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.Rapid measurement method for 137Cs in seawater and its preliminary application
Zeshu LI ; Fei TUO ; Qiang ZHOU ; Baolu YANG ; Weiguo ZHU ; Juncheng LIANG
Chinese Journal of Radiological Medicine and Protection 2025;45(2):116-121
Objective:To establish a highly-sensitive method for the rapid measurement of 137Cs in seawater with an view to its preliminary application in eight coastal provinces of China. Methods:The method employed nickel potassium polyacrylonitrile (KNiFC-PAN), an organic polymer-based ion exchanged resin material, to filter and adsorb 137Cs from seawater at a rate of 60 ml/min via a peristaltic pump. The adsorption efficiency of KNiFC-PAN was determined by measuring the cesium ion concentration before and after adsorption in seawater, with the addition of stable cesium, using inductively coupled plasma mass spectrometry (ICP-MS). Three KNiFC-PAN matrix components of 137Cs standard samples were prepared for the efficiency calibration of well type high purity germanium gamma spectrometer to obtain its detection efficiency. Results:The established measuring method can complete the filtration and adsorption of 137Cs from 20 L seawater within 6-8 h, which was twice as fast as the co-precipitation method with phosphomolybdic acid-ammonium molybdate taking more than 12 h, as stipulated in the GB/T 16145-2022 standard. The cesium recovery rate was as high as 98.02%. The relative standard deviation of the efficiency calibration result for the three prepared standard samples was 1.30%, and the detection limit for 137Cs was 0.26 Bq/m 3. The activity concentrations of 137Cs in offcoast seawater in eight coastal provinces of China were detected ranging from 0.38 to 1.24 Bq/m 3. The activity concentration of 137Cs in coastal seawater of China was at the background level, while as reported in 2019 was 0.03-1.92 Bq/m 3 in the eastern Chinese seas and 1-2 Bq/m 3 in the Pacific Ocean. Conclusions:This method has high detection sensitivity and can quickly obtain the values of activity concentration of 137Cs in seawater, thus providing a rapid and feasible method for emergency monitoring of 137Cs in China.
3.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.
4.Association of depressive and anxiety symptoms with physical activity patterns in boarding and non boarding high school students
WANG Chen, LI Aiqin, LUO Shuaicheng, XIN Jian, YANG Maolin, ZHU Juncheng
Chinese Journal of School Health 2025;46(10):1459-1464
Objective:
To examine differences in depressive and anxiety symptoms between boarding and non boarding high school students and their associations with physical activity (PA) patterns, so as to provide evidence to inform adolescent mental health promotion.
Methods:
From October to December 2024, a convenience sample of 11 782 students aged 15-18 years was recruited from 36 schools in Nanchang, Ganzhou, and Shangrao of Jiangxi Province. Depressive and anxiety symptoms and PA were assessed using the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and International Physical Activity Questionary Short Form (IPAQ-SF). Logistic regression model was used to examine associations between PA patterns, depressive and anxiety symptoms among boarding and non boarding students.
Results:
The detection rates of depressive symptoms were 45.7% and 46.4% among boarding and non boarding students, respectively; for anxiety symptoms, the corresponding rates were 43.0% and 46.7%. Boarding and non boarding students differed significantly in smoking status, screen time, sleep duration, sedentary time, daily vegetable intake, and napping ( χ 2=16.74-664.17, all P <0.01). Across PA pattern groups, the detection rates of depressive and anxiety symptoms differed significantly between boarding and non boarding students ( χ 2 depression = 23.85 , χ 2 anxiety = 22.78, both P <0.01). Adjusted for confounding factors, Logistic regression analysis of high school students showed that compared with the not meeting PA recommendations, both the concentrated and regular PA pattern were associated with lower odds of depressive symptoms [ OR (95% CI )=0.83(0.70-0.98), 0.90(0.83-0.98)]; and the concentrated pattern was also associated with lower odds of anxiety symptoms [ OR (95% CI )=0.78(0.65-0.92)], and the association of anxiety symptoms in concentrated boarding students was consistent with that of the overall group [ OR (95% CI )=0.71(0.52-0.98)] (all P <0.05).
Conclusions
There is a correlation of different physical activity patterns with depressive and anxiety symptoms among boarding and non boarding high school students. Schools should ensure students engage in regular physical activity and work to increase overall activity volume.
