1.Clinical Advantages of Traditional Chinese Medicine in Treatment of Childhood Simple Obesity: Insights from Expert Consensus
Qi ZHANG ; Yingke LIU ; Xiaoxiao ZHANG ; Guichen NI ; Heyin XIAO ; Junhong WANG ; Liqun WU ; Zhanfeng YAN ; Kundi WANG ; Jiajia CHEN ; Hong ZHENG ; Xinying GAO ; Liya WEI ; Qiang HE ; Qian ZHAO ; Huimin SU ; Zhaolan LIU ; Dafeng LONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):238-245
Childhood simple obesity has become a significant public health issue in China. Modern medicine primarily relies on lifestyle interventions and often suffers from poor long-term compliance, while pharmacological options are limited and associated with potential adverse effects. Traditional Chinese Medicine (TCM) has a long history in the prevention and management of this condition, demonstrating eight distinct advantages, including systematic theoretical foundation, diversified therapeutic approaches, definite therapeutic efficacy, high safety profile, good patient compliance, comprehensive intervention strategies, emphasis on prevention, and stepwise treatment protocols. Additionally, TCM is characterized by six distinctive features: the use of natural medicinal substances, non-invasive external therapies, integration of medicinal dietetics, simple exercise regimens, precise syndrome differentiation, and diverse dosage forms. By combining internal and external treatments, TCM facilitates individualized regimen adjustment and holistic regulation, demonstrating remarkable effects in improving obesity-related metabolic indicators, regulating constitutional imbalance, and promoting healthy behaviors. However, challenges remain, such as inconsistent operational standards, insufficient high-quality clinical evidence, and a gap between basic research and clinical application. Future efforts should focus on accelerating the standardization of TCM diagnosis and treatment, conducting multicenter randomized controlled trials, and fostering interdisciplinary integration, so as to enhance the scientific validity and international recognition of TCM in the prevention and treatment of childhood obesity.
2.Efficacy and safety of surgery-assisted transjugular intrahepatic portosystemic shunt in treatment of portal hypertension comorbid with complex portal vein thrombosis
Zhenhua FAN ; Chengbin DONG ; Qimei LI ; Yu ZHANG ; Yifan WU ; Dongfang LIU ; Guangzhong XU ; Dezhong WANG ; Jianfei CHEN ; Zhendong YUE ; Lei WANG
Journal of Clinical Hepatology 2026;42(3):586-592
ObjectiveTo investigate the feasibility, safety, and efficacy of surgery-assisted transjugular intrahepatic portosystemic shunt (SA-TIPS) in the treatment of portal hypertension comorbid with complex portal vein thrombosis, including cavernous transformation of the portal vein (CTPV). MethodsAn analysis was performed for the data of 36 patients with portal hypertension and complex portal vein thrombosis who underwent SA-TIPS in Beijing Shijitan Hospital, Capital Medical University, from November 2023 to January 2025, including general status, technical data of the surgical process (surgical success rate, puncture times, time of operation, the number of stents used, and the length of shunt), perioperative complications, and surgical recovery. The change in portal pressure gradient (PPG) after shunt was compared, and the rate of reaching the standard for PPG reduction was calculated, as well as stent patency rate within 1 week after surgery. The paired samples t-test was used for comparison of continuous data between two groups. ResultsAmong the 36 patients, 34 (94.4%) underwent SA-TIPS successfully. The incidence rate of perioperative complications was 16.7% (6/36), including 3 cases of thoraco-abdominal hemorrhage, 2 cases of intraoperative arrhythmia, and 1 case of incision infection. There was a significant reduction in PPG after SA-TIPS (t=19.85, P<0.01), and the patients achieving a ≥50% reduction in PPG accounted for 76.5% (26/34). Imaging reexamination within 1 week showed a shunt patency rate of 100%. ConclusionSA-TIPS has a high technical success rate, a favorable safety profile, and good efficacy in the treatment of portal hypertension comorbid with complex portal vein thrombosis (including CTPV), and therefore, it holds promise for clinical application.
