1.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.
2.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.
3.Exploration and effectiveness of the integration of biomedical and clinical medical education and teaching reform between China and the UK
Yun HE ; Xujun CHEN ; Jiali WANG ; Jiahe YU ; Yi YANG ; Zhijun LUO
Chinese Journal of Medical Education Research 2025;24(5):583-586
Nanchang University and Queen Mary University of London have integrated their educational and teaching advantageous resources to establish a Sino-foreign cooperative clinical medicine program in China. The program awards the degrees of Bachelor of Science in Biomedical Sciences and Bachelor of Clinical Medicine, aiming to cultivate well-rounded medical talents with both clinical and scientific research capabilities and an international perspective. By introducing biomedical courses and integrating them with basic medical courses, the program emphasizes basic knowledge, practical training, active learning, and the cultivation of scientific research skills and critical thinking ability. The evaluation parameters include academic output, innovation competitions, and the number of students pursuing graduate education. The results showed substantial increases in the number of SCI academic articles published by students in this program, the number of awards in innovation competitions, and the number of students pursuing graduate education. This program is a new attempt in the reform of medical education in China.
4.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.
5.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.
6.Exploration and effectiveness of the integration of biomedical and clinical medical education and teaching reform between China and the UK
Yun HE ; Xujun CHEN ; Jiali WANG ; Jiahe YU ; Yi YANG ; Zhijun LUO
Chinese Journal of Medical Education Research 2025;24(5):583-586
Nanchang University and Queen Mary University of London have integrated their educational and teaching advantageous resources to establish a Sino-foreign cooperative clinical medicine program in China. The program awards the degrees of Bachelor of Science in Biomedical Sciences and Bachelor of Clinical Medicine, aiming to cultivate well-rounded medical talents with both clinical and scientific research capabilities and an international perspective. By introducing biomedical courses and integrating them with basic medical courses, the program emphasizes basic knowledge, practical training, active learning, and the cultivation of scientific research skills and critical thinking ability. The evaluation parameters include academic output, innovation competitions, and the number of students pursuing graduate education. The results showed substantial increases in the number of SCI academic articles published by students in this program, the number of awards in innovation competitions, and the number of students pursuing graduate education. This program is a new attempt in the reform of medical education in China.
7.Research hotspots of prostate cancer at the international conferences on urology in 2022.
Jiahe YI ; Jiangfeng LI ; Liping XIE
Journal of Zhejiang University. Medical sciences 2023;52(2):178-184
The American Urological Association (AUA), European Association of Urology (EUA) and International Urological Society (SIU) annual meetings were held in 2022. Studies on prostate cancer reported in the meetings mainly focus on the advances of diagnostic biomarkers (such as α-2, 3-1inked sialylation of terminal N-glycan on free PSA density, SelectMDx) and imaging techniques [such as multiparametric magnetic resonance imaging, prostate specific membrane antigen(PSMA)-PET/CT], the new method for prostate biopsy, the new treatments of prostate cancer including [177Lu] Ludotadipep and DROP-IN PSMA probe, and the prognosis assessment of prostate cancer (such as AR-V7). This article provides an overview on the research hotspots of three international academic meetings.
Male
;
Humans
;
Urology
;
Positron Emission Tomography Computed Tomography/methods*
;
Prostatic Neoplasms/pathology*
;
Multiparametric Magnetic Resonance Imaging/methods*
;
Gallium Radioisotopes
8.Research and clinical primary application on 3D modeling and printing of fetal hearts based on ultrasound spatio-temporal image correlation imaging technology
Na HOU ; Yitong GUO ; Zekai ZHANG ; Yuntao CHEN ; Zhuojun MAO ; Jiahe LIANG ; Jiangpu YI ; Tiesheng CAO ; Lijun YUAN
Chinese Journal of Ultrasonography 2022;31(4):295-303
Objective:To explore the feasibility and accuracy of three-dimensional (3D) modeling methods based on ultrasound imaging data for normal and abnormal fetal cardiac structures, and to construct a methodology system for 3D printing of fetal heart based on ultrasound.Methods:A total of 93 fetuses examined in Tangdu Hospital of Air Force Military Medical University from January to December 2019 were selected. Fetal echocardiography was obtained using spatio-temporal image correlation (STIC). Ninety-three hearts were 3D modeled by blood flow modeling, blood pool modeling and cavity modeling, and printed by stereolithography technique. The data measured on the 3D digital models and 3D printed solid models were compared with the corresponding fetal echocardiographic images respectively in order to evaluate the accuracy of the modeling methods.Results:The fetal cardiac blood flow models based on Doppler flow image data showed the malformation and trend of small blood vessels. The fetal cardiac structure models printed based on blood pool modeling displayed the malformation of heart and large blood vessels. Models printed based on cavity modeling method accurately displayed valve and structural defects.For 83 normal fetal hearts, the long diameters of left and right ventricles measured on echocardiography [(15.3±1.9)mm, (13.2±1.9)mm] were compared with those measured on digital models [(15.1±1.9)mm, (12.9±1.9)mm] and 3D printed models[(15.1±1.9)mm, (13.0±1.9)mm], respectively, and there were no significant differences between any two groups of them ( P>0.05). Bland-Altman showed good consistency for all measurements within and between operators. Conclusions:The three modeling methods, including blood flow modeling, blood pool modeling and cavity modeling, have their own advantages in displaying different types of fetal heart malformations. Appropriate modeling methods should be selected for 3D modeling and printing to make up for the limitations of single modeling method. The consistency between measurements on 3D models and those on echocardiography is high, and the repeatability between operators is good.
