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
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Humans
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Male
;
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
2.Analysis of thickness changes in peripapillary retinal nerve fiber layer and associated risk factors in patients with Moyamoya disease
Shui-Qin CAO ; Xiao-Han HU ; Fang-Bing HAO ; Qing GUO ; Ran DING ; Hui LI ; Li-Li CHEN ; Li-Li ZHANG ; Ge LIANG
Medical Journal of Chinese People's Liberation Army 2025;50(7):855-861
Objective To investigate the characteristics of thickness changes in peripapillary retinal nerve fiber layer(pRNFL)and identify related risk factors in patients with Moyamoya disease(MMD).Methods A retrospective study was conducted on 150 MMD patients(150 eyes)aged 6-65 years admitted to the Neurosurgery Department of the Fifth Medical Center,Chinese PLA General Hospital from May 2016 to December 2023(observation group),and 150 age-matched healthy volunteers(150 eyes)from the hospital's ophthalmology outpatient department(control group).Both groups were subdivided into pediatric(≤18 years),young adult(18-40 years),and middle-aged(40-65 years)subgroups.The pRNFL thickness in four quadrants was measured by optical coherence tomography(OCT):superior(pRNFL-Sup),inferior(pRNFL-Inf),nasal(pRNFL-Nas),temporal(pRNFL-Tmp),and average thickness(pRNFL-Avg).General clinical data and pRNFL thickness were compared between two groups.Univariate and multivariate logistic regression analyses were performed to identify risk factors for pRNFL thinning in MMD patients.The cohort was randomly divided into training(n=210)and validation(n=90)sets at a 7:3 ratio.A predictive model for pRNFL thinning in MMD patients was constructed based on logistic regression results.Model performance was evaluated using the area under the receiver operating characteristic curve(AUC),and clinical utility was assessed via decision curve analysis.Results Compared with control group,MMD patients exhibited significantly reduced pRNFL-Avg,pRNFL-Sup,pRNFL-Tmp,and pRNFL-Inf thickness(P<0.05 or P<0.001),while pRNFL-Nas showed no significant difference(P>0.05).In the pediatric subgroup,pRNFL-Avg and pRNFL-Inf were thinner(P<0.05).In the young adult subgroup,pRNFL-Avg and pRNFL-Sup were reduced(P<0.001 or P<0.05).In the middle-aged subgroup,pRNFL-Avg,pRNFL-Sup,pRNFL-Inf,and pRNFL-Tmp were all thinner(P<0.05 or P<0.001).Multivariate logistic regression identified visual field defects(OR=15.28,95%CI 2.95-79.10),disease duration(OR=1.11,95%CI 1.05-1.18),and the number of involved cerebral vessels(OR=1.49,95%CI 1.01-2.22)as independent risk factors for pRNFL thinning.The predictive model achieved AUC of 0.94(95%CI 0.91-0.97)and 0.95(95%CI 0.91-0.99)in the training and validation sets,respectively.Decision curve analysis confirmed the model's favorable clinical net benefit.Conclusion Thinning of pRNFL was observed in Moyamoya disease patients with visual field defects,disease duration,and cerebral vascular involvement identified as independent risk factors for pRNFL atrophy.
3.Generalized Functional Linear Models: Efficient Modeling for High-dimensional Correlated Mixture Exposures.
Bing Song ZHANG ; Hai Bin YU ; Xin PENG ; Hai Yi YAN ; Si Ran LI ; Shutong LUO ; Hui Zi WEIREN ; Zhu Jiang ZHOU ; Ya Lin KUANG ; Yi Huan ZHENG ; Chu Lan OU ; Lin Hua LIU ; Yuehua HU ; Jin Dong NI
Biomedical and Environmental Sciences 2025;38(8):961-976
OBJECTIVE:
Humans are exposed to complex mixtures of environmental chemicals and other factors that can affect their health. Analysis of these mixture exposures presents several key challenges for environmental epidemiology and risk assessment, including high dimensionality, correlated exposure, and subtle individual effects.
