、
PubMed、the Cochrane Library、EMBase 等数据库中以安慰剂为对照治疗儿童急性支气管炎的随机对照试验(RCT),检索时间从
建库至2025 年3 月。文献的筛选、提取及质量评价等均由2 名研究人员独立完成,使用R 软件对咳嗽消失率、临床痊愈率、支
气管炎特异性症状体征积分(BSS)进行Meta 分析和Meta 回归分析。结果:最终纳入7 项研究,安慰剂组共648 例。Meta 分析
显示,基于咳嗽症状积分的咳嗽消失率,治疗5 d 的安慰剂效应值保守估计为12. 3%(95%CI 0%,27. 0%);治疗5 d 的急性支气
管炎临床痊愈率的安慰剂效应值保守估计为17. 7%( 95%CI 2. 6%,32. 8%);治疗7 d 的BSS 变化值,合并后的效应值为
3. 04(95%CI 2. 67,3. 41)。Meta 回归分析提示,受试者年龄和疗程,分别可能影响基于咳嗽症状积分评价的咳嗽消失率、临床
痊愈率的安慰剂效应。此外,基于咳嗽视觉模拟量表(VAS)评分评价的咳嗽消失率,治疗5、7 d 的安慰剂效应分别为24. 53%、
38. 46%。结论:儿童急性支气管炎具有安慰剂效应,上述结果可为相关研究提供借鉴与参考,包括以安慰剂为对照的RCT 的样
本量估算、单臂试验的结果解读及临床价值判断。 |
| 关键词: 儿童 急性支气管炎 安慰剂效应 系统评价 Meta 分析 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2026.05.007 |
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| 基金项目: |
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| Placebo Effect in Children with Acute Bronchitis: a Systematic Review and Single-Group Meta-Analysis |
| Zhang Yunhan, Hu Siyuan, Guo Shengxuan, Gao Tongxun, Niu Liqing, Cai Lili |
| (First Teaching Hospital of Tianjin
University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine, Tianjin 300381, China) |
| Abstract: |
| Objective: To systematically evaluate the placebo effect of acute bronchitis in children and explore its influencing factors.
Methods: CNKI, VIP, Wanfang, SinoMed, PubMed, the Cochrane Library, and EMBase databases were searched from the database
establishment to Mar. 2025. Randomized controlled trial(RCT), in which placebos were used as the control treatment for acute
bronchitis in children were included. Literature screening, data extraction, and quality assessment were independently performed by two
researchers. Meta-analysis and Meta-regression analysis were conducted by using R software for cough disappearance rate, clinical cure
rate, and bronchitis-specific symptom and sign score (BSS). Results: A total of 7 studies were ultimately included, with 648 patients in
the placebo group. Meta-analysis revealed that the conservative estimate of the placebo effect for cough disappearance rate based on clinical cure rate after 5 d of treatment was 17. 7% (95% CI 2. 6% to 32. 8%). The pooled effect size for change in bronchitis-specific
symptom and sign score (BSS) after 7 d of treatment was 3. 04 (95% CI 2. 67 to 3. 41). Meta-regression analysis indicated that subject
age, treatment course might respectively affect the placebo effect for cough disappearance rate based on cough symptom scores and
clinical cure rate. Additionally, the placebo effects for cough disappearance rate based on cough visual analog scale (VAS) scores were
24. 53% and 38. 46% for 5-day and 7-day treatments, respectively. Conclusion: Acute bronchitis in children has a placebo effect. The
aforementioned results may provide reference for subsequent studies, including sample size estimation for placebo-controlled RCT,
interpretation of single-arm trial results, and judgment of clinical value. |
| Key words: children acute bronchitis placebo effect systematic review Meta-analysis |
