1.Chufeng Yisuntang Ameliorates PM2.5-induced Dry Eye via ROS/p38 MAPK Signaling Pathway
Yuan ZHONG ; Pan ZHAO ; Shi TAN ; Yu TANG ; Dongdong LI ; Lihao CHEN ; Jun PENG ; Qinghua PENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):191-200
ObjectiveTo establish a mouse model of particulate matter 2.5 (PM2.5)-induced dry eye and investigate whether Chufeng Yisuntang can ameliorate the PM2.5-induced ocular surface damage by regulating the reactive oxygen species (ROS)/p38 mitogen-activated protein kinase (p38 MAPK) signaling pathway. MethodsSixty 8-week-old male C57BL/6J mice were used. Ten were randomly selected as the control group. The remaining 50 mice received topical instillation of 1 drop (0.1 mL) of 5 g·L-1 PM2.5 suspension in both eyes, four times daily. Successfully modeled mice were randomized into four groups (n=10): Model, p38 MAPK inhibitor, Chufeng Yisuntang, and combination (Chufeng Yisuntang at 7.3 g·kg-1 + p38 MAPK inhibitor SB203580 at 5 mg·kg-1). Chufeng Yisuntang was administered via gavage, and the inhibitor group via intraperitoneal injection. The control and model groups received equal volumes of distilled water by gavage. All treatments lasted for 4 weeks. General conditions were dynamically observed. Tear secretion, tear film break-up time, and corneal fluorescein staining were assessed. After intervention for 4 weeks, hematoxylin and eosin (HE) staining was used to examine the histopathological changes. Enzyme-linked immunosorbent assay (ELISA) was adopted to measure serum levels of ROS, malondialdehyde (MDA), superoxide dismutase (SOD) 1, and SOD2. Western blot and Real-time PCR were employed to determine the protein and gene levels, respectively, of p38 MAPK, B-cell lymphoma-2 (Bcl-2), Bcl-2-associated X protein (Bax), and cysteinyl aspartate-specific proteinase-3 (Caspase-3) in the corneal tissue. ResultsCompared with the control group, the model group exhibited reduced tear secretion volume and tear film breakup time, along with increased corneal fluorescein staining scores (P<0.01). Compared with the model group, the Chufeng Yisuntang group, p38 MAPK inhibitor group, and combination group demonstrated increased tear secretion volume and tear film breakup time, along with decreased corneal fluorescein staining scores (P<0.01). HE staining revealed that compared with the control group, the model group exhibited marked increases in corneal epithelial cell layers and epithelial thickness, along with reduced meibomian gland acini and intensely stained, densely packed nuclei around the acini. Compared with the model group, the Chufeng Yisuntang group, p38 MAPK inhibitor group, and combination group showed intact corneal structure, improved cell morphology, and reduced damage severity. ELISA revealed elevated ROS and MDA levels (P<0.01) and decreased SOD1 and SOD2 levels (P<0.01) in the model group compared with the control group. Compared with the model group, Chufeng Yisuntang, p38 MAPK inhibitor, and the combination lowered ROS and MDA levels (P<0.01), while raising SOD1 and SOD2 levels (P<0.05, P<0.01). Western blot revealed that compared with the control group, the model group exhibited increased protein levels of p38 MAPK, Bax, and Caspase-3 (P<0.01) and reduced protein level of Bcl-2 (P<0.01). Compared with the model group, Chufeng Yisuntang, p38 MAPK inhibitor, and the combination down-regulated the protein levels of p38 MAPK, Bax, and Caspase-3 (P<0.01), while up-regulating the protein level of Bcl-2 (P<0.01). Compared with the Chufeng Yisuntang group, the combination group exhibited decreased protein levels of p38 MAPK, Bax, and Caspase-3 (P<0.01) and increased protein level of Bcl-2 (P<0.01). Real-time PCR revealed that compared with the control group, the model group exhibited upregulated mRNA levels of p38 MAPK, Bax, and Caspase-3 (P<0.01), and downregulated mRNA level of Bcl-2 (P<0.01). Compared with the model group, Chufeng Yisuntang, p38 MAPK inhibitor, and the combination down-regulated the mRNA levels of p38 MAPK, Bax, and Caspase-3 (P<0.01), while up-regulating the mRNA level of Bcl-2 (P<0.05, P<0.01). Compared with the Chufeng Yisuntang group, the combination group exhibited decreased mRNA levels of p38 MAPK, Bax, and Caspase-3 expression (P<0.05, P<0.01) and increased mRNA level of Bcl-2 (P<0.01). ConclusionChufeng Yisuntang may partially protect against PM2.5-induced corneal injury by inhibiting the ROS/p38 MAPK pathway, enhancing antioxidant defense, and reducing epithelial apoptosis.
