1.Clinical Efficacy and Mechanism of Bupi Qingfei Prescription in Treating Stable Bronchiectasis
Zi YANG ; Guangsen LI ; Bing WANG ; Bo XU ; Jianxin WANG ; Sheng CAO ; Xinyan CHEN ; Xia SHI ; Qing MIAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):162-169
ObjectiveTo explore the clinical efficacy and mechanism of Bupi Qingfei prescription (BPQF) in treating stable bronchiectasis in the patients with syndromes of lung-spleen Qi deficiency and phlegm-heat accumulation in the lungs. MethodsA randomized, double-blind, placebo-controlled trial was conducted. Patients were randomized into BPQF and placebo control (PC) groups. On the basis of conventional Western medicine treatment, the BPQF granules and placebo were respectively administered at 10 g each time, twice a day, for a course of 24 weeks. The TCM symptom scores, Quality of Life Questionnaire for Bronchiectasis (QOL-B) scores, lung function indicators, T lymphocyte subsets, level of inflammatory factors in the sputum, level of neutrophil elastase (NE) in the sputum, and occurrence of adverse reactions were observed before and after treatment in the two groups. ResultsA total of 64 patients completed the study, encompassing 32 in the BPQF group and 32 in the PC group. After treatment, the BPQF group showed decreased TCM symptom scores (P<0.01), increased QOL-B scores (P<0.01), and declined levels of tumor necrosis factor (TNF)-α and NE (P<0.05, P<0.01). The PC group showed decreased TCM symptom (except spleen deficiency) scores (P<0.01), increased the QOL-B health cognition and respiratory symptom domain scores (P<0.05, P<0.01), and a declined TNF-α level (P<0.01). Moreover, the BPQF group had lower TCM symptom (except chest tightness) scores (P<0.05, P<0.01), higher QOL-B (except treatment burden) scores (P<0.05, P<0.01), and lower levels of interleukin-6 and TNF-α (P<0.05) than the PC group. Neither group showed serious adverse reactions during the treatment process. ConclusionBPQF can ameliorate the clinical symptoms of stable bronchiectasis patients who have lung-spleen Qi deficiency or phlegm-heat accumulation in the lungs by regulating the immune balance and inhibiting airway inflammatory responses.
2.Clinical observation of triptorelin combined with Biejiajian pill in the treatment of adenomyosis
Xiuping WANG ; Xianwei QIAO ; Bing XU
China Pharmacy 2026;37(3):361-365
OBJECTIVE To investigate the clinical effectiveness of triptorelin combined with Biejiajian pill in the treatment of adenomyosis (AM). METHODS Totally 186 patients with AM admitted to Nanyang First People’s Hospital from January 2022 to October 2024 were selected as subjects and randomized into control group (n=93) and observation group (n=93) using the random number table method. Patients in the control group received subcutaneous injections of triptorelin acetate around the umbilicus. In addition to the treatment of control group, patients in the observation group orally administered Biejiajian pill. Both groups underwent treatment for 12 weeks and were followed up for 6 months post-treatment. The clinical efficacy, recurrence and the occurrence of adverse drug reactions were compared between the two groups. Traditional Chinese medicine (TCM) symptoms, endometrial receptivity indicators (endometrial thickness, uterine volume, endometrial resistance index and vascular index), laboratory indexes (serum luteinizing hormone, follicle stimulating hormone, estradiol, carbohydrate antigen 125, insulin-like growth factor-1, and matrix metalloproteinase 9) were compared between the two groups before and after treatment. RESULTS A total of 164 patients completed the treatment and follow-up, among whom 80 cases were in control group and 84 cases in the observation group. The overall effective rate in the observation group was significantly higher than that in the control group, while the incidence of low estrogen levels and recurrence rate were significantly lower in the observation group compared to the control group (P<0.05). There were no statistically significant differences in the incidence of nausea or abnormal liver and kidney function between the two groups (P>0.05). After treatment, the pain Visual Analogue Scale scores, Pictorial Blood Loss Assessment Chart, TCM symptoms scores, endometrial thickness, uterine volume, endometrial resistance index, and laboratory indicators in both groups were significantly lower than those before treatment within the same group (P<0.05). Moreover, these values were significantly lower in the observation group compared to the control group (except for follicle stimulating hormone) (P<0.05). The endometrial vascular index of the two groups was significantly higher than that in the same group before treatment, and the observation group was significantly higher than the control group (P<0.05). CONCLUSIONS Triptorelin combined with Biejiajian pill has a definite therapeutic effect on AM, which can effectively improve the degree of dysmenorrhea and menstrual flow, improve endometrial receptivity, lower the recurrence rate in patients, and demonstrate good safety.
