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.Causal Associations between Particulate Matter 2.5 (PM 2.5), PM 2.5 Absorbance, and Inflammatory Bowel Disease Risk: Evidence from a Two-Sample Mendelian Randomization Study.
Xu ZHANG ; Zhi Meng WU ; Lu ZHANG ; Bing Long XIN ; Xiang Rui WANG ; Xin Lan LU ; Gui Fang LU ; Mu Dan REN ; Shui Xiang HE ; Ya Rui LI
Biomedical and Environmental Sciences 2025;38(2):167-177
OBJECTIVE:
Several epidemiological observational studies have related particulate matter (PM) exposure to Inflammatory bowel disease (IBD), but many confounding factors make it difficult to draw causal links from observational studies. The objective of this study was to explore the causal association between PM 2.5 exposure, its absorbance, and IBD.
METHODS:
We assessed the association of PM 2.5 and PM 2.5 absorbance with the two primary forms of IBD (Crohn's disease [CD] and ulcerative colitis [UC]) using Mendelian randomization (MR) to explore the causal relationship. We conducted two-sample MR analyses with aggregated data from the UK Biobank genome-wide association study. Single-nucleotide polymorphisms linked with PM 2.5 concentrations or their absorbance were used as instrumental variables (IVs). We used inverse variance weighting (IVW) as the primary analytical approach and four other standard methods as supplementary analyses for quality control.
RESULTS:
The results of MR demonstrated that PM 2.5 had an adverse influence on UC risk (odds ratio [ OR] = 1.010; 95% confidence interval [ CI] = 1.001-1.019, P = 0.020). Meanwhile, the results of IVW showed that PM 2.5 absorbance was also causally associated with UC ( OR = 1.012; 95% CI = 1.004-1.019, P = 0.002). We observed no causal relationship between PM 2.5, PM 2.5 absorbance, and CD. The results of sensitivity analysis indicated the absence of heterogeneity or pleiotropy, ensuring the reliability of MR results.
CONCLUSION
Based on two-sample MR analyses, there are potential positive causal relationships between PM 2.5, PM 2.5 absorbance, and UC.
Humans
;
Mendelian Randomization Analysis
;
Particulate Matter/analysis*
;
Polymorphism, Single Nucleotide
;
Inflammatory Bowel Diseases/genetics*
;
Air Pollutants/analysis*
;
Crohn Disease/genetics*
;
Colitis, Ulcerative/genetics*
;
Genome-Wide Association Study
;
Risk Factors
;
Environmental Exposure
3.Serum Lipidomics Profiling to Identify Potential Biomarkers of Ischemic Stroke: A Pilot Study in Chinese Adults.
Ji Jun SHI ; Zu Jiao NIE ; Shu Yao WANG ; Hao ZHANG ; Xin Wei LI ; Jia Ling YAO ; Yi Bing JIN ; Xiang Dong YANG ; Xue Yang ZHANG ; Ming Zhi ZHANG ; Hao PENG
Biomedical and Environmental Sciences 2025;38(8):918-925
OBJECTIVE:
Lipid oxidation is involved in the pathogenesis of atherosclerosis and may be contribute to the development of Ischemic stroke (IS). However, the lipid profiles associated with IS have been poorly studied. We conducted a pilot study to identify potential IS-related lipid molecules and pathways using lipidomic profiling.
METHODS:
Serum lipidomic profiling was performed using LC-MS in 20 patients with IS and 20 age- and sex-matched healthy controls. Univariate and multivariate analyses were simultaneously performed to identify the differential lipids. Multiple testing was controlled for using a false discovery rate (FDR) approach. Enrichment analysis was performed using MetaboAnalyst software.
RESULTS:
Based on the 294 lipids assayed, principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) models were used to distinguish patients with IS from healthy controls. Fifty-six differential lipids were identified with an FDR-adjusted P less than 0.05 and variable influences in projection (VIP) greater than 1.0. These lipids were significantly enriched in glycerophospholipid metabolism (FDR-adjusted P = 0.009, impact score = 0.216).
CONCLUSIONS
Serum lipid profiles differed significantly between patients with IS and healthy controls. Thus, glycerophospholipid metabolism may be involved in the development of IS. These results provide initial evidence that lipid molecules and their related metabolites may serve as new biomarkers and potential therapeutic targets for IS.