METHODS:
We proposed a novel statistical approach, the generalized functional linear model (GFLM), to analyze the health effects of exposure mixtures. GFLM treats the effect of mixture exposures as a smooth function by reordering exposures based on specific mechanisms and capturing internal correlations to provide a meaningful estimation and interpretation. The robustness and efficiency was evaluated under various scenarios through extensive simulation studies.
RESULTS:
We applied the GFLM to two datasets from the National Health and Nutrition Examination Survey (NHANES). In the first application, we examined the effects of 37 nutrients on BMI (2011-2016 cycles). The GFLM identified a significant mixture effect, with fiber and fat emerging as the nutrients with the greatest negative and positive effects on BMI, respectively. For the second application, we investigated the association between four pre- and perfluoroalkyl substances (PFAS) and gout risk (2007-2018 cycles). Unlike traditional methods, the GFLM indicated no significant association, demonstrating its robustness to multicollinearity.
CONCLUSION
GFLM framework is a powerful tool for mixture exposure analysis, offering improved handling of correlated exposures and interpretable results. It demonstrates robust performance across various scenarios and real-world applications, advancing our understanding of complex environmental exposures and their health impacts on environmental epidemiology and toxicology.
Humans
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Environmental Exposure/analysis*
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Linear Models
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Nutrition Surveys
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Environmental Pollutants
;
Body Mass Index
4.Application analysis of laparoscope in operating room
Ming-yin JIANG ; Ya-fen GU ; Ya-bing HU ; Dun-hui LIU ; Dao-xiong WANG ; Bao-jiang HAN
Chinese Medical Equipment Journal 2025;46(2):87-91
Objective To analyze the application of in-use laparoscopes in clincal departments to enhance the laparoscope's effectiveness.Methods The effective utilization data of 29 laparoscopes from January 2024 to June 2024 were acquired with an hospital intelligent medical device management platform.Comparisons were carried out in terms of average daily workload,average daily hours of use and average daily efficiency between the laparoscopes from different departments and brands with non-parametric Kruskal-Wallis test and between the conventional and 3D laparoscopes with non-parametric Mann-Whitney U test.Pearson's correlation coefficient was used to analyze the correlation between the number of years of laparoscope use and the average daily workload,the average daily hours of use,and the average daily efficiency and the chi-square test was applied to investigating the relationship between the surgery grade and the type of equipment selected.Results Thoracic sugery department had the highest average daily workload(3.82 person-time),while the general medical department had the highest average daily hours of use(443.76 min)and the highest daily efficiency(92.45%).There were significant differences between the laparoscopes from different departments in average daily workload,average daily hours of use and average daily efficiency(P<0.05).Brand D laparoscope behaved the best among brands of laparoscopes with the highest average daily workload(3.72 person-time),average daily hours of use(394.41 min)and average daily efficiency(82.17%).There were sig-nificant differences between the brands of laparoscopesin average daily workload,average daily hours of use and average daily efficiency(P<0.05).3D laparoscopes obviously gained advantages over the conventional ones in average