1.Application of the Bayesian mixture model based on a principal stra-tum strategy in clinical trials
Yiwen WU ; Yue SUN ; Zixuan LU ; Jiahe PAN ; Er YU ; Hongmei WO ; Shaowen TANG ; Yang ZHAO ; Juncheng DAI ; Honggang YI
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(7):942-949
AIM:To evaluate the application effec-tiveness of a Bayesian mixture model based on the principal stratum strategy for estimating the com-plier average causal effect(CACE)in clinical trials with non-compliance.METHODS:Using a non-infe-riority randomized controlled trial investigating a novel drug for primary type 2 diabetes mellitus(non-inferiority margin:-0.4)as a case study,the primary analysis applied a Bayesian mixture model under the monotonicity assumption to estimate CACE of between-group differences in glycated he-moglobin(HbA1c)changes within the compliant stratum,followed by non-inferiority testing.Sensi-tivity analyses included a Bayesian mixture model relaxing the monotonicity assumption and compar-ing results with per-protocol set(PPS)analysis.RE-SULTS:In the primary analysis,the posterior mean of CACE for HbA1c change in the compliant stratum was 0.081%,with a one-sided 97.5%credible inter-val lower bound of-0.124,exceeding the non-infe-riority margin(-0.4%),supporting the non-inferiori-ty efficacy of the novel drug in the compliant stra-tum(P(H1|Data)=1).Consistent findings were ob-served in PPS analyses(estimated effect:0.136%;one-sided 97.5%credible interval lower bound:-0.069%),further validating methodological robust-ness.CONCLUSION:In clinical trials with noncom-pliance as an intercurrent event,the Bayesian mix-ture model under the principal stratum strategy ef-fectively adjusts for compliance-related bias and yields conservative,robust estimates of causal ef-fects,supporting its value in efficacy evaluation un-der complex compliance scenarios.
2.Application of perfusion tube in the drying of digestive endoscope channels
Xianglan WANG ; Zi LUO ; Qing WANG ; Xingmin HUANG ; Honggang YU ; Jun LIU
China Journal of Endoscopy 2025;31(9):76-80
Objective To compare the effects of perfusion tube and pressure air gun on endoscopic channels drying by using the stripped endoscope model,so as to explore the application value of perfusion tube in endoscopic channels drying.Methods After the standard manual cleaning and disinfection process,the stripped endoscope model was randomly divided into group A and group B.Each group was subjected to 30 tests.Group A was injected with a perfusion tube,and group B was injected with a pressure air gun.The liquid residues in the endoscope tubes were observed visually and with a magnifying lens,and the time of thorough drying of the endoscope channels and the physical fatigue of the operators were compared between the two groups.Results The average drying time of the group A was(366.47±75.74)s,the average drying time of the group B was(338.40±65.81)s,there was no significant difference between the two groups(t=-1.53,P=0.131).The fatigue degree of the group A was lower than group B(t=16.79,P<0.01).Conclusion There is no statistical difference in the air delivery time between the perfusion tube and the pressure air gun drying endoscopic tube,and the operator's physical fatigue is light when the perfusion tube is used,so it is recommended to use the perfusion tube drying endoscopic tube in clinic.
