1.Five-year survival analysis and influencing factors of elderly lung cancer patients with chronic obstructive pulmonary disease in Mianyang City
Haishi XUE ; Ling HUANG ; Junjie XIA ; Yu QIU ; Ke GE ; Jincheng WANG ; Yuting CHEN ; Runjiao CHEN ; Lingna LI ; An LAN ; Yan HOU
Journal of Public Health and Preventive Medicine 2026;37(1):138-141
Objective To study the five-year survival status and influencing factors of elderly patients with lung cancer complicated with chronic obstructive pulmonary disease (COPD). Methods A cohort study was conducted to follow up 450 patients with lung cancer and chronic obstructive pulmonary disease who were hospitalized in our hospital from January 2018 to December 2023. The endpoint of the follow-up was the end of a five-year period or death. The Life Tables method was used to calculate survival rates and plot survival curves. The Cox proportional hazards model was used to analyze the influencing factors of five-year survival. Results The results indicated that the overall five-year survival rate of patients was 4.89%, and it decreased year by year. Cox regression analysis showed that age, gender, family functioning, and psychological status significantly influenced patient survival rate (all P<0.05). Stratified analysis found that the smoking status, family functioning, and psychological status of male patients all had an impact on survival rate (all P<0.05), while the psychological status of female patients had a more significant impact on survival (P=0.008). Conclusion This study provides a scientific basis for comprehensive intervention of elderly lung cancer patients with COPD. It is recommended that clinical attention should be paid to psychological and family factors to improve patient prognosis.
2.Pharmacodynamic Substance Basis and Mechanisms of Shangkeling Spray on Knee Osteoarthritis
Pengbo GUO ; Changhao XIAO ; Fei XIA ; Chong QIU ; Jigang WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):206-216
ObjectiveTo analyze the pharmacodynamic substance basis of Shangkeling Spray and its potential mechanisms in intervening knee osteoarthritis (KOA) using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS), network pharmacology, and molecular docking technology. MethodsUPLC-MS was used to identify the chemical components of Shangkeling Spray. Pharmacokinetic properties were employed to screen potential active ingredients. Network pharmacology methods were utilized to collect potential targets of these ingredients and the pathological gene set of KOA. An "active ingredient-disease" target network was constructed using databases such as STRING. Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) functional enrichment analyses were performed using clusterProfiler. Libraries including NumPy were employed to calculate shortest path lengths to identify dominant pharmacodynamic links. Core gene clusters were identified using MCODE, validated through the Gene Expression Omnibus (GEO) database, and molecular docking was performed between key active ingredients and core targets. ResultsA total of 322 and 314 chemical components were identified under positive and negative ion modes, respectively, with 410 components in total after de-duplication, mainly including flavonoids, coumarins, terpenoids, organic acids, and alkaloids. Analysis of the "active ingredient-disease" network identified "development and regeneration", "cell growth and death", "immune system", and "nervous system" as the dominant pharmacodynamic links of Shangkeling Spray in the treatment of KOA. Molecular docking showed that key active ingredients, such as bletillin A, formononetin, morin, oxymatrine, aconitine, gallic acid, curdione, apigenin, naringenin, and oleanolic acid, tightly bound to functional domains of 10 key targets including Jun proteins(JUN), interleukin-6 (IL-6), protein kinase B1 (Akt1), Caspase-3, nuclear transcription factor-κB subunit p65(RELA), nuclear factor-kappaB1(NF-κB1), Cyclin D1, mammalian target of rapamycin(mTOR), tumor necrosis factor (TNF), and Fos proto-oncogene protein (FOS). These interactions synergistically regulated the phosphatidylinositol 3-kinase (PI3K)/Akt/mTOR-related signaling axis and nervous system-related pathways, mediating cartilage repair, reducing inflammation and pain, and improving KOA. ConclusionThis study preliminarily clarifies the pharmacodynamic substance basis of Shangkeling Spray and suggests that its main active ingredients may improve KOA by synergistically regulating the PI3K/Akt/mTOR-related pathways, providing a reference for subsequent exploration of its substance benchmark and mechanism of action.
