1.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
;
Child, Preschool
;
Female
;
Humans
;
Male
;
Double-Blind Method
;
Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome
2.Quality evaluation of Bidentis Herba based on HPLC fingerprint, multi-component content determination, and chemometrics.
Guo-Li SHI ; Xin-Feng WANG ; Wei-Qun LI ; Jian-Wei FAN ; Yong-Xia GUAN
China Journal of Chinese Materia Medica 2025;50(14):3944-3950
This study established the HPLC fingerprints and a multi-component content determination method for Bidens pilosa var. radiata and B. pilosa and conducted comprehensive evaluation by integrating fingerprint similarity comparison, cluster analysis(CA), and principal component analysis(PCA), aiming to provide a reference for the establishment of quality standards for Bidentis Herba. HPLC was launched on an Agilent Poroshell 120 EC-C_(18) chromatographic column(4.6 mm×250 mm, 4 μm) by gradient elution with a mobile phase of 0.1% aqueous phosphoric acid-acetonitrile at a flow rate of 0.7 mL·min~(-1), detection wavelength of 270 nm, column temperature of 25 ℃, and an injection volume of 5 μL. The fingerprint similarity of 20 batches of Bidentis Herba ranged from 0.775 to 0.979. A total of 20 common peaks were identified, and seven components were confirmed through comparison with reference substances: neochlorogenic acid, chlorogenic acid, isochlorogenic acid A, isochlorogenic acid B, isochlorogenic acid C, rutin, and hyperoside. These seven components exhibited good linearity within the ranges of 3.4-67.4, 33.0-660.3, 26.6-531.2, 3.5-70.5, 6.2-124.9, 2.4-48.3, and 4.6-91.5 μg·mL~(-1), respectively, with correlation coefficients(r) greater than 0.999. The average recovery rates ranged from 96.47% to 104.6%. CA and PCA classified the 20 batches of Bidentis Herba into two categories. PCA yielded two principal components, with a cumulative variance contribution rate of 80.557%. The established HPLC fingerprints and multi-component content determination method are simple and accurate, providing a scientific basis for the quality control and quality standard formulation of Bidentis Herba.
Chromatography, High Pressure Liquid/methods*
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Drugs, Chinese Herbal/chemistry*
;
Quality Control
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Chemometrics/methods*
;
Bidens/chemistry*
;
Principal Component Analysis
3.Mediating effect of sleep duration between depression symptoms and myopia in middle school students.
Wei DU ; Xu-Xiang YANG ; Ru-Shuang ZENG ; Chun-Yao ZHAO ; Zhi-Peng XIANG ; Yuan-Chun LI ; Jie-Song WANG ; Xiao-Hong SU ; Xiao LU ; Yu LI ; Jing WEN ; Dang HAN ; Qun DU ; Jia HE
Chinese Journal of Contemporary Pediatrics 2025;27(3):359-365
OBJECTIVES:
To explore the mediating role of sleep duration in the relationship between depression symptoms and myopia among middle school students.
METHODS:
This study was a cross-sectional research conducted using a stratified cluster random sampling method. A total of 1 728 middle school students were selected from two junior high schools and two senior high schools in certain urban areas and farms of the Xinjiang Production and Construction Corps. Questionnaire surveys and vision tests were conducted among the students. Spearman analysis was used to analyze the correlation between depression symptoms, sleep duration, and myopia. The Bootstrap method was employed to investigate the mediating effect of sleep duration between depression symptoms and myopia.
