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
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome
2.Metabolites and anti-inflammatory activities of Monascus sanguineus.
Ji-Yuan FAN ; Bing-Yu LIU ; Hui-Ming HUA ; You-Cai HU
China Journal of Chinese Materia Medica 2025;50(13):3699-3735
A variety of chromatographic techniques, including silica gel, ODS, Sephadex LH-20, and HPLC, were employed to isolate and purify the fermentation products of rice with Monascus sanguineus. A total of 38 compounds were isolated, and their structures were identified by UV, IR, NMR, MS, calculated ECD, and comparison with literature data. Compounds 1-4 were identified as new natural products, and other compounds were isolated from this fungus for the first time. A RAW264.7 macrophage model of lipopolysaccharide(LPS)-induced inflammation was used to evaluate the anti-inflammatory activities of all the compounds. The results showed that compound 6 exhibited a certain inhibitory effect on the production of nitric oxide in LPS-induced RAW264.7 cells, with an inhibition rate of 53.08%.
Monascus/chemistry*
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Mice
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Animals
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Anti-Inflammatory Agents/isolation & purification*
;
RAW 264.7 Cells
;
Macrophages/immunology*
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Nitric Oxide/immunology*
;
Oryza/metabolism*
;
Fermentation
3.Expert consensus on the prevention and treatment of radiochemotherapy-induced oral mucositis.
Juan XIA ; Xiaoan TAO ; Qinchao HU ; Wei LUO ; Xiuzhen TONG ; Gang ZHOU ; Hongmei ZHOU ; Hong HUA ; Guoyao TANG ; Tong WU ; Qianming CHEN ; Yuan FAN ; Xiaobing GUAN ; Hongwei LIU ; Chaosu HU ; Yongmei ZHOU ; Xuemin SHEN ; Lan WU ; Xin ZENG ; Qing LIU ; Renchuan TAO ; Yuan HE ; Yang CAI ; Wenmei WANG ; Ying ZHANG ; Yingfang WU ; Minhai NIE ; Xin JIN ; Xiufeng WEI ; Yongzhan NIE ; Changqing YUAN ; Bin CHENG
International Journal of Oral Science 2025;17(1):54-54
Radiochemotherapy-induced oral mucositis (OM) is a common oral complication in patients with tumors following head and neck radiotherapy or chemotherapy. Erosion and ulcers are the main features of OM that seriously affect the quality of life of patients and even the progress of tumor treatment. To date, differences in clinical prevention and treatment plans for OM have been noted among doctors of various specialties, which has increased the uncertainty of treatment effects. On the basis of current research evidence, this expert consensus outlines risk factors, clinical manifestations, clinical grading, ancillary examinations, diagnostic basis, prevention and treatment strategies and efficacy indicators for OM. In addition to strategies such as basic oral care, anti-inflammatory and analgesic agents, anti-infective agents, pro-healing agents, and photobiotherapy recommended in previous guidelines, we also emphasize the role of traditional Chinese medicine in OM prevention and treatment. This expert consensus aims to provide references and guidance for dental physicians and oncologists in formulating strategies for OM prevention, diagnosis, and treatment, standardizing clinical practice, reducing OM occurrence, promoting healing, and improving the quality of life of patients.
Humans
;
Chemoradiotherapy/adverse effects*
;
Consensus
;
Risk Factors
;
Stomatitis/etiology*
4.Overexpression of SULT1E1 alleviates salt-processed Psoraleae Fructus-induced cholestatic liver damage.
Yu WU ; Yan XU ; Hao CAI ; Zhengying HUA ; Meimei LUO ; Letao HU ; Nong ZHOU ; Xinghong WANG ; Weidong LI
Chinese Herbal Medicines 2025;17(2):392-403
OBJECTIVE:
Salt-processed Psoraleae Fructus (SPF) is widely used as a phytoestrogen-like agent in the treatment of osteoporosis. However, due to improper clinical use or misuse, resulting in liver damage. In this study, network pharmacology was employed to analyze the mechanism of cholestatic liver damage. An adeno-associated virus overexpressing SULT1E1 (rAAV8-SULT1E1) was constructed and the hepatotoxicity of SPF, psoralen, and isopsoralen was determined.
METHODS:
By utilizing three databases inclding TCMSP, TCMID, and BATMAN- TCM, the targets of the three databases were summarized, and a total of 45 psoralen compounds were included. Network pharmacology analysis was then performed. The adenoviral vectors were injected into the tail vein of C57BL6 mice to elucidate the role of SULT1E1 in SPF-induced cholestasis-mediated hepatotoxicity in vivo. SPF (10 g/kg), psoralen, and isopsoralen (50 mg/kg each) were intragastrically administered to mice for 30 d. B-ultrasound and samples were collected and examined for follow-up experiments.