3.Effect of Microorganisms on The Spoilage of Donkey Hides From Different Regions
Meng ZHANG ; Qiu-Mei LI ; Jia-Wei KANG ; Jie YU ; Xia LI ; Yue YU
Progress in Biochemistry and Biophysics 2026;53(3):754-766
ObjectiveDonkey hide is the sole legally designated raw material for the preparation of the traditional Chinese medicine Ejiao. The quality stability of donkey hide during preservation directly determines the efficacy and safety of Ejiao. This study focuses on the dynamic succession of microbial communities during the preservation of donkey hides from different origins, aiming to clarify the correlation between microbial biodiversity difference and the degradation profiles of hide collagen and critical biochemical components, thereby providing a theoretical foundation for developing targeted preservation strategies based on microbial regulation. MethodsDonkey hides originating from four different regions were subjected to an accelerated microbial aging assay to simulate the spoilage process. The microbial community succession was analyzed using high-throughput sequencing. Microstructure changes and pore structure characteristics were assessed by scanning electron microscopy and mercury intrusion porosimetry, respectively. Additionally, the content of major components, including lipids, proteins, and sugars were determined by biochemical methods. ResultsAfter 96 h of aging, the collagen fiber structure in Africa donkey hides (ADH) exhibited significant degradation and collapse, followed by Xinjiang donkey hides (XDH). Instead, the microstructure of Dong’e black donkey hides (DDH) and Peru donkey hides (PDH) remained relatively intact. The porosities of DDH, XDH, PDH, and ADH increased from 27.9%, 15.7%, 30.3%, and 46.2% to 36.5%, 52.6%, 42.8%, and 57.7%, respectively, during the aging process, which suggested that the originally compact fiber structure was disrupted by microbial aging. Fourier transform infrared spectrometer analysis revealed the amide bands in XDH exhibited relatively weak intensity, and no collagen amide I band was observed in ADH. Meanwhile, the lipid and protein contents decreased in all four types of donkey hides, indicating that these components served as the primary nutrient sources for the growth of microorganism. Notably, the most severe collagen degradation was observed in XDH and ADH. A substantial increase was detected in the total soluble sugar in PDH aging solution and hydroxyproline in the ADH aging solution, respectively. These results indicated that donkey hides exhibit distinct patterns of structural degradation and nutrient utilization. Furthermore, the viable cells number of donkey hides increased sharply after 48 h of aging. Metagenomic analysis revealed that the relative abundance of Euryarchaeota in ADH, PDH and XDH declining from initial 93.19%, 97.73% and 30.08% to 0.79%, 1.43% and 0.02% after 96 h, respectively. Conversely, a significantly increase was observed in the abundance of Bacillota, with a marked increase in ADH, peaking at 92.75%. Additionally, the abundance of Pseudomonadota in PDH increased from 0.10% to 87.84%, suggesting that Bacillota and Pseudomonadota may be key factors exacerbating donkey hide spoilage. Unlike the other three types of donkey hides, the dominant bacterial phylum in DDH shifted from Pseudomonadota to Bacteroidota, characterized by a substantial abundance increase of Bacteroidota from 0.13% to 44.22%. ConclusionRegional variation in origin significantly influence the microbial aging of donkey hides, leading to distinct patterns of structural deterioration and differential nutrient utilization. Therefore, implementing origin-specific preservation strategies, through the precisely controlling environmental factors to suppress harmful phyla such as Bacillota and Pseudomonadota, is crucial for enhancing the storage quality of donkey hides.
