1.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
2.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
3.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
4.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
5.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
6.Effect of Endoplasmic Reticulum Stress on Intestinal Mucosal Injury in Ulcerative Colitis and TCM Intervention Based on Theory of Sores Depending on Spleen-earth
Youwei XIAO ; Dongsheng WU ; Hui CAO ; Bo ZOU ; Yiqian YU ; Ruoru HUANG ; Qi CHENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):238-247
In recent years, as the incidence of ulcerative colitis (UC) is growing, intestinal mucosal injury has garnered increasing attention, and it is characterized by high recurrence, risk of inflammation-cancer transformation, and difficulty in repair. Intestinal mucosal injury in UC is centered on persistent inflammation and barrier dysfunction, with its pathological mechanisms involving endoplasmic reticulum stress (ERS)-mediated changes such as abnormal apoptosis, abnormal autophagy, and inflammatory responses. ERS induces apoptosis of intestinal epithelial cells, disrupts tight junction proteins, and exacerbates inflammatory responses through pathways such as protein kinase R-like endoplasmic reticulum kinase (PERK), inositol-requiring enzyme 1 alpha (IRE1α), and activating transcription factor 6 (ATF6), ultimately causing intestinal mucosal injury. Traditional Chinese medicine (TCM) has a long history of research on UC. The theory of sores depending on spleen-earth holds that spleen deficiency is the fundamental cause of UC, while pathological products such as dampness-turbidity and blood stasis are the secondary manifestations. Dysfunction of the spleen-earth leads to insufficient production and transformation of Qi and blood, malnutrition of the intestinal mucosa, and invasion of external pathogens. In the active phase of UC, spleen deficiency is often accompanied by excessive pathogenic factors such as dampness-heat and heat-toxin, leading to acute intestinal mucosal damage. In the remission phase, however, it is mainly characterized by spleen deficiency and healthy Qi deficiency, accompanied by residual pathogens, resulting in weak intestinal mucosal repair. Studies have shown that the endoplasmic reticulum, as a key site for protein synthesis and folding, has functions highly similar to the TCM concept of the spleen governing transportation and transformation. From a TCM perspective, the endoplasmic reticulum can be regarded as the carrier of spleen transportation, and ERS is a microcosmic manifestation of spleen dysfunction, leading to intestinal mucosal injury. ERS impairs the structure and function of the endoplasmic reticulum, induces the generation of abnormal Qi, and triggers pathological changes, making inflammation difficult to be reduced and causing the aggravation of ERS, forming a vicious cycle of spleen deficiency-pathological products-intestinal injury. TCM has unique advantages in regulating ERS to prevent and treat intestinal mucosal injury. According to the theory of sores depending on spleen-earth and the modern medical understanding of ERS, this paper delves into the TCM and Western medicine pathogenesis of intestinal mucosal injury in UC. Furthermore, this paper discusses the roles of TCM active components and compound formulas in reducing intestinal mucosal injury in UC by regulating ERS under the guidance of the treatment principles of invigorating the spleen and replenishing Qi as the key and dispelling dampness and removing blood stasis as the supplementation, aiming to provide new ideas and methods for the prevention and treatment of UC.
7.Formulation and modification of high-fat meals in food impact studies
Qian-Qian JIANG ; Wei ZHANG ; Xiao-Na XIANG ; Jun HUANG ; Bo JIANG ; Dan-Dan YANG
The Chinese Journal of Clinical Pharmacology 2024;40(2):273-275
The food effect(FE)on drug absorption is an important part of clinical pharmacological studies of new drugs.The caloric ratios for each component of a high-fat meal are specified in the"Technical Guidelines for Food Bioavailability and Postprandial Bioequivalence Studies"approved by the US Food and Drug Administration(FDA)and the"Technical Guidelines for Food Effect Studies in New Drug Development"approved by the National Medical Products Administration.However,the recipes for high-fat meals vary among clinical research centers,showing their advantages and disadvantages.Thus,we present a modified version of high-fat meal recipes with easy-to-quantify calories,which is a combination of Western and Chinese flavors,easy to prepare,and meets Chinese tastes.The center satisfaction surveys showed that our modified version of the high-fat meal recipe greatly improved subject satisfaction and compliance,thus better safeguarding the quality of the trial.
