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.Global Research of Medical Technology Management: A Bibliometric Analysis.
Liu-Fang WANG ; Yu-Ni HUANG ; Richard Sze-Wei WANG ; Xiao-Ping QIN ; Zhi-Yuan HU ; Bing-Long WANG ; Zhi-Min HU
Chinese Medical Sciences Journal 2025;40(2):120-131
OBJECTIVES:
To explore potential keywords, research clusters, collaborative pattern, and research trends in the field of medical technology management (MTM) through bibliometric analysis, providing insights for researchers, policy makers, and hospital administrators.
METHODS:
A retrieval formula was applied to the title, abstract, and keywords in the Web of Science (WoS) Core Collection, along with system-recommended terms, to identify articles on MTM. A total of 181 articles published between 1974 and 2022 were retained for quantitative analysis. The global trend of research output; total citations, average citations, and H-index; and bibliographic coupling, co-authorship, and keyword co-occurrence were analyzed using VOSviewer.
RESULTS:
The number of articles on MTM has been steadily increasing year by year. The focus of research has shifted from addressing basic medical needs to prioritizing emergency response and medical information security. The United States, Italy, and the United Kingdom emerged as the main contributors, with the United States leading in both volume of publications (60 articles) and academic impact (H-index = 21). Authors from the United Kingdom and the United States led the way in cross-border cooperation. The top five institutions, ranked by total link strength among cross-institutional authors, were primarily located in Canada and Spain.
CONCLUSIONS
The field of MTM has experienced stable growth over the past three decades (1993-2022). The shift of research focus has prompted a heightened emphasis on protecting patient privacy and ensuring the security of medical data. Future research should emphasize interdisciplinary and professional collaboration, as well as international cooperation and open sharing of knowledge.
Bibliometrics
;
Humans
;
Biomedical Technology
3.Predictive efficacy of multimodal MRI-based machine learning models for glioblastoma multiforme MGMT promoter methylation states
Hong-lin LI ; Shi-ting HU ; Zi-heng ZHOU ; Bing LI ; Zhi-ping QI ; Ruo-qi LI ; Kai LIU ; Chun-feng HU ; Hai-tao GE
Chinese Medical Equipment Journal 2025;46(6):7-13
Objective To explore the predictive efficacy of several multimodal MRI-based machine learning models for the promoter methylation states of O6-methylguanine-DNA methyltransferase(MGMT)of glioblastoma muliforme(GBM)patients in terms of the GBM heterogeneity and the complexity of the tumor microenvironment.Methods Firstly,the multimodal MRI images of 317 GBM patients from The University of Pennsylvania Glioblastoma(UPENN-GBM)dataset were pre-processed,with four sequences involved in including T1-weighted imaging(T1WI)sequence,T1-weighted contrast-enhanced imaging(T1CE)sequence,T2-weighted imaging(T2WI)sequence and fluid-attenuated inversion recovery(FLAIR)sequence,and the radiomics features were extracted for two regions of interest(ROIs)such as the tumor core region and the tumor edema region.Secondly,the data of the 317 GBM patients were randomly divided into a training set(254 cases)and a test set(63 cases),which underwent normalization with Z-scores and feature selection and dimensionality reduction with Lasso regression.Finally,three models were established respectively with particle swarm optimization-support vector machine(PSO-SVM),C-support vector classification(C-SVC)and adaptive boosting(adaptive boosting(Adaboost)algorithms,and the predictive efficacy of the three models for glioblastoma multiforme MGMT promoter methylation states were evaluated in terms of accuracy and AUC.Results The Adaboost model based on T2WI sequence and radiomics features of the tumor core region had the highest predictive efficacy with accuracy and AUC values of 67%and 0.74,respectively,higher than those of other combinations of sequences,models and regions of interest.Conclusion The multimodal MRI-based machine learning models can be used for the prediction of glioblastoma multiforme MGMT promoter methylation states,which provides powerful support for personalized treatment and prognostic assessment of GBM.[Chinese Medical Equipment Journal,2025,46(6):7-13]