3.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
Jing WANG ; Liqun WU ; Tiegang LIU ; Yongning CAO ; Jing QIU ; Jing LI ; Huaqing TAN ; Ying ZHANG ; Xulei GOU ; Jia WANG ; Jing LI ; Haipeng CHEN ; Xueying QIN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Lin JIANG ; Yingqi XU ; Jianping LIU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):188-196
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).
4.Analysis of Clinical and Phenomics Characteristics of Patients with Phlegm-Stasis Binding Syndrome and Its Accompanied Patterns in Stable Angina Pectoris of Coronary Heart Disease
Chongchai LI ; Han LI ; Zheng LI ; Zeng LI ; Yushi ZHOU ; Yuhan AO ; Shuang XU ; Xue WANG ; Yaoyao SUN ; Dongning WU ; Hongcai SHANG ; Mingxue ZHANG
Journal of Traditional Chinese Medicine 2026;67(14):1514-1522
ObjectiveTo explore the clinical and phenomics characteristics of patients with phlegm-stasis binding syndrome and its accompanied patterns in stable angina pectoris (SAP) of coronary heart disease (CHD). MethodsA multicenter cross-sectional study design was adopted. A total of 300 patients with SAP of CHD were enrolled and classified into 120 cases of phlegm-stasis binding syndrome, 125 cases of qi deficiency-accompanied syndrome, 38 cases of qi stagnation-accompanied syndrome, and 17 cases of toxin accumulation-accompanied syndrome according to traditional Chinese medicine (TCM) patterns. Data of patients with different TCM patterns were collected, including general condition, TCM symptoms, blood lipids, coagulation function, immune indicators, and serum metabolomics. Metabolic pathway enrichment analysis was used to compare differences in phenomics characteristics among groups. Metabolites with variable importance in projection (VIP) ≥1 and fold change (FC) ≥2 were considered as representative differential metabolites. ResultsPatients in each TCM pattern type were most commonly in the 60-75 years age group, with a relatively high proportion of males. Regarding TCM symptoms, patients with phlegm-stasis binding syndrome most commonly presented with wiry-choppy or wiry-slippery pulse, chest pain, and chest tightness; in patients with qi deficiency-accompanied syndrome, fatigue, chest pain, and weak pulse were most common; in patients with qi stagnation-accompanied sydnrome, wiry-choppy or wiry-slippery pulse, chest pain, and symptoms that increase or decrease with emotional changes, belching, or flatulence were most common; in patients with toxin accumulation-accompanied syndrome, bitter taste in the mouth, chest tightness, irritability, restlessness or manic delirium, and dry and hard stools or foul-smelling diarrhea were most common. Comparisons among the different TCM patterns showed statistically significant differences in coagulation parameters (P<0.05), whereas no statistically significant difference was found in blood lipid levels and immune indicators (P>0.05).Metabolomics analysis suggested that disorders of glycerophosphate metabolism and valine, leucine, and isoleucine metabolism are characteristic features of phlegm-stasis binding syndrome and its accompanied patterns. The representative differential metabolites between phlegm-stasis binding syndrome and qi deficiency-accompanied syndrome were 7,8-dihydrobiopterin (FC = 3.58) and oxypurinol (FC = 124.50). Those between phlegm-stasis binding syndrome and qi stagnation-accompanied syndrome were cytidine 5′-diphosphocholine (FC = 2.62) and D-mannosamine (FC = 2.99). Those between phlegm-stasis binding syndrome and toxin accumulation-accompanied syndrome were anserine (FC = 7.83) and canrenone (FC = 8.94). ConclusionThere are certain differences in the clinical characteristics and phenomics characteristics among patients with SAP due to CHD exhibiting phlegm-stasis binding syndrome and its accompanied patterns. The phenomics characteristics mainly involve biological alterations such as lipid metabolism disorders, amino acid metabolism abnormalities, and multiple immune indicators activation, which may provide a reference for precise differentiation and treatment of SAP of CHD in TCM clinical practice.