8.Clinical trial of inhaled ipratropium bromide in the treatment of patients with non-small cell lung cancer combined with chronic obstructive pulmonary disease
Kuan-Zhe JIN ; Yan-Fei HUANG ; Xiao-Bo WU
The Chinese Journal of Clinical Pharmacology 2024;40(6):802-806
Objective To analyze the clinical effect of inhaled ipratropium bromide in the treatment of patients with non-small cell lung cancer(NSCLC)combined with chronic obstructive pulmonary disease(COPD)and its protective effect on lung function.Methods Clinical data of patients with NSCLC complicated with COPD were retrospectively analyzed.According to the different treatment using cohort methods,the patients were divided into control group and treatment group.After admission,the patients in control group completed the relevant examinations,received conventional anti-infection,oxygen inhalation,asthma,ambroxol injection and other comprehensive treatment,and could be given appropriate mechanical ventilation support according to the development of the patient's condition,and then underwent selective lobectomy.Treatment group inhaled ipratropium bromide treatment:The conventional treatment was the same as control group,combined with atomized ipratropium bromide solution for inhalation 500 μg twice a day,continuous treatment for 1 week,and then selective lobectomy was performed.The clinical efficacy,lung function,inflammatory factor levels and adverse drug reactions were compared between the two groups.Results There were 61 cases in control group and 63 cases in treatment group.After treatment,the total clinical effective rate in treatment group and control group were 76.19%(48 cases/63 cases)and 50.82%(31 cases/61 cases),with significant difference(P<0.05).After treatment,the forced expiratory volume in the first second(FEV1)of treatment group and control group were(1.89±0.61)and(1.57±0.33)L;the percentage of FEV1 in forced vital capacity(FEV1/FVC)were(73.36±6.58)%and(63.69±6.21)%;peak expiratory flow(PEF)were(3.74±0.81)and(3.24±0.50)L·s-1;interleukin-6(IL-6)were(102.51±7.03)and(133.25±7.75)ng·L-1;hypersensitive C-reactive protein(hs-CRP)were(8.24±2.36)and(18.54±2.31)ng·L-1;tumor necrosis factor-α(TNF-α)were(90.36±5.22)and(114.15±5.13)ng·L-1;white blood cell(WBC)were(91.45±9.31)x 109 and(121.16±9.88)x 109·L-1;the differences were all statistically significant(all P<0.05).The total incidence of adverse drug reactions was 4.92%(3 cases/61 cases)in control group and 7.94%(5 cases/63 cases)in treatment group,with no statistical significance(P>0.05).Conclusion Inhaled ipratropium bromide is effective in the treatment of NSCLC complicated with COPD,and has protective effect on lung function and good safety.
9.Bioequivalence study of gliclazide sustained-release tablets in Chinese healthy subjects
Zhou-Ping DUAN ; Xiao-Wei ZHAO ; Jin-Hua WEN ; Shi-Bo HUANG ; Pu LI ; Duan-Wen CAO
The Chinese Journal of Clinical Pharmacology 2024;40(15):2241-2245
Objective To investigate the bioequivalence of gliclazide sustained-release tablets in Chinese healthy subjects.Methods The study was designed using a single-center,open,randomized,single-dose,two-cycle,two-sequence administration method;subjects were orally administered the test/reference preparation 30 mg on an fasting or fed conditions,with self-cross-dosing.The concentration of gliclazide in human plasma was determined by liquid chromatography tandem mass spectrometry(LC-MS/MS)method.The main pharmacokinetic parameters of gliclazide(Cmax,AUC0-t and AUC0-∞)were analyzed by non-atrioventricular model of WinNonlin.Result In the fasting study,24 subjects were recruited and 22 completed the study.The main pharmacokinetic parameters of gliclazide sustained-release tablets test preparation and reference preparation in the fasting group were as follows:Cmax were(862.48±294.48)and(902.96±259.09)ng·mL-1;AUC0-t were(2.60 × 104±8 930.46)and(2.50 ×104±7 573.42)h·ng-1·mL-1;AUC0-∞ were(3.00 × 104±1.43 × 104)and(2.68 × 104±7 085.99)h·ng·mL-1.In the fed study,twenty-four subjects were enrolled and 23 completed the study.The main pharmacokinetic parameters of gliclazide sustained-release tablets test preparation and reference preparation in fed group:Cmax were(1 531.74±273.49)and(1 510.87±241.08)ng·mL-1;AUC0-t were(2.78 ×104±9 565.89)and(2.76 ×104±9 821.43)h·ng·mL-1;AUC0-∞ were(3.02 ×104±1.24 ×104)and(3.02 × 104±1.30 × 104)h·ng·mL-1 h·ng·mL-1.The 90%confidence intervals of the geometric mean ratios of Cmax,AUC0-t,AUC0-∞ for the test preparation and reference preparation gliclazide sustained-release tablets were all between 80%and 125%.Conclusion The test and the reference preparation of gliclazide sustained-release tablets are bioequivalent in Chinese healthy subjects.
10.Preliminary exploration of the pharmacological effects and mechanisms of icaritin in regulating macrophage polarization for the treatment of intrahepatic cholangiocarcinoma
Jing-wen WANG ; Zhen LI ; Xiu-qin HUANG ; Zi-jing XU ; Jia-hao GENG ; Yan-yu XU ; Tian-yi LIANG ; Xiao-yan ZHAN ; Li-ping KANG ; Jia-bo WANG ; Xin-hua SONG
Acta Pharmaceutica Sinica 2024;59(8):2227-2236
The incidence of intrahepatic cholangiocarcinoma (ICC) continues to rise, and there are no effective drugs to treat it. The immune microenvironment plays an important role in the development of ICC and is currently a research hotspot. Icaritin (ICA) is an innovative traditional Chinese medicine for the treatment of advanced hepatocellular carcinoma. It is considered to have potential immunoregulatory and anti-tumor effects, which is potentially consistent with the understanding of "Fuzheng" in the treatment of tumor in traditional Chinese medicine. However, whether ICA can be used to treat ICC has not been reported. Therefore, in this study, sgp19/kRas, an

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