Clinical Efficacy of Xiaoji Hufei Formula in Protecting Children with Close Contact Exposure to Influenza： A Multicenter，Prospective， Non-randomized， Parallel， Controlled Trial
10.13422/j.cnki.syfjx.20251592
- VernacularTitle:消积护肺方对流感密切接触儿童保护作用的临床疗效：一项多中心前瞻性非随机平行对照试验
- Author:
Jing WANG
1
;
Jianping LIU
1
;
Tiegang LIU
1
;
Hong WANG
2
;
Yingxin FU
3
;
Jing LI
4
;
Huaqing TAN
5
;
Yingqi XU
3
;
Yanan MA
5
;
Wei WANG
2
;
Jia WANG
4
;
Haipeng CHEN
6
;
Yuanshuo TIAN
1
;
Yang WANG
1
;
Chen BAI
1
;
Zhendong WANG
1
;
Qianqian LI
1
;
He YU
1
;
Xueyan MA
1
;
Fei DONG
1
;
Liqun WU
6
;
Xiaohong GU
1
Author Information
1. Beijing University of Chinese Medicine，Beijing 100029，China
2. Civil Aviation General Hospital，Beijing 100123，China
3. Beijing Huairou Hospital，Beijing 101400，China
4. Beijing Huairou Maternal and Child Health Care Hospital，Beijing 101400，China
5. Beijing Daxing Maternal and Child Care Hospital，Beijing 102699，China
6. Dongfang Hospital Beijing University of Chinese Medicine，Beijing 100078，China
- Publication Type:Journal Article
- Keywords:
Xiaoji Hufei formula;
children;
influenza;
randomized controlled trial;
prevention
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(21):223-230
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the efficacy and safety of Xiaoji Hufei Formula in protecting children with close contact exposure to influenza， and to provide reference and evidence-based support for better clinical prevention and treatment of influenza in children. MethodsA multicenter， prospective， non-randomized， parallel， controlled trial was conducted from October 2021 to May 2022 in five hospitals， including Dongfang Hospital of Beijing University of Chinese Medicine. Confirmed influenza cases and influenza-like illness （ILI） cases were collected， and eligible children with close contact exposure to these cases were recruited in the outpatient clinics. According to whether the enrolled close contacts were willing to take Xiaoji Hufei formula for influenza prevention， they were assigned to the observation group （108 cases） or the control group （108 cases）. Follow-up visits were conducted on days 7 and 14 after enrollment. The primary outcomes were the incidence of ILI and the rate of laboratory-confirmed influenza. Secondary outcomes included traditional Chinese medicine （TCM） symptom score scale for influenza， influenza-related emergency （outpatient） visit rate， influenza hospitalization rate， and time to onset after exposure to influenza cases. ResultsA total of 216 participants were enrolled， with 108 in the observation group and 108 in the control group. Primary outcomes： （1） Incidence of ILI： The incidence was 12.0% （13/108） in the observation group and 23.1% （25/108） in the control group， with the observation group showing a significantly lower incidence （χ2=4.6， P<0.05）. （2） Influenza confirmation rate： 3.7% （4/108） in the observation group and 4.6% （5/108） in the control group， with no statistically significant difference. Secondary outcomes： （1） TCM symptom score scale： after onset， nasal congestion and runny nose scores differed significantly between the two groups （P<0.05）， while other symptoms such as fever， sore throat， and cough showed no significant differences. （2） Influenza-related emergency （outpatient） visit rate： 84.6% （11 cases） in the observation group and 96.0% （24 cases） in the control group， with no significant difference. （3） Time to onset after exposure： The median onset time after exposure to index patients was 7 days in the observation group and 4 days in the control group， with a statistically significant difference （P<0.05）. ConclusionIn previously healthy children exposed to infectious influenza cases under unprotected conditions， Xiaoji Hufei formula prophylaxis significantly reduced the incidence of ILI. Xiaoji Hufei Formula can be recommended as a specific preventive prescription for influenza in children.
