1.Dingchan Granule (定颤颗粒) for Paroxysmal Atrial Fibrillation with Syndrome of Qi Stagnation and Blood Stasis:A Randomized,Double-Blinded,Placebo-Controlled Clinical Trial
Xiaozhen CHENG ; Xingjuan CHEN ; Weina LI ; Lu XIAO ; Yunhan WANG ; Yun XU ; Yueyue NIU ; Ling FENG
Journal of Traditional Chinese Medicine 2025;66(12):1233-1240
ObjectiveTo observe the clinical effectiveness and safety of Dingchan Granule (定颤颗粒) for paroxysmal atrial fibrillation with syndrome of qi stagnation and blood stasis. MethodsUsing a randomised, double-blind, placebo controlled study method, 90 patients with paroxysmal atrial fibrillation with qi stagnation and blood stasis syndrome were divided into 45 cases each in the treatment group and the control group. Both groups were given conventional western medicine treatment, and the treatment group was additionally treated with Dingchan Granule, while the control group was treated with Dingchan Granule placebo, both of which were taken orally for 8 g each time twice a day. Both groups were treated for 8 weeks. We compared the clinical effectiveness, the improvement of traditional Chinese medicine (TCM) symptoms and the recovery rate of atrial fibrillation between the two groups. We compared the number and duration of atrial fibrillation episodes, TCM symptoms score, atrial fibrillation symptom classification, 24-hour average ventricular rate, Pittsburgh Sleep Quality Index (PSQI), anxiety index, depression index before and after treatment, and evaluated the safety of the two groups. ResultsThe total clinical effectiveness rate in the treatment group was 82.22% (37/45), which was better than 60.00% (27/45) in the control group (P<0.05). The total effective rate of TCM syndrome effectiveness in the treatment group was 88.89% (40/45), which was better than 66.67% (30/45) in the control group (P<0.05); and the rate of atrial fibrillation regression in the treatment group was 26.67% (12/45), better than 6.67% (3/45) in the control group (P<0.05). The number and duration of atrial fibrillation episodes in both groups were significantly decreased (P<0.01), and the number and duration of atrial fibrillation episodes in the treatment group were lower than those in the control group (P<0.01). The TCM syndrome scores of both groups after treatment were significantly lower than before treatment (P<0.01), and the scores of the treatment group was lower than those of the control group (P<0.05). The severity of atrial fibrillation symptoms and the grading of atrial fibrillation symptoms in both groups after treatment were improved (P<0.01), and the degree of symptom improvement in the treatment group was better than that in the control group (P<0.01). The 24-hour average ventricular rate of both groups after treatment was significantly lower (P<0.01). The PSQI, anxiety index and depression index of the treatment group were all lower than before treatment (P<0.01), while the PSQI and anxiety index of the control group were both lower than before treatment (P<0.01 or P<0.05), the PSQI, anxiety index and depression index of the treatment group being lower than those of the control group (P<0.05 or P<0.01). No adverse events occurred in both groups, and no abnormalities were observed in blood, urine, stool routine, liver and kidney function, and coagulation function indexes. ConclusionDingchan Granule for paroxysmal atrial fibrillation with qi stagnation and blood stasis syndrome can alleviate clinical symptom, improve TCM symptom scores, increase atrial fibrillation recovery rate, stabilise the average ventricular rate, and significantly improve the quality of sleep, alleviate the anxiety and depression, with a good safety profile.
2.Treatment of Palpitations Based on the Theory of "Wind and Fire Inciting Each Other"
Yun XU ; Xingjuan CHEN ; Lu XIAO ; Yiru WU ; Ling FENG
Journal of Traditional Chinese Medicine 2024;65(15):1617-1620
By combing the physiological characteristics of wind and fire, the article makes it clear that wind and fire are evils, and external wind is easy to attack and even worse when it encounters fire; burnt and moving fire evils set off internal winds; and the incitement of each other can lead to the occurrence of palpitations. From the perspective of the theory of "wind and fire inciting each other", the clinical diagnosis and treatment of palpitation is discussed, which clarifies that there is an internal and external distinction between wind and fire, and there is an internal and external distinction between the real and the imaginary, which should be carefully distinguished in the diagnosis and treatment of palpitation. In the treatment, wind medicine can be skillfully applied to drive away the wind evil to calm the internal and external, and it is also necessary to clearly identify the source of the fire evil and properly choose the corresponding treatment for the fire evil in order to extinguish the burnt fire. As the positive qi exists and the evil will not dry up, we should not forget to take care of the heart in the treatment. An example of a medical case is attached in order to provide new ideas for the clinical treatment of palpitation.