3.Preventive treatment of latent tuberculosis infections in schools clusters in Hefei during 2022-2024
GUO Ce, ZHANG Qiang, QIAN Bing, CHEN Shuangshuang, HE Yuqin, XU Rui, LI Zhen, ZHAO Cunxi, WU Jinju
Chinese Journal of School Health 2026;47(3):421-424
Objective:
To analyze the school tuberculosis (TB) outbreaks and preventive treatment in Hefei from 2022 to 2024, so as to provide reference for TB prevention and control in schools.
Methods:
Data were collected on all school based TB outbreaks occurring during 2022-2024 in Hefei, defined as ≥2 epidemiologically linked TB cases within the same school during a single semester. Statistical analyses were performed using the Chi square test.
Results:
Close contacts exhibited significantly higher TB incidence (2.88%) and latent mycobacterium tuberculosis infection (LTBI) rates (13.80%) in the school TB outbreaks, compared to non close contacts (0.12% and 2.63%, respectively). Among close contacts, secondary school students showed lower TB incidence (0.48%) and LTBI prevalence (3.42%) than both primary school or younger children (0.68%, 6.95%) and college students ( 0.78% , 6.50%), with statistically significant differences ( χ 2=360.91, 6.37; 791.71, 102.03, all P <0.05). The proportion of LTBI individuals recommended for preventive therapy was higher in primary school or younger groups (98.59%) than in secondary (95.25%) or college students (86.34%) ( χ 2=25.86, P <0.01). However, among those recommended, close contacts had higher uptake (85.82%) and completion rates (87.25%) of preventive therapy than non close contacts (69.63% and 70.57%); similarly, secondary school students demonstrated higher uptake (91.21%) and completion rates (86.45%) compared to primary school or younger (88.57%, 83.87%) and college students (57.28%, 64.08%) ( χ 2=30.52, 26.72; 125.17, 38.84, all P <0.01). Subsequent TB incidence among LTBI close contacts (13.30%) and among those who did not complete preventive therapy (22.73%) were significantly higher than among non close contacts (2.80%, 2.41%), respectively ( χ 2=32.19, 13.87, both P <0.05).
Conclusions
In school TB outbreaks, close contacts face higher LTBI prevalence and subsequent TB risk than non close contacts. College students show notably low adherence to preventive therapy. It is necessary to take targeted measures to improve the compliance of preventive measures among students.
