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.A promising strategy of brain targeted delivery for the treatment of Parkinson's disease: Cyclodextrin supramolecular inclusion complex based thermosensitive gel.
Yan-Qiu WANG ; Li-Ming WANG ; Li-Feng HAN ; Yi-Bing CHEN ; Yuan-Lu CUI
Journal of Pharmaceutical Analysis 2025;15(5):101102-101102
Image 1.
3.Inflammatory Bowel Disease and Dementia: Evidence Triangulation from a Meta-Analysis of Observational Studies and Mendelian Randomization Study.
Di LIU ; Mei Ling CAO ; Shan Shan WU ; Bing Li LI ; Yi Wen JIANG ; Teng Fei LIN ; Fu Xiao LI ; Wei Jie CAO ; Jin Qiu YUAN ; Feng SHA ; Zhi Rong YANG ; Jin Ling TANG
Biomedical and Environmental Sciences 2025;38(1):56-66
OBJECTIVE:
Observational studies have found associations between inflammatory bowel disease (IBD) and the risk of dementia, including Alzheimer's dementia (AD) and vascular dementia (VD); however, these findings are inconsistent. It remains unclear whether these associations are causal.
METHODS:
We conducted a meta-analysis by systematically searching for observational studies on the association between IBD and dementia. Mendelian randomization (MR) analysis based on summary genome-wide association studies (GWASs) was performed. Genetic correlation and Bayesian co-localization analyses were used to provide robust genetic evidence.
RESULTS:
Ten observational studies involving 80,565,688 participants were included in this meta-analysis. IBD was significantly associated with dementia (risk ratio [ RR] =1.36, 95% CI = 1.04-1.78; I 2 = 84.8%) and VD ( RR = 2.60, 95% CI = 1.18-5.70; only one study), but not with AD ( RR = 2.00, 95% CI = 0.96-4.13; I 2 = 99.8%). MR analyses did not supported significant causal associations of IBD with dementia (dementia: odds ratio [ OR] = 1.01, 95% CI = 0.98-1.03; AD: OR = 0.98, 95% CI = 0.95-1.01; VD: OR = 1.02, 95% CI = 0.97-1.07). In addition, genetic correlation and co-localization analyses did not reveal any genetic associations between IBD and dementia.
CONCLUSION
Our study did not provide genetic evidence for a causal association between IBD and dementia risk. The increased risk of dementia observed in observational studies may be attributed to unobserved confounding factors or detection bias.
Humans
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Mendelian Randomization Analysis
;
Inflammatory Bowel Diseases/complications*
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Dementia/etiology*
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Observational Studies as Topic
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Genome-Wide Association Study
4.Improvement effect of lovastatin on hyperlipidemia-induced liver injury in rats and its mechanism
Yi ZHAO ; Bing ZHOU ; Huirui QIU ; Xuan LI ; Xiangli CUI
Journal of Jilin University(Medicine Edition) 2025;51(5):1155-1164
Objective:To investigate the protective effect of lovastatin on liver injury in the rats induced by hyperlipidemia,and to elucidate its possible mechanism.Methods:Fifteen SD rats were randomly divided into control group,hyperlipidemia model group,and lovastatin group,with 5 rats in each group.The rats in control group were fed with standard diet,while the rats in hyperlipidemia model group and lovastatin group were fed high-fat diet for 12 weeks.Starting from the 8th week,the rats were administered treatments via gavage once a day for 4 weeks:the rats in lovastatin group received 2 mng·kg-1 lovastatin,while the rats in control group and hyperlipidemia model group received an equal volume of normal saline.The body weights of the rats in various groups were measured at weeks 1,8,9,10,11,and 12 after the experiment began;the histopathology of liver tissue of the rats in various groups was observed using HE staining;the serum levels of total cholesterol(TC),triglycerides(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),malondialdehyde(MDA),as well as the activities of superoxide dismutase(SOD),glutathione peroxidase(GSH-Px),aspartate aminotransferase(AST),and alanine aminotransferase(ALT),and the levels of interleukin-2(IL-2),interleukin-6(IL-6),interleukin-12(IL-12),and tumor necrosis factor-a(TNF-α)of the rats in various groups were detected using commercial kits;the composition of the gut microbiota of the rats in various groups was analyzed by 16S rRNA sequencing.Results:Compared with control group,the body weight of the rats in hyperlipidemia model group was significantly increased from the 8th week of high-fat diet feeding(P<0.05 or P<0.01 or P<0.001).Compared with hyperlipidemia model group,the body weight of the rats in lovastatin group was significantly decreased at weeks 11 and 12(P<0.05).Compared with control group,the livers of the rats in hyperlipidemia model group appeared rough,pale,enlarged,with blunt edges,and had a granular and greasy texture.Compared with hyperlipidemia model group,the livers of the rats in lovastatin group were light brownish-red,soft,with slightly blunt edges,reduced volume,and less granularity and greasiness.Compared with control group,the liver cells of the rats in hyperlipidemia model group were swollen and disorganized,with pyknotic nuclei,extensive inflammatory