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.Mechanism of Chaijin Jieyu Anshen Formula in regulating synaptic damage in nucleus accumbens neurons of rats with insomnia complicated with depression through TREM2/C1q axis.
Ying-Juan TANG ; Jia-Cheng DAI ; Song YANG ; Xiao-Shi YU ; Yao ZHANG ; Hai-Long SU ; Zhi-Yuan LIU ; Zi-Xuan XIANG ; Jun-Cheng LIU ; Hai-Xia HE ; Jian LIU ; Yuan-Shan HAN ; Yu-Hong WANG ; Man-Shu ZOU
China Journal of Chinese Materia Medica 2025;50(16):4538-4545
This study aims to investigate the effect of Chaijin Jieyu Anshen Formula on the neuroinflammation of rats with insomnia complicated with depression through the regulation of triggering receptor expressed on myeloid cells 2(TREM2)/complement protein C1q signaling pathway. Rats were randomly divided into a normal group, a model group, a positive drug group, as well as a high, medium, and low-dose groups of Chaijin Jieyu Anshen Formula, with 10 rats in each group. Except for the normal group, the other groups were injected with p-chlorophenylalanine and exposed to chronic unpredictable mild stress to establish the rat model of insomnia complicated with depression. The sucrose preference experiment, open field experiment, and water maze test were performed to evaluate the depression in rats. Enzyme-linked immunosorbent assay was employed to detect serum 5-hydroxytryptamine(5-HT), dopamine(DA), and norepinephrine(NE) levels. Hematoxylin and eosin staining and Nissl staining were used to observe the damage in nucleus accumbens neurons. Western blot and immunofluorescence were performed to detect TREM2, C1q, postsynaptic density 95(PSD-95), and synaptophysin 1(SYN1) expressions in rat nucleus accumbens, respectively. Golgi-Cox staining was utilized to observe the synaptic spine density of nucleus accumbens neurons. The results show that, compared with the model group, Chaijin Jieyu Anshen Formula can significantly increase the sucrose preference as well as the distance and number of voluntary activities, shorten the immobility time in forced swimming test and the successful incubation period of positioning navigation, and prolong the stay time of space exploration in the target quadrant test. The serum 5-HT, DA, and NE contents in the model group are significantly lower than those in the normal group, with the above contents significantly increased after the intervention of Chaijin Jieyu Anshen Formula. In addition, Chaijin Jieyu Anshen Formula can alleviate pathological damages such as swelling and loose arrangement of tissue cells in the nucleus accumbens, while increasing the Nissl body numbers. Chaijin Jieyu Anshen Formula can improve synaptic damage in the nucleus accumbens and increase the synaptic spine density. Compared to the normal group, the expression of C1q protein was significantly higher in the model group, while the expression of TREM2 protein was significantly lower. Compared to the model group, the intervention with Chaijin Jieyu Anshen Formula significantly downregulated the expression of C1q protein and significantly upregulated the expression of TREM2. Compared with the model group, the PSD-95 and SYN1 fluorescence intensity is significantly increased in the groups receiving different doses of Chaijin Jieyu Anshen Formula. In summary, Chaijin Jieyu Anshen Formula can reduce the C1q protein expression, relieve the TREM2 inhibition, and promote the synapse-related proteins PSD-95 and SNY1 expression. Chaijin Jieyu Anshen Formula improves synaptic injury of the nucleus accumbens neurons, thereby treating insomnia complicated with depression.