RESULTS:
The prevalence of myopia in the overall population was 74.02% (1 279/1 728), with an average sleep duration of (7.6±1.0) hours. The rate of insufficient sleep was 83.62% (1 445/1 728), and the proportion of students exhibiting depression symptoms was 25.29% (437/1 728). Correlation analysis showed significant negative correlations between visual acuity in both eyes and sleep duration with depressive emotions as measured by the Center for Epidemiologic Studies Depression Scale (with correlation coefficients of -0.064, -0.084, and -0.199 respectively; P<0.01), as well as with somatic symptoms and activities (with correlation coefficients of -0.104, -0.124, and -0.233 respectively; P<0.01) and interpersonal relationships (with correlation coefficients of -0.052, -0.059, and -0.071 respectively; P<0.05). The correlation coefficients for left and right eye visual acuity and sleep duration were 0.206 and 0.211 respectively (P<0.001). Sleep duration exhibited a mediating effect between depression symptoms and myopia (indirect effect=0.056, 95%CI: 0.029-0.088), with the mediating effect value for females (indirect effect=0.066, 95%CI: 0.024-0.119) being higher than that for males (indirect effect=0.042, 95%CI: 0.011-0.081).
CONCLUSIONS
Sleep duration serves as a partial mediator between depression symptoms and myopia in middle school students.
Humans
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Myopia/etiology*
;
Male
;
Female
;
Depression/physiopathology*
;
Cross-Sectional Studies
;
Sleep
;
Adolescent
;
Students
;
Child
;
Time Factors
;
Sleep Duration
4.Expert consensus on the application of nasal cavity filling substances in nasal surgery patients(2025, Shanghai).
Keqing ZHAO ; Shaoqing YU ; Hongquan WEI ; Chenjie YU ; Guangke WANG ; Shijie QIU ; Yanjun WANG ; Hongtao ZHEN ; Yucheng YANG ; Yurong GU ; Tao GUO ; Feng LIU ; Meiping LU ; Bin SUN ; Yanli YANG ; Yuzhu WAN ; Cuida MENG ; Yanan SUN ; Yi ZHAO ; Qun LI ; An LI ; Luo BA ; Linli TIAN ; Guodong YU ; Xin FENG ; Wen LIU ; Yongtuan LI ; Jian WU ; De HUAI ; Dongsheng GU ; Hanqiang LU ; Xinyi SHI ; Huiping YE ; Yan JIANG ; Weitian ZHANG ; Yu XU ; Zhenxiao HUANG ; Huabin LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(4):285-291
This consensus will introduce the characteristics of fillers used in the surgical cavities of domestic nasal surgery patients based on relevant literature and expert opinions. It will also provide recommendations for the selection of cavity fillers for different nasal diseases, with chronic sinusitis as a representative example.
Humans
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Nasal Cavity/surgery*
;
Nasal Surgical Procedures
;
China
;
Consensus
;
Sinusitis/surgery*
;
Dermal Fillers
5.Effects of knocking down miR-221-3p expression on the stemness maintenance and angiogenesis in breast cancer cells under hypoxia conditions
Qian ZHANG ; Qi LI ; Nan MA ; Wei-qun ZHANG
Journal of Regional Anatomy and Operative Surgery 2025;34(6):471-477
Objective To investigate the expression of microRNA-221-3p(miR-221-3p)in breast cancer cells under hypoxia conditions,and the effects of knocking down its expression on the stemness maintenance and angiogenesis in breast cancer cells.Methods Human breast cancer cell line MCF-7 were cultured under normoxic and hypoxic conditions,and the expression of miR-221-3p in cells was detected by quantitative real-time polymerase chain reaction(RT-qPCR).MCF-7 cells were divided into normoxic group(MCF-7 cells were cultured under normoxic conditions),hypoxic group(MCF-7 cells were cultured under hypoxic conditions),hypoxia+miR-221-3p NC group(MCF-7 cells were cultured under hypoxic conditions and transfected with miR-221-3p NC),hypoxia+miR-221-3p inhibitor group(MCF-7 cells were cultured under hypoxic conditions and transfected with miR-221-3p inhibitor).The proliferation