RESULTS:
A total of 854 targets were predicted for 45 active components, with 151 cholestasis-mediated hepatotoxicity-related disease targets obtained for SPF. A total of 126 pathways were enriched based on KEGG pathway analysis, with the "estrogen signaling pathway" identified as one of the top 20 pathways. In terms of pathological hepatic changes, treated mice had visually swollen hepatocytes, dilated bile ducts, and elevated serum biochemical markers, which were more prominent in mice treated with isopsoralen than in those treated with other compounds. Notably, the overexpression of SULT1E1 could reverse liver damage in each treatment group. B-ultrasound was used to observe the size of the gallbladder in vivo. The size of the gallbladder was found to significantly increase on day 30 after treatment in the SPF-, psoralen-, and isopsoralen-treated groups, especially the SPF group. Compared with the expression levels in the negative control group (rAAV8-empty + con), the expression levels of FXR, Mrp2, Bsep, SULT1E1, SULT2A1, Ntcp, and Nrf2 decreased, whereas those of CYP7a1 and IL-6 increased in the SPF-, psoralen-, and isopsoralen-treated groups.
CONCLUSION
The overexpression of SULT1E1 could alleviate the decreased or increased expression of indicators, indicating that SULT1E1 is an important target gene for SPF-induced liver damage. The severity of liver damage was significantly lower in the rAAV8-SULT1E1 groups than in the rAAV8-empty groups.
5.Coupling of an Au@AgPt nanozyme array with an micrococcal nuclease-specific responsiveness strategy for colorimetric/SERS sensing of Staphylococcus aureus in patients with sepsis.
Xueqin HUANG ; Yingqi YANG ; Hanlin ZHOU ; Liping HU ; Annan YANG ; Hua JIN ; Biying ZHENG ; Jiang PI ; Jun XU ; Pinghua SUN ; Huai-Hong CAI ; Xujing LIANG ; Bin PAN ; Junxia ZHENG ; Haibo ZHOU
Journal of Pharmaceutical Analysis 2025;15(2):101085-101085
Rapid and ultrasensitive detection of pathogen-associated biomarkers is vital for the early diagnosis and therapy of bacterial infections. Herein, we developed a close-packed and ordered Au@AgPt array coupled with a cascade triggering strategy for surface-enhanced Raman scattering (SERS) and colorimetric identification of the Staphylococcus aureus biomarker micrococcal nuclease (MNase) in serum samples. The trimetallic Au@AgPt nanozymes can catalyze the oxidation of 3,3',5,5'-tetramethylbenzidine (TMB) molecules to SERS-enhanced oxidized TMB (oxTMB), accompanied by the color change from colorless to blue. In the presence of S. aureus, the secreted MNase preferentially cut the nucleobase AT-rich regions of DNA sequences on magnetic beads (MBs) to release alkaline phosphatase (ALP), which subsequently mediated the oxTMB reduction for inducing the colorimetric/SERS signal fade away. Using this "on-to-off" triggering strategy, the target S. aureus can be recorded in a wide linear range with a limit of detection of 38 CFU/mL in the colorimetric mode and 6 CFU/mL in the SERS mode. Meanwhile, the MNase-mediated strategy characterized by high specificity and sensitivity successfully discriminated between patients with sepsis (n = 7) and healthy participants (n = 3), as well as monitored the prognostic progression of the disease (n = 2). Overall, benefiting from highly active and dense "hot spot" substrate, MNase-mediated cascade response strategy, and colorimetric/SERS dual-signal output, this methodology will offer a promising avenue for the early diagnosis of S. aureus infection.
6.Study on Colorimetric Sensor Array Based on Enzymatic Method for Highly Selective Detection of Sarin
Lian-Bo JIANG ; Guo-Hong LIU ; Zhuang-Hu XU ; Jian LI ; Yong-Ling SHEN ; Cai-Xia XU ; Chuan-Qin ZANG ; Yan-Hua XIAO ; Dan-Ping LI ; Ting LIANG
Chinese Journal of Analytical Chemistry 2025;53(5):832-841,中插21-中插23
Sarin(GB)is a typical representative of nerve agents with high toxicity,and very low amount can cause death.GB can cause water and atmospheric environment poisoning,so the detection of GB in water and air is of great significance.In this work,a colorimetric sensor array(CSA)based on GB inhibition of cholinesterase activity was constructed to detect GB with high selectivity.A 4×4 colorimetric array was constructed using acetylcholinesterase(AChE),butyryl cholinesterase(BuChE)and the corresponding substrate acetylthiocholine iodide(S-ACh),butyryl thiocholine iodide(S-BCh),acetylcholine chloride(ACh),butyryl choline chloride(BCh)and 2,6-dichloroindophenol ethyl ester(DCIE).The linear curve of the sensor was Y=131.3×lgC+271.6(R2=0.997),where Y was the array response Euclidean distance,C was the concentration of GB(mg/L),the linear range was 0.03?0.32 mg/L,and the detection limit was 27.6 μg/L.The method could effectively distinguish chemical warfare agents(CWA)such as VX,Soman(GD),mustard gas(HD),Louie reagent(L),and had high anti-interference ability,sensitivity and good repeatability.It was successfully applied to the detection of GB in simulated water and simulated air samples,and the sample recovery rate was 97.2% ?100.9%.This method would be potentially applied to the field rapid detection of nerve agents.
