1.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).
2.FGF21 overexpression upregulates SIRT1/GPX4 to inhibit ferroptosis and relieve CCl4 mouse acute liver injury
Xutao LING ; Qianqian HUANG ; Lun ZHANG ; Fang XIE ; Nan BAI ; Yingxia WANG ; Haoran HUA ; Haoze WANG ; Wenjing DAI ; Kexin LI ; Jianqing WANG
Acta Universitatis Medicinalis Anhui 2026;61(6):1053-1060
ObjectiveTo investigate the protective effect of liver-targeted fibroblast growth factor 21 (FGF21) overexpression against CCl₄-induced acute liver injury (ALI) and its association with silent information regulator 1/glutathione peroxidase 4 (SIRT1/GPX4) expression and ferroptosis-related markers. MethodsFemale ICR mice (8 weeks old) were randomly divided into Control, CCl₄, adeno-associated virus (AAV)-FGF21, and AAV-FGF21 + CCl4 groups. Liver-targeted FGF21 overexpression was achieved via tail vein injection of AAV8-FGF21 virus with green fluorescent protein (GFP) labeling. ALI was induced by intraperitoneal injection of CCl₄ (0.3 mL/kg), with sample collection at 12 hours. Body weight and liver weight were recorded to calculate the liver weight/body weight. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were measured using a biochemical analyzer. FGF21 expression in liver tissues was detected by immunofluorescence. Hepatic histopathology was evaluated by HE staining. RT-qPCR was performed to assess mRNA expression of ferroptosis and iron metabolism-related genes (ACSL4, PTGS2, HJV, FPN, GPX4), FGF21, and SIRT1. Protein expression of FGF21, SIRT1, and GPX4 were determined by Western blot. Iron content, malondialdehyde (MDA), glutathione (GSH), and superoxide dismutase (SOD) activity in liver homogenate were quantified using assay kits. ResultsCompared with the Control group, the FGF21 mRNA and protein expression elevated in CCl4 group; serum ALT/AST levels and liver weight/body weigh increased. The HE staining results showed that the liver cell membranes were ruptured. The mRNA levels of ACSL4 and PTGS2, the iron content and MDA levels all increased (P<0.01). The mRNA levels of SIRT1, GPX4, HJV, and FPN, the GSH level and SOD activity all decreased (P<0.05), and the protein levels of SIRT1 and GPX4 both decreased (P<0.05). Compared with the CCl4 group, the serum levels of ALT and AST in the AAV-FGF21 + CCl4 group were decreased (P<0.01), and the liver/body ratio of mice decreased (P<0.01). The results of HE staining showed that the degree of liver injury was alleviated. The mRNA levels of ACSL4 and PTGS2, iron content and MDA level all decreased (P<0.01), while the mRNA levels of SIRT1, GPX4, HJV, FPN, GSH level and SOD activity all increased (P<0.05). The protein levels of SIRT1 and GPX4 both increased (P<0.05). ConclusionFGF21 overexpression is associated with enhanced SIRT1/GPX4 expression and suppression of ferroptosis features, thereby contributing to the alleviation of CCl4-induced ALI.