2.Construction and Practice Evaluation of an Integrated Traditional Chinese and Western Medicine Postoperative Rehabilitation Teaching Model Supported by MedOncoGPT
Can BAI ; Zi-Jian WU ; Xian-Jun HAN ; Yuan GAO ; Yong TANG
Progress in Biochemistry and Biophysics 2026;53(5):1264-1278
ObjectiveTo enhance teaching in postoperative cancer rehabilitation, this study developed an integrative Chinese-Western medicine postoperative oncology rehabilitation system, termed the medical oncology generative pre-trained transformer (MedOncoGPT). By introducing MedOncoGPT as an intelligent assistant, an integrated teaching model combining Chinese and Western medicine was established. The study evaluated its impact on students’ integrative clinical reasoning and practical abilities, providing support for instructional reform in related courses. MethodsUsing teaching resources as the knowledge base, MedOncoGPT was built upon the open-source ChatGLM model and incorporated Low-Rank Adaptation (LoRA) fine-tuning and retrieval-augmented generation (RAG) techniques to address postoperative integrative oncology scenarios. The system was applied in courses and clinical clerkships related to integrative oncology. In alignment with course objectives, a five-stage instructional process—pre-class preparation, in-class inquiry, simulated multidisciplinary consultation, clinical reinforcement, and teaching reflection—was designed to guide students in completing syndrome differentiation, comprehensive assessment, and follow-up planning within real or simulated case contexts. Comparative analyses of student engagement, syndrome differentiation thinking, evidence-based awareness, and interdisciplinary integration skills before and after the teaching reform were conducted using questionnaires, course assessments, classroom observations, and semi-structured interviews. ResultsFollowing the implementation of MedOncoGPT, students demonstrated improved performance in case analysis, prescription formulation, and integrative Chinese-Western medical evaluation compared with those receiving traditional instruction. Classroom participation and the relevance of student inquiries also increased. Self-assessment results indicated high levels of satisfaction with respect to clarity of integrative clinical reasoning, ability to retrieve and apply guideline-based evidence, and awareness of appropriate use of intelligent tools in clinical decision-making. More than 92% of students reported that the system facilitated understanding of abstract theoretical concepts presented in textbooks. Instructors noted that the system helped reduce lesson preparation time, enriched typical case materials and discussion scenarios, and promoted the translation of research findings into classroom teaching. Pilot data showed that, with MedOncoGPT assistance, the mean time for initial syndrome differentiation decreased from 18.4 min to 12.1 min, and the agreement rate increased from 68.3% to 82.5%. In the teaching pilot, the experimental group achieved a higher mean score on the final case analysis assessment than the control group (82.6 vs. 74.3). ConclusionThe integration of MedOncoGPT into teaching on postoperative integrative cancer rehabilitation enabled the establishment of a stable instructional process within existing curricula and enhanced students’ integrative clinical reasoning and evidence-based practice capabilities. The approach demonstrates positive potential for advancing the integration of research, clinical practice, and education and represents a valuable exploratory strategy for instructional reform in courses on integrative Chinese-Western medicine.