Animals
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Male
;
Rats
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Nucleus Accumbens/metabolism*
;
Drugs, Chinese Herbal/administration & dosage*
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Depression/complications*
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Membrane Glycoproteins/genetics*
;
Rats, Sprague-Dawley
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Sleep Initiation and Maintenance Disorders/complications*
;
Neurons/metabolism*
;
Receptors, Immunologic/genetics*
;
Signal Transduction/drug effects*
;
Synapses/metabolism*
3.Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury (version 2025)
Kai HUANG ; Lunhao BAI ; Qing BI ; Hong CHEN ; Jiwu CHEN ; Xuesong DAI ; Wenyong FEI ; Weili FU ; Zhizeng GAO ; Lin GUO ; Yinghui HUA ; Jingmin HUANG ; Suizhu HUANG ; Xuan HUANG ; Jian LI ; Qiang LI ; Shuzhen LI ; Yanlin LI ; Yunxia LI ; Zhong LI ; Ning LIU ; Yuqiang LIU ; Wei LU ; Hongbin LYU ; Haile PAN ; Xiaoyun PAN ; Chao QI ; Weiliang SHEN ; Luning SUN ; Jin TANG ; Zimin WANG ; Bide WANG ; Ru WANG ; Shaobai WANG ; Licheng WEI ; Weidong XU ; Yongsheng XU ; Jizhou YANG ; Liang YANG ; Rui YANG ; Hongbo YOU ; Tengbo YU ; Jiakuo YU ; Bing YUE ; Hua ZHANG ; Hui ZHANG ; Qingsong ZHANG ; Xintao ZHANG ; Jiajun ZHAO ; Lilian ZHAO ; Qichun ZHAO ; Song ZHAO ; Jiapeng ZHENG ; Jiang ZHENG ; Zhi ZHENG ; Jingbin ZHOU ; Jinzhong ZHAO
Chinese Journal of Trauma 2025;41(4):325-338
With the rapid development of competitive sports, the incidence of anterior cruciate ligament (ACL) injury is on the rise. Such injuries may shorten athletes′ career and lead to other long-term adverse consequences. Although athletes generally recover well after ACL reconstruction, many still struggle to return to their pre-injury performance levels. Advances in the understanding of ACL anatomy and injury mechanisms, along with the evolution of surgical techniques and rehabilitation methods, have provided more individualized and tailored options for athletes following ACL injuries. However, there is currently no consensus in China regarding surgical and rehabilitation strategies for competitive athletes aiming to return to sports after ACL injuries. To this end, the Sports Medicine Committee of the Chinese Research Hospital Association and the Editorial Board of the Chinese Journal of Trauma jointly formulated the Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury ( version 2025), and presented 14 recommendations covering surgical indications, preoperative rehabilitation, surgical timing, surgical strategies and postoperative rehabilitation strategies, aiming to improve the surgical treatment and rehabilitation system for ACL injuries in competitive athletes and facilitate their return to high-level sports performance after injury.
4.Expert Consensus on the Ethical Requirements for Generative AI-Assisted Academic Writing
You-Quan BU ; Yong-Fu CAO ; Zeng-Yi CHANG ; Hong-Yu CHEN ; Xiao-Wei CHEN ; Yuan-Yuan CHEN ; Zhu-Cheng CHEN ; Rui DENG ; Jie DING ; Zhong-Kai FAN ; Guo-Quan GAO ; Xu GAO ; Lan HU ; Xiao-Qing HU ; Hong-Ti JIA ; Ying KONG ; En-Min LI ; Ling LI ; Yu-Hua LI ; Jun-Rong LIU ; Zhi-Qiang LIU ; Ya-Ping LUO ; Xue-Mei LV ; Yan-Xi PEI ; Xiao-Zhong PENG ; Qi-Qun TANG ; You WAN ; Yong WANG ; Ming-Xu WANG ; Xian WANG ; Guang-Kuan XIE ; Jun XIE ; Xiao-Hua YAN ; Mei YIN ; Zhong-Shan YU ; Chun-Yan ZHOU ; Rui-Fang ZHU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):826-832
With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.
5.Establishment of Cultural Method of Primary Rabbit Spinal Cord Microvascular Endothelial Cells
Hua-Gen MA ; Ming CHI ; Zhi-Yi LIN ; Yuan-Yu TANG ; Wei-Hong CONG
Chinese Journal of Biochemistry and Molecular Biology 2025;41(7):1062-1067
This study aims to isolate and culture primary rabbit spinal cord microvascular endothelial cells in vitro,providing a practical source of test cells for spinal cord injury research.Spinal cord tissue was aseptically extracted from one-month-old rabbits and processed sequentially through mincing,bovine serum albumin density gradient centrifugation,mesh filtration,and type Ⅱ collagenase digestion to ob-tain purified spinal cord microvascular segments.The microvascular segments were homogeneously mixed with an apprapriate volume of M199 complete culture medium and seeded into a culture dish for primary culture.Throughout the culture period,cell growth performance were continuously observed and recor-ded.Additionally,immunocytochemical staining was performed to evaluate the expression of factor Ⅷ-re-lated antigen.The results showed that after 24 hours of inoculation,a small amount of endothelial-like cells were observed to emerge from the spinal cord microvascular segments.Within 36~60 hours,the cell colonies gradually expanded and fused.After 72 hours,the cells spread across the base of the dish,forming a"cobblestone-like"monolayer.Immunocytochemical staining showed that more than 99%of the cells showed brown-red cytoplasm and were positive for factor Ⅷ-related antigen.It is these results that suggest this study has successfully established a convenient and stable primary rabbit spinal cord micro-vascular endothelial cells culture method.