4.B7-H3 molecule inhibits apoptosis of non-small cell lung cancer cells via the SIRT1/p53 signaling pathway
Lin ZHENG ; Jianxin ZHONG ; Ke NIU ; Qing XU ; Huijuan LING ; Yayu ZHU ; Bing CHEN ; Liwen CHEN
Acta Universitatis Medicinalis Anhui 2026;61(2):232-238
ObjectiveTo explore the role of the histone deacetylase Sirtuin-1 (SIRT1)/p53 signaling pathway in promoting apoptosis of non-small cell lung cancer cells (NSCLC) induced by the co-stimulatory molecule B7 homolog 3 (B7-H3). MethodsThe GEPIA 2 platform was used for survival analysis of NSCLC patients based on B7⁃H3 gene expression levels. The Gene Enrichment Analysis (GSEA) method was used to analyze the enrichment characteristics of B7⁃H3 molecules in the gene set of cell apoptosis. In the non-small cell lung cancer A549 cell line, B7⁃H3 was knocked down, and the protein expression levels of SIRT1 and p53 were detected by Western blot. B7⁃H3 was overexpressed in A549 cells and the apoptosis rate was analyzed by flow cytometry after Annexin V/PI double staining. Overexpression of B7⁃H3 and knockdown of SIRT1 were performed in A549 cell line. The expression levels of p53 and apoptosis-related proteins B-cell lymphoma/leukemia-2 (Bcl-2) and Bcl-2-associated X protein (Bax) were detected respectively by Western blot. Cell apoptosis rate was analyzed by flow cytometry after Annexin V/PI double staining. ResultsThe overall survival of the B7-H3 high-expression group was significantly lower than that of the low-expression group (P<0.01). B7-H3 was significantly enriched in the cell apoptosis signaling pathway and the p53 signaling pathway (P<0.05). Compared with the control group, the expression of SIRT1 was significantly downregulated, and p53 was significantly upregulated in the B7⁃H3 knockdown group (both P<0.001). Overexpression of B7-H3 significantly up-regulated SIRT1 protein expression (P<0.05), down-regulated p53 expression (P<0.01), and markedly increased the Bcl-2/Bax ratio of apoptosis-related proteins (P<0.001). The results of Annexin V/PI double staining showed that the apoptosis rate of A549 cells with overexpressed B7⁃H3 decreased (the apoptosis rate of the control group was 26.72%±4.13%, while that of the B7⁃H3 overexpression group was 13.87%±0.82%; P<0.01). In B7-H3-overexpressing cell lines, SIRT1 knockdown significantly reversed apoptosis (P<0.05), up-regulated p53 protein expression (P<0.001), and markedly reduced the Bcl-2/Bax ratio (P<0.001). ConclusionB7-H3 molecule inhibits the apoptosis of non-small cell lung cancer cells via the SIRT1/p53 signaling pathway.
5.Comparative Analysis of Exercise-induced Transcriptomic Responses in Human and Mouse Homologous Genes: Divergence and Convergence Based on The GEPREP Database
Qian SUN ; Wei-Chu TAO ; Ru WANG ; Bing-Xiang XU
Progress in Biochemistry and Biophysics 2025;52(6):1617-1630
Exercise, as a non-pharmacological intervention, holds a pivotal role in metabolic regulation, neuroplasticity, and immune homeostasis maintenance. However, human exercise studies are constrained by ethical limitations in tissue sampling, especially for key organs such as muscles and the brain. Meanwhile, rodent models like mice exhibit physiological differences in exercise patterns and metabolic rates from human. Despite these challenges, approximately 70% of human and mouse genes are conserved, providing a molecular basis for cross-species comparisons. This paper leverages the GEPREP database, which integrates human and mouse exercise transcriptomic data from multiple platforms, to conduct a comprehensive cross-species analysis of exercise-induced gene expression patterns. We employ a stringent data standardization process, including the conversion of orthologous genes and the filtering of low-expressing genes, to ensure the accuracy and reliability of the analysis. A mixed-effects model is utilized to assess differential gene expression across multiple cohorts, identifying genes that are significantly upregulated or downregulated in response to exercise. The analysis reveals a complex pattern of gene expression, with a significant number of genes showing conserved responses between humans and mice, particularly in acute aerobic exercise, where genes such as ATF3, PPARGC1A, and ANKRD1 are commonly upregulated. These genes are implicated in muscle stress response, metabolic regulation, and muscle adaptation, highlighting the shared molecular pathways activated by exercise across species. However, the study also uncovers substantial species-specific differences in gene expression, especially in chronic aerobic exercise, where the number of divergently regulated genes increases. These differences suggest that while some fundamental biological processes are conserved, the specific regulatory mechanisms and gene expression patterns can vary significantly between humans and mice. Functional enrichment analysis further reveals that conserved genes are involved in muscle development, inflammation regulation, and energy metabolism, while species-specific genes are associated with ion transport, extracellular matrix (ECM) organization, and muscle contraction, indicating the multifaceted impact of exercise on skeletal muscle function. The findings emphasize the importance of considering species-specific differences when interpreting results from animal models and translating them to human health applications. The study highlights the need for a more nuanced understanding of the molecular underpinnings of exercise-induced adaptations and underscores the value of cross-species comparative analyses in uncovering the evolutionary and functional basis of these responses. Future research should focus on integrating multi-omics data and expanding the analysis to include other tissues to provide a more comprehensive view of the systemic effects of exercise. Additionally, the development of species-specific gene editing models and the validation of key genes in exercise physiology will further enhance our understanding of the evolutionary logic behind exercise interventions. This study not only provides valuable insights into the molecular mechanisms of exercise-induced adaptations but also underscores the necessity of validating findings from animal models in human cohorts to ensure the reliability and applicability of translational research in exercise science. By addressing these aspects, the study aims to bridge the gap between basic research and clinical applications, ultimately contributing to the development of personalized exercise prescriptions and interventions that can effectively promote health and prevent diseases.