4.Association between small vulnerable newborn phenotypes and the risk of neurodevelopmental delay at the age of 1 year: a prospective cohort study
Jinhua LU ; Songying SHEN ; Wujiangyuan HE ; Fengjuan ZHOU ; Xiaoyan XIA ; Minshan LU ; Jianrong HE ; Huimin XIA ; Xiu QIU ; Wenhao ZHOU
Chinese Journal of Pediatrics 2026;64(1):52-60
Objective:To investigate the association between small vulnerable newborn (SVN) phenotypes and the risk of neurodevelopmental delay at the age of 1 year.Methods:A prospective cohort study was conducted. A total of 25 860 singleton infants from "The Born in Guangzhou Cohort Study" who completed the Gesell developmental scale assessment at 1 year of age between January 2013 and June 2025 were included. Maternal sociodemographic characteristics, and other information were collected using a self-administered questionnaire, and maternal pregnancy-related information and neonatal birth data were extracted from medical records. Global developmental delay (GDD) was defined as a developmental quotient below 86 in ≥3 domains of the Gesell developmental scale, which assesses the adaptive, gross motor, fine motor, language, and personal-social domains. The random forest algorithm was employed for missing data imputation. Based on prematurity, small for gestational age (SGA), and low birth weight (LBW), newborns were categorized into 6 phenotypes: preterm-SGA-LBW, preterm-appropriate for gestational age (AGA)-LBW, preterm-AGA-nonLBW, term-SGA-LBW, term-LBW-only or term-SGA-only, and term-AGA-nonLBW phenotype. Among these, the first 5 were classified as SVN phenotypes, and the last one served as the reference group. Inter-group comparisons were performed using analysis of variance (ANOVA), χ2 tests, or Kruskal-Wallis test, as appropriate.?? Multivariable robust Poisson regression models were applied to analyze the association of different SVN phenotypes with the risks of GDD and developmental delays in specific domains, with stratified analyses by sex. Results:Among the 25 860 infants, 13 719 (53.1%) were male and 12 141 (46.9%) were female. The gestational age at birth was 39.4 (38.6, 40.0) weeks. The overall detection rate of GDD at 1 year of age was 3.7% (962/25 860). The rates of delay across developmental domains, in descending order, language in 8 134 cases (31.5%), gross motor in 4 488 cases (17.4%), personal-social in 1 271 cases (4.9%), adaptive in 1 262 cases (4.9%), and fine motor in 621 cases (2.4%). Compared with the reference group, preterm-AGA-LBW, preterm-SGA-LBW, preterm-AGA-noneLBW, and term-SGA-LBW phenotypes were all associated with an increased risk of GDD, with the adjusted RR (95% CI) of 6.07(5.01-7.35), 4.81(3.11-7.46), 2.10(1.54-2.88) and 1.89(1.29-2.76) respectively.The preterm-AGA-noneLBW phenotype was all associated with an increased risk of delay in gross motor, language and personal-social functional domains (all P<0.05). The term-SGA-LBW phenotype was associated with an increased risk of delay in gross motor, fine motor and personal-social functional domains (all P<0.01). Whereas the term-LBW-only or term-SGA-only phenotype showed no statistically association with developmental delay in any functional domain (all P≥0.05). Conclusion:The combined classification based on gestational age and birth weight helps identify infants at high risk for neurodevelopmental delay at 1 year of age, suggesting that it may offer a reference for the rational allocation of clinical resources.
5.Association between small vulnerable newborn phenotypes and the risk of neurodevelopmental delay at the age of 1 year: a prospective cohort study
Jinhua LU ; Songying SHEN ; Wujiangyuan HE ; Fengjuan ZHOU ; Xiaoyan XIA ; Minshan LU ; Jianrong HE ; Huimin XIA ; Xiu QIU ; Wenhao ZHOU
Chinese Journal of Pediatrics 2026;64(1):52-60
Objective:To investigate the association between small vulnerable newborn (SVN) phenotypes and the risk of neurodevelopmental delay at the age of 1 year.Methods:A prospective cohort study was conducted. A total of 25 860 singleton infants from "The Born in Guangzhou Cohort Study" who completed the Gesell developmental scale assessment at 1 year of age between January 2013 and June 2025 were included. Maternal sociodemographic characteristics, and other information were collected using a self-administered questionnaire, and maternal pregnancy-related information and neonatal birth data were extracted from medical records. Global developmental delay (GDD) was defined as a developmental quotient below 86 in ≥3 domains of the Gesell developmental scale, which assesses the adaptive, gross motor, fine motor, language, and personal-social domains. The random forest algorithm was employed for missing data imputation. Based on prematurity, small for gestational age (SGA), and low birth weight (LBW), newborns were categorized into 6 phenotypes: preterm-SGA-LBW, preterm-appropriate for gestational age (AGA)-LBW, preterm-AGA-nonLBW, term-SGA-LBW, term-LBW-only or term-SGA-only, and term-AGA-nonLBW phenotype. Among these, the first 5 were classified as SVN phenotypes, and the last one served as the reference group. Inter-group comparisons were performed using analysis of variance (ANOVA), χ2 tests, or Kruskal-Wallis test, as appropriate.?? Multivariable robust Poisson regression models were applied to analyze the association of