1.Molecular Mechanism of Astragali Radix and Hedyotis diffusa in Regulating LINC01134-CTCF-p21 Axis to Inhibit Lung Adenocarcinoma Proliferation
Haipeng SUN ; He ZHUANG ; Xue LIU ; Siyuan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):131-138
ObjectiveTo explore the interaction and competitive binding of Homo sapiens long intergenic non-protein-coding RNA 1134 (LINC01134) to CCCTC-binding factor CTCF, affecting the transcription of cyclin-dependent kinase inhibitor (p21) and influencing the proliferation of A549 cells, in order to investigate the possible mechanism of Astragali Radix and Hedyotis diffusa (A-H) in inhibiting A549 proliferation by regulating this axis. MethodsRNA-binding protein immunoprecipitation (RIP) assays were conducted to examine the interaction between LINC01134 and CTCF, and chromatin immunoprecipitation (ChIP) assays were used to study the effect of LINC01134 overexpression on the interaction between CTCF and p21. Stable A549 cell lines (oe-NC and oe-LINC01134) were established using lentiviral transfection, and each group was treated with 10% A-H drug-containing serum. Real-time PCR and Western blot analyses were performed to detect the effects of A-H on the expression of LINC01134, CTCF, and p21 in A549 cells. Cell counting kit-8 (CCK-8) and colony formation assays were used to assess the effects of A-H on A549 cell proliferation via LINC01134. Flow cytometry was employed to evaluate the effects of A-H on the A549 cell cycle through LINC01134, and Western blot was used to detect changes in cell cycle proteins. ResultsCompared with the IgG group, the oe-CTCF group showed a significantly increased abundance of LINC01134 aggregates (P0.01). Compared with the oe-Vector group, p21 abundance in CTCF complexes was significantly reduced in the oe-LINC01134 group (P0.01). Compared with the 10% blank + oe-LINC01134 group, the 10% A-H + oe-LINC01134 group reversed the expression of LINC01134 and p21 (P0.05), but had no significant regulatory effect on CTCF. Compared with the 10% blank + oe-LINC01134 group, the 10% A-H + oe-LINC01134 group reversed cell viability at 72 h (P0.05), inhibited malignant proliferation (P0.05), and reversed the proportions of cells in the G0/G1 and S phases (P0.01). Furthermore, compared with the 10% blank + oe-LINC01134 group, the 10% A-H + oe-LINC01134 group reversed the expression of Cyclin D1, CDK4, Cyclin E, CDK2, phosphorylated retinoblastoma protein (p-Rb), and E2F transcription factor 3 (E2F3) (P0.01). ConclusionA-H regulates the LINC01134-CTCF-p21 axis to block the G1/S phase transition of A549 cell cycle, accelerate cellular senescence, and inhibit malignant proliferation.
2.Molecular Mechanism of Astragali Radix and Hedyotis diffusa in Regulating LINC01134-CTCF-p21 Axis to Inhibit Lung Adenocarcinoma Proliferation
Haipeng SUN ; He ZHUANG ; Xue LIU ; Siyuan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):131-138
ObjectiveTo explore the interaction and competitive binding of Homo sapiens long intergenic non-protein-coding RNA 1134 (LINC01134) to CCCTC-binding factor CTCF, affecting the transcription of cyclin-dependent kinase inhibitor (p21) and influencing the proliferation of A549 cells, in order to investigate the possible mechanism of Astragali Radix and Hedyotis diffusa (A-H) in inhibiting A549 proliferation by regulating this axis. MethodsRNA-binding protein immunoprecipitation (RIP) assays were conducted to examine the interaction between LINC01134 and CTCF, and chromatin immunoprecipitation (ChIP) assays were used to study the effect of LINC01134 overexpression on the interaction between CTCF and p21. Stable A549 cell lines (oe-NC and oe-LINC01134) were established using lentiviral transfection, and each group was treated with 10% A-H drug-containing serum. Real-time PCR and Western blot analyses were performed to detect the effects of A-H on the expression of LINC01134, CTCF, and p21 in A549 cells. Cell counting kit-8 (CCK-8) and colony formation assays were used to assess the effects of A-H on A549 cell proliferation via LINC01134. Flow cytometry was employed to evaluate the effects of A-H on the A549 cell cycle through LINC01134, and Western blot was used to detect changes in cell cycle proteins. ResultsCompared with the IgG group, the oe-CTCF group showed a significantly increased abundance of LINC01134 aggregates (P0.01). Compared with the oe-Vector group, p21 abundance in CTCF complexes was significantly reduced in the oe-LINC01134 group (P0.01). Compared with the 10% blank + oe-LINC01134 group, the 10% A-H + oe-LINC01134 group reversed the expression of LINC01134 and p21 (P0.05), but had no significant regulatory effect on CTCF. Compared with the 10% blank + oe-LINC01134 group, the 10% A-H + oe-LINC01134 group reversed cell viability at 72 h (P0.05), inhibited malignant proliferation (P0.05), and reversed the proportions of cells in the G0/G1 and S phases (P0.01). Furthermore, compared with the 10% blank + oe-LINC01134 group, the 10% A-H + oe-LINC01134 group reversed the expression of Cyclin D1, CDK4, Cyclin E, CDK2, phosphorylated retinoblastoma protein (p-Rb), and E2F transcription factor 3 (E2F3) (P0.01). ConclusionA-H regulates the LINC01134-CTCF-p21 axis to block the G1/S phase transition of A549 cell cycle, accelerate cellular senescence, and inhibit malignant proliferation.