3.Surgical techniques and clinical outcomes of upper urinary tract reconstruction for stone-related ureteral strictures
Xiaoteng YU ; Yixuan HUANG ; Xinfei LI ; Changfu CHEN ; Fangzhou ZHAO ; Honggang YING ; Zihao TAO ; Yiming ZHANG ; Liqing XU ; Zhihua LI ; Kunlin YANG ; Liqun ZHOU ; Xuesong LI ; Zheng ZHAO
Journal of Peking University(Health Sciences) 2025;57(4):670-675
Objective:To summarize the surgical strategies and to evaluate the clinical outcomes of up-per urinary tract reconstruction in patients with stone-related ureteral strictures.Methods:This retro-spective study included 71 patients diagnosed with ureteral strictures secondary to urinary stones who un-derwent upper urinary tract reconstructive surgery at Peking University First Hospital between March 2014 and November 2023.Patient data were collected,including demographic characteristics,clinical presen-tation,laboratory results,imaging findings,surgical procedures,and follow-up outcomes.Ureteral stric-tures were classified according to anatomical location into upper,middle,lower,or multiple segments.Surgical procedures were carried out depending on the stricture characteristics.Surgical success was de-fined as resolution or improvement of clinical symptoms,radiographic improvement or stabilization of hy-dronephrosis,and maintenance of normal and stable renal function.Results:Among the 71 patients,36(50.7%)had strictures in the upper ureter,9(12.7%)in the middle ureter,15(21.1%)in the lower ureter,and 11(15.5%)had multifocal ureteral strictures.The median stricture length was 5.0 cm(interquartile range:3.0-15.0 cm).Surgical approach selection was individualized based on the location and extent of the stricture.For upper ureteral strictures,the most frequently employed techniques were oral mucosal graft ureteroplasty(13/36,36.1%)and appendiceal flap ureteroplasty(8/36,22.2%).Other options included ureteroureterostomy and ileal ureter replacement for longer or more complex strictures.In middle ureteral strictures,treatment was stratified by length:balloon dilation(1/9,11.1%)and ureteroureterostomy(1/9,11.1%)were applied in shorter strictures,while oral mucosal graft ureteroplasty(3/9,33.3%)and ileal ureter replacement(4/9,44.4%)were reserved for longer segments.For lower ureteral strictures,ureteral reimplantation into the bladder was the most common approach(10/15,66.7%),often combined with a psoas hitch or Boari flap when necessary.All the patients with multiple segmental strictures underwent ileal ureter replacement due to the extensive nature of the disease.The median follow-up period was 14.2 months(range:6.1-107.1 months).During follow-up,69 of 71 patients(97.2%)achieved surgical success.Conclusion:Stone-related ure-teral strictures present with considerable heterogeneity in terms of anatomical location,length,and com-plexity.Careful preoperative evaluation and individualized surgical planning are critical to successful re-construction.With appropriate selection of surgical methods,favorable long-term clinical outcomes can be achieved in the majority of patients.
4.Application of perfusion tube in the drying of digestive endoscope channels
Xianglan WANG ; Zi LUO ; Qing WANG ; Xingmin HUANG ; Honggang YU ; Jun LIU
China Journal of Endoscopy 2025;31(9):76-80
Objective To compare the effects of perfusion tube and pressure air gun on endoscopic channels drying by using the stripped endoscope model,so as to explore the application value of perfusion tube in endoscopic channels drying.Methods After the standard manual cleaning and disinfection process,the stripped endoscope model was randomly divided into group A and group B.Each group was subjected to 30 tests.Group A was injected with a perfusion tube,and group B was injected with a pressure air gun.The liquid residues in the endoscope tubes were observed visually and with a magnifying lens,and the time of thorough drying of the endoscope channels and the physical fatigue of the operators were compared between the two groups.Results The average drying time of the group A was(366.47±75.74)s,the average drying time of the group B was(338.40±65.81)s,there was no significant difference between the two groups(t=-1.53,P=0.131).The fatigue degree of the group A was lower than group B(t=16.79,P<0.01).Conclusion There is no statistical difference in the air delivery time between the perfusion tube and the pressure air gun drying endoscopic tube,and the operator's physical fatigue is light when the perfusion tube is used,so it is recommended to use the perfusion tube drying endoscopic tube in clinic.
5.Correlation Between "Pathological Accumulation from Collateral Obstruction" and Gap Junction Communication Dysfunction and Its Application in Tumor Prevention and Treatment
Hongtai XIONG ; Ying SONG ; Yanyuan DU ; Peiyi YU ; Honggang ZHENG
Journal of Traditional Chinese Medicine 2025;66(13):1311-1316
By reviewing modern research and integrating clinical practice, this paper elucidates the correlation between the traditional Chinese medicine theory of pathological accumulation from collateral obstruction and gap junction intercellular communication (GJIC), as well as its theoretical connotation and clinical application in tumor prevention and treatment. Physiologically, gap junction and collateral channels share similarities in structural distribution, substance exchange and information transmission. Pathologically, metabolic coupling mediated by dysfunctional gap junction resembles collaterals stagnation, forming the basis of tumor pathogenesis. The establishment of heterotypic gap junction parallels collateral hyperactivity, contributing to tumor metastasis. The post-translational modifications (PTMs) disorder of connexins is similar to the deficiency of collaterals, serving as a driver of tumor progression. Clinically, tumor treatment should follow the pathomechanism of collateral obstruction leading to pathological accumulation. In the early stage, detoxifying and unblocking collaterals can restore intercellular communication and inhibit tumorigenesis; in the progressive stage, calming hyperactivity and suppressing aberrant collateral pathways can prevent metastasis by interrupting heterotypic gap junction formation; and in the terminal stage, supporting vital qi and modulating PTMs of connexins can help delay tumor progression.