different SVN phenotypes with the risks of GDD and developmental delays in specific domains, with stratified analyses by sex. Results:Among the 25 860 infants, 13 719 (53.1%) were male and 12 141 (46.9%) were female. The gestational age at birth was 39.4 (38.6, 40.0) weeks. The overall detection rate of GDD at 1 year of age was 3.7% (962/25 860). The rates of delay across developmental domains, in descending order, language in 8 134 cases (31.5%), gross motor in 4 488 cases (17.4%), personal-social in 1 271 cases (4.9%), adaptive in 1 262 cases (4.9%), and fine motor in 621 cases (2.4%). Compared with the reference group, preterm-AGA-LBW, preterm-SGA-LBW, preterm-AGA-noneLBW, and term-SGA-LBW phenotypes were all associated with an increased risk of GDD, with the adjusted RR (95% CI) of 6.07(5.01-7.35), 4.81(3.11-7.46), 2.10(1.54-2.88) and 1.89(1.29-2.76) respectively.The preterm-AGA-noneLBW phenotype was all associated with an increased risk of delay in gross motor, language and personal-social functional domains (all P<0.05). The term-SGA-LBW phenotype was associated with an increased risk of delay in gross motor, fine motor and personal-social functional domains (all P<0.01). Whereas the term-LBW-only or term-SGA-only phenotype showed no statistically association with developmental delay in any functional domain (all P≥0.05). Conclusion:The combined classification based on gestational age and birth weight helps identify infants at high risk for neurodevelopmental delay at 1 year of age, suggesting that it may offer a reference for the rational allocation of clinical resources.
6.Mechanism of Yishen Qubi Tongluo Formula (益肾祛痹通络方) in the Treatment of Rheumatoid Arthritis:Based on Network Pharmacology,Molecular Docking and Experimental Verification
Liuping XU ; Canyu YANG ; Ying LU ; Lisha MO ; Qiang CHI ; Yuan XIA ; Shuijuan LIU ; Mingliang QIU
Journal of Traditional Chinese Medicine 2026;67(5):557-566
ObjectiveTo explore the mechanism of Yishen Qubi Tongluo Formula (益肾祛痹通络方, YQTF) in the treatment of rheumatoid arthritis(RA). MethodsNetwork pharmacology was employed to retrieve and screen the active components and potential targets of YQTF as well as RA-related targets using databases including TCMSP, BATMAN, ETCM and GEO. The intersection of targets related to active components and RA-related targets was identified, and a protein-protein interaction (PPI) network was constructed. Gene Ontology (GO) functional enrichment analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis were performed, and a drug-active component-common target network of YQTF in the treatment of RA was established. The core components of YQTF were molecularly docked with key targets. Human rheumatoid arthritis synovial fibroblast cell line MH7A was divided into blank group, model group, methotrexate group and YQTF group. The blank group was cultured with 10% fetal bovine serum, while the other three groups were stimulated with 10 μg/L of recombinant human tumor necrosis factor-α (TNF-α) for 24 h to establish the RA cell model. On this basis, the methotrexate group was treated with methotrexate suspension at a concentration of 20 μmol/L, and the YQTF group was treated with 10% YQTF-medicated serum. After 48 h of intervention, the levels of TNF-α and interleukin-17A(IL-17A)contents in cell supernatants were detected by enzyme-linked immunosorbent assay (ELISA), and mRNA expressions of phosphatidylinositol 3-kinase(PI3K), protein kinase B(AKT) and mammalian target of rapamycin(mTOR) were detected by real-time quantitative polymerase chain reaction (RT-qPCR). ResultsNetwork pharmacological analysis identified 209 active components and 583 potential target genes of YQTF, as well as 818 RA-related targets. A total of 29 common targets were obtained from the intersection of drug-related targets and RA-related targets. Quercetin,β-sitosterol, kaempferol, stigmasterol and luteolin were the core active components of YQTF for the treatment of RA, while matrix metalloproteinase-9 (MMP9), prostaglandin-endoperoxide synthase 2 (PTGS2), Toll-like receptor 4 (TLR4), tumor protein p53 (TP53) and transcription factor AP-1 subunit JUN were the key targets. The GO and KEGG pathway enrichment analysis showed that the involved biological processes and pathways were mainly associated with antioxidant responses, PI3K-AKT signaling pathway and Toll-like receptor (TLR) signaling pathway. Molecular docking results showed that MMP9 and PTGS2 exhibited high binding affinities with quercetin, β-sitosterol, kaempferol, stigmasterol and luteolin; TLR4 exhibited high binding activities with β-sitosterol, stigmasterol and luteolin; and TP53 showed high binding affinity with luteolin. The results of cell experiments showed that compared with the control group, the contents of TNF-α and IL-17A as well as the mRNA expressions of AKT and mTOR in the model group significantly increased (P<0.05 or P<0.01). Compared with the model group, all the above indicators significantly decreased in the YQTF group, while the contents of TNF-α and the mRNA expression of AKT significantly decreased in the methotrexate group (P<0.05 or P<0.01). ConclusionThe mechanism of YQTF in the treatment of RA may be associated with reducing inflammatory cytokine secretion and inhibiting the activation of the PI3K-AKT-mTOR signaling pathway.