3.The value of MRI three-dimensional fat suppression fast spoiled gradient echo sequence in preoperative evaluation of children with congenital radial polydactyly
Jie LI ; Yingyu JIA ; Quan YUN ; Deming BAI ; Qianqian WANG ; Shuming XU ; Huimiao SUN ; Jiangtao LONG
Chinese Journal of Plastic Surgery 2025;41(11):1143-1151
Objective:To explore the clinical value of the three-dimensional fat suppression fast spoiled gradient echo (3D-FS-FSPGR) MRI sequence in the preoperative evaluation of congenital radial polydactyly.Methods:The data of children with congenital radial polydactyly who underwent surgical treatment in the Department of Orthopedics at Shanxi Children’s Hospital from May 2021 to April 2022 were retrospectively analyzed. Preoperative X-ray examinations and MRI 3D-FS-FSPGR sequence scans were performed on the children. Radiologists first described the morphological characteristics of the articular cartilage, and then orthopedic surgeons performed the Wassel classification based on the X-ray and MRI imaging result, focusing on the bifurcation level, morphology, and articular surface of the phalangeal and metacarpal cartilage. The corresponding surgical method was selected according to the Wassel classification, and intraoperative incision exploration was used as the gold standard. Six months after surgery, the surgical outcome was evaluated using the modified Tada scoring system [with a total score of 0-7, and classified as excellent: >5 points, good: 3-5 points, and poor: <3 points; the excellent and good rate = (excellent + good) cases/total number of cases × 100%]. The appearance, function and recurrence of the operated finger were evaluated 1 year after surgery. Descriptive statistics were performed using SPSS 26.0 software, and the Kappa coefficient was used to evaluate the consistency of the Wassel classification result between radiographs, MRI 3D-FS-FSPGR sequences and intraoperative exploration respectively.Results:A total of 45 children (55 fingers) with congenital radial polydactyly were enrolled, including 25 males and 20 females, aged 5 to 60 months, with the median age of 9 months. Unilateral findings were seen in 35 cases and bilateral findings in 10 cases. MRI 3D-FS-FSPGR imaging sequences clearly demonstrated the level of cartilage bifurcation and bone tissue growth and development, which were consistent with intraoperative exploration findings. The accuracy of the MRI 3D-FS-FSPGR Wassel classification was 100% (55/55), and the accuracy of the X-ray Wassel classification was 81.8% (45/55). Disagreements were found in the classifications of five fingers: three with X-ray classifications of Wassel type Ⅳ but actually classified as type Ⅲ, and two with X-ray classifications of Wassel type Ⅳ but actually classified as type Ⅴ. The Kappa coefficients were all >0.85. All patients were followed up for 1 year. The modified Tada score showed excellent in 41 fingers, good in 6 fingers, and poor in 8 fingers, for an excellent and good rate of 85.5% (47/55). At final follow-up, the reconstructed thumbs showed significant improvement in appearance, with normal bone axis restoration, no deviation of the digits, and normal nail appearance. There was no significant scarring or contracture. Functions of thumb flexion, extension, grasping, and opposition were good. There was no postoperative deformity or recurrence.Conclusion:MRI 3D-FS-FSPGR sequences can accurately classify congenital radial polydactyly preoperatively, optimize the surgical incision and osteotomy alignment, and achieve excellent surgical outcomes.
4.Hepatic nontargeted lipidomics study for mechanism of Shaqi concen-trated pills attenuating high-fat diet-induced metabolic dysfunction-asso-ciated fatty liver disease in mice
Shuyin BAO ; Xuan WANG ; Pengju BAI ; Qiong WU ; Qianqian MA
Chinese Journal of Pathophysiology 2025;41(8):1504-1513
AIM:This study aimed to investigate the differences in hepatic lipid metabolites in ICR mice in-duced by a high-fat diet and treated with Shaqi concentrated pills(SQ).METHODS:Thirty 8-week-old SPF-grade ICR mice were randomly assigned to five groups:the normal(CON,n=6)group,the high-fat diet model(HFD,n=6)group,the low-dose SQ administration(SQL,n=6)group,the high-dose SQ administration(SQH,n=6)group,and the liver-protecting tablets positive control(PLT,n=6)group.The HFD group was fed a diet consisting of 60%fat for 8 weeks to es-tablish a metabolic-dysfunction-associated fatty liver disease model.Upon successful model establishment,the SQL group received a daily gavage of 395 mg/kg for 4 weeks,while the SQH group received 790 mg·kg-1·d-1.The PLT group was ad-ministered liver-protecting tablets at a dosage of 0.655 g/kg via gavage.Body weight and food intake were monitored week-ly.Liver indices,including Lee's index,triglyceride(TG),total