9.Relationships between tau and brain atrophy in Alzheimer′s disease based on 18F-THK5317 PET/MR
Liping FU ; Xiaojun ZHANG ; Teng XIE ; Ruimin WANG ; Fang YI ; Jinming ZHANG ; Luning WANG ; Hengge XIE ; Baixuan XU ; Jiahe TIAN
Chinese Journal of Nuclear Medicine and Molecular Imaging 2021;41(6):321-326
Objective:To investigate the neuroimaging relationship between tau protein deposition and brain atrophy, and assess their relationships with cognitive decline in Alzheimer′s disease (AD) patients.Methods:From April 2017 to October 2019, 26 AD patients (12 males, 14 females, age (70.7±12.2) years) and 19 cognitively normal controls (CN; 9 males, 10 females, age (65.6±8.1) years) in Chinese PLA General Hospital were retrospectively enrolled. All subjects received (S)-6-[(3- 18F-fluoro-2-hydroxy)propoxy]-2-(4-methylaminophenyl)quinoline ( 18F-THK5317) PET/MR and the standardized uptake value ratio (SUVR) and gray matter volume (GMV) were measured. General linear model (GLM) was used to evaluate the differences of SUVR and GMV between two groups. Pearson correlation analysis was used to assess the relationships between SUVR and GMV, and relationships of SUVR and GMV with Mini-Mental State Examination (MMSE) scores in AD patients. Results:Compared with CN, the AD patients showed significantly increased 18F-THK5317 retention in lateral temporal, frontal, posterior cingulated/precuneus and occipital cortex with significant differences of SUVR between two groups (2.18±0.54 vs 1.78±0.09, 2.13±0.50 vs 1.82±0.06, 2.03±0.45 vs 1.69±0.08, 2.18±0.57 vs 1.76±0.10, t values: 2.58-6.57, all P<0.001). The AD patients also showed decreased GMV in medial temporal, posterior cingulated/precuneus and orbitofrontal cortex ( t values: 3.67-8.85, all P<0.001). In AD patients, SUVR was negatively associated with GMV in bilateral lateral temporal cortex, pre-frontal cortex and orbital frontal cortex ( r values: from -0.52 to -0.43, all P<0.05). Both SUVR ( r=-0.599, P=0.001) and GMV ( r=0.443, P=0.023) were significantly correlated with MMSE scores in AD patients. Conclusion:AD patients have neocortical 18F-THK5317 abnormal uptake and GMV reduction, which are significantly correlated with cognitive decline.
10.Recombinant human thyrotropin-aided radioiodine treatment of differentiated thyroid carcinoma
Yong DING ; Yahong LONG ; Jialiu XING ; Jiahe TIAN ; Baixuan XU ; Yi FANG
Chinese Journal of Endocrinology and Metabolism 2011;27(6):463-466
Objective To observe the influence of recombinant human thyrotropin(rhTSH)on serum concentration of endogenous thyrotropin(TSH), free triiodothyronine(FT3), free thyroxine(FT4), thyroglobulin antibody(TGAb), and thyroglobulin(Tg). To evaluate the efficacy of rhTSH-aided radioiodine treatment in patients with differentiated thyroid carcinoma(DTC). Methods The study recruitment took place between November 2007 and March 2009. 62 patients(including 45 females)with biopsy confirmed DTC had undergone total or nearly total thyroidectomy, and received 131I treatment. 31 patients(including 22 females), median age of 45 years(23-72), received radioiodine treatment 4 weeks after L-thyroxine(T4)withdrawal. The other 31 patients(including 23 females), median age of 44 years(14-70), underwent rhTSH-aided radioiodine treatment. Before and after rhTSH injection, serum TSH, FT3, FT4, TGAb, and thyroglobulin were tested. Post-radiotherapy whole body scan was performed 5 to 7 days after radioiodine treatment and qualitatively and blindly evaluated by two nuclear medicine physicians. Follow-up took place 6 to 12 months after radioiodine treatment. The efficacy of rhTSH-aided radioiodine treatment was evaluated by whole body scan with diagnostic dose radioiodine. SPSS 13.0 statistical software was applied. Results (1)Before and after rhTSH-aided radioiodine treatment, the serum TSH was(1.08±4.01)vs(140.26±27.20)mIU/L(P<0.05), thyroglobulin(23.75±132.92)vs(169.58±178.49)μg/L(P<0.05), FT3(4.52±1.16)vs(4.42±1.11)pmol/L(P>0.05), and FT4(15.09±5.83)vs(13.66±5.85)pmol/L(P>0.05),respectively.(2)rhTSH-aided radioiodine ablation treatment had the same effect as L-T4withdrawal aided. The complete response ratio was 77.4% vs 71.0%(P>0.05)by radioiodine whole body scan of diagnostic dose. Conclusion rhTSH-aided radioiodine treatment of DTC was effective and safe, and did at least at equivalent degree as did L-T4withdrawal. Furthermore, Serum thyroglobulin level could be effectively stimulated by rhTSH with tumor relapse or metastasis.

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