5.Analysis of Clinical and Phenomics Characteristics of Patients with Phlegm-Stasis Binding Syndrome and Its Accompanied Patterns in Stable Angina Pectoris of Coronary Heart Disease
Chongchai LI ; Han LI ; Zheng LI ; Zeng LI ; Yushi ZHOU ; Yuhan AO ; Shuang XU ; Xue WANG ; Yaoyao SUN ; Dongning WU ; Hongcai SHANG ; Mingxue ZHANG
Journal of Traditional Chinese Medicine 2026;67(14):1514-1522
ObjectiveTo explore the clinical and phenomics characteristics of patients with phlegm-stasis binding syndrome and its accompanied patterns in stable angina pectoris (SAP) of coronary heart disease (CHD). MethodsA multicenter cross-sectional study design was adopted. A total of 300 patients with SAP of CHD were enrolled and classified into 120 cases of phlegm-stasis binding syndrome, 125 cases of qi deficiency-accompanied syndrome, 38 cases of qi stagnation-accompanied syndrome, and 17 cases of toxin accumulation-accompanied syndrome according to traditional Chinese medicine (TCM) patterns. Data of patients with different TCM patterns were collected, including general condition, TCM symptoms, blood lipids, coagulation function, immune indicators, and serum metabolomics. Metabolic pathway enrichment analysis was used to compare differences in phenomics characteristics among groups. Metabolites with variable importance in projection (VIP) ≥1 and fold change (FC) ≥2 were considered as representative differential metabolites. ResultsPatients in each TCM pattern type were most commonly in the 60-75 years age group, with a relatively high proportion of males. Regarding TCM symptoms, patients with phlegm-stasis binding syndrome most commonly presented with wiry-choppy or wiry-slippery pulse, chest pain, and chest tightness; in patients with qi deficiency-accompanied syndrome, fatigue, chest pain, and weak pulse were most common; in patients with qi stagnation-accompanied sydnrome, wiry-choppy or wiry-slippery pulse, chest pain, and symptoms that increase or decrease with emotional changes, belching, or flatulence were most common; in patients with toxin accumulation-accompanied syndrome, bitter taste in the mouth, chest tightness, irritability, restlessness or manic delirium, and dry and hard stools or foul-smelling diarrhea were most common. Comparisons among the different TCM patterns showed statistically significant differences in coagulation parameters (P<0.05), whereas no statistically significant difference was found in blood lipid levels and immune indicators (P>0.05).Metabolomics analysis suggested that disorders of glycerophosphate metabolism and valine, leucine, and isoleucine metabolism are characteristic features of phlegm-stasis binding syndrome and its accompanied patterns. The representative differential metabolites between phlegm-stasis binding syndrome and qi deficiency-accompanied syndrome were 7,8-dihydrobiopterin (FC = 3.58) and oxypurinol (FC = 124.50). Those between phlegm-stasis binding syndrome and qi stagnation-accompanied syndrome were cytidine 5′-diphosphocholine (FC = 2.62) and D-mannosamine (FC = 2.99). Those between phlegm-stasis binding syndrome and toxin accumulation-accompanied syndrome were anserine (FC = 7.83) and canrenone (FC = 8.94). ConclusionThere are certain differences in the clinical characteristics and phenomics characteristics among patients with SAP due to CHD exhibiting phlegm-stasis binding syndrome and its accompanied patterns. The phenomics characteristics mainly involve biological alterations such as lipid metabolism disorders, amino acid metabolism abnormalities, and multiple immune indicators activation, which may provide a reference for precise differentiation and treatment of SAP of CHD in TCM clinical practice.