3.Construction and Practice Evaluation of an Integrated Traditional Chinese and Western Medicine Postoperative Rehabilitation Teaching Model Supported by MedOncoGPT
Can BAI ; Zi-Jian WU ; Xian-Jun HAN ; Yuan GAO ; Yong TANG
Progress in Biochemistry and Biophysics 2026;53(5):1264-1278
ObjectiveTo enhance teaching in postoperative cancer rehabilitation, this study developed an integrative Chinese-Western medicine postoperative oncology rehabilitation system, termed the medical oncology generative pre-trained transformer (MedOncoGPT). By introducing MedOncoGPT as an intelligent assistant, an integrated teaching model combining Chinese and Western medicine was established. The study evaluated its impact on students’ integrative clinical reasoning and practical abilities, providing support for instructional reform in related courses. MethodsUsing teaching resources as the knowledge base, MedOncoGPT was built upon the open-source ChatGLM model and incorporated Low-Rank Adaptation (LoRA) fine-tuning and retrieval-augmented generation (RAG) techniques to address postoperative integrative oncology scenarios. The system was applied in courses and clinical clerkships related to integrative oncology. In alignment with course objectives, a five-stage instructional process—pre-class preparation, in-class inquiry, simulated multidisciplinary consultation, clinical reinforcement, and teaching reflection—was designed to guide students in completing syndrome differentiation, comprehensive assessment, and follow-up planning within real or simulated case contexts. Comparative analyses of student engagement, syndrome differentiation thinking, evidence-based awareness, and interdisciplinary integration skills before and after the teaching reform were conducted using questionnaires, course assessments, classroom observations, and semi-structured interviews. ResultsFollowing the implementation of MedOncoGPT, students demonstrated improved performance in case analysis, prescription formulation, and integrative Chinese-Western medical evaluation compared with those receiving traditional instruction. Classroom participation and the relevance of student inquiries also increased. Self-assessment results indicated high levels of satisfaction with respect to clarity of integrative clinical reasoning, ability to retrieve and apply guideline-based evidence, and awareness of appropriate use of intelligent tools in clinical decision-making. More than 92% of students reported that the system facilitated understanding of abstract theoretical concepts presented in textbooks. Instructors noted that the system helped reduce lesson preparation time, enriched typical case materials and discussion scenarios, and promoted the translation of research findings into classroom teaching. Pilot data showed that, with MedOncoGPT assistance, the mean time for initial syndrome differentiation decreased from 18.4 min to 12.1 min, and the agreement rate increased from 68.3% to 82.5%. In the teaching pilot, the experimental group achieved a higher mean score on the final case analysis assessment than the control group (82.6 vs. 74.3). ConclusionThe integration of MedOncoGPT into teaching on postoperative integrative cancer rehabilitation enabled the establishment of a stable instructional process within existing curricula and enhanced students’ integrative clinical reasoning and evidence-based practice capabilities. The approach demonstrates positive potential for advancing the integration of research, clinical practice, and education and represents a valuable exploratory strategy for instructional reform in courses on integrative Chinese-Western medicine.
4.Analysis of prediction of incidence and epidemiological characteristics of hand, foot and mouth disease among children aged 0-9 years in Guangzhou, 2013-2025
Chinese Journal of School Health 2026;47(7):1026-1030
Objective:
To analyze the epidemiological characteristics of hand, foot and mouth disease (HFMD) among children aged 0-9 years in Guangzhou, so as to provide reference basis for further exploring scientifically effective prevention and control measures.
Methods:
Reported cases of HFMD in children aged 0-9 years in Guangzhou City from 2013-2025 were selected from China disease prevention and control information system, and the incidence in different years was analyzed descriptively; the trends of the composition ratio and incidence in various age groups were analyzed by using the Joinpoint regression model, spatial autocorrelation analyses were performed at the district level, and the seasonal autoregressive integrated moving average model (SARIMA) was applied to predict annual incidence rate for 2026.
Results:
From 2013 to 2025, the average annual reported incidence rate of HFMD among children aged 0-9 years in Guangzhou was 2 513.98/100 000, showing a fluctuating trend. Peaks of incidence occurred from May to July and from September to October. The male to female ratio was 1.49∶1. The average annual incidence rate was 4 743.99/100 000 in the 0-1 years age group, 3 298.19/100 000 in the 2-5 years age group, and 544.22/ 100 000 in the 6-9 years age group. Joinpoint regression analysis showed a decreasing trend in the proportion of the 0-1 years age group (APC= -6.02 %, t =-3.77) and an increasing trend in the proportion of the 6-9 years age group (APC=16.39%, t =5.67) (both P < 0.05 ). No significant global spatial clustering was observed at the district level; however, local scattered clusters were identified in certain areas. Using the SARIMA(2,0,0)(2,0,0) 12 model, the predicted annual incidence rate of HFMD among children aged 0-9 years in Guangzhou in 2026 was 2 680.56/100 000.
Conclusions
From 2013 to 2025, the annual incidence rate of HFMD among children aged 0-9 years in Guangzhou exhibited a fluctuating trend; the highest incidence rate is observed in the 0-1 years age group, while the proportion of cases in the 6-9 years age group increase year by year;and local spatial clusters of abnormal distribution are identified. It is essential to enhance risk monitoring and health education in key populations and areas to mitigate the risk of infection in children.
5.Bidirectional Mendelian randomization analysis of causal relationships between immune cell traits and recurrent aphthous ulceration
XIE Xuejie ; XU Jun ; LIU Yuan ; CHEN Yue ; TANG Li ; GULINUER Awuti
Journal of Prevention and Treatment for Stomatological Diseases 2025;33(4):296-304
Objective:
To explore the bidirectional causal relationship between 731 immune cell phenotypes and recurrent aphthous ulcers (RAU) using Mendelian randomization (MR).