6.Analysis of risk factors for noncontiguous spinal fractures in the elderly
Shi-lei TANG ; Hong-wen GU ; Yin HU ; Kang-en HAN ; Hai-long YU ; Zhi-hao ZHANG ; Hong-wei WANG
Journal of Regional Anatomy and Operative Surgery 2025;34(2):130-133
Objective To explore the risk factors for noncontiguous spinal fractures(NSFs)in the elderly.Methods The clinical data of 614 elderly patients with spinal fracture from January 2013 to December 2019 were analyzed retrospectively.Patients were divided into the NSFs group and the Non-NSFs group according to whether NSFs occurred or not.Univariate analysis and multivariate Logistic regression analysis were used to screen the risk factors of NSFs.Results Univariate analysis showed that female(P=0.003),high-energy violent injury(P=0.032),osteoporosis(P=0.004),fracture in spring(P=0.020),and previous spinal fracture history(P<0.001)were associated with the occurrence of NSFs.Multivariate Logistic regression analysis showed that fracture in spring(P=0.024),previous spinal fracture history(P<0.001)and high-energy violent injury(P=0.038)were the independent risk factors for the occurrence of NSFs in the elderly.Conclusion High-energy violent injury,fracture in spring and previous spinal fracture history are the independent risk factors for the occurrence of NSFs in the elderly.Therefore,elderly patients with the above risk factors should be examined more carefully and comprehensively to avoid missed diagnosis and delayed diagnosis.In order to reduce the incidence of this disease,corresponding measures should be taken according to the preventable risk factors.
7.Establishment and validation of a predictive model for increased drainage volume after open transforaminal lumbar interbody fusion
Yin HU ; Hai-long YU ; Hong-wen GU ; Kang-en HAN ; Shi-lei TANG ; Yuan-hang ZHAO ; Zhi-hao ZHANG ; Jun-chao LI ; Le XING ; Hong-wei WANG
Journal of Regional Anatomy and Operative Surgery 2025;34(11):981-986
Objective To analyze the risk factors for increased drainage volume after open transforaminal lumbar interbody fusion(TLIF),and to establish a predictive model and then validate it.Methods The clinical data of 680 patients who underwent open TLIF at the General Hospital of Northern Theater Command from January 2016 to December 2019 were collected and the patients were randomly divided into the training group(n=476)and the validation group(n=204).Taking the predictive factors screened out by LASSO regression analysis as independent variables,a multivariate Logistic regression predictive model was constructed.The model was internally validated through the receiver operating characteristic(ROC)curve,Hosmer-Lemeshow goodness-of-fit test,and calibration curve,and its clinical utility was assessed via decision curve analysis(DCA).Results LASSO regression analysis screened out four predictive variables:age,number of surgical segments,operative duration,and intraoperative blood loss.The multivariate Logistic regression predictive model demonstrated that age≥60 years,number of surgical segments≥4,operative duration≥2 hours,and intraoperative blood loss≥200 mL were independent influencing factors for the increased postoperative drainage volume in patients undergoing TLIF(P<0.05).ROC curve analysis revealed an area under the curve(AUC)of 0.816(95%CI:0.798 to 0.867)in the training group and 0.783(95%CI:0.685 to 0.823)in the validation group,indicating that the predictive model had good discriminatory ability.Additionally,the Hosmer-Lemeshow goodness-of-fit test and calibration curve indicated that the predictive model had a good degree of fit,and the predicted probability was basically consistent with the actual probability,demonstrating a good calibration.The DCA results confirmed that this predictive model could be applied in clinical practice.Conclusion The risk factors for increased drainage volume after open TLIF include age,number of surgical segments,operative duration,and intraoperative blood loss.The predictive model established based on these factors demonstrates good performance,and it can be applied in clinical guidance for the selection of drainage tube removal time after TLIF.
