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
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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
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome
2.Buqi-Tongluo Decoction inhibits osteoclastogenesis and alleviates bone loss in ovariectomized rats by attenuating NFATc1, MAPK, NF-κB signaling.
Yongxian LI ; Jinbo YUAN ; Wei DENG ; Haishan LI ; Yuewei LIN ; Jiamin YANG ; Kai CHEN ; Heng QIU ; Ziyi WANG ; Vincent KUEK ; Dongping WANG ; Zhen ZHANG ; Bin MAI ; Yang SHAO ; Pan KANG ; Qiuli QIN ; Jinglan LI ; Huizhi GUO ; Yanhuai MA ; Danqing GUO ; Guoye MO ; Yijing FANG ; Renxiang TAN ; Chenguang ZHAN ; Teng LIU ; Guoning GU ; Kai YUAN ; Yongchao TANG ; De LIANG ; Liangliang XU ; Jiake XU ; Shuncong ZHANG
Chinese Journal of Natural Medicines (English Ed.) 2025;23(1):90-101
Osteoporosis is a prevalent skeletal condition characterized by reduced bone mass and strength, leading to increased fragility. Buqi-Tongluo (BQTL) decoction, a traditional Chinese medicine (TCM) prescription, has yet to be fully evaluated for its potential in treating bone diseases such as osteoporosis. To investigate the mechanism by which BQTL decoction inhibits osteoclast differentiation in vitro and validate these findings through in vivo experiments. We employed MTS assays to assess the potential proliferative or toxic effects of BQTL on bone marrow macrophages (BMMs) at various concentrations. TRAcP experiments were conducted to examine BQTL's impact on osteoclast differentiation. RT-PCR and Western blot analyses were utilized to evaluate the relative expression levels of osteoclast-specific genes and proteins under BQTL stimulation. Finally, in vivo experiments were performed using an osteoporosis model to further validate the in vitro findings. This study revealed that BQTL suppressed receptor activator of NF-κB ligand (RANKL)-induced osteoclastogenesis and osteoclast resorption activity in vitro in a dose-dependent manner without observable cytotoxicity. The inhibitory effects of BQTL on osteoclast formation and function were attributed to the downregulation of NFATc1 and c-fos activity, primarily through attenuation of the MAPK, NF-κB, and Calcineurin signaling pathways. BQTL's inhibitory capacity was further examined in vivo using an ovariectomized (OVX) rat model, demonstrating a strong protective effect against bone loss. BQTL may serve as an effective therapeutic TCM for the treatment of postmenopausal osteoporosis and the alleviation of bone loss induced by estrogen deficiency and related conditions.
Animals
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NFATC Transcription Factors/genetics*
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Drugs, Chinese Herbal/pharmacology*
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Ovariectomy
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Osteoclasts/metabolism*
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Female
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Osteogenesis/drug effects*
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Rats, Sprague-Dawley
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Rats
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NF-kappa B/genetics*
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Osteoporosis/genetics*
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Signal Transduction/drug effects*
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Bone Resorption/genetics*
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Cell Differentiation/drug effects*
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Humans
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RANK Ligand/metabolism*
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Mitogen-Activated Protein Kinases/genetics*
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Transcription Factors
3.Associations between Pesticide Metabolites and Decreased Estimated Glomerular Filtration Rate Among Solar Greenhouse Workers: A Specialized Farmer Group.
