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
3.Clinical distribution and diagnostic value of anti-total phospholipid antibodies in patients with antiphospholipid syndrome
Xiaohong XIANG ; Qingmeng CAI ; Xiangjun LIU ; Zelin YUN ; Ru LI ; Rulin JIA ; Chun LI
Chinese Journal of Rheumatology 2025;29(4):280-285
Objective:To investigate the clinical distribution and diagnostic value of anti-total phospholipid-antibodies(aTPL) patients with in antiphospholipid syndrome(APS).Methods:We collected the clinical data and laboratory test results of patients diagnosed with APS, systemic lupus erythematosus, Sj?gren′s syndrome, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, mixed connective tissue disease, and adult Still′s disease in Peking University People′s Hospital from February 2009 to October 2017. A total of 335 cases were studied, of which 163 were APS patients, 122 were disease control(DC) and 50 were health control(HC). Enzyme-linked immunosorbent assay(ELISA) was used to measure aTPL, anti-cardiolipin antibody (aCL), and anti-beta-2-glycoprotein Ⅰ antibody (aβ 2GPⅠ). The Chi-square test was used to compare the differences between groups. Results:The prevalence of aTPL in APS, DC and HC were 39.9%, 3.3%and 2.0% respectively. The sensitivity and specificity were 39.9%, 97.1%. The proportion of thrombosis[75.4%(49/65) vs. 51.0%(50/98), χ2=9.73, P=0.002] and arterial thrombosis[49.2%(32/65) vs. 25.5%(25/98), χ2=9.67, P=0.002] was significantly higher in the aTPL positive group than that of the negative group. In aTPL positive group, the positive rate of aCL[84.6%(55/65) vs.29.6%(29/98), χ2=47.37, P<0.001], aβ 2GPⅠ[83.1%(54/65) vs.37.8%(37/98), χ2=32.55, P<0.001] and LA[61.5%(40/65) vs. 42.9%(42/98), χ2=5.46, P=0.020] was significantly higher than that of negative group.The area under ROC curve (95% CI) of aTPL [0.694(0.636, 0.751)] was slightly higher than that of aCL [0.668(0.610, 0.726)], but lower than that of aβ 2GPⅠ [0.746(0.694, 0.799)]. Conclusion:aTPL exhibits a strong correlation with thrombosis in patients with APS, particularly arterial thrombosis, and demonstrates high specificity, which can assist in the diagnosis of seronegative APS.
4.MRI Characteristics and Differential Diagnosis of Benign and Malignant Ductal Lesions with Microcalcifications Detected by Mammography
Lin CHEN ; Chun-hong ZHENG ; Feng JIANG ; Xiang-xiu ZHANG ; An-wen CAI
Progress in Modern Biomedicine 2025;25(12):2034-2041
Objective:To investigate the MRI characteristics of ductal lesions with microcalcifications detected by mammography,and to evaluate the value of MRI in the differential diagnosis of benign and malignant ductal lesions.Methods:The clinical data of 112 patients with pathologically confirmed ductal lesions with microcalcifications detected by mammography in our hospital from January 2022 to June 2024 were retrospectively analyzed.All patients underwent mammography and MRI examinations.MRI morphological features,dynamic enhancement characteristics,diffusion-weighted imaging(DWI)findings,and apparent diffusion coefficient(ADC)values were analyzed and compared with pathological results.The diagnostic performance of various MRI features was analyzed using ROC curves.Results:Among the 112 patients,there were 47 benign lesions and 65 malignant lesions.Malignant lesions were more likely to present with irregular morphology,heterogeneous T2 signal,lobulation,and spiculation(P<0.05),while benign lesions were more likely to present with round or oval shapes and homogeneous T2 signal(P<0.05).Malignant lesions predominantly showed fast rise-fast washout(Washout type)enhancement curves(58.5%),while benign lesions predominantly showed persistent rise(Progressive type)enhancement curves(55.3%).The ADC values of malignant lesions(0.92±0.21× 10-3 mm2/s)were significantly lower than those of benign lesions(1.45±0.28× 10-3 mm2/s)(P<0.001).The combined application of morphological features,dynamic enhancement curves,and ADC values had the highest diagnostic performance,with a sensitivity of 92.3%,specificity of 89.4%,and accuracy of 91.1%.Conclusion:Multi-parameter MRI can comprehensively evaluate ductal lesions with microcalcifications detected by mammography.The combined application of morphological features,dynamic enhancement curve types,and ADC values can effectively improve the accuracy of differential diagnosis between benign and malignant lesions,providing important basis for clinical treatment decisions.
