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.Application of multi-slice spiral CT in the preoperative diagnosis and classification of inguinal hernia
Qing-jie SONG ; Hong-yu ZHU ; Hui SONG ; Qing-chao HU ; Zhong-hui ZHU
Journal of Regional Anatomy and Operative Surgery 2025;34(5):401-404
Objective To analyze the application value of multi-slice spiral CT(MSCT)in the preoperative diagnosis and classification of inguinal hernia.Methods The clinical data of 130 patients with inguinal hernia admitted to our hospital were collected,and all patients underwent inguinal hernia repair.MSCT examination was conducted for the inguinal hernia of the patients,and the efficacy of MSCT in the diagnosis of different types of inguinal hernia was explored by taking the intraoperative diagnosis results as the gold standard.The contents of the hernia sac in patients with different types of inguinal hernia were analyzed,and the accuracy of MSCT under different scanning directions on the relationship between neck of hernia sac and inferior epigastric artery was analyzed.Results The intraoperative diagnosis results confirmed that there were 92 cases of oblique hernia,26 cases of direct hernia and 12 cases of femoral hernia among 130 patients with inguinal hernia.A total of 139 hernia sacs were present,with 121 unilateral and 9 bilateral hernia sacs.Among patients with oblique hernias,87 cases were unilateral and 5 cases were bilateral;among patients with direct hernias,23 cases were unilateral and 3 cases were bilateral;among patients with femoral hernias,11 cases were unilateral and 1 case was bilateral.The MSCT scan results showed that patients with oblique hernia,direct hernia and femoral hernia were 92 cases,26 cases and 12 cases respectively.The sensitivities of MSCT in diagnosing oblique hernia,direct hernia and femoral hernia were 95.65%,84.62%and 100%respectively,and the specificities were 89.47%,96.15%and 100%respectively.The contents of the hernia sac in oblique hernia were mainly small intestine and mesentery,while those in direct hernia and femoral hernia were mainly small intestine and fat.The proportions of fat and bladder in the contents of the hernia sac of direct hernia were higher than those of oblique hernia and femoral hernia(P<0.05).The proportion of mesentery in the contents of the hernia sac of oblique hernia was higher than that of direct hernia and femoral hernia(P<0.05).According to the relationship between hernia sac neck and inferior epigastric artery,the diagnostic accuracy of inguinal hernia by MSCT under coronal scan was the highest.Conclusion The sensitivity and specificity of MSCT in the preoperative differential diagnosis of inguinal hernia are relatively high,and the accuracy of MSCT in classification diagnosis can be improved if combined the contents of the hernia sac and the relationship between the hernia sac neck and inferior epigastric artery.
3.Expert Consensus on the Ethical Requirements for Generative AI-Assisted Academic Writing
You-Quan BU ; Yong-Fu CAO ; Zeng-Yi CHANG ; Hong-Yu CHEN ; Xiao-Wei CHEN ; Yuan-Yuan CHEN ; Zhu-Cheng CHEN ; Rui DENG ; Jie DING ; Zhong-Kai FAN ; Guo-Quan GAO ; Xu GAO ; Lan HU ; Xiao-Qing HU ; Hong-Ti JIA ; Ying KONG ; En-Min LI ; Ling LI ; Yu-Hua LI ; Jun-Rong LIU ; Zhi-Qiang LIU ; Ya-Ping LUO ; Xue-Mei LV ; Yan-Xi PEI ; Xiao-Zhong PENG ; Qi-Qun TANG ; You WAN ; Yong WANG ; Ming-Xu WANG ; Xian WANG ; Guang-Kuan XIE ; Jun XIE ; Xiao-Hua YAN ; Mei YIN ; Zhong-Shan YU ; Chun-Yan ZHOU ; Rui-Fang ZHU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):826-832
With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.
4.Preliminary study on the quantitative assessment model of mitral regurgitation in echocardiography based on fully convolutional networks: automatic identification and measurement of regurgitant radius
Lu ZHONG ; Hongning SONG ; Bo HU ; Qing DENG ; Jinling CHEN ; Qing ZHOU ; Fengxia JIANG ; Sheng CAO
Chinese Journal of Ultrasonography 2025;34(2):98-106
Objective:To develop an artificial intelligence system using fully convolutional neural networks(FCN)to assist echocardiographers in the quantitative assessment of mitral regurgitation(MR)severity.Methods:From August 2021 to June 2024,echocardiographic images of 441 patients with MR were prospectively collected from Renmin Hospital of Wuhan University and the Central Hospital of Wuhan. After screening,a total of 269 patients(4 917 frames)were included in the study. Of these,3 644 frames(128 patients)of apical four-chamber color Doppler MR flow convergence images from Renmin Hospital of Wuhan University were selected as the training/validation set,while images from 121 patients(813 frames)were used as the internal test set. Additionally,images from 20 patients(460 frames)from the Central Hospital of Wuhan were selected as the external test set. The FCN algorithm was employed to capture features and segment the MR color region on the left atrial side,simultaneously outputting the regurgitant radius(r)for the calculation of the effective regurgitant orifice area and regurgitant volume. The severity of MR was then classified according to the 2017 guidelines of the American Society of Echocardiography. The segmentation and classification performance of the model was evaluated,and the measurement results of the AI system was compared with that of both senior and junior physicians.Results:In the internal test set,the accuracy of r identification for cases classified as Grade Ⅰ to Ⅳ was 0.48,0.81,0.86,and 0.87,respectively. In the external test set,the accuracy of r identification for cases classified as Grade Ⅰ to Ⅳ was 0.60,0.77,0.64,and 0.77,respectively. The average accuracy of MR classification in the internal and external test sets was 0.91 and 0.88,respectively.Conclusions:The FCN model is capable of segmenting the left atrial side regurgitant areas in apical four-chamber heart color Doppler images,aiding physicians in obtaining quantitative assessment parameters for MR,and assisting junior physicians in accurately assessing the severity of MR.
