Abstract: Objective To evaluate the efficacy of Xiaoer Dingchuan granules on viral pneumonia in children (phlegm-heat blocking lung syndrome) and the safety of clinical application of Xiaoer Dingchuan granules.Methods Sixty children diagnosed with viral pneumonia in the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine and the Hospital of Traditional Chinese Medicine of Manzhou Autonomous County from January 2023 to June 2023 were selected and divided into experimental group and control group by random number table method, with 30 children in each group. Based on the basic treatment and symptomatic treatment of budesonide aerosol inhalation in the control group, the experimental group was given corresponding doses of Xiaoer Dingchuan granules according to the age of children. The course of treatment was 7 days. At the end of treatment course, we observed (1) the total effective rate of the symptom improvement score of viral pneumonia in children; (2) total effective rate of improvement of TCM syndromes of viral pneumonia in children; (3) the efficacy and disappearance rate of single symptom treatment for viral pneumonia in children; (4) incidence of adverse reactions/events.Results A total of 3 cases were lost due to patient loss of follow-up or drug replacement. Among the 3 cases, 1 case was lost due to loss of follow-up in the observation group, 1 case was lost due to loss of follow-up in the control group, and 1 case was lost due to drug replacement in the control group. Finally, a total of 57 cases were included in the statistical analysis. After 7 days of treatment, the observation group was significantly better than the control group in the total effective rate of symptom improvement score in children's Viral pneumonia, the total effective rate of TCM syndrome improvement, the disappearance rate in single symptom treatment, and the total effective rate in cough, throat phlegm or sputum symptoms. The difference between the two groups was statistically significant (P<0.05);however, the difference between the two groups was not statistically significant(P>0.05) in the total effective rate in wheezing, fever or lung rales. In terms of adverse reactions/events, during the treatment period, there was 1 case of diarrhea event in the observation group, with an incidence rate of 3.45% (1/29). During the observation period, there was 1 case of diarrhea event and 2 cases of nausea and vomiting event in the control group, with an incidence rate of 10.71% (3/28) in the control group. There was no statistically significant difference in the incidence of adverse reactions/events between the two groups (P>0.05).Conclusion Xiaoer Dingchuan granules can effectively improve the symptoms and TCM syndromes of viral pneumonia in children, and have a significant effect on the typical symptoms of viral pneumonia in children, such as wheezing, cough, phlegm or sputum in the throat, fever, pulmonary auscultation symptoms and disappearance rate; the incidence of adverse reactions is low, and the clinical application is safe.

Key words:

Viral pneumonia, Phlegm-heat blocking lung, Xiaoer Dingchuan granules, Randomized control, Children