cell infiltration,and numerous vacuolar degenerations.Compared with hyperlipidemia model group,the rats in lovastatin group showed significantly reduced hepatocyte swelling and degeneration,more orderly and intact liver cell arrangement,decreased inflammatory cell infiltration,and reduced vacuolar degeneration.Compared with control group,the serum levels of TC,TG,and LDL-C of the rats in hyperlipidemia model group were significantly increased(P<0.05),and the serum HDL-C level was decreased(P<0.05).Compared with hyperlipidemia model group,the serum levels of TC,TG,and LDL-C of the rats in lovastation group were significantly decreased(P<0.05),and the serum HDL-C level was increased(P<0.05).Compared with control group,the serum MDA levels and the ALT and AST activities of the rats in hyperlipidemia model group were significantly increased(P<0.05),and the SOD and GSH-Px activities were significantly decreased(P<0.05).Compared with hyperlipidemia model group,the serum MDA levels and ALT and AST activities of the rats in lovastatin group were decreased(P<0.05),and the SOD and GSH-Px activities were increased(P<0.05).Compared with control group,the serum levels of IL-2,IL-6,IL-12,and TNF-α of the rats in hyperlipidemia model group were significantly increased(P<0.05).Compared with hyperlipidemia model group,the serum levels of IL-2,IL-6,IL-12,and TNF-α of the rats in lovastatin group were significantly decreased(P<0.05).Compared with control group,the ACE and Chao1 indexes of the rats in hyperlipidemia model group were significantly decreased(P<0.05).Compared with hyperlipidemia model group,the ACE and Chao1 indexes of the rats in lovastatin group were significantly increased(P<0.05 or P<0.01).Compared with control group,the relative abundances of Firmicutes and Proteobacteria of the rats in hyperlipidemia model group were significantly increased(P<0.001),and the relative abundances of Bacteroidetes and Actinobacteria were decreased(P<0.001).Compared with hyperlipidemia model group,the relative abundances of Firmicutes and Proteobacteria of the rats in lovastatin group were significantly decreased(P<0.05 or P<0.01),while the relative abundances of Bacteroidetes and Actinobacteria showed no significant changes.Compared with control group,the relative abundance of Lactobacillus of the rats in hyperlipidemia model group was significantly decreased(P<0.001),and the relative abundances of Bacteroides,Desulfovibrio,and Clostridium were significantly increased(P<0.01 or P<0.001).Compared with hyperlipidemia model group,the relative abundance of Lactobacillus of the rats in lovastatin group showed no significant change but the relative abundances of Bacteroides,Desulfovibrio,and Clostridium were significantly decreased(P<0.05 or P<0.01 or P<0.001).Conclusion:Lovastatin ameliorates liver injury induced by hyperlipidemia,and the mechanism may be related to its ability to improve gut microbiota composition and inhibit oxidative stress and inflammatory damage.
5.Study of safety and clinical outcomes of ommaya reservoir combined with external ventricular drainage for intraventricular hemorrhage
Bing QIU ; Zhengyang LI ; Xing ZHENG ; Yuan HU
China Modern Doctor 2025;63(20):26-30
Objective To evaluate safety and clinical effect of Ommaya reservoir combined with external ventricular drainage for intraventricular hematoma(IVH),and to analyze the effects on neurological recovery,blood-brain-barrier(BBB)protection and the incidence of complications.Methods A total of 100 patients admitted to Yichun People's Hospital of Jiangxi Province for IVH and underwent surgical treatment from January 2021 to January 2023 were selected as the study subjects.Using a random number table,the patients were divided into control group(n=50)and treatment group(n=50).The treatment group received Ommaya reservoiv combined with external ventricular drainage,while the control group received conventional external ventricular drainage.The postoperative improvement rate,neurological recovery,BBB index,S100 calcium binding protein beta(neural)(S100β),myelin basic protein(MBP)levels,and hematoma clearance rate were compared between two groups.The incidence of complications in both groups was monitored over a 24-month follow-up period.Results At 3d,7d,and 14d post-surgery,the hematoma clearance rate in treatment group was higher than that in control group.At 3,12,and 24 months post-surgery,the patients of treatment group showed a higher improvement rate then that of control group,with better performance in National Institutes of Health stroke scale and Canadian stroke scale scores for neurological recovery,all differences being statistically significant(P<0.05).During follow-ups at 1,3,12,and 24 months post-surgery,the BBB index,S100β,and MBP levels in treatment group were all lower than those in the control group,with all differences being statistically significant(P<0.05).At 24 months post-surgery,the patients of treatment group had a lower incidence of complications than that of control group(P<0.05).Conclusion Ommaya reservoir combined with exteral ventricular drainage can significantly improve neurological function,protect the BBB,and show good long-term efficacy in follow-up.