Humans
;
Pilot Projects
;
Lipidomics
;
Male
;
Female
;
Biomarkers/blood*
;
Middle Aged
;
Ischemic Stroke/blood*
;
Aged
;
China
;
Lipids/blood*
;
Adult
;
Case-Control Studies
;
East Asian People
4.An intervention tool for poor compliance of specimen submission before therapeutic use of antibiotics based on the Delphi method
Guoai FAN ; Ruirui LIU ; Lin WANG ; Xin LIU ; Bing JI ; Fang LIU
Chinese Journal of Nosocomiology 2025;35(15):2346-2350
OBJECTIVE To construct an intervention tool for poor compliance of specimen collection and submission before the therapeutic use of antimicrobial agents.METHODS An intervention tool for the poor compliance of spec-imen collection and submission before the therapeutic use of antimicrobial agents was developed through literature review,research group discussions,and two rounds of expert consultations.The tool was subsequently applied in clinical practice to verify its effectiveness.RESULTS The authority coefficient of the consulted experts was 0.95,the feedback rate of the two rounds of expert consultations was 100.00%.The coefficients of variation of the two rounds of consultations were 14.77%and 8.60%,and Kendall's Concordance Coefficients were 0.787 and 0.854(all P<0.05).Finally,an intervention tool for the poor compliance of specimen collection and submission before the therapeutic use of antimicrobial agents was formed,which consisted of 2 first-level items,9 second-level i-tems,and 19 third-level items.After one round of intervention with this tool,the rates of specimen collection and submission before the therapeutic use of antimicrobial agents,the rates of pathogen detection related to healthcare-associated infections,and the rates of pathogen detection before the combined use of key drugs reached the expec-ted targets(69.36%,99.00%and 100.00%,respectively).CONCLUSIONS The intervention tool for the poor compliance of specimen collection and submission before the therapeutic use of antimicrobial agents constructed based on the Delphi method demonstrates high reliability and practicality.It can be used to improve the behavior intervention of specimen collection and submission before the therapeutic use of antimicrobial agents.Moreover,it provides a reference for the intervention strategies in increasing the awareness of specimen collection and submis-sion among the target population,ensuring the correct timing of specimen collection orders,and excuting medical orders at reasonable time nodes.
5.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
6.Research hotspots and trends of functional cure of hepatitis B based on bibliometric analysis
Qi-ran ZHANG ; Bing CAO ; Ji-bin XIN ; Li-jun WU ; Yu-lei SUN ; Jun YING ; Wen-hong ZHANG
Fudan University Journal of Medical Sciences 2025;52(2):159-170
Objective To analyze the global literature related to functional cure of hepatitis B from 2019 to 2023 by using bibliometric analysis methods,so as to help researchers understand the research hotspots and trends in this field.Methods The literature related to the topic of functional cure of hepatitis B included in the Science Citation Index Expanded(SCI-Expanded)of the Web of Science Core Collection from 2019 to 2023 was searched.By using VOSviewer and CiteSpace visual analysis tools,analyses were conducted from the perspectives of publication trends,international research cooperation networks,and keyword emergence,and were elaborated with the specific contents of the related literature to elucidate research hotspots and trends.Results A total of 600 eligible papers in this field were included.Keyword co-occurrence and thematic clustering suggested that the main research directions of functional cure were:serum biomarkers for prediction and monitoring of functional cure,functional cure and immunity,nucleoside analog discontinuation,interferon therapy,and long-term prognosis of functional cure.The research contents of the ESI highly cited original research papers were similar to the clustering of the above,but showed more attention on the novel agents for functional cure.The content of the keyword emergence map showed that hotspots of interest changed from virologic mechanisms and serum markers,to nucleoside analog discontinuation and interferon therapy,and finally to immunologic mechanisms and new drug.Conclusion The research hotspots and trends of functional cure of hepatitis B were focused on virological mechanism,serum markers,immunological mechanism,nucleoside analog discontinuation,interferon therapy,and long-term prognosis after cure.
7.Current status,hotspots and prospects of research on liver failure caused by viral hepatitis:a bibliometric and visualization-based analysis
Xiang-yu QIN ; Bing CAO ; Ji-bin XIN ; Li-jun WU ; Jian-ming ZHENG ; Jun YING
Fudan University Journal of Medical Sciences 2025;52(2):180-189
Objective To conduct a bibliometric analysis of relevant literature on liver failure caused by viral hepatitis from the past five years,and to help researchers understand the current status and hotspots in this field,and to provide insights into future research trends.Methods Based on the Science Citation Index Expanded(SCI-Expanded)data from Web of Science Core Collection,visualization analysis and mapping were conducted through VOSviewer and CiteSpace software to generate visual representations of international research collaboration networks,keyword co-occurrence clustering,and keyword bursts.Results From 2019 to 2023,a total of 873 relevant literature were included,with a total citation frequency of 7 364 and an average citation frequency of 8.44.Among them,China had the highest number of publications(458 articles,52.46%)and had the most cooperation with the United States.The research hotspots of viral hepatitis induced liver failure were mainly divided into three categories:basic and clinical research on liver failure caused by non-hepatitis B virus(HBV),the pathogenesis of HBV related liver failure,and treatment and prediction models of liver failure.The keyword time overlay map and burst map showed that the research hotspots had gradually shifted from the prevention and control of new infections to the treatment and prognosis assessment of patients with chronic infection.Conclusion China is a major international research entity in liver failure caused by viral hepatitis and actively participates in international scientific collaborations.The research hotspots on liver failure caused by viral hepatitis have gradually shifted from preventing viral hepatitis infections and expanding treatment options to the treatment of chronic infection patients and prognostic prediction.