daily workload,average daily hours of use and average daily efficiency(P<0.05).The number of years of use correlated negatively with average daily workload,average daily hours of use and average daily efficiency,with Pearson correlation coefficients being-0.095,-0.039 and-0.039 respectively.Grade Three and Four surgeries had significant differences in types of selected equipment(P<0.001),and 3D laparoscopes were preferred for Grade Four surgery.Conclusion Utilization analysis of laparoscopes provides data support for optimized application and setup of laparoscopes.[Chinese Medical Equipment Journal,2025,46(2):87-91]
5.Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults (version 2025)
Bobin MI ; Faqi CAO ; Weixian HU ; Wu ZHOU ; Chenchen YAN ; Hui LI ; Yun SUN ; Yuan XIONG ; Jinmi ZHAO ; Qikai HUA ; Xinbao WU ; Xieyuan JIANG ; Dianying ZHANG ; Zhongguo FU ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Tengbo YU ; Jinhai TAN ; Xi CHEN ; Fengfei LIN ; Zhangyuan LIN ; Dongfa LIAO ; Aiguo WANG ; Shiwu DONG ; Gaoxing LUO ; Zhao XIE ; Dong SUN ; Dehao FU ; Yunfeng CHEN ; Changqing ZHANG ; Kun LIU ; Deye SONG ; Yongjun RUI ; Fei WU ; Ximing LIU ; Junwen WANG ; Meng ZHAO ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Xiao CHEN ; Guandong DAI ; Shiyuan FANG ; Wenchao SONG ; Ming CHEN ; Guanghua GUO ; Yongqing XU ; Lei YANG ; Wenqian ZHANG ; Kun ZHANG ; Xin TANG ; Hua CHEN ; Weiguo XU ; Shuquan GUO ; Yong LIU ; Xiaodong GUO ; Zhewei YE ; Liming XIONG ; Tian XIA ; Hongbin WU ; Qisheng ZHOU ; Mengfei LIU ; Yiqiang HU ; Yanjiu HAN ; Hang XUE ; Kangkang ZHA ; Wei CHEN ; Zhiyong HOU ; Bin YU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Guohui LIU
Chinese Journal of Trauma 2025;41(5):421-432
Postoperative infection of internal fixation of closed fractures the lower limbs in adults represents a devastating complication, characterized by diagnostic challenges, prolonged treatment duration and high disability rates. Current management of these infections faces multiple challenges, such as difficulties in early accurate diagnosis, and various controversies about the treatment plan, leading to poor overall diagnosis and treatment results. To address these issues, based on evidence-based medicine and principles with emphasis on scientific rigor, clinical applicability and innovation, the Trauma Branch of the Chinese Medical Association, Orthopedic Branch of the Chinese Medical Doctor Association, Orthopedics Branch of the Chinese Medical Association, and Trauma Orthopedics and Polytrauma Group of the Resuscitation and Emergency Committee of the Chinese Medical Doctor Association have collaboratively organized a panel of relevant experts to develop the Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults ( version 2025). The guideline proposed 10 recommendations, aiming to provide a foundation for standardized diagnosis and treatment of postoperative infection in adults with closed lower limb fractures.
6.Practical management study of anesthesia ventilators based on quality control testing data
Ming-yin JIANG ; Ya-fen GU ; Ya-bing HU ; Dun-hui LIU ; Dao-xiong WANG ; Bao-jiang HAN
Chinese Medical Equipment Journal 2025;46(9):75-80
Objective To carry out quality control testing of anesthesia ventilators to ensure the reliability and safety during their clinical use.Methods Totally 88 anesthesia ventilators used in some hospital underwent quality control testing in terms of tidal volume,peak airway pressure and positive end-expiratory pressure by using a gas flow analyzer according to JJF(E)61-2020 Calibration Specification of Anesthetic Machines,which included 31 ones,36 ones,12 ones and 9 ones respectively from brand A,B,C and D.The Kruskal-Wallis test was used to analyze the variability of the measured values and errors of the