3.Discrete element modeling and breakage behavior analysis of oral solid dosage form particles
Lin-xiu LUO ; Tian-bing GUAN ; An-qi LUO ; Zeng LIU ; Yu-ting WANG ; Yan-ling JIANG ; Zheng LU ; Jing-cao TANG ; Shuang-kou CHEN ; Hui-min SUN ; Chuan-yun DAI
Acta Pharmaceutica Sinica 2024;59(4):1057-1066
The breakage pattern of unit particles during the production of oral solid dosage forms (OSD) is closely related to the quality of intermediate or final products. To accurately characterize the particles and study the evolution law of particle breakage, the Bonding model of the discrete element method (DEM) was used to investigate the breakage patterns of model parameters, particle shape and process conditions (loading mode and loading rate) on the dynamic breakage, force-time curve, breakage rate, maximum breakage size ratio and fracture strength of particles. The results showed that the particle breakage force was positively correlated with normal strength and bonded disk scale, negatively correlated with normal stiffness per unit area and tangential stiffness per unit area, and weakly correlated with tangential strength. The particle breakage rate was negatively correlated with the aspect ratio of the particles, and the maximum breakage size ratio was positively correlated with the aspect ratio of the particles; among the three loading modes, the breakage rate of compression breakage model was the largest, the breakage rate of shear breakage model was the second largest, and the breakage rate of wear breakage model was the smallest; the maximum breakage size ratio was positively correlated with the loading rate, the loading mode and the loading rate had no mutual influence on particle breakage rate, but had mutual influence on the maximum breakage size ratio. The research results will provide a theoretical basis for the shift of OSD from batch manufacturing to advanced manufacturing.
4.Discussion of the methodology and implementation steps for assessing the causality of adverse event
Hong FANG ; Shuo-Peng JIA ; Hai-Xue WANG ; Xiao-Jing PEI ; Min LIU ; An-Qi YU ; Ling-Yun ZHOU ; Fang-Fang SHI ; Shu-Jie LU ; Shu-Hang WANG ; Yue YU ; Dan-Dan CUI ; Yu TANG ; Ning LI ; Ze-Huai WEN
The Chinese Journal of Clinical Pharmacology 2024;40(2):299-304
The assessment of adverse drug events is an important basis for clinical safety evaluation and post-marketing risk control of drugs,and its causality assessment is gaining increasing attention.The existing methods for assessing the causal relationship between drugs and the occurrence of adverse reactions can be broadly classified into three categories:global introspective methods,standardized methods,and probabilistic methods.At present,there is no systematic introduction of the operational details of the various methods in the domestic literature.This paper compares representative causality assessment methods in terms of definition and concept,methodological steps,industry evaluation and advantages and disadvantages,clarifies the basic process of determining the causality of adverse drug reactions,and discusses how to further improve the adverse drug reaction monitoring and evaluation system,with a view to providing a reference for drug development and pharmacovigilance work in China.
5.Species-level Microbiota of Biting Midges and Ticks from Poyang Lake
Jian GONG ; Fei Fei WANG ; Qing Yang LIU ; Ji PU ; Zhi Ling DONG ; Hui Si ZHANG ; Zhou Zhen HUANG ; Yuan Yu HUANG ; Ben Ya LI ; Xin Cai YANG ; Meihui Yuan TAO ; Jun Li ZHAO ; Dong JIN ; Yun Li LIU ; Jing YANG ; Shan LU
Biomedical and Environmental Sciences 2024;37(3):266-277,中插1-中插3
Objective The purpose of this study was to investigate the bacterial communities of biting midges and ticks collected from three sites in the Poyang Lake area,namely,Qunlu Practice Base,Peach Blossom Garden,and Huangtong Animal Husbandry,and whether vectors carry any bacterial pathogens that may cause diseases to humans,to provide scientific basis for prospective pathogen discovery and disease prevention and control. Methods Using a metataxonomics approach in concert with full-length 16S rRNA gene sequencing and operational phylogenetic unit(OPU)analysis,we characterized the species-level microbial community structure of two important vector species,biting midges and ticks,including 33 arthropod samples comprising 3,885 individuals,collected around Poyang Lake. Results A total of 662 OPUs were classified in biting midges,including 195 known species and 373 potentially new species,and 618 OPUs were classified in ticks,including 217 known species and 326 potentially new species.Surprisingly,OPUs with potentially pathogenicity were detected in both arthropod vectors,with 66 known species of biting midges reported to carry potential pathogens,including Asaia lannensis and Rickettsia bellii,compared to 50 in ticks,such as Acinetobacter lwoffii and Staphylococcus sciuri.We found that Proteobacteria was the most dominant group in both midges and ticks.Furthermore,the outcomes demonstrated that the microbiota of midges and ticks tend to be governed by a few highly abundant bacteria.Pantoea sp7 was predominant in biting midges,while Coxiella sp1 was enriched in ticks.Meanwhile,Coxiella spp.,which may be essential for the survival of Haemaphysalis longicornis Neumann,were detected in all tick samples.The identification of dominant species and pathogens of biting midges and ticks in this study serves to broaden our knowledge associated to microbes of arthropod vectors. Conclusion Biting midges and ticks carry large numbers of known and potentially novel bacteria,and carry a wide range of potentially pathogenic bacteria,which may pose a risk of infection to humans and animals.The microbial communities of midges and ticks tend to be dominated by a few highly abundant bacteria.
