1.Efficacy of MitraClip in functional versus degenerative mitral regurgitation: A systematic review and meta-analysis
Xuhua LI ; Qiyuan BAI ; Zhili WEI ; Shidong LIU ; Hao CHEN ; Yang CHEN ; Bing SONG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(05):807-814
Objective To systematically evaluate the differences in outcomes between functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR) in patients treated with transcatheter edge-to-edge repair (TEER) using the MitraClip device. Methods A systematic literature search was conducted in PubMed, Embase, the Cochrane Library, Web of Science, the CNKI, Wanfang Database, VIP Database, and the CBM from their inception to January 2024. Two researchers independently performed study selection, data extraction, and risk of bias assessment. The quality of cohort studies was evaluated using the Newcastle-Ottawa Scale (NOS). A meta-analysis was performed using Stata 18.0 software. Results A total of 13 cohort studies involving 6 402 patients were included, comprising 4 161 patients in the FMR group and 2 241 in the DMR group. All included studies had NOS scores of ≥6 points. The meta-analysis revealed that compared to the DMR group, the FMR group had a higher 1-year all-cause mortality rate [OR=1.53, 95%CI (1.30, 1.81), P<0.01] and a higher 1-year rehospitalization rate for heart failure [OR=1.90, 95%CI (1.60, 2.26), P<0.01]. Conversely, the FMR group had a lower post-procedural mean transmitral gradient [SMD=–0.47, 95%CI (–0.65, –0.30), P<0.01] and a lower rate of subsequent mitral valve surgery [OR=0.41, 95%CI (0.20, 0.83), P=0.01]. Conclusion Following MitraClip therapy, patients with FMR exhibit favorable short-term outcomes, but their mid- to long-term outcomes are inferior to those of patients with DMR. When determining the treatment strategy with MitraClip, the specific etiology of mitral regurgitation should be considered for a more accurate prediction of therapeutic efficacy and prognosis.
2.Evaluation of the Angle Deviation between Pilot Holes and Actual Implanted Pedicle Screw Trajectories in Freehand Pedicle Screw Placement for Thoracolumbar Spine Surgery: The Impact of Tapping and Work Experience
Jie SHAO ; Shaokang HUANG ; Yiping LUO ; Bingkun MENG ; Qunfei YU ; Yi ZHANG ; Wei LI ; Yushu BAI ; Ziqiang CHEN
Clinics in Orthopedic Surgery 2026;18(1):87-95
Background:
To investigate directional deviations between pilot holes and final pedicle screw trajectories in freehand placement and analyze risk factors for misplacement. While pedicle screws are widely used in thoracolumbosacral surgery, directional deviations between pilot holes and final screw trajectories remain understudied as potential risk factors for misplacement.
Methods:
Thirty-three patients undergoing posterior fixation were prospectively enrolled. Inertial measurement units (IMUs) tracked the spatial positions of pedicle finders and screwdrivers via custom software. Surgeons (n = 6) were stratified into senior, middle, and junior groups. Analyzed variables included the use of tapping, surgeon experience, spinal deformity status, screw tip morphology, and surgical parameters.
Results:
Among 198 implanted screws (6.00 ± 2.88/patient), all exhibited trajectory deviations (8.12° ± 3.47°). Tapping significantly reduced deviations (7.23° ± 3.23° vs. 8.87° ± 3.31°, p < 0.01). Senior surgeons achieved smaller deviations (7.34° ± 3.33°) than the middle group (8.60° ± 3.51°, p = 0.039) and junior group (8.68° ± 3.49°, p = 0.022). Multivariate analysis confirmed tapping (p = 0.001) and senior experience (p = 0.023) as protective factors. No significant associations emerged for spinal deformity (8.43° ± 3.73° vs. 7.97° ± 3.35°, p = 0.377), screw tip type (cylindrical, 8.43° ± 3.26° vs. tapered, 8.07 ± 3.51°; p = 0.637), obesity, or surgical position parameters.
Conclusions
Freehand pedicle screw placement consistently produces trajectory deviations from pilot holes, and surgeon experience and tapping are modifiable protective factors. The IMU-based tracking system enables quantitative surgical motion analysis, suggesting its utility for training optimization and technique standardization.