6.Spicy food consumption and risk of vascular disease: Evidence from a large-scale Chinese prospective cohort of 0.5 million people.
Dongfang YOU ; Dianjianyi SUN ; Ziyu ZHAO ; Mingyu SONG ; Lulu PAN ; Yaqian WU ; Yingdan TANG ; Mengyi LU ; Fang SHAO ; Sipeng SHEN ; Jianling BAI ; Honggang YI ; Ruyang ZHANG ; Yongyue WEI ; Hongxia MA ; Hongyang XU ; Canqing YU ; Jun LV ; Pei PEI ; Ling YANG ; Yiping CHEN ; Zhengming CHEN ; Hongbing SHEN ; Feng CHEN ; Yang ZHAO ; Liming LI
Chinese Medical Journal 2025;138(14):1696-1704
BACKGROUND:
Spicy food consumption has been reported to be inversely associated with mortality from multiple diseases. However, the effect of spicy food intake on the incidence of vascular diseases in the Chinese population remains unclear. This study was conducted to explore this association.
METHODS:
This study was performed using the large-scale China Kadoorie Biobank (CKB) prospective cohort of 486,335 participants. The primary outcomes were vascular disease, ischemic heart disease (IHD), major coronary events (MCEs), cerebrovascular disease, stroke, and non-stroke cerebrovascular disease. A Cox proportional hazards regression model was used to assess the association between spicy food consumption and incident vascular diseases. Subgroup analysis was also performed to evaluate the heterogeneity of the association between spicy food consumption and the risk of vascular disease stratified by several basic characteristics. In addition, the joint effects of spicy food consumption and the healthy lifestyle score on the risk of vascular disease were also evaluated, and sensitivity analyses were performed to assess the reliability of the association results.
RESULTS:
During a median follow-up time of 12.1 years, a total of 136,125 patients with vascular disease, 46,689 patients with IHD, 10,097 patients with MCEs, 80,114 patients with cerebrovascular disease, 56,726 patients with stroke, and 40,098 patients with non-stroke cerebrovascular disease were identified. Participants who consumed spicy food 1-2 days/week (hazard ratio [HR] = 0.95, 95% confidence interval [95% CI] = [0.93, 0.97], P <0.001), 3-5 days/week (HR = 0.96, 95% CI = [0.94, 0.99], P = 0.003), and 6-7 days/week (HR = 0.97, 95% CI = [0.95, 0.99], P = 0.002) had a significantly lower risk of vascular disease than those who consumed spicy food less than once a week ( Ptrend <0.001), especially in those who were younger and living in rural areas. Notably, the disease-based subgroup analysis indicated that the inverse associations remained in IHD ( Ptrend = 0.011) and MCEs ( Ptrend = 0.002) risk. Intriguingly, there was an interaction effect between spicy food consumption and the healthy lifestyle score on the risk of IHD ( Pinteraction = 0.037).
CONCLUSIONS
Our findings support an inverse association between spicy food consumption and vascular disease in the Chinese population, which may provide additional dietary guidance for the prevention of vascular diseases.
