A multicenter, randomized, controlled study on the treatment of pediatric influenza (wind-heat invading lung) with Qingxuan Zhike granules

Xi Ming; Xiaodong Shen; Jinni Chen; Jinya Wang; Jiemin Wang; Fengzhan Chen; Huiping Shen; Huihui Huang; Yingzhu LU; Jialin Zheng; Ziwei Wang; Ji Bian; Zihao Feng; Naichao Feng; Siqi Chen; Xunzhou Liu; Xiaohua Yan; Xiaoyan Wang; Wen Xie; Lei Xiong

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A multicenter, randomized, controlled study on the treatment of pediatric influenza (wind-heat invading lung) with Qingxuan Zhike granules

VernacularTitle:清宣止咳颗粒治疗儿童流感(风热犯肺证)多中心、随机、对照研究
Author: Xi MING ¹ ; Xiaodong SHEN ; Jinni CHEN ; Jinya WANG ; Jiemin WANG ; Fengzhan CHEN ; Huiping SHEN ; Huihui HUANG ; Yingzhu LU ; Jialin ZHENG ; Ziwei WANG ; Ji BIAN ; Zihao FENG ; Naichao FENG ; Siqi CHEN ; Xunzhou LIU ; Xiaohua YAN ; Xiaoyan WANG ; Wen XIE ; Lei XIONG
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1. 云南中医药大学第一附属医院儿科，昆明　650031
Keywords: Child; Influenza; Qingxuan Zhike granules; Oseltamivir
From: Chinese Journal of Applied Clinical Pediatrics 2024;39(8):597-601
CountryChina
Language:Chinese
Abstract: Objective:To evaluate the efficacy and safety of Qingxuan Zhike granules in improving cough symptoms and shortening the course of influenza (wind-heat invading lung) in children.Methods:In this multicenter, randomized, controlled clinical trial, a total of 240 outpatient influenza patients from 7 hospitals, including the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, from April 2023 to December 2023 were collected.The subjects were randomly divided into the control group and the experimental group via SAS software using the block randomization method.The differences between two groups were compared with t test, corrected t test and χ2 test.Subjects in the control group were given Oseltamivir phosphate granules, orally, twice a day (weight ≤15 kg, 30 mg/time; weight >15-23 kg, 45 mg/time; weight >23-40 kg, 60 mg/time; weight >40 kg, 75 mg/time; age≥13 years, 75 mg/time).In addition to Oseltamivir phosphate granules, subjects in the experimental group were also given Qingxuan Zhike granules, orally, 3 times a day (1-3 years old, 1/2 bag each time; >3-6 years old, 3/4 bag each time; >6-14 years old, 1 bag each time).After 5 days of treatment, the medication was suspended for 2 days.The effect of cough, antipyretic effect, clinical recovery rate, clinical recovery time, Canadian Acute Respiratory Illness and Flu Scale (CARIFS) score, traditional Chinese medicine (TCM) syndrome effect, complication rate, and adverse reactions were evaluated between the two groups. Results:Finally, 232 cases were included in the study, including 115 cases in the experimental group and 117 cases in the control group.Before and after treatment, there were no significant difference in CARIFS cough score between the experimental group and the control group (all P>0.05).After treatment, the change in CARIFS cough score in the experimental group [(-1.00±0.91) scores]was significantly higher than that in the control group [(-0.75±0.98) scores] ( t=-1.995, P=0.047).After treatment, the change in TCM syndrome cough score in the experimental group [(-1.69±1.51) scores] was significantly higher than that in the control group [(-0.97±1.63) scores] ( t′=-0.035, P=0.001).The time of complete regression of fever in the experimental group [(44.82±22.72) h] was shorter than that in the control group [(51.35±27.07) h], and the difference between the two groups was statistically significant ( t=-1.966, P=0.050).The fever score showed that the area under the curve between the CARIFS symptom fever score and time in the experimental group was 4.40±2.42, while that in the control group was 5.12±2.44, and the difference between the two groups was statistically significant ( t=-2.252, P=0.025).The clinical recovery rate was 93.91%(108/115) in the experimental group and 92.31%(108/117) in the control group, and there was no significant difference between the two groups ( χ2=0.233, P>0.05).The clinical recovery time in the experimental group [(2.93±1.21) d] was shorter than that in the control group [(3.29±1.15) d], and the difference between the two groups was statistically significant ( t=-2.279, P=0.024).After treatment, there was a significant difference in TCM syndrome score variation between the experimental group [(-12.00±4.13) scores] and the control group [(-10.85±4.31) scores] ( t′=-2.067, P=0.040).No complication occurred in both groups, and there was no significant difference in the incidence of adverse events between the two groups ( χ2=1.299, P>0.05). Conclusions:Qingxuan Zhike granules combined with Oseltamivir phosphate can effectively improve the cough symptoms associated with influenza in children, shorten the time and course of fever, and improve the TCM syndrome score; thus, they are safe in clinical application.