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.Efficacy of remimazolam-based anesthesia in daytime laparoscopic cholecystectomy: a multicenter, non-inferiority, randomized controlled trial
Qian HU ; Jian GUO ; Haijun YUAN ; Weiping LEI ; Haipeng LIU ; Chen YONG ; Yanhui HU ; Junping CHEN ; Jianliang SUN ; Zhijian LAN ; Jianhong XU ; Xin YU ; Gang CHEN
Chinese Journal of Anesthesiology 2025;45(6):720-725
Objective:To evaluate the efficacy of remimazolam-based anesthesia in daytime laparoscopic cholecystectomy.Methods:In this multicenter, non-inferiority, randomized controlled trial, 300 American Society of Anesthesiologists Physical Status classification Ⅰ or Ⅱ patients of either sex, aged 18-60 yr, with body mass index of 18-28 kg/m 2, who underwent daytime laparoscopic cholecystectomy under general anesthesia with tracheal intubation at Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, the Fourth Affiliated Hospital of Zhejiang University School of Medicine, Jinhua Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou First People′s Hospital Affiliated to Westlake University School of Medicine, Ningbo No. 2 Hospital, and the Second Affiliated Hospital of Nanchang University from August 2021 to August 2023, were selected and divided into 2 groups ( n=150 each) using a random number table method: remimazolam group (R group) and propofol group (P group). Anesthesia was induced as follows: Sufentanil was intravenously injected at a rate of 0.5 μg/kg, remimazolam was intravenously injected at a rate of 0.3 mg/kg in group R, propofol was intravenously injected at a rate of 2.0-2.5 mg/kg in group P, and cisatracurium besilate was intravenously injected at a rate of 0.2 mg/kg after loss of consciousness in two groups. The patients were mechanically ventilated after tracheal intubation. Anesthesia was maintained as follows: Remimazolam was intravenously injected at a rate of 0.5-1.0 mg·kg -1·h -1 in group R, propofol was intravenously injected at a rate of 4-10 mg·kg -1·h -1 in group P, and remifentanil was intravenously infused at a rate of 0.25-2.00 μg·kg -1·min -1, maintaining intraoperative bispectral index value of 40-60. The success rate of sedation was recorded, and non-inferiority tests were conducted. The time to loss of consciousness, emergence time, extubation time, recovery time of orientation, time of stay in post-anesthesia care unit and occurrence of delayed emergence were recorded. Liver function and renal function were measured before operation and within 24 h after operation. The occurrence of abnormal alanine transaminase, abnormal aspartate transaminase, abnormal creatinine and abnormal urea was recorded. The occurrence of adverse reactions during and after operation was recorded. Results:The success rates of sedation were 98.6% and 99.3% in group R and group P, respectively, there was no statistically significant difference in the success rate of sedation between the two groups ( P>0.05), and the difference in the success rates of sedation between the two groups was -0.007 (95% confidence interval-0.0301-0.0161), which met the pre-set non-inferiority criteria(95% confidence interval >-0.055). Compared with group P, the time to loss of consciousness and recovery time of orientation were significantly prolonged, and the incidence of delayed emergence was increased ( P<0.05), and no statistically significant changes were found in the emergence time, extubation time, time of stay in post-anesthesia care unit and severity of postoperative nausea and vomiting in group R ( P>0.05). There was no statistically significant difference in the abnormal rates of alanine transaminase, aspartate transaminase, creatinine and urea before and after operation between the two groups ( P>0.05). Conclusions:The efficacy of remimazolam-based anesthesia in daytime laparoscopic cholecystectomy is not inferior to that of propofol-based anesthesia.