Teng Long YAN ; Xin SONG ; Xiao Dong LIU ; Wu LIU ; Yong Lan CHEN ; Xiao Mei ZHANG ; Xiang Juan MENG ; Bin Shuo HU ; Zhen Xia KOU ; Tian CHEN ; Xiao Jun ZHU
Biomedical and Environmental Sciences 2025;38(2):265-269
4.Effects of dapagliflozin on left ventricular diastolic function in elderly patients with HFpEF during a-cute decompensation
Jin XU ; Song LUO ; Zhen-Zhen TENG
Chinese Journal of cardiovascular Rehabilitation Medicine 2024;33(5):575-580
Objective:To study the effects of dapagliflozin on left ventricular diastolic function in elderly patients with heart failure with preserved ejection fraction(HFpEF)during acute decompensation.Methods:A total of 160 elderly patients with HFpEF during acute decompensation treated in Department of Geriatrics,Fujian Provincial Geriatric Hospital were retrospectively enrolled between January 2021 and January 2024.According to different therapeutic regimens,they were divided into routine treatment group(n=80,routine anti-heart failure drug thera-py)and combined dapagliflozin treatment group(n=80,dapagliflozin on basis of routine anti-heart failure drug therapy).All patients were treated for 3 months.The clinical curative effect,changes of left ventricular diastolic function indexes[early diastolic mitral annular peak velocity(e'),ratio of left ventricular early diastolic filling peak velocity(E)to e'(E/e'),tricuspid regurgitation velocity(TRV),left atrial diameter(LAD)],inflammatory factors[serum amyloid A(SAA),high sensitive C-reactive protein(hsCRP),interleukin-6(IL-6)],myocardial enzymes[lactate dehydrogenase(LDH),creatine kinase(CK),creatine kinase isoenzyme(CK-MB),α-hydroxybutyrate dehy-drogenase(α-HBDH)]and N-terminal pro brain natriuretic peptide(NT-proBNP),and the occurrence of adverse re-actions were compared between the two groups.Results:Compared with routine treatment group,total effective rate was significantly higher in combined dapagliflozin treatment group(85.00%vs.95.00%,P=0.035).After treatment,E/e',TRV,LAD,levels of SAA,hsCRP,IL-6,LDH,CK,CK-MB,α-HBDH and NT-proBNP in combined dapaglifloz-in treatment group were significantly lower than those in routine treatment group(P<0.01 all).There was no significant difference in the incidence rate of adverse reactions between the two groups(P=0.718).Conclusion:Dapagliflozin can significantly improve left ventricular diastolic function and effectively alleviate the progression of heart failure in elderly pa-tients with HFpEF during acute decompensation,which has certain clinical significance.
5.Biocompatibility and electrical output performance of composite piezoelectric film and osteogenic differentiation of rabbit bone marrow mesenchymal stem cells
Zhen WANG ; Shunen XU ; Geng TANG ; Siwei LUO ; Jianxiang TENG ; Mengli XIE ; Jialin HE ; Chuan YE
Chinese Journal of Tissue Engineering Research 2024;28(13):1969-1975
BACKGROUND:Adjustable piezoelectric effect can promote tissue regeneration and repair.Piezoelectric materials are widely used in weight-bearing tissue engineering. OBJECTIVE:To prepare a piezoelectric film material that can promote bone regeneration,and to explore its structural characterization,electrical output performance,biocompatibility,and effect of electrical output on osteogenic differentiation of rabbit bone marrow mesenchymal stem cells. METHODS:Using poly-3-hydroxybutyrateco/4-hydroxybutyrate(P34HB)as raw material,barium calcium stannate titanate powder(Ba0.94Ca0.06Sn0.08Ti0.92O3,BCST)was added according to mass ratios of 0%,5%,10%,15%,and 20%.Dichloromethane was added to solve P34HB,and the thickness of 150-200 μm BCST/P34HB piezoelectric film was prepared by vacuum drying method.After polarization in the oil bath,the surface morphology,crystal phase composition,piezoelectric coefficient and open circuit voltage were tested.The effect of BCST/P34HB electrical output at 110 Hz and 0.25 N force on the proliferation and osteogenic differentiation of rabbit bone marrow mesenchymal stem cells was tested. RESULTS AND CONCLUSION:(1)Scanning electron microscopy,X-ray diffraction,water contact angle,piezoelectric coefficient and electrical output performance tests showed that when the mass ratio of BCST increased to 20%,the BCST/P34HB piezoelectric film had good piezoelectric properties(d33=5.9 pC/N)and electrical output performance(180 mV),which was closer to the suitable range of 500 mV for electrical stimulation.(2)Live and dead staining showed that on the first day of co-culture,15%group and 20%group showed less red fluorescence.On the 5th day of culture,the number of green fluorescence in each group was significantly higher than that on the first day,and the red fluorescence was not observed in the 10%,15%and 20%groups,and only a small amount of red fluorescence was observed in the 0%and 5%groups.(3)On the 1st,3rd and 5th days of co-culture with rabbit bone marrow mesenchymal stem cells,Almar blue staining exhibited that the number of cells in each group showed an increasing trend with the increase of time.On the 5th day of culture,the number of cells in the 20%group was significantly more than that in the 0%group(P<0.05).(4)On day 10 of osteogenic induction,alkaline phosphatase staining results showed that the positive rate of the 20%group was significantly higher than that of the 0%group(P=0.000 1).On day 21,alizarin red staining and quantitative analysis of calcium nodules showed a similar trend to alkaline phosphatase staining.Compared with the 0%group,the 15%group and 20%group showed significant differences(P<0.01,P<0.000 1).(5)The results showed that 20%BCST/P34HB films had good piezoelectric properties,electrical output properties,biocompatibility and the ability of promoting osteogenic differentiation of bone marrow mesenchymal stem cells.