7.Effect of mindful diet in overweight/obese children
Qingjiao LI ; Lu TANG ; Liping HU ; Hua CAI
Journal of Clinical Medicine in Practice 2025;29(17):100-103,115
Objective To explore the impact of mindful diet intervention on dietary behaviors,body composition,and mindfulness levels in overweight/obese children.Methods A total of 74 over-weight/obese children who sought treatment at a tertiary-level hospital in Hunan Province were selected as study subjects.They were randomly divided into experimental group and control group using the random number table method,with 37 cases in each group.The control group implemented a conven-tional body weight management program,while the experimental group received mindful diet interven-tion in addition to the conventional program.Changes in body mass index(BMI),body fat percent-age,visceral fat area,dietary behaviors,and mindfulness levels were compared between the two groups before and after intervention.Results Before intervention,there were no statistically signifi-cant differences in general information,body composition,dietary behaviors,and mindfulness levels between the two groups(P>0.05).After 8 weeks of intervention,the BMI,body fat percentage,and visceral fat area of children in both groups were lower than those before intervention.The scores for e-motional diet,restrictive diet,and external diet were also lower than those before intervention,while the mindfulness levels were higher than those before intervention,with statistically significant differ-ences(P<0.05).The experimental group showed better results than the control group in terms of BMI,body fat percentage,visceral fat area,scores for emotional diet,restrictive diet,and external di-et,as well as mindfulness levels(P<0.05).Conclusion Mindful diet intervention can effectively improve dietary behaviors,reduce body fat percentage and visceral fat area,and enhance mindfulness levels in overweight/obese children.
8.Efficacy and safety of ketogenic diet on metabolic and reproductive outcomes in overweight/obese patients with polycystic ovary syndrome:a meta-analysis of randomized controlled trials
Lu TANG ; Sijia WENG ; Liping HU ; Qingjiao LI ; Hua CAI ; Bo JIANG
Journal of Clinical Medicine in Practice 2025;29(20):109-118
Objective The ketogenic diet(KD)is a dietary intervention with potential therapeu-tic effects on polycystic ovary syndrome(PCOS),yet the existing evidence remains controversial.Fur-thermore,there is a lack of evidence-based medicine data for a comprehensive assessment of the safety of KD in the treatment of PCOS.This study aims to systematically evaluate,through a meta-analysis,the effects of KD on body composition,metabolic indicators,and reproductive hormone levels in over-weight/obese patients with PCOS,and to explore its safety and clinical applicability.Methods This study systematically searched PubMed,Web of Science,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI),Wanfang Database,and VIP Database.Randomized controlled trials(RCT)on KD for the treatment of PCOS were included,with the search time frame spanning from the establishment of each database to May 31,2025.Two researchers independently screened and extracted data according to inclusion and exclusion criteria,and assessed the quality of the in-cluded literature using the Cochrane Handbook.The Q-test and inconsistency index(I2)were used to evaluate the heterogeneity of the results.Based on the level of heterogeneity,a fixed-effects model or a random-effects model was selected for data pooling.Sensitivity analysis was employed to explore the robustness of the results.Results A total of 7 RCT studies involving 495 overweight/obese subjects were included in this study.Body composition analysis revealed that,compared with the control group,KD significantly reduced body mass index,body weight,waist circumference,waist-to-hip ra-tio,total fat mass,and visceral fat area in overweight/obese patients with PCOS(P<0.05),but had no significant effect on fat-free mass.Analysis of glucose and lipid metabolism indicated that KD sig-nificantly decreased fasting blood glucose,fasting insulin,insulin resistance index,and triglycerides(P<0.05),but had no significant impacts on total cholesterol,low-density lipoprotein cholesterol,or high-density lipoprotein cholesterol.Reproductive hormone analysis showed that KD significantly reduced luteinizing hormone,the ratio of luteinizing hormone to follicle-stimulating hormone,and total testosterone levels,while significantly increased sex hormone-binding globulin levels(P<0.05),but had no significant effect on follicle-stimulating hormone.Sensitivity analysis suggested that the results were relatively robust.In terms of safety,no serious adverse reactions were observed during the KD intervention;however,further verification through high-quality RCTs with larger sample sizes and long-term interventions is still required.Conclusion KD can effectively improve body composition,glucose metabolism,lipid metabolism indicators,and reproductive hormone levels in overweight/obese patients with PCOS.This study confirms that KD significantly increase sex hormone-binding globulin level and reduce visceral fat area.It is found that KD has a more pronounced effect on impro-ving triglycerides compared to its effects on low-density lipoprotein cholesterol and high-density lipo-protein cholesterol.The current evidence does not indicate significant safety risks associated with KD,but relevant conclusions still require further confirmation with more high-quality evidence.