3.Preventive Effect and Safety Evaluation of Xiaozhen Formula (消疹方) on Skin Toxicity Induced by Epidermal Growth Factor Receptor Inhibitors in the Treatment of Non-small Cell Lung Cancer:A Multicenter,Randomized,Double-Blind,Placebo-Controlled Trial
Ling LUO ; Xintian WANG ; Cheng CHENG ; Zitong HAN ; Chunru WANG ; Guoli WEI ; Jianyue LI ; Li WANG ; Jirong WANG ; Peng SHU ; Liang LI ; Fenglin LIU ; Ran SONG ; Jing BAI ; Haiyan XING
Journal of Traditional Chinese Medicine 2026;67(18):1987-1994
ObjectiveTo evaluate the clinical efficacy and safety of Xiaozhen Formula (消疹方) in preventing skin toxicity induced by epidermal growth factor receptor inhibitors (EGFRIs) in patients with EGFR-mutant non-small cell lung cancer (NSCLC). MethodsA randomized, double-blind, placebo-controlled, multicenter clinical study was conducted. A total of 120 patients with EGFR-mutant NSCLC from seven centers were enrolled and randomly assigned to a treatment group (60 cases) or a control group (60 cases). On the basis of EGFRI-targeted therapy, patients in the treatment group received Xiaozhen Formula granules, whereas those in the control group received Xiaozhen Formula placebo granules, both at 10 g twice daily for 4 consecutive weeks. The primary outcomes were the grading of skin toxicity evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the incidence of rash. Secondary outcomes included the time to onset and time to resolution of the highest-grade rash, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) scores, the Hospital Anxiety and Depression Scale (HADS) scores, and disease control rate, together with safety assessments. ResultsBased on the full analysis set (FAS), the incidence of skin toxicity in the treatment group was 18.33% (11/60), significantly lower than 45.00% (27/60) in the control group (P<0.01), with the highest severity of skin toxicity in both groups was grade 2. Among patients who developed rash, the resolution rate in the treatment group was 90.91% (10/11), higher than that 33.33% (9/27) in the control group. The median time to resolution was 15 days (95%CI: 8-17 days) in the treatment group and it was not reached in the control group; the distribution of time to resolution differed significantly between groups (P<0.001). After treatment, the treatment group had higher EORTC QLQ-C30 functional scale and global health status/quality-of-life scores, and lower symptom scale, single-item scores, as well as HADS-A, and HADS-D scores than the control group (P<0.05). In the FAS analysis, the disease control rate (DCR) was 85.0% (51/60) in the treatment group, lower than 100.0% (60/60) in the control group (P=0.003), whereas no significant between-group difference was observed in the per-protocol set (PPS) analysis (P=0.464). The incidence of adverse events did not differ significantly between the two groups (P>0.05), and no definite safety signals related to the investigational drug were observed. ConclusionXiaozhen Formula can reduce the incidence of EGFRI-induced skin toxicity, and improve the outcome of rash regression, the patients' quality of life and psychological status in EGFR-mutant NSCLC patients.
4.Quality evaluation of Zhachong-13 pills based on the content determination of 12 components combined with multivariate statistical analysis
Wei ZHANG ; Qian ZHANG ; Tuya BAI ; Xinkui LI ; Yuxia HU ; Mengdi ZHANG ; Jing LIU ; Fang WANG ; Jun LI
China Pharmacy 2026;37(19):2509-2515
OBJECTIVE To evaluate the quality of Zhachong-13 pills.METHODS The contents of agarotetrol, costunolide, hypaconitine, dehydrocostus lactone, mesaconitine, aconitine, liquiritigenin, glycyrrhizic acid, ellagic acid, liquiritin, corilagin, and gallic acid in 18 batches of samples were determined by high-performance liquid chromatography-tandem triple quadrupole mass spectrometry (HPLC-MS/MS) method. Cluster analysis (CA) was performed using the Microbioinformatics online analysis platform. Principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) were performed using SIMCA 14.1 software. Random forest, extremely randomized trees, and extreme gradient boosting machine learning models were constructed using the SPSSAU online analysis platform. The comprehensive quality of the samples was evaluated by the entropy weight-technique for order preference by similarity to ideal solution (TOPSIS) method.RESULTS The contents of the above 12 components were 104.331-694.382, 652.217-1 085.075, 6.051-130.980, 612.174-1 417.179, 1.018-32.239, 0.953-24.967, 65.552-652.239, 2 019.412-5 385.807, 52.867-4 990.450, 156.307-883.180, 10.142-475.722, and 1 102.863-4 826.396 μg/g, respectively. The results of CA and PCA showed that the 18 batches of samples were divided into two categories: S1-S6, S10-S15 were grouped into one category, while S7-S9 and S16-S18 were grouped into another category. The OPLS-DA results showed that the variable importance in projection values of mesaconitine, glycyrrhizic acid, liquiritin, ellagic acid, hypaconitine, liquiritigenin, agarotetrol, gallic acid, and dehydrocostus lactone were greater than 1. The results of the three machine learning models showed that ellagic acid and hypaconitine had relatively large differential contributions. The entropy weight-TOPSIS results showed that the overall quality of samples from manufacturer B was superior to that of the other four manufacturers.CONCLUSIONS The established method is stable and feasible, and can be used to evaluate the quality of Zhachong-13 pills, in combination with multivariate statistical analysis. Ellagic acid and hypaconitine are differential markers that affect its quality.