cholesterol(TC),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),alanine aminotransferase(ALT),and aspartate transaminase(AST)levels,were measured in each group.Hematoxylin-eosin(HE)staining and oil red O staining were performed to assess the extent of pathological damage in liver tissues.Western blot analysis was conducted to evaluate the protein expres-sion levels of choline/ethanolamine phosphotransferase-1(CEPT1),adipose triglyceride lipase(ATGL),and diacylglycerol acyltransferase(DGAT)in the liver.A non-targeted lipidomic analysis using LC-MS was employed to detect changes in hepatic lipid content,and multivariate statistical analyses(principal component analysis and orthogonal partial least squares discriminant analysis)were utilized to compare lipid metabolic profiles among the groups and identify differential lipid metabolites.RESULTS:Compared to the CON group,mice in the HFD group exhibited significantly increased body weight,blood glucose levels,serum TG,TC,LDL-C,ALT,and AST levels,accompanied by a marked decrease in HDL-C levels.HE and oil red O staining results revealed significant lipid droplet accumulation in the liver tissues of HFD mice.In contrast,mice in the SQL and SQH groups showed significant reductions in body weight,blood glucose,serum TG,TC,LDL-C,ALT,and AST levels,along with increased HDL-C levels and less lipid accumulation in liver tissues compared to the HFD group.Staining of liver sections confirmed that SQ treatment mitigated the abnormal accumulation of lipid droplets.Lipidomic analysis indicated that SQ treatment normalized 25 aberrantly expressed lipid metabolites to lev-els comparable to the CON group and identified nine representative differential lipid metabolites.Western blot results dem-onstrated that SQ treatment reduced the protein expression levels of ATGL and DGAT while increasing the expression of CEPT1.CONCLUSION:Treatment with SQ can alleviate metabolic dysfunction-associated fatty liver disease(MAFLD)by modulating triglyceride metabolism,phosphatidylcholine metabolism,and dimethylphosphatidylethanolamine lipid me-tabolism,thereby altering the hepatic lipid profile in MAFLD mice.
5.Relationship of 25- (OH) D and MCP-1 levels with bone mineral density and bone metabolism indexes in preschool children after fractures
Jiangtao LONG ; Jie LI ; Deming BAI ; Qianqian WANG ; Yuankai YANG ; Hongwei XI
Chinese Journal of Endocrine Surgery 2025;19(2):252-256
Objective:To investigate the relationship of the levels of 25-hydroxyvitamin (OH) D, monocyte chemoattractant protein-1 (MCP-1) and bone mineral density (BMD) and bone metabolism in preschool children after fractures.Methods:General data of 200 preschool children with fractures admitted to the Department of Orthopedics of Shanxi Children’s Hospital from Apr. 2021 to Jun. 2024 were retrospectively analyzed. The 25- (OH) D level of the children after fracture was determined by electrochemical luminescence method. According to the 25- (OH) D level, the children were divided into VitD deficiency group, VitD insufficient group and VitD sufficient group. The MCP-1 level, BMD and bone metabolism indexes of children among groups were compared and analyzed. SPSS 26.0 statistical software was used to analyze the data in the paper. According to the data type, t test or χ2 test were used to compare among the groups, and the correlation of 25- (OH) D and MCP-1 levels with BMD and bone metabolism indexes was analyzed by Spearman and Pearson methods. Results:The difference of 25- (OH) D levels in different age childeren was statistically significant ( t = 145.26, P<0.05) , and the analysis showed that 26 cases were VitD deficient, 64 cases were VitD insufficient, and 110 cases were VitD sufficient; The mean BMD in VitD patients with different levels was significantly different ( F=783.25, P<0.05) ; With the increase of MCP-1, PTH and TPINP levels decreased ( F=78.98, 703.57, 243.27, P<0.05) , while the levels of PICP and BGP increased ( F=122.97, 340.32, P<0.05) ; 25- (OH) D was positively correlated with BMD, PICP and BGP ( r=0.93, 0.76, 0.87, P<0.05) , and negatively correlated with PTH and TPINP ( r=-0.94, -0.81, P<0.05) . MCP-1 was negatively correlated with BMD, PICP and BGP ( r=-0.54, -0.51, -0.56, P<0.05) , and positively correlated with PTH and TPINP ( r=0.57, 0.55, P<0.05) . Conclusions:The 25- (OH) D level is significantly correlated with BMD and bone metabolism indexes in preschool children after fracture, and the lack and insufficiency of VitD significantly affect BMD and bone metabolism status. At the same time, MCP-1 may also play an important role in metabolic changes after fracture. Therefore, in clinical treatment, it is necessary to strengthen the monitoring and management of 25- (OH) D and MCP-1 levels after fracture in children, which is of great significance to promote bone healing and improve bone density.