6.Diagnosis and treatment guideline for acute cervical spinal cord injury without fracture-dislocation in adults (version 2025)
Qingde WANG ; Tongwei CHU ; Jian DONG ; Liangjie DU ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Yong HAI ; Da HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Fang LI ; Feng LI ; Li LI ; Weishi LI ; Fangcai LI ; Xiaoguang LIU ; Hongjian LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Xuhua LU ; Keya MAO ; Xuexiao MA ; Yong QIU ; Limin RONG ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Bing WANG ; Linfeng WANG ; Yu WANG ; Qinghe WANG ; Jigong WU ; Hong XIA ; Guoyong YIN ; Jinglong YAN ; Wen YUAN ; Yong YANG ; Qiang YANG ; Cao YANG ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Zezhang ZHU ; Yingjie ZHOU ; Zhongmin ZHANG ; Yan ZENG ; Dingjun HAO ; Baorong HE ; Wei MEI
Chinese Journal of Trauma 2025;41(3):243-252
Cervical spinal cord injury without fracture-dislocation (CSCIWFD) is referred to as a special type of cervical spinal cord injury characterized by traumatic spinal cord dysfunction and no significant bony structural abnormalities on imagines. Duo to the high risk of missed diagnosis during the initial consultation, CSCIWFD may lead to progressive neurological deterioration or even complete paralysis, severely impacting patients′ prognosis. Currently, there are no established consensuses over the diagnosis and treatment of CSCIWFD, such as the lack of evidence-based standards for indications of non-surgical treatment and risk of secondary neurological injury, as well as debates over the optimal timing for surgical intervention and indications for different surgical approaches. To address these issues, the Spine Trauma Group of the Orthopedic Branch of the Chinese Medical Doctor Association organized experts in the relevant fields to formulate Diagnosis and treatment guideline for acute cervical spinal cord injury without fracture- dislocation in adults ( version 2025) . Based on evidence-based medicine and the principles of scientific rigor and clinical applicability, the guidelines proposed 11 recommendations covering terminology, diagnosis, evaluation treatment, and rehabilitation, etc., aiming to standardize the management of CSCIWFD.
7.Identification of GSK3 family and regulatory effects of brassinolide on growth and development of Nardostachys jatamansi.
Yu-Yan LEI ; Zheng MA ; Jing WEI ; Wen-Bing LI ; Ying LI ; Zheng-Ming YANG ; Shao-Shan ZHANG ; Jing-Qiu FENG ; Hua-Chun SHENG ; Yuan LIU
China Journal of Chinese Materia Medica 2025;50(2):395-403
This study identified 8 members including NjBIN2 of the GSK3 family in Nardostachys jatamansi by bioinformatics analysis. Moreover, the phylogenetic tree revealed that the GKS3 family members of N. jatamansi had a close relationship with those of Arabidopsis. RT-qPCR results showed that NjBIN2 presented a tissue-specific expression pattern with the highest expression in roots, suggesting that NjBIN2 played a role in root growth and development. In addition, the application of epibrassinolide or the brassinosteroid(BR) synthesis inhibitor(brassinazole) altered the expression pattern of NjBIN2 and influenced the photomorphogenesis(cotyledon opening) and root development of N. jatamansi, which provided direct evidence about the functions of NjBIN2. In conclusion, this study highlights the roles of BIN2 in regulating the growth and development of N. jatamansi by analyzing the expression pattern and biological function of NjBIN2. It not only enriches the understanding about the regulatory mechanism of the growth and development of N. jatamansi but also provides a theoretical basis and potential gene targets for molecular breeding of N. jatamansi with improved quality in the future.