6.Determining Disease Activity and Glucocorticoid Response in Thyroid-Associated Ophthalmopathy:Preliminary Study Using Dynamic Contrast-Enhanced MRI
Hao HU ; Xiong-Ying PU ; Jiang ZHOU ; Wen-Hao JIANG ; Qian WU ; Jin-Ling LU ; Fei-Yun WU ; Huan-Huan CHEN ; Xiao-Quan XU
Korean Journal of Radiology 2024;25(12):1070-1082
Objective:
To assess the role of dynamic contrast-enhanced (DCE)-MRI of the extraocular muscles (EOMs) for determining the activity of thyroid-associated ophthalmopathy (TAO) and treatment response to glucocorticoids (GCs).
Materials and Methods:
We prospectively enrolled 65 patients with TAO (41 active, 82 eyes; 24 inactive, 48 eyes). Twenty-two active patients completed the GC treatment and follow-up assessment, including 15 patients (30 eyes) and 7 patients (14 eyes), defined as responsive and unresponsive, respectively. Model-free (time to peak [TTP], area under the curve [AUC], and Slope max) and model-based (Ktrans , Kep, and Ve) parameters of EOMs in embedded simplified histogram analyses were calculated and compared between groups. Multivariable logistic regression analysis was used to identify the independent predictors. The area under the receiver operating characteristic curve (AUROC) was used to evaluate the diagnostic performance.
Results:
Active patients exhibited significantly higher TTP at the 10th percentile (-10th), TTP-mean, and TTP at the 90th percentile (-90th); AUC-10th, AUC-mean, AUC-90th, and AUC-max; Ktrans -10th and Ktrans -mean; and Ve-10th, Ve-mean, Ve-90th, and Ve-max than inactive patients (P < 0.05). Responsive patients exhibited significantly lower TTP-min; higher Ktrans -mean and Ktrans -max; and higher Kep-10th, Kep-mean, and Kep-max than unresponsive patients (P < 0.05). TTP-mean and Ve-mean were independent variables for determining disease activity (P = 0.017 and 0.022, respectively). A combination of the two parameters could determine active TAO with moderate performance (AUROC = 0.687). TTP-min and Ktrans -mean were independent predictors of the response to GCs (P = 0.023 and 0.004, respectively), uniting which could determine the response to GCs with decent performance (AUROC = 0.821).
Conclusion
DCE-MRI-derived model-free and model-based parameters of EOMs can assist in the evaluation of TAO. In particular, TTP-mean and Ve-mean could be useful for determining the activity of TAO, whereas TTP-min and K trans -mean could be promising biomarkers for determining the response to GCs.
7.Determining Disease Activity and Glucocorticoid Response in Thyroid-Associated Ophthalmopathy:Preliminary Study Using Dynamic Contrast-Enhanced MRI
Hao HU ; Xiong-Ying PU ; Jiang ZHOU ; Wen-Hao JIANG ; Qian WU ; Jin-Ling LU ; Fei-Yun WU ; Huan-Huan CHEN ; Xiao-Quan XU
Korean Journal of Radiology 2024;25(12):1070-1082
Objective:
To assess the role of dynamic contrast-enhanced (DCE)-MRI of the extraocular muscles (EOMs) for determining the activity of thyroid-associated ophthalmopathy (TAO) and treatment response to glucocorticoids (GCs).
Materials and Methods:
We prospectively enrolled 65 patients with TAO (41 active, 82 eyes; 24 inactive, 48 eyes). Twenty-two active patients completed the GC treatment and follow-up assessment, including 15 patients (30 eyes) and 7 patients (14 eyes), defined as responsive and unresponsive, respectively. Model-free (time to peak [TTP], area under the curve [AUC], and Slope max) and model-based (Ktrans , Kep, and Ve) parameters of EOMs in embedded simplified histogram analyses were calculated and compared between groups. Multivariable logistic regression analysis was used to identify the independent predictors. The area under the receiver operating characteristic curve (AUROC) was used to evaluate the diagnostic performance.