5.Establishing a dose-response curve for 137Cs γ-ray irradiation-induced chromosomal aberrations in human peripheral blood lymphocytes through automated analysis
Tianxi ZHANG ; Haipeng YE ; Huijuan YU ; Yan LIU ; Yaping BI ; Yanna LE
Chinese Journal of Radiological Medicine and Protection 2025;45(9):858-862
Objective:To establish a dose-response curve of dicentric chromosomes and centromeric rings (dic+ r) in γ-ray irradiation-induced chromosomal aberrations in human peripheral blood lymphocytes through automated analysis.Methods:Peripheral blood samples from three healthy donors were irradiated in vitro at doses of 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, and 5 Gy and a dose rate of 0.80 Gy/min using a 137Cs γ-ray source. Post-irradiation, lymphocytes were cultured based on standard protocols, harvested using an automatic cell harvester, and prepared on slides using an automatic slide preparation system. dic+ r were analyzed fully automatically using the DCScore software, and a dose-response curve of dic+ r was established through fitting and then validated using the CABAS software. Results:The dose-response curve followed a linear-quadratic model, i. e., y = 0.093 65+ 0.030 21 D+ 0.025 31 D2 ( R2 = 0.999 2), where y was the quantity of dic+ r and D was the absorbed dose of γ-ray irradiation (Gy). Doses to samples for blind validation were estimated using this curve, yielding deviations of less than 24% from the actual irradiation doses. Conclusions:The fully automated analysis of dic+ r in 137Cs γ-ray irradiation-induced chromosomal aberrations, followed by the construction of the dose-response curve, holds significant potential for rapid, high-throughput biodosimetry in large-scale nuclear emergencies.
6.The diagnosis and treatment of subclinical ptosis
Jiheng CUI ; Duo ZHANG ; Haipeng LIU
Chinese Journal of Plastic Surgery 2025;41(6):553-559
Subclinical ptosis is a common congenital abnormality of bilateral upper eyelid development; the clinical manifestations are upper eyelid skin covering the upper corneal margin of more than 2 mm, upper eyelid bloat, narrow lid fissure, often accompanied by epicanthus and eyebrow elevation when the eyes are opened. Patients often present with a single eyelid, which can be easily missed and misdiagnosed. The cause of subclinical ptosis is an increase in the afterload of the levator muscle during contraction due to a variety of reasons, such as gravitational, volumetric, and tensile loads; the clinical manifestations and the normalisation of the levator muscle strength are the main basis for diagnosis and identification of true ptosis. Depending on the type of afterload, different surgical treatments are available, such as blepharoplasty, orbicularis oculi myotomy, upper eyelid tissue reduction, fibrous mesh band release, anterior displacement of the levator complex, and shortening of the levator complex.
7.Clinical guideline for diagnosis and treatment of nonunion of osteoporotic vertebral fractures (version 2025)
Haipeng SI ; Le LI ; Junjie NIU ; Wencan ZHANG ; Fuxin WEI ; Jinqiu YUAN ; Qiang YANG ; Hongli WANG ; Guangchao WANG ; Shihong CHEN ; Yunzhen CHEN ; Xiaoguang CHENG ; Jianwen DONG ; Shiqing FENG ; Rui GU ; Yong HAI ; Tianyong HOU ; Bo HUANG ; Xiaobing JIANG ; Lei ZANG ; Chunhai LI ; Nianhu LI ; Hua LIN ; Hongjian LIU ; Peng LIU ; Xinyu LIU ; Sheng LU ; Shibao LU ; Chunshan LUO ; Lvy CHAOLIANG ; Lvy WEIJIA ; Xuexiao MA ; Wei MEI ; Chunyang MENG ; Cailiang SHEN ; Chunli SONG ; Ruoxian SONG ; Jiacan SU ; Honglin TENG ; Hui SHENG ; Beiyu WANG ; Bingwu WANG ; Liang WANG ; Xiangyang WANG ; Nan WU ; Guohua XU ; Yayi XIA ; Jin XU ; Youjia XU ; Jianzhong XU ; Cao YANG ; Maowei YANG ; Zibin YANG ; Xiaojian YE ; Hailong YU ; Xijie YU ; Hua YUE ; Zhili ZENG ; Xinli ZHAN ; Hui ZHANG ; Peixun ZHANG ; Wei ZHANG ; Zhenlin ZHANG ; Jianguo ZHANG ; Tengyue ZHU ; Qiang LIU ; Huilin YANG
Chinese Journal of Trauma 2025;41(10):932-945
Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.
8.Ethical issues and countermeasures of off-label drug use in children
Limin LI ; Haipeng HU ; Xiaoqin CAO ; Xiaohong LIU
Chinese Medical Ethics 2025;38(2):227-231
Children, as a special group, frequently experience of off-label drug use worldwide. Common reasons for off-label drug use in children include the lack of data on pediatric patients during the clinical trial stage of drug development, delayed updates to drug instructions, and the non-standard professional behavior of some doctors. Off-label drug use in children is a double-edged sword. It could save lives and provide a way to explore additional functions of drugs, while it may also lead to the phenomenon of hyper-indication abuse, increasing the risk of adverse drug events. Regulating off-label drug use in children can safeguard the best treatment rights and interests of children. It is recommended to encourage pharmaceutical enterprises to conduct research and development of pediatric new drugs, simplify the approval process for drug instructions amendments, accumulate evidence-based medical evidence for off-label drug use in children, standardize the process of off-label drug use in children in medical institutions, continuously improve the standardized diagnosis and treatment capabilities of pediatricians, and actively cooperate with the families of pediatric patients in diagnosis and treatment, so as to comprehensively safeguard the rights and interests of both doctors and patients.