6.Genetic characteristics of VP1 region of Coxsackievirus A10 from 2004 to 2023
CHEN Yanghuiling ; CHEN Guoqing ; LI Feng ; AN Ran ; XU Bing ; YAO Xuejun
Journal of Preventive Medicine 2025;37(5):486-489
Objective:
To analyze the phylogenetic characteristics of VP1 gene of Coxsackievirus A10 (CVA10) isolates from 2004 to 2023, and to understand the genetic evolution and epidemic trends of CVA10, so as to provide references for the prevention and control of hand, foot, and mouth disease.
Methods:
The full-length sequences of the VP1 region of CVA10 isolates were retrieved from the BV-BRC database before December 15, 2024. Gene typing, sequence analysis, evolutionary analysis, and amino acid mutation site analysis were conducted using bioinformatics software.
Results:
A total of 1 253 CVA10 isolates VP1 region nucleotide full-length sequences from 2004 to 2023 were included, with 9 strains from 2004 to 2008, 338 strains from 2009 to 2012, and 906 strains from 2013 to 2023. China had the highest number of CVA10 isolates, with 1 143 strains accounting for 91.22%, and the predominant genotype was C3. Compared to the prototype strain, the nucleotide sequence homology of the VP1 region of CVA10 isolates ranged from 74.94% to 77.63%, while the amino acid sequence homology ranged from 88.59% to 93.62%. The third codon position preferred cytosine and thymine. The top three most abundant amino acids were threonine, alanine, and valine. The average relative synonymous codon usage of 30 amino acid codon groups was greater than 1. The average amino acid substitution entropy value was 0.04, with four amino acid mutation-prone sites identified, and the mutation-prone rate was 1.35%.
Conclusions
From 2004 to 2023, the majority of CVA10 isolates were primarily sourced from China, with genotype C3 being the predominant circulating strain in China. The nucleotide homology between the CVA10 isolates and the prototype strain was relatively low, and mutation-prone sites were identified, indicating that enhanced monitoring of viral variation is necessary.
7.Arsenic trioxide preconditioning attenuates hepatic ischemia- reperfusion injury in mice: Role of ERK/AKT and autophagy.
Chaoqun WANG ; Hongjun YU ; Shounan LU ; Shanjia KE ; Yanan XU ; Zhigang FENG ; Baolin QIAN ; Miaoyu BAI ; Bing YIN ; Xinglong LI ; Yongliang HUA ; Zhongyu LI ; Dong CHEN ; Bangliang CHEN ; Yongzhi ZHOU ; Shangha PAN ; Yao FU ; Hongchi JIANG ; Dawei WANG ; Yong MA
Chinese Medical Journal 2025;138(22):2993-3003
BACKGROUND:
Arsenic trioxide (ATO) is indicated as a broad-spectrum medicine for a variety of diseases, including cancer and cardiac disease. While the role of ATO in hepatic ischemia/reperfusion injury (HIRI) has not been reported. Thus, the purpose of this study was to identify the effects of ATO on HIRI.