Methods:
A two-sample bidirectional MR study was conducted using publicly available genome-wide association study (GWAS) summary statistics for 731 immune cell phenotypes and the RAU GWAS summary data from the FinnGen consortium. The inverse-variance weighted (IVW) method was used as the primary analysis tool, with supplementary analyses including the weighted median (WM) method, MR-Egger regression, weighted mode, and simple mode. Sensitivity analyses were conducted using Cochran’s Q test, the mendelian randomization pleiotropy residual sum and outlier (MR-PRESSO) method for detecting pleiotropy and outliers, and leave-one-out cross-validation. Furthermore, differential analysis was performed using a clinical cohort dataset from the Gene Expression Omnibus (GEO) to further validate the MR results.
Results:
In the forward MR analysis, 731 immune cell phenotypes were considered as exposures and RAU as the outcome. Among them, 52 immune cell phenotypes showed a significant causal effect on RAU (P<0.05). After false discovery rate (FDR) correction, two immune phenotypes remained significantly associated with RAU risk: with increased monocyte-derived myeloid suppressor cells (M-MDSC) (OR = 1.06; 95% CI: 1.03-1.09) and CD33 on granulocytic myeloid-derived suppressor cells (G-MDSC) (OR = 1.06; 95% CI: 1.03-1.09), the risk of RAU also increased. In reverse MR, RAU was found to have a significant causal effect on two immune cell phenotypes (P<0.05), but no significant effects were found after FDR correction. Sensitivity analysis showed no significant heterogeneity between SNPs (P>0.05). Differential analysis of the GEO dataset revealed that the characteristic genes of myeloid-derived suppressor cells (MDSC) (CTBS, IPMK, and UBA3) were significantly upregulated in RAU (P<0.05).
Conclusion
The MR results of 731 immune cell phenotypes suggest that M-MDSC and CD33 molecules on G-MDSC may be risk factors for RAU development. The clinical GEO dataset further validated that MDSC may play a role in RAU, while RAU did not show a significant causal association with the 731 immune cell phenotypes.
6.Percutaneous coronary intervention vs . medical therapy in patients on dialysis with coronary artery disease in China.
Enmin XIE ; Yaxin WU ; Zixiang YE ; Yong HE ; Hesong ZENG ; Jianfang LUO ; Mulei CHEN ; Wenyue PANG ; Yanmin XU ; Chuanyu GAO ; Xiaogang GUO ; Lin CAI ; Qingwei JI ; Yining YANG ; Di WU ; Yiqiang YUAN ; Jing WAN ; Yuliang MA ; Jun ZHANG ; Zhimin DU ; Qing YANG ; Jinsong CHENG ; Chunhua DING ; Xiang MA ; Chunlin YIN ; Zeyuan FAN ; Qiang TANG ; Yue LI ; Lihua SUN ; Chengzhi LU ; Jufang CHI ; Zhuhua YAO ; Yanxiang GAO ; Changan YU ; Jingyi REN ; Jingang ZHENG
Chinese Medical Journal 2025;138(3):301-310
BACKGROUND:
The available evidence regarding the benefits of percutaneous coronary intervention (PCI) on patients receiving dialysis with coronary artery disease (CAD) is limited and inconsistent. This study aimed to evaluate the association between PCI and clinical outcomes as compared with medical therapy alone in patients undergoing dialysis with CAD in China.
METHODS:
This multicenter, retrospective study was conducted in 30 tertiary medical centers across 12 provinces in China from January 2015 to June 2021 to include patients on dialysis with CAD. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Secondary outcomes included all-cause death, the individual components of MACE, and Bleeding Academic Research Consortium criteria types 2, 3, or 5 bleeding. Multivariable Cox proportional hazard models were used to assess the association between PCI and outcomes. Inverse probability of treatment weighting (IPTW) and propensity score matching (PSM) were performed to account for potential between-group differences.
RESULTS:
Of the 1146 patients on dialysis with significant CAD, 821 (71.6%) underwent PCI. After a median follow-up of 23.0 months, PCI was associated with a 43.0% significantly lower risk for MACE (33.9% [ n = 278] vs . 43.7% [ n = 142]; adjusted hazards ratio 0.57, 95% confidence interval 0.45-0.71), along with a slightly increased risk for bleeding outcomes that did not reach statistical significance (11.1% vs . 8.3%; adjusted hazards ratio 1.31, 95% confidence interval, 0.82-2.11). Furthermore, PCI was associated with a significant reduction in all-cause and cardiovascular mortalities. Subgroup analysis did not modify the association of PCI with patient outcomes. These primary findings were consistent across IPTW, PSM, and competing risk analyses.
