Evaluation of CARIFS Score and Negative Antigen Conversion Rate of Qingxuan Daozhi Formula in Treatment of Influenza in Children （Heat Accumulation in Lung and Stomach Syndrome）：A Multi-center Randomized Controlled Clinical Study
10.13422/j.cnki.syfjx.20252499
- VernacularTitle:清宣导滞方治疗儿童流行性感冒（肺胃积热证）的抗原转阴率及CARIFS评分评价——一项多中心随机对照临床研究
- Author:
Jing WANG
1
;
Liqun WU
2
;
Tiegang LIU
3
;
Yongning CAO
4
;
Jing QIU
5
;
Jing LI
6
;
Huaqing TAN
7
;
Ying ZHANG
8
;
Xulei GOU
7
;
Jia WANG
6
;
Jing LI
9
;
Haipeng CHEN
2
;
Xueying QIN
3
;
Yuanshuo TIAN
3
;
Yang WANG
3
;
Chen BAI
3
;
Zhendong WANG
3
;
Qianqian LI
3
;
He YU
3
;
Xueyan MA
3
;
Fei DONG
3
;
Lin JIANG
3
;
Yingqi XU
10
;
Jianping LIU
3
;
Xiaohong GU
3
Author Information
1. Wangjing Hospital of China Academy of Chinese Medical Sciences，Beijing 100102，China
2. Dongfang Hospital，Beijing University of Chinese Medicine，Beijing 100078，China
3. Beijing University of Chinese Medicine，Beijing 100029，China
4. Sun Simiao Hospital of Beijing University of Chinese Medicine，Tongchuan 602300，China
5. Beijing Miyun District Hospital of Traditional Chinese Medicine，Beijing 101500，China
6. Beijing Huairou District Maternal and Child Health Care Hospital，Beijing 101400，China
7. Beijing Daxing Maternal and Child Care Hospital，Beijing 102699，China
8. Affiliated Heji Hospital of Changzhi Medical College，Changzhi 046011
9. Beijing Changping District Hospital of Traditional Chinese and Western Medicine，Beijing 100096， China
10. Beijing Huairou Hospital，Beijing 101400，China
- Publication Type:Journal Article
- Keywords:
Qingxuan Daozhi formula;
child;
influenza;
randomized controlled study;
treatment
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(13):188-196
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThis paper aims to observe the syndrome improvement and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children （heat accumulation in the lung and stomach syndrome）. MethodsThrough a multi-center randomized controlled methodology design，confirmed influenza cases were collected from October 2022 to April 2023 in the pediatrics department of eight hospitals，such as Dongfang Hospital of Beijing University of Chinese Medicine. A total of 180 children with influenza and heat accumulation in the lung and stomach syndrome conforming to the standard were recruited through the clinic. The sick children meeting the inclusion criteria were randomly divided into groups by a block-randomized method. The children in the experimental group were treated with Qingxuan Daozhi formula for five days，and those in the control group were treated with Oseltamivir Phosphate Granules for five days. The primary efficacy indicator was the negative conversion rate of influenza antigen detection. Secondary efficacy indicators were the Canadian acute respiratory illness and flu scale （CARIFS） and the incidence of complications，severe cases， and critical cases. Follow-up observation was conducted on the day of enrollment，48 hours after medication，72 hours after medication， and （6+1） d after medication. ResultsOne hundred and eighty participants were randomly assigned to the experimental group （90 cases） or the control group （90 cases）. All participants were followed up during the study. Comparison of influenza antigen detection results in the primary efficacy indicators showed that the average time of negative influenza antigen conversion in the experimental group was （5.29±1.25） d，and that in the control group was （5.40±1.68） d，without a statistically significant difference. After five days of intervention，52 cases in the experimental group and 51 cases in the control group converted to negative，without a statistically significant difference. CARIFS score results in the secondary efficacy indicators showed that during 72 hours after intervention，there were statistically significant differences between the experimental group and the control group in three dimensions， including headache，muscle soreness， and the need for extra care （P<0.05）. On the （6+1） days after the intervention，the differences in both the experimental group and the control group were statistically significant in 10 dimensions， including sore throat，bad sleep，uncomfortable feeling，poor spirit and fatigue，crying more than usual，the need for extra care，symptom，function，influence on parents，and total score （P<0.05）. The comparison results within the group in the dimensional scores of symptom， function， and influence on parents，as well as the CARIFS total score showed that with the delay of follow-up time，scores of both groups decreased significantly，with a statistically significant difference （P<0.01）. Inter-group comparison results showed that the mean score of the experimental group was higher than that of the control group at the time of enrollment. With the progress of intervention，the score of the experimental group was significantly decreased compared with that of the control group. At the end of follow-up，the mean score of the experimental group was lower than that of the control group，with no statistically significant difference. In terms of the incidence of complications，severe cases， and critical cases， there were no complications，severe cases， and critical cases in the two groups，without a statistically significant difference. ConclusionThe symptom improvement effect and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children （heat accumulation in the lung and stomach syndrome） are not inferior to Oseltamivir Phosphate granules， and children's acceptance is better. It can be more widely used in clinical treatment of influenza in children （heat accumulation in the lung and stomach syndrome）.