METHODS:
In the present study, we established a 70% hepatic warm I/R injury and partial hepatectomy (30% resection) animal models in vivo and hepatocytes anoxia/reoxygenation (A/R) models in vitro with ATO pretreatment and further assessed liver function by histopathologic changes, enzyme-linked immunosorbent assay, cell counting kit-8, and terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) assay. Small interfering RNA (siRNA) for extracellular signal-regulated kinase (ERK) 1/2 was transfected to evaluate the role of ERK1/2 pathway during HIRI, followed by ATO pretreatment. The dynamic process of autophagic flux and numbers of autophagosomes were detected by green fluorescent protein-monomeric red fluorescent protein-LC3 (GFP-mRFP-LC3) staining and transmission electron microscopy.
RESULTS:
A low dose of ATO (0.75 μmol/L in vitro and 1 mg/kg in vivo ) significantly reduced tissue necrosis, inflammatory infiltration, and hepatocyte apoptosis during the process of hepatic I/R. Meanwhile, ATO obviously promoted the ability of cell proliferation and liver regeneration. Mechanistically, in vitro studies have shown that nontoxic concentrations of ATO can activate both ERK and phosphoinositide 3-kinase-serine/threonine kinase (PI3K-AKT) pathways and further induce autophagy. The hepatoprotective mechanism of ATO, at least in part, relies on the effects of ATO on the activation of autophagy, which is ERK-dependent.
CONCLUSION
Low, non-toxic doses of ATO can activate ERK/PI3K-AKT pathways and induce ERK-dependent autophagy in hepatocytes, protecting liver against I/R injury and accelerating hepatocyte regeneration after partial hepatectomy.
Animals
;
Arsenic Trioxide
;
Autophagy/physiology*
;
Reperfusion Injury/prevention & control*
;
Mice
;
Male
;
Proto-Oncogene Proteins c-akt/physiology*
;
Arsenicals/therapeutic use*
;
Oxides/therapeutic use*
;
Liver/metabolism*
;
Extracellular Signal-Regulated MAP Kinases/metabolism*
;
Mice, Inbred C57BL
8.Medication rules of Astragali Radix in ancient Chinese medical books based on "disease-medicine-dose" pattern.
Jia-Lei CAO ; Lü-Yuan LIANG ; Yi-Hang LIU ; Zi-Ming XU ; Xuan WANG ; Wen-Xi WEI ; He-Jia WAN ; Xing-Hang LYU ; Wei-Xiao LI ; Yu-Xin ZHANG ; Bing-Qi WEI ; Xian-Qing REN
China Journal of Chinese Materia Medica 2025;50(3):798-811
This study employed the "disease-medicine-dose" pattern to mine the medication rules of traditional Chinese medicine(TCM) prescriptions containing Astragali Radix in ancient Chinese medical books, aiming to provide a scientific basis for the clinical application of Astragali Radix and the development of new medicines. The TCM prescriptions containing Astragali Radix were retrieved from databases such as Chinese Medical Dictionary and imported into Excel 2020 to construct the prescription library. Statical analysis were performed for the prescriptions regarding the indications, syndromes, medicine use frequency, herb effects, nature and taste, meridian tropism, dosage forms, and dose. SPSS statistics 26.0 and IBM SPSS Modeler 18.0 were used for association rules analysis and cluster analysis. A total of 2 297 prescriptions containing Astragali Radix were collected, involving 233 indications, among which sore and ulcer, consumptive disease, sweating disorder, and apoplexy had high frequency(>25), and their syndromes were mainly Qi and blood deficiency, Qi and blood deficiency, Yin and Yang deficiency, and Qi deficiency and collateral obstruction, respectively. In the prescriptions, 98 medicines were used with the frequency >25 and they mainly included Qi-tonifying medicines and blood-tonifying medicines. Glycyrrhizae Radix et Rhizoma, Angelicae Sinensis Radix, Ginseng Radix et Rhizoma, Atractylodis Macrocephalae Rhizoma, and Citri Reticulatae Pericarpium were frequently used. The medicines with high frequency mainly have warm or cold nature, and sweet, pungent, or bitter taste, with tropism to spleen, lung, heart, liver, and kidney meridians. In the treatment of sore and ulcer, Astragali Radix was mainly used with the dose of 3.73 g and combined with Glycyrrhizae Radix et Rhizoma to promote granulation and heal up sores. In the treatment of