4.Predictive efficacy of multimodal MRI-based machine learning models for glioblastoma multiforme MGMT promoter methylation states
Hong-lin LI ; Shi-ting HU ; Zi-heng ZHOU ; Bing LI ; Zhi-ping QI ; Ruo-qi LI ; Kai LIU ; Chun-feng HU ; Hai-tao GE
Chinese Medical Equipment Journal 2025;46(6):7-13
Objective To explore the predictive efficacy of several multimodal MRI-based machine learning models for the promoter methylation states of O6-methylguanine-DNA methyltransferase(MGMT)of glioblastoma muliforme(GBM)patients in terms of the GBM heterogeneity and the complexity of the tumor microenvironment.Methods Firstly,the multimodal MRI images of 317 GBM patients from The University of Pennsylvania Glioblastoma(UPENN-GBM)dataset were pre-processed,with four sequences involved in including T1-weighted imaging(T1WI)sequence,T1-weighted contrast-enhanced imaging(T1CE)sequence,T2-weighted imaging(T2WI)sequence and fluid-attenuated inversion recovery(FLAIR)sequence,and the radiomics features were extracted for two regions of interest(ROIs)such as the tumor core region and the tumor edema region.Secondly,the data of the 317 GBM patients were randomly divided into a training set(254 cases)and a test set(63 cases),which underwent normalization with Z-scores and feature selection and dimensionality reduction with Lasso regression.Finally,three models were established respectively with particle swarm optimization-support vector machine(PSO-SVM),C-support vector classification(C-SVC)and adaptive boosting(adaptive boosting(Adaboost)algorithms,and the predictive efficacy of the three models for glioblastoma multiforme MGMT promoter methylation states were evaluated in terms of accuracy and AUC.Results The Adaboost model based on T2WI sequence and radiomics features of the tumor core region had the highest predictive efficacy with accuracy and AUC values of 67%and 0.74,respectively,higher than those of other combinations of sequences,models and regions of interest.Conclusion The multimodal MRI-based machine learning models can be used for the prediction of glioblastoma multiforme MGMT promoter methylation states,which provides powerful support for personalized treatment and prognostic assessment of GBM.[Chinese Medical Equipment Journal,2025,46(6):7-13]
5.Study on the effect of different administration regimens of iprrazole enteric-coated tablets on inhibiting gastric acid secretion
Ting-Yuan PANG ; Zhi WANG ; Zi-Shu HU ; Zi-Han SHEN ; Yue-Qi WANG ; Ya-Qian CHEN ; Xue-Bing QIAN ; Jin-Ying LIANG ; Liang-Ying YI ; Jun-Long LI ; Zhi-Hui HAN ; Guo-Ping ZHONG ; Guo-Hua CHENG ; Hai-Tang HU
The Chinese Journal of Clinical Pharmacology 2024;40(1):92-96
Objective To compare the effects of 20 mg qd and 10 mg bidadministration of iprrazole enteric-coated tablets on the control of gastric acid in healthy subjects.Methods A randomized,single-center,parallel controlled trial was designed to include 8 healthy subjects.Randomly divided into 2 groups,20 mg qd administration group:20 mg enteric-coated tablets of iprrazole in the morning;10 mg bid administration group:10 mg enteric-coated tablets of iprrazole in the morning and 10 mg in the evening.The pH values in the stomach of the subjects before and 24 h after administration were monitored by pH meter.The plasma concentration of iprazole after administration was determined by HPLC-MS/MS.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin(V8.0)software.Results The PK parameters of iprrazole enteric-coated tablets and reference preparations in fasting group were as follows:The Cmax of 20 mg qd group and 10 mg bid group were(595.75±131.15)and(283.50±96.98)ng·mL-1;AUC0-t were(5 531.94±784.35)and(4 686.67±898.23)h·ng·mL-1;AUC0-∞ were(6 003.19±538.59)and(7 361.48±1 816.77)h·ng·mL-1,respectively.The mean time percentage of gastric pH>3 after 20 mg qd and 10 mg bid were 82.64%and 61.92%,and the median gastric pH within 24 h were 6.25±1.49 and 3.53±2.05,respectively.The mean gastric pH values within 24 h were 5.71±1.36 and 4.23±1.45,respectively.The correlation analysis of pharmacokinetic/pharmacodynamics showed that there was no significant correlation between the peak concentration of drug in plasma and the inhibitory effect of acid.Conclusion Compared with the 20 mg qd group and the 10 mg bid group,the acid inhibition effect is better,the administration times are less,and the safety of the two administration regimes is good.