performance indicators between different brands of anesthesia ventilators,the chi-square test was applied to discussing the variability of the accuracy class of the performance indicators between different brands of anesthesia ventilators,and the Pearson correlation coefficient was adopted to investigate the correlation between the years of use and the absolute values of the relative errors of the performance indicators.Results The 88 anesthesia ventilators had the overall pass rate for quality control testing being 42.05%,of which,brand B had the highest pass rate(52.78%)and brand C had the lowest pass rate(8.33%).Brand B gained advantages in tidal volume when compared with brand A,C and D,with the differences being significant(P<0.05);brand A behaved the best in peak airway pressure and positive end-expiratory pressure when compared with brand B,C and D,with the differences being significant(P<0.05).Brand A had the highest proportion(63.08%)of distinction and credit in terms of the three performance indicators.The absolute value of the relative error in tidal volume was positively correlated with the years of use at the 3 measurement points for setting values of 400,600,and 800 mL respectively(P<0.05),and there was a significant correlation between the absolute value of the relative error and the years of use at a peak airway pressure setting of 10 cmH2O(1 cmH2O=98.07 Pa)(P<0.05).Conclusion Quality control testing of anesthesia ventilators contributes to finding the risks during their application,which can be an effective tool to ensure the safety of anesthesia ventilators used in medical institutions.[Chinese Medical Equipment Journal,2025,46(9):75-80]
7.Role of GLUT1-dependent glycolysis in attenuation of oxygen-glucose deprivation-reoxygenation injury by dexmedetomidine in HK-2 cells
Wei DING ; Wen-hui TAO ; Yu-le WU ; Jian-xiao WU ; Jing-yi GUO ; Li-fang XIE ; Bing-qian FAN ; Xue-song GU ; Yang LI ; Xian-wen HU
Chinese Pharmacological Bulletin 2025;41(3):444-450
Aim To evaluate the role of the glucose transporter protein 1(GLUT1)-dependent glycolytic in the attenuation of oxygen-glucose deprivation-reoxygen-ation(OGD/R)injury in HK-2 cells by dexmedetomi-dine(Dex).Methods C57/BL6 mice were random-ly divided into three groups(n=6),namely,sham operation group(Sham group),renal ischemia reper-fusion group(I/R group)and Dex group(I/R+Dex group).Serum creatinine(Cr)and urea nitrogen(BUN)were measured,while the levels of key glyco-lytic enzymes HK2,PFKFB3 and GLUT1 were meas-ured.HK-2 cells were cultured and randomised into seven groups(n=6),which was treated with OGD/R,overexpression or interference with GLUT1,Dex and glycolysis inhibitor 2-DG.CCK-8 and LDH activi-ty were used to detect cellular damage.Glycolysis lev-els were detected by lactate and ECAR.The inflamma-tory level was reflected by qRT-PCR for IL-6 and TNF-α.qRT-PCR and Western blot were performed to de-tect the levels of GLUT1,HK2,and PFKFB3.Results Dex significantly ameliorated kidney injury and HK-2 cell injury(P<0.05).Dex inhibited the OGD/R-induced rise in lactate and extracellular acidification rate(ECAR),as evidenced by suppression of the ex-pression of GLUT1,HK2 and PFKFB3(P<0.05).In vitro experiments showed that GLUT1 knockdown sig-nificantly improved OGD/R-induced cellular damage.Lactate,ECAR,glycolysis-related mRNAs and pro-teins were inhibited by GLUT1 knockdown(P<0.05).Significantly,there were no significant differ-ences in above indexes after Dex treatment based on GLUT1 knockdown.Overexpression of GLUT1 abroga-ted the protective effects of Dex,while reversing the inhibitory effects of Dex on the expression of GLUT1,HK2,and PFKFB3(P<0.05).Conclusions Dexmedetomidine attenuates OGD/R induced injury in HK-2 cells by inhibiting GLUT1-dependent glycolysis.