Results:
Active patients exhibited significantly higher TTP at the 10th percentile (-10th), TTP-mean, and TTP at the 90th percentile (-90th); AUC-10th, AUC-mean, AUC-90th, and AUC-max; Ktrans -10th and Ktrans -mean; and Ve-10th, Ve-mean, Ve-90th, and Ve-max than inactive patients (P < 0.05). Responsive patients exhibited significantly lower TTP-min; higher Ktrans -mean and Ktrans -max; and higher Kep-10th, Kep-mean, and Kep-max than unresponsive patients (P < 0.05). TTP-mean and Ve-mean were independent variables for determining disease activity (P = 0.017 and 0.022, respectively). A combination of the two parameters could determine active TAO with moderate performance (AUROC = 0.687). TTP-min and Ktrans -mean were independent predictors of the response to GCs (P = 0.023 and 0.004, respectively), uniting which could determine the response to GCs with decent performance (AUROC = 0.821).
Conclusion
DCE-MRI-derived model-free and model-based parameters of EOMs can assist in the evaluation of TAO. In particular, TTP-mean and Ve-mean could be useful for determining the activity of TAO, whereas TTP-min and K trans -mean could be promising biomarkers for determining the response to GCs.
8.Determining Disease Activity and Glucocorticoid Response in Thyroid-Associated Ophthalmopathy:Preliminary Study Using Dynamic Contrast-Enhanced MRI
Hao HU ; Xiong-Ying PU ; Jiang ZHOU ; Wen-Hao JIANG ; Qian WU ; Jin-Ling LU ; Fei-Yun WU ; Huan-Huan CHEN ; Xiao-Quan XU
Korean Journal of Radiology 2024;25(12):1070-1082
Objective:
To assess the role of dynamic contrast-enhanced (DCE)-MRI of the extraocular muscles (EOMs) for determining the activity of thyroid-associated ophthalmopathy (TAO) and treatment response to glucocorticoids (GCs).
Materials and Methods:
We prospectively enrolled 65 patients with TAO (41 active, 82 eyes; 24 inactive, 48 eyes). Twenty-two active patients completed the GC treatment and follow-up assessment, including 15 patients (30 eyes) and 7 patients (14 eyes), defined as responsive and unresponsive, respectively. Model-free (time to peak [TTP], area under the curve [AUC], and Slope max) and model-based (Ktrans , Kep, and Ve) parameters of EOMs in embedded simplified histogram analyses were calculated and compared between groups. Multivariable logistic regression analysis was used to identify the independent predictors. The area under the receiver operating characteristic curve (AUROC) was used to evaluate the diagnostic performance.
Results:
Active patients exhibited significantly higher TTP at the 10th percentile (-10th), TTP-mean, and TTP at the 90th percentile (-90th); AUC-10th, AUC-mean, AUC-90th, and AUC-max; Ktrans -10th and Ktrans -mean; and Ve-10th, Ve-mean, Ve-90th, and Ve-max than inactive patients (P < 0.05). Responsive patients exhibited significantly lower TTP-min; higher Ktrans -mean and Ktrans -max; and higher Kep-10th, Kep-mean, and Kep-max than unresponsive patients (P < 0.05). TTP-mean and Ve-mean were independent variables for determining disease activity (P = 0.017 and 0.022, respectively). A combination of the two parameters could determine active TAO with moderate performance (AUROC = 0.687). TTP-min and Ktrans -mean were independent predictors of the response to GCs (P = 0.023 and 0.004, respectively), uniting which could determine the response to GCs with decent performance (AUROC = 0.821).
Conclusion
DCE-MRI-derived model-free and model-based parameters of EOMs can assist in the evaluation of TAO. In particular, TTP-mean and Ve-mean could be useful for determining the activity of TAO, whereas TTP-min and K trans -mean could be promising biomarkers for determining the response to GCs.
9.Determining Disease Activity and Glucocorticoid Response in Thyroid-Associated Ophthalmopathy:Preliminary Study Using Dynamic Contrast-Enhanced MRI
Hao HU ; Xiong-Ying PU ; Jiang ZHOU ; Wen-Hao JIANG ; Qian WU ; Jin-Ling LU ; Fei-Yun WU ; Huan-Huan CHEN ; Xiao-Quan XU
Korean Journal of Radiology 2024;25(12):1070-1082
Objective:
To assess the role of dynamic contrast-enhanced (DCE)-MRI of the extraocular muscles (EOMs) for determining the activity of thyroid-associated ophthalmopathy (TAO) and treatment response to glucocorticoids (GCs).