5.Preliminary study on the quantitative assessment model of mitral regurgitation in echocardiography based on fully convolutional networks: automatic identification and measurement of regurgitant radius
Lu ZHONG ; Hongning SONG ; Bo HU ; Qing DENG ; Jinling CHEN ; Qing ZHOU ; Fengxia JIANG ; Sheng CAO
Chinese Journal of Ultrasonography 2025;34(2):98-106
Objective:To develop an artificial intelligence system using fully convolutional neural networks(FCN)to assist echocardiographers in the quantitative assessment of mitral regurgitation(MR)severity.Methods:From August 2021 to June 2024,echocardiographic images of 441 patients with MR were prospectively collected from Renmin Hospital of Wuhan University and the Central Hospital of Wuhan. After screening,a total of 269 patients(4 917 frames)were included in the study. Of these,3 644 frames(128 patients)of apical four-chamber color Doppler MR flow convergence images from Renmin Hospital of Wuhan University were selected as the training/validation set,while images from 121 patients(813 frames)were used as the internal test set. Additionally,images from 20 patients(460 frames)from the Central Hospital of Wuhan were selected as the external test set. The FCN algorithm was employed to capture features and segment the MR color region on the left atrial side,simultaneously outputting the regurgitant radius(r)for the calculation of the effective regurgitant orifice area and regurgitant volume. The severity of MR was then classified according to the 2017 guidelines of the American Society of Echocardiography. The segmentation and classification performance of the model was evaluated,and the measurement results of the AI system was compared with that of both senior and junior physicians.Results:In the internal test set,the accuracy of r identification for cases classified as Grade Ⅰ to Ⅳ was 0.48,0.81,0.86,and 0.87,respectively. In the external test set,the accuracy of r identification for cases classified as Grade Ⅰ to Ⅳ was 0.60,0.77,0.64,and 0.77,respectively. The average accuracy of MR classification in the internal and external test sets was 0.91 and 0.88,respectively.Conclusions:The FCN model is capable of segmenting the left atrial side regurgitant areas in apical four-chamber heart color Doppler images,aiding physicians in obtaining quantitative assessment parameters for MR,and assisting junior physicians in accurately assessing the severity of MR.
6.Application of multi-slice spiral CT in the preoperative diagnosis and classification of inguinal hernia
Qing-jie SONG ; Hong-yu ZHU ; Hui SONG ; Qing-chao HU ; Zhong-hui ZHU
Journal of Regional Anatomy and Operative Surgery 2025;34(5):401-404
Objective To analyze the application value of multi-slice spiral CT(MSCT)in the preoperative diagnosis and classification of inguinal hernia.Methods The clinical data of 130 patients with inguinal hernia admitted to our hospital were collected,and all patients underwent inguinal hernia repair.MSCT examination was conducted for the inguinal hernia of the patients,and the efficacy of MSCT in the diagnosis of different types of inguinal hernia was explored by taking the intraoperative diagnosis results as the gold standard.The contents of the hernia sac in patients with different types of inguinal hernia were analyzed,and the accuracy of MSCT under different scanning directions on the relationship between neck of hernia sac and inferior epigastric artery was analyzed.Results The intraoperative diagnosis results confirmed that there were 92 cases of oblique hernia,26 cases of direct hernia and 12 cases of femoral hernia among 130 patients with inguinal hernia.A total of 139 hernia sacs were present,with 121 unilateral and 9 bilateral hernia sacs.Among patients with oblique hernias,87 cases were unilateral and 5 cases were bilateral;among patients with direct hernias,23 cases were unilateral and 3 cases were bilateral;among patients with femoral hernias,11 cases were unilateral and 1 case was bilateral.The MSCT scan results showed that patients with oblique hernia,direct hernia and femoral hernia were 92 cases,26 cases and 12 cases respectively.The sensitivities of MSCT in diagnosing oblique hernia,direct hernia and femoral hernia were 95.65%,84.62%and 100%respectively,and the specificities were 89.47%,96.15%and 100%respectively.The contents of the hernia sac in oblique hernia were mainly small intestine and mesentery,while those in direct hernia and femoral hernia were mainly small intestine and fat.The proportions of fat and bladder in the contents of the hernia sac of direct hernia were higher than those of oblique hernia and femoral hernia(P<0.05).The proportion of mesentery in the contents of the hernia sac of oblique hernia was higher than that of direct hernia and femoral hernia(P<0.05).According to the relationship between hernia sac neck and inferior epigastric artery,the diagnostic accuracy of inguinal hernia by MSCT under coronal scan was the highest.Conclusion The sensitivity and specificity of MSCT in the preoperative differential diagnosis of inguinal hernia are relatively high,and the accuracy of MSCT in classification diagnosis can be improved if combined the contents of the hernia sac and the relationship between the hernia sac neck and inferior epigastric artery.
