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

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 ; Myelodysplastic Syndromes/blood* ; Aged ; WT1 Proteins/blood* ; Mean Platelet Volume ; Erythrocyte Indices ; ROC Curve ; Male ; Female

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.

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.

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.

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.

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.

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.

AIM: To observe the effects and mechanisms of ferroptosis on high glucose(HG)-induced retinal pigment epithelium(RPE)cells injury, and to provide new ideas for the treatment of diabetic retinopathy(DR).METHODS: The ARPE-19 cell lines cultured in vitro were divided into normal control group(NC group), high glucose group(HG group), and high glucose+Ferrostatin-1 group(Fer-1 group). The cell viability of each group was detected by CCK-8 assay. The expressions of interleukin 6(IL-6), IL-1β and monocyte chemotactic protein-1(MCP-1)were detected using ELISA kits. The levels of malondialdehyde(MDA), glutathione(GSH), glutathione peroxidase 4(GPX4)and iron content were detected using the corresponding assay kits. The mitochondrial changes in ARPE-19 cells were observed by transmission electron microscopy. The expressions of ferroptosis-related proteins including long-chain lipoyl CoA synthase 4(ACSL4)and GPX4, as well as vascular endothelial growth factor(VEGF)were detected by Western blotting and immunofluorescence staining.RESULTS: Compared with NC group, the cell viability of HG group decreased significantly, the expression levels of inflammatory factors in cell supernatant increased, the contents of MDA and iron significantly increased, GSH and GPX4 significantly decreased(all P<0.01), the mitochondria of ARPE-19 cells shrunk, the expression of proteins ACSL4 and VEGF increased, while the expression of GPX4 decreased(all P<0.01). Compared with HG group, the cell viability of Fer-1 group significantly increased, the expression levels of inflammatory factors in cell supernatant decreased, MDA and iron contents significantly decreased, GSH contents and GPX4 viability significantly increased(all P<0.05), the morphology of mitochondria in ARPE-19 cells improved, the expression of ACSL4 and VEGF decreased, while the expression of GPX4 increased(all P<0.05).CONCLUSION: Ferroptosis is involved in the injury of RPE induced by HG. Inhibiting ferroptosis can improve cell viability, reduce inflammation and oxidative stress, and alleviate HG-induced RPE cells injury.

Objective: To investigate the safety and efficacy of troxatabine in advanced or relapsed malignant tumors resistant to standard therapy in China. Methods: This is a phase Ⅰ prospective study. During dose escalation, patients in Cancer Hospital, Chinese Academy of Medical Sciences received a single-dose intravenous infusion of troxacitabine. The planned dosing groups were 1.8, 3.6, 4.8, 6.4 and 8.0 mg/m(2) on days 1 and 8 every 3 weeks. The data of all patients were collected for safety analyses. Safety and tolerability were evaluated by monitoring adverse events. Results: Nineteen patients were enrolled from April 2018 to May 2019. The major adverse events were fatigue (89.5%, 17/19), leukopenia (84.2%, 16/19) and neutropenia (78.9%, 15/19). The dose limiting toxicity was neutropenia. The maximum tolerated dose was 6.4 mg/m(2). The best effect was stable disease (43.8%). The half-life of elimination phase from 15.91 hours to 76.63 hours in each dose group. Conclusions: The toxicity of troxacitabine is well tolerant. We recommend that the dose for Phase Ⅱ clinical trial should be 6.4 mg/m(2).
Humans ; Antineoplastic Agents/adverse effects* ; Maximum Tolerated Dose ; Neoplasms/drug therapy* ; Neutropenia/chemically induced* ; Prospective Studies