6.Causal relationship between obesity and male infertility:A two-sample Mendelian randomization study
Zhi-Chao LI ; Zhi-Hai TENG ; Zhen-Wei HAN ; Yan-Ping ZHANG ; Cheng-Gen JIN ; Ya-Xuan WANG
National Journal of Andrology 2024;30(4):306-314
Objective:To clarify the causal relationship between obesity and male infertility through Mendelian randomization(MR)study.Methods:We assessed the causal effect of genetically predicted body mass index(BMI)on the risk of male infertility via a two-sample MR analysis,with the BMIs of 99 998 cases and 12 746 controls as the exposure factor and genetic information on male infertility obtained from a genome-wide association study of 73 479 Europeans.In the univariable MR(UVMR)analysis of the causal relationship,we mainly used inverse variance weighting(IVW),with MR-Egger regression and weighted median filtering as the supplementary methods.Sensitivity analyses including the Cochran's Q test,Egger intercept test,MR-PRESSO,leave-one-out analysis and funnel plot were performed to verify the robustness of the MR results.To evaluate the direct causal effects of BMI on MI risk,mult-ivariable MR(MVMR)was performed.Results:UVMR indicated a causal relationship between genetically predicted BMI and an in-creased risk of male infertility(OR:1.237,95%CI:1.090-1.404,P=0.001).Sensitivity analysis revealed little evidence of bias in the current study(P>0.05).With such risk factors as type 2 diabetes,alcohol consumption and smoking adjusted,MVMR confirmed a direct causal effect of genetically predicted BMI on the risk of male infertility(P<0.05).Conclusion:Genetically pre-dicted BMI may be associated with an increased risk of male infertility.Further studies are expected to explore the underlying mecha-nisms of this association and provide some new strategies for the prevention and treatment of BMI-related male infertility.
7.Research on the health performance of basic medical insurance for flexible employees
Fang-Teng FU ; Bao-Zhen DAI ; Peng MIAO
Chinese Journal of Health Policy 2024;17(7):25-34
This paper evaluates the impact of basic medical insurance on the health status of flexible employees based on the CFPS three-period balanced panel data from 2016 to 2020,using Ordered Probit Model and Two-way Fixed Effects Model.It is found that basic medical insurance significantly promotes the physical and mental health of flexible employees.Further heterogeneity analysis reveals that the health performance of basic medical insurance was particularly significant for middle-aged and old-aged,rural,east-central and better-educated flexible employees.In addition,the mediation effect analysis indicates that basic medical insurance promots the health of flexible employees through the mediation channels of improving the utilization of medical services and reducing the burden of disease costs.This paper suggests promoting the comprehensive participation of flexible employees;improving the medical insurance system for middle-aged and elderly flexible employees;accelerating the sinking of high-quality medical resources to rural and western areas;and actively exploring a new mode of participation in medical check-ups by flexible employees,with a view to lowering the incidence of serious illnesses and major illnesses among flexible employees and improving health performance.
