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
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Child
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Child, Preschool
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Female
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Humans
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Male
;
Double-Blind Method
;
Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome
2.Expression and Correlation of Serum MCV, MPV and WT-1 in Elderly Patients with MDS.
Huan-Ying LI ; Jun-Xia WANG ; Fei GUO ; Ai-Hua CHENG
Journal of Experimental Hematology 2025;33(2):475-480
OBJECTIVE:
To investigate the expression levels and combined detection efficiency of serum mean corpuscular volume (MCV), mean platelet volume (MPV), and tumor gene ( WT-1) in elderly patients with myelodysplastic syndrome (MDS).
METHODS:
One hundred elderly MDS patients admitted to our hospital from January 2020 to January 2021 were selected as observation group, and eighty healthy subjects during the same period were selected as control group. The levels of MCV, MPV and WT-1 were detected, and receiver operating characteristic (ROC) curve was drawn to analyze the value of combined detection of the three indicators in the prediction of MDS. The expression and correlation of MCV, MPV and WT-1 in elderly patients with MDS were analyzed and evaluated.
RESULTS:
The levels of MCV, MPV, and WT-1 in the observation group were higher than those in the control group (all P <0.001). Pearson correlation analysis showed that MCV was positively correlated with MPV and WT-1 (r =0.724, 0.733), while MPV was positively correlated with WT-1 (r =0.731). MCV, MPV, and WT-1 were independent influencing factors for elderly MDS (all P <0.05). The combined detection of the three indicators had the largest area under the curve (AUC) (0.873, 95%CI : 0.776-0.893) in the diagnosis of elderly MDS, with a sensitivity of 95.00%, a specificity of 90.00%, and Youden index of 0.850. The diagnostic value was significantly higher than that of a single indicator (both P <0.05). The levels of MCV, MPV, and WT-1 in severe patients were significantly higher than those in mild patients (all P <0.01). Logistic regression analysis showed that high expression of MCV, MPV, and WT-1 were influencing factors of severe elderly MDS. The ROC curve analysis showed that the combined diagnosis of MCV, MPV and WT-1 had the largest AUC for predicting severe MDS in elderly patients (0.897, 95%CI : 0.709-0.926), and the sensitivity and specificity were 93.18% and 91.07%, respectively (P <0.05).
CONCLUSION
MCV, MPC, and WT-1 are highly expressed in elderly patients with severe MDS. These three indicators can reflect the bone marrow hematopoietic function status of the subjects. However, compared with single indicator detection, the combined detection of the three indicators is more effective in diagnosis. It has certain advantages in elderly MDS and disease staging, and its promotion and application value is higher.
Humans
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Myelodysplastic Syndromes/blood*
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Aged
;
WT1 Proteins/blood*
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Mean Platelet Volume
;
Erythrocyte Indices
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ROC Curve
;
Male
;
Female
3.Application of a multidimensional nursing intervention based on Pender's Health Promotion Model in patients with gastrointestinal bleeding
Li CHENG ; Hua AI ; Dandan SONG
Chinese Journal of Modern Nursing 2025;31(30):4185-4189
Objective:To examine the effect of a multidimensional nursing intervention based on Pender's Health Promotion Model on recovery outcomes in patients with gastrointestinal bleeding.Methods:Using convenience sampling, 200 patients with gastrointestinal bleeding who received treatment at the China-Japan Union Hospital of Jilin University from June 2023 to June 2024 were enrolled. Patients were randomly assigned by a random-number table to a control group ( n=100) receiving routine nursing or an observation group ( n=100) receiving the multidimensional nursing intervention based on Pender's Health Promotion Model in addition to routine nursing. Outcomes included bleeding control (time to melena cessation), scores on the Health-Promoting Lifestyle Profile, Generic Quality of Life Inventory, Connor-Davidson Resilience Scale 10, and the incidence of adverse events. Results:After the intervention, the time to melena cessation in the observation group was shorter than that in the control group, and the difference was statistically significant ( P<0.05). Scores on the Health-Promoting Lifestyle Profile, Generic Quality of Life Inventory, Connor-Davidson Resilience Scale 10 (all dimensions and total scores) were higher in the observation group than thoes in the control group, and the differences were statistically significant ( P<0.05). The incidence of adverse events was 3.00% (3/100) in the observation group versus 11.00% (11/100) in the control group, and the difference was statistically significant ( P<0.05) . Conclusions:In patients with gastrointestinal bleeding, a multidimensional nursing intervention based on Pender's Health Promotion Model optimizes bleeding control, strengthens psychological resilience, improves health status and quality of life, and reduces adverse events. This approach merits wider clinical adoption.