6.Platelet/lymphocyte ratio predicts the failure of non-surgical treatment in patients with small bowel obstruction treated with intestinal obstruction catheter
Zhi-Bing HOU ; Yang HE ; Hu ZHAO ; Yu WANG ; Lie WANG ; Xin Zai WU
Parenteral & Enteral Nutrition 2024;31(4):233-238
Objective:To investigate the predictive value of platelet/lymphocyte ratio (PLR) for conversion surgery in patients with small bowel obstruction treated with intestinal obstruction catheter. Methods:The clinical data of patients with intestinal obstruction treated by intestinal obstruction catheter in the 900TH Hospital of Joint Logistics Support the Force were retrospectively collected. Logistic regression analyses were performed to identify independent predictors of conversion surgery. Restricted cubic spline (RCS) curves assessed the dose-response relationship between PLR and conversion surgery. Receiver operating characteristic (ROC) curves assessed the validity of the predictive model. Results:A total of 73 patients with small bowel obstruction treated conservatively with intestinal obstruction catheter were included and 25 (34.2%) patients were referred for surgical intervention after poor outcome of conservative treatment. Multivariate logistic regression analysis showed that PLR was an independent predictor of conversion surgery (P=0.032). The RCS analysis showed a non-linear correlation between a progressively higher risk of conversion surgery as the PLR increased. The ROC curves show that the incorporation of PLR into the prediction model significantly enhances its predictive efficacy (All P<0.05). Conclusion:PLR was found to be significantly associated with conversion surgery in small bowel obstruction patients treated with intestinal obstruction catheter,with a non-linear correlation. Incorporating PLR into the prediction model can significantly enhance the predictive efficacy,thus providing reference value for clinicians' decision-making.
7.Theoretical Reaction Model Combined with Characteristic MS2 Information for Systematical Detection and Annotation of Novel Theaflavins in Yunnan Black Tea
Yong-Lin LI ; Jie GUO ; Zhi-Hao YU ; Si-Yu LI ; Yong-Dan HU ; Lun-Zhao YI ; Da-Bing REN
Chinese Journal of Analytical Chemistry 2024;52(6):846-855,中插24-中插35
In black tea,theaflavins (TFs) are one important class of substances that determine sensory quality and have significant medicinal activities. In addition to the four kinds of common TFs,there may be many other theaflavin analogues (TFAs) with similar chemical structures in tea,but the study on them is very limited. Based on the characteristic sub-structure,mass spectrometry (MS) and MS/MS information,a method for screening and annotation of TFAs from the complex ultra high performance liquid chromatography-high-resolution mass spectrometry (UPLC-HRMS) data was proposed in this work. By analyzing the oxidation and polymerization process of a few TFs,the theoretical reaction model of TFs were summarized,which was used to calculate the precursor ion values of potential TFAs. Meanwhile,the diagnostic fragmentation ions and neutral loss of TFAs according to the fragmentation pathways obtained from chemical standards or documented in literatures were summarized. As a result,36 kinds of compounds were successfully annotated based on the calculated precursor ion values and the MS fragmentation patterns,among which 6 kinds of compounds were reported for the first time in tea. In vitro synthesis experiments were carried out to verified the annotation results. Based on the results of quantitation of 36 kinds of TFAs,a partial least squares-discriminant analysis model was used to investigate the changes of these components during black tea manufacturing. The results indicated that these novel TFAs could be used to effectively distinguish the black tea samples before and after fermentation.
8.Chemical constituents from stems and leaves of Mycetia hainanensis and their anti-rheumatoid arthritis activities.
Xiao-Ya FU ; Jia-Yi HU ; Jing-Su YU ; Yan-Zhi LIU ; Ke-Jin JIANG ; Bing-Yan SUN ; Yan-Ping LIU ; Yan-Hui FU
China Journal of Chinese Materia Medica 2024;49(24):6692-6698
The chemical constituents from the stems and leaves of Mycetia hainanensis were isolated by silica gel, ODS gel, and Sephadex LH-20 gel column chromatography and preparative HPLC. The chemical structures of all the isolated compounds were identified on the basis of their physicochemical properties, spectroscopic data, as well as the comparison of their physicochemical and spectroscopic data with the reported data in literature. Twelve compounds were isolated from the 85% ethanol extract of the stems and leaves of M. hainanensis, and they were identified as mycehainanic acid(1), 11-methoxyviburtinal(2), isovaltrate acetoxyhydrin(3), jatamanvaltrate K(4), jatamanin C(5), sarmentol F(6), 4,5-dihydroblumenol A(7), petasitolone(8), xylaguaianol D(9), aristolan-9-en-1-one(10), 3α-hydroxycostic acid(11), and ilicic acid(12). Among them, compound 1 was a new nor-sesquiterpene, and compounds 2-12 were isolated from Mycetia for the first time. In addition, the MTS method was employed to assess the anti-rheumatoid arthritis activities of compounds 1-12 based on their anti-proliferative effects on synoviocytes in vitro. The results showed that compounds 1 and 6-12 exhibited notable anti-rheumatoid arthritis activities, showcasing inhibitory effects on the proliferation of MH7A synovial fibroblast cells with the IC_(50) ranging from(5.27±0.07) to(172.68±0.32)μmol·L~(-1), which were comparable to that of the positive control methotrexate \[IC_(50) of(132.39±0.21)μmol·L~(-1)\].
