A Multicenter， Double-blind，Randomized Controlled Study of Qingfei Huatan Tongqiao Formula for Treating Adenoid Hypertrophy in Children
10.13422/j.cnki.syfjx.20251726
- VernacularTitle:清肺化痰通窍方治疗儿童腺样体肥大的多中心双盲随机对照试验
- Author:
Anqi LIU
1
;
Zhiyan JIANG
1
;
Xiufeng CHEN
1
Author Information
1. Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine， Shanghai 200032，China
- Publication Type:Journal Article
- Keywords:
Qingfei Huatan Tongqiao formula;
adenoid hypertrophy;
obstructive sleep apnea hypopnea syndrome;
XU's pediatrics;
clinical research
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(17):203-209
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo verify the clinical efficacy of Qingfei Huatan Tongqiao Formula in treating children with adenoid hypertrophy （AH） of the lung-heat obstructing the nose syndrome， and to observe its effects on quality of life. MethodsA multicenter， double-blind， double-dummy， randomized controlled clinical trial was conducted. A total of 160 pediatric AH outpatients meeting the inclusion and exclusion criteria were enrolled between November 2022 and November 2024 from Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine， Shanghai Municipal Hospital of Traditional Chinese Medicine， Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine， and Yueyang Hospital of Integrated Traditional Chinese and Western Medicine. The children were randomly assigned to a treatment group （80 cases） or a control group 80 cases）. The treatment group received Qingfei Huatan Tongqiao Formula combined with a montelukast sodium placebo， while the control group received a Qingfei Huatan Tongqiao Formula placebo combined with montelukast sodium. The treatment course lasted 90 days. After treatment， therapeutic efficacy， sleep monitoring parameters， and Obstructive Sleep Apnea-18 （OSA-18） scores were compared between groups. ResultsCompared with pre-treatment values within each group， both groups showed significant decreases in the adenoid-to-nasopharyngeal ratio （A/N）， primary symptom scores， and TCM syndrome scores. OSA-18 scores were significantly reduced. Sleep monitoring showed decreases in the Apnea-Hypopnea Index （AHI） and Oxygen Desaturation Index （ODI）， and an increase in minimum SpO2 （all P<0.05）. After treatment， compared with the control group， the treatment group had a lower A/N ratio and higher overall effectiveness rate and TCM syndrome effectiveness rate. The treatment group also had lower total OSA-18 scores and lower subscale scores （sleep disturbance， physical symptoms， emotional distress， and caregiver impact）， with statistically significant differences （all P<0.05）. There was no significant difference in daytime symptoms （P=0.201）. Regarding sleep monitoring indices， the treatment group had lower AHI and ODI and higher minimum SpO2 （all P<0.05）， with no significant difference in average SpO2 （P=0.116）. ConclusionQingfei Huatan Tongqiao formula can significantly reduce adenoid size in children with AH， alleviate clinical symptoms， improve quality of life， reduce sleep-disordered breathing events， and ameliorate hypoxia. Its therapeutic efficacy is significantly superior to that of montelukast sodium.