6.Sanjie Quban Prescription Affects Proliferation, Apoptosis, Migration, and Invasion of Human Keloid Fibroblasts via AhR/CYP1A1 Signaling Pathway
Zhihong HE ; Fengchuan ZHANG ; Dingquan YANG ; Chuhan HUANG ; Zhihan WANG ; Yatong WU ; Qingwu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(17):164-174
ObjectiveTo investigate the effects of Sanjie Quban prescription (SJQB)-containing serum on the proliferation, apoptosis, migration, and invasion of human keloid fibroblasts (KFs) and to elucidate its underlying mechanism, with a focus on the aryl hydrocarbon receptor (AhR)/cytochrome P450 family 1 subfamily A member 1 (CYP1A1) signaling pathway. MethodsPrimary human KFs were cultured in vitro and assigned to the following groups: control (KFs+blank serum), asiaticoside (KFs+asiaticoside-containing serum), SJQB (KFs+SJQB-containing serum), AhR agonist (KFs+β-naphthoflavone), AhR inhibitor (KFs+CH223191), and AhR inhibitor+SJQB (KFs+CH223191+SJQB-containing serum). The optimal intervention concentrations were determined through the cell counting kit-8 (CCK-8) assay. Cell proliferation, apoptosis, migration, and invasion were evaluated by the EdU assay, flow cytometry, wound healing assay, and Transwell assay, respectively. The expression of transforming growth factor-β1 (TGF-β1) and α-smooth muscle actin (α-SMA) was visualized by immunofluorescence. The mRNA and protein levels of AhR, CYP1A1, TGF-β1, and α-SMA were measured by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot, respectively. ResultsCompared with the control group, the SJQB, asiaticoside, and AhR agonist groups demonstrated inhibited cell proliferation, migration, and invasion, along with an increased apoptosis rate (P<0.01). The AhR inhibitor group showed enhanced proliferation, migration, and invasion together with a reduced apoptosis rate in comparison with the AhR agonist group (P<0.01). The AhR inhibitor+SJQB group exhibited increased proliferation, migration, and invasion as well as decreased apoptosis compared with the SJQB group (P<0.05, P<0.01). At the molecular level, compared with the control group, the SJQB, asiaticoside, and AhR agonist groups presented upregulated protein and mRNA levels of AhR and CYP1A1 (P<0.05, P<0.01), while the SJQB and AhR agonist groups showed downregulated TGF-β1 and α-SMA expression at both protein and mRNA levels (P<0.05, P<0.01), and the asiaticoside group displayed decreased protein level of TGF-β1 and mRNA level of α-SMA (P<0.05, P<0.01). Compared with both the AhR agonist and control groups, the AhR inhibitor group exhibited decreased AhR and CYP1A1 expression but increased TGF-β1 and α-SMA expression at protein and mRNA levels (P<0.01). In comparison with the SJQB group, the AhR inhibitor+SJQB group demonstrated reduced AhR and CYP1A1 expression (P<0.01) and elevated TGF-β1 and α-SMA expression (P<0.05, P<0.01) at both protein and mRNA levels. ConclusionSJQB may activate the AhR/CYP1A1 signaling pathway to downregulate TGF-β1 and α-SMA expression, thereby suppressing the proliferation, migration, and invasion and inducing the apoptosis of KFs.
7.Intervention mechanism of Yiqi Fumai Formula in mice with experimental heart failure based on "heart-gut axis".