5.MRI Characteristics and Differential Diagnosis of Benign and Malignant Ductal Lesions with Microcalcifications Detected by Mammography
Lin CHEN ; Chun-hong ZHENG ; Feng JIANG ; Xiang-xiu ZHANG ; An-wen CAI
Progress in Modern Biomedicine 2025;25(12):2034-2041
Objective:To investigate the MRI characteristics of ductal lesions with microcalcifications detected by mammography,and to evaluate the value of MRI in the differential diagnosis of benign and malignant ductal lesions.Methods:The clinical data of 112 patients with pathologically confirmed ductal lesions with microcalcifications detected by mammography in our hospital from January 2022 to June 2024 were retrospectively analyzed.All patients underwent mammography and MRI examinations.MRI morphological features,dynamic enhancement characteristics,diffusion-weighted imaging(DWI)findings,and apparent diffusion coefficient(ADC)values were analyzed and compared with pathological results.The diagnostic performance of various MRI features was analyzed using ROC curves.Results:Among the 112 patients,there were 47 benign lesions and 65 malignant lesions.Malignant lesions were more likely to present with irregular morphology,heterogeneous T2 signal,lobulation,and spiculation(P<0.05),while benign lesions were more likely to present with round or oval shapes and homogeneous T2 signal(P<0.05).Malignant lesions predominantly showed fast rise-fast washout(Washout type)enhancement curves(58.5%),while benign lesions predominantly showed persistent rise(Progressive type)enhancement curves(55.3%).The ADC values of malignant lesions(0.92±0.21× 10-3 mm2/s)were significantly lower than those of benign lesions(1.45±0.28× 10-3 mm2/s)(P<0.001).The combined application of morphological features,dynamic enhancement curves,and ADC values had the highest diagnostic performance,with a sensitivity of 92.3%,specificity of 89.4%,and accuracy of 91.1%.Conclusion:Multi-parameter MRI can comprehensively evaluate ductal lesions with microcalcifications detected by mammography.The combined application of morphological features,dynamic enhancement curve types,and ADC values can effectively improve the accuracy of differential diagnosis between benign and malignant lesions,providing important basis for clinical treatment decisions.
6.Clinical distribution and diagnostic value of anti-total phospholipid antibodies in patients with antiphospholipid syndrome
Xiaohong XIANG ; Qingmeng CAI ; Xiangjun LIU ; Zelin YUN ; Ru LI ; Rulin JIA ; Chun LI
Chinese Journal of Rheumatology 2025;29(4):280-285
Objective:To investigate the clinical distribution and diagnostic value of anti-total phospholipid-antibodies(aTPL) patients with in antiphospholipid syndrome(APS).Methods:We collected the clinical data and laboratory test results of patients diagnosed with APS, systemic lupus erythematosus, Sj?gren′s syndrome, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, mixed connective tissue disease, and adult Still′s disease in Peking University People′s Hospital from February 2009 to October 2017. A total of 335 cases were studied, of which 163 were APS patients, 122 were disease control(DC) and 50 were health control(HC). Enzyme-linked immunosorbent assay(ELISA) was used to measure aTPL, anti-cardiolipin antibody (aCL), and anti-beta-2-glycoprotein Ⅰ antibody (aβ 2GPⅠ). The Chi-square test was used to compare the differences between groups. Results:The prevalence of aTPL in APS, DC and HC were 39.9%, 3.3%and 2.0% respectively. The sensitivity and specificity were 39.9%, 97.1%. The proportion of thrombosis[75.4%(49/65) vs. 51.0%(50/98), χ2=9.73, P=0.002] and arterial thrombosis[49.2%(32/65) vs. 25.5%(25/98), χ2=9.67, P=0.002] was significantly higher in the aTPL positive group than that of the negative group. In aTPL positive group, the positive rate of aCL[84.6%(55/65) vs.29.6%(29/98), χ2=47.37, P<0.001], aβ 2GPⅠ[83.1%(54/65) vs.37.8%(37/98), χ2=32.55, P<0.001] and LA[61.5%(40/65) vs. 42.9%(42/98), χ2=5.46, P=0.020] was significantly higher than that of negative group.The area under ROC curve (95% CI) of aTPL [0.694(0.636, 0.751)] was slightly higher than that of aCL [0.668(0.610, 0.726)], but lower than that of aβ 2GPⅠ [0.746(0.694, 0.799)]. Conclusion:aTPL exhibits a strong correlation with thrombosis in patients with APS, particularly arterial thrombosis, and demonstrates high specificity, which can assist in the diagnosis of seronegative APS.