7.Assessment of ochratoxin A exposure in the diets of pregnant women in Shanghai
Kailin LI ; Renjie QI ; Hua CAI ; Xia SONG ; Jingjin YANG ; Danping QIU ; Zhenni ZHU ; Yi HE ; Baozhang LUO ; Hong LIU
Shanghai Journal of Preventive Medicine 2026;38(3):181-186
ObjectiveTo investigate the contamination status of ochratoxin A (OTA) in commercially available food products in Shanghai, and to assess OTA exposure levels and the associated non-carcinogenic and carcinogenic risks among pregnant women by integrating dietary consumption data of this population. MethodsThe levels of OTA contamination in 1 520 food samples collected in Shanghai from 2022 to 2023 were determined using liquid chromatography-tandem mass spectrometry. An exposure assessment model was developed based on the dietary consumption levels of pregnant women from the 2016‒2017 Shanghai Pregnant Women Dietary Monitoring Survey to calculate the estimated daily intake (EDI) of OTA, the margin of exposure for non-carcinogenic toxicity (MOE1), and the margin of exposure for carcinogenic toxicity (MOE2). An MOE1 greater than 200 and an MOE2 greater than 10 000 indicate that the non-carcinogenic toxicity and carcinogenic toxicity resulting from exposure are negligible, respectively. For samples with OTA contamination levels below the limit of detection (LOD), which accounted for more than 80% of the samples, the OTA levels were assigned values of 0 and LOD, respectively, for subsequent calculations. ResultsThe detection rates of OTA in cereals, nuts, dried fruits, and alcohol samples collected in 2022 were 2.03%, 0, 0, and 0, respectively. The OTA detection rates in cereals, nuts, dried fruits, beans, and alcohol samples collected in 2023 were 2.50%, 0.39%, 2.47%, 1.67%, and 13.33%, respectively. For pregnant women in Shanghai in 2022, simulation results indicated that when assigning a value of 0 and the LOD, theP50 values of EDI for dietary OTA exposure were 0.05 and 0.72 ng·(kg·d)-1, respectively, and the P95 values of EDI for dietary OTA exposure were 0.25 and 2.40 ng·(kg·d)-1, respectively. For pregnant women in Shanghai in 2023, the P50 values of EDI for dietary OTA exposure were 0.04 and 1.00 ng·(kg·d)-1, respectively, and the P95 values of EDI for dietary OTA exposure were 0.23 and 2.67 ng·(kg·d)-1, respectively, both substantially below the tolerable daily intake (TDI) for OTA [17 ng·(kg·d)-1]. The EDI for dietary OTA exposure in 100.0% of Shanghai pregnant women was lower than the TDI, indicating an overall low level of dietary OTA exposure among this population. For 100.0% of pregnant women, the MOE₁ for dietary OTA exposure exceeded 200. When assigned a value of 0, the MOE₂ for 100.0% of pregnant women in both 2022 and 2023 exceeded10 000. When assigned the LOD value, 72.3% and 81.8% of pregnant women in 2022 and 2023, respectively, had an MOE₂ exceeding 10 000. ConclusionFrom 2022 to 2023, samples of cereals, nuts, dried fruits, beans, and alcohol sold in Shanghai exhibited varying degrees of OTA contamination. The overall EDI of OTA exposure among pregnant women in Shanghai remained at a low level. The non-carcinogenic and carcinogenic risks associated with OTA exposure were generally low and at controllable levels.