4.Application of a multidimensional nursing intervention based on Pender's Health Promotion Model in patients with gastrointestinal bleeding
Li CHENG ; Hua AI ; Dandan SONG
Chinese Journal of Modern Nursing 2025;31(30):4185-4189
Objective:To examine the effect of a multidimensional nursing intervention based on Pender's Health Promotion Model on recovery outcomes in patients with gastrointestinal bleeding.Methods:Using convenience sampling, 200 patients with gastrointestinal bleeding who received treatment at the China-Japan Union Hospital of Jilin University from June 2023 to June 2024 were enrolled. Patients were randomly assigned by a random-number table to a control group ( n=100) receiving routine nursing or an observation group ( n=100) receiving the multidimensional nursing intervention based on Pender's Health Promotion Model in addition to routine nursing. Outcomes included bleeding control (time to melena cessation), scores on the Health-Promoting Lifestyle Profile, Generic Quality of Life Inventory, Connor-Davidson Resilience Scale 10, and the incidence of adverse events. Results:After the intervention, the time to melena cessation in the observation group was shorter than that in the control group, and the difference was statistically significant ( P<0.05). Scores on the Health-Promoting Lifestyle Profile, Generic Quality of Life Inventory, Connor-Davidson Resilience Scale 10 (all dimensions and total scores) were higher in the observation group than thoes in the control group, and the differences were statistically significant ( P<0.05). The incidence of adverse events was 3.00% (3/100) in the observation group versus 11.00% (11/100) in the control group, and the difference was statistically significant ( P<0.05) . Conclusions:In patients with gastrointestinal bleeding, a multidimensional nursing intervention based on Pender's Health Promotion Model optimizes bleeding control, strengthens psychological resilience, improves health status and quality of life, and reduces adverse events. This approach merits wider clinical adoption.
5.Investigation as well as prevention and control of infectious endophthalmi-tis cluster events after cataract operation
Na LIU ; Dong-yan GUO ; Ai-hua CHENG ; Wen-ju ZHENG ; Zhe GAO ; Jing GAO
Chinese Journal of Infection Control 2024;23(12):1573-1578
Objective To investigate the causes and intervention measures of healthcare-associated infection(HAI)cluster events after cataract phacoemulsification combined intraocular lens(Phaco+Iol)implantation in an eye hospital,and provide reference for the prevention and control of HAI.Methods Epidemiological investigation was carried out on 4 cases of endophthalmitis after Phaco+Iol implantation within 34 days from July 25 to August 27,2020.Environmental hygiene monitoring on surgical environment was carried out,and comprehensive interven-tion measures were taken(from October to November)to avoid the spread of HAI.Results Within 34 days,a to-tal of 1 219 patients underwent Phaco+Iol implantation,and 4 patients developed endophthalmitis,with an infec-tion rate of 0.32%.The 4 infected patients,with an average age of 74 years,were implanted with three different brands and models of intraocular lenses respectively.They were diagnosed with endophthalmitis at different periods from the 2nd to the 9th day after surgery,which was initially suspected to be a cluster event of HAI.A total of 13 environmental hygiene monitoring specimens from operating room were unqualified.After taking infection preven-tion and control measures,the qualified rate of environmental hygiene monitoring before and after intervention was compared,difference was statistically significant(P=0.006).Three different bacterial species(Staphylococcus chromo genes,Staphylococcus epidermidis,and Enterococcus faecalis)were identified from vitreous and aqueous humor specimens of 4 patients.Bacteria culture results of vitreous specimens from 1 patient was negative.After the implementation of the infection prevention and control strategy,no similar infection occurred.Conclusion Impro-ving the awareness on HAI prevention and control,strengthening the comprehensive monitoring and management of the operating room and related departments in the hospital,as well as taking timely and targeted preventive and con-trol measures can effectively control the occurrence of HAI cluster events.