9.Molecular Mechanism of Astragali Radix and Hedyotis diffusa Regulating Sp1-miR-582-3p-p27 Axis to Inhibit Lung Adenocarcinoma Proliferation
Haipeng SUN ; Lufan XU ; Xue LIU ; Siyuan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):116-124
ObjectiveTo investigate the effects of excessive activation of the Specific protein 1 (Sp1)-MicroRNA-582-3p (miR-582-3p)-cyclin-dependent kinase inhibitor (p27) axis on the cell cycle and proliferation of A549 lung adenocarcinoma cells at the cellular level, thereby investigating the possible mechanisms by which Astragali Radix and Hedyotis diffusa(A-H) regulate the axis to inhibit A549 cells proliferation. MethodsLentiviral plasmid transfection technology was used to obtain four stable A549 transgenic cell lines: shRNA-Sp1+LV-miR-582-3p mimic, shRNA-Sp1+LV-mNC, shRNA-NC+LV-miR-582-3p mimic, and shRNA-NC+LV-mNC. Real-time PCR was used to detect the effect of Sp1 on miR-582-3p expression in A549 lung adenocarcinoma cells. CCK-8 and colony formation assay were used to detect the effect of Sp1 on cell proliferation through miR-582-3p, while flow cytometry was used to detect the effect of Sp1 on cell cycle via miR-582-3p. Western blot was used to detect the effect of Sp1 on cyclin in A549 cells through miR-582-3p. CCK-8 was employed to detect the effects of different concentrations (5%, 10%, 20%, 40%, 80%) of A-H on A549 cell viability, and the optimal concentration was selected for subsequent mechanism exploration. Stable transgenic strains oe-Sp1 and control oe-Vector were constructed using the above-mentioned transfection techniques. Real-time PCR was then used to investigate the effect of A-H on miR-582-3p expression in A549 cells, while Western blot was employed to detect the effect of A-H on Sp1 and p27 expression in A549 lung adenocarcinoma cells. ResultsCompared with the shRNA-NC+LV-mNC group, the expression of miR-582-3p was significantly inhibited in the shRNA-Sp1+LV-mNC group (P<0.01). Compared with the shRNA-Sp1+LV-mNC group, the shRNA-Sp1+LV-miR-582-3p mimic group significantly reversed miR-582-3p expression (P<0.01), indicating that Sp1 has a significant regulatory effect on miR-582-3p. Compared with the shRNA-Sp1+LV-mNC group, the shRNA-Sp1+LV-miR-582-3p mimic group significantly reversed cell proliferation (P<0.01), suggesting that miR-582-3p can partially reverse the proliferative effect of Sp1 on A549 lung adenocarcinoma. Compared with the shRNA-Sp1+LV-mNC group, the shRNA-Sp1+LV-miR-582-3p mimic group showed a significant decrease in G0/G1 proportions, while the G2/M and S phase proportions increased significantly (P<0.01), indicating that miR-582-3p can partially reverse the effect of Sp1 on the A549 cell cycle. Compared with the shRNA-Sp1+LV-mNC group, the shRNA-Sp1+LV-miR-582-3p mimic group significantly reversed the expression of various proteins with the decrease of p27 and the increase of Cyclin D1, CDK4, Cyclin E, CDK2, p-Rb, and E2F3 (P<0.01), indicating that miR-582-3p can partially reverse the effect of Sp1 on the cell cycle of A549 lung adenocarcinoma. Compared with the blank group, the serum containing A-H significantly inhibited A549 cell viability in a concentration-dependent manner. Therefore, 10% A-H was selected for intervention of subsequent mechanism experiments. Compared with A-H+oe-Vector, A-H+oe-Sp1 significantly reversed the downregulation of Sp1, miR-582-3p, and the upregulation of p27 (P<0.01). This suggests that Sp1 can partially reverse the effects of A-H on miR-582-3p and p27 levels in A549 lung adenocarcinoma cells. ConclusionOveractivation of the Sp1-miR-582-3p-p27 axis significantly promotes the proliferation of A549 lung adenocarcinoma cells, and the potential mechanism of the inhibitory effect of A-H on the proliferation of A549 cells may be related to its inhibition on the overactivation of the Sp1-miR-582-3p-p27 axis.
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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