Objective

2

To reveal the clinical efficacy of Yunpi Huatan Tongqiao prescription in relieving inflammation， hypoxia， and adenoidal hypertrophy （AH）， and improving the quality of sleep-disordered breathing in children with AH by promoting M2-type polarization of macrophages through a randomized double-blind clinical trial.

Method

2

Seventy-one AH children who met the research criteria and were treated in the Department of Pediatrics of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from March 2022 to February 2023 were divided into an observation group （36 cases） and a control group （35 cases）. A randomized double-blind method was adopted. The patients in the observation group were given Yunpi Huatan Tongqiao prescription combined with placebo of montelukast sodium chewable tablets， while those in the control group were given montelukast sodium chewable tablets combined with placebo of Yunpi Huatan Tongqiao prescription. The treatment course was 84 days. After treatment， the therapeutic effect and sleep monitoring indicators were compared. Before and after treatment， venous blood was collected to compare the levels of macrophage polarization-related inflammatory factors between the two groups.

Result

2

The adenoidal/nasopharyngeal space （A/N） integral in the nasal and pharyngeal lateral radiographs， After treatment， the AH therapeutic effect score， and the traditional Chinese medicine （TCM） syndrome therapeutic effect score in both groups were lower than those before treatment （

P

<

0.01）. Compared with the control group after treatment， the observation group showed a more significant reduction in various integral levels （

P

<

0.05，

P

<

0.01）. The improvement degree of A/N in the nasal and pharyngeal lateral radiographs in the observation group was better than that in the control group （

Z

=-2.970，

P

<

0.01）， and the total effective rate of the therapeutic effect of AH （

χ

2

=7.715，

P

<

0.01） and the TCM syndrome therapeutic effect （

χ

2

=13.239，

P

<

0.01） were superior to those in the control group. The levels of interleukin-6 （IL-6） and tumor necrosis factor-alpha （TNF-

α

） in both groups after treatment were lower， and the level of interleukin-10 （IL-10） was higher than those before treatment （

P

<

0.01）. The level of transforming growth factor-beta （TGF-

β

） showed an increasing trend， but the difference was not statistically significant. Compared with the control group after treatment， the observation group showed more significant improvement in IL-10 and TNF-

α

levels （

P

<

0.01）， a decreasing trend in IL-6， and an increasing trend in TGF-

β

， but the difference was not statistically significant. Compared with the results before treatment， the apnea-hypopnea index （AHI） and oxygen desaturation index （ODI） in both groups decreased significantly （

P

<

0.01）. The observation group showed a significant reduction in the duration of the longest apnea and the longest hypopnea， as well as a significant increase in the mean and lowest oxygen saturation （

P

<

0.01）. The control group also showed improvements in the above indicators， but the difference was not statistically significant. Compared with the control group after treatment， the observation group showed a more significant improvement in AHI， ODI， the duration of the longest hypopnea， and mean and lowest oxygen saturation （

P

<

0.05，

P

<

0.01）. There was a decreasing trend in the longest duration of apnea， but the difference was not statistically significant.

Conclusion

2

Yunpi Huatan Tongqiao prescription can reduce the size of adenoids， alleviate clinical symptoms and signs in AH children， improve the constitution characterized by "spleen deficiency and phlegm obstruction"， reduce the occurrence of sleep-disordered breathing events， alleviate the degree of hypoxia in the child's body during sleep at night， and has satisfactory clinical efficacy. The improvement of clinical symptoms and sleep quality in AH children by Yunpi Huatan Tongqiao prescription may be achieved by promoting macrophage polarization from M1 to M2.