8.Effects and mechanisms of Shenwuyishen tablets in treating chronic kidney disease
Jin-hong REN ; Ze LIU ; Xiang-da MENG ; Zi-ling YUAN ; Zhi-tang SUN ; Cheng HAN
Chinese Pharmacological Bulletin 2025;41(11):2185-2193
Aim To explore the therapeutic effect of Shenwuyishen tablets(SWYST)in treating chronic kidney disease(CKD)and the underlying mechanism.Methods The pharmacological action of SWYST was evaluated in folic acid(FA)-induced mouse models by levels of serum creatinine and blood urea nitrogen,in-dexes of tubulointerstitial inflammation and tubular in-jury,and degrees of renal fibrosis.Differential genes from 22 types of cells in kidney tissue of CKD were i-dentified by single-cell and single-nuclei RNA sequen-cing datasets.Network pharmacology was used to pre-dict key ingredients,cells,and targets.The binding mode between the key ingredients and key targets was elucidated using molecular docking and molecular dy-namics simulation.Results Serum creatinine and blood urea nitrogen levels,tubulointerstitial inflamma-tion and tubular injury indexes,and renal fibrosis de-grees were significantly reduced by SWYST administra-tion.Quercetin,kaempferol,luteolin,baicalein and wogonin were considered as key components that main-ly acted through FOS and JUN of endothelial cells,neu-trophils and thick ascending limb cells to ameliorate CKD.Molecular docking and molecular dynamics sim-ulation revealed that quercetin stably occupied the cross pocket of FOS-JUN heterodimers to inhibit the binding between FOS-JUN heterodimers and DNA.Conclusion SWYST inhibits the binding of FOS-JUN heterodimers and DNA of endothelial cells,neutrophils and thick ascending limb cells to ameliorate CKD.
9.Establishment of Cultural Method of Primary Rabbit Spinal Cord Microvascular Endothelial Cells
Hua-Gen MA ; Ming CHI ; Zhi-Yi LIN ; Yuan-Yu TANG ; Wei-Hong CONG
Chinese Journal of Biochemistry and Molecular Biology 2025;41(7):1062-1067
This study aims to isolate and culture primary rabbit spinal cord microvascular endothelial cells in vitro,providing a practical source of test cells for spinal cord injury research.Spinal cord tissue was aseptically extracted from one-month-old rabbits and processed sequentially through mincing,bovine serum albumin density gradient centrifugation,mesh filtration,and type Ⅱ collagenase digestion to ob-tain purified spinal cord microvascular segments.The microvascular segments were homogeneously mixed with an apprapriate volume of M199 complete culture medium and seeded into a culture dish for primary culture.Throughout the culture period,cell growth performance were continuously observed and recor-ded.Additionally,immunocytochemical staining was performed to evaluate the expression of factor Ⅷ-re-lated antigen.The results showed that after 24 hours of inoculation,a small amount of endothelial-like cells were observed to emerge from the spinal cord microvascular segments.Within 36~60 hours,the cell colonies gradually expanded and fused.After 72 hours,the cells spread across the base of the dish,forming a"cobblestone-like"monolayer.Immunocytochemical staining showed that more than 99%of the cells showed brown-red cytoplasm and were positive for factor Ⅷ-related antigen.It is these results that suggest this study has successfully established a convenient and stable primary rabbit spinal cord micro-vascular endothelial cells culture method.
10.Effects and mechanisms of Shenwuyishen tablets in treating chronic kidney disease
Jin-hong REN ; Ze LIU ; Xiang-da MENG ; Zi-ling YUAN ; Zhi-tang SUN ; Cheng HAN
Chinese Pharmacological Bulletin 2025;41(11):2185-2193
Aim To explore the therapeutic effect of Shenwuyishen tablets(SWYST)in treating chronic kidney disease(CKD)and the underlying mechanism.Methods The pharmacological action of SWYST was evaluated in folic acid(FA)-induced mouse models by levels of serum creatinine and blood urea nitrogen,in-dexes of tubulointerstitial inflammation and tubular in-jury,and degrees of renal fibrosis.Differential genes from 22 types of cells in kidney tissue of CKD were i-dentified by single-cell and single-nuclei RNA sequen-cing datasets.Network pharmacology was used to pre-dict key ingredients,cells,and targets.The binding mode between the key ingredients and key targets was elucidated using molecular docking and molecular dy-namics simulation.Results Serum creatinine and blood urea nitrogen levels,tubulointerstitial inflamma-tion and tubular injury indexes,and renal fibrosis de-grees were significantly reduced by SWYST administra-tion.Quercetin,kaempferol,luteolin,baicalein and wogonin were considered as key components that main-ly acted through FOS and JUN of endothelial cells,neu-trophils and thick ascending limb cells to ameliorate CKD.Molecular docking and molecular dynamics sim-ulation revealed that quercetin stably occupied the cross pocket of FOS-JUN heterodimers to inhibit the binding between FOS-JUN heterodimers and DNA.Conclusion SWYST inhibits the binding of FOS-JUN heterodimers and DNA of endothelial cells,neutrophils and thick ascending limb cells to ameliorate CKD.

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