Plant Leaves/chemistry*
;
Plant Stems/chemistry*
;
Arthritis, Rheumatoid/physiopathology*
;
Humans
;
Drugs, Chinese Herbal/isolation & purification*
;
Animals
;
Cell Line
;
Molecular Structure
9.Mechanism of DNA methyltransferase 3a mediating progression of lung squamous cell carcinoma and prognostic correlation analysis
Xin ZHOU ; Hao FAN ; An WANG ; Jia-Pei QIN ; Yi-Bing BAI ; Zhi-Qiang MA ; Yi HU
Medical Journal of Chinese People's Liberation Army 2024;49(12):1426-1436
Objective To investigate the correlation between DNA methyltransferase 3a(DNMT3a)expression and prognosis of lung squamous cell carcinoma(LSCC),as well as to elucidate the potential molecular mechanisms of DNMT3a in LSCC progression.Methods A retrospective analysis was conducted on a cohort of 47 LSCC patients who underwent surgery in the Department of Thoracic Surgery,the Second Affiliated Hospital of Air Force Medical University between May 2009 and January 2014.DNMT3a expression in LSCC tissues and paired adjacent non-cancerous tissues was assessed using immunohistochemical(IHC)staining.Patients were categorized into two groups based on the median IHC score of DNMT3a in LSCC tissues:high DNMT3a expression group(n=25)and low DNMT3a expression group(n=22).Prognostic correlation was analyzed in combination with clinicopathological data and public biological databases.To explore the molecular mechanisms of DNMT3a in LSCC progression,H1703 LSCC cell lines with overexpressed DNMT3a were established using a lentiviral infection method,with the creation of DNMT3a overexpression group and control group.Functional phenotype experiments were then conducted to test the differences in cell proliferation and migration between the two groups.DNMT3a overexpression tumor xenograft models were also established in nude mice,with the creation of DNMT3a overexpression group and control group(3 mice per group),to observe the growth of subcutaneous xenograft tumors.Western blotting analysis was employed to detect the expression of related proteins in the two groups of cells and subcutaneous xenograft tumors.Functional rescue experiments involved treating DNMT3a overexpression cells with c-Myc inhibitor(10058-F4)and assessing cell proliferation using EdU proliferation staining.Subsequently,DNMT3a overexpression cells were infected with RNAi-Zinc finger E-box binding homeobox 1(ZEB1)lentivirus to knock down ZEB1 expression,and a Transwell migration assay was utilized to detect cell migration.Finally,DNMT3a overexpression group and control group were treated with DNMT specific inhibitor(SGI-1027),and the effects of DNMT3a inhibition on cell proliferation and migration were observed in both overexpression and control groups.Results IHC analysis revealed significantly higher DNMT3a level in LSCC tissues compared to adjacent non-cancerous tissues(P<0.0001).High DNMT3a expression was closely associated with N stage,clinical stage and tumor differentiation degree(P<0.05 or P<0.01),and it was identified as an independent risk factor for poor prognosis in LSCC patients(P<0.05).Functional phenotype experiments indicated that DNMT3a overexpression group exhibited significantly higher colony formation number,proportion of EdU-positive cells,wound healing migration rate,and Transwell cell migration number compared with control group(P<0.05).The volume and weight of subcutaneous xenograft tumors in DNMT3a overexpression group were significantly higher than those in control group(P<0.001).Western blotting showed that the protein expression levels of c-Myc and ZEB1 in DNMT3a overexpression group were significantly higher than those in control group.Functional rescue experiments demonstrated a significant reduction in the proportion of EdU-positive cells after 10058-F4 treatment in DNMT3a overexpression group(P<0.05).Knockdown of ZEB1 led to a significant decrease in the number of Transwell cell migration in DNMT3a overexpression group(P<0.05),with no significant change in DNMT3a protein expression.Additionally,inhibition of DNMT3a with SGI-1027 resulted in a significant decrease in colony formation number and migration rate in both DNMT3a overexpression group and control group(P<0.05).Conclusions High expression of DNMT3a is a significant independent risk factor for poor prognosis of LSCC patients.DNMT3a is likely to promote the proliferation of LSCC by upregulating c-Myc expression and to enhance the migration of LSCC by increasing ZEB1 expression.

Result Analysis
Print
Save
E-mail