5.Sutureless aortic versus transcatheter aortic valve implantation for aortic valve disease: A systematic review and meta-analysis of propensity score matching studies
Yang CHEN ; Zhili WEI ; Qiyuan BAI ; Xuhua LI ; Shidong LIU ; Yuyuan HE ; Yuan HU ; Bing SONG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(10):1670-1676
Objective To evaluate the clinical outcomes of sutureless aortic valve replacement (SU-AVR) and transcatheter aortic valve implantation (TAVI) for aortic valve disease. Methods We conducted a computer-based search of databases including CNKI, WanFang Database, VIP, Chinese Biology Medicine disc, PubMed, The Cochrane Library, Embase and Web of Science from the inception of the databases to March 2024. Two reviewers independently screened articles, extracted data and used the Newcastle-Ottawa Scale to evaluate the quality of the included studies. Meta-analysis was performed using Stata 18.0 software. Results The included 17 propensity score matching studies involved with 6 630 patients, including 3 319 patients in the SU-AVR group and 3 311 patients in the TAVI group. The SU-AVR group had lower mortality than the TAVI group at 1-year [RR=0.58, 95%CI(0.38, 0.87), P=0.009], 2-year [RR=0.61, 95%CI(0.43, 0.85), P=0.004] and 5-year [RR=0.63, 95%CI(0.50, 0.79), P<0.001]. The SU-AVR group had a significantly lower rate of new permanent pacemaker implantation (PPI) [RR=0.75, 95%CI(0.58, 0.98), P=0.037], moderate-to-severe paravalvular leak [RR=0.20, 95%CI(0.12, 0.32), P<0.001], myocardial infarction [RR=0.30, 95%CI (0.11, 0.80), P=0.017], more-than-mild residual aortic regurgitation [RR=0.29, 95%CI(0.17, 0.48), P<0.001]. In addition, the SU-AVR group had a higher postoperative mean aortic gradient [SMD=0.39, 95%CI (0.17, 0.62), P<0.001] than the TAVI group. Conclusion The early and mid-term clinical outcomes of SU-AVR are superior to TAVI.
6.Analysis of the current status of red blood cell transfusion in very preterm infants from Chinese Neonatal Network in 2022
Yan MO ; Aimin QIAN ; Ruimiao BAI ; Shujuan LI ; Xiaoqing YU ; Jin WANG ; K. Shoo LEE ; Siyuan JIANG ; Qiufen WEI ; Wenhao ZHOU
Chinese Journal of Pediatrics 2025;63(1):55-61
Objective:To analyze the current status of red blood cell transfusion in very preterm infants (VPI) (gestational age at birth <32 weeks) from Chinese Neonatal Network (CHNN) in 2022.Methods:This cross-sectional study was based on the CHNN VPI cohort. It included 6 985 VPI admitted to CHNN 89 participating centers within 24 hours after birth in 2022. VPI with major congenital anomalies or those transferred to non-CHNN centers for treatment or discharged against medical advice were excluded. VPI were categorized based on whether they received red blood cell transfusions, their gestational age at birth, the type of respiratory support received during transfusion, and whether the pre-transfusion hemoglobin levels exceeded the thresholds. General characteristics, red blood cell transfusion rates, number of transfusions, timing of the first transfusion, and pre-transfusion hemoglobin levels were compared among different groups. The incidence of adverse outcomes between the group of VPI who received transfusions above the threshold and those who received transfusions below the threshold were compared. Comparison among different groups was conducted using χ2 tests, Kruskal-Wallis H tests, Mann-Whitney U test, and so on. Trends by gestational age at birth were evaluated by Cochran-Armitage tests and Jonckheere-Terpstra tests for trend. Results:Among the 6 985 VPI, 3 865 cases(55.3%) were male, with a gestational age at birth of 30.0 (28.6, 31.0) weeks and a birth weight of (1 302±321) g. Overall, 3 617 cases (51.8%) received red blood cell transfusion, while 3 368 cases (48.2%) did not. The red blood cell transfusion rate was 51.8% (3 617/6 985), with rates of 77.7% (893/1 150) for those born before 28 weeks gestational age and 46.7% (2 724/5 835) for those born between 28 and 31 weeks