6.A Case of Azvudine-induced Acute Kidney Injury
Herald of Medicine 2025;44(2):308-310
The article reported a case of 59-year-old male patient with novel coronavirus infection who developed acute kidney injury after treatment with azvudine,which is considered as an adverse reaction caused by azfudine.After 13 days of discontinuation of azvudine,the renal function gradually returned to normal.It is suggested that the adverse reaction of kidney injury should be vigilant in the clinical application of azvudine,and clinical attention should be paid to improve drug safety.
7.Relationship of 25- (OH) D and MCP-1 levels with bone mineral density and bone metabolism indexes in preschool children after fractures
Jiangtao LONG ; Jie LI ; Deming BAI ; Qianqian WANG ; Yuankai YANG ; Hongwei XI
Chinese Journal of Endocrine Surgery 2025;19(2):252-256
Objective:To investigate the relationship of the levels of 25-hydroxyvitamin (OH) D, monocyte chemoattractant protein-1 (MCP-1) and bone mineral density (BMD) and bone metabolism in preschool children after fractures.Methods:General data of 200 preschool children with fractures admitted to the Department of Orthopedics of Shanxi Children’s Hospital from Apr. 2021 to Jun. 2024 were retrospectively analyzed. The 25- (OH) D level of the children after fracture was determined by electrochemical luminescence method. According to the 25- (OH) D level, the children were divided into VitD deficiency group, VitD insufficient group and VitD sufficient group. The MCP-1 level, BMD and bone metabolism indexes of children among groups were compared and analyzed. SPSS 26.0 statistical software was used to analyze the data in the paper. According to the data type, t test or χ2 test were used to compare among the groups, and the correlation of 25- (OH) D and MCP-1 levels with BMD and bone metabolism indexes was analyzed by Spearman and Pearson methods. Results:The difference of 25- (OH) D levels in different age childeren was statistically significant ( t = 145.26, P<0.05) , and the analysis showed that 26 cases were VitD deficient, 64 cases were VitD insufficient, and 110 cases were VitD sufficient; The mean BMD in VitD patients with different levels was significantly different ( F=783.25, P<0.05) ; With the increase of MCP-1, PTH and TPINP levels decreased ( F=78.98, 703.57, 243.27, P<0.05) , while the levels of PICP and BGP increased ( F=122.97, 340.32, P<0.05) ; 25- (OH) D was positively correlated with BMD, PICP and BGP ( r=0.93, 0.76, 0.87, P<0.05) , and negatively correlated with PTH and TPINP ( r=-0.94, -0.81, P<0.05) . MCP-1 was negatively correlated with BMD, PICP and BGP ( r=-0.54, -0.51, -0.56, P<0.05) , and positively correlated with PTH and TPINP ( r=0.57, 0.55, P<0.05) . Conclusions:The 25- (OH) D level is significantly correlated with BMD and bone metabolism indexes in preschool children after fracture, and the lack and insufficiency of VitD significantly affect BMD and bone metabolism status. At the same time, MCP-1 may also play an important role in metabolic changes after fracture. Therefore, in clinical treatment, it is necessary to strengthen the monitoring and management of 25- (OH) D and MCP-1 levels after fracture in children, which is of great significance to promote bone healing and improve bone density.