Zi-Xuan ZHANG ; Yu-Zhuo WU ; Ke-Dian CHEN ; Jian-Qin WANG ; Yang SUN ; Yin JIANG ; Yi-Xuan LIN ; He-Rong CUI ; Hong-Cai SHANG
China Journal of Chinese Materia Medica 2025;50(12):3399-3412
This paper aimed to investigate the therapeutic effect and mechanism of action of the Yiqi Fumai Formula(YQFM), a kind of traditional Chinese medicine(TCM), on mice with experimental heart failure based on the "heart-gut axis" theory. Based on the network pharmacology integrated with the group collaboration algorithm, the active ingredients were screened, a "component-target-disease" network was constructed, and the potential pathways regulated by the formula were predicted and analyzed. Next, the model of experimental heart failure was established by intraperitoneal injection of adriamycin at a single high dose(15 mg·kg~(-1)) in BALB/c mice. After intraperitoneal injection of YQFM(lyophilized) at 7.90, 15.80, and 31.55 mg·d~(-1) for 7 d, the protective effects of the formula on cardiac function were evaluated using indicators such as ultrasonic electrocardiography and myocardial injury markers. Combined with inflammatory factors in the cardiac and colorectal tissue, as well as targeted assays, the relevant indicators of potential pathways were verified. Meanwhile, 16S rDNA sequencing was performed on mouse fecal samples using the Illumina platform to detect changes in gut flora and analyze differential metabolic pathways. The results show that the administration of injectable YQFM(lyophilized) for 7 d significantly increased the left ventricular end-systolic internal diameter, fractional shortening, and ejection fraction of cardiac tissue of mice with experimental heart failure(P<0.05). Moreover, markers of myocardial injury were significantly decreased(P<0.05), indicating improved cardiac function, along with significantly suppressed inflammatory responses in cardiac and intestinal tissue(P<0.05). Additionally, the species of causative organisms was decreased, and the homeostasis of gut flora was improved, involving a modulatory effect on PI3K-Akt signaling pathway-related inflammation in cardiac and colorectal tissue. In conclusion, YQFM can affect the "heart-gut axis" immunity through the homeostasis of the gut flora, thereby exerting a therapeutic effect on heart failure. This finding provides a reference for the combination of TCM and western medicine to prevent and treat heart failure based on the "heart-gut axis" theory.
Animals
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Drugs, Chinese Herbal/administration & dosage*
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Heart Failure/microbiology*
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Mice
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Mice, Inbred BALB C
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Male
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Disease Models, Animal
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Gastrointestinal Microbiome/drug effects*
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Heart/physiopathology*
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Humans
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Signal Transduction/drug effects*
8.Comparative Study on the Differences in Average Transaction Costs Per-referral of Patients in Different Models of Integrated Delivery Systems
Chunping HU ; Jinxin CUI ; Dongfang ZHU ; Qiuping ZHAO ; Pengfei WANG ; Jian WU ; Yadong NIU ; Yudong MIAO
Chinese Hospital Management 2025;(9):46-50,56
Objective To compare the differences in the average transaction costs per-referral patients under different models of Integrated Delivery Systems(IDS).Methods Using a typical case sampling method,it selected referred patients from three IDS models:the county medical alliance in D City(Qinghai Province),the urban medical consortium in J District(Zhengzhou City,Henan Province),and the health management coalition in N County(Shandong Province).Structured questionnaires collected demographics,average transaction costs per-referral and cost perceptions.t-tests and ANOVA assessed cost differences;generalized linear regression identified influencing factors.Results Among 915 patients,the average transaction costs per-referral were 1 035.05 yuan(county alliance),195.31 yuan(urban consortium),and 700.97 yuan(health management coalition),with statistically significant differences(P<0.05).The urban consortium exhibited lower time costs and specialized input costs.Key influencing factors included older age(county alliance),education level,employment status,and referral travel time(urban consortium),as well as urban-rural disparities(health management coalition).Patients'cost perceptions significantly differed across models(P<0.05).Conclusion The urban medical consortium demonstrated the lowest patient the average transaction costs,highlighting its institutional advantage in minimizing financial burdens.
9.Clinical Efficacy of Xiaoji Hufei Formula in Protecting Children with Close Contact Exposure to Influenza: A Multicenter,Prospective, Non-randomized, Parallel, Controlled Trial
Jing WANG ; Jianping LIU ; Tiegang LIU ; Hong WANG ; Yingxin FU ; Jing LI ; Huaqing TAN ; Yingqi XU ; Yanan MA ; Wei WANG ; Jia WANG ; Haipeng CHEN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Liqun WU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):223-230
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.
10.Clinical Efficacy of Xiaoji Hufei Formula in Protecting Children with Close Contact Exposure to Influenza: A Multicenter,Prospective, Non-randomized, Parallel, Controlled Trial
Jing WANG ; Jianping LIU ; Tiegang LIU ; Hong WANG ; Yingxin FU ; Jing LI ; Huaqing TAN ; Yingqi XU ; Yanan MA ; Wei WANG ; Jia WANG ; Haipeng CHEN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Liqun WU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):223-230
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.

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