gestational age. A total of 9 616 times red blood cell transfusions were administered to 3 617 VPI, with 632 times missing pre-transfusion hemoglobin data, and 8 984 times included in the analysis. Of the red blood cell transfusions, 25.6% (2 459/9 616) were administered when invasive respiratory support was required, 51.3% (4 934/9 616) were receiving non-invasive respiratory support, while 23.1% (2 223/9, 616) were given when no respiratory support was needed. Compared to the non-transfusion group, the red blood cell transfusion group had a higher rate of pregnancy-induced hypertension in mothers, lower rates of born via cesarean section and mother′s antenatal steroid administration, smaller gestational age, lower birth weight, a higher proportion of small-for-gestational-age, multiple births, and proportions of Apgar score at the 5 th minute after birth ≤3 (all P<0.05). They were also less likely to be female, born in hospital or undergo delayed cord clamping (all P<0.01). Additionally, higher transport risk index of physiologic stability score at admission were observed in the red blood cell transfusion group ( P<0.001). The number of red blood cell transfusion was 2 (1, 3) times, with the first transfusion occurring at an age of 18 (8, 29) days, and a pre-transfusion hemoglobin level of 97 (86, 109) g/L. For VPI ≤7 days of age, the pre-transfusion hemoglobin levels for invasive respiratory support, non-invasive respiratory support, or no respiratory support, respectively, with no statistically significant differences between groups ( H=5.59, P=0.061). For VPI aged 8 to 21 days and≥22 days, the levels with statistically differences between groups (both P<0.01). Red blood cell transfusions above recommended thresholds were observed in all respiratory support categories at different stages of life, with the highest prevalence in infants aged 8 to 21 days and≥22 days who did not require respiratory support, at 90.1% (264/273) and 91.1%(1 578/1 732), respectively. The rate of necrotizing enterocolitis was higher in the above-threshold group ( χ2=10.59, P=0.001), and the duration of hospital stay was longer in the above-threshold group ( Z=4.67, P<0.001) compared to the below-threshold group. Conclusions:In 2022, the red blood cell transfusion rate was relatively high among VPI from CHNN. Pre-transfusion hemoglobin levels frequently exceeded recommended transfusion thresholds.
7.Construction of a Disease-Syndrome Integrated Diagnosis and Treatment System for Gastric "Inflammation-Cancer" Transformation Based on Multi-Modal Phenotypic Modeling
Hao LI ; Huiyao ZHANG ; Wei BAI ; Tingting ZHOU ; Guodong HUANG ; Xianjun RAO ; Yang YANG ; Lijun BAI ; Wei WEI
Journal of Traditional Chinese Medicine 2025;66(5):458-463
By analyzing the current application of multi-modal data in the diagnosis of gastric "inflammation-cancer" transformation, this study explored the feasibility and strategies for constructing a disease-syndrome integrated diagnosis and treatment system. Based on traditional Chinese medicine (TCM) phenomics, we proposed utilizing multi-modal data from literature research, cross-sectional studies, and cohort follow-ups, combined with artificial intelligence technology, to establish a multi-dimensional diagnostic and treatment index system. This approach aims to uncover the complex pathogenesis and transformation patterns of gastric "inflammation-cancer" progression. Additionally, by dynamically collecting TCM four-diagnostic information and modern medical diagnostic information through a long-term follow-up system, we developed three major modules including information extraction, multi-modal phenotypic modeling, and information output, to make it enable real-world clinical data-driven long-term follow-up and treatment of chronic atrophic gastritis. This system can provide technical support for clinical diagnosis, treatment evaluation, and research, while also offering insights and methods for intelligent TCM diagnosis.