8.Application of metal cushion block combined with Jumbo cup in reconstruction of acetabular bone defect in revision of artificial hip joint
Feng-Zhen LI ; Wen-Teng SI ; Ai-Li TIAN ; Yu ZHOU ; Ming-Wei CHEN
China Journal of Orthopaedics and Traumatology 2024;37(5):464-469
Objective To investigate the application effect and imaging changes of metal cushion block combined with Jumbo cup in the reconstruction of acetabular bone defect after revision of artificial hip joint.Methods Retrospective analysis was made on the clinical data of 83 patients who underwent revision acetabular bone defect reconstruction of the artificial hip joint in our hospital from September 2019 to October 2021.They were divided into group A and group B according to different surgical methods.There were 42 patients in group A,including 26 males and 16 females,aged from 44 to 72 years old with an average of(60.57±4.62)years,who underwent revision with metal cushion block and Jumbo cup.There were 41 patients in group B,including 22 males and 19 females,aged from 42 to 71 years old with an average of(58.74±4.25)years,who under-went revision with metal cushion block and bone cement mortar cup.The operation related indexes,Harris hip function score and visual analogue scale(VAS)of pain before operation,1 month and 12 month after operation were compared between two groups.The results of X-ray imaging examination(hip rotation center height,acetabular abduction angle,femoral eccentricity and imaging standard qualification rate)before and 12 month after operation were evaluated,and the incidence of complica-tions was compared between two groups.Results There was no significant difference in operation time,intraoperative bleeding volume and postoperative drainage volume between two groups(P>0.05).Both groups were followed up for 12 to 36 months with an average of(25.36±3.59)months.The scores of pain,function,deformity and Harris'total score in the two groups at 1 month after operation were higher than those before operation(P<0.05),and the scores of pain,function,deformity,joint activ-ity and Harris'total score in two groups at 1 year after operation were higher than those before operation and 1 month after op-eration(P<0.05),and the above scores in group A were higher than those in group B at 1 year after operation(P<0.05).The VAS of two groups decreased successively at 1 month and 1 year after operation(P<0.05),but there was no significant differ-ence in both groups at each time point(P>0.05).The femoral eccentricity increased in both groups at 1 year after operation(P<0.05),and group A was higher than group B(P<0.05).The height of rotation center and acetabular abduction angle de-creased in both groups at 1 year after operation(P<0.05),and the height of rotation center in group A was lower than that in group B(P<0.05),but there was no significant difference in acetabular abduction angle between two groups(P>0.05).The imaging qualification rate of group A was higher than that of group B(P<0.05).There was no significant difference in the inci-dence of adverse reactions between two groups(P>0.05).Conclusion Metal cushion block combined with Jumbo cup in the treatment of acetabular bone defects can provide the hip joint function,and restore the hip joint rotation center,femoral eccen-tricity and acetabular abduction angle,with obvious clinical effect.
9.Correlations between sST2,NT-proBNP,hs-cTnT and left ventricular geometry in patients with chronic kidney disease
Lin LIN ; Xue-Ping LIN ; Bo SHEN ; Yi-Qin SHI ; Zhen ZHANG ; Jie TENG
Chinese Journal of Clinical Medicine 2023;30(6):919-926
Objective To investigate the associations between soluble growth stimulation expressed gene 2 protein(sST2),conventional biomarkers and left ventricular geometry in patients with chronic kidney disease(CKD).Methods Patients with non-dialysis-dependent CKD in Department of Nephrology,Zhongshan Hospital,Fudan University were enrolled from August 2019 to December 2020.Clinical data were collected,and serum sST2,N-terminal pro-B-type natriuretic peptide(NT-proBNP)and high-sensitivity cardiac troponin T(hs-cTnT)were measured.Left ventricular structure was assessed by transthoracic echocardiography.Left ventricular geometric patterns were defined according to left ventricular mass index(LVMI)and relative wall thickness(RWT).Differences of cardiac biomarkers between different left ventricle geometric groups were analyzed with Tukey's post-hoc test.Multiple linear regression models were used to evaluate the correlations between biomarkers and cardiac structure parameters.Results A total of 652 patients with CKD were enrolled,and the detection rate of LVH was 33.4%.The detection rate of LVH increased as kidney function worsened,with 64.3%in CKD G5 patients.Compared with normal geometry group,NT-proBNP and hs-cTnT levels elevated in both concentric LVH(cLVH)and eccentric LVH(eLVH)patients(P<0.001),while sST2 level only elevated in the cLVH patients(P=0.025).Multiple linear regression analysis showed that sST2 was associated with LAD and LVMI(P<0.01);NT-proBNP was associated with left atrial diameter(LAD),left ventricular end-diastolic diameter(LVEDD),left ventricular end-systolic diameter(LVESD),posterior wall thickness(PWT),interventricular septum thickness(IVST),left ventricular ejection fraction(LVEF),left ventricular mass(LVM),and LVMI(P<0.000 1);hs-cTnT was associated with LAD,PWT,IVST,LVM,RWT and LVMI(P<0.01).Conclusions sST2 could increase in CKD patients with cLVH,while has not significant change in eLVH patients,which is different from NT-proBNP and hs-cTnT.

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