7.Visualization Analysis of Artificial Intelligence Literature in Forensic Research
Yi-Ming DONG ; Chun-Mei ZHAO ; Nian-Nian CHEN ; Li LUO ; Zhan-Peng LI ; Li-Kai WANG ; Xiao-Qian LI ; Ting-Gan REN ; Cai-Rong GAO ; Xiang-Jie GUO
Journal of Forensic Medicine 2024;40(1):1-14
Objective To analyze the literature on artificial intelligence in forensic research from 2012 to 2022 in the Web of Science Core Collection Database,to explore research hotspots and developmen-tal trends.Methods A total of 736 articles on artificial intelligence in forensic medicine in the Web of Science Core Collection Database from 2012 to 2022 were visualized and analyzed through the litera-ture measuring tool CiteSpace.The authors,institution,country(region),title,journal,keywords,cited references and other information of relevant literatures were analyzed.Results A total of 736 articles published in 220 journals by 355 authors from 289 institutions in 69 countries(regions)were identi-fied,with the number of articles published showing an increasing trend year by year.Among them,the United States had the highest number of publications and China ranked the second.Academy of Forensic Science had the highest number of publications among the institutions.Forensic Science Inter-national,Journal of Forensic Sciences,International Journal of Legal Medicine ranked high in publica-tion and citation frequency.Through the analysis of keywords,it was found that the research hotspots of artificial intelligence in the forensic field mainly focused on the use of artificial intelligence technol-ogy for sex and age estimation,cause of death analysis,postmortem interval estimation,individual identification and so on.Conclusion It is necessary to pay attention to international and institutional cooperation and to strengthen the cross-disciplinary research.Exploring the combination of advanced ar-tificial intelligence technologies with forensic research will be a hotspot and direction for future re-search.
8.Effects of climate change on scrub typhus in Xiamen
Xue-Mei KE ; Jiao-Na CHEN ; Shan-Shan MA ; Si-Han WU ; Chun-Xiang CAI ; Xiao-Yan WANG ; Shi-Jie HUANG
Chinese Journal of Zoonoses 2024;40(10):965-970
This study was aimed at examining the influence of meteorological factors on scrub typhus in Xiamen.Scrub ty-phus monitoring data and meteorological factors were collected in Xiamen from 2005 to 2023.Spearman correlation analysis and nonlinear regression were used to analyze the correlation between scrub typhus incidence and meteorological factors.The inci-dence of scrub typhus first increased and subsequently decreased in Xiamen from 2005 to 2023.The highest incidence was be-tween 2014 and 2016,and the peak incidence was from June to October.The monthly incidence of scrub typhus positively cor-related with daily minimum temperature(r=0.637,P<0.001,daily average temperature(r=0.627,P<0.001),daily maxi-mum temperature(r=0.612,P<0.001),sunshine duration(r=0.405,P<0.001),average relative humidity(r=0.346,P<0.001),and daily rainfall(r=0.207,P=0.002),and negatively correlated with average atmospheric pressure(r=-0.549,P<0.001),whereas no correlation was observed with the average wind speed in Xiamen.The regression equation of scrub ty-phus monthly incidence and meteorological parameters was y=-433.869-11.503x1+0.381x1 2+9.150x2-0.197x2 2+3.936 x3-0.132x3 2+0.881x4+0.035x4 2-1.048x5+0.009x5 2+0.186x6-0.023x6 2+0.421x7+6.210×10-5x8-1.051 × 10-10x8 2 in Xiamen,and the R2 was 0.473,thus indicating good model fit.Scrub typhus incidence correlated with the daily minimum av-erage temperature,average temperature,daily maximum tem-perature,sunshine duration,daily rainfall,relative humidity,and average atmospheric pressure in Xiamen.Various meteoro-logical factors had differing effects on scrub typhus.