8.Clinical Study on the Treatment of 70 Cases Chronic Atrophic Gastritis with Intestinal Metaplasia Using Xianglian Huazhuo Granules (香连化浊颗粒):A Randomized,Double-Blind,Placebo-Controlled Trial
Ziyu LI ; Maopeng ZHANG ; Wen ZHAO ; Wei LI ; Shiyun SHENG ; Haiyan BAI ; Qian YANG
Journal of Traditional Chinese Medicine 2025;66(5):473-479
ObjectiveTo observe the clinical efficacy and possible mechanisms of Xianglian Huazhuo Granules (香连化浊颗粒, XHG) in the treatment of chronic atrophic gastritis with intestinal metaplasia. MethodsA total of 140 patients with chronic atrophic gastritis and intestinal metaplasia were randomly divided into a treatment group and a control group, with 70 cases in each group. The treatment group received 12.5 g of XHG orally, twice daily. The control group received 12.5 g of placebo orally, twice daily. Both groups were treated for 6 months. The traditional Chinese medicine (TCM) symptom scores, pathological types, serum tumor markers of the digestive system, and serum bile acids (TBA), interleukin-23 (IL-23), and Dickkopf-related protein 1 (DKK-1) levels were observed before and after treatment. Safety indicators and adverse events were recorded. After treatment, TCM syndrome efficacy and pathological types were evaluated, and patients were followed up for 18 months with gastric endoscopy and pathological results, which were compared with the results after treatment finished. ResultsTwo patients dropped out in the control group, and a total of 168 cases were included in the final analysis, 70 in the treatment group and 68 in the control group. The treatment group showed a significant reduction in TCM symptom scores, serum TBA, IL-23, and DKK-1 levels, and a significant increase in alpha-fetoprotein (AFP), carbohydrate antigen 125 (CA125), carbohydrate antigen 199 (CA199) levels; in the control group, carcinoembryonic antigen (CEA), CA125, CA199 levels significantly increased (P<0.05 or P<0.01); and carbohydrate antigen 242 (CA242) level in both the treatment group and the control group decreased significantly (P<0.01). The treatment group had lower TCM symptom scores and lower levels of serum TBA, IL-23, and DKK-1 compared to the control group (P<0.05). The effective rate for TCM syndrome efficacy in the treatment group was 80.00% (56/70), significantly higher than the 20.59% (14/68) in the control group (P < 0.05). The effective rate for pathological classification in the treatment group was 72.73% (8/11) for mixed intestinal metaplasia, significantly better than 46.15% (6/13) in the control group (P<0.05). No adverse events were reported in either group. Among 40 patients who had a follow-up endoscopy after one year, 21 were from the treatment group, of whom 11 showed reduced intestinal metaplasia, 9 showed no significant changes, and 1 had worsened; while 19 patients in the control group had 4 with reduced intestinal metaplasia, 13 with no significant changes, and 2 with worsened conditions. No cancer was detected in either group. The treatment group showed significantly better improvement in intestinal metaplasia on follow-up gastric endoscopy pathology than the control group (P<0.05). ConclusionXHG can significantly improve the clinical symptoms in patients with chronic atrophic gastritis and intestinal metaplasia and reduce the degree of mixed intestinal metaplasia. The mechanism may involve lowering serum TBA, DKK-1, and IL-23 levles, thus delaying the progression from inflammation to cancer.
9.Impact of non-high-density lipoprotein cholesterol on all-cause and cause-specific mortality in the elderly over 60 years old
Zhiqing FU ; Yongyi BAI ; Li AN ; Wei ZHANG ; Song LAI ; Shan LI
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(7):847-852
Objective To determine the effect of non-high-density lipoprotein cholesterol(non-HDL-C)on all-cause and cause-specific mortality in an ≥60-year-old elderly population.Methods A total of 16 642 older adults(≥60 years)were subjected from the National Health and Nutrition Examination Survey between 1999 and 2018.According to the tertile of non-HDL-C level,the par-ticipants were divided into tertile 1(<3.15 mmol/L,n=5499),tertile 2(3.15-4.06 mmol/L,n=5499),and tertile 3 groups(>4.06 mmol/L,n=5644).The occurrences of all-cause,cardiovascu-lar,and non-cardiovascular death were identified as the study endpoint.Cox proportional hazards regression,Kaplan-Meier survival and restricted cubic spline curve analyses were applied for sta-tistical study.Results An obvious L-shaped associations were observed in non-HDL-C level with risks for all-cause,cardiovascular,and non-cardiovascular death.After adjusting multivariable,the tertile 1 group had significantly higher risks for all-cause,cardiovascular,and non-cardiovascular death than the tertile 2 group(HR=1.123,95%CI:1.054-1.200,P=0.000;HR=1.142,95%CI:1.024-1.292,P=0.027;HR=1.113,95%CI:1.033-1.210,P=0.011).Kaplan-Meier survival analysis showed that the tertile 1 group had notably lower survival rate than the tertile 2 group and the tertile 3 group(P<0.01).Threshold effect analysis revealed that when non-HDL-C level was lower than 3.36,3.18 and 3.59 mmol/L,respectively,the risk of all-cause,cardiovascular,and noncardiovascular mortality was increased.Conclusion In the elderly ≥60-year-old population,non-HDL-C level exhibited a L-shaped association with all-cause and cause-specific mortality,and>3.18 mmol/L is regarded as a rational range.
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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