Brassinosteroids/metabolism*
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Steroids, Heterocyclic/metabolism*
;
Gene Expression Regulation, Plant/drug effects*
;
Plant Proteins/metabolism*
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Phylogeny
;
Nardostachys/metabolism*
;
Plant Growth Regulators/pharmacology*
;
Plant Roots/drug effects*
8.Effect of rituximab combined with short-course glucocorticoid therapy on cellular immunity and cytokines in children with new-onset nephrotic syndrome
Ting-Ting YUAN ; Bing-Bing ZHU ; Yan LI ; Rui-Feng ZHANG ; Shan QIU ; Juan LYU ; Su-Qin ZHOU
Chinese Journal of Contemporary Pediatrics 2025;27(12):1500-1505
Objective To explore the effect of rituximab on cellular immunity and cytokines in children with new-onset steroid-sensitive nephrotic syndrome(SSNS).Methods Clinical data of 60 children with new-onset SSNS treated at Xuzhou Children's Hospital from December 2021 to March 2023 were retrospectively analyzed.Children were allocated according to rituximab use into a control group(no rituximab)and an observation group(rituximab).The relapse rate,T-lymphocyte subsets and cytokines before and after treatment,and the incidence of adverse reactions were compared between groups.Results The relapse rate was lower in the observation group than in the control group(27%vs 73%,P<0.05).After treatment,CD3+and CD4+T-lymphocyte counts,the CD4+/CD8+ratio,and serum interleukin-2 increased in the observation group and were higher than in the control group(P<0.05).Interleukin-6 and tumor necrosis factor-α levels decreased after treatment in the observation group and were lower than in the control group(P<0.05).After treatment,CD8+T-lymphocyte counts decreased,interferon-γ increased,and interleukin-10 decreased in both groups,with no significant differences between the two groups(P>0.05).The incidence of adverse reactions did not differ significantly between the two groups(P>0.05).Conclusions Rituximab can reduce the relapse rate in children with new-onset nephrotic syndrome and shows good safety.Its therapeutic effect is achieved by regulating the number and function of T cells and by modulating the anti-inflammatory effects of cytokines.
9.Study of safety and clinical outcomes of ommaya reservoir combined with external ventricular drainage for intraventricular hemorrhage
Bing QIU ; Zhengyang LI ; Xing ZHENG ; Yuan HU
China Modern Doctor 2025;63(20):26-30
Objective To evaluate safety and clinical effect of Ommaya reservoir combined with external ventricular drainage for intraventricular hematoma(IVH),and to analyze the effects on neurological recovery,blood-brain-barrier(BBB)protection and the incidence of complications.Methods A total of 100 patients admitted to Yichun People's Hospital of Jiangxi Province for IVH and underwent surgical treatment from January 2021 to January 2023 were selected as the study subjects.Using a random number table,the patients were divided into control group(n=50)and treatment group(n=50).The treatment group received Ommaya reservoiv combined with external ventricular drainage,while the control group received conventional external ventricular drainage.The postoperative improvement rate,neurological recovery,BBB index,S100 calcium binding protein beta(neural)(S100β),myelin basic protein(MBP)levels,and hematoma clearance rate were compared between two groups.The incidence of complications in both groups was monitored over a 24-month follow-up period.Results At 3d,7d,and 14d post-surgery,the hematoma clearance rate in treatment group was higher than that in control group.At 3,12,and 24 months post-surgery,the patients of treatment group showed a higher improvement rate then that of control group,with better performance in National Institutes of Health stroke scale and Canadian stroke scale scores for neurological recovery,all differences being statistically significant(P<0.05).During follow-ups at 1,3,12,and 24 months post-surgery,the BBB index,S100β,and MBP levels in treatment group were all lower than those in the control group,with all differences being statistically significant(P<0.05).At 24 months post-surgery,the patients of treatment group had a lower incidence of complications than that of control group(P<0.05).Conclusion Ommaya reservoir combined with exteral ventricular drainage can significantly improve neurological function,protect the BBB,and show good long-term efficacy in follow-up.
10.Consensus of experts on the management of thoracic anesthesia with spontaneous respiration
Qisen FAN ; Lan LAN ; Jingxiang WU ; Yuan QIU ; Guiping XU ; Jiang WANG ; Duozhi WU ; Jinhui LUO ; Jian RAN ; Ying-fen LI ; Peng PAN ; Bing ZHANG ; Yuelan ZHOU ; Yiwen ZHANG ; Xuebing XU ; Yatao LIU ; Yingbin WANG ; Yan WANG ; Yulong WANG ; Youyang HU ; Shoushi WANG ; Hongwei MENG ; Haixia XU ; Peijia TANG ; Xia-oxue ZHUANG ; Canzhou ZHANG
The Journal of Practical Medicine 2025;41(13):1945-1951
Thoracic anesthesia with spontaneous respiration represents a form of precision anesthesia meticulously customized to individual patients.Considering the more stringent requirements this anesthesia approach imposes on the regulation of respiratory function,the writing group of the"Consensus of Experts on the Management of Thoracic Anesthesia with Spontaneous Respiration"has formulated elaborate guidelines regarding indications and contraindications,preoperative evaluation,anesthesia implementation,common complications,and treatment strategies.This was accomplished by referencing relevant domestic and international literature and integrating it with actual clinical requirements.The objective is to standardize the rational application of this anesthesia method.

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