5.Value of CT with 3D reconstruction technique in diagnosis and selecting surgical methods for elderly patients with pituitary tumor
Peng JIANG ; Peng ZUO ; Xin WANG ; Juncheng YANG ; Li DING
China Medical Equipment 2025;22(8):67-71
Objective:To explore the clinical value of computed tomography(CT)with three-dimensional(3D)reconstruction technique in diagnosis and selecting surgical methods for patients with pituitary tumor.Methods:A retrospective analysis was performed on the clinical data of 82 elderly patients with suspected pituitary tumor at Huanggang Central Hospital between January 2021 and December 2023.All of patients underwent CT examination with 3D reconstruction technique and MRI examination.The postoperatively pathological results were used as the golden standard to compare the diagnostic results and efficiency of CT with 3D reconstruction technique and MRI for pituitary tumor.The differences of the two examination methods were compared in images quality.The clinical value of CT with 3D reconstruction technique for the selection of surgical method was further analyzed.Results:In 82 elderly patients with suspected pituitary tumor,56 cases were confirmed by postoperatively pathological examination,and 49 cases were confirmed by CT with 3D reconstruction technique,and 60 cases were confirmed by MRI.The characteristics of CT imaging were:quasi-circular or circular tumors were the majority,which had clear boundaries,and tumors grew to the side of sella turcica and around of the sella turcica,which accompanied by enlarged pituitary fossa.MRI imaging characteristics of pituitary tumors were as follows:the most of them accompanied with equal T1 and slightly high T2 signals,and there was enhancement of obvious ring,and the snowman sign.There was no significant difference in diagnostic accuracy between CT with 3D reconstruction technique and MRI(P>0.05).The diagnostic specificity of CT with 3D reconstruction technique was 96.15%,which was higher than 76.92%of MRI,while its sensitivity was 85.71%,which was lower than 96.43%of MRI,and the differences were statistically significant(x2=4.413,3.953,P<0.05).There were no significant differences in the maximum transverse diameter and maximum vertical diameter of tumors between CT with 3D reconstruction technique and MRI(P>0.05).Compared with the results of CT with 3D reconstruction technique,all of 56 patients with pituitary tumor adopted resection for pituitary tumor through nasal sphenoid approach.After surgery,2 cases occurred diabetes insipidus,and 1 case occurred intracranial infection and 1 case occurred decline in olfactory function.Conclusion:Both CT with 3D reconstruction technique and MRI have higher diagnostic value for pituitary tumors in the elderly,which can display characteristics of pituitary tumors,and have direct guidance roles for the selection of surgical methods.The diagnostic specificity of CT with 3D reconstruction technique is better.
6.Efficacy and safety of hepatic arterial infusion chemotherapy plus bevacizumab with sintilimab vs.atezolizumab in advanced hepatocellular carcinoma
Xiang TANG ; Zhoutian YANG ; Li HU ; Wei PENG ; Zhiwei YE ; Dandan HU ; Juncheng WANG ; Yaojun ZHANG
Chinese Journal of General Surgery 2025;34(7):1382-1389
Background and Aims:In recent years,with the continuous progress of systemic therapy,hepatic arterial infusion chemotherapy(HAIC)combined with immune checkpoint inhibitors and anti-angiogenic agents has demonstrated significant efficacy in the treatment of advanced hepatocellular carcinoma(HCC).However,direct comparisons between different immunotherapeutic targets,such as PD-1 and PD-L1 inhibitors,in terms of clinical benefit and safety remain limited.This study aimed to compare the efficacy and safety of HAIC plus bevacizumab and sintilimab(HAIC-BP1)versus HAIC plus bevacizumab and atezolizumab(HAIC-BPL)in advanced HCC.Methods:A retrospective analysis was conducted on 88 patients with advanced HCC who received first-line HAIC-BP1or HAIC-BPL at Sun Yat-sen University Cancer Center between January 2020 and December 2022.Progression-free survival(PFS),overall survival(OS),objective response rate(ORR),disease control rate(DCR),and adverse events(AEs)were compared between the two groups.Cox regression analysis was performed to identify prognostic factors affecting PFS.Results:A total of 47 patients were included in the HAIC-BP1 group and 41 patients in the HAIC-BPL group,with no statistically significant differences in baseline characteristics between the two groups(all P>0.05).The ORR(59.6%vs.65.9%)and DCR(72.3%vs.80.5%)did not significantly differ between the HAIC-BP1 group and the HAIC-BPL group(both P>0.05).After a median follow-up of 16.3 months,there were no significant differences in median OS(21.3 months vs.22.4 months)or median PFS(6.7 months vs.6.2 months)between the HAIC-BP1 group and the HAIC-BPL group(both P>0.05).The incidence of AEs was similar,and no treatment-related deaths occurred.Multivariate Cox regression analysis identified tumor diameter>10 cm as an independent adverse prognostic factor for PFS(HR=0.48,95%CI=0.27-0.83,P=0.009).Conclusion:Both HAIC-BP1 and HAIC-BPL demonstrated comparable efficacy and favorable safety profiles as first-line treatment options for advanced HCC.Tumor diameter>10 cm was an independent unfavorable prognostic factor for PFS,underscoring the importance of patient stratification in clinical decision-making.