8.Research hotspots and trends of functional cure of hepatitis B based on bibliometric analysis
Qi-ran ZHANG ; Bing CAO ; Ji-bin XIN ; Li-jun WU ; Yu-lei SUN ; Jun YING ; Wen-hong ZHANG
Fudan University Journal of Medical Sciences 2025;52(2):159-170
Objective To analyze the global literature related to functional cure of hepatitis B from 2019 to 2023 by using bibliometric analysis methods,so as to help researchers understand the research hotspots and trends in this field.Methods The literature related to the topic of functional cure of hepatitis B included in the Science Citation Index Expanded(SCI-Expanded)of the Web of Science Core Collection from 2019 to 2023 was searched.By using VOSviewer and CiteSpace visual analysis tools,analyses were conducted from the perspectives of publication trends,international research cooperation networks,and keyword emergence,and were elaborated with the specific contents of the related literature to elucidate research hotspots and trends.Results A total of 600 eligible papers in this field were included.Keyword co-occurrence and thematic clustering suggested that the main research directions of functional cure were:serum biomarkers for prediction and monitoring of functional cure,functional cure and immunity,nucleoside analog discontinuation,interferon therapy,and long-term prognosis of functional cure.The research contents of the ESI highly cited original research papers were similar to the clustering of the above,but showed more attention on the novel agents for functional cure.The content of the keyword emergence map showed that hotspots of interest changed from virologic mechanisms and serum markers,to nucleoside analog discontinuation and interferon therapy,and finally to immunologic mechanisms and new drug.Conclusion The research hotspots and trends of functional cure of hepatitis B were focused on virological mechanism,serum markers,immunological mechanism,nucleoside analog discontinuation,interferon therapy,and long-term prognosis after cure.
9.Current status,hotspots and prospects of research on liver failure caused by viral hepatitis:a bibliometric and visualization-based analysis
Xiang-yu QIN ; Bing CAO ; Ji-bin XIN ; Li-jun WU ; Jian-ming ZHENG ; Jun YING
Fudan University Journal of Medical Sciences 2025;52(2):180-189
Objective To conduct a bibliometric analysis of relevant literature on liver failure caused by viral hepatitis from the past five years,and to help researchers understand the current status and hotspots in this field,and to provide insights into future research trends.Methods Based on the Science Citation Index Expanded(SCI-Expanded)data from Web of Science Core Collection,visualization analysis and mapping were conducted through VOSviewer and CiteSpace software to generate visual representations of international research collaboration networks,keyword co-occurrence clustering,and keyword bursts.Results From 2019 to 2023,a total of 873 relevant literature were included,with a total citation frequency of 7 364 and an average citation frequency of 8.44.Among them,China had the highest number of publications(458 articles,52.46%)and had the most cooperation with the United States.The research hotspots of viral hepatitis induced liver failure were mainly divided into three categories:basic and clinical research on liver failure caused by non-hepatitis B virus(HBV),the pathogenesis of HBV related liver failure,and treatment and prediction models of liver failure.The keyword time overlay map and burst map showed that the research hotspots had gradually shifted from the prevention and control of new infections to the treatment and prognosis assessment of patients with chronic infection.Conclusion China is a major international research entity in liver failure caused by viral hepatitis and actively participates in international scientific collaborations.The research hotspots on liver failure caused by viral hepatitis have gradually shifted from preventing viral hepatitis infections and expanding treatment options to the treatment of chronic infection patients and prognostic prediction.
10.An intervention tool for poor compliance of specimen submission before therapeutic use of antibiotics based on the Delphi method
Guoai FAN ; Ruirui LIU ; Lin WANG ; Xin LIU ; Bing JI ; Fang LIU
Chinese Journal of Nosocomiology 2025;35(15):2346-2350
OBJECTIVE To construct an intervention tool for poor compliance of specimen collection and submission before the therapeutic use of antimicrobial agents.METHODS An intervention tool for the poor compliance of spec-imen collection and submission before the therapeutic use of antimicrobial agents was developed through literature review,research group discussions,and two rounds of expert consultations.The tool was subsequently applied in clinical practice to verify its effectiveness.RESULTS The authority coefficient of the consulted experts was 0.95,the feedback rate of the two rounds of expert consultations was 100.00%.The coefficients of variation of the two rounds of consultations were 14.77%and 8.60%,and Kendall's Concordance Coefficients were 0.787 and 0.854(all P<0.05).Finally,an intervention tool for the poor compliance of specimen collection and submission before the therapeutic use of antimicrobial agents was formed,which consisted of 2 first-level items,9 second-level i-tems,and 19 third-level items.After one round of intervention with this tool,the rates of specimen collection and submission before the therapeutic use of antimicrobial agents,the rates of pathogen detection related to healthcare-associated infections,and the rates of pathogen detection before the combined use of key drugs reached the expec-ted targets(69.36%,99.00%and 100.00%,respectively).CONCLUSIONS The intervention tool for the poor compliance of specimen collection and submission before the therapeutic use of antimicrobial agents constructed based on the Delphi method demonstrates high reliability and practicality.It can be used to improve the behavior intervention of specimen collection and submission before the therapeutic use of antimicrobial agents.Moreover,it provides a reference for the intervention strategies in increasing the awareness of specimen collection and submis-sion among the target population,ensuring the correct timing of specimen collection orders,and excuting medical orders at reasonable time nodes.

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