6. Analysis of cerebral gray matter structure in multiple sclerosis and neuromyelitis optica
Xiao-Li LIU ; Ai-Xue WU ; Ru-Hua LI ; An-Ting WU ; Cheng-Chun CHEN ; Lin XU ; Cai-Yun WEN ; Dai-Qian CHEN
Acta Anatomica Sinica 2024;55(1):17-24
Objective The volume and cortical thickness of gray matter in patients with multiple sclerosis (MS) and neuromyelitis optica (NMO) were compared and analyzed by voxel⁃based morphometry (VBM) and surface⁃based morphometry (SBM), and the differences in the structural changes of gray matter in the two diseases were discussed. Methods A total of 21 MS patients, 16 NMO patients and 19 healthy controls were scanned by routine MRI sequence. The data were processed and analyzed by VBM and SBM method based on the statistical parameter tool SPM12 of Matlab2014a platform and the small tool CAT12 under SPM12. Results Compared with the normal control group (NC), after Gaussian random field (GRF) correction, the gray matter volume in MS group was significantly reduced in left superior occipital, left cuneus, left calcarine, left precuneus, left postcentral, left central paracentral lobule, right cuneus, left middle frontal, left superior frontal and left superior medial frontal (P<0. 05). After family wise error (FWE) correction, the thickness of left paracentral, left superiorfrontal and left precuneus cortex in MS group was significantly reduced (P<0. 05). Compared with the NC group, after GRF correction, the gray matter volume in the left postcentral, left precentral, left inferior parietal, right precentral and right middle frontal in NMO group was significantly increased (P<0. 05). In NMO group, the volume of gray matter in left middle occipital, left superior occipital, left inferior temporal, right middle occipital, left superior frontal orbital, right middle cingulum, left anterior cingulum, right angular and left precuneus were significantly decreased (P<0. 05). Brain regions showed no significant differences in cortical thickness between NMO groups after FWE correction. Compared with the NMO group, after GRF correction, the gray matter volume in the right fusiform and right middle frontal in MS group was increased significantly(P<0. 05). In MS group, the gray matter volume of left thalamus, left pallidum, left precentral, left middle frontal, left middle temporal, right pallidum, left inferior parietal and right superior parietal were significantly decreased (P<0. 05). After FWE correction, the thickness of left inferiorparietal, left superiorparietal, left supramarginal, left paracentral, left superiorfrontal and left precuneus cortex in MS group decreased significantly (P<0. 05). Conclusion The atrophy of brain gray matter structure in MS patients mainly involves the left parietal region, while NMO patients are not sensitive to the change of brain gray matter structure. The significant difference in brain gray matter volume between MS patients and NMO patients is mainly located in the deep cerebral nucleus mass.
7.Lycium barbarum miR2911-loaded exosomes promote spermatogenic function recovery in rats with non-obstructive azoospermia by regulating Wnt/β-catenin signaling pathways
Jia TIAN ; Zhi-Yuan XIE ; Cheng-Bin PEI ; Ai-Hua SONG ; Yue ZHOU ; Liang-Hong MA
National Journal of Andrology 2024;30(6):483-492
Objective:To investigate the effect of exosomes loaded with Lycium barbarum miRNA(Lb-miR2911)on spermato-genic function recovery in non-obstructive azoospermia(NOA)rats through cross-regulation of the Wnt/β-catenin signaling pathways.Methods:We established an NOA model in 30 four-week-old male SD rats by intraperitoneal injection of busulfan.At 5 weeks after modeling,we equally randomized the rats into a model control group(MC,untreated),an Lb-miR2911EXO group(Lb-miR2911EXO,treated by intratesticular injection of Lb-miR2911-loaded exosomes),and a sham group(Shame,treated by intratesticular injection of exosomes-empty drug),with another 10 male SD rats taken as normal controls(NC).We observed the uptake and metabolic changes of Lb-miR2911 in the testis tissue of the rats by RNA FISH at 2 and 6 weeks after treatment,detected cell proliferation,spermatogenesis