8.Bibliometric and research focus analysis of saturation diving in China
Chuanlu LYU ; Linfang MO ; Shunhai QIU ; Xia WANG
Journal of Navy Medicine 2025;46(9):940-945
Objective To explore the research focus and current status of saturation diving in China by bibliometric method,so as to provide reference for the development of saturation diving.Methods With the subject term of"saturation diving",the relevant literatures were retrieved from China National Knowledge Infrastructure(CNKI),VIP,Wanfang,and Chinese biomedical literature database.NoteExpress software was used to remove repetitive literatures.Results A total of 306 literatures were included,which were published in 90 journals.The journals with more publications were Chinese Journal of Nautical Medicine and Hyperbaric Medicine,Journal of Navy Medicine,and Chinese Journal of Applied Physiology,etc.A total of 501 keywords were used 1 716 times.Visual analysis revealed that the hotspot keywords were saturation diving,simulation experiments,animal experiments,patrol diving,helium oxygen saturation diving,saturation diving systems,and ternary gas mixtures.There were 55 keywords with word frequency≥4,forming 5 meaningful clusters.Research hotspots focused on saturation diving equipment,saturation diving support system,physiological function,medical support and so on.Conclusion The development of saturation diving in China is driven by important events.Technological breakthroughs depend heavily on the contribution of military scientific research.However,experimental research achievements are far more than applied practice.In the future,saturation diving experiment chamber with larger simulation depth should be built,saturation diving system with stronger practical performance should be developed,and the training of saturation divers and medical support personnel should be increased,so as to improve the operation technique and level of saturation diving in China.
9.Anti-tumor effect of metal ion-mediated natural small molecules carrier-free hydrogel combined with CDT/PDT.
Wen-Min PI ; Gen LI ; Xin-Ru TAN ; Zhi-Xia WANG ; Xiao-Yu LIN ; Hai-Ling QIU ; Fu-Hao CHU ; Bo WANG ; Peng-Long WANG
China Journal of Chinese Materia Medica 2025;50(7):1770-1780
Metal ion-promoted chemodynamic therapy(CDT) combined with photodynamic therapy(PDT) offers broad application prospects for enhancing anti-tumor effects. In this study, glycyrrhizic acid(GA), copper ions(Cu~(2+)), and norcantharidin(NCTD) were co-assembled to successfully prepare a natural small-molecule, carrier-free hydrogel(NCTD Gel) with excellent material properties. Under 808 nm laser irradiation, NCTD Gel responded to the tumor microenvironment(TME) and acted as an efficient Fenton reagent and photosensitizer, catalyzing the conversion of endogenous hydrogen peroxide(H_2O_2) within the tumor into oxygen(O_2), and hydroxyl radicals(·OH, type Ⅰ reactive oxygen species) and singlet oxygen(~1O_2, type Ⅱ reactive oxygen species), while depleting glutathione(GSH) to stabilize reactive oxygen species and alleviate tumor hypoxia. In vitro and in vivo experiments demonstrated that NCTD Gel exhibited significant CDT/PDT synergistic therapeutic effects. Further safety evaluation and metabolic testing confirmed its good biocompatibility and safety. This novel hydrogel is not only simple to prepare, safe, and cost-effective but also holds great potential for clinical transformation, providing insights and references for the research and development of metal ion-mediated hydrogel-based anti-tumor therapies.
Hydrogels/chemistry*
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Animals
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Photochemotherapy
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Humans
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Mice
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Antineoplastic Agents/administration & dosage*
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Photosensitizing Agents/chemistry*
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Neoplasms/metabolism*
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Female
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Copper/chemistry*
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Reactive Oxygen Species/metabolism*
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Tumor Microenvironment/drug effects*
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Cell Line, Tumor
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Male
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
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Child
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome


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