8.miR-146a chitosan nanoparticles preparation and protective effects on acute liver cell injury induced by LPS
Saining WANG ; Huifang BAI ; Ning JIANG ; Qianqian DANG ; Fengying YIN ; Lin SUN ; Xuelin WANG
Chinese Journal of Veterinary Science 2025;45(6):1260-1267
This study aims to investigate the characteristics of chitosan-loaded miR-146a nanoparti-cles and explore their protective effect against acute liver cell injury induced by LPS in vitro.Galac-tosylated arginine chitosan(GCA)nanoparticles were successfully synthesized,prepared and used to further prepare GCA-miR-146a nanoparticles with different mass ratios by ion cross-linking method.The binding efficiency of miR-146a by GCA nanoparticles was detected by gel retardation experiment.Particle size,morphology and potential were observed and detected by transmission e-lectron microscopy and Zetasizer NanoZS90 respectively.The cytotoxicity of GCA nanoparticles on HepG2 cells was detected by CCK-8 kit.Cellular uptake was assayed by fluorescence microscopy to select the optimum ratio for the further study.The LPS induced acute liver cell injury were evalua-ted by real-time fluorescence quantitative PCR.The results showed that the mass ratio of GCA-miR-146a was 5∶1.Encapsulation efficiency and drug loading efficiency of the nanoparticles reached 97.11%and 20.08%,respectively.The 100 nm nanoparticles with 1.15 mV surface charge showed uniform morphology.The GCA-miR-146a nanoparticles had no cytotoxicity and had high transfection efficiency on HepG2 cells.The study demonstrated that GCA-miR-146 ananoparticles could significantly increase the expression of miR-146a in HepG2 cells and reduce the mRNA ex-pression levels of IL-6 and TNF-α in vitro.The prepared GCA nanoparticles loaded with miR-146a had high loading efficiency and could protect LPS-induced acute liver cell injury in vitro.
9.Process parameter optimization and immunogenicity evaluation of calcium phosphate-coated foot-and-mouth disease virus-like particles.
Lihua REN ; Wei GUO ; Qianqian XIE ; Ruipeng LIU ; Shiqi SUN ; Hu DONG ; Yun ZHANG ; Manyuan BAI ; Huichen GUO ; Zhidong TENG
Chinese Journal of Biotechnology 2025;41(7):2672-2681
Bio-mineralization has emerged as a promising strategy to enhance vaccine immunogenicity. This study optimized the calcium phosphate (CaP) mineralization process of foot-and-mouth disease virus-like particles (FMD VLPs) to achieve high mineralization efficiency and scalability. Key parameters, including concentrations of Ca2+, HPO42-, NaCl, and VLPs, as well as stirring speed, were systematically optimized. Stability of the scaled-up reaction system and immunogenicity of the mineralized vaccine were evaluated. Optimal conditions [25.50 mmol/L Ca(NO3)2, 15 mmol/L Na2HPO4, 300 mmol/L NaCl, 0.75 mg/mL VLPs, and 1 500 r/min] yielded CaP-mineralized VLPs (VLPs-CaP) with high mineralization efficiency, uniform morphology, and a favorable particle size. Scaling up the reaction by 25 folds maintained consistent mineralization efficiency and particle characteristics. Immunization in mice demonstrated that VLPs-CaP induced higher titers of specific antibodies and neutralizing antibodies than unmineralized VLPs (P < 0.05). Higher IgG2a/IgG1 ratio and enhanced IFN-γ secretion (P < 0.05) further indicated robust cellular immune responses. We establish a stable and scalable protocol for VLPs-CaP, providing a theoretical and technical foundation for developing high-efficacy VLPs-CaP vaccines.
Vaccines, Virus-Like Particle/immunology*
;
Immunogenicity, Vaccine
;
Calcium Phosphates/chemistry*
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Foot-and-Mouth Disease Virus
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Biomineralization
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Particle Size
;
Animals
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Mice
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Antibodies, Neutralizing/blood*
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Antibodies, Viral/blood*
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Immunity, Cellular
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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