Humans
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Male
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Female
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Prospective Studies
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Middle Aged
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Aged
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Vascular Diseases/etiology*
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Risk Factors
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China/epidemiology*
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Adult
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Proportional Hazards Models
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Cerebrovascular Disorders/epidemiology*
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East Asian People
7.The application of sequential analysis for continuous post-market vaccine safety surveillance
Zixuan LU ; Musu LI ; Jiahe PAN ; Yiwen WU ; Huilin LI ; Er YU ; Hongmei WO ; Shaowen TANG ; Yang ZHAO ; Juncheng DAI ; Honggang YI
Chinese Journal of Epidemiology 2025;46(3):514-518
To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines. Under the dynamic monitoring data of vaccines post-market approval, this research introduces the fundamental principles of maximizing sequential probability ratio test (MaxSPRT) and Bayesian sequential analysis, employing R software. Through an example of dynamic safety monitoring data of vaccines post-market approval, we analyze using the MaxSPRT and Bayesian sequential analysis. The MaxSPRT identified a safety signal in week 4 ( P<0.05), while Bayesian sequential analysis indicated that the 95% highest density interval for the RR value at week 4 is 1.13-3.27, suggesting the first appearance of a safety signal at week 4. The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data, thereby serving as a valuable method for post-market safety surveillance of vaccines.
8.Surgical techniques and clinical outcomes of upper urinary tract reconstruction for stone-related ureteral strictures
Xiaoteng YU ; Yixuan HUANG ; Xinfei LI ; Changfu CHEN ; Fangzhou ZHAO ; Honggang YING ; Zihao TAO ; Yiming ZHANG ; Liqing XU ; Zhihua LI ; Kunlin YANG ; Liqun ZHOU ; Xuesong LI ; Zheng ZHAO
Journal of Peking University(Health Sciences) 2025;57(4):670-675
Objective:To summarize the surgical strategies and to evaluate the clinical outcomes of up-per urinary tract reconstruction in patients with stone-related ureteral strictures.Methods:This retro-spective study included 71 patients diagnosed with ureteral strictures secondary to urinary stones who un-derwent upper urinary tract reconstructive surgery at Peking University First Hospital between March 2014 and November 2023.Patient data were collected,including demographic characteristics,clinical presen-tation,laboratory results,imaging findings,surgical procedures,and follow-up outcomes.Ureteral stric-tures were classified according to anatomical location into upper,middle,lower,or multiple segments.Surgical procedures were carried out depending on the stricture characteristics.Surgical success was de-fined as resolution or improvement of clinical symptoms,radiographic improvement or stabilization of hy-dronephrosis,and maintenance of normal and stable renal function.Results:Among the 71 patients,36(50.7%)had strictures in the upper ureter,9(12.7%)in the middle ureter,15(21.1%)in the lower ureter,and 11(15.5%)had multifocal ureteral strictures.The median stricture length was 5.0 cm(interquartile range:3.0-15.0 cm).Surgical approach selection was individualized based on the location and extent of the stricture.For upper ureteral strictures,the most frequently employed techniques were oral mucosal graft ureteroplasty(13/36,36.1%)and appendiceal flap ureteroplasty(8/36,22.2%).Other options included ureteroureterostomy and ileal ureter replacement for longer or more complex strictures.In middle ureteral strictures,treatment was stratified by length:balloon dilation(1/9,11.1%)and ureteroureterostomy(1/9,11.1%)were applied in shorter strictures,while oral mucosal graft ureteroplasty(3/9,33.3%)and ileal ureter replacement(4/9,44.4%)were reserved for longer segments.For lower ureteral strictures,ureteral reimplantation into the bladder was the most common approach(10/15,66.7%),often combined with a psoas hitch or Boari flap when necessary.All the patients with multiple segmental strictures underwent ileal ureter replacement due to the extensive nature of the disease.The median follow-up period was 14.2 months(range:6.1-107.1 months).During follow-up,69 of 71 patients(97.2%)achieved surgical success.Conclusion:Stone-related ure-teral strictures present with considerable heterogeneity in terms of anatomical location,length,and com-plexity.Careful preoperative evaluation and individualized surgical planning are critical to successful re-construction.With appropriate selection of surgical methods,favorable long-term clinical outcomes can be achieved in the majority of patients.