activity of cells in each group was detected by CCK-8 method;the number of cell tumor spheres in each group was detected by tumor sphere formation assay;the proportion of cells labeled with the stemness marker aldehyde dehydrogenase 1(ALDH1)in each group was detected by flow cytometry;the expression of cluster of differentiation 133(CD133),cluster of differentiation 44(CD44)and sex determination region Y-box protein 2(SOX2)of cells in each group was detected by Western blot;the number of human umbilical vein endothelial cells(HUVEC)tubes formed by cell supernatant culture in each group was detected by in vitro tube formation experiment;the expression of hypoxia-inducible factor-1α(HIF-1α)and vascular endothelial growth factor(VEGF)of cells in each group was detected by Western blot.Results Compared with normoxic group,the expression levels of miR-221-3p,and CD133,CD44,SOX2,HIF-1α,VEGF protein of cells in hypoxic group were significantly up-regulated(P<0.05),and the cell proliferation activity,the number of tumor spheres,the proportion of ALDH1+cells and the number of HUVEC tubes were significantly increased(P<0.05).Compared with hypoxia+miR-221-3p NC group,the expression levels of miR-221-3p,and CD133,CD44,SOX2,HIF-1α,VEGF protein of cells in hypoxia+miR-221-3p inhibitor group were significantly down-regulated(P<0.05),and the cell proliferation activity,the number of tumor spheres,the proportion of ALDH1+cells,and the number of HUVEC were significantly decreased(P<0.05).Conclusion Under hypoxic conditions,the expression of miR-221-3p in breast cancer cells is up-regulated,and knocking down the expression of miR-221-3p can reduce the stemness and angiogenesis ability of breast cancer cells.
6.Study on the inhibition mechanism of melatonin for neuroglioma cell proliferation based on whole transcriptome sequencing
Li XU ; Xiu-jiao CHEN ; Wei-nan ZHENG ; Xin-ling MAO ; Li-bin LIN ; Qun XIE ; Qing-dong JIN
Chinese Pharmacological Bulletin 2025;41(1):163-170
Aim To detect the non-coding RNA(ncRNA)expression profile of neuroglioma cells via whole transcriptome sequencing,establish the ceRNA network and reveal the molecular mechanism of ncRNA participating in the inhibition of neuroglioma cell prolif-eration by melatonin.Methods Neuroglioma cells were intervened with by 0,2,4,6 and 8 mmol·L-1 melatonin for 24,48 and 72 h,and the inhibitory effect of melatonin on cell proliferation was detected via CCK-8;after the intervention of 0 and 4 mmol·L-1 melatonin to U251 cells for 24 h,differentially ex-pressed miRNA(DEmiRNA),lncRNA(DElncRNA)and mRNA(DEmRNA)were detected through whole transcriptome sequencing,along with GO and KEGG enrichment analysis of DEmRNA;the ceRNA network was constructed,and the key gene expression of ceR-NA was verified through qRT-PCR.Results Melato-nin exerts a time-dose-dependent inhibitory effect on the proliferation of neuroglioma cells;a total of 5049 DEmRNA,635 DElncRNA and 146 DEmiRNA in 0 and 4 mmol·L-1 melatonin groups were screened out via whole transcriptome sequencing;DEmRNAs were mainly enriched in cancer-related signaling pathways,such as ferroptosis,mTOR signaling pathway,FoxO signaling pathway and cell cycle;the ceRNA network included 4 lncRNAs,3 miRNAs and 48 mRNAs.As verified through real-time PCR,the expressions of hsa-miR-129-5p,hsa-miR-362-5p,LINC00707 and SLC16A1-AS1 of U251 cells were consistent with the sequencing results,and the gene expression of U87 cells was basically consistent with the sequencing re-sults.Conclusions Melatonin affects cancer-related signaling pathways through the differential expression of ncRNA so as to inhibit the proliferation of U251 cells;the ceRNA network composed of LINC00707,SLC16A1-AS1,hsa-miR-129-5p and hsa-miR-362-5p may take a part in the molecular mechanism of melato-nin in inhibiting neuroglioma cell proliferation.