and gene expressions of the Wnt/β-catenin signaling pathways in the testis tissue by Transcriptome sequencing analysis combined with Western blot and RT-PCR at 12 weeks,evaluated the recovery of the spermatogenic function based on the testis tissue morphology and sperm quality,and assessed the organ toxicity of Lb-miR2911 in the tissue and organs of the rats based on histomorphological analysis and the levels of serum TNF-α,IL-1β,Aspartate aminotransferase(AST),Alanine aminotransferase(ALT)and other relevant indi-cators.Results:After 12 weeks of treatment,histomorphological analysis showed regular arrangement of spermatogenic cells at all levels in the testis tissue,with a large number of mature sperm in the tubular lumen,and with significantly higher Johnsen scores,tes-tis weight,testicular index,sperm concentration and sperm motility in the Lb-miR2911EXO than in the sham group(all P<0.05).Compared with the model controls,the Lb-miR2911EXO group exhibited remarkably down-regulated gene expression of DACT3(P<0.05),up-regulated expressions of DVL2 and β-catenin(P<0.05),elevated levels of p-DVL2 and β-catenin(nucleus)proteins(P<0.05),increased expressions of cell proliferation-related genes CCND1,CCNE1 and CCNE2(P<0.05)and spermatogenesis-related genes DMC1,CCR6,JAM2 and KLC3(P<0.05).No pathological changes were observed in the lung,liver and kidney tis-sues of the rats,or in the levels of serum TNF-α,IL-1β,AST,ALT,creatinine and urea nitrogen in the rats treated with Lb-miR2911EXO compared with the normal controls(P>0.05).Conclusion:Lb-miR2911-loaded exosomes promote spermatogenic function recovery in NOA rats through cross-regulation of the DACT3,Wnt and β-catenin signaling pathways.
8.Investigation as well as prevention and control of infectious endophthalmi-tis cluster events after cataract operation
Na LIU ; Dong-yan GUO ; Ai-hua CHENG ; Wen-ju ZHENG ; Zhe GAO ; Jing GAO
Chinese Journal of Infection Control 2024;23(12):1573-1578
Objective To investigate the causes and intervention measures of healthcare-associated infection(HAI)cluster events after cataract phacoemulsification combined intraocular lens(Phaco+Iol)implantation in an eye hospital,and provide reference for the prevention and control of HAI.Methods Epidemiological investigation was carried out on 4 cases of endophthalmitis after Phaco+Iol implantation within 34 days from July 25 to August 27,2020.Environmental hygiene monitoring on surgical environment was carried out,and comprehensive interven-tion measures were taken(from October to November)to avoid the spread of HAI.Results Within 34 days,a to-tal of 1 219 patients underwent Phaco+Iol implantation,and 4 patients developed endophthalmitis,with an infec-tion rate of 0.32%.The 4 infected patients,with an average age of 74 years,were implanted with three different brands and models of intraocular lenses respectively.They were diagnosed with endophthalmitis at different periods from the 2nd to the 9th day after surgery,which was initially suspected to be a cluster event of HAI.A total of 13 environmental hygiene monitoring specimens from operating room were unqualified.After taking infection preven-tion and control measures,the qualified rate of environmental hygiene monitoring before and after intervention was compared,difference was statistically significant(P=0.006).Three different bacterial species(Staphylococcus chromo genes,Staphylococcus epidermidis,and Enterococcus faecalis)were identified from vitreous and aqueous humor specimens of 4 patients.Bacteria culture results of vitreous specimens from 1 patient was negative.After the implementation of the infection prevention and control strategy,no similar infection occurred.Conclusion Impro-ving the awareness on HAI prevention and control,strengthening the comprehensive monitoring and management of the operating room and related departments in the hospital,as well as taking timely and targeted preventive and con-trol measures can effectively control the occurrence of HAI cluster events.
9.Leonurine inhibits ferroptosis in renal tubular epithelial cells by activating p62/Nrf2/HO-1 signaling pathway.