CONCLUSION
This study indicated that PCI in patients on dialysis with CAD was significantly associated with lower MACE and mortality when comparing with those with medical therapy alone, albeit with a slightly increased risk for bleeding events that did not reach statistical significance.
Humans
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Percutaneous Coronary Intervention/methods*
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Male
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Female
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Coronary Artery Disease/drug therapy*
;
Retrospective Studies
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Renal Dialysis/methods*
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Middle Aged
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Aged
;
China
;
Proportional Hazards Models
;
Treatment Outcome
7.Diagnosis and treatment of colorectal liver metastases: Chinese expert consensus-based multidisciplinary team (2024 edition).
Wen ZHANG ; Xinyu BI ; Yongkun SUN ; Yuan TANG ; Haizhen LU ; Jun JIANG ; Haitao ZHOU ; Yue HAN ; Min YANG ; Xiao CHEN ; Zhen HUANG ; Weihua LI ; Zhiyu LI ; Yufei LU ; Kun WANG ; Xiaobo YANG ; Jianguo ZHOU ; Wenyu ZHANG ; Muxing LI ; Yefan ZHANG ; Jianjun ZHAO ; Aiping ZHOU ; Jianqiang CAI
Chinese Medical Journal 2025;138(15):1765-1768
8.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
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Alzheimer Disease/drug therapy*
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Male
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Female
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Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
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Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People
9.Mechanism of Chaishao Kaiyu Decoction in ameliorating hippocampal neuroinflammation in depressed rats based on complement component C3/C3aR pathway.
Ying-Juan TANG ; Hai-Peng GUO ; Man-Shu ZOU ; Yuan-Shan HAN ; Jun-Cheng LIU ; Yu-Hong WANG
China Journal of Chinese Materia Medica 2025;50(1):1-9
This study investigated the mechanism of Chaishao Kaiyu Decoction in improving hippocampal neuroinflammation in depressed rats based on complement component 3(C3)/C3 receptor(C3aR). A total of 60 SD rats were randomly divided into a blank group, a model group, high, medium, and low dose groups of Chaishao Kaiyu Decoction, and a positive drug group, with 10 rats in each group. Except for the blank group, chronic unpredictable mild stress(CUMS) was used to construct depression models in other groups. Sucrose preference, open-field experiment, forced swimming, and water maze were used to detect the changes in depression-like behavior in each group. Enzyme-linked immunosorbent assay(ELISA) was used to detect the serum inflammatory factor level in rats, and hematoxylin-eosin(HE) staining and Nissl staining were employed to observe the pathological damage of hippocampal neurons. Golgi-Cox staining was used to observe the dendritic spine damage of hippocampal neurons, and immunofluorescence and Western blot were utilized to detect the expression of microglial marker Iba-1 and C3/C3aR protein in the hippocampus of rats. The behavioral results showed that compared with the model group, Chaishao Kaiyu Decoction could significantly strengthen the sugar water preference, increase the distance and number of voluntary activities, shorten the immobility time in forced swimming and the successful incubation period of positioning navigation, and prolong the stay time of space exploration in the target quadrant. ELISA results showed that the content of inflammatory factors in the hippocampus of depressed rats was significantly higher than that of the blank group, and the content of inflammatory factors decreased significantly after the intervention of Chaishao Kaiyu Decoction. In addition, Chaishao Kaiyu Decoction could relieve pathological damage such as cell swelling and loose arrangement of hippocampus tissue. In the Western blot experiment, the expression levels of C3 and C3aR proteins in the model group were higher than those in the blank group, while the expression of C3 and C3aR in Chaishao Kaiyu Decoction could be down-regulated. Immunofluorescence results showed that compared with the model group, the fluorescence intensity of microglia marker Iba-1 decreased significantly after the intervention of Chaishao Kaiyu Decoction and positive drugs. The antidepressant effect of Chaishao Kaiyu Decoction may be related to the down-regulation of C3/C3aR signaling pathway-related proteins, thus alleviating hippocampal inflammation.
Animals
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Hippocampus/metabolism*
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Rats, Sprague-Dawley
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Drugs, Chinese Herbal/administration & dosage*
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Rats
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Male
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Depression/metabolism*
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Complement C3/metabolism*
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Receptors, Complement/metabolism*
;
Humans
;
Neuroinflammatory Diseases/genetics*
10.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
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
;
Treatment Outcome


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