9.Coupling of an Au@AgPt nanozyme array with an micrococcal nuclease-specific responsiveness strategy for colorimetric/SERS sensing of Staphylococcus aureus in patients with sepsis
Xueqin HUANG ; Yingqi YANG ; Hanlin ZHOU ; Liping HU ; Annan YANG ; Hua JIN ; Biying ZHENG ; Jiang PI ; Jun XU ; Pinghua SUN ; Huai-Hong CAI ; Xujing LIANG ; Bin PAN ; Junxia ZHENG ; Haibo ZHOU
Journal of Pharmaceutical Analysis 2025;15(2):389-400
Rapid and ultrasensitive detection of pathogen-associated biomarkers is vital for the early diagnosis and therapy of bacterial infections.Herein,we developed a close-packed and ordered Au@AgPt array coupled with a cascade triggering strategy for surface-enhanced Raman scattering(SERS)and colorimetric identification of the Staphylococcus aureus biomarker micrococcal nuclease(MNase)in serum samples.The trimetallic Au@AgPt nanozymes can catalyze the oxidation of 3,3',5,5'-tetramethylbenzidine(TMB)molecules to SERS-enhanced oxidized TMB(oxTMB),accompanied by the color change from colorless to blue.In the presence of S.aureus,the secreted MNase preferentially cut the nucleobase AT-rich regions of DNA sequences on magnetic beads(MBs)to release alkaline phosphatase(ALP),which subsequently mediated the oxTMB reduction for inducing the colorimetric/SERS signal fade away.Using this"on-to-off"triggering strategy,the target S.aureus can be recorded in a wide linear range with a limit of detection of 38 CFU/mL in the colorimetric mode and 6 CFU/mL in the SERS mode.Meanwhile,the MNase-mediated strategy characterized by high specificity and sensitivity successfully discriminated between patients with sepsis(n=7)and healthy participants(n=3),as well as monitored the prog-nostic progression of the disease(n=2).Overall,benefiting from highly active and dense"hot spot"substrate,MNase-mediated cascade response strategy,and colorimetric/SERS dual-signal output,this methodology will offer a promising avenue for the early diagnosis of S.aureus infection.
10.XIONG Jibai's Experience in Treating Henoch-schonlein Purpura by Staged Diagnosis and Treatment with "Simultaneous Treatment of Wind and Blood"
Wenfeng XU ; Hua HU ; Yajun PENG ; Fan WU ; Wei CAI ; Zhaohong GONG ; Chao TAN
Journal of Traditional Chinese Medicine 2024;65(13):1318-1322
This article aimed to summarise the clinical experience of Professor XIONG Jibai in treating henoch-schonlein purpura (HSP) from the perspective of "simultaneous treatment of wind and blood". HSP was devided into acute phase and transitional phase in clinic. It was considered that the wind pathogen exists throughout the disease course, and the treatment is guided by the "four methods of treating blood" in TANG Rongchuan's Treatise on Blood Syndromes - Blood Vomiting (《血证论·吐血》), which are stanching bleeding, expelling stasis, tranquilising blood, and tonifying blood. In the acute phase, wind-heat damaging collateral symdrome and blood-heat frenetic flow syndrome are common, which could be treated by the method of cooling blood to dispel wind, and eliminating stasis to stop bleeding, with self-prescribed modified Ziping Xiaofeng Powder (紫萍消风散); in the transitional phase, syndrome of effulgent fire due to yin deficiency and syndrome of qi deficiency failing to control are common, which could be treated by the method of tranquilising blood and tonifying deficiency, with modified Zhibai Dihuang Decoction (知柏地黄汤) and Guipi Decoction (归脾汤). At the same time, it is believed that wind-related medicinal has the function of eliminating stasis, stanching bleeding, and cooling blood, and the wind-related medicinal should be used throughout the treatment.

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