Materials and Methods:
We prospectively enrolled 65 patients with TAO (41 active, 82 eyes; 24 inactive, 48 eyes). Twenty-two active patients completed the GC treatment and follow-up assessment, including 15 patients (30 eyes) and 7 patients (14 eyes), defined as responsive and unresponsive, respectively. Model-free (time to peak [TTP], area under the curve [AUC], and Slope max) and model-based (Ktrans , Kep, and Ve) parameters of EOMs in embedded simplified histogram analyses were calculated and compared between groups. Multivariable logistic regression analysis was used to identify the independent predictors. The area under the receiver operating characteristic curve (AUROC) was used to evaluate the diagnostic performance.
Results:
Active patients exhibited significantly higher TTP at the 10th percentile (-10th), TTP-mean, and TTP at the 90th percentile (-90th); AUC-10th, AUC-mean, AUC-90th, and AUC-max; Ktrans -10th and Ktrans -mean; and Ve-10th, Ve-mean, Ve-90th, and Ve-max than inactive patients (P < 0.05). Responsive patients exhibited significantly lower TTP-min; higher Ktrans -mean and Ktrans -max; and higher Kep-10th, Kep-mean, and Kep-max than unresponsive patients (P < 0.05). TTP-mean and Ve-mean were independent variables for determining disease activity (P = 0.017 and 0.022, respectively). A combination of the two parameters could determine active TAO with moderate performance (AUROC = 0.687). TTP-min and Ktrans -mean were independent predictors of the response to GCs (P = 0.023 and 0.004, respectively), uniting which could determine the response to GCs with decent performance (AUROC = 0.821).
Conclusion
DCE-MRI-derived model-free and model-based parameters of EOMs can assist in the evaluation of TAO. In particular, TTP-mean and Ve-mean could be useful for determining the activity of TAO, whereas TTP-min and K trans -mean could be promising biomarkers for determining the response to GCs.
10.Determining Disease Activity and Glucocorticoid Response in Thyroid-Associated Ophthalmopathy:Preliminary Study Using Dynamic Contrast-Enhanced MRI
Hao HU ; Xiong-Ying PU ; Jiang ZHOU ; Wen-Hao JIANG ; Qian WU ; Jin-Ling LU ; Fei-Yun WU ; Huan-Huan CHEN ; Xiao-Quan XU
Korean Journal of Radiology 2024;25(12):1070-1082
Objective:
To assess the role of dynamic contrast-enhanced (DCE)-MRI of the extraocular muscles (EOMs) for determining the activity of thyroid-associated ophthalmopathy (TAO) and treatment response to glucocorticoids (GCs).
Materials and Methods:
We prospectively enrolled 65 patients with TAO (41 active, 82 eyes; 24 inactive, 48 eyes). Twenty-two active patients completed the GC treatment and follow-up assessment, including 15 patients (30 eyes) and 7 patients (14 eyes), defined as responsive and unresponsive, respectively. Model-free (time to peak [TTP], area under the curve [AUC], and Slope max) and model-based (Ktrans , Kep, and Ve) parameters of EOMs in embedded simplified histogram analyses were calculated and compared between groups. Multivariable logistic regression analysis was used to identify the independent predictors. The area under the receiver operating characteristic curve (AUROC) was used to evaluate the diagnostic performance.
Results:
Active patients exhibited significantly higher TTP at the 10th percentile (-10th), TTP-mean, and TTP at the 90th percentile (-90th); AUC-10th, AUC-mean, AUC-90th, and AUC-max; Ktrans -10th and Ktrans -mean; and Ve-10th, Ve-mean, Ve-90th, and Ve-max than inactive patients (P < 0.05). Responsive patients exhibited significantly lower TTP-min; higher Ktrans -mean and Ktrans -max; and higher Kep-10th, Kep-mean, and Kep-max than unresponsive patients (P < 0.05). TTP-mean and Ve-mean were independent variables for determining disease activity (P = 0.017 and 0.022, respectively). A combination of the two parameters could determine active TAO with moderate performance (AUROC = 0.687). TTP-min and Ktrans -mean were independent predictors of the response to GCs (P = 0.023 and 0.004, respectively), uniting which could determine the response to GCs with decent performance (AUROC = 0.821).
Conclusion
DCE-MRI-derived model-free and model-based parameters of EOMs can assist in the evaluation of TAO. In particular, TTP-mean and Ve-mean could be useful for determining the activity of TAO, whereas TTP-min and K trans -mean could be promising biomarkers for determining the response to GCs.

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