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.Rapid measurement method for 137Cs in seawater and its preliminary application
Zeshu LI ; Fei TUO ; Qiang ZHOU ; Baolu YANG ; Weiguo ZHU ; Juncheng LIANG
Chinese Journal of Radiological Medicine and Protection 2025;45(2):116-121
Objective:To establish a highly-sensitive method for the rapid measurement of 137Cs in seawater with an view to its preliminary application in eight coastal provinces of China. Methods:The method employed nickel potassium polyacrylonitrile (KNiFC-PAN), an organic polymer-based ion exchanged resin material, to filter and adsorb 137Cs from seawater at a rate of 60 ml/min via a peristaltic pump. The adsorption efficiency of KNiFC-PAN was determined by measuring the cesium ion concentration before and after adsorption in seawater, with the addition of stable cesium, using inductively coupled plasma mass spectrometry (ICP-MS). Three KNiFC-PAN matrix components of 137Cs standard samples were prepared for the efficiency calibration of well type high purity germanium gamma spectrometer to obtain its detection efficiency. Results:The established measuring method can complete the filtration and adsorption of 137Cs from 20 L seawater within 6-8 h, which was twice as fast as the co-precipitation method with phosphomolybdic acid-ammonium molybdate taking more than 12 h, as stipulated in the GB/T 16145-2022 standard. The cesium recovery rate was as high as 98.02%. The relative standard deviation of the efficiency calibration result for the three prepared standard samples was 1.30%, and the detection limit for 137Cs was 0.26 Bq/m 3. The activity concentrations of 137Cs in offcoast seawater in eight coastal provinces of China were detected ranging from 0.38 to 1.24 Bq/m 3. The activity concentration of 137Cs in coastal seawater of China was at the background level, while as reported in 2019 was 0.03-1.92 Bq/m 3 in the eastern Chinese seas and 1-2 Bq/m 3 in the Pacific Ocean. Conclusions:This method has high detection sensitivity and can quickly obtain the values of activity concentration of 137Cs in seawater, thus providing a rapid and feasible method for emergency monitoring of 137Cs in China.
9.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.
10.Efficacy and safety of hepatic arterial infusion chemotherapy plus bevacizumab with sintilimab vs.atezolizumab in advanced hepatocellular carcinoma
Xiang TANG ; Zhoutian YANG ; Li HU ; Wei PENG ; Zhiwei YE ; Dandan HU ; Juncheng WANG ; Yaojun ZHANG
Chinese Journal of General Surgery 2025;34(7):1382-1389
Background and Aims:In recent years,with the continuous progress of systemic therapy,hepatic arterial infusion chemotherapy(HAIC)combined with immune checkpoint inhibitors and anti-angiogenic agents has demonstrated significant efficacy in the treatment of advanced hepatocellular carcinoma(HCC).However,direct comparisons between different immunotherapeutic targets,such as PD-1 and PD-L1 inhibitors,in terms of clinical benefit and safety remain limited.This study aimed to compare the efficacy and safety of HAIC plus bevacizumab and sintilimab(HAIC-BP1)versus HAIC plus bevacizumab and atezolizumab(HAIC-BPL)in advanced HCC.Methods:A retrospective analysis was conducted on 88 patients with advanced HCC who received first-line HAIC-BP1or HAIC-BPL at Sun Yat-sen University Cancer Center between January 2020 and December 2022.Progression-free survival(PFS),overall survival(OS),objective response rate(ORR),disease control rate(DCR),and adverse events(AEs)were compared between the two groups.Cox regression analysis was performed to identify prognostic factors affecting PFS.Results:A total of 47 patients were included in the HAIC-BP1 group and 41 patients in the HAIC-BPL group,with no statistically significant differences in baseline characteristics between the two groups(all P>0.05).The ORR(59.6%vs.65.9%)and DCR(72.3%vs.80.5%)did not significantly differ between the HAIC-BP1 group and the HAIC-BPL group(both P>0.05).After a median follow-up of 16.3 months,there were no significant differences in median OS(21.3 months vs.22.4 months)or median PFS(6.7 months vs.6.2 months)between the HAIC-BP1 group and the HAIC-BPL group(both P>0.05).The incidence of AEs was similar,and no treatment-related deaths occurred.Multivariate Cox regression analysis identified tumor diameter>10 cm as an independent adverse prognostic factor for PFS(HR=0.48,95%CI=0.27-0.83,P=0.009).Conclusion:Both HAIC-BP1 and HAIC-BPL demonstrated comparable efficacy and favorable safety profiles as first-line treatment options for advanced HCC.Tumor diameter>10 cm was an independent unfavorable prognostic factor for PFS,underscoring the importance of patient stratification in clinical decision-making.


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