consumptive disease, Astragali Radix was mainly used with the dose of 37.30 g and combined with Ginseng Radix et Rhizoma to tonify deficiency and replenish Qi. In the treatment of sweating disorder, Astragali Radix was mainly used with the dose of 3.73 g and combined with Glycyrrhizae Radix et Rhizoma to consolidate exterior and stop sweating. In the treatment of apoplexy, Astragali Radix was mainly used with the dose of 7.46 g and combined with Glycyrrhizae Radix et Rhizoma to dispell wind and stop convulsions. Astragali Radix can be used in the treatment of multiple system diseases, with the effects of tonifying Qi and ascending Yang, consolidating exterior and stopping sweating, and expressing toxin and promoting granulation. According to the manifestations of different diseases, when combined with other medicines, Astragali Radix was endowed with the effects of promoting granulation and healing up sores, tonifying deficiency and Qi, consolidating exterior and stopping sweating, and dispelling wind and replenishing Qi. The findings provide a theoretical reference and a scientific basis for the clinical application of Astragali Radix and the development of new medicines.
Drugs, Chinese Herbal/history*
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Humans
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Medicine, Chinese Traditional/history*
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History, Ancient
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Astragalus Plant/chemistry*
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China
;
Astragalus propinquus
9.Functional characterization of flavonoid glycosyltransferase AmGT90 in Astragalus membranaceus.
Guo-Qing PENG ; Bing-Yan XU ; Jian-Ping HUANG ; Zhi-Yin YU ; Sheng-Xiong HUANG
China Journal of Chinese Materia Medica 2025;50(6):1534-1543
Astragalus membranaceus(A. membranaceus), a traditional tonic, contains flavonoids as one of its main bioactive components and key indicators for quality standard detection. These compounds predominantly exist in glycosylated forms after glycosylation modification within the plant. The catalytic products of flavonoid glycosyltransferases in A. membranaceus have been reported to be mostly monoglycosides, and only AmUGT28 catalyzes luteolin to form diglycosides. In this study, we cloned a glycosyltransferase gene, AmGT90, from A. membranaceus, with an ORF length of 1 335 bp, encoding 444 amino acids, and the protein had a relative molecular mass of 50.5 kDa. Phylogenetic tree analysis indicated that AmGT90 belongs to the UGT74 family. In vitro enzymatic reaction showed that AmGT90 had broad substrate specificity and could catalyze the glycosylation of various flavonoids, including isoflavones, flavones, flavanones, and chalcones. AmGT90 not only catalyzed the formation of monoglycosides but also diglycosides. In addition, the mechanism of AmGT90 catalyzing the formation of diglycosides from luteolin was preliminarily explored. The experimental results showed that AmGT90 may preferentially recognize C4'-OH of luteolin and then recognize C7-OH to form diglycosides. This study reported a glycosyltransferase from A. membranaceus capable of converting flavonoids into monoglycosides and diglycosides. This finding not only enhances our understanding of the biosynthetic pathways of flavonoid glycosides in A. membranaceus but also introduces a new component for glycoside production through synthetic biology.
Glycosyltransferases/chemistry*
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Flavonoids/chemistry*
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Astragalus propinquus/classification*
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Phylogeny
;
Glycosylation
;
Plant Proteins/chemistry*
;
Substrate Specificity
;
Cloning, Molecular
;
Amino Acid Sequence
10.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
;
Child
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Child, Preschool
;
Female
;
Humans
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Male
;
Double-Blind Method
;
Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome


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