7.Expert Consensus on the Ethical Requirements for Generative AI-Assisted Academic Writing
You-Quan BU ; Yong-Fu CAO ; Zeng-Yi CHANG ; Hong-Yu CHEN ; Xiao-Wei CHEN ; Yuan-Yuan CHEN ; Zhu-Cheng CHEN ; Rui DENG ; Jie DING ; Zhong-Kai FAN ; Guo-Quan GAO ; Xu GAO ; Lan HU ; Xiao-Qing HU ; Hong-Ti JIA ; Ying KONG ; En-Min LI ; Ling LI ; Yu-Hua LI ; Jun-Rong LIU ; Zhi-Qiang LIU ; Ya-Ping LUO ; Xue-Mei LV ; Yan-Xi PEI ; Xiao-Zhong PENG ; Qi-Qun TANG ; You WAN ; Yong WANG ; Ming-Xu WANG ; Xian WANG ; Guang-Kuan XIE ; Jun XIE ; Xiao-Hua YAN ; Mei YIN ; Zhong-Shan YU ; Chun-Yan ZHOU ; Rui-Fang ZHU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):826-832
With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.
8.Morphology of enteric nervous system in C57BL/6 mice based on fMOST high-resolution 3D reconstruction system
Li-Ge LENG ; Guan-Xiong YANG ; Ze-En WANG ; Yi CHEN ; Zhi-Liang QIAO ; Qing-Zhong HU ; Ming-Yan WANG ; Feng TIAN
Acta Anatomica Sinica 2025;56(1):114-119
Objective To initially explore the possibility of applying the fluorescence micro-optical sectioning tomography(fMOST)high-resolution 3D reconstruction system to the morphological study of the intestinal nervous system and to preliminarily establish a method for studying the morphology of the intestinal nervous system using this system.Methods fMOST high-resolution 3D reconstruction system was used to study the intestinal nervous system of C57BL/6 mice in detail.Based on this method,a new morphological method of the visceral nervous system of small animal models was explored at the single-cell level.Results Compared with the large intestine,the small intestine lacked the typical myenteric plexus(Auerbach),deep mucosal plexus(Henley),and submucosal superficial plexus(Meissner).Conclusion The result of this paper provide a clearer and systematic display of the anatomical structure of the enteric nervous system in C57BL/6 mice,and further clarify the similarities and differences between the enteric nervous system of mice and human,and provide a theoretical basis for its rational application in the study of digestive system diseases.The morphological study of fMOST high-resolution 3D reconstruction system is not limited to the central nervous system,but can be extended to the morphological study of multiple visceral nervous systems.
9.Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Chaonan JIN ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):883-892
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results:593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores.Conclusion:After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).
10.Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Peng XIA ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):893-903
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the safety profile of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects that previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extending or switching TMF treatment for 48 weeks. Safety profiles of kidney, bone, metabolism, body weight, and others were evaluated.Results:666 subjects from the initial TMF group and 336 subjects from TDF group with at least one dose of assigned treatment were included at week 144. The overall safety profile was favorable in each group and generally similar between extended or switched TMF treatments from week 96 to 144. In subjects switching from TDF to TMF, the non-indexed estimated glomerular filtration rate (by non-indexed CKD-EPI formula) and creatinine clearance (by Cockcroft-Gault formula) were both increased, which were (2.31±8.33) ml/min and (4.24±13.94) ml/min, respectively. These changes were also higher than those in subjects with extending TMF treatment [(0.91±8.06) ml/min and (1.30±13.94) ml/min]. Meanwhile, switching to TMF also led to an increase of the bone mineral density (BMD) by 0.75% in hip and 1.41% in spine. On the other side, a slight change in TC/HDL ratio by 0.16 (IQR: 0.00, 0.43) and an increase in body mass index (BMI) by (0.54±0.98) kg/m 2 were oberved with patients switched to TMF, which were significantly higher than that in TMF group. Conclusion:CHB patients receiving 144 weeks of TMF treatment showed favorable safety profile. After switching to TMF, the bone and renal safety was significantly improved in TDF group, though experienceing change in metabolic parameters and weight gain (NCT03903796).

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