9.Development and validation of an intelligent surveillance system for upper gastrointestinal high-risk patients
Mei DENG ; Guoen LYU ; Conghui SHI ; Jia LI ; Lianlian WU ; Jun LIU ; Honggang YU
Chinese Journal of Digestive Endoscopy 2025;42(3):190-196
Objective:To develop an intelligent surveillance system for identifying upper gastrointestinal high-risk patients and assigning surveillance intervals, and to verify its efficacy.Methods:The endoscopic and pathological reports of 23 035 patients undergoing endoscopy at Renmin Hospital of Wuhan University from January to October 2021 were collected retrospectively. A training set of 17 934 patients (January to August) and a test set of 5 101 patients (September to October) were established. Keywords in the endoscopic and pathological reports were extracted by the intelligent surveillance system, and high-risk patients were automatically identified and classified into 7 risk levels. Then the standardized surveillance intervals were assigned based on the guideline. Guideline-based surveillance intervals assigned by expert endoscopists based on endoscopic and pathological reports were used as the golden standard. The accuracy of the intelligent surveillance system was calculated. Of the patients within the test set, 189 were hospitalized and the surveillance intervals given by physicians could be obtained from the electronic health records. The accuracy of the intelligent surveillance system with that of physicians from different departments was compared. Then 67 patients were randomly selected from 189 patients by simple random sampling to evaluate the adjunctive effect of the system in assigning surveillance intervals among 3 endoscopists.Results:The overall accuracy of the intelligent surveillance system in identifying upper gastrointestinal high-risk patients was 99.94% (5 098/5 101), and that of assigning surveillance intervals to correctly included patients was 100.00% (534/534). The intelligent surveillance system achieved significantly higher accuracy compared with all physicians from different departments [98.94% (187/189) VS 35.45% (67/189), χ2=118.01, P<0.001] as well as physicians from department of gastroenterology [100.00% (117/117) VS 24.79% (29/117), χ2=86.01, P<0.001]. With the assistance of the intelligent surveillance system, the endoscopists' accuracy of assigning surveillance intervals to 67 patients was significantly improved [55.22% (111/201) VS 22.39% (45/201), χ2=58.68, P<0.001]. Conclusion:The intelligent surveillance system can accurately identify upper gastrointestinal high-risk patients and assign surveillance intervals according to risk levels, which can alleviate the workload of doctors and improve the follow-up rate of patients.
10.Development and clinical application value of an artificial intelligence-assisted system for calculating effective colonoscopy withdrawal time
Rongrong GONG ; Liwen YAO ; Lianlian WU ; Huiling WU ; Xun LI ; Honggang YU ; Xiangwu DING
Chinese Journal of Digestive Endoscopy 2025;42(1):42-46
Objective:To develop an artificial intelligence (AI) calculation system for the effective withdrawal time of colonoscopy and to evaluate its clinical application value.Methods:First, 17 118 colonoscopy pictures from Renmin Hospital of Wuhan University were used for training and testing to establish a deep convolutional neural network model to recognize various colonoscopy fields. Then this model was integrated with the internal and external recognition model and cecum recognition model developed by the research group to create an AI system for automatic calculation of the effective withdrawal time. Finally, 944 colonoscopy videos from the Endoscopy Center of Renmin Hospital of Wuhan University from July 1, 2020 to October 10, 2020 were included in a retrospective analysis. AI automatic computing system was used to calculate the effective withdrawal time, and 89 of them were manually calculated to evaluate the accuracy of the AI automatic computing system. The remaining 855 cases were divided into two groups according to AI calculations, namely, the effective withdrawal time <6 min group ( n=615) and the effective withdrawal time ≥6 min group ( n=240), and the differences in the overall detection rate of adenoma and polyp were compared and analyzed. Results:The accuracy of AI automatic calculation system for effective withdrawal time reached 92.1% (82/89). The overall adenoma detection rate in the group with effective withdrawal time ≥6 min was 37.5% (90/240), that in the group with effective withdrawal time <6 min was 19.0% (117/615), and the difference was statistically significant ( χ2=32.11, P<0.001). The overall polyp detection rate in the group with effective withdrawal time ≥6 min was 75.0% (180/240), and that in the group with effective withdrawal time <6 min was 45.2% (278/615), with statistical significance ( χ2=61.62, P<0.001). Conclusion:AI automatic computing system can accurately calculate the effective withdrawal time of colonoscopy, and can be used to monitor the effective withdrawal time of clinical colonoscopy. In addition, effective withdrawal time ≥6 min can effectively improve the detection rate of adenoma and polyps.

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