7.Guidelines for Medical Examination for Cancer in Health Examination Agency(2025 Edition)
Wanqing CHEN ; Zhijian XU ; Qiang ZENG ; Ni LI ; Wei CAO ; Kexin CHEN ; Feng SUN ; Yuping LIU ; Yutong HE ; Peng WANG ; Shiqi TANG ; Qun ZHANG ; Kaifeng PAN ; Jie HE
China Cancer 2025;34(9):667-697
Cancer incidence in China has been rising steadily,with a particularly heavy burden from several high-prevalence malignancies.Medical examination for cancer plays a critical role in the early detection of cancer,precancerous lesions,and precursor conditions,thereby facilitating timely diagnosis and intervention.Such examination also addresses the growing demand for person-alized cancer screening services among diverse population groups.The development of evidence-based,context-specific cancer screening guidelines is essential to enhance the standardization,quality,and equity of preventive screening practices across the country,ultimately improving out-comes in early cancer detection and treatment.Guided by the Department of Medical Emergency Response of the National Health Commission,the Guidelines for Medical Examination for Cancer in Health Examination Agency(2025 Edition)were developed under the leadership of the National Cancer Center.A multidisciplinary panel of experts formulated the guidelines in accordance with the principles and methodology of the World Health Organization Handbook for Guideline Deve-lopment.The guidelines provide evidence-based recommendations on key clinical domains:target cancers and populations,overall screening workflow,screening protocols,diagnostic technolo-gies,result interpretation,follow-up procedures,and quality control.The primary objective is to standardize cancer screening practices in health examination agency and strengthen China's ca-pacity for prevention and control of high-burden cancers.
8.Expert Consensus on the Ethical Requirements for Generative AI-Assisted Academic Writing
You-Quan BU ; Yong-Fu CAO ; Zeng-Yi CHANG ; Hong-Yu CHEN ; Xiao-Wei CHEN ; Yuan-Yuan CHEN ; Zhu-Cheng CHEN ; Rui DENG ; Jie DING ; Zhong-Kai FAN ; Guo-Quan GAO ; Xu GAO ; Lan HU ; Xiao-Qing HU ; Hong-Ti JIA ; Ying KONG ; En-Min LI ; Ling LI ; Yu-Hua LI ; Jun-Rong LIU ; Zhi-Qiang LIU ; Ya-Ping LUO ; Xue-Mei LV ; Yan-Xi PEI ; Xiao-Zhong PENG ; Qi-Qun TANG ; You WAN ; Yong WANG ; Ming-Xu WANG ; Xian WANG ; Guang-Kuan XIE ; Jun XIE ; Xiao-Hua YAN ; Mei YIN ; Zhong-Shan YU ; Chun-Yan ZHOU ; Rui-Fang ZHU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):826-832
With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.
9.Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study.
Chao QUAN ; Hongyu ZHOU ; Huan YANG ; Zheng JIAO ; Meini ZHANG ; Baorong ZHANG ; Guojun TAN ; Bitao BU ; Tao JIN ; Chunyang LI ; Qun XUE ; Huiqing DONG ; Fudong SHI ; Xinyue QIN ; Xinghu ZHANG ; Feng GAO ; Hua ZHANG ; Jiawei WANG ; Xueqiang HU ; Yueting CHEN ; Jue LIU ; Wei QIU
Chinese Medical Journal 2025;138(4):452-458
BACKGROUND:
Disease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.
METHODS:
This non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.
RESULTS:
Eighty-two patients were assigned to variant ( n = 42) and wild type groups ( n = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUC tau ) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.
CONCLUSION:
ABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients.
REGISTRATION
NCT04410965, https://clinicaltrials.gov .