9. Rho A/ROCK signaling pathway involved in hyper responsiveness to aortic contraction in mice with type 2 diabetes
Shu-Zhen CHEN ; Yan-Xiang ZHENG ; Xiao-Yue QIN ; Chun-Yu DENG ; Shu-Zhen CHEN ; Yong-Jiang CAI ; Yan-Xiang ZHENG ; Xiao-Yue QIN ; Su-Juan KUANG ; Hui YANG ; Fang RAO ; Chun-Yu DENG ; Yong-Jiang CAI ; Chun-Yu DENG
Chinese Pharmacological Bulletin 2023;39(8):1484-1492
Aim To investigate the mechanism of RhoA/ROCK signaling pathway in abnormal aortic contractility in type 2 diabetes (T2DM) mice. Methods The experiment was divided into two groups, the control group (db/m mice) and the model group (db/db mice). Changes of the response to different methods were measured in aorta rings using a Multi Myograph System. At the same time, the protein expression changes of aortic smooth muscle contraction signaling pathway in mice were determined by Western method. Results Compared with the control group, the blood glucose and body weight levels of the mice in the T2DM group significantly increased, and the cardiac function was abnormal (P <0. 01). The contractile response of the aorta of the diabetic mice induced by the contractile agents Phe, 5-HT and CaCl
10.Quantitative Pulmonary Administration of Essential Oil from Alpiniae Zerumbet Fructus for Treatment of Emphysema
Zi-min CAI ; Jian-qing PENG ; Yi CHEN ; Di PAN ; Yan-yan ZHANG ; Ling TAO ; Xiang-chun SHEN ; Qing-de LONG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(3):91-97
ObjectiveTo investigate the effect of quantitative pulmonary administration of the essential oil from Alpiniae Zerumbet Fructus (EOAZF) on porcine pancreatic elastase (PPE)-induced emphysema in mice and explore its action mechanism. MethodC57BL/6J mice were randomly divided into five group, namely the control group, model group, low- (2 mg·kg-1) and high-dose (20 mg·kg-1) EOFAZ groups, and positive control dexamethasone (DEX,1 mg·kg-1) group. The mice were treated with pulmonary administration of PPE using a microsprayer aerosolizer, once every seven days, for four times in total, for inducing emphysema. During this period, EOFAZ were administered with a quantitative microsprayer aerosolizer once every other day, for 14 times. The lung tissues were then sampled and stained with hematoxylin-eosin (HE) for observing the morphological changes and calculating the pulmonary mean linear intercept (MLI). The concentrations of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) in the plasma were determined by enzyme-linked immunosorbent assay (ELISA). The activities of superoxide dismutase (SOD) and catalase (CAT) and the content of malondialdehyde (MDA) in the lung tissues were measured using the biochemical assay kits. The protein expression levels of nuclear factor E2-related factor 2 (Nrf2), quinone oxidoreductase1 (NQO1), B cell lymphoma-2 (Bcl-2)-associated X protein (Bax), and Bcl-2 in lung tissues were detected by Western blot. ResultThe results of lung morphological observation and MLI detection showed that compared with the control group, the model group showed obvious inflammatory infiltration, alveolar enlargement and fusion, and increased MLI (P<0.05). Compared with the model group, EOFAZ effectively alleviated the pathological changes such as alveolar dilatation, pulmonary inflammatory cell infiltration, and lung cell apoptosis caused by PPE, and decreased the MLI (P<0.05). As revealed by ELISA, the inflammatory level of mice in the model group increased significantly (P<0.01), while the TNF-α, IL-1β, and IL-6 levels in the plasma were decreased after quantitative administration of EOFAZ (P<0.01). Compared with the control group, the model group exhibited significantly enhanced oxidative stress (P<0.01). After treatment with EOFAZ by quantitative administration, the activities of SOD and CAT in the lung tissue were increased (P<0.01) and the content of MDA was decreased (P<0.01). Western blot results demonstrated that the apoptosis-related protein expression in the model group was increased significantly as compared with that in the control group (P<0.01), whereas the expression levels of antioxidant stress proteins Nrf2 and NQO1 declined (P<0.05). The relative protein expression of apoptosis-related proteins Bax/Bcl-2 in the EOFAZ groups was lower than that in the model group (P<0.01), while the expression of antioxidant stress proteins Nrf2 and NQO1 was higher (P<0.05). ConclusionQuantitative pulmonary administration of EOFAZ effectively alleviates the inflammation and oxidative stress, reduces lung cell apoptosis, and hinders the occurrence and development of emphysema. Its antioxidant mechanism is closely related to the up-regulation of Nrf2 and its downstream NQO1.

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