Ai-Jun WU ; Nai-Qing CHEN ; Li-Hua HUANG ; Ran CHENG ; Xiao-Wan WANG ; Chuang LI ; Wei MAO ; Qing-Ming HUANG ; Peng XU ; Rui-Min TIAN
China Journal of Chinese Materia Medica 2023;48(8):2176-2183
To investigate the protective effect and the potential mechanism of leonurine(Leo) against erastin-induced ferroptosis in human renal tubular epithelial cells(HK-2 cells), an in vitro erastin-induced ferroptosis model was constructed to detect the cell viability as well as the expressions of ferroptosis-related indexes and signaling pathway-related proteins. HK-2 cells were cultured in vitro, and the effects of Leo on the viability of HK-2 cells at 10, 20, 40, 60, 80 and 100 μmol·L~(-1) were examined by CCK-8 assay to determine the safe dose range of Leo administration. A ferroptosis cell model was induced by erastin, a common ferroptosis inducer, and the appropriate concentrations were screened. CCK-8 assay was used to detect the effects of Leo(20, 40, 80 μmol·L~(-1)) and positive drug ferrostatin-1(Fer-1, 1, 2 μmol·L~(-1)) on the viability of ferroptosis model cells, and the changes of cell morphology were observed by phase contrast microscopy. Then, the optimal concentration of Leo was obtained by Western blot for nuclear factor erythroid 2-related factor 2(Nrf2) activation, and transmission electron microscope was further used to detect the characteristic microscopic morphological changes during ferroptosis. Flow cytometry was performed to detect reactive oxygen species(ROS), and the level of glutathione(GSH) was measured using a GSH assay kit. The expressions of glutathione peroxidase 4(GPX4), p62, and heme oxygenase 1(HO-1) in each group were quantified by Western blot. RESULTS:: showed that Leo had no side effects on the viability of normal HK-2 cells in the concentration range of 10-100 μmol·L~(-1). The viability of HK-2 cells decreased as the concentration of erastin increased, and 5 μmol·L~(-1) erastin significantly induced ferroptosis in the cells. Compared with the model group, Leo dose-dependently increased cell via-bility and improved cell morphology, and 80 μmol·L~(-1) Leo promoted the translocation of Nrf2 from the cytoplasm to the nucleus. Further studies revealed that Leo remarkably alleviated the characteristic microstructural damage of ferroptosis cells caused by erastin, inhibited the release of intracellular ROS, elevated GSH and GPX4, promoted the nuclear translocation of Nrf2, and significantly upregulated the expression of p62 and HO-1 proteins. In conclusion, Leo exerted a protective effect on erastin-induced ferroptosis in HK-2 cells, which might be associated with its anti-oxidative stress by activating p62/Nrf2/HO-1 signaling pathway.
Humans
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Ferroptosis
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Reactive Oxygen Species/metabolism*
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NF-E2-Related Factor 2/metabolism*
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Sincalide/pharmacology*
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Signal Transduction
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Epithelial Cells/metabolism*
;
Glutathione
10.Identification of an LDLR variant in a Chinese familial hypercholesterolemia and its relation to ROS/NLRP3-Mediated pyroptosis in hepatic cells.
Wen-Zhuo CHENG ; Wei-Hua WANG ; Ai-Ping DENG ; Xiao DANG ; Chao LIU ; Xian-Can WANG ; Ju-Yi LI ; Si JIN
Journal of Geriatric Cardiology 2023;20(5):341-349
BACKGROUND:
Familial hypercholesterolemia (FH) is a common autosomal dominant hereditary disease. Its early diagnosis and intervention significantly improve the patient's quality of life. However, there are few types of research on the FH pathogenic genes in China.
METHODS:
In this study, we recruited a family diagnosed with FH and used whole exome sequencing (WES) to analyze the proband variants. Intracellular cholesterol level, reactive oxygen species (ROS) level, and the expression of pyroptosis-related genes were detected after overexpression of wild-type or variant LDLR in L02 cells.
RESULTS:
A heterozygous missense variant predicted to be deleterious to LDLR (c.1879G > A, p.Ala627Thr) was identified in the proband. Mechanistically, intracellular cholesterol level, ROS level, and the expression of pyroptosis-related genes, nucleotide-binding oligomerization domain-like receptor family protein 3 (NLRP3) inflammasome and components (caspase 1, apoptosis-associated speck-like protein containing a caspase recruitment domain (ASC) and NLRP3), gasdermin D (GSDMD), interleukin (IL) -18, IL-1β was elevated in the variant LDLR group, which was attenuated by inhibition of ROS.
CONCLUSIONS
FH is associated with a variant (c.1879G>A, p.Ala627Thr) in the LDLR gene. Regarding the mechanism, the ROS/NLRP3-mediated pyroptosis in hepatic cells may contribute to the pathogenesis of the LDLR variant.

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