Humans
;
Crotonates/adverse effects*
;
Toluidines/adverse effects*
;
Nitriles
;
Hydroxybutyrates
;
Female
;
Male
;
Adult
;
ATP Binding Cassette Transporter, Subfamily G, Member 2/genetics*
;
Middle Aged
;
Multiple Sclerosis, Relapsing-Remitting/genetics*
;
Prospective Studies
;
Young Adult
;
Neoplasm Proteins/genetics*
;
East Asian People
10.Characterization and features of dampness-heat obstruction syndrome in rats with knee osteoarthritis based on "disease-syndrome-symptom" combination research strategy.
Li-Li WANG ; Teng-Teng XU ; Xiao-Xiao WANG ; Qun LI ; Li-Ting XU ; Wei-Heng CHEN ; Chun-Fang LIU ; Na LIN
China Journal of Chinese Materia Medica 2025;50(7):1861-1871
A combination of the "disease-syndrome-symptom" approach was used to study the syndrome characterization and features of dampness-heat obstruction syndrome in papain-induced knee osteoarthritis(KOA) model rats during the disease process. Forty-eight male SD rats were randomly divided into sham and model groups. The KOA model was established by injecting a mixture of papain and L-cysteine into the joint cavity on days 1, 3, and 5. During the 8 weeks following model establishment, the rats were assessed weekly for the plantar mechanical pain threshold, knee joint diameter, local skin temperature of the knee joint, weight-bearing difference between the two hind feet, and the modified Lequesne MG score of the knee joint. Samples were collected at 1, 2, 4, 6, and 8 weeks after model establishment to observe the gross lesions in cartilage and synovium. Histopathological changes in joint tissues were examined using hematoxylin-eosin, Masson's trichrome, and Senna red O-solid green staining. ELISA and immunohistochemical analysis were performed to detect the levels of interleukin(IL)-1β, IL-6, tumor necrosis factor(TNF)-α, prostaglandin E2(PGE2), and the expression of aquaporins(AQP) 1 and 3 in serum and synovium. The results showed that the ink score of articular cartilage in the model group significantly increased from 4 to 8 weeks, the cartilage Mankin's score and the percentage of Masson-positive area in cartilage increased significantly from 1 to 8 weeks. The percentage of red-stained area for cartilage proteoglycans decreased significantly from 1 to 8 weeks. The synovitis score from 1 to 6 weeks and the percentage of blue-stained collagen fibers in the synovium from 1 to 8 weeks increased significantly, with statistically significant differences compared to the sham group. The mechanical pain threshold in the model group significantly decreased from 1 to 8 weeks, the knee joint diameter significantly increased from 1 to 6 weeks, and the local skin temperature of the knee joint, the weight-bearing difference between the two hind feet, and the modified Lequesne MG score from 1 to 5 weeks significantly increased, all with statistically significant differences compared to the sham group. The levels of IL-1β, IL-6, TNF-α, and PGE2 in serum and synovium of the model group significantly increased from 1 to 6 weeks. Serum TNF-α and PGE2, and synovial IL-1β, also significantly increased at 8 weeks. The levels of cartilage AQP1 and AQP3 significantly increased from 1 to 4 weeks, while synovial AQP1 and AQP3 increased significantly from 1 to 6 weeks, with all differences statistically significant compared to the sham group. In conclusion, papain-induced KOA rats exhibited pathological changes, including articular cartilage degeneration and synovial inflammation, within 1 week of induction. The KOA rats showed characteristics of dampness-heat obstruction syndrome, such as joint pain, swelling, elevated skin temperature, and decreased function, as well as increased inflammatory factors and AQP1、AQP3 in serum and joint tissues within 5 to 6 weeks of disease onset. These results provide an experimental model for studying the syndromes of KOA with dampness-heat obstruction syndrome.
Animals
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Male
;
Rats, Sprague-Dawley
;
Rats
;
Osteoarthritis, Knee/physiopathology*
;
Disease Models, Animal
;
Humans
;
Interleukin-1beta/metabolism*
;
Interleukin-6/metabolism*
;
Tumor Necrosis Factor-alpha/metabolism*
;
Knee Joint/pathology*

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