8.Treatment of Insomnia Using the Method of Resolving Depression and Regulating the Middle and Tranquillising Mind
Chengyun HU ; Jun ZHANG ; Qian GUO ; Shuting DU ; Zhihao LIN ; Bing GAO ; Hui HUANG
Journal of Traditional Chinese Medicine 2025;66(12):1277-1280
To summarise the clinical experience of treating insomnia with the method of resolving depression, regulating the middle, and tranquilising mind. It is believed that the key to the pathogenesis of insomnia lies in qi depression, disharmony of qi pivot, and disharmony of qi and blood, and the core treatment is to resolve depression, regulating the middle, and tranquilising mind. The self-prescribed Jieyu Anmian Formula (解郁安眠方) could be used as the basic treatment, then modified according to the performance of the patient and syndromes. For syndrome of liver depression restricting spleen, the treatment should soothe liver and invigorate spleen, resolve depression and regulate the middle; for syndrome of liver depression and phlegm coagulation, the treatment should resolve depression and phlegm, support the earth and free the wood; for syndrome of liver depression transforming into fire, the treatment should soothe liver and clear fire, resolve depression and dysphoria; for syndrome of qi stagnation and blood stasis, the treatment should activate blood and regulate the middle, resolve depression and tranquilise mind.
9.Metabolites and anti-inflammatory activities of Monascus sanguineus.
Ji-Yuan FAN ; Bing-Yu LIU ; Hui-Ming HUA ; You-Cai HU
China Journal of Chinese Materia Medica 2025;50(13):3699-3735
A variety of chromatographic techniques, including silica gel, ODS, Sephadex LH-20, and HPLC, were employed to isolate and purify the fermentation products of rice with Monascus sanguineus. A total of 38 compounds were isolated, and their structures were identified by UV, IR, NMR, MS, calculated ECD, and comparison with literature data. Compounds 1-4 were identified as new natural products, and other compounds were isolated from this fungus for the first time. A RAW264.7 macrophage model of lipopolysaccharide(LPS)-induced inflammation was used to evaluate the anti-inflammatory activities of all the compounds. The results showed that compound 6 exhibited a certain inhibitory effect on the production of nitric oxide in LPS-induced RAW264.7 cells, with an inhibition rate of 53.08%.
Monascus/chemistry*
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Mice
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Animals
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Anti-Inflammatory Agents/isolation & purification*
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RAW 264.7 Cells
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Macrophages/immunology*
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Nitric Oxide/immunology*
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Oryza/metabolism*
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Fermentation
10.Characterization of Acute Myeloid Leukemia Patients with DEK-NUP214 Fusion Gene Positive.
Ran HUANG ; Yuan-Bing WU ; Ya-Xue WU ; Xiao-Hui HU
Journal of Experimental Hematology 2025;33(5):1293-1298
OBJECTIVE:
To analyze the clinical features of acute myeloid leukemia patients with DEK-NUP214 fusion gene positive.
METHODS:
The DEK-NUP214 fusion gene was amplified by multi-nested PCR in 26 patients admitted to the First Affiliated Hospital of Soochow University from January 2018 to October 2023, and the disease course and post-transplant survival data were obtained by searching outpatient and inpatient medical records and telephone follow-up.
RESULTS:
The median follow-up time of pateints was 21.25(0.9-60.2) months. Among 26 patients with DEK-NUP214 fusion gene positive AML, 15 patients had FLT3-ITD gene mutation positive. One patient died after abandoning treatment due to non-remission of induction chemotherapy, one died due to infection, and 23 patients received allo-HSCT after achieving CR, of which one patient died within one month after transplantation due to multiple infections and one died due to severe pulmonary infection that did not respond to treatment. One patient received allo-HSCT in non-remission state and later died due to recurrence.
CONCLUSION
DEK-NUP214 fusion gene positive AML is a type of acute leukemia subtype with high risk and poor prognosis. Allo-HSCT treatment at the early stage of disease remission is the most effective way to improve the prognosis of patients.
Humans
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Leukemia, Myeloid, Acute/genetics*
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Poly-ADP-Ribose Binding Proteins
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Oncogene Proteins, Fusion/genetics*
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Nuclear Pore Complex Proteins/genetics*
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Oncogene Proteins/genetics*
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Chromosomal Proteins, Non-Histone/genetics*
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Male
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Female
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Adult
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Mutation
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Hematopoietic Stem Cell Transplantation
;
Middle Aged

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